Welcome to the latest edition of the BioLines Weekender...
The COVID-19 pandemic necessitated changes in nearly every aspect of our lives. Nowhere was this more apparent than in our health care system.
Among the hardest hit states in the early days of the pandemic, New Jersey's health care system immediately stepped to the plate to treat and triage COVID-19 Patients. Additionally, the Garden State's vibrant life sciences ecosystem delivered unprecedented innovation -- from providers and others adapting to a new and unknown virus to the ongoing research and development of vaccines and treatments that have played a major factor in our return to "normal."
The pandemic highlighted the critical need for industry, government and non-profits to work collaboratively to drive best practices and solutions. It pushed us to be more resourceful, innovative, resilient and collaborative. In doing so, the pandemic offered an opportunity to look anew at our health care system to see where we may improve in areas of mental health, work force shortages and alignment of resources. The pandemic also revealed -- and in some cases exacerbated -- inequities and disparities in access to safe, high quality essential health and social services while also revealing a need for additional investment in innovation and in our public health infrastructure.
 With the benefit of the pandemic learning experiences of the last year, BioNJ and the New Jersey Health Care Quality Institute joined forces to create a multi-stakeholder "Lessons from COVID-19 Work Group" to generate consensus recommendations to address and prepare for future health emergencies. The work group included representatives from all facets of our health care delivery system, from the patient advocacy, provider, health care facility, health plan and biopharmaceutical sectors as well as with input from public health and other government officials.
"Lessons from COVID-19 Work Group" identifies our strengths, considers opportunities and offers recommendations, best practices and pragmatic solutions. The 24 recommendations identified in the report are designed to protect the health, well-being and safety of Patients and contribute to the economic stability and prosperity of New Jersey.
The report is just a starting point. We look forward to working collaboratively with our elected officials, policy makers and leaders within our communities to turn these recommendations into real-world change that address the challenges ahead and create a health system where all people receive equitable and affordable health care and can live their healthiest possible lives. Please click here for a copy of the report.
Thank you to all who made this important report possible. Please contact John Slotman, Vice President of Government Affairs for BioNJ, at [email protected] to learn more.
Because Patients Can't Wait®,
The BioNJ Team
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 | BioNJ Calendar |  |
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IWSTEM Virtual Networking Event
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July 15, 2021
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Manufacturing Briefing: Pandemic-Induced Innovation & Adaptation
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September 29, 2021
| | C-Suite Summit: Transitioning to the 'Next Normal': Biopharma's Role in Addressing the COVID-19 Crisis and What's Next |
October 15, 2021
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 | Putting Patients First: The Value of Medical Innovation |  |
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Simply wishing that drug pricing reforms won't happen will only lead to draconian solutions imposed upon industry that undermine the long-term interests of the U.S. public and global health. The biotech industry must act to support appropriate legislation that protects innovation, supports a vibrant, sustainable market-based biotechnology ecosystem and ensures patients have timely and broad-based access to the most cutting-edge medicines. President Biden has called for the U.S. to become the world's "arsenal of vaccines." The truth is that we already are. Congress has, over the years, enabled the U.S. to become the world's medicine chest. Yet today Congress is considering polices that if enacted into law may cause irreparable harm to the country's preeminent position in biotechnology and ultimately great harm to public health.
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| Pride of New Jersey |  |
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New Jersey is embracing the future of medicine and has a new identity as "The State of Innovation." Evolving beyond our nickname as "The Medicine Chest of the World," New Jersey is where disruptive start-ups grow and global companies on the forefront of next-generation therapeutics want to be. That's why 13 of the top 20 pharmaceutical companies in the world are already located here and we are ranked the #2 U.S. state for biotech strength. Still an epicenter for discovery, 40% of FDA approvals came from companies with a New Jersey footprint in 2020. As the global biopharma community enters a new era of personalized medicine, New Jersey is leading the way in cell and gene therapy. The State is also taking an active role in the addressing the COVID-19 pandemic.
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The shore. Bruce. Taylor ham, or pork roll as the case may be. What's not to like?
New Jersey now officially ranks as the best state in America to live in, according to WalletHub's annual list released Tuesday. The Garden State just edged out Massachusetts for top honors, with New York coming in third. WalletHub's survey considered 52 different weighted metrics, from cost of living and property taxes at the high end to low birthweights and move theaters per capita at the low end.
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| BioNJ in News | |
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BioNJ President and CEO Debbie Hart in a recent op-ed argued that H.R. 3, the "Lower Drug Costs Now Act," would impede continued innovation while imperiling Patient access to new and groundbreaking therapies. Noting a recent Vital Transformation report analyzing the impact on New Jersey's biopharmaceutical sector and the Patients we serve, Hart said "H.R. 3 would be a disaster for New Jersey, and we owe it to our sick and vulnerable to reject it as such." The Vital Transformation report estimates a nearly 90 percent reduction in novel therapies if H.R. 3 were in place over the last decade along with more than 70,000 lost jobs in the Garden State.
