Avidea Technologies Inc., of Baltimore, said preclinical data published in Nature Immunology show how the route of vaccine administration imprints on the quality of anticancer T-cell responses that affect treatment efficacy. The results showed that SNAP Cancer Vaccine (SNAP CV) induced a higher proportion of stem-like (TCF1+) tumor antigen-specific CD8+ T-cell responses associated with improved tumor clearance when administered intravenously as compared with more conventional routes of vaccination (for example, subcutaneous). Researchers reported that TCF1+ CD8 T cells provide a proliferative burst in response to checkpoint inhibitor treatment. SNAP CV was previously shown to improve personalized cancer vaccine manufacturing and significantly increase neoantigen-specific CD8+ T-cell responses in mice and primates when delivered subcutaneously.
Cellarity Inc., of Cambridge, Mass., which is developing medicines to treat diseases at the level of cell behaviors, agreed to work with data and analytics company Excelra, which will provide Cellarity access to its Global Online Structure Activity Relationship database (GOSTAR), a small-molecule medicinal chemistry intelligence platform encompassing more than 8 million compounds. Terms of the agreement were not disclosed.
Crescita Therapeutics Inc., of Laval, Quebec, said it entered an exclusive agreement with Juyou-Biotechnology Co. Ltd., of Huhehaote, China, which develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis (lidocaine/tetracaine) in mainland China. Under the terms, Juyou will be responsible for the overall clinical development and regulatory filings with China’s NMPA. Crescita will receive an up-front payment in cash of $125,000 and will be eligible for regulatory and sales milestones of up to $1million and $1.8 million, respectively. Crescita will supply Pliaglis at a predetermined price per unit including a profit margin and will also be eligible for double-digit royalties once the product is available for commercial sale. Pliaglis is a topical local anesthetic cream designed to provide local dermal analgesia on intact skin prior to superficial dermatological procedures.
Cymabay Therapeutics Inc., of Newark, Calif., said it will provide its investigational GPR119 agonist, MBX-2982, and will assist in regulatory filings for a clinical study to be conducted by the Adventhealth Translational Research Institute. Cymabay wholly owns and retains all rights to MBX-2982. The objective of the study is to determine if GPR119 agonists have potential to prevent hypoglycemia for people living with type 1 diabetes. The trial is funded by a nearly $1.2 million grant from The Leona M. and Harry B. Helmsley Charitable Trust.
Egenesis Inc., of Cambridge, Mass., started a research collaboration with Duke University School of Medicine. The arrangement will encompass evaluation of gene-edited pancreatic islet cells in nonhuman primate recipients as a prerequisite to advancing to human trials. This collaboration is in addition to an existing Egenesis partnership with Massachusetts General Hospital begun in 2017.
Isotopia Molecular Imaging, of Petach Tikva, Israel, is collaborating with Y-mabs Therapeutics Inc., of New York, for the supply of the medical radioisotope no-carrier-added Lutetium-177 to support clinical development for 177Lu-DTPA-omburtamab for the treatment of B7-H3-positive CNS and leptomeningeal metastasis from tumors in adult patients.177Lu-DTPA-omburtamab embodies Y-mabs’ naked omburtamab antibody radiolabeled with lutetium-177, using DTPA to chelate the lutetium radioisotope to the antibody.
Metriopharm AG, of Zurich, Switzerland, disclosed the publication of preclinical data showing its lead compound, MP-1032, could be a promising option for prevention and treatment of the COVID-19-induced cytokine storm. MP-1032 is an orally available small-molecule drug candidate that combines localized, autoregulated ROS-scavenging and immune-modulating effects with specific antiviral properties against COVID-19. The data were published in Medrxiv.
Neoleukin Therapeutics Inc., of Seattle, said data published in Science details the creation of de novo protein decoys that were specifically designed to bind the SARS-CoV-2 spike protein with high affinity, preventing its association with the viral receptor hACE2, which is required for infection. The optimized, hyperstable proteins act as decoys that bind to the virus and block cellular entry. The lead molecule, NL-CVX1 (CTC-445.2d), is shown to prevent infection of multiple human cell lines and to protect hamsters from serious consequences of SARS-CoV-2 infection. Prophylactic intranasal administration of the protein decoy led to survival of all hamsters challenged with a lethal dose of SARS-CoV-2.
Oncoceutics Inc., of Philadelphia, received grants from Michael Mosier Defeat DIPG Foundation, Dragon Master Foundation and The Chadtough Foundation to fund an expanded access program for ONC-201 in the U.S. The program will allow Oncoceutics to work with physicians to provide ONC-201 to patients with H3 K27M-mutant glioma, including diffuse intrinsic pontine glioma, who meet certain eligibility criteria and who cannot otherwise access ONC-201 by participating in an ongoing trial. The program has been made available to select hospitals, though accrual is not yet open to patients.
Ose Immunotherapeutics SA, of Nantes, France, said it completed its human ex vivo study of Covepit, a prophylactic vaccine based on optimized epitopes selected to induce a lasting sentinel T lymphocyte immune response against SARS-CoV-2, the virus that causes COVID-19. The study, conducted in 120 convalescent COVID-19 subjects vs. unexposed subjects, aimed at assessing the memory T-cell immune response at a distance from a resolving infection with SARS-CoV-2 adults. The main objective of the study was achieved: the identification of T memory immuno-dominant epitopes after infection with COVID-19 and incorporation in the vaccine composition.
Proteonic BV, of Leiden, the Netherlands, licensed its 2G UNic technology for boosting therapeutic protein production to Gilead Sciences Inc., of Foster City, Calif. Under the terms, Gilead gains nonexclusive commercial rights for application of Proteonic's technology platform to the development of its proprietary products from mammalian cells. Financial details of the agreement were not disclosed.
Qualigen Therapeutics Inc., of Carlsbad, Calif., signed a contract with STA Pharmaceutical Co. Ltd., a subsidiary of Wuxi Apptec Co. Ltd., of Shanghai, for GMP production of AS-1411, Qualigen's lead drug candidate for the treatment of COVID-19 and other viral diseases, for potential clinical trials. Preclinical studies at the University of Louisville's Center for Infectious Disease have demonstrated the ability of AS-1411, described as a novel aptamer-based molecule, to protect cells from the damaging effects of the virus.
Rexahn Pharmaceuticals Inc., of Rockville, Md., said the merger transaction with Ocuphire Pharma Inc., of Farmington Hills, Mich., was expected to be effective shortly after 4 p.m. ET Nov. 5. Company stockholders previously voted to approve all proposals required for the merger as well as a 1-for-4 reverse stock split.
Saniona AB, of Ballerup, Denmark, said it regained exclusive global rights to the GABAa5 negative allosteric modulator program from Boehringer Ingelheim GmbH, of Ingelheim, Germany, which terminated the collaboration for strategic reasons. That provides Saniona with rights to a portfolio of more than 800 molecules, and the company said it intends to evaluate their applicability in rare diseases. The companies inked the collaboration in 2016. A second collaboration between Saniona and Boehringer Ingelheim, initiated in 2020, is ongoing. Separately, Saniona and the Treatment Research Center at the University of Pennsylvania jointly discontinued their collaboration to develop NS-2359 for cocaine addiction. Saniona will evaluate next steps for that program and may evaluate the applicability of NS-2359 in rare diseases. Meanwhile, the company said it continues to advance the lead compounds emerging from its ion channel platform. SAN-711, which targets GABAa3, is expected to begin phase I trials for rare neuropathic disorders in the first half of 2021. SAN-903, an IK channel blocker, is in preclinical development and expected to begin phase I trials for rare inflammatory disorders in the first half of 2022.