Biopharmx Corp., of Campbell, Calif., said, in anticipation of closing its merger with Woodcliff Lake, N.J.-based Timber Pharmaceuticals Inc., it will undertake a 1-for-12 reverse stock split of its outstanding common stock, expected to be effective May 19. The split is intended to increase the per share trading price of the company’s common stock in order to meet NYSE American listing requirements, which will require, among other things, a $2 per share price, post-split, upon the closing of the merger. Biopharmx will change its name to Timber Pharmaceuticals Inc. and its common stock is expected to begin trading on the NYSE American on a post-reverse stock split basis under the symbol TMBR.
Cellect Biotechnology Ltd., of Tel Aviv, Israel, said it signed a development agreement with an international consortium to examine the therapeutic effects of Apograft-treated stem cells on the reduction of pulmonary manifestations caused by COVID-19. The company has completed the technology and material transfer and the preclinical studies are ongoing. The company will receive royalties upon the commercialization of the intended product. Neither terms of the agreement, nor any members of the international consortium, were disclosed.
CNS Pharmaceuticals Inc., of Houston, said pending the receipt of additional information from the company, Nasdaq has halted the trading in the company's common stock. CNS is working with the staff of Nasdaq to provide it with all requested information and said it hopes to begin trading as soon as possible. The May 1 temporary suspension of trading by the SEC expired on May 15.
E-therapeutics plc, of Oxford, U.K., started testing on the first set of compounds for the treatment of COVID-19 identified using its Network-driven Drug Discovery platform. The company will work with Wuxi Apptec Co. Ltd., of Shanghai, to perform the studies. The company continues to pursue an approach to identify approved and known drugs, both alone and as synergistic combinations, that could be rapidly repositioned for the treatment of COVID-19.
CARB-X, of Boston, is awarding Facile Therapeutics Inc., of Belmont, Calif., up to $1.26 million to develop a new orally bioavailable drug to treat recurring infections caused by Clostridium difficile. Facile could receive up to $17 million more in additional funding if the project achieves certain development milestones, for a potential total of $18.26 million. Facile’s small-molecule drug, ebselen, is an antitoxin that has been shown to be a potent inhibitor of a key biochemical function of C. difficile toxins A and B, which drive the damage done by the infection, the company said.
Hoth Therapeutics Inc., of New York, obtained exclusive worldwide licensing rights to the Biolexa Platform, a proprietary, patented antimicrobial therapy focused on treating atopic dermatitis. The agreement serves as an extension to the previously executed sublicense agreement for the compound with Chelexa Biosciences Inc., of Auburndale, Mass., the company said. Terms were not disclosed.
Immunogen Inc., of Waltham, Mass., disclosed preclinical data for its next-generation anti-folate receptor alpha (FRα) antibody-drug conjugate, IMGN-151, which is being investigated in tumors with a broad range of FRα expression. The data will be shared via poster presentation at the virtual American Association for Cancer Research annual meeting in June. IMGN-151 comprises an asymmetric, bivalent, biparatopic antibody targeting two independent epitopes of FRα, linked to a maytansinoid derivative, DM21, via a cleavable peptide linker with enhanced stability, longer half-life and increased bystander activity. The average drug per antibody ratio is 3.5. IMGN-151 activity was characterized against cell lines and xenograft models with a wide range of FRα expression and compared to mirvetuximab soravtansine (IMGN-853). Cell lines and xenograft models originated from ovarian, endometrial, breast and cervical cancer. In tumor cells with medium and high FRα expression, IMGN-151 boosted antibody binding events and payload delivery by 100% and 170%, respectively.
Inventiva SA, of Dais, France, said preclinical data published in PLOS One showed that in vitro, treatment with oral small-molecule odiparcil was associated with reduced intracellular GAG content in skin fibroblasts isolated from mucopolysaccharidosis (MPS) VI patients. Furthermore, Inventiva’s research team observed in vivo in wild-type rats that odiparcil was well distributed in MPS VI disease-relevant tissues and organs such as bone, cartilage, heart and cornea, where enzyme replacement therapy, the current standard of care for MPS VI, has shown poor penetration. In a mouse genetic model of MPS VI, treatment with odiparcil was consistently associated with urinary excretion of GAGs throughout the treatment period and significantly reduced GAG accumulation in tissues such as liver and kidney. Treatment with odiparcil was also associated with diminished pathological cartilage thickening of trachea and femoral growth plates of MPS VI mice.
Mercaptor Discoveries Inc., of Novato, Calif., said it is pivoting its neurotherapeutic development plan toward COVID-19. Mercaptor's lead Capton product inhibits COX2, an upstream component of the inflammatory response, thereby restricting the cytokine storm that leads neuroinflammation, protecting the patient from pulmonary and cardiac collapse. It is becoming increasingly clear that damage caused by neuroinflammation can lead to organ failure in severe cases of COVID-19 infection, the company said.
Moleculin Biotech Inc., of Houston, said pending the receipt of additional information from the company, Nasdaq has halted trading in the company's common stock. The company is working with the staff of Nasdaq to provide it with all requested information, and said it hopes to begin trading as soon as possible. The May 1 temporary suspension of trading by the SEC expired May 15.