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| NJ Company News |  |
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South Plainfield-based BioNJ Member PTC Therapeutics, Inc. presented pooled placebo data from multiple studies in which the results confirmed the clinical benefit of EMFLAZA ® (deflazacort) over prednisone for the treatment of Duchenne muscular dystrophy (DMD). The results demonstrated that DMD patients on daily EMFLAZA performed better on key measures of physical function including the six-minute-walk test, key timed function tests, and the North Star Ambulatory Assessment than patients taking daily prednisone. "The results of this analysis adds to the body of evidence and clearly demonstrates the clinical benefit of EMFLAZA over prednisone," stated
Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "Importantly, these results also reflect the benefit that patients experience in the real-world setting."
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South Plainfield-based BioNJ Member PTC Therapeutics, Inc. announced that Evrysdi™ (risdiplam) was approved in Japan by the Japanese Ministry of Health, Labor and Welfare for the treatment of spinal muscular atrophy (SMA). The approval has been granted based on data from two pivotal studies evaluating Evrysdi in infants and adults living with type 1, 2 or 3 SMA. The first commercial sale will trigger a $10M milestone payment to PTC from Roche under its License and Collaboration agreement. Evrysdi is designed to treat SMA by increasing and sustaining the production of SMN protein, which is found throughout the body and is critical for maintaining healthy motor neurons and movement. Evrysdi has been approved for the treatment of patients with SMA, aged 2 months and older by the FDA and the EMA.
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Princeton-based BioNJ Member Oyster Point Pharma, Inc. announced enrollment of the first subject in the OLYMPIA Phase 2 clinical trial of OC-01 (varenicline) nasal spray for the treatment of Stage 1 Neurotrophic Keratopathy (NK). "This is an exciting milestone as we continue to develop this potentially new treatment option for patients with Stage 1 Neurotrophic Keratopathy," said Jeffrey Nau, Ph.D., MMS, President and Chief Executive Officer of Oyster Point Pharma. "We believe that NK affects more patients than are currently diagnosed as the disease has the potential to be undiagnosed or misdiagnosed. Stage 1 NK patients may present with additional ocular surface issues, including dry eye disease, which affects 38 million patients."
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Basking Ridge-based BioNJ Member Caladrius Biosciences, Inc. announced that the U.S. Food and Drug Administration ("FDA") has authorized its investigational new drug ("IND") application for the study of CLBS201, a CD34+ cell therapy for the treatment of diabetic kidney disease ("DKD"). "Our latest development program, CLBS201, is designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic patients with reduced kidney function. Specifically, we will be targeting patients with later stage chronic kidney disease. Based on a wealth of published preclinical and early clinical data, it appears that the innate ability of CD34+ cells to promote the growth of new microvasculature could be a means to attenuate the progression, or even reverse the course, of DKD," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius.
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Rafael Holdings, Inc. announced that it has entered into a merger agreement with Cranbury-based BioNJ Member Rafael Pharmaceuticals, Inc., a privately held, late-stage clinical oncology company focused on cancer metabolism-based therapeutics. The Boards of Directors of the two companies, as well as a special independent committee of the Rafael Holdings Board of Directors, have unanimously approved a merger agreement that provides for the combination of the two companies. Howard Jonas will serve as the Chairman, Ameet Mallik will serve as the Chief Executive Officer and Sanjeev Luther, the President and Chief Executive Officer of Rafael Pharmaceuticals, will join the Board of Directors of the combined company.
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Princeton-based BioNJ Member Photocure announces a new study on the early use of Blue Light Cystoscopy (BLC®) after BCG induction for high risk non-muscle invasive bladder cancer (NMIBC). The objective of the trial was to compare detection rates of BCG refractory tumors between the use of white light and blue light cystoscopy. The study was designed as a single center, single-arm retrospective study, including 136 patients with high-risk non-muscle-invasive bladder cancer diagnosed from January 2017 to January 2021. All patients underwent initial BLC TURBT and restaging TURBT if needed, followed by full-dose BCG.
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Lawrenceville-based BioNJ Member Celsion Corporation announced that its new wholly owned subsidiary, Celsion GmbH, will manage all current and future investigator-sponsored development of ThermoDox®, the Company's proprietary heat-activated liposomal encapsulation of doxorubicin.
Andreas Voss, M.D., a leading oncology researcher, has been named Managing Director of Celsion GmbH and will step down from Celsion's board of directors later this year to head the subsidiary, which is based in Zug, Switzerland. Establishing Celsion GmbH allows Celsion's management to focus solely on GEN-1, its DNA-mediated IL-12 immunotherapy currently in Phase I/II development for the treatment of advanced ovarian cancer, and PLACCINE™, its nucleic acid vaccine platform.
