Welcome to the latest edition of the BioLines Weekender...
 
Core to BioNJ's mission is helping companies find the talent they need to ensure New Jersey's life sciences ecosystem has the required expertise to drive medical innovation forward. With this in mind, BioNJ's Talent Services Career Portal was specifically designed to bring together top talent with leading companies in the New Jersey region. 

Featuring a state-of-the-art platform, both job seekers and hiring managers benefit from a sophisticated search engine as well as many user-friendly features. BioNJ's Talent Services Career Portal has quickly become THE place where life sciences applicants are going to find their next job opportunity. Click here to take a look for yourself!

All job seekers are invited to post your resumes for free -- allowing hiring managers to find you easily. Meanwhile, BioNJ Members who are looking for talent can post jobs at a discounted rate! Contact Peggy Schell at [email protected] to learn more. 
 
Meanwhile, the BioNJ Team is busy planning for our fall calendar of events and look forward to seeing you -- including at the C-Suite Summit, our first in-person event on October 15! Click here for the 2021 schedule. And, contact Kim Minton at [email protected] to learn about our broad offering of sponsorship opportunities.

Because Patients Can' Wait®,
The BioNJ Team

BioNJ Calendar

Human Resources Briefing
September 9, 2021
Manufacturing Briefing: Pandemic-Induced Innovation & Adaptation
September 29, 2021
C-Suite Summit: Transitioning to the "Next Norm" (BioNJ's First In-Person  Event!)
October 15, 2021
Putting Patients First: The Value of Medical Innovation

The pandemic has illustrated just how valuable the biopharmaceutical industry truly is, both in terms of the health care it provides and the economy it sustains. As a major asset to our State, New Jersey drug companies not only have our gratitude, but deserve our continued support. Unfortunately, government officials' recent legislative activity could undercut those efforts. Recently, members of the New Jersey Legislature introduced A2418, a piece of legislation intended to tamp down on health care costs throughout the State. To do that, the bill would establish a Prescription Drug Affordability Board -- an entity imbued with the authority to institute "upper payment limits," or price controls, on prescription medications purchased by or on behalf of the State.

Rapid advances in scientific discovery have ushered in a new era of medicine, transforming our ability to treat, and in some cases cure, many of the most challenging diseases, including cancer, rare diseases and autoimmune conditions. Over the past year, America's biopharmaceutical companies have played a critical role in the global response to COVID-19. The unprecedented speed of developing new treatments and vaccines is due in large part to the productivity of the United States' biomedical research ecosystem, which is sustained by a policy framework designed to support and advance the innovation of new medicines.

While more than 90% of seniors and people with disabilities report that they are very satisfied with their Medicare Part D prescription drug coverage, they also acknowledge concerns with rising out-of-pocket costs. It is no surprise that this has been a recurring discussion on Capitol Hill with many putting forth proposals aimed at lowering the cost of medicines, including principles released by Senator Wyden just last week. Unfortunately, many of these so-called Medicare "negotiation" proposals would create more problems at a time when we can least afford them.

During the COVID-19 pandemic, people have been exposed to an abundance of information from a large number of sources. Amid all this information, many people have also been exposed to health misinformation: information that is false, inaccurate, or misleading according to the best available evidence at the time. Misinformation has caused confusion and led people to decline COVID-19 vaccines, reject public health measures such as masking and physical distancing, and use unproven treatments. Although health misinformation is not a recent phenomenon, in recent years it has spread at unprecedented speed and scale, especially online. But, together, we have the power to build a healthier information environment where we make more informed decisions about our health and the health of our loved ones and communities.

Pride of New Jersey

Life sciences lab space has emerged as a coveted sector of commercial real estate as hefty increases in funding and employment have fueled both demand for lab space and construction of it in leading U.S. life sciences markets, according to a new report from CBRE. One of the top life sciences clusters in Q1 2021 was in New Jersey, which boasts 20.4 million square feet of lab and R&D space. According to the report, net lease pricing (tenant agrees to pay rent and any additional cost associated with the property) for lab space in New Jersey increased between 10% and 15% since mid-2020, showing the tremendous demand for space.

NJ Company News

Monmouth Junction-based BioNJ Member Advaxis Inc. will merge with Israeli pharma development firm Biosight Ltd. under a definitive agreement. The new public company will be majority-owned by Biosight shareholders after the stock transaction, and Advaxis will be renamed Biosight Therapeutics. The company will prioritize the clinical advancement and commercialization of Biosight's lead product, the cancer drug aspacytarabine, or BST-236. "We believe the combined company's strong and diversified oncology pipeline, with late-stage and early stage assets, near-term milestones, seasoned leadership team and focus on both hematological malignancies and solid tumors have the potential to provide transformative benefits to patients while also providing value to our stockholders," said Kenneth A. Berlin, Advaxis' CEO, President and interim CFO.

Monmouth Junction-based BioNJ Member Advaxis, Inc. announced the initiation of its Phase 1 clinical study evaluating ADXS-504 in patients with biochemically recurrent prostate cancer. The study, being conducted at Columbia University Irving Medical Center, is the first clinical evaluation of ADXS-504, Advaxis' off-the-shelf neoantigen immunotherapy drug candidate for early prostate cancer. The Phase 1 open-label dose escalation study will evaluate the safety and tolerability of two dose levels (1e7 and 1e8 CFU) of ADXS-504 monotherapy, administered via infusion every four weeks for six total doses in 9-18 patients with biochemically recurrent prostate cancer (i.e., those with elevation of prostate-specific antigen (PSA) in the blood after radical prostatectomy or radical radiotherapy (external beam or brachytherapy) and who are not currently receiving androgen ablation therapy). 

