Welcome New Members

• Edenbridge Pharmaceuticals, LLC
• EmphyCorp, Inc.

 Learn more at www.BioNJ.org/Membership.

Statement by BioNJ President and CEO Debbie Hart

In response to the World Trade Organization Ministerial Conference Decision to Endorse a COVID-19 Vaccine Intellectual Property Waiver

“The decision by the World Trade Organization (WTO) Ministerial Conference (MC12) to endorse a COVID-19 vaccine intellectual property waiver threatens to dismantle the foundation of innovation and weaken our ability to end the current pandemic and respond to future ones. Waiving IP protections for COVID-19 vaccines that showcase the very best of the biopharmaceutical sector, including the companies that call New Jersey home, will not guarantee more effective distribution of vaccines abroad and could undermine the standards for these drugs and the supply chain that has demonstrated efficacy during the pandemic. Instead, we must work together to overcome global vaccine hesitancy and strengthen local healthcare systems to make certain that new medical breakthroughs get to Patients around the world…Because Patients Can’t Wait.”

A New JAMA Study Misleads About Drug Prices—And Launches a New Attack on Patients With Ultra-Rare Diseases

The authors of a new JAMA study claimed that “prices for new drugs are skyrocketing.” However, the study’s headline conclusion is highly misleading. The authors obscure the real story with mathematical sleight-of-hand that misrepresents the underlying data and overlooks the true nature of today’s pharmaceutical innovations. Some important points to consider:

• Authors discount the fact that the most expensive new drugs treat ultra-rare conditions affecting extraordinarily small patient populations.
• Authors made a misleading decision by creating an equally weighted price index of all new drugs that happened to be approved in a given year. Each product approved in a given year had the same contribution in that year’s average, regardless of utilization (population treated, number of prescriptions, etc.).
• That’s simply not the correct way to calculate an accurate price index. This method wildly overstates average prices, by overweighting costly new drugs that treat ultra-rare conditions in limited populations.
• Expensive drugs for ultra-rare conditions have a minimal impact on overall drug spending, despite their headline-grabbing price tags.

New Poll Shows Voters Sounding the Alarm on Health Insurance Companies and PBMs

Many Americans battle with an illness every day, but unfortunately for some, their illness is not the only battle they face. A recent Morning Consult/PhRMA poll of 2,004 registered voters shows that Americans are frustrated by the hurdles imposed by insurance companies and pharmacy benefit managers (PBMs) that can stand between them and their medicines, and they want lawmakers to advance solutions that increase transparency and require insurance companies and PBMs to share rebates or discounts they receive directly with patients to lower out-of-pocket costs at the pharmacy counter.

In Comments to Federal Agency, PhRMA Warns of the Growing Influence of Middlemen Over Patient Access and Out-Of-Pocket Costs for Prescription Medicines

In comments submitted to the Federal Trade Commission (FTC), PhRMA urged the agency to examine how pharmacy benefit managers (PBMs) leverage their extraordinary power to maximize profits, often in ways that harm patients. PhRMA's letter urges the FTC to conduct a rigorous analysis to better understand the market power of PBMs, identify conflicts of interest, and address the harms PBMs cause to patients and competition in the health care system.

Opinion: Innovation is Driving Breakthroughs in Health Care

A Letter to the Editor by Debbie Hart, President & CEO, BioNJ

Regarding Washington Post article “Cancer Drug Trial Success has Researchers Wondering What Will Come Next”

The outcome of a new colorectal cancer study in which 100 percent of patients who received treatment were cleared of the condition serves as the latest reminder of how innovation in health care is driving significant medical breakthroughs.

Medicines are helping patients live healthier lives by treating and curing diseases once thought to be a virtual death sentence. As of 2019, there were an estimated 16.9 million cancer survivors living in the United States, a number that is projected to grow to more than 22.1 million by 2030. Death rates from cancer fell 31 percent from 1991 to 2018, while overall U.S. life expectancy increased in 2018 in large part because of rapid advancements in cancer treatment. While still early in the clinical trial process, the colorectal cancer study gives us even greater hope that existing treatments in development can soon eradicate the disease, as well as fuel new treatments for other cancers.

It is because of an ecosystem that fosters medical advances that patients can have hope for a disease-free future. We must continue to foster a policy environment that values innovation, incentivizes further development of lifesaving treatments and drives scientific research and innovation, because patients can’t wait.

NJ Health Commissioner on Pandemic Leadership, Partnerships & Innovation

Discussing the importance of leadership, partnerships and innovation throughout the COVID-19 pandemic, New Jersey Health Commissioner Judith Persichilli graciously accepted the Sol J. Barer Award at BioNJ’s 29th Annual Dinner Meeting and Innovation Celebration. Overseeing the State’s health care system, and with a core mission of helping people in New Jersey live long healthy lives, Persichilli said that mission-driven leadership, rooted in a foundation of strong values “is the engine that inspires all of us. … That is what I experienced repeatedly throughout the pandemic. … I worked through the AIDS epidemic, the anthrax scare, the Ebola threat and the measles outbreak, but never experienced anything like [COVID]. We needed to be overprepared and told hospitals to stop all elective admissions, double their ICU bed capacities, set up tents outside of their facilities to isolate patients. … I was asking hospital CEOs to do something unfathomable; to basically set up a war zone,” Persichilli recalled.

NJ’s Burgeoning Biotech Industry

New Jersey’s biotechnology cluster has grown from a mere 30 companies in the early 1990s to approximately 3,200 establishments in the State today, with 46 of those firms responsible for a staggering 70 new FDA drug approvals between 2020 and 2021, according to the trade association BioNJ. And several sources indicate that despite recent IPO and capital market challenges, the biotech cluster’s ascension continues. Debbie Hart, President and CEO of BioNJ, says of the overall U.S./global biotech community: “The science is advancing by leaps and bounds, and it’s creating lots of opportunities, new companies and new advances in therapies and treatments. When you look at what happened during the [coronavirus] pandemic – how the industry can really save the world – [it’s] not an understatement. It just speaks to ability and the science.”

BioNJ Celebrates NJ’s Medical Innovation at Annual Dinner

In what felt like a return to normalcy, last Thursday evening at the Hilton East Brunswick at its 29th Annual Dinner Meeting & Innovation Celebration, BioNJ shined a spotlight on the unprecedented medical innovation that has emerged from the Garden State during the pandemic. “It’s hard to believe that it has been more than two years since our last in-person Annual Dinner Meeting on Feb. 4, 2020,” said BioNJ CEO and President Debbie Hart. “To say the last two years have been tumultuous is an understatement. Despite the tumult, with 70 new FDA drug approvals coming from companies with a footprint in New Jersey over the last two years – account for 40% of ALL new approvals – our great state continued to lead the way in helping patients live longer, better lives. We were pleased to celebrate their innovation in this way.” The annual event, which brought out a who’s who in New Jersey’s life sciences community, was dedicated to “Patients…Because they just can’t wait.”

PTC Therapeutics Signs 360K-Square-Foot Lease to Move HQ to Warren

Biopharmaceutical company and BioNJ Member PTC Therapeutics will move its global headquarters from South Plainfield to Warren signing a long-term, 360,000-square-foot lease with the the Warren Corporate Center. PTC will occupy a new facility at the park. The agreement spans two full buildings and will include offices, collaboration and conference spaces and research laboratories upon completion. “Our new headquarters allows us to have a Class A facility for our growing team, while keeping the new flexible work paradigm in mind,” said PTC Vice President of Global Facilities Doug McLeester. “As PTC grows into one of the world’s leading rare disease companies, our in-house capabilities must similarly grow and adapt.

SCYNEXIS Announces Submission of Supplemental New Drug Application of BREXAFEMME® (ibrexafungerp tablets) to the U.S. Food and Drug Administration for an Expanded Indication for the Prevention of Recurrent Vaginal Yeast Infections

Jersey City-based BioNJ Member SCYNEXIS announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) of an additional indication for BREXAFEMME® (ibrexafungerp tablets) for the prevention of recurrent vulvovaginal candidiasis (RVVC). BREXAFEMME, approved by the U.S. FDA in June 2021 for the treatment of vulvovaginal candidiasis (VVC), is a novel class of antifungal and the first and only oral fungicidal treatment that can cure a vaginal yeast infection in adults and postmenarchal pediatric patients. If approved for the additional indication, BREXAFEMME would be the first and only oral non-azole treatment for the prevention of recurrent yeast infections, defined as three or more episodes of VVC in the previous 12 months.

