Welcome to the latest edition of the BioLines Weekender. 

We hope you had a happy, healthy and safe Fourth of July. After a fun holiday week, the BioNJ Team has been busy preparing for next week's BioCruise with NewYorkBIO. Please join us on Thursday, July 19, at the  New York Harbor  World Yacht at Pier 81. O ur dinner cruise will set sail on the Hudson at 4:30 p.m. Over dinner, live music and drinks, you'll enjoy great scenery, spending time with old friends and making interesting new ones. Click here for details.

Congratulations to 
C ongressmen Leonard Lance and Tom MacArthur who were presented  with the American Life Sciences Innovation Council's 2018 Champion of Health Care Innovation Award. 

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

New X2 BioCruise with NewYorkBio
New York Harbor World Yacht at Pier 81, New York, NY

July 19, 2018
Beyond Value Frameworks: Defining the Value of Medical Innovation Workshop
Amicus Therapeutics, Cranbury, NJ

October 11, 2018
Save the date!
BioNJ's C-Suite Summit
Bridgewater Marriott, Bridgewater, NJ

October 25, 2018
BioNJ's Patient Advocacy Summit
Celgene Corporation, 179 Passaic Ave, Summit, NJ

December 13, 2018

Putting Patients First: The Value of Medical Innovation
Brought to You by Celgene Corporation

Medical innovation enables longer and better quality lives and, in turn, reduces the costs of healthcare. Share with our community how your medical innovation is improving lives and impacting healthcare 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.

ASCO 2018 will be remembered for the potential paradigm changing innovations across hematologic and solid tumor diseases, but there was a critical discussion also taking place around the tremendous value these advances are offering patients.  Celgene presented a workshop entitled "Understanding the Value of Innovation in Oncology" that looked at what value means to different stakeholders, including patients, physicians and health economists.

Interested in Receiving BioNJ's Biweekly Jobs Beat Featuring the Latest Job Opportunities? Click here!

Whatever your services needs may be,  BioNJ's Member Service Provider Directory   can guide you to the right source. This Member-only categorical listing by service sector is your "one-stop-shop" solution to support and drive your business.  Click on the RESOURCES tab at www.BioNJ.org to view the full BioNJ Member Service Provider Directory categories. Here's a sample for Real Estate / Engineering and Construction / Property Development providers:   

NJ Company News

Ever proud of our ecosystem, we are pleased to share our New Jersey Company News. Be sure to click on the article titles below to read the full release.

Bedminster-based BioNJ Member  Matinas BioPharma Holdings, Inc.  announced a research collaboration focused on the development of a novel therapy for the treatment of human immunodeficiency virus (HIV) combining targeted antisense oligonucleotides (ASO) and Matinas' LNC delivery technology. The goal of this collaboration is to leverage the unique attributes of Matinas' LNC technology to safely, effectively and efficiently deliver ASO intracellularly to inhibit Trans-Activator of Transcription (Tat)/viral mRNA translation. 

Bedminster-based BioNJ Member  Advaxis, Inc.  announced a clinical update, as follows:  Plans to withdraw its Conditional Marketing Authorization Application (MAA) in the European Union for axalimogene filolisbac to treat metastatic cervical cancer in patients who progress beyond first-line therapy; s ubmission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to study its first ADXS-HOT drug candidate for the treatment of non-small cell lung cancer (NSCLC) and s election of prostate cancer as the second cancer type within its ADXS-HOT program to move towards the clinic, with an IND filing anticipated within the next six months.

Princeton-based BioNJ Member Soligenix, Inc. announced that it has received notice of allowance for European (application No. 12786638.2) and Canadian (application No. 2836273) patent applications further extending protection around ThermoVax® including coverage of the company's ricin toxin vaccine, RiVax®. ThermoVax® is a proprietary vaccine heat stabilization platform technology and the patent, titled "Thermostable vaccine compositions and methods of preparing same," has been previously allowed in Japan, Australia and New Zealand with applications pending in China, United States and other worldwide jurisdictions.

Princeton-based BioNJ Member Soligenix, Inc. announced underwritten public offering of 7,766,990 shares of its common stock and warrants to purchase up to an aggregate of 3,106,796 shares of its common stock at a combined offering price of $1.03. In addition, the underwriters partially exercised the over-allotment to purchase additional warrants to purchase 466,019 shares of common stock. The warrants have a per share exercise price of $2.25, subject to customary adjustment, are exercisable immediately and will expire forty-two months from the date of issuance. 