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Berkeley Heights-based BioNJ Member Amgen announced that the Japanese Ministry of Health, Labour and Welfare has granted marketing approval for Aimovig® (erenumab) for the suppression of onset of migraine attacks in adults. Aimovig is the first and only approved treatment in Japan to block the calcitonin gene-related peptide receptor (CGRP-R), which is believed to play a critical role in migraine. "Today's approval further strengthens Amgen's commitment to the migraine community, and we continue to look for ways to expand the availability of Aimovig to help more patients," said
Murdo Gordon, Executive Vice President of Global Commercial Operations at Amgen.
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BioNJ Member Pfizer Inc., with offices in Peapack, announced that the first participant has been dosed in TALAPRO-3, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial. The study will evaluate the efficacy and safety of talazoparib, an oral poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with enzalutamide, an androgen receptor inhibitor, compared with placebo plus enzalutamide in men with DNA damage response (DDR)-deficient metastatic castration-sensitive prostate cancer (mCSPC). The first patient was dosed at a site in Glendale, California.
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BioNJ Member Pfizer Inc., with offices in Peapack, and the Academic Research Organization (ARO) from the Hospital Israelita Albert Einstein announced that the New England Journal of Medicine has published positive findings from the STOP-COVID study (NCT04469114) evaluating the efficacy and safety of oral Janus kinase (JAK) inhibitor tofacitinib in 289 hospitalized adult patients with COVID-19 pneumonia who were not on ventilation. The trial was a research collaboration between Pfizer and the ARO from the Hospital Israelita Albert Einstein in Sao Paulo, Brazil, which was the trial coordinating center.
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East Hanover-based BioNJ Member Sandoz announced the launch of generic oncology treatment Pemetrexed in 11 countries across Europe, including Germany, Switzerland, Netherlands and Spain. Pemetrexed, as a monotherapy or in combination with cisplatin, is indicated for first-line, second-line and maintenance treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology, and for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
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East Hanover-based BioNJ Member Novartis announced that VISION data published in
The New England Journal of Medicine shows that 177Lu-PSMA-617 plus standard of care (SOC) significantly improved both overall survival (HR = 0.62 [95% CI: 0.52−0.74]; P<0.001; median 15.3 vs 11.3 months) and imaging-based progression-free survival (HR = 0.40 [99.2% CI: 0.29−0.57]; P<0.001; median, 8.7 vs 3.4 months) versus SOC alone in patients with progressive PSMA-positive mCRPC. "We believe that radioligand therapy with 177Lu-PSMA-617 has great potential to improve outcomes in advanced prostate cancer and have already started two new Phase III studies in earlier lines of treatment," said Jeff Legos, Global Head of Oncology Development, Novartis.
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East Hanover-based BioNJ Member Novartis disclosed new data showing mean IgG and IgM levels remain unchanged in adults with relapsing multiple sclerosis (RMS) treated with Kesimpta® (ofatumumab) over 3.5 years. The ongoing open label extension of the ALITHIOS study includes 1,703 people living with MS taking Kesimpta for up to 5 years. At the time of analysis, 456 of these people had reached 3.5 years of Kesimpta treatment duration. The long-term findings were consistent with the Phase III ASCLEPIOS trials data, which demonstrated that the overall incidence of infections was low, and no association was observed between decreased immunoglobulin levels and the risk of serious infections. These data reinforce Kesimpta as a well-tolerated treatment option for people living with RMS.
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East Hanover-based BioNJ Member Novartis announced new Phase II data for iptacopan (LNP023), an investigational oral treatment for paroxysmal nocturnal hemoglobinuria (PNH). In the study (NCT03896152), treatment with 12 weeks of iptacopan monotherapy was generally well tolerated with no unexpected safety findings and resulted in rapid and durable transfusion-free improvement of hemoglobin levels in the majority of patients. All patients completing at least 12 weeks of iptacopan treatment (n=11) achieved the primary endpoint of at least a 60% reduction in their lactate dehydrogenase (LDH) levels, a biomarker of intravascular hemolysis.
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East Hanover-based BioNJ Member Novartis announced data that reinforce the transformational benefit of Zolgensma® (onasemnogene abeparvovec), an essential, one-time treatment and the only gene therapy for spinal muscular atrophy (SMA). New late-breaker data from the completed two-copy cohort of the Phase 3 SPR1NT clinical trial demonstrate age-appropriate milestone development in presymptomatic children with SMA without respiratory or nutritional support of any kind, and with no serious, treatment-related adverse events. The completed Phase 3 STR1VE-EU trial demonstrated rapid improvements in motor function following treatment with Zolgensma, and the majority of patients achieved motor milestones not observed in the natural history of SMA Type 1.
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Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO® (rivaroxaban) in pediatric patients. The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure. If approved, XARELTO® will be the first and only oral Factor Xa inhibitor indicated in the U.S. for use in pediatric patients.
