Welcome to the latest edition of the  BioLines Weekender

New Jersey is a leading hub for the life sciences industry. The discovery and medical innovation coming from the Garden State has reached unparalleled heights. We are seeing an increasing number of new therapies that have the potential to cure -- not just treat.

However, as we hear in the news every day, it is also a challenging time in reference to Patient access. It is for this reason that BioNJ is proud to take a leadership role in increasing awareness of the dangers that organizations, such as the Institute for Clinical and Economic Review (ICER), pose to Patients' access to life-saving medicines. ICER's framework ignores real-life Patient experiences in its reviews, instead basing its determinations of a drug's value on financial considerations alone -- allowing ICER, rather than physicians, to make treatment decisions for Patients. When Patients can't access the treatments they need, it can lead to complications, increased doctor visits, increased costs, trips to the ER and even death.
Click here to join us in our efforts to advocate for policies and solutions that help Patients access the medicines they need and promote a thriving life sciences industry in New Jersey. For additional resources and information on the value of medical innovation, please visit www.BioNJ.org/Protect-Medical-Innovation. Thank you.

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

Cybersecurity Awareness Breakfast Briefing
Princeton Innovation Center BioLabs, Princeton, NJ
December 12, 2019
2020 Annual Dinner Meeting & Innovation Celebration
Hilton East Brunswick, NJ
February 6, 2020
BioNJ's 10th Annual BioPartnering Conference
Somerset, NJ
Save the date!
May 13, 2020
Putting Patients First: The Value of Medical Innovation

Medical innovation enables longer and better quality lives and, in turn, reduces the costs of health care. Share with our community how your medical innovation is improving lives and impacting health care costs. Send us your Patient and related stories to BioNJ@BioNJ.org. Plus, click here for valuable tools and resources on the Value of Medical Innovation.

While efforts to improve the frameworks for drug value assessment are emerging, we are missing an important opportunity if we continue to focus all value assessment energy on just drugs. To be truly relevant to sustainable value-based health care decision-making, we must advance methods and tools that can effectively support comparative assessment of a broader array of medical interventions.

The Trump Administration is committed to lowering prescription drug prices while encouraging medical innovation to help patients access new lifesaving drugs. H.R. 3, the Lower Drug Costs Now Act of 2019, may share the Trump Administration's first goal of lowering prices, but the threat it poses to continued medical innovation will harm American patients in ways that far outweigh any benefits. H.R. 3 aims to lower prices for select drugs by effectively forcing drug manufacturers to accept prices set by the Secretary of Health and Human Services-or otherwise face an excise tax of up to 95 percent of sales.

Speaker Nancy Pelosi's Lower Drug Costs Now Act of 2019, H.R.3, could result in at least 56 fewer new medicines for patients over 10 years, according to a new analysis from economic consulting firm Vital Transformation. The study examined the impact of foreign reference pricing provisions in H.R.3 on treatments and cures from small, emerging U.S. biotech companies that rely on venture capital to finance their research and development. The analysis was commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Innovation Organization (BIO) and the Council of State Bioscience Associations (CSBA).

NJ Company News

Princeton-based BioNJ Member Adastra Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Orphan Drug Designation to zotiraciclib for the treatment of glioma. Zotiraciclib is currently the subject of two separate Phase 1b clinical trials in glioblastoma (GBM). Adastra expects to report results from the two studies during 2020.

Princeton-based BioNJ Member  Soligenix, Inc. announced it has completed patient enrollment in its Phase 3 "Fluorescent Light Activated Synthetic Hypericin" (FLASH) study for SGX301 (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL).  The study successfully enrolled 169 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study's primary efficacy endpoint by an independent Data Monitoring Committee (DMC). With enrollment completed, top-line results are expected in the first quarter of 2020.  

