Athira Pharma Inc., of Seattle, said it was awarded a research grant by the U.S. NIH that the company expects to total $15 million in a three-year period. The grant supports Athira’s lead candidate, ACT-AD, in a phase II trial for treating mild to moderate Alzheimer's disease. The study will use quantitative electroencephalogram and event-related potential to assess the impact of treating certain brain wave signals associated with learning, memory formation and higher cognitive functions. A secondary outcome measure is the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11.
Betterlife Pharma Inc., of Vancouver, British Columbia, said it signed a definitive agreement to acquire 100% of the assets in Transcend Biodynamics LLC, valued at $10 million in an all-stock transaction. Transcend is a biotechnology company developing patented psychedelic therapeutics, including the LSD derivative BOL-148, a nontoxic second-generation LSD-derived molecule that mimics the therapeutic potential of LSD without the psychedelic effects or hallucinations, according to Betterlife.
Biocytogen Boston Corp., of Wakefield, Mass., and Beijing, said Xencor Inc., of Monrovia, Calif., will license Biocytogen’s Renmab/Renlite Mouse platform to generate and screen fully human antibody hits and identify therapeutic candidates with high affinities, specificities and diversities. Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies to treat cancer and autoimmune diseases.
The Biomed X Institute, of Heidelberg, Germany, said it completed its first joint research neuroscience project with Boehringer Ingelheim GmbH, of Ingelheim, Germany. The project launched in 2016 to uncover the contribution of astrocytes, a subtype of glial cells, to molecular phenotypes in depression. The research found defective neuro-glia interactions and their consequences for neurotransmitter homeostasis and identified molecular components regulating crucial processes impaired in depression, according to Biomed X.
Centogene NV, of Rostock, Germany, and Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said they launched a genetic screening program of the at-risk population for hereditary transthyretin-related amyloidosis and longitudinal monitoring of TTR-positive subjects. The study is a follow-up to Centogene’s epidemiological analysis for hereditary transthyretin-related amyloidosis. Since 2017, 5,000 participants from Germany, Austria and Switzerland with polyneuropathy and/or cardiomyopathy of no obvious etiology were screened for hereditary transthyretin-related amyloidosis as part of the study. More than 1% of the participants were diagnosed with the condition, clinically characterized and regionally mapped.
Checkmate Pharmaceuticals Inc., of Cambridge, Mass., and Bristol Myers Squibb Co. (BMS), of New York, said they will evaluate the combination of Checkmate’s CMP-001, a Toll-like receptor 9 agonist, and BMS’s Opdivo (nivolumab), a PD-1-blocking antibody in two clinical trials. There will be a single-arm phase II study of CMP-001 in combination with nivolumab in subjects with unresectable or metastatic melanoma that is refractory to PD-1 blockade as a monotherapy or in combination with other therapies. There will also be a randomized phase II study of first-line CMP-001 in combination with nivolumab compared to nivolumab monotherapy in subjects with unresectable or metastatic melanoma. Checkmate is the sponsor and BMS will supply nivolumab.
Chinook Therapeutics Inc., of Vancouver, British Columbia, said it entered a license agreement with Atlanta’s Morehouse School of Medicine for certain patents supporting development of therapeutics in kidney diseases disproportionately affecting people of West African descent and underserved communities. Chinook was granted an exclusive, worldwide, sublicensable, royalty-bearing right and license under certain patents related to methods and compositions for treating and detecting kidney diseases, including HIV-associated nephropathy and/or focal segmental glomerulosclerosis using endothelin-1 receptor antagonists, to develop and commercialize therapeutic products. Terms were not disclosed.
Ciloa SAS, of Montpelier, France, said it created a new GMP-compliant production unit as part of developing a new generation of exosome-based vaccines and therapeutic vectors. The company said the unit gives the company complete manufacturing control and independence. Ciloa specializes in the customization, production and purification of exosomes.
Fresh data from a proof-of-concept large animal study of induced mesenchymal stem cell therapy for acute inflammatory respiratory conditions including COVID-19-related acute respiratory distress syndrome by Cranford, N.J.-based Citius Pharmaceuticals Inc. subsidiary Novecite Inc. showed improved oxygenation, less systemic shock and reduced lung injury compared to a control group. Novecite was created to develop, manufacture and commercialize induced mesenchymal stem cells.