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Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced overall survival (OS) results from the Phase 3 MAIA (NCT02252172) study showing the addition of DARZALEX® (daratumumab) to lenalidomide and dexamethasone (D-Rd) resulted in a statistically significant survival benefit over lenalidomide and dexamethasone (Rd) alone in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for autologous stem cell transplant (ASCT) and were treated to progression. The prespecified interim analysis for OS found that after a median follow-up of nearly five years (56.2 months), a 32 percent reduction in the risk of death was observed in the D-Rd treatment arm vs. Rd arm.
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Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced primary results from the pivotal Phase 3 GLOW study (NCT03462719) evaluating fixed-duration IMBRUVICA® plus venetoclax (I+V) compared to chlorambucil plus obinutuzumab (Clb+O) for first-line treatment of elderly or unfit patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study demonstrated superior progression-free survival (PFS) of a once-daily, all-oral, fixed-duration regimen of I+V versus Clb+O as first-line treatment of CLL; the study also showed improved duration of remission and significantly improved depth of remission.
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The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Bridgewater-based BioNJ Member Eli Lilly and Company's investigational antibody therapy for Alzheimer's disease (AD). The Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval. The FDA Breakthrough Therapy designation is based on clinical evidence for donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG.
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Bridgewater-based BioNJ Member Eli Lilly will be conducting a head-to-head study comparing once-monthly injectable Emgality® (galcanezumab-gnlm) with Nurtec® ODT (rimegepant), an orally disintegrating tablet patients take every other day. CGRP is a protein in the brain thought to play a key role in migraine. Emgality binds to this protein, preventing it from attaching to the CGRP receptors, whereas Nurtec ODT blocks the receptor for this protein. This study aims to answer important questions that will help clinicians and patients make more informed treatment decisions on the path to more migraine-free days.
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Bridgewater-based BioNJ Member Eli Lilly launched Think Talk Treat Migraine™, a new initiative to empower people living with migraine and their primary care providers to recognize key symptoms of migraine and have better conversations about the disease that can lead to proper diagnosis and treatment. The initiative is currently in pilot stage -- available in four metropolitan areas -- Hartford/New Haven (Connecticut), Raleigh/Durham (North Carolina), Indianapolis (Indiana) and Denver (Colorado) -- and provides people living with migraine and their health care providers with simple resources to think about, talk about and treat migraine.
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Princeton-based BioNJ Member Evotec SE announced that the company has launched an initiative for pandemic preparedness ("PRROTECT"). PRROTECT leverages a comprehensive set of novel projects and technologies to be better prepared for and respond faster to viral pandemics of the future. Virus outbreaks that can develop into dynamic pandemics are a permanent global threat. Besides preventive measures and vaccines, highly effective therapeutics are the backbone of any pandemic response. Evotec's PRROTECT initiative includes the development and delivery of superior novel therapeutics to curb the next viral pandemic.
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Kenilworth-based BioNJ Member Merck & Co. announced that LYNPARZA has been granted conditional approval in China as monotherapy for the treatment of adult patients with germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment that included a new hormonal agent (abiraterone, enzalutamide). The approval by the Chinese National Medical Products Administration was based on a subgroup analysis of the Phase 3 PROfound trial which showed that LYNPARZA demonstrated a substantial improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus abiraterone or enzalutamide in men with BRCA1/2 mutations.
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Kenilworth-based BioNJ Member Merck & Co. announced the creation of the Kenneth C. Frazier Award for Maternal Health Equity, a grant award that will be bestowed annually to one organization in recognition of its commitment to and progress toward more equitable, high-quality maternal health care. The award will be granted by Merck for Mothers, Merck's global initiative to help create a world where no woman has to die while giving life. The Kenneth C. Frazier Award for Maternal Health Equity is named in recognition of the legacy and commitment to maternal health by Kenneth C. Frazier, Chairman and Chief Executive Officer, Merck.
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Kenilworth-based BioNJ Member Merck & Co. announced that the pivotal Phase 3 KEYNOTE-826 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with platinum-based chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin) with or without bevacizumab, met its primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of patients with persistent, recurrent or metastatic cervical cancer. Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA plus platinum-based chemotherapy with or without bevacizumab demonstrated statistically significant and clinically meaningful improvements in OS and PFS compared to the same platinum-based chemotherapy regimens with or without bevacizumab alone, regardless of PD-L1 status; KEYTRUDA is the first anti-PD-1/PD-L1 therapy to demonstrate this.
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Bridgewater-based BioNJ Member Sanofi announced the European Commission (EC) has approved Aubagio® (teriflunomide) for the treatment of pediatric patients 10 to 17 years of age with relapsing-remitting multiple sclerosis (RRMS). The EC approval is based on data from the Phase 3 TERIKIDS study. The approval confirms Aubagio as the first oral multiple sclerosis (MS) therapy for first-line treatment of children and adolescents with MS in the European Union. Aubagio was initially approved in the EU in 2013 for the treatment of adult patients with RRMS and the EC approval for the pediatric indication provides an additional year of marketing protection in the European Union.
