4D pharma plc, of Leeds, U.K., a pharmaceutical company leading the development of Live Biotherapeutics, entered a research collaboration and option to license agreement with Merck & Co. Inc., of Kenilworth, N.J., to discover and develop Live Biotherapeutics for vaccines. 4D's Microrx platform will be paired with Merck's expertise in the development and commercialization of vaccines to work on new vaccines in up to three undisclosed indications. 4D has the right, subject to certain conditions, to cause Merck to purchase $5 million in ordinary shares in 4D during the first 12 months of the collaboration. In addition to an up-front cash payment, for each indication, 4D will be eligible to receive up to $347.5 million in option exercise and development and regulatory milestone payments, plus tiered royalties on annual net sales of any licensed products.
Adamis Pharmaceuticals Corp., of San Diego, offered data on its investigational high-dose naloxone product (ZIMHI) at the Institute of Human Virology meeting in Baltimore. Naloxone is an opioid antagonist that knocks opioids off their receptors in the brain. Rapid and efficient reversal by naloxone is critical as brain injury and death can occur within minutes. Adamis presented data comparing the pharmacokinetics of ZIMHI to current doses of other naloxone products. ZIMHI had significantly higher and more rapid levels of naloxone in the blood compared to the other products.
Addex Therapeutics Ltd., of Geneva, said Indivior plc, of Richmond, Va., will provide Addex with an additional $800,000 in 2019 to accelerate research progress in their collaboration to develop further oral gamma-aminobutyric acid subtype B (GABAB)-positive allosteric modulator (PAM) compounds for the treatment of addiction. Under the terms of the original agreement signed with Indivior in January 2018, Addex received $5 million up front and a minimum of $2 million per year of research funding for two years. Activation of the GABAB pathway is clinically and commercially validated, but to date treatment is limited due to side effects, the company said, and targeting GABAB with PAMs could produce fewer adverse effects and lead to less tolerance compared to direct agonists.
Allosource, a nonprofit organization based in Centennial, Colo., disclosed research results showing that Prochondrix CR (osteochondral allograft, Stryker Inc.) maintains consistent, high cell viability for two years when stored at -80 degrees C. The research found the presence, on average, of 94.97% viable cells in Prochondrix CR, representative of the osteochondral allograft's ability to be used as an effective mechanism of repair for articular defects. The data display viable cells within each Prochondrix CR sample that has been cryopreserved for a period of two years.
Amag Pharmaceuticals Inc., of Waltham, Mass., signed a settlement agreement with hedge fund Caligan Partners whereby the board appointed Paul Fonteyne, former CEO of the U.S. arm of Boehringer Ingelheim GmbH, of Ingelheim, Germany, and David Johnson, partner and co-founder of Caligan, to the Amag board. The appointments temporarily expand the size of the board to 11 directors, 10 of whom are independent and four of whom have been appointed within the past six months. Caligan has withdrawn its pending consent solicitation and agreed to a customary standstill, voting commitment and related terms.
Beyondspring Inc., of New York, said Chem and Cell Reports published new data that shed light on the mechanism of action of the company's lead phase III asset, plinabulin, being developed in parallel for the treatment of cancer and prevention of chemotherapy-induced neutropenia. In the article, titled "Structure, Thermodynamics and Kinetics of Plinabulin Binding to Two Tubulin Isotypes," researchers utilizing X-ray crystallography and thermodynamics calculations demonstrated that plinabulin as a new chemical entity is differentiated from other tubulin-binding agents in both its binding site and the kinetics of the binding. The research also provides evidence that this binding may explain the beneficial efficacy and superior safety profile found with plinabulin in the clinic, compared to other agents that bind to a nearby colchicine site in tubulin, such as C4AP or colchicine. The Cell Reports article demonstrates that plinabulin destabilizes microtubule and releases immune defense protein GEF-H1, a critical signaling protein for dendritic cell maturation, antigen cross-presentation and effective priming of CD8 T cells.
Bristol-Myers Squibb Co. (BMS), of New York, disclosed the extension of the expiration date of the offers to exchange notes issued by Celgene Corp., of Summit, N.J., for up to $19.85 billion aggregate principal amount of new notes to be issued by BMS and cash and the related consent solicitations being made by BMS on behalf of Celgene to adopt certain proposed amendments to the indentures governing the Celgene notes. BMS extended the date to 5 p.m. ET on Oct. 25, 2019. (See BioWorld, Jan. 4, 2019.)
Chipscreen Biosciences Co. Ltd., of Shenzhen, China, and Beijing-based Novogene Co. Ltd. have partnered for companion diagnostics development (CDx). Novogene will develop a CDx for Chipscreen's chiauranib, the company's antitumor candidate, and will provide molecular testing services during chiauranib's clinical trial. Chiauranib is a multikinase inhibitor designed to inhibit a tumor's angiogenesis and mitosis. The deal's financial terms were not disclosed.
Context Therapeutics LLC, of Philadelphia, and the Wisconsin Oncology Network will collaborate on a phase II trial to evaluate complete hormone blockade in treating breast cancer in patients who are resistant to antiestrogen plus CDK4/6 inhibitor therapy. The study is designed to assess the value of combining a progesterone receptor agonist, Apristor (onapristone ER), and Faslodex, (fulvestrant) in 40 patients. The study's data are intended to support Context's ongoing and future clinical trials.
Cygnal Therapeutics Inc., of Cambridge, Mass., was unveiled by Flagship Pioneering this week as a startup developing drugs targeting exoneural biology, an understanding of how nerves and neural signaling drive human health and disease. The company, led by CEO Pearl Huang, is focused initially on cancer and inflammatory disease.
Datavant, of San Francisco, has become a founding member of the Boston University Data Privacy Collaborative. Datavant, which uses artificial intelligence and machine learning to speed drug development, intends to a design multiparty, computing-enabled method of sharing insights from multiple health data sources. The collaborative is part of the Hariri Institute for Computing, which said it aims to promote responsible use of private data by developing privacy preserving technology.
Editas Medicine Inc., of Cambridge, and Maxcyte Inc., of Gaithersburg, Md., agreed to a new clinical and commercial license agreement in which Editas receives nonexclusive clinical and commercial rights to Maxcyte's cell engineering platform to develop up to five therapies, including four immune-oncology therapies. Maxcyte receives development and approval milestones, sales-based payments and other licensing fees. No financial terms were disclosed.
Expesicor LLC, of Kalispell, Mont., received a $343,042 Fast Track Small Business Innovation Research grant from the NIH's National Institute of Neurological Disorders and Stroke to develop treatments for neurological disorders. The three-year award is part of a $1.4 million grant from the institute.