Cranbury-based BioNJ Member Rafael Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for CPI-613® (devimistat) for the treatment of biliary cancer. Biliary cancer, which includes gallbladder cancer and bile duct cancer (which is also known as cholangiocarcinoma), is classified as a rare disease, affecting just 12,000 people in the United States each year, respectively. Biliary cancer appears when cancer cells form in the bile ducts or gallbladder, an essential aspect of the gastrointestinal system.

Berkeley Heights-based BioNJ Member Cyclacel Pharmaceuticals, Inc. announced dosing of the first patient in the company's multi-cohort Phase 1/2 study of oral fadraciclib in patients with advanced solid tumors. "Advancing oral fadraciclib, our lead candidate, into this Phase 1/2 trial, represents a key clinical milestone and corporate objective for our team," said Spiro Rombotis, Cyclacel's President and Chief Executive Officer. "This is the first of four streamlined Phase 1/2 studies we plan to open over the coming months as we expand our clinical programs to evaluate the potential of fadraciclib and CYC140, our oral PLK1 inhibitor, first in solid tumors and lymphomas and then in leukemias."

Princeton-based BioNJ Member Oyster Point Pharma, Inc. announced preclinical data in non-human primates and in vitro models evaluating OC-01 (varenicline) nasal spray against SARS-CoV-2 and the alpha and beta variants, the viruses that cause COVID-19 disease. Administration of OC-01 (varenicline) nasal spray, a highly selective nicotinic acetylcholine receptor agonist, protected rhesus macaques against SARS-CoV-2 nasal infection. "We believe this is the first in vivo and in vitro data illustrating a nicotinic acetylcholine receptor agonists' potential to inhibit viral entry and disrupt replication of the SARS-CoV-2 virus and variants," said Jeffrey Nau, Ph.D., MMS, President and CEO of Oyster Point.

North Brunswick-based BioNJ Member BioAegis Therapeutics Inc. announced that it was awarded a contract from Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to further develop the company's novel host-directed therapy for the critically ill sepsis patient population. The DRIVe (BARDA's Division of Research, Innovation and Ventures) Solving Sepsis initiative seeks innovative host-based approaches for the development of diagnostics, devices and therapeutics. BioAegis offers a novel recombinant protein therapy with the potential to broadly treat inflammatory disorders, like sepsis, that can arise from injury or infection. 

Lawrenceville-based BioNJ Member Celsion Corporation announces commencement of enrollment in Oxford University's Phase I PanDox study with ThermoDox® in conjunction with Focused Ultrasound in patients with pancreatic cancer. ThermoDox® is Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin. This investigator-led study sponsored by the University of Oxford and supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre has now received ethics, MHRA and institutional R&D approval to commence. The PanDox study is expected to be completed by December 2022 and is similar in design to Oxford's 10-patient TARDOX study, which demonstrated that ThermoDox® plus focused ultrasound increased doxorubicin tumor concentrations by up to 10-fold and enhanced nuclear drug uptake in patients with liver tumors. 

Nutley-based BioNJ Member Y-mAbs Therapeutics, Inc. announced that the Committee for Orphan Medicinal Products of the European Medicines Agency has recommended the granting of orphan medicinal product designation in the European Union for Lu-omburtamab-DTPA for the treatment of medulloblastoma. The positive opinion from the EMA's COMP has been sent to the European Commission, which is expected to grant the orphan drug designation within 30 days. Obtaining OMPD for 177Lu-omburtamab-DTPA is part of an overall plan to expand the company's European development programs and ultimately obtain orphan drug exclusivity to protect 177Lu-omburtamab-DTPA for the treatment of medulloblastoma in the EU.

Cherry Hill-based BioNJ Member Vyant Bio, Inc. announced that its wholly-owned subsidiary, StemoniX, Inc., was issued US Patent No. 11054408, titled "High Throughput Optical Assay of Human Mixed Cell Population Spheroids" by the United States Patent and Trademark Office (USPTO). The patent covers a unique approach to applying human-induced Pluripotent Stem Cells (iPSCs) as a powerful tool to illuminate the biology of complex human cell types such as those of the central nervous system (CNS). Human iPSC-based, high-throughput platforms have lacked reliability and functional consistency. 

Cranbury-based BioNJ Member Palatin Technologies, Inc. announced the completion of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for PL9643 for the treatment of dry eye disease (DED). The EOP2 meeting scope included all aspects of PL9643's development plan, with the FDA and Palatin reaching agreement on all key elements of a pivotal Phase 3 clinical program, including study design, endpoints, interim assessment and patient population. In addition, a potential second Phase 3 study and long-term safety study were discussed to support a New Drug Application (NDA). Palatin remains on track to initiate the Phase 3 program in DED patients during the fourth quarter of calendar year 2021. 

Hampton-based BioNJ Member Celldex Therapeutics, Inc. announced updated data from the company's ongoing, open label Phase 1b clinical trial of CDX-0159 in patients with antihistamine refractory cold urticaria and symptomatic dermographism, the two most common forms of chronic inducible urticaria. These diseases, which are often severe and debilitating, can significantly impact patients' lives. CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. All 19/19 (100%) patients who received a single full dose of CDX-0159 experienced a clinical response to provocation testing. 18/19 (95%) experienced a complete response and 1/19 (5%) experienced a marked partial response.