Eyepoint Pharmaceuticals Inc., of Watertown, Mass., said it would effect a 1-for-10 reverse stock split on Dec. 8. On Dec. 9, the company said its common stock will trade on Nasdaq on a split-adjusted basis. The reverse stock split is intended to enable Eyepoint (NASDAQ:EYPT) to regain compliance with Nasdaq’s $1 minimum closing bid price required for continued listing. Eyepoint is developing ophthalmic products to treat serious eye disorders.
Genprex Inc., of Austin, Texas, said it completed the technology transfer of its manufacturing process for producing Reqorsa immunogene therapy, the company’s lead drug candidate, from the cancer research institution where it was previously manufactured to commercial contract development and manufacturing organizations. The company said the change should result in a reliable, scalable, reproducible and stable drug product suitable for storage, shipment and patient use. The company is preparing for two clinical trials that combine Reqorsa with Tagrisso from Cambridge, U.K.-based Astrazeneca plc, and with Keytruda from Kenilworth, N.J.-based Merck & Co. Inc. The studies are set to begin in the first half of 2021.
Halix BV, of Leiden, the Netherlands, said it signed an agreement with Astrazeneca AB, of Södertälje, Sweden, a unit of Astrazeneca plc, for large-scale commercial drug substance manufacture of the adenovirus vector-based COVID-19 vaccine AZD-1222. Halix said it will provide commercial manufacturing at its cGMP facility at the Leiden Bio Science Park.
Havn Life Sciences Inc., of Vancouver, British Columbia, said it signed a memorandum of agreement with the Heroic Hearts Project to supply low-dosage psychedelic compounds to clinical studies focused on veterans and post-traumatic stress disorder. Heroic Hearts connects military veterans struggling with mental trauma to psychedelic therapy options including ayahuasca, psilocybin and ketamine. It has branches across the U.S., Canada and the U.K.
New preclinical data from Inventiva SA, of Daix, France, showed positive effects of lanifibranor, a pan-peroxisome proliferator-activated receptor agonist, on cirrhosis. The research showed lanifibranor improved portal hypertension, fibrosis and liver vascular resistance, three frequent and severe clinical syndromes associated with cirrhosis. The drug candidate also reduced ascites, sinusoidal capillarization, liver sinusoidal endothelial cells and hepatic stellate cells activated phenotypes as well as microvascular function and liver inflammation. Inventiva is developing oral small-molecule therapies for treating nonalcoholic steatohepatitis and mucopolysaccharidoses.
Kubota Vision Inc., of Seattle, said it submitted its vascular adhesion protein-1 inhibitor compounds to the National Cancer Institute’s Developmental Therapeutics Program, which will evaluate the compounds’ antitumor activity against 60 human cancer cell lines from nine types of tumors, including leukemia, lung, colon, breast, prostate, brain, kidney, ovarian and skin cancers. Kubota Vision is a wholly owned subsidiary of Kubota Pharmaceutical Holdings Co. Ltd., whose pipeline includes drug candidates for treating diabetic retinopathy, Stargardt disease, and optogenetics-based gene therapy for treating retinitis pigmentosa.
Lineage Cell Therapeutics Inc., of Carlsbad, Calif., said it developed an enhanced differentiation process to improve production and quality of its OPC1 cell therapy drug product, OPC1, an oligodendrocyte progenitor cell allogeneic transplant for treating acute spinal cord injuries. Improvements include a new ready-to-inject formulation of OPC1 that enables clinical use at spinal cord treatment centers and accelerates enrollment for a registrational clinical trial. OPC1 is an oligodendrocyte progenitor cell transplant therapy designed to provide clinically meaningful improvements in motor recovery in patients with acute spinal cord injuries.
Hyundai Bioscience, of Seoul, South Korea, said that CP-COV03, its COVID-19 oral drug candidate, demonstrated a 100% inhibitory concentration level in the blood for 12 hours against viral activity with a single administration. CP-COV03 is a niclosamide-based modified oral drug developed by CN Pharm Co. Ltd., a biotech company holding major shares of Hyundai Bioscience.
Mannkind Corp., of Westlake Village, Calif., said it acquired privately held Qrumpharma Inc., of Doylestown, Pa., which is developing inhalation treatments for severe chronic and recurrent pulmonary infections, including nontuberculous mycobacterial lung disease. Mannkind purchased all Qrumpharma’s outstanding capital stock for $3.5 million in cash and more than 3 million shares of Mannkind common stock.
Mind Cure Health Inc., of Vancouver, British Columbia, said it launched a research program that will initially focus on psilocybin, ketamine and ibogaine. The three psychedelic compounds have demonstrated safety profiles with proven efficacy but have not been optimized for medical use, the company said. The research program will enable Mind Cure to investigate those compounds for use in pharmaceuticals that treat physical and psychological pain and related mental health illnesses.
