Addex Therapeutics Ltd., of Geneva, and the SIB Swiss Institute of Bioinformatics said they were awarded a CHF600,000 (US$660,880) Innosuisse grant to apply computational approaches developed by SIB to assess the repurposing of dopamine D1 receptor antagonist, ADX-10061, for additional therapeutic indications.
Akers Biosciences Inc., of Thorofare, N.J., and Premas Biotech Pvt Ltd., of Gurugram, India, reported findings from a four-week test of the SARS-CoV-2 vaccine candidate, PRAK-03202, in mice. The study in 50 mice divided into 10 cohorts dosed with 5, 10 and 20 mcg of the protein subunit vaccine candidate met its co-primary endpoints of safety and immune response, generating response against the SARS-Cov2 antigens S, E and M. PRAK-03202 elicited neutralizing antibody titer levels at all dose cohorts from 5 to 20 mcg. After three doses in mice, all cohorts showed binding antibody levels similar to those of convalescent patients. Premas is seeking to further characterize the immune response while pursuing additional safety studies and testing in larger animals, with the goal of submitting an IND in the U.S.
Ascentage Pharma Group International, of Suzhou, China, said preclinical results of its inhibitor of apoptosis proteins antagonist, APG-1387, in chronic hepatitis B virus (HBV) infection were presented at the digital International Liver Congress 2020 conducted by the European Association for the Study of the Liver. Compared to vehicle injection, dosing with APG-1387 for four to 20 weeks in different models led to complete clearance of HBsAg, HBeAg and HBV DNA in serum as well as HBcAg and HBV replicative intermediates in infected livers, with no relapse after completion of therapy.
Assembly Biosciences Inc., of South San Francisco, and Arbutus Biopharma Corp., of Warminster, Pa., said they agreed to conduct a clinical collaboration of Assembly’s lead hepatitis B virus (HBV) core inhibitor candidate, ABI-H0731, in combination with Arbutus’ GalNAc-delivered RNAi therapeutic, AB-729, and standard-of-care nucleos(t)ide reverse transcriptase inhibitor (Nrti) therapy in chronic HBV infection. In the first half of 2021, the companies plan to initiate an open-label phase II trial to explore the triple combination vs. double combinations of ABI-H0731 and, separately, AB-729, both with an Nrti. The trial is expected enroll approximately 60 virologically suppressed patients with HBeAg-negative or -positive chronic HBV infection, who will be dosed for 48 weeks, with a 24 week follow-up period. As part of the collaboration, the companies may add cohorts in the future to evaluate other populations and/or combinations. Financial terms were not disclosed.
Autolus Therapeutics plc, of London, said it plans to expand its operations at the Cell and Gene Therapy Catapult manufacturing center and is collaborating with the center to license commercial manufacture of its CAR T-cell therapies.
Beigene Ltd. and Singlomics (Beijing Danxu) Biopharmaceuticals Co. Ltd., both of Beijing, said they executed an exclusive license agreement for Beigene to develop, manufacture and commercialize outside greater China anti-COVID-19 antibodies, including DXP-593 and DXP-604, developed by Singlomics. Using high-throughput single-cell sequencing of convalescent blood samples from individuals who recovered from COVID-19, Singlomics identified multiple antibodies shown to be potent preclinically in neutralizing SARS-CoV-2. A phase I trial expected to enroll up to 30 healthy individuals is expected to begin in Australia in September 2020, with a multinational phase I/II trial in people with mild to moderate COVID-19 infection planned to begin by early October 2020. As part of the agreement, Beigene also gained rights outside China to a series of antibody sequences that could target COVID-19. Singlomics will receive an up-front payment and is eligible for regulatory and commercial milestone payments, along with tiered royalties increasing up to double digits.
