Ajinomoto Bio-Pharma Services, of San Diego, Calif., said Newark, Calif.-based Revance Therapeutics Inc. has tapped it for commercial manufacturing of daxibotulinumtoxin A for injection, currently under review at the FDA for the potential use in glabellar lines. Aji Bio-Pharma will serve as a dual supply source and provide drug product manufacturing services for Revance, it said.
Aldeyra Therapeutics Inc., of Lexington, Mass., said a preclinical study of ADX-1612, also known as ganetespib, in SARS-CoV-2-infected primary human cells showed antiviral activity for the candidate. The results were derived from a collaboration between the company and the Max Delbrück Center for Molecular Medicine in the Helmholtz Association in Berlin, which plans additional studies with colleagues at the Charité – Universitätsmedizin Berlin University Hospital in cell and animal COVID-19 models, according to the company.
Alterity Therapeutics Ltd., of Melbourne, Australia, has been granted a license by Uniquest, the commercialization company of the University of Queensland, to zinc ionophore technology to combat antimicrobial resistance in superbugs. Alterity said the license covers worldwide rights to develop and commercialize therapies that re-sensitize bacteria to antibiotics. In exchange for the grant of exclusive worldwide rights, should Alterity generate revenue from the technology, Uniquest is entitled to receive certain payments, including milestone and royalty payments commensurate with academic licenses.
Ascentage Pharma Group International, of Suzhou, China, said recent dosing of the first patient in a trial of UBX-1325 in patients with diabetic macular edema by its South San Francisco-based licensee, Unity Biotechnology Inc., has qualified Ascentage for a milestone payment. The payment was made in common stocks from Unity, totaling 228,310 shares (NASDAQ:UBX). Unity shares rose 6% on Dec. 22 to close at $5.62.
Atomwise Inc., of San Francisco, announced a newly formed joint venture (JV) company with RNA-virus expert Nito Panganiban. The JV, called Vairus LLC, will use AI-based screening to find small-molecule compounds to act as broad-spectrum antivirals against flaviviruses, a genus of RNA-viruses that includes Zika virus, dengue fever, West Nile virus and other emerging and tropical diseases.
The Newark, N.J.-based Barer Institute, a cancer drug development subsidiary of Rafael Holdings Inc., has reached an agreement with Princeton University's Office of Technology Licensing for technology from the laboratory of Joshua Rabinowitz at Princeton University, for an exclusive worldwide license to its serine hydroxymethyltransferase inhibitor program and related intellectual property.
Bayer AG, of Whippany, N.J., and Veracyte Inc., of South San Francisco, said they are collaborating to advance the Precision Oncology Patient Identification Program in thyroid cancer. Through the program, Bayer will offer testing with Veracyte’s Afirma Xpression Atlas to identify underlying genomic drivers, including NTRK gene fusions, within patients’ tumors. The program will focus on patients with advanced or metastatic thyroid cancer that is radioactive iodine refractory who may potentially benefit from biomarker-driven therapies.
Celsius Therapeutics Inc., of Cambridge, Mass., and Servier SAS, of Paris, said they are collaborating to find novel colorectal cancer (CRC) drug targets. Under the terms, Celsius will analyze hundreds of samples from defined CRC patient populations using its single-cell genomics platform and will work to identify and validate new drug targets during the three-year research period. Servier will receive an exclusive option to research, develop and commercialize products directed to up to three of the targets. Celsius would receive an up-front payment and research funding, and would be eligible to receive more than $700 million in potential discovery, development and commercialization milestone payments, along with tiered royalties.
Genprex Inc., of Austin, Texas, said it completed the manufacturing scale-up of Reqorsa immunogene therapy. The clinical-grade production is intended to supply the company’s upcoming Acclaim-1 and Acclaim-2 clinical trials for the treatment of non-small-cell lung cancer, on track to start in the first half of 2021. Shares of Genprex (NASDAQ:GNPX) gained 12.3%, or 49 cents, to close Dec. 22 at $4.47.
Ilya Pharma AB, of Uppsala, Sweden, said it signed a two-year extension to its immunophysiology and synthetic biology research agreement with Uppsala University, Department of Medical Cell Biology. The work is intended to help further de-risk and accelerate development of Ilya’s pipeline of advanced therapies based on modified lactic acid bacteria expressing human chemokines beyond acute skin wounds to diabetic wounds and inflammatory bowel disease. Under the terms, Ilya will invest SEK6 million (US$720,000).
Leap Therapeutics Inc., of Cambridge, Mass., said preclinical data published in Molecular Cancer Research characterized a murine version of DKN-01 (mDKN-01) in order to better understand the mechanism of action of DKK1 inhibition in two mouse cancer models. Results showed targeting DKK1 suppresses tumor growth, reduces intratumoral myeloid-derived suppressor cells (MDSC) in the tumor and spleen, activates NK cells and up-regulates PD-L1 expression on MDSC. Tumor cell signaling analysis in those studies indicated that mDKN-01 is not acting as a Wnt/B-catenin pathway agonist, but is inducing a collection of favorable immune changes in the tumor microenvironment.
Nektar Therapeutics Inc., of San Francisco, said it agreed to sell to entities managed by Healthcare Royalty Management LLC (HCR) its royalties on future sales of Adynovate (antihemophilic factor [recombinant], pegylated), under Nektar's agreement with Baxalta Inc., part of Osaka, Japan-based Takeda Pharmaceutical Co. Ltd., and Movantik (naloxegol), under Nektar's agreement with Astrazeneca plc, of Cambridge, U.K. Under the terms of the new purchase and sale agreement, HCR will pay Nektar an aggregate cash payment of $150 million by Dec. 31. Nektar intends to use the net proceeds toward the funding of clinical trials for its early and late stage immune-oncology programs. For the nine-month period ended Sept. 30, Nektar recognized $30.5 million in aggregate royalties from net sales of Adynovate and Movantik.
