Agex Therapeutics Inc., of Alameda, Calif., said that, based on a strategic review of its operations, giving consideration to the status of its product development programs, human resources, capital needs and resources, and current conditions in the capital markets resulting from the COVID-19 pandemic, it is initiating layoffs. The move is anticipated to affect 12 employees, primarily R&D personnel. Agex expects to pay about $105,000 in accrued payroll and unused paid time off and other benefits and expects to recognize approximately $194,800 in restructuring charges in connection with the reduction in staffing.
Aradigm Corp., of Newark, Calif., said the bankruptcy court entered an order conditionally approving the disclosure statement for the combined Chapter 11 plan and disclosure statement filed by Aradigm. The order directed the company to distribute the combined plan to creditors and shareholders for voting. It also fixed April 24, 2020, as the record date for shareholders and creditors to vote.
Coimmune Inc., of Durham, N.C., completed the merger with Formula Pharmaceuticals Inc., of Berwyn, Pa. Formula Pharmaceuticals merged into Coimmune, with the latter as the surviving company. The firm will continue to focus on running a phase IIb trial for lead asset CMN-001 in advanced renal cell carcinoma. Coimmune will use the newly acquired technology, CAR-CIK (cytokine-induced killer cells), for clinical development in acute lymphoblastic leukemia. Cole Schotz P.C. represented Coimmune in the merger.
Enzychem Lifesciences Inc., of Englewood, N.J., said preclinical research published in Frontiers in Immunology suggests lead compound EC-18 (PLAG) has activity in gouty arthritis. The publication reports results from a study examining a mitigating effect of PLAG on gouty inflammation, one of the sterile inflammations caused by MSU crystal, a substance thought to be DAMP (damage-associated molecular pattern). Neutrophil infiltration to the tophi is a major cause of the pain in the gouty tissues, and neutrophils are recruited by chemotactic activity in response to neutrophil attracting chemokines, such as CXCL8, which are produced in MSU-accumulated tissues. Therefore, modulating the chemokine production to result in earlier DAMP clearance may be a new therapeutic target to reduce the pain of acute gout.
Evergreenhealth Inc., of Kirkland, Wash., is preparing to move forward with the next phase of clinical research studying Foster City, Calif.-based Gilead Sciences Inc.’s antiviral remdesivir as a potential treatment for COVID-19. The trial known as the Adaptive COVID-19 Treatment Trial, sponsored by the National Institute of Allergy and Infectious Diseases, part of the NIH, is the first clinical trial launched in the U.S. to evaluate an experimental treatment for COVID-19. The second phase of the trial will eliminate the placebo group, and instead provide all study participants with remdesivir to further evaluate its effectiveness against the virus.
Lixte Biotechnology Holdings Inc., of East Setauket, N.Y., said investigators at the National Cancer Institute and the National Institute of Neurological Disorders and Stroke reported that Lixte’s lead clinical compound, LB-100, enhanced pharmacological immunotherapy of intracranial brain tumors in immune-competent mice, including 25% complete regression and immunity to tumor re-challenge. LB-100 plus a PD-1-blocker shrank glioblastoma cancers implanted in the brain, including elimination of tumor and development of immunity to re-challenge with the same tumor in 25% of the animals, the company said. LB-100 is a phosphatase inhibitor with indications in solid tumors, acute ischemia, vascular complicates such as type 2 diabetes, obesity and depression.
Moderna Inc., of Cambridge, Mass., and Lonza Ltd., of Basel, Switzerland, entered a 10-year strategic collaboration agreement to enable larger scale manufacture of Moderna’s mRNA vaccine, mRNA-1273, against SARS-CoV-2 and additional Moderna products in the future. They plan to establish manufacturing suites at Lonza’s facilities in the U.S. and Switzerland. Technology transfer is expected to begin in June with the first batches of mRNA-1273 manufactured at Lonza U.S. in July. The companies plan to establish additional production suites across Lonza’s worldwide facilities to manufacture the material equivalent to up to 1 billion doses of mRNA-1273 per year for use worldwide.
Oxford Biodynamics plc, of Oxford, U.K., said it is participating in the Chief Scientist Office of Scotland-funded biomarker study’s randomized controlled study of the antiviral favipiravir as an early treatment arm of Asterix in COVID-19 hospitalized patients. The study concerns COVID-19 disease severity and response to the antiviral therapy, which is a selective inhibitor of viral RNA-dependent RNA polymerase. It is one of the COVID-19 research projects at the University of Glasgow. The company focuses on discovering and developing epigenetic biomarkers.
Puma Biotechnology Inc., of Los Angeles, licensed rights to Nerlynx (neratinib) in South Korea to Bixink Therapeutics Co. Ltd., of Seoul, South Korea. Bixink will be responsible for gaining regulatory approval. Puma is eligible for up-front and milestone payments of $6 million, as well as significant double-digit royalties on sales of the drug in South Korea.
Teva Pharmaceutical Industries Ltd., of Tel Aviv, Israel, published an abstract in the 2020 American Academy of Neurology Science Highlights Supplement looking at information in the FDA Adverse Events Reporting System for drugs targeting the calcitonin gene-related peptide pathway: Aimovig (erenumab-aooe, Amgen Inc./Novartis AG), Ajovy (fremanezumab-vfrm, Teva) and Emgality (galcanezumab-gnlm, Eli Lilly and Co.). Migraine, headache or drug ineffective, as well as migraine-associated symptoms and injection-site reactions, were the most commonly reported adverse event for all three products. Constipation ranked second for Aimovig but did not make the top 10 adverse events for the other two drugs. Cardiovascular events weren't in the top 10 adverse events for any of the drugs.
Vivus Inc., of Campbell, Calif., was granted a 30-day grace period by IEH Biopharma LLC, which holds approximately $170.1 million of the company's convertible senior notes that matured on May 1, 2020. Vivus will pay IEH Biopharma $3.8 million in accrued and unpaid interest. During the grace period, the two parties will work to restructure the outstanding principal. Vivus agreed to settle or otherwise satisfy the remaining $11.3 million in principal and $253,373 in accrued and unpaid interest held by other note holders.
Xbiotech USA Inc., of Austin, Texas, has identified patients with antibodies to the novel coronavirus that causes COVID-19 who didn't have serious illness. The company plans to use its True Human antibody platform to identify the genes responsible for producing the antibodies in those individuals.