A novel antifungal developed by Jersey City-based BioNJ Member Scynexis for the yeast infection vulvovaginal candidiasis (VVC) has bested the current standard therapy in a midstage trial and is moving to a Phase 3 program.
Scynexis' CEO and BioNJ Board Member Marco Taglietti, M.D. told investors on a conference call that SCY-078 could become a new treatment for the "many VVC patients not currently well served with oral fluconazole" which is currently the drug of choice in most cases.

Englewood Cliffs-based BioNJ Member Immune Pharmaceuticals and WuXi Biologics announced a development and manufacturing agreement for the production of bertilimumab, Immune's first-in-class anti-eotaxin-1 monoclonal antibody. Bertilimumab is designed to block the protein eotaxin-1, which is responsible for causing inflammation in a significant number of diseases.

Princeton-based BioNJ Member Genmab A/S announced that it will pay a milestone payment of USD 7 million to Seattle Genetics, Inc. following progress in the HuMax-AXL-ADC development program. The milestone payment was triggered by the initiation of expansion cohorts in the ongoing Phase I/II trial in solid tumors. Genmab originally licensed Seattle Genetics' ADC technology in September 2014, in order to combine it with Genmab's proprietary HuMax-AXL antibody to target multiple tumor types.

Plainsboro-based BioNJ Member Novo Nordisk announced the headline results from PIONEER 3, a Phase 3a trial with oral semaglutide for the treatment of adults with type 2 diabetes. Oral semaglutide is an investigational GLP-1 analogue taken once daily as a tablet. The 78-week trial investigated the efficacy and long-term safety of 3, 7 and 14 mg oral semaglutide compared with 100 mg sitagliptin in 1,864 people with type 2 diabetes inadequately controlled with metformin, with or without sulfonylurea. 

Princeton-based BioNJ Member Bristol-Myers Squibb Company announced Opdivo (nivolumab) 3 mg/kg plus low-dose Yervo y(ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.

Princeton-based BioNJ Member Bristol-Myers Squibb Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended expanded approval of the current indications for Opdivo (nivolumab) to include the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. 

Princeton-based BioNJ Member Bristol-Myers Squibb's Sprycel, or dasatinib, received approval from the European Commission for an expansion on the drug's indication to include 1- to 18-year-old patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase. The commission also approved a powder formulation for oral suspension. In April, the advisory group CHMP adopted a positive opinion backing approval.

The SMC Committee has accepted East Hanover-based BioNJ Member Advanced Accelerator Applications' radiopharmaceutical Lutathera (lutetium oxotretide) to treat gastroenteropancreatic tumors, a rare type of cancer that develops in the gut or pancreas.  Through the SMC's Patient and Clinician Engagement (PACE) process for medicines used to treat very rare and end of life conditions, patients and clinicians highlighted the debilitating symptoms of the condition. 

Woodcliff Lake-based Eisai Co., Ltd. and Biogen Inc. announced positive topline results from the Phase II study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer's disease. The study achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in Alzheimer's Disease Composite Score (ADCOMS) and on reduction of amyloid accumulated in the brain as measured using amyloid-PET (positron emission tomography).

Woodcliff Lake-based Eisai Co., Ltd. and Mochida Pharmaceutical Co., Ltd. announce that results from two Phase 3 clinical trials (a 2-week double-blind placebo-controlled phase 3 trial and an open-label single-arm 52-week long-term phase 3 trial) for the bile acid transporter inhibitor "GOOFICE® 5mg Tablet" (nonproprietary name: elobixibat hydrate; development code: AJG533, hereinafter "elobixibat") have been published in The Lancet Gastroenterology & Hepatology.

Woodcliff Lake-based Eagle Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted seven years of orphan drug exclusivity (ODE) in the U.S., for BENDEKA™ (bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride.

New Brunswick-based Hemispherx Biopharma, Inc. announced the filing of a clinical study report on AMP-600, a Phase I/II trial of intranasal Ampligen® in combination with FluMist® influenza vaccine with the U.S. Food and Drug Administration. Hemispherx is a research and development and, consistent with its commercial and early access program approvals, an emerging commercial development company focused on unmet medical needs in immunology, with a special emphasis in immuno-oncology.

New Brunswick-based Hemispherx Biopharma, Inc. announced the immediate expansion of its Treatment Protocol/Expanded Access Programs for ME/CFS in the United States, known as AMP-511, to new enrollees for the first time in more than a year. This opportunity to expand the scope of AMP-511 is based on the successful completion of the first phase of its Ampligen manufacturing initiative producing sufficient quantities of Ampligen to support new enrollees in this FDA-approved program.

