Augustine Therapeutics, of Leuven, Belgium, said it was awarded a €1.2 million (US$1.42 million) research grant from the Flanders Agency for Innovation and Entrepreneurship to develop new neuromuscular diseases therapies. The grant will be used in a 2.5-year study to further characterize the biology of Charcot-Marie-Tooth disease. Augustine, a Flanders Institute of Biotechnology Center for Medical Biotechnology spinoff, said it plans to identify potential neuroprotective actions of HDAC6 inhibitors.
Celonic Group, of Basel, Switzerland, and University College London said they will collaborate to produce protein candidates using Celonic’s cell expression platform. The goal is to establish stable high-performance cell lines for recombinant human proteins’ expression and variants for proof-of-concept clinical trials, according to Celonic. The platform is based on CHO-K1 host cell line and suitable for a range of applications, from non-GMP R&D testing to GMP development and commercial market supply, the company added.
Cipla Therapeutics, an affiliate of Cipla Ltd., of Mumbai, India, and Siga Technologies Inc., of New York, said they will partner to develop antibacterial drugs for use against biothreats. The collaboration will provide the U.S. Biomedical Advanced Research and Development Authority with solutions for its biothreat and public health needs, according to Cipla.
The Chronic Obstructive Pulmonary Disease Foundation and Devpro Biopharma LLC, of Basking Ridge, N.J., entered an alliance to develop treatments for chronic obstructive pulmonary disease and related lung conditions. Devpro is a clinical research and development accelerator and the foundation is a not-for-profit organization formed in 2004.
Cure Pharmaceutical Holding Corp., of Oxnard, Calif., said it received an extension to its schedule I U.S. Drug Enforcement Agency (DEA) license allowing it to research psychedelics-based pharmaceuticals using compounds that include LSD, MDMA and psilocybin as mental health disorder treatments. Schedule I licenses are granted to companies with qualifications and research protocols for handling drug substances with no accepted medical use and a high potential for abuse. Cure’s existing DEA license allows it to manufacture cannabinoid-based pharmaceuticals, the company added.
New preclinical challenge study data from Curevac NV, of Tübingen, Germany, demonstrated its COVID-19 vaccine candidate, CVnCoV, protected against the SARS-CoV-2 B.1.351 South African variant and a strain of the original SARS-CoV-2 B1 lineage. The transgenic mouse model study showed the neutralization capacity of antibody titers was impacted by the B.1.351 variant compared to the original strain, the company said. However, vaccinated animals were fully protected from lethal challenge infections with both strains, Curevac added.
Evelo Biosciences Inc., of Cambridge, Mass., and Abdul Latif Jameel Health, of Monaco, will collaborate to develop and commercialize Evelo’s lead inflammation product candidate, EDP-1815, in the Middle East, Turkey and Africa. Evelo reported positive phase Ib data for EDP-1815 in atopic dermatitis and is conducting a phase II study of EDP-1815 in psoriasis, as well as two trials in patients hospitalized with COVID-19.
Eyenovia Inc., of New York, and Eversana Inc., of Chicago, will partner to help commercialize Mydcombi in the U.S. The FDA accepted Eyenovia’s NDA for Mydcombi, a fixed combination mydriatic (pupil dilation) agent for use in eye exams. If approved, Mydcombi would be the first microdosed ocular therapeutic, the companies said. The PDUFA date for Mydcombi is Jan. 2, 2022. If Mydcombi is approved, Eversana will be Eyenovia’s exclusive distributor for the U.S.
Hepion Pharmaceuticals Inc., of Edson, N.J., disclosed positive results from an in vivo study of CRV-431 in a diet-induced animal model of nonalcoholic fatty liver disease. The firm’s laboratory established nonalcoholic steatohepatitis by feeding animals with a fat- and sugar-enriched Western diet for 34 weeks, followed by eight weeks treatment with oral dosing of CRV-431 or two comparator drugs, obeticholic acid and elafibranor. Fibrosis was reduced, as determined using picrosirius red staining, by 47% with CRV-431, 35% with obeticholic acid and 37% with elafibranor, relative to vehicle controls.