Genmab Announces Late-Breaking Phase 2 Trial Results of Investigational Epcoritamab (DuoBody®-CD3xCD20) in Relapsed/Refractory Large B-cell Lymphoma (LBCL) Patients Presented at European Hematology Association (EHA) Presidential Symposium

Princeton-based BioNJ Member Genmab announced primary results from the large B-cell lymphoma (LBCL) expansion cohort in the EPCORE™ NHL-1 Phase 2 clinical trial evaluating subcutaneous epcoritamab (DuoBody®-CD3xCD20), an investigational bispecific antibody. In the study, treatment with epcoritamab demonstrated deep and durable responses with an overall response rate (ORR) of 63 percent and a complete response rate (CR) of 39 percent in patients who had previously received at least two prior lines of systemic anti-lymphoma therapy. Additionally, patients naïve to treatment with chimeric antigen receptor (CAR) T-cell therapy achieved 69 percent ORR and 42 percent CR and patients previously treated with CAR T achieved a 54 percent ORR and 34 percent CR. 

Tevogen Bio Initiates Final Dose Level in Proof-of-Concept Clinical Trial of its Investigational T cell Therapy for High-Risk COVID-19 Patients

Warren-based BioNJ Member Tevogen Bio announced it has initiated the fourth and final dose level of its investigational T cell therapy for high-risk COVID-19 patients. The open-label clinical trial is designed to study the safety and optimal dose of its investigational target-specific T cell therapy when given to high-risk COVID-19 patients (age ≥ 18 years with predefined high-risk criteria) or those who are 65 or older (with or without previously identified comorbid conditions). Participants receiving the investigational therapy will be compared to patients receiving standard of care within the context of the study. Each patient in the third cohort received a single infusion (1 x 106cells/kg) of TVGN-489, a higher dosing level than the first (1 x 105cells/kg) and second cohorts (3 x 105 cells/kg).

Taiho Oncology Announces Updated Efficacy and Safety Data for Futibatinib in Cholangiocarcinoma at ASCO Annual Meeting

Princeton-based BioNJ Member Taiho Oncology announced updated results of the Phase 2 FOENIX-CCA2 trial of futibatinib, confirming results observed in an earlier analysis. The trial was conducted in patients with locally advanced or metastatic unresectable intrahepatic (inside the liver) cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements including fusions. Each year, approximately 8,000 individuals in the U.S. are diagnosed with cholangiocarcinoma (CCA), a cancer of the bile ducts of the liver. Worldwide, approximately 0.3-6 people per 100,000 individuals live with CCA. CCA is mainly seen in people 65 years of age or older, and treatment options are limited. FGFR2 gene rearrangements, including gene fusions, which can form a hybrid gene and promote tumor proliferation, are observed more frequently in the iCCA patient population, with approximately 10-16% of patients having tumors with these rearrangements.

Longer-Term Data from CARTITUDE Program Continue to Show Deep and Durable Responses With Ciltacabtagene Autoleucel Across Lines of Therapy in Patients With Multiple Myeloma

Somerset-based BioNJ Member Legend Biotech presented new and updated results from the CARTITUDE clinical development program studying ciltacabtagene autoleucel (cilta-cel) in the treatment of multiple myeloma. Earlier data from the CARTITUDE-1 study supported recent regulatory approvals for CARVYKTITM by the U.S. Food and Drug Administration and the European Commission, and ongoing results from the multi-cohort CARTITUDE-2 study are being used to inform future trials of CARVYKTITM treatment in multiple patient populations and treatment settings. Data from the ongoing Phase 1b/2 CARTITUDE-1 study continue to show deep and durable responses in heavily pretreated patients with relapsed or refractory multiple myeloma at a median 28-month follow up (MFU), with an overall response rate (ORR) of 98 percent (95 percent Confident Interval [CI], 92.7-99.7).

ADC Therapeutics Announces Results from Pivotal Phase 2 Clinical Trial of Camidanlumab Tesirine (Cami) in Relapsed or Refractory Hodgkin Lymphoma

New Providence-based BioNJ Member ADC Therapeutics announced results from the ongoing pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami) in relapsed or refractory (r/r) Hodgkin lymphoma. An overall response rate (ORR) of 70.1% and a complete response (CR) rate of 33.3% was observed with a median duration of response of 13.7 months for all responders in r/r Hodgkin lymphoma patients who were refractory or had relapsed after a median of 6 prior treatments, including brentuximab vedotin (BV) and a PD-1 blockade. The safety profile of Cami was substantially consistent with previously reported interim findings. The Phase 2 single-arm, multicenter, open-label clinical trial is evaluating Cami in 117 patients with r/r Hodgkin lymphoma who have received ≥3 prior lines of treatment (≥2 lines if ineligible for hematopoietic stem cell transplantation, HSCT). Patients received a median of 6 prior lines of systemic therapy.

Amarin Receives Positive Recommendation from United Kingdom’s (UK) National Institute for Health and Care Excellence (Nice) for Reimbursement of Vazkepa® (Icosapent Ethyl)

Bridgewater-based BioNJ Member Amarin Corporation announced that the UK’s National Institute for Health and Care Excellence (NICE) is recommending icosapent ethyl (marketed under the brand name VAZKEPA®) for reimbursement and use across the National Health Service (NHS) in England and Wales to reduce the risk of cardiovascular (CV) events in adult statin-treated patients at high cardiovascular risk who have elevated triglycerides (≥150 mg/dL [≥ 1.7 mmol/L]), LDL-C levels >1.04 mmol/L (and ≤ 2.60 mmol/L) and established cardiovascular disease (eCVD), at a price of £144.21 per 120 soft capsules (i.e. 30-day supply; equivalent of approximately 170 EUR or 181 USD*). Cardiovascular disease ranks as one of the UK’s leading causes of death. More than six million people live with cardiovascular disease in England, costing the NHS around £7.4 billion each year.

Cornerstone Pharmaceuticals Announces Published Data on CPI-613® (Devimistat) as an Effective Approach to Targeting Carcinoma Catabolism

Cranbury-based BioNJ Member Cornerstone Pharmaceuticals announced a publication on preclinical data supporting CPI-613® (devimistat) targeting carcinoma catabolism. The study published in PLOS ONE titled, “Evidence for a novel, effective approach to targeting carcinoma catabolism exploiting the first-in-class, anti-cancer mitochondrial drug, CPI-613,” addresses the multi-target, tumor-preferential inhibition of the mitochondrial tricarboxylic acid (TCA) cycle by the first-in-class drug, devimistat. By suppressing the TCA hub, indispensable to many metabolic pathways, devimistat substantially reduces the effective redundancy of tumor catabolism. The authors of the study note that their preclinical results indicate a clearly defined, detailed, potentially general class of approaches to improved clinical targeting of carcinoma catabolism. Devimistat preferentially suppresses multiple essential components of the TCA cycle in carcinomas.

FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) As First and Only Systemic Medicine for Adults With Severe Alopecia Areata

BioNJ Member Eli Lilly and Company, with a site in Branchburg, and Incyte announced that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA), available as 4-mg, 2-mg and 1-mg tablets. The recommended dose is OLUMIANT 2-mg/day, with an increase to 4-mg/day if treatment response is inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4-mg/day. Once an adequate response is achieved on 4-mg/day, the dosage is to be decreased to 2-mg/day. 

