Welcome to the latest edition of the BioLines Weekender...

Dear BioNJ Community:

The COVID-19 pandemic has necessitated changes in nearly every aspect of our lives during the last year. Nowhere has this been more apparent than in our health care system. The Coronavirus pandemic has presented an unprecedented challenge to our health care system and had a profound impact on people's lives and livelihoods. 

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. Our health care heroes continue to deliver critical services to Patients today with vaccine distribution added to the continued responsibility of caring for all Patients. Innovation has also been a hallmark of our state's response to the pandemic, from providers and others adapting to a new and unknown virus to the ongoing research and development into the vaccines and treatments that will be a major factor in a future return to "normal."

Still, the pandemic highlighted the critical need for industry, government and non-profits to work collaboratively to drive best practices and solutions. It has pushed us to be more resourceful, innovative, resilient and collaborative. The pandemic has also been 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 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 healthcare 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.  

We look forward to continuing the dialogue on these important issues and 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. Click here for an interview on the report as featured on NJ Spotlight News and here for coverage by NJ 101.5. Please contact John Slotman, Vice President of Government Affairs for BioNJ, at JSlotman@BioNJ.org to learn more. 

Because Patients Can't Wait®,
The BioNJ Team
BioNJ Calendar

BioNJ Finance Briefing: SEC Rule Changes, American Rescue Plan & New Jersey Economic Recovery Act
May 5, 2021
BioNJ BioPartnering Virtual Conference With J.P. Morgan and Johnson & Johnson Innovation
May 18-19, 2021
BioNJ Virtual Clinical Development Briefing
May 27, 2021
BioNJ in the News

As Featured in New Jersey Business Magazine

BioNJ and the New Jersey Health Care Quality Institute have released an independent, comprehensive report designed to strengthen the State's health care system in the wake of the COVID-19 pandemic. The two organizations brought together experts from all sectors of the health care system to form the COVID 19 Work Group, which created "Emerging from COVID-19: An Action Plan for a Healthier State." "BioNJ is proud to release this report in partnership with the Quality Institute. The report celebrates the dedication of the health care workers who protected and cared for so many; the resourcefulness, resiliency and collaboration across the entire health care ecosystem; and the innovation of the biopharmaceutical industry that brought forward testing, therapies and vaccines in record time," said Debbie Hart, founding president and CEO of BioNJ. "In that spirit of positive change and action, the Action Plan considers what went well and what areas need to be addressed to ensure we are better prepared for future pandemics."

NJ Company News

Princeton-based BioNJ Member Soligenix, Inc. announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted HyBryte™ as the proposed brand name for SGX301 (synthetic hypericin), the company's novel first-in-class photodynamic therapy for first-line treatment of early stage cutaneous T-cell lymphoma (CTCL). "We are pleased that the FDA has conditionally accepted the name HyBryte™ for SGX301," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "This is yet another important step towards U.S. commercialization, as we continue to focus on submission of the rolling new drug application (NDA) in 2Q 2021 for this first-in-class therapy."

South Plainfield-based BioNJ Member PTC Therapeutics, Inc. announced that results from Part 2 of the pivotal FIREFISH trial demonstrated that infants with type 1 spinal muscular atrophy (SMA) treated with Evrysdi™ (risdiplam) obtained increases in survival and sustained improvements in achieving key motor milestones, including head control, sitting, rolling over and further developing towards acquiring the ability to stand and walk. Data from Part 2 of the FIREFISH trial demonstrated that at 24 months of treatment, 93% (38/41) of infants were alive and 83% (34/41) were alive without permanent ventilation. Importantly, infants treated with Evrysdi maintained the ability to feed orally 92% (35/38) at month 24. Further exploratory data suggests similar maintenance in ability to swallow 95% (36/38).

South Plainfield-based BioNJ Member PTC Therapeutics, Inc. announced that it has been named a winner of the 2021 "Don Clifton Strengths-Based Culture Award" from Gallup. The award recognizes organizations with strong workplace cultures that get the best out of their employees by focusing and developing their strengths and placing them at the center of how they work every day. "We are honored to accept this award and appreciate the recognition," said  Stuart W. Peltz, Ph.D., Chief Executive Officer of PTC Therapeutics. "While the past year has presented many challenges due to the COVID-19 pandemic, our team has proven that we can work smarter and go farther together. At PTC we say that science is our foundation, and our culture is our heart."