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Bridgewater-based BioNJ Member Sanofi announced results from Part A of CADENZA, a pivotal Phase 3 double-blind, placebo-controlled study evaluating the safety and efficacy of sutimlimab in people with cold agglutinin disease (CAD) without a recent history of blood transfusion (within the prior six months). The data demonstrated treatment with sutimlimab resulted in rapid and sustained inhibition of C1-activated hemolysis in people with CAD, noted within one week of treatment, and clinically significant improvements in hemoglobin and fatigue when compared to placebo during the course of the study.
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Sanofi Pasteur, the vaccines global business unit of Bridgewater-based BioNJ Member Sanofi and Translate Bio have initiated a Phase 1 clinical trial evaluating an mRNA-based investigational vaccine against seasonal influenza. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. Flu seasons that are dominated by A/H3N2 strain circulation activity tend to be more severe, especially among those considered at-risk such as older adults and younger children. Sanofi and Translate Bio have developed and will evaluate two formulations of the vaccine (MRT5400 and MRT5401) in the Phase 1 influenza mRNA vaccine clinical trial.
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Morris Plains-based BioNJ Member Gilead Sciences, Inc. announced positive data from three retrospective studies of the real-world treatment of patients hospitalized with COVID-19, adding to the body of mortality and hospital discharge data for patients treated with Veklury® (remdesivir). All three of the real-world analyses observed that, in the overall patient populations, patients who received Veklury treatment had significantly lower risk for mortality compared with matched controls. A reduction in mortality was observed across a spectrum of baseline oxygen requirements. The results were consistently observed at different timeframes over the course of the pandemic and across geographies. Two of the studies also observed that patients who received Veklury had a significantly increased likelihood of discharge from the hospital by Day 28.
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Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has granted full Marketing Authorization for Onureg® (azacitidine tablets) as a maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT). Onureg is the first and only once-daily, frontline oral maintenance therapy to demonstrate significant overall survival and show a relapse-free survival benefit in patients with a broad range of AML subtypes.
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Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has granted full Marketing Authorization for Onureg® (azacitidine tablets) as a maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT). Onureg isthe first and only once-daily, frontline oral maintenance therapy to demonstrate significant overall survival and show a relapse-free survival benefit in patients with a broad range of AML subtypes.
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Princeton-based BioNJ Member Bristol Myers Squibb and Eisai Co., Ltd. announced that the companies have entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC). MORAb-202 is Eisai's first ADC and combines Eisai's in-house developed anti-folate receptor alpha (FRα) antibody, and Eisai's anticancer agent eribulin, using an enzyme cleavable linker. It is a potential best-in-class FRα ADC with a favorable pharmacology profile and demonstrated single agent activity in patients with advanced solid tumors. Eisai is currently investigating MORAb-202 in FRα-positive solid tumors (inclusive of endometrial, ovarian, lung and breast cancers) in two studies: a Phase 1 clinical study in Japan and a Phase 1/2 clinical study in the United States.
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Woodcliff Lake-based Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD). The FDA's Breakthrough Therapy designation for lecanemab is based on the recently published results of a Phase 2b clinical trial (Study 201) of 856 patients with mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology. The proof-of-concept Study 201 explored the impact of treatment with lecanemab on reducing brain amyloid beta (Aβ) and clinical decline.
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Bedminster-based Mallinckrodt plc announced that the U.S. Food and Drug Administration has approved StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen - dsat) for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns). The FDA approval is supported by data from the pivotal Phase 3 STRATA2016 clinical trial of a single application of StrataGraft in patients with acute thermal burns containing intact dermal elements (deep partial-thickness burns) involving 3%-37% total body surface area, which was conducted at U.S. burn centers. Results showed a significantly smaller area of burn wounds treated with StrataGraft required autografting by 3 months compared to the area of burn wounds treated exclusively with autograft (p<0.0001).
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Basking Ridge-based Regeneron Pharmaceuticals, Inc. welcomed positive results from the largest trial assessing any monoclonal antibody treatment in patients hospitalized with severe COVID-19. The UK RECOVERY trial found that adding investigational REGEN-COV™ to usual care reduced the risk of death by 20% in patients who had not mounted a natural antibody response on their own against SARS-CoV-2, compared to usual care on its own. RECOVERY is the first trial large enough to definitively determine whether REGEN-COV reduces mortality in patients hospitalized with severe COVID-19. Previous Phase 3 trials in non-hospitalized COVID-19 patients have shown that REGEN-COV reduced viral levels, shortened the time to resolution of symptoms and significantly reduced the risk of hospitalization or death.