South Plainfield-based BioNJ Member   PTC Therapeutics, Inc.  announced that the  United States Food and Drug Administration  ( FDA ) has granted priority review for the New Drug Application (NDA) for risdiplam (RG7916) for the treatment of spinal muscular atrophy (SMA). The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the  FDA  is  May 24, 2020 . The filing acceptance by the  FDA  triggers a  $15M  milestone payable to PTC by  Roche The NDA filing is based on 12-month data from the dose-finding portion of the pivotal FIREFISH and SUNFISH studies, and clinical and preclinical pharmacokinetic and pharmacodynamic data.

Cranbury -based BioNJ Member  Outlook Therapeutics, Inc.  announced that it has received agreement from the  U.S. Food and Drug Administration  ("FDA") on three Special Protocol Assessments ("SPAs") for three additional registration clinical trials for its ongoing Phase 3 program for ONS-5010, an investigational ophthalmic formulation of bevacizumab. The agreements reached with the  FDA  on these SPAs cover the protocols for NORSE 4, a registration clinical trial to treat BRVO, and NORSE 5 and NORSE 6, two registration clinical trials to treat DME.  Outlook Therapeutics  intends to initiate NORSE 4, 5 and 6 in 2020.

Princeton-based BioNJ Member  Oyster Point Pharma, Inc.  announced the positive top-line results from its Phase 1 "ZEN" study in healthy volunteers. The ZEN Study was an open-label, single-center, randomized, 2-way crossover study to evaluate the relative bioavailability of varenicline administered as a preservative-free nasal spray (OC-01 nasal spray) as compared to varenicline administered orally as a single oral dose of Chantix®The ZEN study was designed to assess the relative bioavailability of varenicline administered intranasally at its highest intended clinical strength (1.2 mg/ml in a 50 microliter nasal spray) compared to varenicline administered as a single oral dose at its commercially available maintenance oral tablet strength (1 mg). 

Morris Plains-based BioNJ-Member  Immunomedics, Inc. announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.  "We are pleased to have reached this important milestone and believe that sacituzumab govitecan, if approved, could become an important new treatment option for patients with late-stage mTNBC," said Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics. 

Morris Plains-based BioNJ-Member  Immunomedics, Inc.  announced it has commenced an underwritten public offering of $250,000,000 of shares of its common stock. In addition, Immunomedics expects to grant the underwriters a 30-day option to purchase up to an aggregate of an additional $37,500,000 of shares of common stock sold in connection with the offering at the public offering price. Immunomedics intends to use the net proceeds from this offering primarily to accelerate commercial launch readiness, pending FDA approval, of sacituzumab govitecan in the United States in metastatic triple-negative breast cancer, continue to expand the clinical development programs for sacituzumab govitecan, invest in the broader clinical development of the platform (including IMMU-130 and IMMU-140), continued scale-up of manufacturing and manufacturing process improvements, as well as for working capital and general corporate purposes.

Cranbury-based BioNJ Member Rafael Pharmaceuticals, Inc. announced the expansion of its Phase 2 clinical trial of CPI-613® (devimistat) for patients with relapsed or refractory Burkitt's lymphoma/leukemia. The clinical trial will begin enrolling patients at Massachusetts General Hospital in Boston starting this month. The trial is currently underway at Memorial Sloan Kettering Cancer Center in New York City and at City of Hope in Duarte, California. "Burkitt's lymphoma is a rare disease, with approximately 1,200 people in the United States diagnosed annually, so treatment options for these patients are very limited," said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals.