Lilly's AWARD-PEDS Trial Investigating Use of Trulicity® (Dulaglutide) in Youth and Adolescents With Type 2 Diabetes Showed Superiority in A1C Reduction Vs Placebo

In the Phase 3 AWARD-PEDS clinical trial from BioNJ Member Eli Lilly and Company, with a site in Branchburg, Trulicity® (dulaglutide) (at 0.75 mg and 1.5 mg doses) led to superior A1C reductions at 26 weeks versus placebo in youth and adolescents (ages 10 to 17 years old) with type 2 diabetes inadequately controlled with diet and exercise, with or without metformin and/or basal insulin. The study published in the New England Journal of Medicine, met all of its primary and secondary glycemic control objectives: percent of patients achieving A1C of <7%, fasting plasma glucose (FPG) change from baseline and mean change in A1C in the individual dose groups. Significant reductions in both A1C and fasting glucose were observed through week 26 compared to placebo. Among patients treated with Trulicity (pooled data), 51.5% reached an A1C of <7% based on treatment regimen estimand.

Lilly's SURMOUNT-1 Results Published in the New England Journal of Medicine Show Tirzepatide Achieved Between 16.0% and 22.5% Weight Loss in Adults With Obesity or Overweight

Detailed results from BioNJ Member Eli Lilly and Company's Phase 3 SURMOUNT-1 clinical trial evaluating tirzepatide for the treatment of obesity or overweight were published in The New England Journal of Medicine. Tirzepatide met both co-primary endpoints of superior mean percent change in body weight from baseline and greater percentage of participants achieving body weight reductions of at least 5% compared to placebo for both estimands. For the efficacy estimand, participants taking tirzepatide achieved average weight reductions of 16.0% (35 lb. or 16 kg on 5 mg), 21.4% (49 lb. or 22 kg on 10 mg) and 22.5% (52 lb. or 24 kg on 15 mg), compared to placebo (2.4%, 5 lb. or 2 kg). Additionally, 89% (5 mg) and 96% (10 mg and 15 mg) of people taking tirzepatide achieved at least 5% body weight reductions compared to 28% of those taking placebo.

Jardiance® Decreased Relative Risk of Hospitalization for Heart Failure by 50% Versus DPP-4 Inhibitors and by 30% Versus GLP-1 Receptor Agonists in Adults With Type 2 Diabetes in Real-World Evidence Study

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced two analyses of the final U.S. data from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) real-world study show that Jardiance® (empagliflozin) was associated with a reduction in risk of hospitalization for heart failure compared with two other classes of glucose-lowering therapies in adults with type 2 diabetes in routine care. Relative risk reductions were 50% versus dipeptidyl peptidase-4 (DPP-4) inhibitors and 30% versus glucagon-like peptide 1 (GLP-1) receptor agonists. Compared with GLP-1 receptor agonists, Jardiance was associated with similar risks of heart attack, stroke and all-cause mortality. All results for Jardiance compared with GLP-1 receptor agonists, and with liraglutide (a GLP-1 receptor agonist) specifically, were consistent for people with and without cardiovascular disease.

Eight Out of Ten Patients Maintained Skin Clearance at One Year in Lilly's Lebrikizumab Atopic Dermatitis Monotherapy Trials

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced topline results from one-year analyses of the efficacy and safety of lebrikizumab, the company's investigational IL-13 inhibitor for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Additionally, patients treated with lebrikizumab maintained itch relief across the two trials over the one-year period. 

FDA Approves Dupixent® (Dupilumab) as First Biologic Medicine for Children Aged 6 Months to 5 Years With Moderate-to-Severe Atopic Dermatitis

Bridgewater-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for children aged 6 months to 5 years with moderate- to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. A regulatory filing for this age group is under review by the European Medicines Agency and submissions to regulatory authorities in additional countries are underway. Atopic dermatitis is a chronic type 2 inflammatory skin disease. Eighty-five to ninety percent of patients first develop symptoms before 5 years of age, which can often continue through adulthood. 

Sanofi-GSK Next-Generation COVID-19 Booster Delivers Strong Immune Response Against Variants of Concern, Including Omicron

Bridgewater-based BioNJ Member Sanofi reported data from two trials, VAT02 Cohort 2 and COVIBOOST VAT013, conducted with its new next-generation COVID-19 booster vaccine candidate modelled on the Beta variant antigen and including BioNJ Member GSK’s pandemic adjuvant. In the Phase 3 VAT02 Cohort 2 study, the Sanofi-GSK next-generation vaccine candidate induced (at day 15 post-immunization) a significant boost in antibody titers above baseline against multiple variants of concern (15-fold increase against D614 parent virus, 30-fold increase against Beta strain) in adults previously primed with mRNA COVID-19 vaccines. In particular against Omicron, preliminary data show a 40-fold increase against BA.1. The Sanofi-GSK next-generation booster candidate generated double the number of neutralizing antibodies against Omicron BA.1 and BA.2 compared to the D614-based (original parent virus) booster.

Three-Year Data from Phase 3 CheckMate -9LA Trial Demonstrate Long-Term, Durable Survival Outcomes of Opdivo (nivolumab) Plus Yervoy (ipilimumab) With Two Cycles of Chemotherapy for Patients With Metastatic Non-Small Cell Lung Cancer

Princeton-based BioNJ Member Bristol Myers Squibb announced three-year follow-up results from the Phase 3 CheckMate -9LA trial demonstrating durable survival benefits with Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy compared to four cycles of chemotherapy in previously untreated patients with metastatic non-small cell lung cancer (mNSCLC). With a minimum follow-up of three years (36.1 months), the dual immunotherapy-based combination continued to show sustained improvement in overall survival (OS), the trial’s primary endpoint, with 27% of patients treated with Opdivo plus Yervoy with two cycles of chemotherapy alive compared to 19% of patients treated with chemotherapy alone at three years (Hazard Ratio [HR] 0.74; 95% Confidence Interval [CI]: 0.62 to 0.87).

Landmark Five-Year Data from Phase 3 CheckMate -227 Trial Demonstrate Long-Term, Durable Survival Outcomes With Opdivo(nivolumab) Plus Yervoy (ipilimumab) in First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer

Princeton-based BioNJ Member Bristol Myers Squibb announced five-year results from Part 1 of the Phase 3 CheckMate -227 trial, which continues to demonstrate long-term, durable survival benefits of first-line treatment with Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to chemotherapy in patients with metastatic non-small cell lung cancer (mNSCLC), regardless of PD-L1 expression levels. “With these results from CheckMate -227, we’ve now seen substantial increases in five-year survival rates compared to historical expectations with the dual immunotherapy combination in metastatic lung cancer and melanoma, and in advanced renal cell carcinoma, bringing hope for improved long-term outcomes for patients across numerous types of cancer,” said Abderrahim Oukessou, M.D., Vice President, Thoracic Cancers Development Lead, Bristol Myers Squibb.

Novo Nordisk A/S: Sogroya® Data Show Potential as Once-Weekly Treatment in Children Living With Growth Hormone Deficiency

Plainsboro-based BioNJ Member Novo Nordisk announced results of once-weekly Sogroya® (somapacitan) injection in helping children achieve growth targets of annualised height velocity (AHV). “We are excited about the REAL 4 Phase 3 study results showing that the weekly use of Sogroya® worked as well as daily treatment with Norditropin® (somatropin) injection,” said Martin Lange, Executive Vice President and Dead of Development at Novo Nordisk. “Sogroya® shows Novo Nordisk’s commitment to the rare endocrine community and our continued vision to deliver innovative therapeutic solutions for all patient needs.” GHD is a rare disease, estimated to affect approximately 1 in 3,500 to 10,000 children. Symptoms often start early in life, leading to short stature as well as other growth-related health complications.

Boehringer Ingelheim and CarthroniX Announce Partnership to Pursue Small Molecule Therapeutics in Canine Oncology

Boehringer Ingelheim, with a site in North Brunswick, and CarthroniX announce that they have entered into a research collaboration to pursue small molecule therapeutics in canine oncology. When it comes to the treatment of cancer in dogs, veterinarians have limited therapeutic options compared to other areas. Due to this unmet medical need, Boehringer Ingelheim is committed to oncology research in animal health. Under the agreement, Boehringer Ingelheim will test a select group of small molecules provided by CarthroniX with the goal of determining their impact on canine cancers. 

