Adamis Pharmaceuticals Corp., of San Diego, disclosed a license to commercialize Tempol, an investigational drug for the treatment of COVID-19 from Matrix Biomed Inc., of Irvine, Calif. The license includes the worldwide use of Tempol for the treatment of all respiratory diseases, including asthma, respiratory syncytial virus, influenza and COVID-19. It also includes the use of Tempol for reducing radiation dermatitis in patients undergoing treatment for cancer. A phase II radiation dermatitis study has already been completed, as well as discussions with the FDA regarding the design of a pivotal phase III study. Adamis paid Matrix $250,000 following signing of the definitive agreement. Adamis will also issue to Matrix 1 million shares of Adamis convertible preferred stock, which will be convertible into an equal number of shares of common stock after and contingent on an increase in the number of available authorized shares of common stock under the company’s restated certificate of incorporation. Under the agreement, if any products are commercialized, net profits will be equally distributed between the parties. The drug is a stable nitroxyl antioxidant.
Agex Therapeutics Inc., of Alameda, Calif., and Pluristyx Inc., of Seattle, signed a manufacturing, marketing and distribution agreement through which Pluristyx will undertake those activities on behalf of Agex with respect to Agex’s research and clinical-grade ESI brand human embryonic stem cells. The agreement builds on Pluristyx’s strategy with standardized Ready-to-Use brand and Ready-to-Differentiate pluripotent stem cells to industry and academic scientists intent on developing therapeutic products to treat human disease, the company said. Agex’s ESI lines are the first clinical-grade hESC lines created under GMP guidelines, the company noted.
Annovis Bio Inc., of Berwyn, Pa., completed the rat cohort of a chronic toxicology study of its lead therapeutic compound, ANVS-401, reporting no negative side effects. The six-month study was part of a series of animal toxicology studies, funded by a $1.7 million grant from the NIH that began in the fourth quarter of 2019. The safety seen in the rats corroborates the positive results from the company’s prior one-month safety studies in mice, rats, dogs and humans. A nine-month dog safety study remains ongoing under the NIH-funded program, with results expected in the third quarter of 2020.
Cascade Chemistry Inc., of Eugene, Ore., said it has been selected to produce the active pharmaceutical ingredient for clinical trial supplies of RBT-9, Dallas-based Renibus Therapeutics Inc.’s investigational therapy entering a phase II trial for the treatment of COVID-19 patients who are at high risk of deteriorating health due to age or co-morbid conditions such as kidney or cardiovascular disease. Awarded fast-track designation by the FDA, RBT-9 has demonstrated both antiviral and immune-modulating activities in preclinical studies, the companies noted.
Cobra Biologics Ltd., of Keele, U.K., signed a supply agreement with Astrazeneca plc, of Cambridge, U.K., to provide GMP manufacture of the adenovirus vector-based COVID-19 vaccine candidate AZD-1222, previously known as ChAdOx1 n-CoV-19. The production agreement is part of Astrazeneca's recently disclosed, in-licensed program with the University of Oxford to ensure broad and equitable supply of the vaccine throughout the world, at no profit during the COVID-19 pandemic. Cobra, along with other consortium members, will be manufacturing the vaccine with first deliveries to begin in the U.K. in September 2020.
Forte Biosciences Inc., of Torrance, Calif., closed its merger with Tocagen Inc., of San Diego. The stockholders of Forte have become the majority owners of Tocagen, and the operations of Forte and Tocagen have combined. The company will be led by Paul Wagner as CEO. The new combined company known as Forte Biosciences will commence trading on Nasdaq under the symbol FBRX.
Genprex Inc., of Austin, Texas, said it expanded the manufacturing program for its lead drug candidate, Oncoprex immunogene therapy, by entering a new agreement with Aldevron LLC, of Fargo, N.C. The collaboration provides for production of TUSC2 plasmid DNA, the active agent in Oncoprex, at full commercial scale. Genprex’s upcoming clinical trials include a phase I/II trial of Oncoprex combined with Tagrisso (osimertinib, Astrazeneca plc) for non-small-cell lung cancer. Data indicate that TUSC2 plasmid DNA, when transfected into cancer cells, induces cell signaling that triggers programmed cell death and modulates the immune system, making cancer cells susceptible to treatment, Genprex said.
Hoth Therapeutics Inc., of New York, expanded its sponsored research agreement with George Washington University to explore WEG-232, a specific substance P-receptor inhibitor, for topical and/or systemic therapy to counter dermatological side effects of chemotherapy and immunotherapy in cancer patients. Programs include preventing skin rash/hair loss and determining WEG-232’s impact on neurogenic inflammation. Preclinical data suggest the application could be effective in suppressing erlotinib-induced facial rash/hair loss with an approximate 71% reduction, Hoth said.