Pennington-based BioNJ Member OncoSec Medical Incorporated announced that it has received authorization to CE mark its proprietary next generation go-to-market gene delivery device, GenPulse™, a part of the OncoSec Medical System (OMS) electroporation device platform for use in solid tumors. The CE mark certification augments the Notified Body certification to the International Organization for Standardization's (ISO) 13485 standard for the design, development, manufacture and distribution of electroporation devices, which is renewed annually, subject to a successful audit.

Bridgewater-based BioNJ Member Amarin Corporation plc provided updates regarding its plans for the commercial launch of VAZKEPA (icosapent ethyl) in Europe following the announcement of receipt of market authorization from the European Commission (EC). VAZKEPA is the first EC-approved product to be marketed and sold for cardiovascular risk reduction in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and other risk characteristics as studied in REDUCE-IT®.

Princeton-based BioNJ Member Advaxis, Inc. announced an agreement with Columbia University Irving Medical Center to fund a Phase 1 clinical study evaluating ADXS-504 in patients with biochemically recurrent prostate cancer. The study, expected to begin in Q2 2021, will be the first clinical evaluation of ADXS-504, Advaxis' off-the-shelf neoantigen immunotherapy drug candidate for early prostate cancer.  Mark Stein, M.D., Associate Professor of Medicine in the Division of Hematology/Oncology at Columbia University Vagelos College of Physicians and Surgeons, will be the study's principal investigator.

Princeton-based BioNJ Member Advaxis, Inc. and Precision for Medicine announced data on the development of a novel flow immunophenotyping assay to accurately evaluate total PD-1 expression as a pharmacodynamic marker during PD-1 blockade, and translational data demonstrating immune responses correlated to observed clinical benefit from the company's ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA®. ADXS-503 is the first drug construct from the ADXS-HOT off-the-shelf, cancer-type specific, immunotherapy program which leverages Advaxis' proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens.

Princeton-based BioNJ Member Advaxis, Inc. announced it has entered into definitive agreements with two healthcare-focused, institutional investors for the purchase of (i) 17,577,400 shares of common stock , (ii) 7,671,937 pre-funded warrants (the "Pre-Funded Warrants") to purchase 7,671,937 shares of common stock and (iii) registered common share purchase warrants to purchase 11,244,135 shares of common stock. The company plans to use the net proceeds from the offering to fund its continued research and development initiatives in connection with expanding its product pipeline including, but not limited to, investment in its ADXS-HOT program and for general corporate purposes.

Princeton-based BioNJ Member BioAegis Therapeutics Inc. announced publication of new research entitled "Plasma gelsolin modulates the production and fate of IL-1β-containing microparticles following high-pressure exposure and decompression" in the Journal of Applied Physiology. Research was conducted at the University of Maryland School of Medicine. While human subjects were found to exhibit a modest decrease in gelsolin levels when exposed to high pressure, a profound decrease was measured after decompression, in a condition known as decompression sickness. These changes occurred concurrent with elevations of circulating microparticles carrying interleukin-1β.

Hampton-based BioNJ Member Celldex Therapeutics, Inc. announced the presentation of promising data from the company's growing bispecific platform at the American Association of Cancer Research (AACR) Annual Meeting. The company described the discovery and characterization of ILT4 inhibitory monoclonal antibodies (mAbs) for engineering bispecific antibodies (bsAbs) that revert myeloid cell suppression by antagonizing ILT4 and activate T-cell responses through PD-(L)1 inhibition. Based on the results reported, Celldex is developing clinical bispecific candidates that co-target ILT4 and PD-(L)1. Expression of ILT4 in several tumor types is associated with poor outcome. In preclinical models, antagonist antibodies to ILT4 have demonstrated immune enhancing and antitumor effects.

Madison-based BioNJ Member AbbVie announced that it has submitted applications seeking approval for SKYRIZI® (risankizumab-rzaa, 150 mg) to the U.S. Food and Drug Administration (FDA) and for SKYRIZI® (risankizumab, 150 mg) to the European Medicines Agency (EMA) for the treatment of adults with active psoriatic arthritis. The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

Morris Plains-based BioNJ Member Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001). 

Morris Plains-based BioNJ Member Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Trodelvy® (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. The accelerated approval was based on data from the international Phase 2, single-arm TROPHY study.

Princeton-based BioNJ Member Genmab and Seagen Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of Oct 10, 2021. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor (TF), a cell-surface protein expressed on multiple solid tumors including cervical cancer, and is associated with tumor growth, angiogenesis, metastasis and poor prognosis.

Florham Park-based BioNJ Member Celularity announced today the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company's non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, CYNK-001, for the treatment of patients with malignant gliomas. CYNK-001 is currently being investigated in a phase 1 clinical trial (NCT04489420) for the treatment of patients with glioblastoma multiforme (GBM), an indication within the scope of this orphan designation.