Merck and Ridgeback Announce New Data for Investigational LAGEVRIO™ (molnupiravir) from Phase 3 MOVe-OUT Study

Kenilworth-based BioNJ Member Merck & Co. and Ridgeback Biotherapeutics announced the Annals of Internal Medicine has published additional data from the Phase 3 MOVe-OUT trial evaluating LAGEVRIO™ (molnupiravir), an investigational oral antiviral medicine, in non-hospitalized adults with mild to moderate COVID-19 who were at high risk for progressing to severe disease. Analyses of pre-specified exploratory endpoints indicate that a lower proportion of LAGEVRIO-treated participants in the modified intent-to-treat (MITT) population had an acute care visit or a COVID-19-related acute care visit versus placebo-treated participants in the MITT population: 7.2% of participants who received LAGEVRIO reported an acute care visit through Day 29, versus 10.6% of placebo participants, with a relative risk reduction [RRR] of 32.1% [CI, 4.4% to 51.7%]; 6.6% of participants who received LAGEVRIO reported a COVID-19-related acute care visit, versus 10.0% of placebo participants, with a RRR of 33.8% [CI, 5.6% to 53.6%].

Adjuvant Treatment With Merck’s KEYTRUDA® (pembrolizumab) Demonstrates Statistically Significant & Clinically Meaningful Improvement in Distant Metastasis-Free Survival in Patients With Resected Stage IIB or IIC Melanoma in Phase 3 KEYNOTE-716 Trial

Kenilworth-based BioNJ Member Merck & Co. announced distant metastasis-free survival (DMFS) results from the Phase 3 KEYNOTE-716 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, versus placebo as adjuvant therapy for patients with resected stage IIB or IIC melanoma. With a median follow-up of 27.4 months, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in DMFS versus placebo (HR=0.64 [95% CI, 0.47-0.88]; p=0.0029). Median DMFS was not reached in either arm. In the study, the safety profile of KEYTRUDA was consistent with previously reported studies in patients with solid tumors, and no new safety signals were observed at the time of DMFS analysis. Treatment-related adverse events Grade 3 or higher were observed in 17% of patients receiving KEYTRUDA versus 5% of patients receiving placebo. 

FDA Accepts Application for Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Stage IB (≥4 centimeters)-IIIA Non-Small Cell Lung Cancer Following Complete Surgical Resection

Kenilworth-based BioNJ Member Merck & Co. announced the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA for the adjuvant treatment of patients with stage IB (≥4 centimeters), II or IIIA non-small cell lung cancer (NSCLC) following complete surgical resection. The sBLA is based on data from the pivotal Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS, conducted in collaboration with the European Organization for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP). The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of January 29, 2023.

Myovant Sciences and Pfizer Announce Publication in The Lancet of Phase 3 SPIRIT 1 and SPIRIT 2 Studies of Once-Daily Relugolix Combination Therapy in Women With Endometriosis-Associated Pain

BioNJ Member Pfizer, with a site in Peapack, and Myovant Sciences announced that results of the Phase 3 SPIRIT 1 and SPIRIT 2 studies of investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in over 1,200 women with moderate to severe pain associated with endometriosis were published in The Lancet. As previously reported, both studies achieved their co-primary endpoints by demonstrating clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain in women with endometriosis. SPIRIT 1 and 2 each met their co-primary endpoints with 75% of women in the relugolix combination therapy group in both studies achieving a clinically meaningful reduction in dysmenorrhea compared with 27% and 30% of women in the placebo groups at Week 24, respectively (both p < 0.0001).

Pfizer and BioNTech Provide Update on Rolling Submission to European Medicines Agency for a Potential Variant-Adapted Vaccine

BioNJ Member Pfizer, with a site in Peapack, and BioNTech SE announced the European Medicines Agency (EMA) has initiated a rolling review for a variant-adapted version of the companies’ COVID-19 vaccine. This rolling review is initially based on chemistry, manufacturing and controls (CMC) data shared with EMA earlier this month. As clinical data become available, including data on immunogenicity against Omicron and its subvariants, it will be added to the rolling submission. The companies also plan to begin the submission of data supporting a potential variant-adapted vaccine to the U.S. Food and Drug Administration (FDA) in the coming weeks. Pfizer and BioNTech are evaluating several variant-adapted vaccines.

Pfizer Completes Acquisition of ReViral

BioNJ Member Pfizer, with a site in Peapack, announced the successful completion of its acquisition of ReViral, a privately held, clinical-stage biopharmaceutical company focused on discovering, developing and commercializing novel antiviral therapeutics that target respiratory syncytial virus (RSV). ReViral brings to Pfizer a portfolio of promising therapeutic candidates, including sisunatovir, an orally administered inhibitor designed to block fusion of the RSV virus to the host cell. Sisunatovir has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). It significantly reduced viral load in a Phase 2 RSV human challenge study in healthy adults and is currently in phase 2 clinical development in infants. 

Pfizer Presents First Data from Planned Interim Analysis of Pivotal Phase 2 MagnetisMM-3 Trial of BCMA-CD3 Bispecific Antibody Elranatamab Under Investigation for Relapsed/Refractory Multiple Myeloma

BioNJ Member Pfizer, with a site in Peapack, announced new data from a planned interim analysis of the Phase 2 MagnetisMM-3 registration-enabling trial of elranatamab in people with relapsed/refractory multiple myeloma (RRMM) whose disease is refractory to at least one agent in each of three major classes of medications approved for the disease. Elranatamab is an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody in development for the treatment of multiple myeloma (MM). MagnetisMM-3 is an open-label, multicenter, single arm, Phase 2 study evaluating the safety and efficacy of elranatamab monotherapy in patients with RRMM. The participants included in this study represent a particularly difficult-to-treat MM patient population: 95.7% of participants in the current interim analysis population had triple-class refractory disease and 39.4% had penta-drug refractory disease.

Pfizer Announces Overall Survival Results from Phase 3 PALOMA-2 Trial of IBRANCE® (palbociclib) for the First-Line Treatment of ER+, HER2- Metastatic Breast Cancer

BioNJ Member Pfizer, with a site in Peapack, announced overall survival (OS) results from the Phase 3 PALOMA-2 trial, which evaluated IBRANCE® (palbociclib) in combination with letrozole compared to placebo plus letrozole for the first-line treatment of postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC). With a median follow-up of 90 months, patients receiving IBRANCE in combination with letrozole had numerically longer OS compared to placebo plus letrozole (median (95% CI) 53.9 months (49.8–60.8) vs median 51.2 months (43.7–58.9); the results were not statistically significant (Hazard Ratio (HR)=0.956 [95% CI, 0.777–1.177]). 

Pfizer, MorphoSys and Incyte Enter into Clinical Trial Collaboration for Monjuvi® (tafasitamab-cxix) in Combination With TTI-622, a Fusion Protein Directed Against CD47

BioNJ Member Pfizer, with a site in Peapack, MorphoSys U.S. Inc. and Incyte announced a clinical trial collaboration and supply agreement to investigate the immunotherapeutic combination of Pfizer’s TTI-622, a novel SIRPα-Fc fusion protein, and Monjuvi® (tafasitamab-cxix) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT). “TTI-622 blocks the signal-regulatory protein (SIRP)α–CD47 axis, which is a key checkpoint expected to become an important backbone immunotherapy across multiple tumors, especially hematological cancers,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. 

Janssen Presents Updated Data at EHA for Teclistamab in Patients With Relapsed or Refractory Multiple Myeloma

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced updated efficacy and safety results from the teclistamab cohort of the Phase 1b TriMM-2 study. Teclistamab, an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting B-cell maturation antigen (BCMA) is being studied in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in patients with relapsed or refractory multiple myeloma (RRMM) who have received three or more prior lines of therapy. Patients in the study, including a high proportion with prior anti-CD38 exposure, achieved encouraging overall response rates (ORR) with this combination treatment. 