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Warren-based GlaxoSmithKline and iTeos Therapeutics announced an agreement to co-develop and co-commercialise EOS-448, an anti-TIGIT monoclonal antibody currently in phase I development as a potential treatment for patients with cancer. TIGIT, part of the CD226 checkpoint axis, has demonstrated potential as a promising target for the next generation of immuno-oncology therapies based on compelling preclinical data and a phase II randomised clinical trial. With this collaboration GSK is uniquely positioned with access to antibodies that synergistically target all three known CD226 checkpoints -- TIGIT, CD96 and PVRIG.
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Warren-based GlaxoSmithKline and Vir Biotechnology, Inc. announced final, confirmatory results from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial demonstrating that sotrovimab, an investigational SARS-CoV-2 monoclonal antibody, significantly reduced the risk of hospitalisation or death among high-risk adult outpatients with mild-to-moderate COVID-19. Additionally, the U.S. National Institutes of Health (NIH) updated its COVID-19 treatment guidelines to recommend sotrovimab for non-hospitalised patients with mild-to-moderate COVID-19 who are at high risk of clinical progression and noted that sotrovimab appears to retain activity against current variants of concern and interest.
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Daiichi Sankyo Company, with offices in Basking Ridge, announced that Daiichi Sankyo Biotech Co., Ltd. has made its shipment of VAXZEVRIATM Intramuscular Injection, a vaccine against novel coronavirus (development code, AZD1222; hereinafter, COVID-19 vaccine) developed by AstraZeneca K.K. This shipment of the COVID-19 vaccine is to be provided to Southeast Asian countries and other regions through the Japanese Government. The Japanese government has announced that it will supply 30 million doses of AstraZeneca's COVID-19 vaccine to various countries and regions through COVAX and through other means.
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Daiichi Sankyo Company, with offices in Basking Ridge, and AstraZeneca announced that the first patient was dosed in DESTINY-Breast09, a global head-to-head Phase 3 trial evaluating the safety and efficacy of ENHERTU® (trastuzumab deruxtecan) with or without pertuzumab compared to standard of care (THP: taxane, trastuzumab and pertuzumab) as a potential first-line treatment in patients with HER2 positive metastatic breast cancer. This is the first trial to evaluate ENHERTU in the first-line metastatic setting in patients with HER2 positive breast cancer. Many patients with HER2 positive metastatic breast cancer have aggressive disease due to progression from an earlier stage, with a significant proportion having their disease relapse after receiving THP or other standard anti-HER2 therapies in an adjuvant setting.
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Ridgefield Park-based BeiGene, Ltd. announced that the first patient was dosed in the global Phase 3 AdvanTIG-302 trial of BeiGene's investigational anti-TIGIT antibody ociperlimab (BGB-A1217) in combination with its anti-PD-1 antibody tislelizumab, for the first-line treatment of patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations. This marks the initiation of the first Phase 3 clinical trial in the planned global pivotal program for ociperlimab.
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Ridgefield Park-based BeiGene, Ltd. presented results from the interim analysis of the Phase 3 ALPINE trial comparing its BTK inhibitor BRUKINSA® (zanubrutinib) to ibrutinib in adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), including superiority in the primary endpoint of investigator-assessed overall response rate (ORR) and superiority in a key secondary endpoint of atrial fibrillation or flutter. "While ibrutinib has transformed the outlook for patients with chronic lymphocytic leukemia, or CLL, not all patients respond to treatment and toxicities associated with prolonged exposure remain an issue," commented Peter Hillmen, MBChB, Ph.D., Professor of Experimental Haematology at University of Leeds and Principal Investigator of the ALPINE trial.
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Ridgefield Park-based BeiGene, Ltd. announced that the China National Medical Products Administration (NMPA) has granted its anti-PD-1 antibody tislelizumab approval for the first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC) and conditional approval for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with at least one systemic therapy. "With today's approvals, tislelizumab is now available in China in five indications covering lung, liver, bladder, and lymphoma, and is becoming an important immunotherapy in the world's most populous country," commented
Xiaobin Wu, Ph.D., President, Chief Operating Officer and General Manager of China at BeiGene.
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Ridgefield Park-based BeiGene, Ltd. announced that BRUKINSA® (zanubrutinib) has received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of adult patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy. The supplemental new drug application was previously granted priority review by the Center for Drug Evaluation (CDE) of the NMPA in October 2020. The conditional approval granted by the NMPA was based on findings from a single-arm pivotal Phase 2 trial (NCT03332173) in China evaluating the safety and efficacy of BRUKINSA in patients with WM who have received at least one prior therapy.
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Ridgefield Park-based BeiGene, Ltd. announced that the China National Medical Products Administration (NMPA) has granted its anti-PD-1 antibody tislelizumab approval for the first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC) and conditional approval for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with at least one systemic therapy. "With today's approvals, tislelizumab is now available in China in five indications covering lung, liver, bladder, and lymphoma, and is becoming an important immunotherapy in the world's most populous country," commented
Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene.