Princeton-based BioNJ Member Evotec SE announced the most advanced asset arising from their joint venture with Exscientia has entered human clinical trials. The A2a receptor antagonist, which is in development for adult patients with advanced solid tumours, was co-invented and developed between Exscientia and Evotec, including application of Exscientia's next generation 3-D evolutionary AI-design platform, Centaur Chemist®The drug candidate has potential for best-in-class characteristics, with high selectivity for the target receptor, bringing together potential benefits of reduced systemic side effects as well as minimal brain exposure to avoid potential undesired centrally-mediated side effects.

Princeton-based BioNJ Member Taiho Oncology, Inc. announced efficacy and safety results from the Phase 2 FOENIX-CCA2 trial, a single-arm multicenter Phase 2 study evaluating futibatinib (TAS-120) in patients with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements including gene fusions who have failed at least one line of therapy. In the FOENIX-CCA2 trial, 103 patients with locally advanced or metastatic unresectable iCCA harboring FGFR2 gene rearrangements including fusions who had received one or more prior lines of systemic therapy received futibatinib 20 mg once daily until disease progression or unacceptable toxicity. 

Lawrenceville-based BioNJ Member Celsion Corporation announced the closing of its previously announced registered direct offering of 11,538,462 shares of common stock at a purchase price of $1.30 per share, resulting in net proceeds of $13.9 million, after deducting placement agents' fees but before expenses payable by the company. Celsion intends to use the net proceeds for general corporate purposes, including research and development activities, capital expenditures and working capital.

BioNJ Member Pfizer Inc., with offices in Peapack, announced that the U.S. Food and Drug Administration (FDA) has extended the priority review period for the New Drug Application (NDA) for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) goal date has been extended three months to early Q3 2021. The FDA has also extended the review period for the Supplemental New Drug Applications (sNDAs) for XELJANZ® / XELJANZ® XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis (AS) by three months, with a goal date in early Q3 2021.

BioNJ Member Pfizer Inc., with offices in Peapack, and Hackensack-based Myovant Sciences announced that the first participant has been dosed in the Phase 3 SERENE study evaluating the contraceptive efficacy of relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in healthy women ages 18-35 years who are at risk for pregnancy. The SERENE study will enroll 900 sexually active, healthy women ages 18-35 years with presumed normal fertility. The primary efficacy endpoint is the at-risk Pearl Index, defined as the number of on-treatment pregnancies per 100 women-years of treatment. 

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo® (nivolumab) in combination with Cabometyx® (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma (RCC). The EC's decision is based on results from the Phase 3 CheckMate -9ER trial, which demonstrated superior efficacy with Opdivo in combination with Cabometyx versus sunitinib across three key endpoints: progression-free survival (PFS), the primary endpoint, and objective response rate (ORR) and overall survival (OS). The combination of Opdivo and Cabometyx was well tolerated, with safety reflective of the known profiles of both medicines and a low rate of treatment-related adverse events leading to discontinuation. 

Princeton-based BioNJ Member Bristol Myers Squibb announced positive topline results from the Phase 3 CheckMate -648 trial evaluating treatment with Opdivo (nivolumab) plus chemotherapy or Opdivo plus Yervoy (ipilimumab) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). In the study, Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful benefit for the primary and secondary endpoints of overall survival (OS) in patients whose tumors express PD-L1 and in the all-randomized patient population at the pre-specified interim analysis. 

Princeton-based BioNJ Member Bristol Myers Squibb announced results from the CheckMate -816 study, which showed that neoadjuvant treatment with three cycles of Opdivo (nivolumab) plus chemotherapy significantly improved pathologic complete response (pCR), a primary endpoint, compared to chemotherapy alone in patients with resectable stage Ib to IIIa non-small cell lung cancer (NSCLC). In the study, 24% of patients treated with Opdivo plus chemotherapy prior to surgery achieved pCR, compared to 2.2% of patients treated with chemotherapy alone (Odds Ratio [OR] 13.94, 99% Confidence Interval [CI]: 3.49-55.75; p<0.0001), with pCR defined as no evidence of cancer cells in their resected tissue as assessed by a blinded independent pathology review. 

Warren-based BioNJ Member GlaxoSmithKline plc and Vir Biotechnology, Inc. announced that the European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. The review will include data from an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. 