Basking Ridge-based Daiichi Sankyo Company, Limited announced that it has obtained approval in Japan for an additional indication and dosage for Diagnogreen® for injection 25 mg for evaluation of blood circulation in vascular and tissues. The Review Committee for Unapproved or Off-label Use of Drugs with High Medical Needs recommended that a public knowledge-based application should be made concerning this indication, and the acceptability of a public knowledge-based application was determined by the First Committee on New Drugs of the Pharmaceutical Affairs and Food Sanitation Council.

Hampton-based Mallinckrodt plc   announced it has completed enrollment of the company's ongoing Phase 4 clinical trial of H.P. Acthar® Gel for Rheumatoid Arthritis (RA) patients. The study is assessing the efficacy and safety of H.P. Acthar Gel in RA patients with persistently active disease.  Target  enrollment was 230 patients, and that goal has been exceeded.

Hackensack-based BrainStorm Cell Therapeutics Inc.  announced that it has received a Decision to Grant notice from the Japanese Patent Office ("JPO") to issue a patent entitled: "Methods of generating mesenchymal stem cells which secrete neurotrophic factors."  This patent provides protection for MSC-NTF cells (NurOwn®) in  Japan  until 2033. The Decision to Grant notice is the final approval stage and precedes actual granting which is expected shortly. 

Newark-based Cellix Biosciences Inc. announced confirmation from the U.S. Food and Drug Administration (FDA) that the 505(b)(2) regulatory pathway is appropriate for development of CLX-106 for treatment of relapsing-remitting multiple sclerosis (RRMS). CLX-106 is a novel molecular conjugate designed to deliver an optimal therapeutic profile of monomethyl fumarate (MMF) for RRMS. MMF is the active moiety of dimethyl fumarate (DMF), an approved RRMS therapy that achieved global sales of over $4 billion in 2016. 

Athenex, Inc., with offices in  Cranford,  announced that it has entered into the following agreements: A  joint venture with Xiangxue Life Sciences  for the research, development and commercialization of T-cell receptor-engineered T cells (TCR-T); i n-licensing of worldwide rights to a pegylated genetically modified human arginase from  Avalon PolyTom (HK) Limited  (PolyTom) ; and a  strategic investment of  U.S. $100 million  from  Perceptive Advisors .

Parsippany-based GSK and Medicines for Malaria Venture (MMV) announced that the Antimicrobial Drugs Advisory Committee (AMDAC) of the United States Food and Drug Administration (FDA) voted that there is substantial evidence of the effectiveness (13 for; 0 against) and adequate evidence of the safety (12 for; 1 against) of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax)malaria in patients 16 years of age and older.

Teva Pharmaceuticals USA is moving its U.S. headquarters to Parsippany.  The move is expected to create 832 high-paying jobs in New Jersey while retaining the 232 existing jobs the company already has in the State.  "The presence of global life sciences companies like Teva Pharmaceuticals is critical to New Jersey's ability to strengthen a thriving innovation ecosystem," Governor Murphy said in a statement.  "We are thrilled to expand our welcome to Teva, and its more than 1,000 employees, in the Garden State -- the place to be for the world's most competitive life sciences companies."

Somerset-based  Catalent Inc. has agreed to acquire  Juniper Pharmaceuticals Inc. for $133 million.  Under the acquisition, a subsidiary of Catalent will submit a tender offer of $11.50 per Juniper share. At the end of the offer, Catalent said it will complete the deal by acquiring the remainder of Juniper shares at the same price through a merger with a newly formed wholly-owned subsidiary of Calalent.

Plainsboro-based Integra LifeSciences has announced plans to move into a bigger headquarters, also in Plainsboro. The company recently secured $1.78 million in annual tax incentives over the next 10 years as an incentive to remain in the state by the New Jersey Economic Development Association's Grow NJ program. It's expected to occupy its new 167,000-square-foot facility at 1100 Campus by mid-2019. 

Takeda Pharmaceutical Company Limited, with offices in East Windsor announced that the randomized, Phase 3 TOURMALINE-MM3 study met its primary endpoint, demonstrating single-agent oral NINLARO®  (ixazomib) as a maintenance therapy resulted in a statistically significant improvement in progression-free survival (PFS) versus placebo. The trial evaluated the effect of NINLARO as a maintenance therapy in adult patients diagnosed with multiple myeloma who responded to high-dose therapy (HDT) and autologous stem cell transplant (ASCT). 

