Acerus Pharma Corp., of Toronto, said it received a waiver letter from SWK Funding LLC related to the required minimum revenue covenant for the fourth quarter of 2020 in its credit facility with Acerus. All other terms and conditions in the loan agreement remain unchanged, according to Acerus. In November, the company issued 526 million of its common shares under a rights offering of 25 cents per share for gross proceeds of approximately $13.165 million. Net proceeds were partially meant for repaying the loan’s principal and interest. Acerus is developing Natesto, a testosterone nasal gel for androgen replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Agios Pharmaceuticals Inc., of Cambridge, Mass., said its shareholders approved the sale of its commercial, clinical and research-stage oncology portfolio to Servier Pharmaceuticals LLC, of Boston.
Agios said it expects the transaction to close around March 31. Agios’ most advanced candidate is a pyruvate kinase R activator, mitapivat, that is being evaluated for treating three distinct hemolytic anemias.
Alvotech hf, of Reykjavik, Iceland, said it disputes North Chicago-based Abbvie Inc.’s allegations of wrongdoing relating to AVT-02, Alvotech’s proposed biosimilar to Humira (adalimumab). According to Alvotech, Abbvie waited more than three years from the purported date of the alleged wrongdoing to file its case, doing so after a former Abbvie employee left Alvotech and without naming the employee as a defendant. Alvotech added that the case may be part of a larger Abbvie strategy to delay an emerging competitor from providing a lower-cost alternative to Humira.
New preclinical data from Ascentage Pharma Group International, of Suzhou, China, demonstrated enhanced T-cell-mediated antitumor immunity was induced by its MDM2-p53 Inhibitor, APG-115. The data showed that mice lacking MDM2 in T cells exhibit more rapidly growing tumors with diminished numbers of tumor-infiltrating CD8-positive T cells. The study also showed that MDM2 stabilizes signal transducer and activator of transcription 5 (STAT5), a protein essential for T-cell function and survival. APG-115 disrupts the MDM2-p53 complex, potentially acting as an MDM2 enhancer, the company said, to stabilize STAT5 and hence augment T-cell immunity. APG-115 is an orally active molecule that activates p53-mediated apoptosis in tumor cells with wild-type p53 and/or MDM2 amplification.
Bright Peak Therapeutics Inc., of San Diego, and Ajinomoto Co. Inc., of Tokyo, entered a research collaboration and license agreement to create Immunocytokines, created by chemically synthesizing cytokines via ligating together customized peptide segments. Immunocytokines will allow tissue- and cell-specific targeting of the cytokine payload with the added potential for synergistic efficacy through potency-enhancing avidity effects, according to Bright Peak. Bright Peak will receive exclusive worldwide rights to use the technology to conjugate certain cytokine payloads, including but not limited to interleukin-2. Bright Peak will make an exclusivity payment and Ajinomoto is eligible to receive development, regulatory and commercial milestone payments as well as royalties on commercial sales.
Brooklyn Immunotherapeutics Inc., of Brooklyn, N.Y., said it completed a reverse merger with NTN Buzztime Inc. Brooklyn said it will focus on advancing IRX-2, its cytokine-based compound for treating various cancers, as well as opportunities in the area of gene editing/cell therapy. Brooklyn's common stock (NYSE American:BTX) began trading March 26. At the merger’s closing, Brooklyn Immunotherapeutics merged with a wholly owned subsidiary of NTN Buzztime and became a wholly owned subsidiary of NTN Buzztime, which changed its name to Brooklyn Immunotherapeutics Inc.
Dunad Therapeutics Ltd., of Cambridge, U.K., has secured its initial financing to develop small-molecule therapeutics based on its differentiated, tuneable and targeted protein degradation technology. Its molecule platform induces targeted degradation of disease-causing and often undruggable proteins via direct modification of the target using monovalent small molecules, the company said. Dunad's platform could unlock access to orally bioavailable and CNS-accessible degrader therapeutics and expand frontiers of protein degradation targets, the company added. Funding came through Epidarex Capital.
Goliver Therapeutics SA, of Nantes, France, said it received a €1 million (US$1.2 million) grant from the French government to market regenerative medicine products at an affordable price and low production cost. The cell therapy developed by Goliver offers regenerative medicine to treat severe liver failure with no therapeutic solution other than liver transplantation, including chronic liver diseases such as nonalcoholic steatohepatitis.
Haima Therapeutics LLC, of Cleveland, said it received two awards from the U.S. Department of Defense (DoD) to support research evaluating co-administration of its synthetic platelet hemostatic technology, Synthoplate, with lyophilized plasma and a red blood cell surrogate. The focus, the company said, is to integrate its dried synthetic platelets with field-deployable technologies to provide rapid rescue from hemorrhagic shock and mitigating bleeding. The DoD’s U.S. Army Medical Research and Development Command awarded Haima $1.4 million and the DoD’s Combat Readiness Medical Research Program awarded Haima a $1.6 million.
New preclinical data from Intellia Therapeutics Inc., of Cambridge, Mass., showed its base editors can expand genome editing capabilities by enabling introduction of multiple gene knockouts simultaneously with no detectable increase in translocation above background levels. The combination of Intellia’s base editor with its cell engineering process achieved more than 90% T-cell editing efficiency while maintaining translocations at background levels, the company said. Intellia has developed a cytosine deaminase base editor that is equipotent to Cas9 for T-cell editing, the company added.
Paul Hastings LLP, a New York-based law firm, said it has secured a "precedent-setting victory" on behalf of Osaka, Japan-based Mitsubishi Tanabe Pharma Corp. (MTPC) in what it said was the first Hatch-Waxman litigation to be tried remotely from start to finish in the U.S. District Court for the District of New Jersey, and one of the first nationally. The case, Mitsubishi Tanabe Pharma Corporation, et al. v. Sandoz Inc., et al., involved three Orange Book-listed patents covering the endocrinology drugs Invokana (canagliflozin) and Invokamet (canagliflozin/metformin), which are sold by MTPC's marketing partner, Janssen Pharmaceuticals Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson.
Novadiscovery SAS, of Lyon, France, said it entered a new collaboration with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, aimed at incorporating clinical simulation technology on virtual patients into Takeda France’s access strategy. This agreement builds on an existing relationship between the companies that began in 2017. Earlier this year, in February, Nova raised €2.5 million (US$3.03 million) in a series A2 financing round from Paris-based Sanofi SA to support advancement of its simulation platform, Jinko.
Open Orphan plc, of London, said that its subsidiary, Hvivo Ltd., entered a contract with a U.S.-based biotechnology company to run a human viral challenge study for a respiratory syncytial virus prophylactic and treatment. The total contract value is £7.5 million (US$10.3 million) and the study is due to start during the fourth quarter, with most revenues being recognize this year, the company said.
Tetra Bio-Pharma Inc., of Ottawa, Ontario, said it has initiated research projects with Targeted Pharmaceuticals LLC, of Marlborough, Mass., though its research agreement with the George Mason University National Center for Biodefense and Infectious Diseases, to investigate the potential benefits of ARDS-003 in neuroinflammation and other antiviral applications. The candidate is a cannabinoid CB2 receptor agonist.