Bridgewater-based BioNJ Member Sanofi announced final results of Part A of the pivotal Phase 3 CARDINAL open label, single-arm study evaluating the safety and efficacy of sutimlimab for 26 weeks in people with primary cold agglutinin disease (CAD) were published in the New England Journal of Medicine. Sutimlimab, a first-in-class investigational C1s inhibitor, met the primary and secondary endpoints in the study and demonstrated sustained inhibition of classical complement pathway mediated hemolysis with improvements in anemia within one week of treatment. CAD is a chronic autoimmune hemolytic anemia that causes the body's immune system to mistakenly attack healthy red blood cells and cause their rupture (hemolysis).

Bridgewater-based BioNJ Member Sanofi outlined several key projects that the company will implement to increase the impact of its Corporate Social Responsibility (CSR) strategy. Embedded in Sanofi's long-term strategy, the company's commitment is based on four essential pillars in which Sanofi is uniquely positioned to make a difference: access to medicines, support for vulnerable communities, preservation of the environment and inclusion and diversity of its employees. A cornerstone of Sanofi's CSR strategy, Sanofi Global Health is a newly formed nonprofit unit within the company. Sanofi Global Health is dedicated to increasing access to medicines considered essential by the World Health Organization (WHO) for patients in 40 lower income countries

Bridgewater-based BioNJ Member Sanofi's Interim data from a first-in-human trial evaluating the safety, therapeutic activity and maximum tolerable dose of THOR-707 (SAR444245), a highly differentiated not-alpha interleukin-2 (IL-2) candidate, as a monotherapy and in combination with anti-PD-1, were presented at AACR. Interim safety, anti-tumor activity and biomarker data further validate the not-alpha IL-2 profile seen preclinically. In both the combination and monotherapy settings, initial activity was observed, with three confirmed partial responses, which includes patients who have received prior anti-PD-1 therapeutics.

Bridgewater-based BioNJ Member Sanofi acquired Tidal Therapeutics, a privately owned, pre-clinical stage biotech company with a novel mRNA-based approach for in vivo reprogramming of immune cells. The technology is based on proprietary nanoparticles that deliver mRNA (messages) to reprogram immune cells inside the body. The new technology platform will expand Sanofi's research capabilities in both immuno-oncology and inflammatory diseases, and may have applicability to other disease areas as well. Sanofi acquired Tidal Therapeutics for an upfront payment of $160 million and up to $310 million upon achievement of certain milestones. 

Bridgewater-based BioNJ Member Sanofi announced a €400 million investment over five years to create a unique vaccine production center in Singapore, pushing the boundaries of operations through cutting edge manufacturing and digital technologies. In partnership with the Singapore Economic Development Board (EDB), the new site will mainly supply the Asian region and complement existing manufacturing capacities in Europe and North America. The investment furthers Sanofi's commitment to driving the future of vaccines by expanding manufacturing capabilities to ensure quality and scale, while responding to the risk of future pandemics. 

New Brunswick-based BioNJ Member Johnson & Johnson findings from an analysis of the first 500 patients enrolled in the SPHERE registry (SelexiPag: tHe usErs dRug rEgistry) found more than three-quarters (76%) of pulmonary arterial hypertension (PAH) patients treated with UPTRAVI® (selexipag) either maintained (56%) or reduced (20%) their one-year mortality risk score. The SPHERE results were published in the April issue of the Journal of Heart and Lung Transplantation (JHLT). SPHERE is an ongoing real-world, observational, user registry using two different risk assessment methods that describes the clinical characteristics, outcomes and dosing/titration regimens in patients with PAH who are being treated with UPTRAVI.

Bridgewater-based BioNJ Member Eli Lilly and Company announced for the first time data from the Phase 1/2 LIBRETTO-001 trial showing treatment with Retevmo® (selpercatinib) demonstrated encouraging antitumor activity and safety across RET fusion-positive advanced solid tumors beyond lung and thyroid cancers, including multiple treatment-refractory gastrointestinal (GI) malignancies. In the Phase 1/2 LIBRETTO-001 trial, 32 adult patients with 12 unique RET fusion-positive advanced cancer types were enrolled by the efficacy cutoff date of September 19, 2020 (with follow-up through March 19, 2021). 

Bridgewater-based BioNJ Member Eli Lilly and Company announced changes to the purchase agreements with the U.S. government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. As part of Lilly's planned transition to only supply bamlanivimab and etesevimab together, Lilly and the U.S. government have agreed to modify the purchase agreement of bamlanivimab alone and focus on supply of bamlanivimab and etesevimab together. Additionally, the bamlanivimab and etesevimab agreement has been modified to enable the supply of etesevimab to complement doses of bamlanivimab the U.S. government already purchased, some of which have already been delivered to sites of care. 