Ocugen Inc., of Malvern, Pa., and Bharat Biotech Ltd., of Hyderabad, India, said they signed a binding letter of intent to co-develop Bharat Biotech’s COVID-19 vaccine candidate, Covaxin, an advanced-stage whole-viron inactivated vaccine candidate, for the U.S. market. Under the terms, Ocugen will have U.S. rights and, in collaboration with Bharat Biotech, will be responsible for clinical development, registration and commercialization in the U.S. Financial terms were not disclosed. Covaxin is currently part of a phase III trial in India involving 26,000 volunteers.
Polypid Ltd., of Petah Tikvah, Israel, reported preclinical data from its Oncoplex intratumoral therapy program, which uses the firm’s Plex technology to provide prolonged and controlled local exposure of docetaxel in the intraoperative tumor resection setting. In a syngeneic mouse model for solid tumors of colon carcinoma, a single local application showed 25% overall tumor recurrence at the end of the study (day 39 post-surgery) compared to 75% in the systemic treatment arm and 100% in the untreated control arm. Oncoplex also demonstrated 75% overall tumor-free survival at the end of the study, compared to 25% in the systemic treatment arm and 0% in the untreated control arm. The Oncoplex arm showed 75% overall survival at the end of the study vs. 50% in the systemic treatment arm and 0% in the untreated control arm.
Proteostasis Therapeutics Inc., of Boston, said stockholders approval all proposals related to the merger with Yumanity Therapeutics Inc., of Cambridge, Mass. The combined company will operate under the Yumanity name and pursue development of Yumanity’s pipeline of disease-modifying programs targeting neurodegenerative diseases.
The Russian Direct Investment Fund (RDIF), of Moscow, the Gamaleya National Center, Astrazeneca plc, of Cambridge, U.K., and R-Pharma US LLC, of Princeton, N.J., said they signed an agreement aimed at the development and implementation of a clinical research program to assess the immunogenicity and safety of the combined use of one of the components of the Sputnik V vaccine developed by the Gamaleya Center, and one of the components of the AZD-1222 vaccine, developed by Astrazeneca and the University of Oxford. The parties have also agreed to develop scientific and business relations and explore the possibilities for joint use of the Sputnik V vaccine and the AZD-1222 vaccine in order to create more effective and long-term immunization against potential new coronavirus infections. Clinical trials of the combination will begin soon. R-Pharm will be among the organizations funding the trial.
Resverlogix Corp., of Calgary, Alberta, said findings published in the Proceedings of the National Academy of Sciences provide new evidence for the therapeutic potential of BET inhibitors in treating COVID-19. Research is consistent with recent in-house studies performed by Resverlogix, which demonstrated that apabetalone inhibits the expression of angiotensin-converting enzyme 2 (ACE2), the receptor utilized by the novel coronavirus to enter human cells. Further, preliminary data from collaborators – working with live coronavirus in multiple cell models – suggest apabetalone treatment prior to SARS-CoV-2 exposure significantly reduces viral infection.
Sosei Heptares Ltd. of Cambridge, U.K., and Captor Therapeutics SA, of Warsaw, Poland, and Allschwil, Switzerland, said they entered a technology collaboration focused on the discovery and development of small molecules that target the degradation of disease-associated G protein-coupled receptors (GPCRs). The companies initially will focus on identifying small molecules targeting a GPCR with a key role in a strongly validated signaling pathway implicated in gastrointestinal disorders. A further aim of the collaboration is to generate high resolution structural information around the GPCR-E3 ligase complex to enhance drug discovery efforts as well as provide proof of concept for targeted degradation discovery approaches with other GPCRs and other target classes. Discovery and development will be jointly conducted, and the firms will co-own any resulting products, with Sosei Heptares supporting initial R&D costs. Further financial terms were not disclosed.
Tonix Pharmaceuticals Holding Corp., of Chatham, N.J., said it acquired the exclusive license to the University of Geneva’s technology for using oxytocin to treat insulin resistance and related syndromes, including obesity, from privately held Katana Pharmaceuticals Inc., of San Francisco. The license allows Tonix to expand its intranasal potentiated oxytocin development program, TNX-1900, into cardiometabolic syndromes, which include insulin resistance, impaired glucose tolerance and obesity. The patents covering the technology are expected to provide Tonix with freedom to operate in those indications as well as market exclusivity in the U.S. and Europe through 2031, upon its approval, independently of other Tonix-held patents covering the formulation and potentiation technologies related to TNX-1900. Financial terms were not disclosed.
Xeris Pharmaceuticals Inc., of Chicago, said it entered an exclusive distribution agreement with Megapharm Ltd., of Ra’anana, Israel, for the commercialization in Israel and the Palestinian Authority of Xeris’ Gvoke (glucagon injection) for the treatment of severe hypoglycemia in adults and children with diabetes, ages 2 and older. Under the terms, Megapharm will be responsible for registration and marketing of Gvoke, a ready-to-use liquid glucagon, in those territories, as well as for named patient services supply, and Xeris will be responsible for manufacturing, product supply, quality assurance and control, regulatory support, and maintenance of IP. Gvoke is expected to be available in Israel in 2022 and will be available in Israel prior to registration on a named patient basis starting in early 2021.