New IMBRUVICA® (ibrutinib) Data in Fixed-Duration Combination Regimen Presented at EHA 2022 Shows Deep, Durable Response at Three Years in Untreated Chronic Lymphocytic Leukemia

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced new and updated results from the Phase 2 CAPTIVATE study evaluating IMBRUVICA® (ibrutinib) in combination with venetoclax (I+V) as a potential fixed-duration (FD) treatment in adult patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Updated data from the FD cohort with three years of follow-up shows that I+V continues to demonstrate deep and durable responses and clinically meaningful progression-free survival (PFS) and overall survival (OS) in the first-line treatment setting. New data will be presented from the minimal residual disease (MRD) cohort, which suggests immune restoration with this combination. 

Janssen Presents Updated Results Evaluating First-in-Class GPRC5D Bispecific Antibody Talquetamab in Heavily Pretreated Patients With Multiple Myeloma

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 1 MonumenTAL-1 first-in-human dose-escalation study of talquetamab (NCT03399799), an investigational, off-the-shelf, T cell redirecting bispecific antibody targeting both GPRC5D, a novel multiple myeloma target, and CD3 on T cells. Results from the study showed encouraging responses in heavily pretreated patients with relapsed or refractory multiple myeloma (RRMM) who received talquetamab at the recommended subcutaneous Phase 2 dose (RP2D) administered weekly (QW) or every two weeks. No new safety signals were identified with longer follow-up of either dose cohort. The most common adverse events (AEs) at the 405 µg/kg QW dose were cytokine release syndrome (CRS; 76.7 percent; 3.3 percent Grade 3/4), neutropenia (66.7 percent; 60 percent Grade 3/4), skin-related AEs (66.7 percent; all Grade 1/2), and dysgeusia (63.3 percent; all Grade 1/2).

Janssen Presents Initial Results from the Phase 2 RAGNAR Study of BALVERSA® (erdafitinib) in Patients With Advanced Solid Tumors With FGFR Alterations

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced initial results from the pivotal Phase 2 RAGNAR study evaluating the investigational use of BALVERSA® (erdafitinib), a fibroblast growth factor receptor (FGFR) kinase inhibitor, in patients with advanced solid tumors with prespecified FGFR alterations. At a planned interim analysis (IA), responses were observed across a variety of FGFR-driven solid tumors for patients who had exhausted standard treatment options prior to being treated with BALVERSA®. RAGNAR (NCT04083976) is a Phase 2 clinical study designed to evaluate the efficacy and safety of BALVERSA® in patients with advanced or metastatic solid tumors and prespecified FGFR gene alterations, regardless of tumor location or histology (tumor-agnostic). 

Longer-Term Data from CARTITUDE-1 Study Demonstrate Continued Deep and Durable Responses to CARVYKTI™ (ciltacabtagene autoleucel) in Heavily Pretreated Patients With Relapsed or Refractory Multiple Myeloma

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 1b/2 CARTITUDE-1 study evaluating the efficacy and safety of CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy. The study included patients with relapsed or refractory multiple myeloma (RRMM) who had received >3 lines of therapy including a proteasome inhibitor (PI), an anti-CD38 monoclonal antibody and an immunomodulatory agent (IMiD) or were double refractory to an IMiD and PI and who had received a PI, an IMiD and an anti-CD38 as part of previous therapy. 

Evotec, Janssen Enter Drug Discovery Alliance

Princeton-based BioNJ Member Evotec has entered a drug discovery collaboration with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Evotec’s TargetAlloMod platforms will be evaluated to discover first-in-class novel mode of action therapeutic candidates. The agreement was facilitated by Johnson & Johnson Innovation. Under the agreement, Evotec and Janssen will jointly conduct screens on the identified targets and collaborate with hit identification and lead optimization of the most promising chemical assets, leveraging Evotec’s integrated drug discovery and development platform. Dr. Cord Dohrmann, Chief Scientific Officer of Evotec, said, “We are very proud to enter into this collaboration to explore unique approaches to high potential cell surface drug targets with novel therapeutic modalities and to deliver and make innovative therapeutic options available to patients.”

Novartis Five-Year Kymriah® Data Show Durable Remission and Long-Term Survival Maintained in Children and Young Adults With Advanced B-Cell ALL

East Hanover-based BioNJ Member Novartis announced long-term results from the ELIANA pivotal clinical trial of Kymriah® (tisagenlecleucel), the first-ever approved CAR-T cell therapy, in children and young adult patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL), with a maximum survival follow-up of 5.9 years. For the 79 patients treated with Kymriah in this study, the five-year overall survival (OS) rate was 55% (95% CI, 43-66), while the median event-free survival (EFS) for patients in remission within three months of infusion (n=65) was 43.8 months. These findings demonstrate the curative potential of Kymriah, the only CAR-T cell therapy available for these patients who previously had limited treatment options.

Novartis Scemblix®, With Novel Mechanism of Action, Shows Superior, Long-Term Efficacy and Consistent Tolerability in 96-Week Follow-Up of Chronic Myeloid Leukemia Trial

East Hanover-based BioNJ Member Novartis announced longer-term follow-up data from the Phase III ASCEMBL trial for patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors (TKIs). In this analysis, the proportion of patients in the Scemblix® (asciminib) arm (n=157) who achieved a major molecular response (MMR) at 96 weeks was more than double that in the Bosulif® (bosutinib) arm (n=76) (37.6% vs. 15.8% [P=.001]), substantially increasing from previous analyses. Additionally, the probability of maintaining MMR for at least 72 weeks for patients treated with Scemblix was 96.7% (95% CI, 87.4%–99.2%), reflecting long-term durability of efficacy.

Novartis Tafinlar® (Dabrafenib) + Mekinist® (Trametinib) Demonstrates Unprecedented Efficacy in Pediatric Patients With BRAF V600 Low-Grade Gliomas in Phase II/III Study

East Hanover-based BioNJ Member Novartis announced Tafinlar® (dabrafenib) + Mekinist® (trametinib) significantly improved efficacy in patients ages 1 to 17 years old with BRAF V600 pediatric low-grade glioma (pLGG) requiring first systemic treatment compared to chemotherapy, the current standard-of-care for these patients1. In this study, patients randomized to receive Tafinlar + Mekinist experienced a statistically significant overall response rate (ORR) of 47% (CI: 35-59%) compared to 11% (CI: 3-25%, p<0.001) for those randomized to receive chemotherapy. A new liquid formulation of Tafinlar + Mekinist that can be easier to administer than chemotherapy was used in this trial.

GSK Announces Positive Pivotal Phase III Data for its Respiratory Syncytial Virus (RSV) Vaccine Candidate for Older Adults

Warren-based BioNJ Member GSK announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 Phase III trial. The interim analysis was reviewed by an Independent Data Monitoring Committee, and the primary endpoint was exceeded with no unexpected safety concerns observed. AReSVi 006 is a Phase III trial investigating GSK’s respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above. Results from this Phase III trial will be presented in a peer-reviewed publication and at an upcoming scientific meeting. The AReSVi 006 trial will continue to evaluate both an annual revaccination schedule and longer-term protection over multiple seasons following one dose of the RSV older adult (OA) vaccine candidate.

GSK Announces U.S. FDA Approval of Priorix for the Prevention of Measles, Mumps and Rubella in Individuals 12 Months of Age and Older

Warren-based BioNJ Member GSK announced that the U.S. Food and Drug Administration (FDA) has approved Priorix (Measles, Mumps and Rubella Vaccine, Live) for active immunization for the prevention of measles, mumps and rubella (MMR) in individuals 12 months of age and older. Priorix is currently licensed in more than 100 countries worldwide, including all European countries, Canada, Australia and New Zealand, with more than 800 million doses distributed to date. Measles, mumps and rubella are acute and highly-contagious viral diseases responsible for considerable morbidity and mortality throughout the world. In recent years, measles outbreaks have occurred in the U.S. and globally, with more than 400,000 cases confirmed in 2019, reversing decades of progress toward measles elimination in many countries.