Kenilworth-based BioNJ Member Merck & Co. announced that the pivotal Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, met its primary endpoint of disease-free survival (DFS) for the potential adjuvant treatment of patients with renal cell carcinoma (RCC) following nephrectomy (surgical removal of a kidney) or following nephrectomy and resection of metastatic lesions. Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA monotherapy demonstrated a statistically significant and clinically meaningfully improvement in DFS compared with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint. 

Basking Ridge-based Daiichi Sankyo Company, Limited and AstraZeneca announced that the first patient was dosed in DESTINY-CRC02, a global phase 2 trial evaluating the efficacy and safety of ENHERTU® (trastuzumab deruxtecan) in patients with HER2 overexpressing locally advanced, unresectable or metastatic colorectal cancer with progression following treatment with standard of care chemotherapy. Colorectal cancer is the third most common cancer and second most common cause of cancer death globally. Approximately 20% of patients have metastatic disease at diagnosis, meaning the disease has spread to distant organs, and about 50-60% of patients initially diagnosed with early stage colorectal cancer will eventually develop metastases.

Basking Ridge-based Daiichi Sankyo Company, Limited announced the first patient has been dosed in the first-in-human phase 1/2 study of DS-1594, a selective small-molecule menin inhibitor, in adults with relapsed/refractory acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The trial is being conducted by The University of Texas MD Anderson Cancer Center under an existing strategic research collaboration. Inhibition of the menin protein is being studied as a novel treatment approach for acute leukemias with MLL rearrangement (MLLr) or NPM1 mutation (NPM1m), two gene alterations that drive cancer development and growth.

Basking Ridge-based Daiichi Sankyo Company, Limited announced that the first patient was dosed in a Phase 2 study to evaluate the safety and efficacy of pexidartinib, a CSF-1R inhibitor, in Japanese patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitation and not amenable to improvement with surgery. TGCT, also referred to as pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), is a rare, typically non-malignant tumor that can be locally aggressive. TGCT affects the synovium-lined joints, bursae and tendon sheaths, resulting in reduced mobility in the affected joint or limb. 

Basking Ridge-based Regeneron Pharmaceuticals, Inc. announced that newly updated National Institutes of Health (NIH) COVID-19 Treatment Guidelines strongly recommend that REGEN-COV™ (casirivimab with imdevimab) be used in non-hospitalized COVID-19 patients ("outpatients") at high risk of clinical progression. The Category 'AIIa' is a 'strong' rating based on results of randomized trials. The recommendation from the NIH COVID-19 Treatments Guidelines Panel is a critical step in helping make monoclonal antibody therapies like REGEN-COV available for all appropriate patients in the U.S. 

Basking Ridge-based Regeneron Pharmaceuticals, Inc. announced positive data from a Phase 3 trial (2069B) of recently infected asymptomatic COVID-19 patients, evaluating REGEN-COV™ (casirivimab with imdevimab) 1,200 mg administered via subcutaneous (SC) administration. REGEN-COV reduced the overall risk of progressing to symptomatic COVID-19 by 31% (primary endpoint), and by 76% after the third day. The trial also demonstrated that REGEN-COV shortened symptom duration and markedly reduced viral levels.

Basking Ridge-based Regeneron Pharmaceuticals, Inc. announced positive results from a Phase 3 trial (2069A) assessing the ability of REGEN-COV™ (casirivimab with imdevimab) to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals. The trial, which was jointly run with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), met its primary and key secondary endpoints, showing that REGEN-COV 1,200 mg administered subcutaneously (SC) reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial.

Englewood Cliffs-based Enzychem Lifesciences announced that it has completed patient enrollment in Stage 2 of its Phase 2 clinical trial of EC-18 in chemoradiation induced oral mucositis (CRIOM). Stage 2 of the Phase 2 study successfully enrolled 80 subjects, evaluating both safety and efficacy. Database Lock (DBL) is expected in near end of 2Q 2021. After the completion of DBL, data analysis including drafting top-line summaries will begin. EC-18, the company's lead investigational candidate, is a novel, first-in-class, immunomodulator, which facilitates the resolution of inflammation and enhances anti-infective and tissue-healing pathways of the immune system.