Princeton-based BioNJ Member Advaxis, Inc. announced it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical study of ADXS-504, the Company's ADXS-HOT drug candidate for prostate cancer. ADXS-504 is part of the company's ADXS-HOT off-the-shelf immunotherapy platform which targets hotspot neoantigens, allowing for the development of multiple cancer-type specific clinical candidates. Advaxis has designed over ten 'HOT' drug candidates that are in various stages of development, with the company's Phase 1/2 clinical trial for ADXS-503 in NSCLC currently enrolling patients at five centers

Edison-based BioNJ Member Hepion Pharmaceuticals, Inc. announced that CRV431, an anti-fibrotic agent, prevented the development of liver cirrhosis in a highly aggressive, preclinical model of liver disease. In this study, conducted by Physiogenex, S.A.S. (France), rats were administered the hepatotoxic compound, thioacetamide, for nine weeks to induce liver injury and fibrosis, in combination with either CRV431 or vehicle control for the entire study period. Blinded, histopathological analysis of the livers was conducted at the end of the study period.

Jersey City-based BioNJ Member Mitsubishi Tanabe Pharma America, Inc. announced the initiation of a global Phase 3 study evaluating the long-term safety and tolerability of an investigational oral suspension formulation of edaravone (MT-1186) in patients with amyotrophic lateral sclerosis (ALS). The intravenous (IV) formulation of edaravone, known as RADICAVA® (edaravone), is a treatment option previously approved by the U.S. Food and Drug Administration (FDA) that was shown in a prior clinical study to slow the loss of physical function in ALS patients.

Berkeley Heights-based BioNJ Member Chugai Pharmaceutical Co., Ltd. announced that an anticancer agent/anti-PD-L1 (Programmed Death-Ligand 1) monoclonal antibody Tecentriq® Intravenous Infusion 840 mg [generic name: atezolizumab (recombinant)] has been listed on the National Health Insurance (NHI) reimbursement price list and launched. Tecentriq 840 mg is an optimal formulation to be dosed every two weeks for the treatment of PD-L1-positive hormone receptor-negative and HER2-negative inoperable or recurrent breast cancer.

Princeton -based BioNJ Member  Bristol-Myers Squibb Company   announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ORENCIA ®  (abatacept) for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors. There are no approved therapies for the prevention of acute GvHD, a potentially life-threatening medical complication that can impact patients receiving such transplants for the treatment of certain genetic diseases and hematologic cancers.

Princeton -based BioNJ Member  Bristol-Myers Squibb Company  and Acceleron Pharma Inc. announced the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee will hold a review of Bristol-Myers Squibb's supplemental Biologics License Application (sBLA) for the use of Reblozyl ® (luspatercept-aamt) in patients with myelodysplastic syndromes (MDS). Bristol-Myers Squibb is seeking approval of Reblozyl, an erythroid maturation agent representing a new class of therapy, for the treatment of adult patients with very low- to intermediate-risk MDS-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions.

Kenilworth-based BioNJ Member  Merck & Co. and AstraZeneca announced that the companies have received marketing authorization from China's National Medical Products Administration (NMPA) for LYNPARZA as a first-line maintenance treatment of adult patients with newly diagnosed advanced germline or somatic BRCA-mutated (gBRCAm or sBRCAm) epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. The approval in China is based on the results from the pivotal Phase 3 SOLO-1 trial.

Kenilworth-based BioNJ Member  Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck's anti-PD-1 therapy. The application seeks approval of KEYTRUDA monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy (removal of bladder). 

Kenilworth-based BioNJ Member  Merck & Co. announced that KEYTRUDA, Merck's anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China in combination with carboplatin and paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). This new indication was granted full approval based on overall survival (OS) findings from the pivotal Phase 3 KEYNOTE-407 trial, including interim data from an extension of the global study in Chinese patients. 

Madison-based BioNJ Member LEO Pharma A/S and Portal Instruments announced a global collaboration and license agreement to develop Portal's innovative needle-free drug delivery system for use in combination with LEO Pharma's portfolio of investigational and approved medicines. Portal Instruments has developed a needle-free jet injector platform to address the increasing needs of patients to self-administer biologics without the need for needles. This simplifies administration, eliminates the need for "sharps containers" in the home, and reduces the time needed to perform self-injections.