AbbVie Announces Late-Breaking Results from Phase 2 Trial of Investigational Epcoritamab (DuoBody®-CD3xCD20) in Patients With Relapsed/Refractory Large B-cell Lymphoma (LBCL) at the European Hematology Association (EHA) Annual Congress

BioNJ Member AbbVie, with a site in Madison, announced primary results from the large B-cell lymphoma (LBCL) expansion cohort in the EPCORE™ NHL-1 phase 2 clinical trial evaluating epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody. In this study, epcoritamab demonstrated efficacy with durable responses in patients who had previously received at least two prior lines of anti-lymphoma therapy including chimeric antigen receptor (CAR) T-cell therapy. The study cohort, which included 157 relapsed/refractory LBCL patients, previously treated with a median of three lines of prior therapy, demonstrated an overall response rate (ORR) of 63 percent and a complete response (CR) rate of 39 percent. Baseline characteristics included 61 percent of patients who were refractory to primary treatment, 20 percent who had prior autologous stem cell transplantation (ASCT), and 39 percent who were treated with CAR T-cell therapy (75 percent of those refractory to CAR T). 

AbbVie Presents Investigational Navitoclax Preliminary Data in JAK Inhibitor Naïve Myelofibrosis Patients

BioNJ Member AbbVie, with a site in Madison, announced new data from Cohort 3 of its Phase 2 REFINE study of investigational navitoclax in combination with ruxolitinib in JAK inhibitor naïve patients with myelofibrosis (MF), a rare and difficult to treat blood cancer. These preliminary findings show spleen volume and symptomatic improvement in this cohort. These data are consistent with previously observed data from relapsed/refractory patients in Cohort 1a . REFINE is a Phase 2 non-randomized open-label multi-cohort study evaluating the safety and efficacy of navitoclax alone or in combination with ruxolitinib in MF.

New Data Demonstrates AbbVie's VENCLYXTO®/VENCLEXTA® Combination Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients After Four Years Off Treatment

BioNJ Member AbbVie, with a site in Madison, announced five-year follow-up results from the Phase 3 CLL14 trial, finding that over 60 percent of patients with previously untreated chronic lymphocytic leukemia (CLL) who had received one-year fixed-duration combination treatment of VENCLYXTO®/VENCLEXTA® (venetoclax) plus obinutuzumab (GAZYVA®) continued to show longer progression-free survival (PFS) and higher rates of undetectable minimal residual disease (MRD) after four years off treatment. Data shows that after more than five years of median follow-up (65.4 months), PFS remained significantly superior among patients treated with the VENCLYXTO/VENCLEXTA and obinutuzumab combination compared to the chlorambucil and obinutuzumab chemotherapy regimen (n=432; median NR vs 36.4 months; hazard ratio [HR] 0.35 [95% CI 0.26-0.46], p<0.0001). 

Final Data from Phase 3 ASCENT Study Demonstrates Trodelvy Extends Overall Survival Over Chemotherapy in Second-Line Metastatic TNBC

BioNJ Member Gilead Sciences, with a site in Morris Plains, presented final data from the Phase 3 ASCENT study of Trodelvy® (sacituzumab govitecan-hziy) in patients with relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies, at least one of them for metastatic disease. In a follow-up analysis from the final database lock, Trodelvy improved median progression-free survival versus physicians’ choice of chemotherapy (4.8 vs. 1.7 months; HR: 0.41; p<0.0001) and extended median overall survival (OS) by almost five months (11.8 vs. 6.9 months; HR: 0.51; p<0.0001) in the intent-to-treat population. The two-year OS rate was 20.5% (95% CI: 15.4-26.1) in the Trodelvy arm, compared with 5.5% (95% CI: 2.8-9.4) with physicians’ choice of chemotherapy.

Trodelvy® Improved Progression-Free Survival by 34% in Heavily Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients

BioNJ Member Gilead Sciences, with a site in Morris Plains, announced positive results from the primary analysis of the Phase 3 TROPiCS-02 study of Trodelvy® (sacituzumab govitecan-hziy) versus physicians’ choice of chemotherapy (TPC) in heavily pre-treated HR+/HER2- metastatic breast cancer patients who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. The study met its primary endpoint of progression-free survival (PFS) with a statistically significant and clinically meaningful 34% reduction in the risk of disease progression or death (median PFS 5.5 vs. 4 months; HR: 0.66; 95% CI: 0.53-0.83; P<0.0003). The first interim analysis of the key secondary endpoint of overall survival (OS) demonstrated a trend in improvement.

China NMPA Approves Tislelizumab for Recurrent or Metastatic Nasopharyngeal Cancer

Hopewell-based BeiGene announced that the China National Medical Products Administration (NMPA) has approved BeiGene’s anti-PD-1 antibody, tislelizumab, in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC). This approval was supported by clinical results from the randomized, double-blind, Phase 3 clinical trial RATIONALE 309 (NCT03924986) to evaluate the efficacy and safety of tislelizumab combined with gemcitabine and cisplatin versus placebo combined with gemcitabine and cisplatin as a first-line treatment for patients with recurrent or metastatic NPC. This approval was supported by clinical results from the randomized, double-blind, Phase 3 clinical trial RATIONALE 309 (NCT03924986) to evaluate the efficacy and safety of tislelizumab combined with gemcitabine and cisplatin versus placebo combined with gemcitabine and cisplatin as a first-line treatment for patients with recurrent or metastatic NPC.

BeiGene Announces BRUKINSA™ (zanubrutinib) Is Approved in 50 Markets

Hopewell-based BeiGene announced that its BTK inhibitor BRUKINSA™ (zanubrutinib) has been approved by the Ministry of Health in Kuwait, the National Health Regulatory Authority in Bahrain and the Ministry of Public Health in Qatar for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. BeiGene is working with NewBridge Pharmaceuticals, a specialty company in the Middle East and North Africa (MENA) regions established to bridge the access gap by partnering with global pharma and biotech companies, to bring BRUKINSA to patients in Kuwait, Bahrain, Qatar, Saudi Arabia, United Arab Emirates and other markets in the MENA region following regulatory approvals.

Eisai Presents New Findings for Antibody Drug Conjugate Farletuzumab Ecteribulin at 2022 ASCO Annual Meeting

Nutley-based Eisai announced new investigational data from the platinum-resistant ovarian cancer (PROC) cohort expansion of a Phase 1 study (Study 101) evaluating the antibody drug conjugate (ADC) co-developed by Eisai and Princeton-based BioNJ Member Bristol Myers Squibb, farletuzumab ecteribulin (MORAb-202). Farletuzumab ecteribulin is composed of Eisai’s in-house developed farletuzumab, a humanized IgG1 monoclonal antibody that binds to the folate receptor alpha (FRα), and Eisai’s anticancer agent eribulin, a microtubule dynamics inhibitor, using an enzymatically cleavable linker. Ovarian cancer is typically diagnosed at advanced stages of disease, with most patients facing a poor prognosis because of high rates of recurrence and subsequent development of chemoresistance.

Quizartinib Plus Chemotherapy Significantly Improved Overall Survival Compared to Chemotherapy in Patients With Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia

Positive results from the global pivotal QuANTUM-First Phase 3 trial of Basking Ridge-based Daiichi Sankyo’s quizartinib combined with standard induction and consolidation chemotherapy and then continued as a single agent demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) in adult patients aged 18-75 with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) compared to standard chemotherapy alone. Quizartinib combined with standard induction and consolidation chemotherapy and then continued as a single agent demonstrated a 22.4% reduction in the risk of death compared to standard chemotherapy alone (HR = 0.776 [95% CI: 0.615-0.979; 2-sided p=.0324]) in patients with newly diagnosed FLT3-ITD positive AML. 

DS-6000 Suggests Early Clinical Activity in Patients With Advanced Ovarian Cancer or Renal Cell Carcinoma

Basking Ridge-based Daiichi Sankyo and Sarah Cannon Research Institute (Sarah Cannon) announced that initial results from the first-in-human Phase 1 study of DS-6000, a CDH6 directed DXd antibody drug conjugate (ADC), suggest early clinical activity in patients with advanced ovarian cancer or renal cell carcinoma with disease progression following standard of care treatment. Patients with advanced ovarian cancer or renal cell carcinoma may have disease progression after initial treatments and there is a need for new therapeutic approaches for recurrent disease, as five-year survival rates in the U.S. are low at 30% and 15%, respectively. The CDH6 protein is significantly overexpressed in ovarian cancer and renal cell carcinoma and has been identified as a promising therapeutic target.