Paramus-based SK Life Science, Inc. will present post-hoc analyses of data from a subset of patients in a large, multi-center, open-label Phase 3 safety study (C021) with cenobamate in adults with uncontrolled partial-onset seizures during the American Academy of Neurology's Annual Meeting. The post-hoc analyses examined a subset of 240 patients from Study C021 across 10 sites in the U.S. Among those 240 patients, 177 patients remained on cenobamate as of the last clinic visit analyzed on or after September 1, 2019. In one analysis, 33.9% (60/177) of patients who remained on cenobamate had sustained seizure freedom for at least 12 months as of their last clinic visit and 46.9% (83/177) of patients who remained on cenobamate were seizure-free for at least one year at any time during the follow-up

Fort Lee-based Kedrion Biopharma announced that the last patient has been treated in the CARES10 (Clinical Assessment of phaRmacokinetics, Efficacy, Safety of a 10% Ig) trial. CARES10 is a phase III, open-label, prospective, multi-center study that assessed efficacy, safety, and pharmacokinetics of a 10 percent intravenous immunoglobulin (IVIG) in individuals diagnosed with primary immunodeficiency disease (PI). PI, a rare disease affecting approximately 250,000 people in the United States, is a group of disorders in which a part of the body's immune system is missing or does not function properly.

Ridgefield Park-based BeiGene, Ltd. announced that clinical data on its anti-PD-1 antibody tislelizumab, in combination with the investigational spectrum-selective kinase inhibitor sitravatinib were presented at AACR. Data presented were from two cohorts of a Phase 1b trial (NCT03666143), in patients with unresectable or metastatic melanoma who were refractory or resistant to PD-1/L1 inhibitors and in patients with advanced platinum-resistant ovarian cancer. "We believe that sitravatinib in combination with tislelizumab could potentially provide clinical benefit to patients with advanced solid tumors, which supports our plan to further evaluate this innovative combination in our ongoing clinical trials," said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene

Bridgewater-based Amneal Pharmaceuticals Inc. has completed its previously announced acquisition of almost all of Kashiv Specialty Pharmaceuticals LLC. Amneal, through subsidiary Amneal Pharmaceuticals LLC, acquired a 98% interest in the unit of Kashiv BioSciences LLC for approximately $100 million. "We are very pleased to announce the completion of this transaction," Chirag and Chintu Patel, co-CEOs of Amneal, said "Through the acquisition of Kashiv Specialty Pharma, Amneal has gained an exciting pipeline of both 505(b)2 branded products and complex generics. Perhaps most importantly, we are adding a team of world-class R&D scientists with a proven track record of developing complex generic products, as well as a platform of innovative drug delivery technologies."

Englewood Cliffs-based Silo Pharma, Inc. announced that it has finalized an agreement to sublicense the technology covered by its recently announced provisional patent applications filed with the United States Patent and Trademark Office (USPTO). The patent applications pertain to Silo Pharma's novel and proprietary central nervous system (CNS) homing peptides for use in the therapeutic treatment of pain from neuroinflammation in cancer patients. Eric Weisblum, CEO of Silo Pharma, Inc, stated "We are excited about the next steps of this relationship and the sublicense culminates the previous Letter of Intent announced earlier in February. We are pleased to have a broader team of industry participants working to explore and expand the use of our novel peptides."

Mendham-based Antios Therapeutics, Inc. announced the successful completion of a $96 million Series B financing. The proceeds from this financing will support the ongoing Phase 2 clinical program which is evaluating the potential for the company's lead clinical candidate, ATI-2173, to be a backbone of a once-daily curative regimen for chronic hepatitis B. ATI-2173 is a novel, orally administered, liver-targeted Active Site Polymerase Inhibitor Nucleotide (ASPIN) that can shut down HBV polymerase activity and viral replication.

People in the News

Princeton-based BioNJ Member Oyster Point Pharma, Inc. announced the appointment of an additional member to its Board of Directors. Effective immediately, George Eliades, Ph.D, current Senior Vice President, Corporate Development and Chief Transformation Officer of Jazz Pharmaceuticals, will join Oyster Point's Board of Directors and serve as a member of the Compensation Committee. "George has extensive experience developing global sales and marketing strategies for numerous therapies in biotech and pharma, and we look forward to his insights and contributions as we work to bring transformative therapies to patients with ocular surface diseases," said President and CEO Jeffrey Nau, Ph.D., M.M.S. 

Warren-based BioNJ Member GlaxoSmithKline plc announces that Dr. Anne Beal will join the Board of the Company as a Non-Executive Director. On joining the Board, Dr. Beal will become a member of the Corporate Responsibility Committee which provides important oversight of the Company's Trust agenda including policies towards access to medicines, global health, inclusion and diversity and environmental sustainability. Dr. Beal will bring to GSK extensive healthcare experience as a physician and entrepreneur combined with a passion for patient advocacy. 