Hampton-based BioNJ Member Celldex Therapeutics, Inc. announced that it is proposing to offer and sell, subject to market conditions, $175 million of shares of its common stock in an underwritten public offering. Celldex expects to grant the underwriters a 30-day option to purchase up to an additional $26.25 million of shares of common stock offered in the public offering. All of the shares of common stock are being offered by the company. Celldex intends to use the net proceeds from the offering to continue clinical and preclinical development of its product candidates and for general corporate purposes. 

Florham Park-based BioNJ Member Celularity Inc. announced expansion of its ongoing Phase 1 clinical trial of CYNK-001 in AML (NCT04310592) to include patients with relapsed/refractory AML (r/r AML) in addition to its ongoing trial in patients with MRD. "The absence of dose limiting toxicity to date in the Phase 1 trial enables us to continue with our scheduled dose escalation and to expand the trial to include patients with r/r AML," said Robert J. Hariri, M.D., Ph.D., Founder, Chairman and CEO at Celularity. 

Florham Park-based BioNJ Member Celularity Inc. announced the companies have entered into an exclusive partnership to distribute and commercialize Celularity's biomaterial products for orthopedic surgery and sports medicine.  Under the terms of the agreement, Celularity will provide Arthrex with exclusive commercial distribution rights for orthopedic surgery and sports medicine and will continue to be responsible for product manufacturing and supply. Stephen A. Brigido, D.P.M., President of Celularity's Degenerative Diseases Division, said, "Arthrex is highly innovative, progressive, and committed to new product development. Our shared commitment to medical and surgical education creates important cultural synergies between the two companies." 

Edison-based BioNJ Member Hepion Pharmaceuticals, Inc. announced positive topline results from its Phase 2a 'AMBITION' NASH clinical trial. All primary endpoints of the trial were met. AMBITION was a Phase 2a randomized, multi-center, placebo controlled, single-blind trial designed to investigate once daily oral administration of CRV431 at doses of 75 mg and 225 mg administered as soft gelatin capsules to presumed F2 and F3 NASH subjects for 28 days, followed by a 14-day observation period for safety. The primary outcome measure of the AMBITION trial was the incidence of safety and tolerability events of CRV431 versus placebo. 

Pennington-based BioNJ Member OncoSec Medical Incorporated announced it has entered into a Clinical Trial Collaboration and Supply Agreement with Kenilworth-based BioNJ Member Merck to evaluate the combination of OncoSec's DNA-plasmid interleukin-12 (IL-12) TAVO™ (tavokinogene telseplasmid) with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in a global Phase 3 randomized clinical trial, KEYNOTE-C87. The planned clinical trial will evaluate the overall survival of patients treated with the TAVO™ in combination with KEYTRUDA® versus standard of care in late-stage patients with metastatic melanoma who are refractory to immune checkpoint therapy.

Kenilworth-based BioNJ Member Merck & Co. announced that the European Commission (EC) has approved KEYTRUDA, Merck's anti-PD-1 therapy, in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10). This approval is based on results from the Phase 3 KEYNOTE-590 trial, in which KEYTRUDA plus 5-fluorouracil (5-FU) and cisplatin demonstrated statistically significant improvements in overall survival (OS) and progression-free survival (PFS) compared with 5-FU and cisplatin alone in all pre-specified  study populations.

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. This approval is based on data from the second interim analysis of the Phase 2 KEYNOTE-629 trial, in which KEYTRUDA demonstrated an objective response rate (ORR) of 50% (95% CI, 36-64) (n=54), including a complete response rate of 17% and a partial response rate of 33% in the cohort of patients with locally advanced disease. Among the 27 responding patients, 81% had a duration of response (DOR) of six months or longer, and 37% had a DOR of 12 months or longer. 

Kenilworth-based BioNJ Member Merck announced the presentation of data from the company's HIV clinical development program at the 11th International AIDS Society Conference on HIV Science. Presentations will feature new data for islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, which is currently being evaluated across a variety of doses, formulations and frequencies for both the treatment of HIV-1 infection in combination with other antiretroviral agents and for the prevention of HIV-1 infection as a monotherapy. These data include results from a late-breaking presentation from a Phase 2a study evaluating the safety and pharmacokinetics (PK) of once-monthly (QM) oral islatravir for pre-exposure prophylaxis (PrEP) through 24 weeks.

Berkeley Heights-based BioNJ Member Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca. The FDA grants Priority Review to applications for medicines that offer significant advantages over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act goal date for a decision by the FDA is during the first quarter of 2022.

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior fluoropyrimidine-based combination chemotherapy. The EC's decision is based on results from the Phase 2 CheckMate -142 trial in which Opdivo plus Yervoy demonstrated a clinically meaningful improvement in objective response rate (ORR) in patients with MSI-H/dMMR mCRC who received prior treatment with fluoropyridine, oxaliplatin and irinotecan. 

Access to the world's largest browsable resource linking rare protein-coding genetic variants to human health and disease was launched through a genetic exome sequence analysis collaboration between BioNJ Members AbbVie and Pfizer and Biogen Inc. Managed by the Broad Institute of MIT and Harvard, the browser gives access to results from analyses of whole exome sequencing data from 300,000 UK Biobank research participants. These genetic data have been paired with detailed health information to create this browsable resource. The collaboration between AbbVie, Biogen and Pfizer to make these data available highlights the importance of working together to advance science. 