ENHERTU® Reduced the Risk of Disease Progression or Death by 50% vs. Chemotherapy in Patients With HER2 Low Metastatic Breast Cancer With HR Positive and HR Negative Disease

Basking Ridge-based Daiichi Sankyo announced detailed positive results from the pivotal DESTINY-Breast04 phase 3 trial showed that ENHERTU® (trastuzumab deruxtecan) demonstrated superior and clinically meaningful progression-free survival (PFS) and overall survival (OS) in previously treated patients with HER2 low (immunohistochemistry (IHC) 1+ or IHC 2+/in-situ hybridization (ISH)-negative) unresectable and/or metastatic breast cancer with hormone receptor (HR) positive or HR negative disease versus standard of care physician’s choice of chemotherapy. Results have been published in The New England Journal of Medicine. ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo (TSE: 4568) and AstraZeneca.

TROPION-Breast02 Phase 3 Trial of Datopotamab Deruxtecan Initiated in Patients With Previously Untreated Metastatic Triple Negative Breast Cancer

Basking Ridge-based Daiichi Sankyo announced that the first patient was dosed in the global TROPION-Breast02 Phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd) versus investigator’s choice of chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) not eligible to receive PD-1/PD-L1 inhibitor therapy. Datopotamab deruxtecan is a specifically designed TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca. Approximately 10 to 15% of breast cancers are considered triple negative, the most aggressive subtype of breast cancer. Compared to patients with other breast cancer subtypes, the prognosis for patients with metastatic TNBC is generally worse, with five-year survival rates estimated at 12% and median overall survival generally less than two years.

BD Unveils World's First Spectral Cell Sorter With High-Speed Imaging Technology that Sorts Cells Based on Visual Characteristics

Franklin Lakes-based Becton, Dickinson and Company announced it will introduce new cell sorting technology that enables researchers to see and sort cells at speeds never before possible, which creates the potential to transform research and cell-based therapeutic development across a range of fields such as virology and oncology, as well as numerous disease states. The new BD FACSDiscover™ S8 Cell Sorter features the breakthrough BD CellView™ Image Technology profiled earlier this year on the cover of the journal Science. It is the first cell sorter to combine advanced spectral flow cytometry with sort-capable image analysis that will potentially enable researchers to yield more accurate data and sort cells that previously could not be identified.

CerTest Biotec and BD Announce Collaboration on Molecular Diagnostic Test for Monkeypox

Franklin Lakes-based Becton, Dickinson and Company and CerTest Biotec announced a collaboration to develop a molecular diagnostic test for the Monkeypox virus. As part of the collaboration, the assay will leverage the BD MAX™ open system reagent suite to validate the CerTest VIASURE Monkeypox CE/IVD molecular test on the BD MAX™ System. The assay will be available for BD MAX™ users and may help advance understanding of the global spread of the disease. The BD MAX™ System is a fully integrated, automated platform that performs nucleic acid extraction and real-time PCR providing results for up to 24 samples across multiple syndromes in less than three hours.

Becton Dickinson to Buy Pharmacy Automation Firm Parata Systems for $1.5 Billion

Entering the fast-growing pharmacy automation space, Franklin Lakes-based Becton, Dickinson and Company said it will purchase Parata Systems from Frazier Healthcare Partners for more than $1.5 billion in cash. The medical product giant Monday said Parata will be a part of the “medical segment” under BD’s “medication management solutions business” and will expand the company’s offerings to provide “new innovative pharmacy automation solutions for hospitals, retail pharmacy, long-term care and home settings,” a company spokesman said. The deal with the private equity firm Frazier is expected to close the transaction by the end of the first half of BD’s fiscal year 2023, the companies said.

BD Collaborates With Mayo Clinic on Real-World Data

Franklin Lakes-based Becton, Dickinson and Company announced a collaboration with a Mayo Clinic platform that will give the medical company access to real-world data, providing deeper insights into what patients need. The collaboration gives BD access to de-identified patient data – which means individuals’ identities are protected – from Mayo Clinic Platform_Discover. This platform includes data sets from 10 million patients, including both structured and unstructured data, images, 1.2 billion lab test results, 3 million echocardiograms and more than 640 million clinical notes. Using data mining, next generation artificial intelligence and machine learning, BD will analyze this data “to perform detailed post-market surveillance on its products to fuel innovation and unlock a faster, more efficient path to market, with the ultimate goal of improving patient care,” the company said.

Eagle Pharmaceuticals Completes Acquisition of Acacia Pharma Group

Woodcliff Lake-based Eagle Pharmaceuticals said it completed the previously announced acquisition of Britain-based Acacia Pharma in a deal that values the firm at around $102 million. Eagle will gain possession of two marketed products, Byfavo, a sedative medicine for adults undergoing procedures lasting 30 minutes or less; and Barhemsys, approved in U.S. for rescue treatment of postoperative nausea and vomiting despite prophylaxis and also approved for preventing/treating PONV in those who have not received prophylaxis. “The closing of this transaction is a great achievement for Eagle, both strategically and financially. The addition of the two products expands our presence in the acute care space, and we believe that our highly capable hospital-based salesforce will have great success commercializing these assets,” said Scott Tarriff, CEO and President of Eagle Pharmaceuticals.

Vyluma and Laboratoires Théa Enter into Licensing Agreement for the Registration and Commercialization of NVK002 in Canada, Mexico, and Select South American Countries

Bridgewater-based Vyluma and Laboratoires Théa announced that they have recently entered into an exclusive licensing agreement for the registration and commercialization of NVK002 in Canada, Mexico and select South American Countries. This agreement represents an expansion of the previously announced exclusive licensing agreement for the commercialization of NVK002 in Europe and other select countries. NVK002 is a proprietary, investigational, preservative-free eye drop administered nightly and intended for slowing the progression of myopia in children ages three to 17. It is currently under late-stage clinical evaluation in the CHAMP (Childhood Atropine for Myopia Progression) study, a Phase III multi-center clinical trial being carried out in the U.S. and Europe.

Zoetis Acquiring Basepaws, Leader in Pet Care Genetics

Parsippany-based Fortune 500 company Zoetis announced that it has an agreement to acquire Basepaws, a privately held pet care genetics company that provides pet owners with genetic tests, analytics and early health risk assessments that can help manage the health, wellness and quality of care for their pets. The acquisition will advance Zoetis’ portfolio in the precision animal health space and will inform and shape its future pipeline of pet care innovations. As a pioneer in pet care genetics, Basepaws offers easy-to-use genetic screening tools for the early detection of disease risk in pets, as well as individualized breed and health reports that can identify traits, biomarkers and potential hereditary conditions for pets.

Organon to Pay $73M to License Global Biosimilar Commercialization Rights

Jersey City-based pharmaceutical company Organon entered into an agreement with Shanghai Henlius Biotech Inc. to license commercialization rights for biosimilar candidates referencing two products: Perjeta, which treats breast cancer, and Prolia/Xgeva, which treats osteoporosis. Organon will pay Henlius $73 million. Approximately $30 million in additional payments will be made upon achievement of certain development, regulatory and commercial milestones. Through the deal, Organon will acquire exclusive global commercialization rights except for China, including for Hong Kong, Macau and Taiwan. “Biosimilars are a key growth pillar for Organon, and this collaboration represents the successful execution of our strategy to expand our biosimilars portfolio leveraging our strong global footprint and deep commercial expertise,” said Organon CEO Kevin Ali.

Pharma Company Buys Basking Ridge Complex for $4.6M

Looking for a larger footprint in a convenient location, Aucta Pharmaceuticals Inc. acquired a five-building corporate complex located in Basking Ridge. “Aucta is an innovative, growing pharmaceutical company in New Jersey that understands the demand for better quality and research to deliver the best products available to those that need them,” said Peter Wisniewski, Executive Vice President, Kislak Commercial Real Estate Services. After Aucta sets up at the site, it may offer available space to other lab or office companies looking to expand in the market. Aucta, with locations in Piscatway and China, is a technology-based company focused on the development and commercialization of branded specialty products.

