Angelini Pharma SpA, of Rome, will develop, manufacture and commercialize New York-based Ovid Therapeutics Inc.’s OV-101 (gaboxadol) to treat Angelman syndrome in the European Union, Turkey, the U.K. and Russia. Ovid said OV-101, a delta-selective GABAA receptor agonist, is being evaluated in the pivotal phase III NEPTUNE trial in Angelman syndrome. Top-line results are expected in the fourth quarter of 2020. Ovid will receive an up-front payment of $20 million and could receive up to an additional $212.5 million in payments upon achieving development, manufacturing and sales milestones for the initial indication, as well as double-digit royalties on net sales if OV-101 is commercialized. Ovid retains all U.S. and rest-of-world commercial rights to OV-101.
Byondis BV, of Nijmegen, the Netherlands, said its HER2-targeted antibody-drug conjugate, SYD-985 ([vic-]trastuzumab duocarmazine), was selected by the Quantum Leap Healthcare Collaborative for inclusion in the ongoing I-Spy 2 trial in patients with breast cancer.
Cardior Pharmaceuticals GmbH, of Hanover, Germany, published preclinical data on its H19 gene therapy that expresses a long noncoding RNA in the European Heart Journal. Delivery of the mouse or human version of the H19 gene therapy resulted in significantly attenuated heart failure even when cardiac hypertrophy was already established.
Citius Pharmaceuticals Inc., of Cranford, N.J., regained compliance with the minimum bid price requirement under Nasdaq listing rule 5550(a)(2).
Cobra Biologics Ltd., of Keele, U.K., produced and supplied two additional DNA plasmids to Combigene AB, of Lund, U.K., for use in Combigene's gene therapy drug candidate, CG-01, which is being developed for the treatment of drug-resistant focal epilepsy.
Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., disclosed publication of a peer-reviewed study of fadraciclib, in PLOS ONE. The publication, authored by scientists from Cyclacel and The Institute of Cancer Research in London, describes the discovery of fadraciclib and shows its ability to target CDK2 and CDK9. In parallel with evaluating fadraciclib in patients with acute myeloid leukemia and myelodysplastic syndromes, the firm is executing a precision medicine strategy to evaluate fadraciclib in patients with solid tumors, with study enrollment expected to begin by the first quarter of next year.
Dewpoint Therapeutics Inc., of Boston, forged an exclusive collaboration agreement with Merck & Co. Inc., of Kenilworth, N.J., to apply Dewpoint’s platform for condensate-based drug discovery to the development of a novel mechanism for the treatment of HIV. While drug discovery has traditionally treated the cell’s molecular activity largely as a black box, or focused on individual molecular targets, Dewpoint’s high-throughput condensate platform provides the ability to see and understand the complex interactions of biomolecular communities and to find drugs that intervene in entirely new ways, the company said. Under the terms of the agreement, Dewpoint will receive up to $305 million in up-front and milestone payments, as well as royalties on sales of any approved product resulting from the collaboration.
Exegi Pharma LLC, of Rockville, Md., disclosed the results of a 70-patient trial evaluating a new biologic drug candidate in hospitalized COVID-19 patients. The study was conducted in a hospital setting in Rome and published in Frontiers in Medicine. It compared outcomes of patients who received standard drug treatments alone or standard treatments combined with an oral bacteriotherapy. Of the patients in the bacteriotherapy group, all experienced an elimination of diarrhea within seven days, while fewer than half of the patients who were not treated with bacteriotherapy had a disappearance in diarrhea. The bacteriotherapy group also showed significant improvements in other signs and symptoms associated with COVID-19, including fever, shortness of breath, abnormal physical weakness and myalgia.
Hemogenyx Pharmaceuticals plc, of London, disclosed the pharma partner in its previously announced development agreement. The company signed a biological investigation and material supply agreement with Indianapolis-based Eli Lilly and Co. Under the terms, Lilly will supply Hemogenyx with certain biological materials and related confidential information for research and development activities aimed at the discovery and validation of novel materials to be used for the treatment of systemic lupus erythematosus and possibly other autoimmune diseases. Hemogenyx will grant Lilly a research license for anything jointly developed under the deal, as well as an option for an exclusive worldwide license to commercially exploit jointly developed materials. If such option is not exercised by Lilly, Hemogenyx will have an option to license the jointly developed materials itself.
Immunoprecise Antibodies Ltd., of Victoria, British Columbia, announced the identification of additional, human lead candidate antibodies generated against SARS-CoV-2, also demonstrating potent in vitro neutralizing activity, discovered using the company’s B cell Select and Single Step Cloning Hybridoma platforms. The company made known the finding of a series of lead candidates late last month. The functional antibodies were derived from human and llama samples using IPA’s Deep Display phage technology.