Madison-based BioNJ Member AbbVie announced that upadacitinib (15 mg or 30 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all secondary endpoints at one-year (week 52) in the Phase 3 ulcerative colitis maintenance study. Significantly more upadacitinib-treated patients achieved clinical remission at week 52 compared to placebo (15 mg: 42 percent and 30 mg: 52 percent versus placebo: 12 percent; p<0.001). "Ulcerative colitis is a disease with unpredictable symptoms and frequent flares, which can make daily life challenging," said Michael Severino, M.D., Vice Chairman and President, AbbVie. "We are encouraged by these results that demonstrate upadacitinib's potential as a treatment option for patients with moderate to severe ulcerative colitis."

Plainsboro-based BioNJ Member Novo Nordisk A/S and Prothena Corporation announced that the companies have entered into a definitive purchase agreement under which Novo Nordisk has acquired Prothena's clinical stage antibody PRX004 and broader ATTR amyloidosis program. PRX004 is a phase 2ready anti-amyloid immunotherapy designed to deplete the amyloid deposits that are associated with the disease pathology of ATTR amyloidosis. ATTR amyloidosis is a rare, progressive and fatal disease characterised by the abnormal build-up of amyloid deposits composed of misfolded transthyretin protein in organs and tissues, most commonly the heart and/or nervous system.

Morris Plains-based BioNJ Member Gilead Sciences, Inc. announced that the company completed submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection. The submission is supported by data from the Phase 2/3 CAPELLA trial, which evaluated the safety and efficacy of lenacapavir administered subcutaneously every six months in combination with an optimized antiretroviral background regimen. 

The EMPEROR-Preserved Phase III trial met its primary endpoint, establishing Jardiance® (empagliflozin) as the first and only therapy to significantly reduce the risk of the composite of cardiovascular death or hospitalization for heart failure in adults, with or without diabetes, who live with heart failure with preserved ejection fraction (HFpEF). Bridgewater-based BioNJ Member Eli Lilly and Company and Boehringer Ingelheim announced the topline results. When added to the EMPEROR-Reduced trial results, these findings demonstrate Jardiance's efficacy in all forms of heart failure regardless of ejection fraction. The safety profile was generally consistent with the known safety profile of Jardiance.

Tirzepatide led to superior A1C and body weight reductions from baseline across all three doses in adults with type 2 diabetes after 40 weeks of treatment in Bridgewater-based BioNJ Member Eli Lilly Company's SURPASS-1 monotherapy clinical trial evaluating the efficacy and safety of tirzepatide compared to placebo. Study participants in SURPASS-1, 54.2 percent of whom were treatment-naïve, had a relatively short mean duration of diabetes of 4.7 years, a baseline A1C of 7.9 percent and a baseline weight of 85.9 kg. For the efficacy estimand, tirzepatide reduced A1C by up to 2.07 percent and body weight by up to 9.5 kg (20.9 lb., 11.0 percent) compared to placebo (+0.04 A1C change and body weight change of -0.7 kg [1.5 lb., 0.9 percent]).

Bridgewater-based BioNJ Member Eli Lilly announced new Phase 2 data showing that gene expression changes induced by mirikizumab in patients with ulcerative colitis (UC) over a 12-week induction treatment were maintained for up to one year. These gene transcript changes, which were unique among those who responded to mirikizumab compared to placebo, were associated with mucosal healing, indicating that mirikizumab affects a distinct molecular healing pathway, compared to the spontaneous healing that occurred among those who responded to placebo. Mirikizumab is being studied in Phase 3 trials for UC and Crohn's disease (CD), two forms of inflammatory bowel disease that can cause serious and debilitating symptoms, and disruptions in daily life.

Bridgewater-based BioNJ Member Eli Lilly and Banner Alzheimer's Institute announced a strategic research collaboration as part of the planned Phase 3, randomized, placebo-controlled study evaluating donanemab in participants at risk for cognitive and functional decline related to Alzheimer's disease (TRAILBLAZER-ALZ 3). TRAILBLAZER-ALZ 3 will evaluate whether treatment with donanemab can slow the clinical progression of Alzheimer's disease in trial participants. As part of the collaboration, Banner will leverage its expertise and proven leadership in Alzheimer's prevention trials, and support enrollment of trial participants with and without the e4 type of the apolipoprotein E (APOE4) gene through the Alzheimer's Prevention Registry's GeneMatch program. 

Parsippany-based Teva Pharmaceutical Industries Ltd. and Bioeq AG announced that they have entered into a strategic partnership for the exclusive commercialization of Bioeq's FYB201, a biosimilar candidate to Lucentis® (ranibizumab) in Europe, Canada, Israel and New Zealand. This strategic partnership combines Teva's long-standing commercial presence, extensive distribution network and wide-reaching sales and marketing activities across Europe and international markets with Bioeq's capabilities in the development of biosimilar drugs for highly regulated countries with stringent quality standards. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon AG.

Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson
announced new three-year data from the long-term extension (LTE) of the STELARA® (ustekinumab) Phase 3 UNIFI study. The data demonstrated the majority (55.2 percent) of adult patients with moderately to severely active ulcerative colitis (UC) who initially responded to treatment with STELARA sustained symptomatic remission rates at nearly three years (week 152). Furthermore, a majority (96.4 percent) of the patients in symptomatic remission at week 152 were corticosteroid-free. 

New Brunswick-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date. "Today's newly announced studies reinforce the ability of the Johnson & Johnson COVID-19 vaccine to help protect the health of people globally," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. 