Many patients today are entering the operating room with multiple factors that can cause disruptive bleeding during surgery, which can be challenging to manage and potentially dangerous. To help address this, BioNJ Member Johnson & Johnson Medical Devices Companies announced that Ethicon has launched VISTASEAL Fibrin Sealant (Human) to help surgeons manage bleeding during surgery. VISTASEAL Fibrin Sealant (Human) contains a combination of fibrinogen and thrombin, clotting proteins found in human plasma. 

The Research & Development Council of New Jersey awarded winners on Nov. 14 at the Liberty Science Center in Jersey City. Innovative patent work spanned 15 R&D categories including: information technology, environmental, enabling technology, medical technology, medical device, energy, industrial process, emerging therapy, pharmaceutical, agriculture, telecommunications, biotechnology, smart grid, medical imaging and telecommunication systems. Congratulations to these BioNJ Members on their awards: Bristol-Myers Squibb; Celgene Corporation; Ethicon, Inc., a Johnson & Johnson Company; Insmed Incorporated; Merck & Co., Inc; New Jersey Institute of Technology; and Rutgers, The State University of New Jersey.

Parsippany-based BioNJ Member Ferring Pharmaceuticals and Blackstone Life Sciences announced the joint investment of over $570 million USD in nadofaragene firadenovec (rAd-IFN/Syn3), an investigational novel gene therapy in late stage development for patients with high-grade, Bacillus Calmette-Guérin (BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC). FerGene, a new gene therapy company and Ferring subsidiary, has been created to potentially commercialize nadofaragene firadenovec in the U.S. and to advance the global clinical development. 

Princeton -based BioNJ Member Evotec SE announced an expansion of the company's strategic partnership with Celmatix Inc., the leading precision health company advancing the fields of reproductive medicine and fertility at the intersection of big data and genomics. Furthermore, together with investors including Life Sciences Innovation Fund and Topspin Fund, Evotec participates in a funding round which will allow Celmatix to expand its broader, innovative, therapeutics initiatives.

Paramus-based SK Life Science, Inc. and its U.S. subsidiary SK Life Science, Inc. announced that the U.S. Food and Drug Administration (FDA) approved XCOPRI® (cenobamate tablets) as a treatment for partial-onset seizures in adults. The approval is based on results from two global, randomized, double-blind, placebo-controlled studies and a large, global, multi-center, open-label safety study that enrolled adults with uncontrolled partial-onset seizures, taking one to three concomitant anti-epileptic drug (AEDs). In the randomized studies (Study 013 and Study 017), XCOPRI demonstrated significant reductions in seizure frequency compared to placebo at all doses studied.

Warren-based Aquestive Therapeutics, Inc. announced that Exservan™ (riluzole) Oral Film received early-action approval from the U.S. Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS), an orphan disease. "We received full FDA approval for Exservan in advance of our PDUFA action date. We appreciate the ongoing feedback from the FDA and its early action approval. We anticipate that Exservan, via our orally administered PharmFilm® dosage form, will bring meaningful treatment to patients who are diagnosed with ALS and face difficulties swallowing or administering traditional forms of medication," said Keith J. Kendall, Chief Executive Officer of Aquestive.

Morristown-based Newron Pharmaceuticals S.p.A. announced that the U.S. Food and Drug Administration (FDA) has granted the Rare Pediatric Disease designation for sarizotan, the company's product candidate for the treatment of Rett syndrome, a rare neurodevelopmental disorder primarily affecting females, with no approved treatments currently available. "The decision of the FDA to designate sarizotan for the treatment of a rare pediatric population, following an earlier decision to grant it an Orphan Drug designation (ODD), highlights the critical need within the Rett community for treatments for this devastating disease," stated Ravi Anand, Newron's Chief Medical Officer.

Bridgewater-based Amarin Corporation plc announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) seeking approval for icosapent ethyl (brand name Vascepa® in the United States) as a treatment to reduce the risk of cardiovascular events in high-risk patients who have their cholesterol levels controlled with statin treatment, but have elevated triglycerides,135 mg/dL or above, and other cardiovascular risk factors.