The Novo Nordisk Foundation said its Bioinnovation Institute has been established as an independent foundation in recognition of its success incubating and accelerating life science research. The institute was established in December 2017 by the Novo Nordisk Foundation to advance research, innovation and entrepreneurship within biotechnology and life science. In the last two years, 85 research projects and startups from Denmark and the Nordic countries have received funding and support through the institute to develop new solutions and technologies within therapeutics, bioindustrials and health tech.
Pascal Biosciences Inc., of Vancouver, British Columbia, and Sōrse Technology Corp., of Seattle, said they have validated and optimized a formula for oral cannabinoid delivery. They are advancing the cannabinoid PAS-393 toward clinical testing against cancer. Following characterization of safety and pharmacology in a phase Ia trial, Pascal and Sōrse said they may continue clinical development as equal partners in a phase Ib cancer trial in combination with a checkpoint inhibitor. Sōrse’s technology converts oil into a proprietary water-soluble emulsion for infusing cannabidiol and other functional ingredients into beverages, food items, topicals and medical applications.
Recce Pharmaceuticals Ltd., of Sydney, Australia, said it was awarded an Advanced Overseas Finding for AU$17.15 million (US$12.7 million) of Synthetic Antibiotic R&D from the Australian government. The finding will support the company’s synthetic antibiotic development program with a 43.5% cash rebate on applicable expenditures. Recce focuses on developing new classes of synthetic anti-infectives designed to address antibiotic-resistant superbugs and emerging viral pathogens.
New data from Secarna Pharmaceuticals GmbH & Co. KG, of Munich and Martinsried, Germany, showed that targeting metadherin significantly slowed progression and metastasis of colorectal and lung cancers in vivo. Secarna is developing antisense oligonucleotides for immune-oncology and immunology plus viral, neurodegenerative and cardiometabolic diseases.
Soligenix Inc., of Princeton, N.J., said it demonstrated extended protection with its heat stable ricin toxin vaccine, Rivax. Mice, vaccinated twice on days one and 21, were protected for at least 365 days against subsequent ricin challenge, the company said. The company said the results reinforce the practicality of stockpiling and potentially utilizing the Rivax vaccine in soldiers and civilian first responders without the complexities that arise for vaccines that require cold chain handling.
Sunshine Biopharma Inc., of Montreal, said it ordered a new batch of Adva-27a from its manufacturer in China. Sunshine said it plans to use the material to conduct testing on various types of cancer cells that overproduce topoisomerase II. Following cell culture studies, Sunshine said it will conduct studies on mice harboring tumors of human origin with topoisomerase II amplification, a cell cycle enzyme that is amplified in approximately 4% of all human cancers.
Shares of Therapix Biosciences Ltd., of Tel Aviv, began trading on the OTCQB Dec. 8 under the symbol TRPXY. The company is developing technologies and assets based on cannabinoid pharmaceuticals for treating Tourette syndrome, obstructive sleep apnea, pain, autism spectrum disorder and epilepsy.
Fresh findings for TH-1902 from Theratechnologies Inc., of Montreal, showed that in addition to ovarian and triple-negative breast cancers, the peptide-drug conjugate showed preclinical in vivo efficacy in colorectal, pancreatic, melanoma and endometrial cancers. Data from the toxicity study concluded that TH-1902 can be administered at three times the maximum tolerated dose of docetaxel alone, the company said. Those cancer types express the sortilin receptor.
Tris Pharma Inc., of Monmouth Junction, N.J., and Neuraxpharm Group, of Dusseldorf, Germany, and Barcelona, Spain, said they entered an agreement for Neuraxpharm to receive exclusive rights to commercialize Tris' FDA-approved Quillivant XR and Quillichew ER for treating attention deficit hyperactivity disorder in Europe. Neuraxpharm specializes in products for treating the CNS.
Virpax Pharmaceuticals Inc., of West Chester, Pa., said new data from ex vivo studies showed MMS-019, a high-density mucoadhesive polymer, demonstrated reduction of infectivity from respiratory viruses such as influenza and SARS-COV-2. MMS-019 could act as a molecular masking spray to prevent or treat respiratory infections, the company said. The polymer is being developed as a pharmaceutical excipient for clinical use under IND-enabling studies using an analgesic molecule, with ongoing research funded by the U.S. NIH’s National Center for Advancing Translational Sciences.