Soligenix; Diving into HyBryte CTCL Treatment Efficacy and Safety With Dr. Jennifer DeSimone

In this interview, Dr. Jennifer DeSimone, Director of Cutaneous Lymphoma, Inova Schar Cancer Institute, and an investigator for BioNJ Member Soligenix's Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study, answers questions about cutaneous T-cell lymphoma (CTCL), current treatments and the important potential role HyBryte™ may play for early stage patients. 

Biotech Investment Veteran Alethia Young Joins PTC Therapeutics' Board of Directors

South Plainfield-based BioNJ Member PTC Therapeutics announced the election of Alethia Young to the company's Board of Directors. Ms. Young has more than 20 years of experience in health care and biotech equity research and investing. She is currently the Chief Financial Officer of Graphite Bio where she oversees the company's finance, investor relations and corporate communications functions, and plays a key role in overall corporate strategy. Prior to her role at Graphite Bio, Ms. Young worked at Cantor Fitzgerald as senior biotech analyst and head of research, managing the equity research department covering small-cap, mid-cap and large-cap biotechnology companies. Prior to joining Cantor Fitzgerald, Ms. Young held senior biotech analyst positions at Credit Suisse and Deutsche Bank. 

ADC Therapeutics Names David Gilman as Chief Business & Strategy Officer

New Providence-based BioNJ Member ADC Therapeutics announced it has appointed industry veteran David Gilman to the new role of Chief Business & Strategy Officer reporting to Chief Executive Officer Ameet Mallik. In this role, Mr. Gilman will be responsible for all business development and portfolio strategy efforts globally and he will serve on the company’s executive leadership team. Mr. Gilman is a pharmaceutical business executive with over 25 years of experience. At Novartis, he was Global Head of Portfolio Strategy and Business Development for Novartis Oncology, from 2018-2019. He joins ADC Therapeutics from ClearView Healthcare Partners where he played a key role in direct client service as well as global expansion efforts helping his clients accomplish significant business development and strategic transactions from 2019-2022. 

Amarin Appoints Tom Reilly as New Chief Financial Officer

Bridgewater-based BioNJ Member Amarin Corporation announced the appointment of Tom Reilly as Chief Financial Officer. The appointment follows the resignation of Michael W. Kalb who will leave the company to pursue other interests after a brief transition period. Mr. Reilly is an experienced senior leader with significant expertise in corporate and commercial finance in the pharmaceutical and biotechnology sectors. Most recently, he served as Chief Financial Officer for Cara Therapeutics, where he was responsible for leading all aspects of Cara’s financial operations and planning. Prior to his role at Cara, Mr. Reilly served as Head of Finance for the U.S. General Medicines unit at Allergan, where he led all financial management for that business.

BD Names Campion as Medical Segment President

Franklin Lakes-based Becton, Dickinson and Company has appointed Simon Campion as Executive Vice President and President of the Medical segment for BD. Mr. Campion will replace Alberto Mas who previously announced his intent to retire from BD. In this role, Mr. Campion will be responsible for the global strategic, operational and commercial performance of the Medical segment portfolio and will be accountable for delivering the segment’s innovation agenda aligned to the BD 2025 strategy. Mr. Campion will also continue to lead the Interventional segment in the interim until a successor is named. He will report to Tom Polen, Chairman, CEO and President of BD.

NJ/NY Market Ranks No. 4 in Life Sciences Talent

The New Jersey/New York market ranks No. 4 in the country in CBRE’s inaugural Life Sciences Talent Report, which identifies the top 25 life sciences labor markets in the country. New Jersey/New York had the most annual graduates in biological and biomedical sciences in the U.S. – more than 2,000 new degrees than runner-up Los Angeles/Orange County. As a result, the market is ideal for major employers seeking the most highly educated talent. According to CBRE, New Jersey/New York issued 9.8% of all biological and biomedical sciences PhDs, the highest of any market in the country. Moreover, New Jersey/New York received $3.4 billion in NIH funding, the largest commitment to any market in the U.S. in 2021.

Imagining the Unimaginable: Houshmand’s 10 Years as President of Rowan are Marked by Successes — and Growth — That Go Well Beyond Even His Biggest Dreams

By the time he became President of Rowan University in 2012, Ali Houshmand already had lived the American Dream many times over. A mathematical scholar from Iran, he had studied in England and the U.S., worked in private practice and served as a leader in higher education. But that didn’t stop Houshmand from “imagining beyond the imaginable,” as he puts it. He envisioned a Rowan University that no one else saw. One that one would make Rowan an anchor for both higher education and economic development in South Jersey. One that would see Houshmand go from being a disruptive rebel to a visionary emulated by college presidents around the state and the country. As he celebrates his 10th anniversary as the leader of the Glassboro-based school, Houshmand continues to prove that he still is ahead of his time.

Rutgers Cancer Institute of N.J. Team Heads Group Awarded $25M for Research

A team led by Dr. Eileen White of the Rutgers Cancer Institute of New Jersey, in collaboration with Cold Spring Harbor Laboratory and Weill Cornell Medicine, has been awarded a $25 million Cancer Grand Challenges grant to tackle the condition of cancer cachexia. Cancer Grand Challenges is a global funding platform, co-founded by Cancer Research U.K. and the National Cancer Institute in the U.S., which supports a community of diverse, global teams to come together, think differently and take on some of cancer’s toughest challenges. The groups will address the challenge of cancer cachexia — a debilitating wasting condition people often experience in the later stages of their cancer, accompanied by fatigue and tissue dysfunction and imparting a poor prognosis and quality of life.

Princeton, NJIT, Stevens Rank High on List of Best Engineering Schools in Country

Three schools from New Jersey made Money Magazine’s list of the Best Colleges for engineering majors. The rankings had Princeton University at No. 7, New Jersey Institute of Technology at No. 10 and Stevens Institute of Technology at No. 16. Money Magazine said its list is based heavily on the median salaries of recent alumni with engineering degrees, as well as the number and share of recent graduates earning bachelor’s degrees in engineering. All three schools also fared well in the magazine’s ranking of top overall schools in the Northeast, with Princeton coming in at No. 2, followed by NJIT at No. 13 and Stevens at No. 23.

The Jersey City Summit

June 23, 2022

Convening leading principals, investors, owners, developers, advisors, operators and site selectors to help accelerate growth, job creation and innovations. We'll be bringing together the folks behind the largest, most exciting and transformative projects to share what's great and what's next.

New Jersey Research Cores Partnering Conference

June 29, 2022

The New Jersey Research Cores Partnering Conference will showcase cutting-edge resources and facilities available to innovators at universities and companies across the Garden State. Hosted at Rutgers University, the conference will include sessions on successful collaborations between companies and universities, posters and presentations from Princeton, NJIT, Rowan, Rutgers, Montclair and Hackensack Meridian Health. Attendees who do not have a Rutgers parking permit are required to register your vehicle here.

ON Helix

July 7, 2022

This one-day conference will address the main bio innovation trends, from the developments in life sciences and technology research to their translation into new diagnostics, prevention tools or treatments. Don’t miss this opportunity to reconnect with the One Nucleus network and keep up to date with the latest trends in BIO Innovation for Health. BioNJ Members receive a 10% discount to attend the conference. Contact RBromberg@BioNJ.org for the discount code. 

Bio-Manufacturing Innovation Summit

July 7-8, 2022

Driving meaningful innovation, impact and value creation in Bio-Manufacturing and ensuring resilient, adaptable supply chains, efficient re-shoring, on-shoring and cutting edge pharma manufacturing solutions to meet demand and accelerate the development and production of essential novel therapeutics and vaccines, in the U.S. and globally. The Summit will cover: What solutions can technology transfer from the world-leading institutions and most innovative private companies provide? Which partners can provide the expertise to move these innovations to the market? How can industry and private companies reduce costs and accelerate their own programs? How to re-shore on on-shore rapidly and efficiently? What are the intellectual property and regulatory considerations? BioNJ Members receive a 50% discount on admission. Contact RBromberg@BioNJ.org for the discount code.