Aerie Pharmaceuticals, Inc., with offices in Bedminster,  announced the  European Commission  (EC) has granted a marketing authorisation for Rhokiinsa ®  (netarsudil ophthalmic solution) 0.02% for the reduction of elevated intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension. "The receipt of an EC marketing authorisation for Rhokiinsa® is an important milestone for Aerie as it once again demonstrates the potential value of Aerie's netarsudil franchise at an international level," said  Vicente Anido, Jr. , Ph.D., Chairman and Chief Executive Officer at Aerie. 

Lexicon Pharmaceuticals, Inc., with offices in Basking Ridge, announced the completion of a safety review of the initial run-in cohort of the Telotristat Ethyl for Advanced Biliary Tract Cancer, or TELE-ABC, study, which is a Phase 2 clinical study of telotristat ethyl in patients with biliary tract cancer. Telotristat ethyl is a novel, oral tryptophan hydroxylase (TPH) inhibitor approved as XERMELO® for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy alone.

Somerset-based Catalent announced that it has entered into a partnership with Ethicann Pharmaceuticals Inc. ("Ethicann"), a Calgary-based pharmaceutical company using botanically sourced cannabinoid oils to formulate prescription drugs. The program will initially focus on using Catalent's proven Zydis® orally disintegrating tablet technology to develop a new combination pharmaceutical-grade cannabidiol (CBD) and tetrahydrocannabinol (THC) product that, if approved, would treat patients suffering from multiple sclerosis (MS) spasticity.

Heron Therapeutics, Inc., with offices in  Jersey City,  announced that Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status and accepted by  Health Canada Health Canada's  Priority Review status provides an accelerated 6-month review target for the NDS.  Health Canada  grants Priority Review status to drug submissions intended for the treatment, prevention or diagnosis of serious, life-threatening or severely debilitating illnesses or conditions for which there is substantial evidence of clinical effectiveness and a benefit/risk profile that is improved over existing therapies.

Morristown-based Lonza Pharma & Biotech and Navrogen Inc. announced that they have entered a licensing agreement for the production of Navrogen biotherapeutics using Lonza's GS Xceed Expression System. Navrogen recently announced funding to develop biotherapeutics targeting Humoral Immuno-Oncology (HIO) factors to reverse their inhibitory activity against the pharmacologic effects of antibody-based therapies. Navrogen's biological drugs involve novel protein and antibody-based configurations.

Monmouth Junction-based DiamiR announced a $492,000 award in support of the project entitled "Circulating brain-enriched microRNAs as peripheral biomarkers of neurodegeneration." The award will accelerate the development of DiamiR's targeted diagnostic technology for detection and prediction of Alzheimer's disease (AD) progression. The award is provided by the Alzheimer's Drug Discovery Foundation (ADDF) Diagnostics Accelerator, a fund set up in collaboration with Bill Gates and other philanthropic partners.

Parsippany-based Zoetis Inc. announced it has acquired  ZNLabs , a veterinary diagnostic laboratory company.  This deal follows Zoetis' recent entrance into the reference laboratory services market with  its acquisition of Phoenix Lab , providing it the opportunity to develop more comprehensive diagnostic services for veterinarians. "The addition of ZNLabs strengthens our portfolio, expands our diagnostics footprint and enhances our value proposition to veterinary customers," said Kristin Peck, Executive Vice President and Group President, U.S. Operations, Business Development and Strategy for Zoetis. "We plan to grow further in this space through a mixture of small, business development activities combined with organic expansions in key markets in the coming years."