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Ridgefield Park-based BeiGene, Ltd. announced that the first patient was dosed in the global Phase 3 AdvanTIG-302 trial of BeiGene's investigational anti-TIGIT antibody ociperlimab (BGB-A1217) in combination with its anti-PD-1 antibody tislelizumab, for the first-line treatment of patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations. This marks the initiation of the first Phase 3 clinical trial in the planned global pivotal program for ociperlimab.
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Bedminster-based Aerie Pharmaceuticals, Inc. announced the completion of patient enrollment for its first Phase 3 clinical trial of netarsudil ophthalmic solution in Japan, comparing netarsudil ophthalmic solution 0.02% ("netarsudil"), administered once a day in the evening, to ripasudil hydrochloride hydrate ophthalmic solution 0.4% ("ripasudil"), marketed as Glanatec® in Japan, administered twice a day, in the morning and evening. The first patient to enter this randomized, single-masked, multi-center, parallel-group Phase 3 study was dosed in early December 2020. A total of 245 patients were successfully randomized across the netarsudil and ripasudil treatment arms.
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Paramus-based Brainstorm Cell Therapeutics Inc. announced the grant and/or allowance of a series of patents and patent applications. These patents and patent applications, which were granted/allowed in 2020 and 2021, are expected to provide broad protection for Brainstorm's proprietary NurOwn® (MSC-NTF cells) technology in territories including the U.S., E.U., Canada, Israel and Hong Kong. "We continue to see success developing a comprehensive global patent portfolio for NurOwn and these latest patents further strengthen our overall IP position in major markets," said Chaim Lebovits, Chief Executive Officer of Brainstorm Cell Therapeutics.
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Avalon GloboCare Corp., a Freehold-based developer of cell-based technologies, has agreed to acquire a Chinese cell therapy company. Avalon said that it will issue 81 million shares of common stock to acquire Hebei Senlang Biotechnology Co. Ltd., and then will sell a 15.6% equity stake to an institutional health care investor for approximately $30 million. SenlangBio's core platforms include CAR-T cells and other candidates for solid tumors and hematologic malignancies. The deal also will include SenlangBio Clinical Laboratory, a subsidiary that provides clinical testing services, and the company's 16,000-square-foot biomanufacturing facility.
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Catalent, the Somerset-based provider of drug delivery technologies and solutions, has agreed to acquire a German developer and manufacturer of stem cells. The company said that the deal for RheinCell Therapeutics GmbH will build on its existing custom cell therapy development and manufacturing capabilities. The German company's employees will join Catalent's Cell & Gene Therapy business. "This latest acquisition fuels the extraordinary growth of Catalent Cell & Gene Therapy, and the expertise and deep knowledge in iPSC cell lines that RheinCell brings will immediately boost our cell therapy portfolio, allowing us to offer iPSC banks to our customers as a premium source for their therapeutic development pathway," said Manja Boerman, President of Catalent Cell & Gene Therapy.
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| People in the News |  |
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Daniel J. O'Connor, J.D.,CEO & President & Director, OncoSec Medical, Inc. & BioNJ Board Member Featured on "Business of Biotech"
Before earning his law degree and crafting a career as a biotech entrepreneur, Daniel O'Connor, J.D. was Marine Captain Daniel O'Connor. He earned that rank in Saudi Arabia, where he was deployed to serve Operation Desert Shield just days following Iraq's invasion of Kuwait. On a recent episode of the "Business of Biotech" podcast, he shared how being a Marine prepared him for leadership of a blossoming biopharma company.
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Princeton-based BioNJ Member Amicus Therapeutics announced the election and appointment of Eiry W. Roberts, M.D. to its Board of Directors. Dr. Roberts is an esteemed drug developer who brings approximately 30 years of pharmaceutical industry experience to the Company's Board of Directors, having served in various leadership positions throughout her career and bringing extensive experience advancing therapies across all phases of drug development. Dr. Roberts currently serves as the Chief Medical Officer of Neurocrine Biosciences, a commercial stage biopharmaceutical company focused on the research and development of treatments for life threatening and under-addressed neurological, endocrine and psychiatric disorders.
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Kenilworth-based BioNJ Member Merck & Co. announced that Michael Klobuchar has been appointed Executive Vice President and Chief Strategy Officer, a newly created role, effective July 5, 2021. As Chief Strategy Officer, Mr. Klobuchar will become a member of Merck's Executive Committee and lead the advancement and execution of the company's strategy. "Our company's strength lies in the insight and expertise of our team and our unrelenting commitment to creating and deploying new medicines and vaccines that address important human and animal health needs," said Rob Davis, President, Merck.
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Warren-based Aquestive Therapeutics Inc. has named its interim Chief Financial Officer to the full-time post. A. Ernest "Ernie" Toth, Jr., who joined the Warren-based pharmaceutical company as interim CFO in December, has transitioned to the permanent role of Senior Vice President and CFO. "Ernie is a seasoned and experienced financial executive," Keith Kendall, CEO and President. "He has become a valued member of our team and an important part of our external relationships in the financial community. We look forward to the effective leadership of the financial functions of the company that Ernie will bring."