Bridgewater-based BioNJ Member Sanofi announced that in positive topline results from the Phase 2/3 MEDLEY trial, nirsevimab showed a similar safety and tolerability profile compared to palivizumab when administered to preterm infants or those with chronic lung disease (CLD) or congenital heart disease (CHD) entering their first respiratory syncytial virus (RSV) season. Safety and tolerability were assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs). RSV, a seasonal virus that typically circulates in autumn through spring in temperate regions, is the most common cause of lower respiratory tract infections (LRTI) and the leading cause of hospitalizations in all infants.

Bridgewater-based BioNJ Member Sanofi announced a new study of Soliqua (insulin glargine 100 Units/mL and lixisenatide, iGlarLixi) met its two primary endpoints and all key secondary endpoints in a head-to-head comparison against premixed insulin (biphasic insulin aspart 30, BIAsp 30) in adults living with type 2 diabetes, the most common form of diabetes, uncontrolled on insulin and one or two oral anti-diabetic medicines. The study also met its key secondary endpoints with Soliqua achieving a greater proportion of people reaching a HbA1c target of <7% without weight gain, a greater proportion of people reaching a HbA1c target of <7% without weight gain and without hypoglycemia and superiority in reduction of HbA1c compared with those using premixed insulin.

Bridgewater-based BioNJ Member Sanofi and Regeneron Pharmaceuticals, Inc. announced that the European Medicines Agency will update the Dupixent® (dupilumab) summary of product characteristics (SmPC) adding long-term safety results for adults with moderate-to-severe atopic dermatitis based on a positive opinion by the Committee for Medicinal Products for Human Use (CHMP). Data from a single-arm Phase 3 open label extension (OLE) trial showed the long-term safety profile in adults with atopic dermatitis observed up to three years was generally consistent with what was observed in the controlled pivotal Phase 3 trials. The OLE trial assessed the long-term safety of Dupixent 300 mg weekly in adults who had previously participated in controlled Dupixent trials or had been screened for a Phase 3 trial. 

Basking Ridge-based Regeneron Pharmaceuticals, Inc. and Intellia Therapeutics, Inc. announced positive interim data from an ongoing Phase 1 clinical study of their lead in vivo genome editing candidate, NTLA-2001, which is being developed as a single-dose treatment for transthyretin (ATTR) amyloidosis. The Phase 1 study, run by Intellia as the program's development and commercialization lead, is evaluating NTLA-2001 in people living with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). NTLA-2001 is the first CRISPR/Cas9-based therapy candidate to be administered systemically, via intravenous infusion, for precision editing of a gene in a target tissue in humans.

Basking Ridge-based Regeneron Pharmaceuticals, Inc. announced that scientists from the Regeneron Genetics Center® (RGC) have discovered rare genetic mutations in the GPR75 gene associated with protection against obesity. As reported in Science, almost 650,000 people were sequenced to find rare individuals with this genetic 'superpower,' providing new insights into the genetic basis of obesity. Potential therapeutics mimicking these genetic superpowers are being developed at Regeneron, utilizing its VelecImmune technologies and novel technologies from collaborators such as Alnylam Pharmaceuticals, Inc.

Whippany-based Bayer announced the United States (U.S.) Food and Drug Administration (FDA) has approved KERENDIA® (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction (MI) and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). The approval is based on the results of the pivotal Phase III FIDELIO-DKD trial data that demonstrated positive kidney and cardiovascular outcomes in patients with CKD associated with T2D, published in the New England Journal of Medicine, and follows priority review designation granted by the FDA.

Woodcliff Lake-based Eisai Co., Ltd. and Biogen Inc. announced the U.S. Food and Drug Administration (FDA) has approved an updated label for ADUHELM™ (aducanumab-avwa) injection 100 mg/mL solution. The update includes an addition to the Indications and Usage section of the label to emphasize the disease stages studied in the clinical trials. Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen, said, "Based on our ongoing conversations with prescribing physicians, FDA and patient advocates, we submitted this label update with the goal to further clarify the patient population that was studied across the three ADUHELM clinical trials that supported approval. We are committed to continue to listen to the community's needs as clinical practice adapts to this important, first-in-class treatment option." 

Woodcliff Lake-based Eisai Co., Ltd. announced that its Hong Kong subsidiary Eisai (Hong Kong) Co., Ltd. has launched the in-house-discovered and developed orexin receptor antagonist DAYVIGO® (generic name: lemborexant) for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Eisai received approval for DAYVIGO in Hong Kong on February 28, 2021, and this launch is the first for DAYVIGO in Asia outside of Japan. DAYVIGO is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating sleep-wake rhythm by binding competitively to the two subtypes of orexin receptors (OX1R and OX2R).

Raritan-based Ortho Clinical Diagnostics became one of the first to have its quantitative COVID-19 IgG antibody test receive emergency use authorization from the U.S. Food and Drug Administration. Ortho's new quantitative COVID-19 IgG antibody test targets the S1 spike protein and is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test offers 100% specificity and excellent sensitivity. The test is calibrated to the international standards by the World Health Organization for anti-SARS-CoV-2 IgG antibodies, which gives clinicians and public health leaders a standard tool to measure antibody response to SARS-CoV-2.

Ridgefield Park-based BeiGene, Ltd. announced that the China National Medical Products Administration (NMPA) has conditionally approved KYPROLIS® (carfilzomib) for injection in combination with dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent. KYPROLIS is licensed to BeiGene in China under a strategic collaboration with Amgen. This is the first approval for KYPROLIS in China. The conditional approval of KYPROLIS was based on results from the Phase 3 trial (NCT03029234) in China evaluating the efficacy and safety of KYPROLIS plus dexamethasone in 123 patients with R/R multiple myeloma. 

