Awakn Life Sciences Inc., of Toronto, said it is partnering with the U.K.’s Drug Science, which works to provide evidence for widespread application of psychedelic drugs within public health models.
Cytodyn Inc., of Vancouver, Wash., said it filed a listing application package with Nasdaq to request an uplisting of the company’s common stock.
Dynavax Technologies Corp., of Berkeley, Calif., and the Icahn School of Medicine at Mount Sinai said they entered a collaboration to develop a universal influenza vaccine. The Mount Sinai Collaborative Influenza Vaccine Innovation Centers team will evaluate a novel approach they have developed called chimeric hemagglutinin, designed to protect against all strains of influenza, in combination with Dynavax’s CpG 1018 adjuvant.
Emmaus Life Sciences Inc., of Torrance, Calif., said it engaged Partner International to lead the out-licensing activity for Emmaus’ prescription grade L-glutamine (PGLG) oral powder for use in the treatment of diverticulosis. It is the same active pharmaceutical ingredient found in Endari, which is approved by the FDA and the Israeli Ministry of Health to reduce acute complications of sickle cell disease in adult and pediatric patients 5 and older. A phase I trial testing the PGLG oral powder in diverticulosis is ongoing, and Emmaus intends to pursue a phase III study under the FDA’s 505(b)(2) pathway.
F-star Therapeutics Ltd., of Cambridge, U.K., disclosed progress in its immuno-oncology collaboration with Merck KGaA, of Darmstadt, Germany, which has chosen to exercise early its option to license a preclinical program and will take over responsibility for future development and commercialization. This is the second license option exercised by Merck, which in May 2019 brought the first program from the collaboration into its pipeline. An undisclosed option exercise payment has been made to F-star, and Merck will pay future success-based milestones and royalties on net sales resulting from the transaction. The companies have also agreed to the licensing terms for the inclusion of two additional preclinical programs under the existing partnership. No financial terms related to the revised agreement are being disclosed.
Humanigen Inc., of Burlingame, Calif., and Catalent said they expanded their relationship, under which Catalent will provide development, manufacturing and commercialization services for lenzilumab, Humanigen’s Humaneered anti-human GM-CSF monoclonal antibody. Mayo Clinic recently announced data on the first clinical use of lenzilumab in 12 patients with severe and critical COVID-19 pneumonia, the majority of whom showed rapid recovery and hospital discharge. A phase III study is currently underway evaluating hospitalized COVID-19 patients.
Idorsia Ltd., of Allschwil, Switzerland, said it expanded in the U.S. by establishing commercial operations in Radnor, Pa. Idorsia US will be led by Patricia “Patty” Torr, president and general manager.
Immuron Ltd., of Melbourne, Australia, updated its research collaboration with the Naval Medical Research Center (NMRC), stating the firm will have a hyperimmune bovine colostrum harvested in September 2020. The drug substance and drug product will be manufactured by the end of 2020 and will be available for the clinical development program to prevent acute infectious diarrhea, which the NMRC plans to initiate at the beginning of 2021, the company said.
Kalytera Therapeutics Inc., of San Francisco, said it entered a license agreement with Salzman Group Inc., under which the latter granted to Kalytera an exclusive, worldwide license to develop and commercialize R-107 for the treatment of coronavirus and COVID-19 infection. Under the terms, Kalytera will pay a license fee to Salzman Group of 130 million Kalytera common shares. The license agreement is the first step in a larger transaction in which Kalytera will acquire Salzman Group, a deal expected to close later this year. R-107 is a liquid prodrug of nitric oxide. Kalytera expects to complete a phase I safety and pharmacokinetic study this year, and intends to apply for funding from the U.S. Department of Health and Human Services for the costs of phase II and phase III studies in COVID-19 and coronavirus infection.
Kronos Bio Inc., of San Mateo, Calif., said it entered an asset purchase agreement to acquire Foster City, Calif.-based Gilead Sciences Inc.’s SYK inhibitor portfolio, which includes clinical-stage compounds entospletinib, tested in phase I and II trials in oncology patients, and lanraplenib, which has been evaluated in phase II trials in patients with autoimmune diseases. Kronos intends to initially focus on developing the SYK inhibitor program in a biomarker-defined subset of patients with acute myelogenous leukemia. Under the terms, Gilead will receive an up-front cash payment and a note convertible into Kronos equity, and will be eligible to receive regulatory and commercial milestones and royalties on future sales of products arising from the acquired programs.
Marinomed Biotech AG, of Vienna, said preclinical data show that Carragelose has the potential to reduce the risk of an infection with SARS-CoV-2 and may also treat COVID-19. Results from a cell-culture study confirm that Carragelose works in a dose-dependent manner to reduce the infection of cells from the SARS-CoV-2 virus. Carragelose coats the mucosal tissues of the respiratory tract susceptible to attack from SARS-CoV-2, forming a physical barrier that helps to protect against viral infection and viral spread. That in turn may suppress the viral load, and the body’s own natural defenses may fight the virus more efficiently.
Mydecine Innovations Group Inc., of Denver, said its prospective acquisition target, Neuropharm Inc., of Vancouver, British Columbia, entered a collaborative relationship with Leiden University Medical Center of the Netherlands for the initiation of clinical trials. The project, "Neuropharm Veteran PTSD Research Project," is preparing an institutional review board-ready protocol to be used for a trial for the specific treatment of post-traumatic stress disorder in veterans.