Lawrenceville-based  Celsion Corporation  announced that results from a Phase I trial of ThermoDox®  were published in the peer-reviewed journal,  The Lancet Oncology . Conducted by a multi-disciplinary team of biomedical engineers, oncologists, radiologists and anesthetists at the University of  Oxford, United Kingdom , the trial evaluated the safety and efficacy of ThermoDox® , Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin, along with focused ultrasound for the treatment of liver cancer. 

Franklin Lakes-based  Becton Dickinson and Co., a medical technology company, announced it has acquired TVA MEdical Inc., a developer of minimally invasive solutions for patients with chronic kidney disease requiring hemodialysis. The addition of TVA will enable BD to advance its solutions for chronic kidney disease. it will now offer the everlinQ endoAVF System, a new endovascular arteriovenous fistula creation technology that adds to BD's End-Stage Renal Disease portfolio.

People in the News

EY unveiled the 12 New Jersey winners of its  Entrepreneur of the Year 2018 Award at a gala at the Hyatt Regency in New Brunswick.  Each of the  33 New Jersey regional finalists  were placed in 12 different categories. Congratulations to BioNJ Board Member Dr. Christopher Schaber, Soligenix Inc. and  BioNJ Member John Thero, Amarin Corp. who were recognized in the Life Sciences category.

Institution and Education News

The Inspira Health Network Innovation Fund and Rowan University jointly granted $20,000 in seed money to three health care entrepreneurs. The awards were given after a two-day evaluation process, called the Health Hack event, in South Jersey Technology Park. It was sponsored by Republic Bank, Horizon Blue Cross Blue Shield of New Jersey, Cerner and the city of Glassboro.

Rutgers Cancer Institute of New Jersey researchers have elucidated the mechanism behind an 'on/off' switch in the the most commonly mutated gene in human cancer -- findings which senior investigator  Darren R. Carpizo, M.D., Ph.D. , Director of the Hepatobiliary/Liver Cancer Program and member of the Gastrointestinal Cancer Program, says could lead to a new paradigm in cancer therapeutics.

RWJBarnabas Health officials said the health care system is in the process of expanding its footprint in Monmouth County with the recent acquisition of the Myer Center parcel at Fort Monmouth.  RWJBH officials said they will knock down the existing structure and replace it with a state-of-the-art facility that will include an ambulatory care center, a  Rutgers Cancer Institute of New Jersey  Cancer Center, a medical office building, a system business office and campus space for future medical and health facilities.

Special Programs from Our Partners for BioNJ Members

July 17-18, 2018 | Bedminster

The 14th annual Public Relations Communications Summit, taking place on July 17­-18 at Mallinckrodt's Bedminster, NJ offices, is designed to help life sciences communicators push boundaries and move outside of your comfort zone to better position the industry, your company, your brands and yourself. This is the only meeting place exclusively designed for life sciences communicators, and it provides you with the content and networking you need to improve your communications strategy and expand your professional network. Learn more about the conference and its attendees here: https://goo.gl/RNFApx.

September 24-26, 2018 | Philadelphia

The MedTech Conference is the leading North American gathering of global medtech executives. More than 2,700 attendees will network, gain access to capital and share insights in Philadelphia, PA. from September 24-26. The conference features world-class plenary speakers, networking and business development. BioNJ Members receive a 10% discount. Contact RBromberg@BioNJ.org for BioNJ's special discount code. Visit www.themedtechconference.com to learn more about the conference.

As the biotech/pharma stage is pushed toward a Patient-focused path, the voice of the Patient is increasingly demanded throughout the drug development process. As this demand rises, Patient advocates in life sciences emerge. The new landscape and the growing responsibilities of such a role, as well as the regulatory and compliance-related restrictions that surround it, bares the question of how to properly prepare individuals for this role. Professional Patient Advocates in the Life Science (PPALS), a non-profit professional patient advocacy organization working to support and improve Patient advocacy in the biotech/pharmaceutical sphere, have noted, as many others have, this need for a solid background for those who wish to join this field. 

In order to undertake the task of assessing the need for such a program, PPALS has organized a feasibility study with a short survey component. The survey allows for four major groups to voice their views on this important idea, HR/hiring professionals, Patient advocates who have/have not participated in the PPALS's Patient Advocacy Certificate Training, and Patients. PPALS needs help in understanding the future of Patient advocacy and how to improve it not only for the benefit of Patient advocates, but also for industry, non-profit partners, regulatory groups, and, most importantly, for patients and caregivers. Please participate by July 20th. Click here to get started.