Ridgefield Park-based BeiGene, Ltd. announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental Biologics License Application (sBLA) for anti-PD1 antibody tislelizumab for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression following or are intolerant to first-line standard chemotherapy. The sBLA is supported by clinical results from a randomized, open-label, multi-center, global Phase 3 clinical trial RATIONALE 302 (NCT03430843) to evaluate the efficacy and safety of tislelizumab as a second-line treatment for patients with locally advanced or metastatic ESCC compared to chemotherapy. 

Mendham-based Antios Therapeutics, Inc. and Arbutus Biopharma Corporation announced that the companies have entered into a clinical collaboration agreement to evaluate a triple combination of Arbutus' proprietary GalNAc delivered RNAi therapeutic, AB-729, Antios' proprietary active site polymerase inhibitor nucleotide (ASPIN), ATI-2173, and Viread (tenofovir disoproxil fumarate), for the treatment of subjects with chronic hepatitis B virus (HBV) infection. ATI-2173, AB-729 and Viread will be evaluated in combination in a single cohort in the ongoing Antios Phase 2a ANTT201 clinical trial. 

Warren-based GlaxoSmithKline and Alector announced a strategic global collaboration for the development and commercialization of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels. PGRN is a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, making it one of the most attractive genetically validated targets for the development of new immuno-neurology treatments. The collaboration brings together Alector's leading immuno-neurology expertise with GSK's R&D focus on the science of the immune system and human genetics, proven late-stage drug development capabilities and global footprint. 

Franklin-based BD (Becton, Dickinson and Company) announced the commercial release of a new bdbiosciences.com web and eCommerce site, an entirely "reimagined" digital marketplace designed to provide an enhanced online purchasing experience for users and their procurement teams. The new BD Biosciences website offers a full array of BD research, clinical and single-cell multiomic products, making this online destination one of the most comprehensive for flow cytometry users. The completely overhauled online purchasing experience offers intuitive navigation, a fully integrated shopping experience, and a look and feel that addresses flow cytometry users' buying needs.



People in the News

Bridgewater-based BioNJ Member Hillstream BioPharma, Inc. announced the expansion of the Scientific Advisory Board with the addition of Scott J. Dixon, Ph.D., Associate Professor, Biology, Stanford University and Faculty Fellow of Stanford's ChEM-H initiative and Member, Stanford Cancer Institute. Randy Milby, CEO of Hillstream, stated, "Dr. Dixon is a great addition to our Scientific Advisory team and brings extensive experience and understanding of iron mediated cell death/ferroptosis.  He joins a superb group of world-class scientists on our Scientific Advisory Board as we advance Hillstream's product pipeline.  We look forward to working more closely with Dr. Dixon."

Cranbury-based BioNJ Member Palatin Technologies, Inc. announced the strengthening of its senior leadership team with three key executive management appointments: Michael B. Raizman, M.D. as Chief Medical Officer; James E. Hattersley as Senior Vice President of Business Development; and, J. Don Wang, Ph.D. as Vice President of Product Development. "We are at a critical stage in the advancement of our inflammatory and autoimmune programs, and we believe Dr. Raizman, Mr. Hattersley, and Dr. Wang will significantly aid the company in responding to the evolving challenges in the market with agility, expertise and determination," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. 

East Hanover-based BioNJ Member announced the appointment of Rob Kowalski, Pharm.D., Global Head Regulatory Affairs and U.S. Head of Drug Development as Chief People & Organization Officer. He will report to Vas Narasimhan, M.D., CEO of Novartis and become a member of the Executive Committee of Novartis (ECN). Steven Baert, currently Chief People & Organization Officer, will step down from the Executive Committee of Novartis after 15 years with the company and almost 8 years in position. Vicki Rawlinson, U.S. Head People & Organization will lead the function ad-interim until Dr. Kowalski takes over.

Lawrenceville-based BioNJ Member Celsion Corporation announced the addition of Dan H. Barouch, M.D., Ph.D and Luke D. Handke, Ph.D. to its Vaccine Advisory Board (VAB). They join Britt A. Glaunsinger, Ph.D. and Xinzhen Yang, M.D., Ph.D. on the VAB, which was formed in February 2021.  Dr. Barouch is the principal investigator at the Barouch Laboratory, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and William Bosworth Castle Professor of Medicine at Harvard Medical School. In addition, he is a key participant in the Bill & Melinda Gates Foundation Collaboration for AIDS Vaccine Discovery, the National Institutes of Health Martin Delaney HIV-1 Cure Collaboratory and the Ragon Institute of MGH, MIT and Harvard. 

Kenilworth-based BioNJ Member Merck & Co. announced that Michael Klobuchar has been appointed Executive Vice President and Chief Strategy Officer, a newly created role. 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. "Mike's insights, experience in key strategic, operational and financial roles, and deep commitment to scientific innovation will help drive our company's evolution, and I look forward to collaborating with him in this important new role."

Study after study has shown effective diversity, equity & inclusion programs help companies in a variety of ways. That's why, for the first time, ROI-NJ is honoring many of the top leaders of DEI programs in companies across the State. Congratulations to these BioNJ Members for making the list: EisnerAmper, Shaquan Williams; EY, Theresa Harrison; Hackensack Meridian School of Medicine, David Kountz; Hackensack Meridian Health, Avonia Richardson-Miller; Johnson & Johnson, Wanda Hope; McCarter & English, Simone Wilson-Brito; Merck & Co., Raul Suarez-Rodriguez; NJEDA, Michelle Bodden; Princeton University, Khristina Gonzalez; Rowan University, Monika Shealey; Rutgers University - New Brunswick, Anna Branch; The College of New Jersey, James Felton; and Withum, Bill Bradshaw.