Mymetics Corp., of Epalinges, Switzerland, said its subsidiary, Mymetics BV, signed a research collaboration agreement with Baylor College of Medicine and Texas Children’s Center for Vaccine Development to evaluate the rationally designed recombinant protein-based SARS-CoV and SARS-CoV-2 antigens and combine them with Mymetics’ virosomes for the development of a COVID-19 vaccine. Since the end of April, Mymetics has started a project for the rapid development of a COVID-19 virosome-based vaccine. The firm is partnering with academic institutions to explore and select the best SARS-CoV antigens.
Neurotrope Inc., of New York, and Metuchen Pharmaceuticals LLC, of Manalapan Township, N.J., will merge to form Petros Pharmaceuticals Inc. in an all-stock transaction. Petros' cornerstone product will be Metuchen's Stendra (avanafil) for erectile dysfunction. Petros' pipeline will include Metuchen's recently in-licensed product, H-100 for Peyronie's disease, and include a business development program exploring various men's health products, such as endothelial dysfunction, prostate cancer, psychosexual and psychosocial ailments, hormone health and substance use disorders. Neurotrope shareholders will own about 20% and Metuchen shareholders will own about 80% of the combined company.
James Hansen, the inventor of the platform used by Patrys Ltd., of Melbourne, Australia, received a $1.83 million research grant from the NIH. The grant will support his work using PAT-DX1 and its nanoparticle conjugated form, PAT-DX1-NP, against glioblastoma multiforme, the most common form of malignant brain cancer. Patrys released new preclinical data for PAT-DX1 and PAT-DX1-NP showing the agents can cross the blood-brain barrier.
New data from Provention Bio Inc., of Oldwick, N.J., and Vactech Oy, of Tampere, Finland, show that a preclinical prototype of Provention's polyvalent coxsackievirus B (CVB) vaccine, PRV-101, is well-tolerated, immunogenic and highly protective in animal models. Provention is developing PRV-101 as a vaccine for acute coxsackievirus infection and for prevention of type 1 diabetes (T1D). In addition to immunogenicity and safety in nonhuman primates, the prototype vaccine was efficacious in three relevant murine species. In non-obese diabetic mice, which are genetically at risk to develop diabetes, the prototype vaccine did not trigger or accelerate diabetes. In SOCS-1-tg mice, a murine model for virus-induced T1D in which the insulin-producing beta cells are highly susceptible to CVB-induced destruction, the prototype prevented both infection by CVB and the development of CVB-induced diabetes. In BALB/c mice, a common wild-type murine strain, the prototype vaccine prevented infections known to cause CVB-induced myocarditis, a serious complication of acute CVB infection in humans.
Stallergenes Greer Ltd, of London, said production of its subcutaneous products will fully resume in Antony, France, starting with skin prick tests (Alyostal) for diagnosis and Alustal for treating allergies. Production resumed when the French Agency for Medicines and Health lifted its injunction that impacted production of subcutaneous products in Europe.
Supernus Pharmaceuticals Inc., of Rockville, Md., said it received a paragraph IV notice letter from Apotex Inc., of North York, Ontario, and subsidiary Apotex Corp. on their submission of an abbreviated new drug application to the FDA seeking approval for oxcarbazepine extended-release tablets. Supernus said it will vigorously enforce its intellectual property rights relating to Oxtellar XR, its once-daily, oral extended-release oxcarbazepine, which is protected by nine patents listed in the FDA’s Orange Book that expire no earlier than 2027.
Vir Biotechnology Inc., of San Francisco, identified and characterized S309, an antibody isolated from a patient who recovered from severe acute respiratory syndrome in 2003. The antibody has been shown to prevent SARS-CoV-2 live virus infection of cells. Vir is advancing two clinical development candidates based on the S309 antibody as potential therapeutics for COVID-19, VIR-7831 and VIR-7832, in collaboration with London-based Glaxosmithkline plc. VIR-7831 and VIR-7832 are monoclonal antibodies that have demonstrated the ability to neutralize SARS-CoV-2 live virus in vitro.
Wize Pharma Inc., of Hod Hasharon, Israel, and Haifa, Israel’s Bonus Biogroup Ltd., in which Wize owns an 8.9% equity stake, reported preliminary preclinical results in an animal model of Mesencure, developed to treat life-threatening acute respiratory distress in COVID-19 patients and pneumonia patients. Bonus reported that following treatment with Mesencure, the microscopic appearance of treated lungs was similar to healthy lungs, and a significant improvement in additional parameters was achieved. Mesencure consists of activated mesenchymal cells isolated from the adipose tissue of healthy donors. Following intravenous transfusion, the activated cells are expected to reach the lungs, reduce inflammation, and alleviate respiratory and other symptoms. The preclinical study was conducted on an animal model suffering from severe respiratory distress symptoms similar to those of COVID-19 patients, including massive infiltration of immune cells to the lungs, a marked increase in fluid in the lungs and a decrease in blood lymphocyte cell counts.
Wuxi Advanced Therapies, of Philadelphia, said it expanded its service capabilities to offer a fully integrated closed process CAR T-cell therapy platform to accelerate the timeline for cell and gene therapy development, manufacturing and release while providing greater predictability. The platform is designed to provide advanced therapy companies worldwide with integrated capabilities for CAR T production, including in-stock raw materials with established batch records, regulatory and technical expertise, and process and analytical development.