Hoth Therapeutics Inc., of New York, disclosed in vitro data demonstrating SARS-CoV-2 antiviral activity for its lead peptide candidate, HT-002, a therapeutic targeted for the treatment of COVID-19. The study was conducted using a standard cytoprotection assay with live SARS-CoV-2 virus (strain USA-WA1/2020 World Reference Center for Emerging Viruses and Arboviruses) and tested in Vero E6 cells using serial dilutions of the novel peptide. The lead HT-002 peptide candidate was shown to inhibit 50% of the cytopathic effect of the SARS-CoV-2 virus at 61.7 µM. No cytotoxicity was demonstrated at concentrations of up to 200 µM. Shares (NASDAQ:HOTH) closed at $2.51, up 33 cents, or 15%.
Immunome Inc., of Exton, Pa., advanced its first oncology program into IND-enabling studies and anticipates filing an IND in the second half of 2021. The IL-38 target was identified through the interrogation of a B-cell sample from a head and neck cancer patient using the Immunome discovery engine. IL-38 appears to function as a novel innate immune checkpoint, secreted by tumors to inhibit myeloid cell activation and dampen innate antitumor immunity, the company said.
Intervivo Solutions Inc., of Toronto, signed a co-development agreement with Mindset Pharma Inc., also of Toronto, to co-develop a new translational testing platform that will set the performance standards for psychedelic medicines. The psychedelics industry requires a standardized reference dataset to identify and develop medicines with enhanced therapeutic benefit and improved safety and pharmacological profiles, the companies noted, and the pair intends to establish the first comprehensive psychedelics benchmark reference dataset.
Iontas Ltd., of Cambridge, U.K., and Fairjourney Biologics SA, of Porto, Portugal, disclosed the identification of neutralizing antibodies that bind to multiple emerging SARS-CoV-2 variants. The results, generated from a combination of phage display technology and B-cell receptor repertoire sequencing of hospitalized COVID-19 patients, have identified potent neutralizing antibodies with distinct mechanisms of action. Based on that approach, the company has developed a panel of therapeutic candidates.
JSR Life Sciences LLC, of Sunnyvale, Calif., disclosed the launch of its life sciences corporate venture fund. JSR will leverage the new fund to invest in multiple deals within the next few years.
Lead Discovery Center GmbH, of Dortmund, Germany, signed a collaboration with Heidelberg University Hospital and Novo Nordisk A/S, of Bagsvaerd, Denmark, to develop a new therapy against heart failure. Cardiac Ca2+/calmodulin-dependent kinase II (CaMKII) plays a central role in maladaptive processes in the diseased heart. The partners aim to develop a new class of CaMKII modulators by using a strategy expected to block the aberrant effects of CaMKII while preserving physiological CaMKII functions.
Life Edit Therapeutics Inc., of Research Triangle Park, N.C., received an award from the Cystic Fibrosis Foundation to identify potential gene editing approaches to treat certain patients with cystic fibrosis. The award will enable Life Edit to screen its library of base editors for a potential treatment targeting people who are not able to be treated by existing small-molecule treatments due to nonsense genetic mutations.
Lyell Immunopharma Inc., of San Francisco, said it completed its $65 million Lyfe Manufacturing Center in Bothell, Wash.
Maze Therapeutics Inc., of South San Francisco, disclosed its first three lead candidates, which include an oral therapy targeting GYS1 for Pompe disease, an oral therapy targeting APOL1 for chronic kidney disease and a gene therapy targeting ATXN2 for amyotrophic lateral sclerosis. The company also said it is using its Compass platform to advance additional discovery-stage programs across metabolic, cardio/renal and neurological diseases.
Organicell Regenerative Medicine Inc., of Miami, said it entered a material cooperative research and development agreement with the U.S. CDC to determine the anti-inflammatory and anti-infective effectiveness of Zofin in experimental models of influenza infection. Organicell will supply the CDC with its lead compound, an acellular material derived from human amniotic fluid, and, using well-established in vitro and in vivo experimental models of influenza infection, the CDC will test the anti-infective and anti-inflammatory properties of Zofin.