Running a business is never easy. And running a business during a deadly global pandemic is even more difficult. The numbers often just don't add up. The folks on NJBIZ's Accounting Power 50 List have demonstrated time and again the sort of forward thinking and professionalism that businesses need to operate at a high level -- to make the numbers add up. Congratulations to these BioNJ Members for making the list: CBRE, Gil Medina; CohnReznick, Steven Schinella; Deloitte & Touche, Paul Krieger; EisnerAmper, Diane Wasser, Jay Weinstein and Travis Epp; Friedman LLP, Michael Saccomanno and Chris Smith; Monmouth University, Jeffrey Christakos; Pricewaterhouse Coopers, Bayaan Oluyadi; Rutgers University (Rutgers University Accounting Research Center), Miklos A. Vasarhelyi; and Withum Smith & Brown, Glen Bellomy, James Bourke, Jr. and Bill Hagaman.

Based upon participation with the Best Places to Work survey, from fellow BridgeTower Media firm Best Companies Group, the 2021 NJBIZ Best Places to Work honorees across small (15 - 49 employees), medium (50 - 249 employees) and large (more than 250 employees) employers are determined from the highest authority on the subject: their own employees. Congratulations to these BioNJ Members for making the list: Small Companies - SmithSolve; Medium Companies - Porzio, Bromberg & Newman and under Large Companies - EisnerAmper LLP, Friedman LLP, GENEWIZ LLC, Langan Engineering & Environmental Services, Lowenstein Sandler LLP and RSM US LLP.

Princeton-based Slayback Pharma LLC announced the appointment of Pete A. Meyers as its Chief Financial Officer. Mr. Meyers has nearly three decades of rich experience in the pharmaceutical industry straddling the investment banking side as well as being the CFO of multiple public and private companies. He most recently served as Chief Financial Officer of Eagle Pharmaceuticals, Inc. In addition to leading, managing, and directing the company's finance function, he collaborated with Eagle's commercial team on strategy for their injectable NDA portfolio. Prior to his role at Eagle Pharmaceuticals, Mr. Meyers served as Chief Financial Officer at Motif BioSciences Inc., where he successfully led the execution of the company's US initial public offering.

Franklin-based BD (Becton, Dickinson and Company) announced that David F. Melcher will be non-executive chair of the Board of Directors, and Claire Pomeroy, M.D., MBA, will be a Director of the company formed in connection with the previously announced separation of the Diabetes Care business into an independent, publicly traded company ("NewCo").  Tom Polen, Chairman, CEO and President of BD said, "The selection of David and Claire to the NewCo board of directors will provide significant health care and public company leadership experience for NewCo, which will be critical for the future direction of this standalone business as one of the largest diabetes-focused organizations in the world."

Funding

The New Jersey Economic Development Authority (NJEDA) Board approved proposed amendments to the state's Angel Investor Tax Credit Program rules that will help fuel investments into early stage New Jersey technology companies and bolster New Jersey's innovation economy. The amendments were based on expansions and revisions made to the program by both the Economic Recovery Act of 2020, which was enacted in January 2021, and legislation signed into law by Governor Phil Murphy in 2019. Concurrently, the NJEDA Board also approved publishing the proposed amendments in the New Jersey Register for a 60-day public comment period.

The New Jersey Economic Development Authority (NJEDA) announced pre-registration for the Small Business Emergency Assistance Loan Program (Phase 2) will open at 9:00 a.m. EST on Tuesday, July 20, 2021. The Emergency Assistance Loan Program provides up to $100,000 in financing to New Jersey small businesses and non-profits. All applicants must pre-register to be eligible to apply. More information is available at https://business.nj.gov/covid/emergency-assistance-loan-program.   

Academia/Institutions/Incubators

The BioFoundry helps researchers who are commercializing technology in innovative cell and gene therapies find their business way forward. Our 14-week program focuses on the business side of science -- from investor networks and pharma partnerships to internal team building and commercialization strategy. We focus on connecting scientists with pharma executives, serial biotech entrepreneurs, and life science investors through weekly interactive sessions. Our program is designed to support companies who have animal data, have raised mostly non-dilutive funding through grants and are looking to fundraise within the next 12-18 months. Applications will be open through August 1st and are reviewed on a rolling basis.

Gov. Phil Murphy and the Office of the Secretary of Higher Education announced the distribution of $30 million in additional federal support for New Jersey's higher education sector. The bulk of the money, about $28.5 million, will go to 35 colleges and universities in support of the Opportunity Meets Innovation Challenge. Through this competitive grant program, institutions will use their grant awards to implement best administrative practices for college-wide reforms to address barriers to student access caused by the pandemic, as well as develop sustainable systemic reforms to address vulnerabilities laid bare by the crisis.

If the State needed more statistical evidence that it has the best school systems in the country, U.S. News & World Report provided it during the release of its annual Healthiest Communities list. When it came to the education benchmark, eight of New Jersey's 21 counties were ranked in the Top 25 -- including three in the Top 4 -- of approximately 3,000 areas across the country. The education ranking was one of 10 categories that U.S. News uses to gauge the Healthiest Communities.

Clearly, the most critical public health issue facing New Jersey and the nation is the race to vaccinate as many people against COVID-19 as possible. While the process has worked well in many states -- including the Garden State -- significant resistance remains, sometimes among surprising groups. In addition, experts are now debating whether fully vaccinated individuals might require a booster in defense of more infectious variants. In the latest edition of NJBIZ Conversations, Editor Jeff Kanige spoke with Brian Strom, the Chancellor of Rutgers Biomedical and Health Sciences about the vaccines, the reluctant populations and the potential need for additional shots.