Bridgewater-based BioNJ Member Eli Lilly and Company announced that  Diogo Rau will join the company as Senior Vice President and Chief Information and Digital Officer. Mr. Rau most recently served as the top executive of information technology for retail and online stores at Apple, Inc. During his 10 years at Apple, he led the development and implementation of the technology supporting the Apple Online Store and Apple retail stores, including the e-commerce platform, mobile point of sale, the Apple Store App and systems used by store team members. Prior to joining Apple, Mr. Rau was a partner with McKinsey & Company

Bridgewater-based BioNJ Member Amarin Corp. PLC said that its CEO and President is retiring, and announced its succession plan for the role. John F. Thero, the company's CEO and President, will retire effective Aug. 1, also stepping down from the board at that time. Karim Mikhail, Amarin's senior Vice President and Head of Commercial for Europe, has been named Thero's successor as CEO, President and a board member, as of that date. Amarin's lead product is known as Vascepa in the U.S. and Vazkepa in Europe. It is a drug for high-risk patients with persistent cardiovascular risk after statin therapy.

Princeton-based Integra LifeSciences Holdings Corporation announced the appointment of Shaundra Clay to its Board of Directors. Ms. Clay is currently the global vice president of finance at Beam Suntory, Inc., a premium spirits company, where she is responsible for enterprise-wide financial planning and analysis and leads the integration of the short-, mid-, and long-term planning processes to optimize resource deployment. Prior to Beam Suntory, she was a managing director in the commercial banking group at JP Morgan Chase. Ms. Clay also spent 13 years in leadership roles within the healthcare industry in the United States and internationally.

Mullica Hill-based Inspira Health Network appointed four new members: Dawn Flitcraft, Robert L. Hickok, Toni Pergolin and Virna Alexander Rhodes. The board said the four will focus on strategic planning and growth; patient safety and clinical excellence; fiscal responsibility and assessing and meeting the needs of the communities served.

Funding News

The New Jersey Economic Development Authority announced it will begin accepting applications in May for a number of the recently announced programs that are aimed at providing $85 million in grants to various types of small businesses. The programs include $25 million for microbusinesses (5 or fewer employees), $15 million for small businesses (6 to 50 employees), $10 million for child care centers and $35 million for eating/drinking establishments. The EDA is calling it Phase 4 of its Small Business Emergency Assistance Grant Program. And, if your business did not get any funding during Phase 3, you get to go first. 

The New Jersey Economic Development Authority (NJEDA) released a draft of the rules and targeted industry definitions under which the new Emerge business tax incentive program will be administered. Members of the public are encouraged to review the preliminary rules and industry definitions and provide feedback through one of three virtual Public Listening Sessions hosted by the Authority in April, or to submit written feedback through an online form available on the Economic Recovery Act website. The Emerge program is expected to begin accepting applications in late May.

Members of New Jersey's innovation community had the opportunity to learn about public and private resources available to entrepreneurs of color during a "Removing Barriers for Diverse Entrepreneurs" Instagram Live discussion last night featuring New Jersey Economic Development Authority (NJEDA) Chief Executive Officer (CEO) Tim Sullivan and Digitalundivided CEO Lauren Maillian. The chat also spotlighted the recently-proposed Black and Latino Seed Fund, which the NJEDA intends to create to drive capital to Black- and Latino-owned enterprises.

The Commission on Science, Innovation and Technology (CSIT) reminded emerging companies within New Jersey's clean energy sector that it is currently accepting applications for its Clean Tech Research and Development (R&D) Voucher Program. 
The $435,000 program, funded through the New Jersey Board of Public Utilities (NJBPU), is designed to help early stage New Jersey clean technology companies more easily access resources such as specialized equipment within the Garden State. CSIT developed the program in coordination with the NJBPU and the New Jersey Economic Development Authority (NJEDA).

Institution and Education News

Ludwig Cancer Research is proud to announce on its 50th anniversary the launch of the newest Branch of the Ludwig Institute for Cancer Research. Based at Princeton University, the Ludwig Princeton Branch will be wholly dedicated to the study of cancer metabolism and the translation of its findings into new paradigms for cancer prevention and treatment.
Ludwig Princeton is directed by chemical biologist and cancer researcher Joshua Rabinowitz, a Professor in the Department of Chemistry and the Lewis-Sigler Institute for Integrative Genomics at Princeton University. Rabinowitz has made foundational contributions to the field of metabolomics-the large-scale, quantitative analysis of metabolites-and remains a world leader in the development and application of new technologies for the dynamic analysis of metabolic processes. 

Rutgers Cancer Institute of New Jersey has received a $1.3 million, five-year grant from the National Cancer Institute (1T32CA257957) to support the Cancer Metabolism and Growth and Tumor Host Interactions Training Program. The program, which will focus on providing postdoctoral candidates the highest quality training and research experience, leverages the unique research strengths and resources of New Jersey's only NCI-designated Comprehensive Cancer Center to provide translational research training in the area of cancer metabolism.