Immunocore Ltd., of Oxfordshire, U.K., said preclinical data on its Immtav (immune mobilizing monoclonal T -cell receptors against virus) bispecific molecules, published in Hepatology, suggested the potential for functional cure of chronic hepatitis B virus (HBV). The company’s team generated multiple Immtav molecules to recognize fragments of three different viral proteins and achieve T-cell redirection in vitro. Immtav-Env (HBsAg) molecules were further characterized and shown to redirect a broad range of T-cell subsets toward HBsAg positive cells, with T-cell responses seen from both healthy and HBV‐infected donors. Redirection of T cells by Immtav‐Env resulted in elimination of hepatocellular carcinoma cells containing integrated HBV-DNA and cells infected with HBV in vitro – cells representing both major sources of HBsAg – resulting in reduction of hepatitis B viral protein, or HBeAg, and elimination of up to 97% of cells expressing viral RNA. Immunocore has received regulatory approval to move into the clinic with an HBV candidate, IMC-I109V, a T-cell redirecting TCR anti-CD3 bispecific.
Oncology Pharma Inc., of San Francisco, said it extended its letter of intent with Kalos Therapeutics Inc., also of San Francisco, for global license and co-development of KTH-222, a preclinical MAP kinase inhibitor that the companies plan to assess to treat COVID-19. Oncology also said it retained an interim CEO to assist in its financing efforts, and its board of directors voted to approve a 1-for-100 reverse stock split.
Pluristem Therapeutics Inc., of Haifa, Israel, said the FDA cleared its expanded access program (EAP) for the use of its PLX-PAD cells to treat acute respiratory distress syndrome caused by COVID-19, enabling treatment of individuals ineligible for the company’s ongoing phase II U.S. study. The EAP will include up to 100 individuals, and data from the program will be collected and evaluated alongside trial findings.
Seattle Genetics Inc., of Bothell, Wash., said it expects to receive a milestone payment from Glaxosmithkline plc, of London, triggered by the EC’s conditional marketing authorization for Blenrep (belantamab mafodotin), an antibody-drug conjugate targeting B-cell maturation antigen approved to treat multiple myeloma in certain adults. The milestone amount was not disclosed.
Stoke Therapeutics Inc., of Bedford, Mass., said preclinical data from studies of its SCN1A gene stimulator, STK-001, suggested improvements in survival and reductions in seizure frequency in a mouse model of Dravet syndrome. When Dravet syndrome mice were treated with a single dose at postnatal day 2, 97% survived to day 90 vs. 23% in the placebo group. The data, published in Science Translational Medicine, also showed that STK-001 achieved target engagement, pharmacologic activity and efficacy by selectively increasing Scn1a gene and Nav1.1 protein expression.
T3D Therapeutics Inc., of Research Triangle Park, N.C., said it received a $740,000 grant from the Alzheimer's Association Part the Cloud-Gates Partnership Grant Program to support biomarker studies in conjunction with an upcoming phase II study of T3D-959, the company’s oral insulin sensitizer and PPAR delta/gamma agonist targeting Alzheimer’s disease. The PIONEER (Prospective therapy to Inhibit and Overcome Alzheimer's Disease Neurodegeneration via Brain EnErgetics and Metabolism Restoration) study is expected to enroll up to 252 adults with mild to moderate disease and begin dosing in early 2021.
Vaccitech Ltd., of Oxford, U.K., said it received a grant from the U.K. government to support COVID-19 research using its technology platform. The grant is part of the U.K. Research and Innovation-National Institute for Health Research COVID-19 rapid response rolling call for proposals for projects with potential to deliver public health impacts within 12 months. Vaccitech was awarded £155,000 (US$204,553) for the first phase of the project, with the potential for up to £2.3 million in funding. Vaccitech said proceeds will be used to complete preclinical studies and manufacture sufficient quantities required to initiate a phase I study of its recombinant viral vector COVID-19 vaccine candidate in 2021. Preclinical data suggested Vaccitech’s platform induces antibody and cell-mediated immune responses compared with adenoviral platforms currently in vaccine trials to treat COVID-19.
Vitanova Biomedical Inc., of San Antonio, Texas, was awarded a National Science Foundation SBIR grant for $225,000 to conduct research and development on the company’s light-activated intracellular acidosis targeted cancer therapy. Vitanova Is developing a prostate specific membrane antigen targeted drug, VNBp-1, formulated as a first line treatment for local stage prostate cancer. Light-activated VNBp-1 is designed as an effective alternative to the current standard of care treatments, with the potential to eliminate the unwanted side effects of current cancer treatments.