Innovation Pharma Inc., of Wakefield, Mass., provided perspectives on the planned clinical trial testing of brilacidin, administered intravenously, for the treatment of COVID-19. The exigencies of the pandemic coupled with brilacidin’s multiple therapeutic properties – its antiviral SARS-CoV-2 activity, its anti-inflammatory potential to abate the COVID-19-associated cytokine storm, as well as its proven antibacterial properties – have the company working to advance brilacidin into human trials against COVID-19 during the fourth quarter of 2020, Innovation said. Manufacturing steps are now underway to prepare brilacidin for COVID-19 trial use, including the sourcing of materials and making of sterile drug product.
Kainomyx Inc., of South San Francisco, launched programs to address malaria and other parasitic diseases. Leveraging expertise in cytoskeletal biology, Kainomyx was founded by five current and former Stanford University scientists. Existing efforts to develop therapeutic agents for treatment of malaria and other parasitic diseases often start with screening for small-molecule inhibitors of invasion of the parasites into their host cells, the company noted. While it’s an important approach, the likelihood of success in drug development correlates well with the understanding of the mechanism of action of the target. Kainomyx’s approach is to develop small-molecule therapeutics against target proteins that have been studied for decades and meet six characteristics – they are vital components of parasite function, mechanistically well-understood, essential at multiple stages of the parasite life cycle, highly druggable, less likely to be subject to resistance, and can be targeted with high specificity, the company said.
Lipocine Inc., of Salt Lake City, was told by Nasdaq that the company has regained compliance with Nasdaq's minimum bid price for continued listing. Shares (NASDAQ:LPCN) closed July 13 at $1.25.
Mateon Therapeutics Inc., of Agoura Hills, Calif., said it will fund observational studies for artemisinin, an herbal supplement, that demonstrated potent in vitro activity against the COVID-19 virus. By collecting data from multiple clinical observational studies globally, the company expects to establish artemisinin efficacy against COVID-19 as an affordable front-line treatment. Artemisinin is derived from sweet wormwood, an abundantly grown herb.
Menarini Silicon Biosystems, of Bologna, Italy, will have its Cellsearch system, Cellsearch CEC kit, for enumerating and sorting rare cells, and COVID-19-related products marketed and sold by Opgen Inc., of Huntingdon Valley, Pa. Opgen will offer the infectious disease products to hospitals, labs and research centers, along with distributors and other relevant stakeholders in the COVID-19 testing space.
Oncology Venture A/S, of Hoersholm, Denmark, acquired full ownership of its PARP inhibitor (2X-121) program along with its 2X-111 program, by acquiring all outstanding shares in Oncology Venture U.S. Inc. (formerly 2X Oncology Inc.) from external shareholders and warrant holders. Oncology now has full ownership of 2X-121, which is being developed as a cancer therapeutic and as an antiviral agent against COVID-19. It also now has full ownership of 2X-111, which is being developed as a cancer therapeutic.
PCI Biotech AS, of Oslo, Norway, disclosed a six-month extension of the evaluation period under its preclinical research collaboration with Cambridge, U.K.-based Astrazeneca plc. The collaboration was initiated in September 2015 to determine whether PCI Biotech's Fimanac technology has the potential to enhance the delivery of Astrazeneca's nucleic acid therapeutic compounds. The evaluation of the potential for a further collaboration now runs to the end of 2020.
Pear Therapeutics Inc., of Boston and San Francisco, enrolled the first participant in an open-label, decentralized clinical trial evaluating Somryst, an FDA-authorized prescription digital therapeutic for treating chronic insomnia. The study will enroll about 350 adults in the U.S. for nine weeks of digitally delivered treatment to avoid COVID-19 constraints.
Premier Inc., of Charlotte, N.C., and Fresenius Kabi AG, of Bad Homburg, Germany, agreed to supply Diprivan (propofol) injectable emulsion, USP. Diprivan is indicated for anesthesia and sedation, including for patients who require sedation during mechanical ventilation and is commonly used as an anesthetic in elective surgical procedures. According to Premier data, demand for propofol nationwide in April spiked to about six times historical rates, while fill rates in the U.S. fell to less than 50% of ordered quantities, particularly for larger vial sizes preferred for 24-hour ventilator sedation. It was added to the FDA’s drug shortage list that same month.
Samsung Biologics Co., of South Korea, expanded its deal with Stcube & Co. Inc., of Seoul, South Korea, with a development and manufacturing service agreement of STM-418, an anti-PD-1 immuno-oncology candidate. Samsung Biologics is responsible for cell line development, process development, nonclinical and clinical material manufacturing, and IND submission for global clinical trials of STM-418.
Tonix Pharmaceuticals Holding Corp., of New York, and Kansas State University plan to develop a vaccine candidate for COVID-19 using a novel live virus vaccine vector platform and the CD40-ligand, also known as CD154, or 5c8 antigen, to stimulate T-cell immunity. The school will advance preclinical development of a live replicating virus vaccine to protect against COVID-19 based on bovine parainfluenza virus. Attenuated bovine parainfluenza virus has previously been shown to be an effective antigen delivery vector in humans, Tonix noted.