People in the News

Bridgewater-based BioNJ Member  Eli Lilly and Company  announced new leadership and strategic direction in oncology R&D, combining the  Lilly Research Laboratories  (LRL) oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The new organization, named Loxo Oncology at Lilly, will be led jointly by Josh Bilenker , M.D., Jacob Van Naarden  and  Nisha Nanda , Ph.D., and will report into Daniel Skovronsky , M.D., Ph.D., Lilly's Chief Scientific Officer and President of  Lilly Research Laboratories .

Chester-based BioNJ Member Hillstream BioPharma Inc. announced the addition of clinician-scientist Kwok-Kin Wong, M.D., Ph.D. to Hillstream's Scientific Advisory Board. Dr. Wong brings a wealth of experience from being a professor of oncology to conducting leading-edge research in lung cancer. Dr. Wong is the Chief of Hematology and Medical Oncology at The Perlmutter Cancer Center at NYU Langone Medical Center. During his distinguished career, Dr. Wong served in various investigative and leadership roles at Dana-Farber Cancer Institute, Brigham & Women's Hospital, and Harvard Medical School. 

Paramus-based Ichnos Sciences Inc. is pleased to announce two important additions to its leadership team. Patrick E. Flanigan III  has assumed the role of Chief Financial Officer, and effective  January 7, 2020  Martin L. Wilson will start as General Counsel. Mr. Flanigan is a finance leader with over 20 years of experience in the biotechnology industry. Prior to joining Ichnos Sciences, he served as Senior Vice President of Investor Relations & Treasury for Celgene Corporation. Mr. Wilson is joining Ichnos Sciences from Teligent, Inc., where he served as General Counsel from 2017-2019.

BrainsWay Ltd., with offcies in Hackensack, announced its Board of Directors has appointed Dr. Christopher von Jako as its new CEO and President, effective January 2020.  Prior to BrainsWay, Mr. von Jako served as CEO of Dynatronics Corp. Before that, he was the CEO and President of NinePoint Medical Inc. Additionally, he served as CEO and President of NeuroTherm Inc. Earlier in his career, he held senior roles with other leading medical device companies, such as Integra LifeSciences, Covidien, Medtronic and Radionics.

Institution and Education News

Jersey City's  Liberty Science Center  planned SciTech Scity was gifted $10 million this week from former U.S. Rep. and New Jersey state Sen., philanthropist and real estate developer Frank Guarini. SciTech Scity will total 30 acres, include Liberty Science Center, and be named the Frank J. Guarini Innovation Campus. According to LSC, the $15 million in new funding sets the stage for phase one of the project to open in late 2022. Jersey City donated 12.5 acres of land for the project that aims to rethink K-12 science education and foster science and tech companies. 

Howard Kimmel, Professor Emeritus in Chemical Engineering at New Jersey Institute of Technology (NJIT), has received a Presidential Award for Excellence in Science, Mathematics and Engineering Mentoring (PAESMEM). He is one of 15 awardees nationwide and the only recipient in New Jersey this year. Bestowed by the National Science Foundation in partnership with the White House Office of Science and Technology, the achievement recognizes the strong contributions made by the recipients in expanding, enhancing and retaining science, technology, engineering and mathematics (STEM) talent through mentorship. 

The American Lung Association organization announced its new research team, which includes Dr. Sharon Pine of Rutgers. Dr.  Pine's research titled  "Treating PI3 Kinase-mutant NSCLC,"  was given the Lung Cancer Discovery Award and received $100,000 in funding for the 2019-2020 fiscal year. Dr. Pine proposes to test a novel way to treat squamous cell carcinomas that have a mutation in the gene called PIK3CA. A mutation in PIK3CA is believed to be the driver of the tumor. She proposes pre-clinical pilot studies to examine a new treatment option for these patients.

A $150,000 pledge from the Om Foundation will aid investigators at Rutgers Cancer Institute of New Jersey in examining a certain type of medication that impacts gene activity in the treatment of a form of pediatric brain cancer.  Ependymoma is the third most common childhood brain cancer, for which treatment results have been unsatisfactory due to a lack of effective drugs. Surgical removal and radiation therapy are standard treatments, and chemotherapy has not been shown to improve survival. Researchers at Rutgers Cancer Institute want to explore whether drugs known as epigenetic modifiers will improve treatment results in ependymoma.