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Bedminster-based Aerie Pharmaceuticals, Inc. announced the appointment of Frank Estrada, Ed.D., as Director, Salesforce Training, reporting to Evan Hockman, Aerie's Vice President of Sales. Dr. Estrada will design, develop and implement the training curriculum for both Territory Sales Managers and the Sales Management Team across the United States. He most recently held a related position at Agendia Inc. In connection with his acceptance of the position as Director, Salesforce Training,
Dr. Estrada will receive awards totaling 16,900 stock options that will vest over 4 years, with 25% vesting on the first anniversary of the hire date and the remainder vesting ratably on each of the subsequent 36 monthly anniversaries of the hire date.
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Integra LifeSciences' CEO and President is leaving at year-end to become CEO and president of GE Healthcare, the Princeton-based company. The medical technology company has begun a formal search to replace Peter Arduini, who will stay on through Dec. 31 or until a new CEO and President is named. "On behalf of our entire organization, I want to thank Pete for his inspirational leadership and dedication over the past 11 years," Stuart Essig, Chairman of the Board. "Pete has been instrumental in transforming and shaping Integra into the company it is today -- a mission-driven organization positively impacting the lives of millions of patients annually."
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| Institution and Education News |  |
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CaroGen Corporation has selected BioCentriq™ as their partner for clinical manufacturing to support Phase 1 clinical trials of its lead immunotherapy candidate, CARG-201 which has been designed to generate multiple hepatitis B virus (HBV) antigens and to stimulate broad immune responses. BioCentriq™ is a New Jersey based full-service concept-to-clinic contract development manufacturing organization (CDMO) with a mission to support innovative companies reach clinical success. "CaroGen's mission is to develop transformative immunotherapies that will recognize and fight infectious diseases of unmet need, like those generated by HBV, that result in chronic liver conditions and cancer" said Bijan Almassian, Ph.D., CaroGen's Co-Founder and CEO.
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At a lab at Rutgers University, Dr. Zeeshan Ahmed works on a field of research, called precision medicine, that exudes all the usual promise of a really big idea. In this case, it bears health care-revolutionizing potential. In more practical terms, the real-world impact of this area of study on the practice of medicine has been ... imprecise, to put it kindly. Although it faces some ongoing hurdles to implementation, Dr. Ahmed is confident that the insights of precision medicine -- and the artificial intelligence and machine learning emphasis his team puts on it at his Rutgers lab -- are increasingly useful to a pandemic-stressed health care system.
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Giuseppe R. Palmese, Ph.D., will join Rowan University as the next Dean of the Henry M. Rowan College of Engineering. Formerly Interim Dean of Drexel University's College of Engineering and longtime head of its Chemical and Biological Engineering Department, Dr. Palmese is a distinguished university professor of chemical engineering and the first George B. Francis Professor of Engineering at Drexel in Philadelphia, where he has served on the faculty since 2000. He is also professor of materials science and engineering by courtesy.
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Tiny genetic markers, circulating in the blood, have shown great promise in diagnosing and treating disease. Yet identifying and harvesting these extracellular vesicles (EVs) have been a major challenge for science. Now a laboratory at the Hackensack Meridian Center for Discovery and Innovation (CDI) in Nutley has discovered a highly sensitive methodology that can efficiently find and harness EVs -- particularly exosomes and the micro RNAs they carry. These could be crucial clues to identifying diseases such as cancer early on in its development.
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The John Theurer Cancer Center at Hackensack University Medical Center announced an affiliation with Regional Cancer Care Associates in Toms River -- an agreement that Hackensack Meridian Health officials feel will bring the advanced therapies and groundbreaking clinical trials of the Theurer Center to Toms River. The new affiliation, located at the Toms River Regional Cancer Center at 40 Bey Lea Road, will also provide better access to Jersey Shore University Medical Center surgical services and Centers of Excellence in lung, esophageal and hepatobiliary and pancreatic cancer, in addition to a surgical team in endocrine, breast, colorectal and gynecological oncology.
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| Events |  |
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A panel of distinguished entrepreneurs and business leaders will discuss how you can make a positive impact and build resilience in your community-and why it's important -- as we enter the "next normal."
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| BioNJ Member Services Provider Directory |  |
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BioNJ recognizes the vital role that our Service Provider Members play in the growth of New Jersey's robust life sciences ecosystem. For this reason, we are delighted to remind our community about BioNJ's Member Service Provider Directory, a categorical listing of BioNJ Members by service sector. By working with fellow BioNJ Member organizations, you are not only supporting our community, but benefiting from a wide variety of high quality organizations. To learn how you can become a Member and be featured on this resource tool, please contact Kim Minton at [email protected], or 609-890-3185. Find providers in these categories:
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