Rutgers Cancer Institute of New Jersey, Rutgers New Jersey Medical School (NJMS) and the Center for Theoretical Biological Physics (CTBP) at Rice University have demonstrated that a technology with favorable biological attributes known as phage display could be a viable platform for the development of new vaccines to protect against COVID-19. Findings from the proof-of-concept work were published online in the Proceedings of the National Academy of Sciences journal. In this study, the authors developed two independent phage display-based vaccination approaches against SARS-CoV-2, the virus that causes COVID-19. 

Enhancing its emphasis on a commitment to quality in cancer research analysis, the Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey have welcomed nationally recognized biostatistician Hao Liu, Ph.D. Dr. Liu will serve as a professor in the Department of Biostatistics and Epidemiology at Rutgers School of Public Health and as the Director of the Biostatistics Shared Resource and a resident researcher at Rutgers Cancer Institute. Dr. Liu brings more than 15 years of experience in biostatistics, cancer research, and leadership to Rutgers.

Rutgers Biomedical and Health Sciences announced it has opened a new brain imaging research center in an effort to improve the diagnosis of neurological and psychiatric disorders and to help personalize and monitor treatments. Officials say the goal of the Rutgers Center for Advanced Human Brain Imaging Research will make it possible to develop novel therapies for neuropsychiatric and neurological disorders, including addiction, schizophrenia, anxiety, depression, autism, brain injury, stroke and Parkinson's and Alzheimer's diseases.

Federal funding supporting New Jersey's "Opportunity Meets Innovation" higher education challenge will introduce Newark high school students to forensic science as a pathway to college - and a STEM education - under a new program from New Jersey Institute of Technology. The NJIT Forensic Science Initiative (FSI) is backed by $1.4 million in seed money from the U.S. Department of Education, which the state is distributing in the second round of its Governor's Emergency Education Relief (GEER) fund. FSI will welcome its first students in the summer of 2022 with a five-week intensive experience at NJIT featuring class work, lab work, field research, tutoring and college preparation counseling. 

RWJBarnabas Health and Rutgers Cancer Institute of New Jersey in partnership with the New Brunswick Development Corporation (DEVCO) broke ground on the State's first freestanding cancer hospital. At the ceremony, it was also announced that the 510,000-square-foot structure will be named the Jack and Sheryl Morris Cancer Center in recognition of the philanthropic leadership of Jack Morris, who has been a longtime supporter and pillar in New Brunswick development, and his wife, Sheryl.

The Hackensack Meridian School of Medicine has announced its latest round of $100,000 in grants to support Hackensack Meridian Health physicians and researchers seeking novel breakthroughs and treatments for some of the most difficult afflictions challenging medicine today. The Research Pilot Project Funding Program is supported by the school's Office of Research and Graduate Studies, Hackensack Meridian Health's Office of Research Administration, and the Hackensack University Medical Center Foundation.

Hackensack Meridian Health marked its five-year anniversary as the largest, integrated healthcare network in New Jersey. "The merger between Hackensack University Health Network and Meridian Health (which occurred in 2016) facilitated significant advancements in innovation, technology and education. From the launch of the Hackensack Meridian School of Medicine, to the merger with Carrier Clinic, to the opening of the Center for Discovery and Innovation (CDI) -- the network has tirelessly focused on transforming health care and served millions throughout New Jersey," said Robert C. Garrett, FACHE, CEO of Hackensack Meridian Health.

Scientists from the Hackensack Meridian Center for Discovery and Innovation, working with collaborators from across the globe, said they have uncovered the mechanism of action of a novel anti-tuberculosis drug that they have helped develop. The new findings show how the enzyme inhibitor triaza-coumarin, or TA-C, is metabolized by the TB germs, which makes it effective in inhibiting the disease from within, like in a "Trojan horse" attack, according to the new paper in the journal Proceedings of the National Academy of Sciences. "This is a promising new direction of research," said Thomas Dick, a member of the CDI faculty. "We are hoping this work can make a difference in the ongoing fight against TB."

Horizon Blue Cross Blue Shield of New Jersey announced that is donating $1 million and will be a founding corporate sponsor of SciTech Scity, the transformative 30-acre innovation campus being created by Liberty Science Center in Jersey City. Called a "City of Tomorrow," SciTech Scity is the much-heralded campus that aims to launch and grow dozens of world-changing science and technology companies and reimagine public school science education with a magnet school. The campus aims to bring together entrepreneurs, scientists, academics, students and other thinkers.

The U.S. Department of Commerce's National Institute of Standards and Technology (NIST) has made two awards totaling $153 million to the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). The awards were announced by U.S. Secretary of Commerce Gina Raimondo at the NIIMBL annual meeting in Washington, D.C. NIIMBL is a public-private partnership designed to accelerate innovation in the U.S. biopharmaceutical industry, which produces vaccines, monoclonal antibodies, gene therapies and other medical products derived from biological sources. NIIMBL is a Manufacturing USA® institute sponsored by the Department of Commerce.

Events
Monday, July 19, 9:00 p.m.

The conference will feature Taiwan-U.S. bilateral industry, university and research experts sharing insights on precision health-related genetic testing and treatment, and progress in cloud computing for biomedical data. 

Please contact BioNJ at [email protected] 
or call 609-890-3185 with any questions.