Two genes that appear to help stem cells in the intestine burn dietary fat may play a role in colon cancer, according to a Rutgers study. The study, published in the journal Gastroenterology , describes a new connection between the way cells consume fat and how genes regulate stem cell behavior in the intestines of mice. "This is important because scientists have shown that when there's too much dietary fat in the intestine, stem cell numbers increase, boosting susceptibility to colon cancer," said senior author Michael Verzi, Associate Professor, Department of Genetics, School of Arts and Sciences, Rutgers University-New Brunswick

In what is believed to be one of the largest studies of a rare disorder known as primary cutaneous gamma delta T-cell lymphoma (PCGDTCL), Rutgers Cancer Institute of New Jersey investigators and other collaborators examined characteristics, treatment patterns and outcomes of the disease, and determined accurate diagnosis of the disease requires ongoing analysis. Results of the work are being shared at the American Society of Hematology Annual Meeting by lead investigator  Kevin David, M.D. , Hematologist/Oncologist at Rutgers Cancer Institute. 

The  Coriell Institute for Medical Research in Camden has been awarded a $7.7 million contract for medical research by the  National Institute of Neurological Disorders and Stroke, part of the  National Institutes of Health. The five-year award will support the  NINDS Human Genetics Resource Center , a collection of biological samples and genetic data for research.  The repository includes samples from subjects with various diseases such as cerebrovascular disease, epilepsy, Tourette Syndrome and more.

Funding News

Hackensack Meridian Health has invested in the clinical-stage biotechnology company  Adaptive Phage Therapeutics (APT), as part of the health network's successful innovation program, the Bear's Den.  The investment is the third external company that has been funded by Hackensack Meridian Health.  APT is taking aim at the toughest multi-drug resistant "superbugs" using precision-targeted, genomically-screened, and highly purified viruses known as bacteriophages, or "phages."

New Jersey tech, life sciences and manufacturing companies have a unique opportunity to partner with their Israeli counterparts in a research and development effort that will lead to commercialization.  The State signed a memo of understanding between the  New Jersey Economic Development Authority  (NJEDA) and the  Israel Innovation Authority  (IIA) in 2018 to create a mechanism through which New Jersey companies could work side by side with Israeli high-tech firms. This is the first implementation of that mechanism.

Special Programs from Our Partners for BioNJ Members

December 10, 2019  | Webinar

Join this free webinar to learn more and understand how the favourable regulatory pathway works in Australia. The featured speakers will draw upon their experience with U.S. biopharmaceutical companies and will discuss the strategies being followed by U.S. biopharmaceutical companies in planning their first in human studies, which are ultimately accelerating their drug development pathway.

December 19, 2019  | Galloping Hill Golf Course, Kenilworth

This is the 22nd year for the New Jersey Chapter of the Licensing Executives Society to host his holiday event. Click here to register. The New Jersey Chapter uses online registration for members and non-members. Members should login to the registration page with their LES online account.

January 14, 2020 | Allentown High School

Showcase your college/university, technical program, military service branch and more! Set up a table or demonstration!  This year's event will be held during the school day to enable all students to explore the variety of careers offered to them within Science, Technology, Engineering & Math (STEM).  Please RSVP to Dale Cruzan at cruzand@ufrsd.net or 609-259-7292 ext. 1443 by December 16, 2019. 

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:

The NJBAC is a state agency offering free and confidential assistance to help your business grow. As a "one-stop shop," NJBAC can help businesses of all sizes and types manage the state's regulatory processes, boost exports, gain access to financial resources where applicable and tackle other obstacles along the way. You can download the NJBAC guide by clicking here or contact their business advocates at 1-800 JERSEY 7.

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