Nabriva Therapeutics plc, of Dublin, said it entered an exclusive agreement with subsidiaries of Merck & Co. Inc., of Kenilworth, N.J., to market, sell and distribute Sivextro (tedizolid phosphate) in the U.S. and certain of its territories. Sivextro is an oxazolidinone-class antibacterial indicated in adults and pediatric patients 12 and older for the treatment of acute bacterial skin and skin structure infections caused by certain susceptible gram-positive microorganisms. Under the terms, Nabriva will procure Sivextro from Merck and be responsible for marketing, sales and distribution through Dec. 31, 2023, with renewable three-year extensions.
Novartis AG, of Basel, Switzerland, said it launched a program to help patients in low-income and lower-middle-income countries access medicines to treat the major symptoms of COVID-19, such as inflammation and respiratory problems. The Novartis COVID-19 portfolio includes 15 medicines from its Sandoz division for gastrointestinal illness, acute respiratory symptoms, pneumonia as well as septic shock. Novartis said the medicines were chosen based on clinical relevance and availability to ensure demand can be met globally. The medicines on the list include: amoxicillin, ceftriaxone, clarithromycin, colchicine, dexamethasone, dobutamine, fluconazole, heparin, levofloxacin, loperamide, pantoprazole, prednisone, prednisolone, salbutamol and vancomycin. They will be made available to governments, non-governmental organizations and other institutional customers in up to 79 eligible countries at zero-profit.
Oncorus Inc., of Cambridge, Mass., said it entered a clinical trial collaboration with Merck & Co. Inc., of Kenilworth, N.J., to test the combination of ONCR-177 with Merck’s Keytruda (pembrolizumab) in adults with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors. ONCR-177, Oncorus’ lead product candidate, is an intratumorally administered oncolytic herpes simplex virus viral immunotherapy being developed for the treatment of multiple solid tumor indications.
Ose Immunotherapeutics SA, of Nantes, France, said it will receive a grant of up to €200,000 (US$228,680) from Nantes Metropole, the metropolitan area of Nantes community, dedicated to the development of a prophylactic vaccine against the pandemic virus SARS-CoV-2. The funding was awarded as part of the Metropolitan Fund to Support Health Innovations Linked to the COVID-19 Health Crisis, a €1 million fund created by Nantes Metropole for health innovations to address the COVID-19 health crisis. Ose said it expects the first preclinical results for its vaccine candidate this summer and could launch the clinical phase at the end of the year, provided the firm has sufficient funding. Ose’s work aims to develop a prophylactic vaccine focused on memory T cells and is based on a multiepitope-peptide approach.
Promethera Biosciences SA, of Mont-Saint-Guibert, Belgium, and Hao Tian Development Group Ltd., of Hong Kong, through subsidiary Aceso Life Science Holding Ltd., said they entered an agreement to form a joint venture. Aceso and Promethera hold 60% and 40% of the equity, respectively, in the joint venture, which will have the exclusive right to develop, register, distribute and commercialize Promethera’s therapeutic products (cell therapies and antibodies developed by Promethera Group) in China and Southeast Asia.
Recce Pharmaceuticals Ltd., of Sydney, said it entered an agreement with Path Bioanalytics Inc. (PBA), a precision medicine company based in Durham, N.C., to study Recce-327 and Recce-529 against SARS-CoV-2. Recce-327 is a broad-spectrum synthetic antibiotic formulated using synthetic polymer technology to treat blood infections and sepsis. Recce-529 is a new synthetic polymer formulation, built upon the company’s anti-infective expertise. Under the terms, researchers at PBA will evaluate the two drugs against SARS-CoV-2 in an ex vivo respiratory organoid model system. Preliminary data are anticipated in September 2020.
Scynexis Inc., of Jersey City, N.J., said it filed a certificate of amendment to its amended and restated certificate of incorporate to effect a reverse stock split at a ratio of 1-for-10, effective 12:01 a.m. ET on July 17.
Silence Therapeutics plc, of London, said Mallinckrodt plc, of Staines-Upon-Thames, U.K., exercised the option, under the collaboration agreement announced in July 2019, to obtain exclusive worldwide licenses for two additional complement-targeted RNAi assets from Silence. Silence will receive a $2 million milestone payment upon initiation of work for each asset, and the parties anticipate starting work on both programs in due course. Silence will be responsible for preclinical activities and for executing the development program of each asset until the end of phase I, after which Mallinckrodt will assume clinical development and responsibility for the global commercialization. Silence is also eligible to receive up to $10 million in research milestones for each asset, and up to $703 million per asset in clinical, regulatory and commercial milestones. Silence will also receive tiered, low double-digit to high-teen royalties on net sales for each asset.
Summit Therapeutics plc, of Oxford, U.K., said it intends to relocate the corporate domicile of its holding company from the U.K. to the U.S. The company said the proposed redomiciliation is in line with its increasing focus on business operations in the U.S., including its plans to commercialize ridinilazole for the treatment of C. difficile infection, if approved. In addition, Summit said it expects to gain greater corporate flexibility and improve its access to capital by operating within a jurisdiction more familiar to U.S.-focused health care investors.
Tevogen Bio Inc., of Metuchen, N.J., said it intends to evaluate its antigen-specific T-cell technology as a potential treatment for COVID-19 patients. Tevogen is also developing a bivalent COVID-19 and influenza vaccine to assess its ability to generate cellular immunity.
Tonix Pharmaceuticals Holding Corp., of New York, said it entered a research collaboration and option agreement with Columbia University focused on studying the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. The research collaboration will focus on T-cell and antibody responses to SARS-CoV-2, the virus that causes COVID-19, at the cellular level, including human monoclonal antibodies and anti-idiotypes. The research is designed to fill in gaps in understanding the detailed immune responses to COVID-19, and to provide a foundation upon which to target vaccines and therapeutics to appropriate individuals by precision medicine.