New Jersey Institute of Technology was awarded a 2021 Ellucian Impact Award for its successful digital transformation initiatives, which allowed the university to pivot quickly to support students during the pandemic. The university will receive a $25,000 grant as part of the recognition. The annual Ellucian Impact Awards celebrate visionaries who are inspiring others to push the boundaries of higher education technology and innovation. The announcement was made during Ellucian Live, the industry's top global technology conference. This year, Ellucian recognized six institutions that represent excellence across the categories of student well-being, innovation and digital transformation. 

Rowan University has named a new Dean of its College of Science & Mathematic. Vojislava Pophristic will take over July 19 for Karen Magee-Sauer, a two-time Dean of the college who is retiring after 32 years with the university. Dr. Pophristic, who is a professor of chemistry and interim dean of the Misher College of Arts and Sciences at the University of the Sciences in Philadelphia, was chosen after a national search. "I am looking forward to joining Rowan University and leading the next chapter of the College of Science & Mathematics, building on Dr. Magee-Sauer's leadership, the college's many successes and the university's tremendous growth," Dr. Pophristi said.

Bob Garrett can rattle off all of the areas in which the scientists at the Center for Discovery and Innovation are doing research -- in addition to their efforts involving COVID-19. "In terms of its presence, its focus, CDI is really advancing science in a lot of different clinical areas," Garrett said. But when Garrett, the CEO of Hackensack Meridian Health, talks about the depth of research going on at the facility in Nutley that will celebrate its second anniversary in May, he said it's easier to measure the growth of the facility in another way.
"We're out of room," Garrett added. "We just had a meeting with the master facility planning folks to develop additional space on the upper floors of the building. We need to expand our laboratories."

Linda McHugh, a veteran executive with more than three decades of experience at the Cleveland Clinic, has been named the Chief Experience and People Officer of Hackensack Meridian HealthIn the role, Ms. McHugh will be responsible for the strategic management and delivery of all experience, hospitality and people programs, policies, processes and practices for the network. "Linda has an impressive background and concrete understanding of health networks and academic medical centers, bringing expertise in human resources transformation, diversity and inclusion, labor relations, employee engagement and succession planning," said HMH CEO Bob Garrett. 

Bergen New Bridge Medical Center is the first in the State to offer post-vaccine antibody testing for the SARS-CoV-2 IgG Spike protein. This COVID-19 antibody testing uses the Abbott platform to help physicians recognize vaccine generated immunity versus autoimmunity from prior infection in their patients, according to an announcement, and is part of Bergen New Bridge's ongoing effort to expand its scope of services. "I am proud to continue to lead the way in COVID-19 mitigation and management", said Bergen New Bridge Medical Center President and Chief Executive Officer Deborah Visconi in a prepared statement.

In a breakthrough that will give better insight into how and where COVID-19 variants are spreading within New Jersey, Atlantic Health System is among the first hospitals in the region to be able to rapidly screen for key viral variants. The organization will begin surveillance testing for Covid-19 variants for population health using internally developed PCR-based tests, as well as partnering with Seegene, Inc., using their recently developed research-use variant detection multiplex tests to rapidly screen for multiple variants -- specifically the UK, Brazilian and South African variants. Atlantic Health plans to continue developing tests to identify additional strains such as the California and New York variants.

Bill Arnold has been named CEO and President of Robert Wood Johnson University Hospital in New Brunswick, RWJBarnabas Health. Mr. Arnold has held leadership roles since joining the system in 1994. He currently serves as President, Southern Region, for RWJBarnabas Health, which includes Monmouth Medical Center, Monmouth South and Community Medical Center. Mr. Arnold will retain his duties for the Southern Region and continue efforts toward integrating RWJUH programs there for quaternary care services, including cardiovascular care, trauma, neuroscience and organ transplantation.

Special Programs from Our Partners for BioNJ Members

April 30, 11:00 a.m.

Join NJBIA, Einstein's Alley, and the New Jersey Business Immigration Coalition for a virtual event that will present a "big picture" view of the current system of employment-based immigration, along with a variety of industry perspectives on how immigration reform can foster economic recovery and growth. We will also review the state of play on immigration reform in Washington.

BioNJ Member Services Provider Directory

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 KMinton@BioNJ.org, or 609-890-3185. Find providers in these categories:

Please contact BioNJ at BioNJ@BioNJ.org 
or call 609-890-3185 with any questions.