Plus Therapeutics Inc., of Austin, Texas, said it entered a master services agreement (MSA) with Piramal Pharma Solutions for the development, manufacture and supply of Plus’ Rhenium Nanoliposome intermediate drug product. Plus anticipates the MSA will lead to clinical and commercial supply agreements for the drug product at the appropriate stage of development. Terms were not disclosed.
Point Biopharma Inc., of Toronto, and nuclear innovation company Terrapower said they signed a research and clinical supply agreement for the medical radioisotope actinium-225 (Ac-225), further expanding the number of radioisotopes in Point’s pipeline of next-generation precision radiopharmaceutical treatments. Terms were not disclosed.
Sangamo Therapeutics Inc., of Boston, and investigators from Massachusetts General Hospital reported preclinical data in Science Advances describing the use of zinc finger protein transcription factors (ZFP-TFs) to target and silence the expression of the gene that codes for tau. Mice with Alzheimer’s disease received a single injection of the treatment, which employed a harmless virus to deliver the ZFP-TFs to cells, directly into the hippocampus region of the brain or intravenously into a blood vessel. Treatment with ZFP-TFs reduced tau protein levels in the brain by 50% to 80% out to 11 months, the longest time point studied.
Scholar Rock Inc., of Cambridge, Mass., said preclinical data published in the International Journal of Toxicology showed selective inhibition of latent TGFβ1 activation by SRK-181 helped avoid dose-limiting toxicities associated with pan-TGFβ inhibitors in pharmacology studies. In vitro data showed the drug had no effect on human platelet aggregation, activation or binding and that SRK-181 does not trigger a proinflammatory cytokine response in peripheral blood mononuclear cells. A four-week toxicology study showed weekly intravenous administration of SRK-181 achieved sustained serum exposure and was well-tolerated in rats and monkeys with no treatment-related adverse findings.
Selexis SA, of Geneva, and Tallac Therapeutics Inc., of Burlingame, Calif., said they signed both a commercial license agreement and a service agreement to advance Tallac’s Toll-like receptor agonist antibody conjugate platform, which is designed to harness the power of innate and adaptive immunity to treat cancer. Under the terms, Tallac will employ Selexis’ Suretechnology Platform to develop the research cell banks necessary to bring its immunotherapy candidates for the treatment of solid tumors to the clinic. Terms were not disclosed.
Viracta Therapeutics Inc., of San Diego, and Xoma Corp., of Emeryville, Calif., said Xoma purchased the potential future milestones and royalties associated with existing licenses relating to two clinical-stage drug candidates that were obtained in Viracta's merger with Sunesis Pharmaceuticals Inc. in exchange for an up-front payment of $13.5 million and up to $20 million in a pre-commercialization, event-based milestone. The first candidate, DAY-101 (pan-RAF kinase inhibitor), is being developed by Day One Biopharmaceuticals Inc., of South San Francisco, which recently initiated a pivotal phase II trial in pediatric low-grade glioma. The second candidate, vosaroxin (topoisomerase II inhibitor), is being developed by Denovo Biopharma LLC, of San Diego, as a potential treatment for acute myeloid leukemia. Under the terms, Xoma has acquired potential royalty economics related to DAY-101 and up to $54 million in pre-commercialization, event-based milestones and high single-digit net royalties on sales related to vosaroxin and up to $57 million in regulatory and commercial milestones.
Zenas Biopharma Inc., of Hong Kong and Boston, launched March 23 as a cross-border company focused on immune-based therapies for patients in China and throughout the world. Founded and initially funded by Tellus Bioventures and Fairmount Funds Management LLC, Zenas is also backed by a syndicate of global life science investment funds, including Quan Capital, Wuxi Biologics Healthcare Ventures and Wellington Management. The company makes its debut with a pipeline of seven candidates, including ZB-001, an insulin-like factor-1 receptor monoclonal antibody in development for treating patients with China with thyroid eye disease.