Immunomic Therapeutics Inc., of Rockville, Md., and Ichor Medical Systems, of San Diego, entered a license agreement supporting development of Immunomic’s investigational plasmid DNA vaccine therapy, ITI-1001. Immunomic will use Ichor’s platform to increase cellular uptake of ITI-1001, which targets the pp65, IE-1 and gB viral antigens of cytomegalovirus expressed in glioblastoma. Ichor’s technology applies electrical fields in a target tissue for increasing intracellular nucleic acid uptake in the local area, resulting in enhanced gene expression.
Despite an original projected completion date of June 15, Kalytera Therapeutics Inc., of San Francisco, said it is refining a definitive agreement to acquire the privately held Salzman Group Inc., of West Tisbury, Mass. Salzman is developing R-107 for treating COVID-19-associated lung disease, chlorine inhalation lung injury and pulmonary arterial hypertension. The two companies plan to submit an IND to the FDA and the Australian Therapeutics Goods Administration in June for the indication.
The Lead Discovery Center GmbH, of Dortmund, Germany, and Qurient Co., of Gyeonggi-do, South Korea, said they founded QLi5 Therapeutics GmbH to advance proteasome inhibitors toward preclinical and clinical development for treating cancer and inflammatory and autoimmune disorders. The Max Planck Society is a partner in the endeavor.
Moleculin Biotech Inc., of Houston, said a repeat of previous in vitro testing corroborated the antiviral potential of WP-1122 on human coronavirus 229E, a surrogate of SARS-CoV-2, the virus responsible for COVID-19. Moleculin said it expected to file an IND in the second half of 2020. Initial preclinical testing involved a cell viability assay, followed by a virus yield reduction assay.
Monopar Therapeutics Inc., of Chicago, and Northstar Medical Radioisotopes LLC, of Beloit, Wis., created a 50-50 collaboration to develop radio-immunotherapeutics for treating severe COVID-19. They plan to couple MNPR-101 to a therapeutic radioisotope supplied by Northstar to create a highly selective agent to kill aberrantly activated cytokine-producing immune cells. The goal is to spare healthy cells while reducing cytokine storm and its systemic effects.
Olix Pharmaceuticals Inc., of Suwon, South Korea, signed an exclusive contract with London-based contract development and manufacturing organization LGC Biosearch Technologies Inc. to scale production of its OLX-301D candidate, a potential treatment for choroidal neovascularization and subretinal fibrosis in patients with wet macular degeneration.
Princeton, N.J.-based clinical research organization Quartesian LLC said it will work with Philadelphia-based Amyndas Pharmaceuticals Inc. on a phase II study evaluating the efficacy of the C3 complement inhibitor AMY-101 in COVID-19 patients with acute respiratory distress syndrome. The trial, called AMY-1010_SAVE, is designed to determine whether AMY-101 can halt the broad thrombo-inflammatory response associated with COVID-19.
Sanofi SA, of Paris, said it would invest more than €610 million (US$689.8 million) to create new production and research centers in France, both dedicated to vaccines. The production center in Neuville sur Saône will represent an investment of €490 million over a five-year period and is expected to create 200 new jobs, the company said. A new R&D center in Marcy-l'Etoile is expected to draw investment of €120 million by the company.
Treos Bio Ltd., of London, said it has developed a preventive COVID-19 peptide vaccine, PolyPEPI-SCoV-2, and has transferred all rights, including pending patent applications, to a newly formed subsidiary, Peptc Vaccines Ltd. In silico preclinical testing of the candidate in about 16,000 HLA genotyped subjects from a U.S. bone marrow donor database resulted in an equally high proportion of subjects showing both CD8-positive and CD4-positive T-cell responses in each ethnic group, the company said. Initial funding for the work came from Treos and a group of individual investors, including some of Treos’ existing shareholders.
Vyripharm Biopharmaceuticals, a Houston-based subsidiary of Vyripharm Enterprises LLC, said it has signed off on a master drug program agreement with Regis Technologies Inc., a privately held contract development manufacturing organization in Morton Grove, Ill. The CDMO will help Vyripharm with process research, preclinical and clinical studies of its antiviral diagnostic agents.
Xenetic Biosciences Inc., of Framingham, Mass, secured a master services agreement with PJSC Pharmsynthez to advance the development of the XCART technology for B-cell malignancies. The initial stage of the collaboration will include an exploratory trial to evaluate and refine the XCART front-end process of target identification, screening and lead characterization, in a real-world clinical setting, Xenetic said.