Affibody AB, of Solna, Sweden, said partner Alexion Pharmaceuticals Inc., of Boston, has terminated the co-development agreement for FcRn inhibitor ABY-039 in myasthenia gravis (MG), based on phase I tolerability observations. The program’s main competitor, efgartigimod (Argenx NV), also recently demonstrated positive phase III results in MG. Affibody and Alexion inked the ABY-039 deal in 2019. The termination will become effective June 18, 2020.
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia, said it filed with securities regulatory authorities in the provinces of British Columbia, Alberta, Manitoba and Ontario to qualify the securities underlying 19.6 million special warrants the company issued May 13. Each special warrant will automatically be converted into one common share of Algernon and one common share purchase warrant. Each warrant is exercisable for one share on or before May 13, 2022, at an exercise price of 55 cents per share. Algernon is a drug re-purposing company investigating compounds that have never been approved in the U.S. or Europe to avoid off-label prescription writing.
Amabiotics Inc., of New York, said it is changing its name to Stellate Therapeutics Inc., which it said will reflect the company’s focus on using the human gut-brain axis to change the trajectory of brain disorders, including Parkinson’s and Alzheimer’s disease.
Common shares of Appili Therapeutics Inc., of Halifax, Nova Scotia, now trade on the OTCQX Best Market under the ticker symbol APLIF. Appili is investigating favipiravir, an oral antiviral that inhibits PNA-dependent RNA polymerase, for treating COVID-19.
Batavia Biosciences BV., of Leiden, the Netherlands, and Valneva Sweden AB, of Saint-Herblain, France, will collaborate to accelerate market-access of a low-cost inactivated polio vaccine (IPV). In 2019, Batavia received a Bill & Melinda Gates Foundation grant to use its vaccine manufacturing process in combination with manufacturing equipment developed by Univercells SA, of Gosselies, Belgium, to deliver clinical-grade IPV bulks to selected developing country vaccine manufacturers for phase I/II studies. The IPV vaccine is based on the Sabin vaccine strains (sIPV), which Batavia obtained from the World Health Organization. Valneva will manufacture the sIPV vaccine while Valneva will receive an up-front payment and monthly service fees.
Brainstorm Cell Therapeutics Inc., of New York, was granted small and medium-sized enterprise status by the EMA's micro, small and medium-sized enterprise office.
Catalent Inc., of Somerset, N.J., said it will provide Cambridge, U.K.-based Astrazeneca plc vial filling and packaging capacity to prepare for large-scale commercial supply of the University of Oxford’s adenovirus, vector-based COVID-19 vaccine candidate, AZD-1222. Catalent plans round-the-clock manufacturing schedules to supply hundreds of millions of doses from August 2020 and potentially through to March 2022 should the product be approved. The recombinant adenovirus vaccine technology was created by the Jenner Institute at the University of Oxford. The vaccine candidate is currently in clinical trials.
Dr. Reddy's Laboratories Inc., of Hyderabad, India, and Princeton, N.J., said Foster City, Calif.-based Gilead Sciences Inc. granted Dr. Reddy’s the right to register, manufacture and sell Gilead’s remdesivir, a potential treatment for COVID-19, in 127 countries, including India. Dr. Reddy’s will receive technology transfer from Gilead for manufacturing. Remdesivir has an FDA emergency use authorization.
Foundation Medicine Inc., of Cambridge, Mass., said it acquired Lexent Bio Inc., of San Francisco, which is developing multiomics liquid biopsy platforms for treating cancer. Lexent's monitoring platform is in development and is based on low-pass whole genome sequencing (WGS) and DNA methylation analysis. Foundation said it plans to incorporate WGS and methylation into new assay platforms to support treatment decision-making across all disease stages. Foundation is a molecular information company studying genomic changes contributing to individual cancers.
New proof-of-concept data from Kalytera Inc., of San Francisco, demonstrated that R-107, an injectable liquid prodrug of nitric oxide, reduced tissue damage and increased survival in a lethal rodent model of chlorine inhalational lung injury that mimics pulmonary damage of chlorine exposure in humans. Injection of R-107 or its active payload, R-100, each increased survival from 50% to 90% over 21 days of follow-up after chlorine exposure. The improvement in survival was supported by the results of tissue microscopy, which revealed a 50% reduction in histologic damage and the level of inflammatory white cells in the lung.
Kancera AB, of Solna, Sweden, reported that KAND-567, a fractalkine blocker for counteracting hyperinflammation in various disease states, had a positive effect on mobility in a preclinical model of spinal cord injury. Those treated with KAND-567 showed significantly improved mobility compared to the control group, which was treated with vehicle only. An analysis of spinal cord tissue showed that KAND-567 prevented nerve cells from dying, the company added. The nerve-protective effect is likely due to KAND-567 suppressing the hyperinflammation that occurs after spinal cord injury, the company added.
Ligand Pharmaceuticals Inc., of Cambridge, U.K., and San Diego, said its affiliate, Vernalis Research, expanded its oncology collaboration with Servier Laboratories, of Suresnes, France, to identify new therapeutic targets. Vernalis will receive research and success fees, along with potential for milestone payments, and royalties on sales of any target advanced by Servier. Financial terms of the agreement were not disclosed.
Atum, of Newark, Calif., and Phylex Biosciences Inc., of Del Mar, Calif., will collaborate to develop a cell line needed for manufacturing Phylex's universal SARS coronavirus vaccine candidate antigen, which contains conserved epitopes close to the receptor-binding domain of the SARS coronavirus S-protein. A large number of copies of the antigen are displayed on a virus-like particle, expressed by a single gene, which self-assembles after being secreted by the cell line that is being developed by Atum, the company said.
Mapi Pharma Ltd., of Ness Ziona, Israel, said Hertfordshire, U.K.-based Mylan NV has invested an additional $20 million investment in support of an ongoing phase III study of glatiramer acetate (GA) depot, a proposed once-monthly injection for the treatment of patients with relapsing-remitting multiple sclerosis for which Mapi intends to file an NDA. To date, more than 170 patients have been dosed across 56 sites, Mapi said. In parallel, Mapi is also building capacity at its facility to supply GA depot for commercial sale, pending final approval by the FDA. The depot would provide patients with a long-acting injectable version of GA, which commercially available as Copaxone.
Novelion Therapeutics Inc., a Vancouver, British Columbia, which implemented a voluntary liquidation, effective Jan. 16., said a court-appointed liquidator has allowed CA$446,886 (US$446,886) worth of claims against the company and is in the process of resolving and responding to the remaining claims.
Oncolys Biopharma Inc., of Tokyo, said it has sublicensed the nucleoside reverse transcriptase inhibitor OBP-601 to Westport, Conn.-based Transposon Therapeutics Inc. for up-front, development and sales milestone payments in excess of $300 million. Oncolys original licensed OBP-601 from Yale University, and has been developing the compound as an HIV drug candidate since 2006. But more recently, research conducted by Transposon and its academic collaborators showed that OBP-601 potently inhibits a new target enzyme that has been implicated in neurodegenerative diseases and diseases of aging, Oncolys said.
Oryzon Genomics SA, of Madrid, said the Spanish Ministry of Science and Innovation has approved funding for its investigation of the oral LSD1 inhibitor vafidemstat (ORY-2001) as a potential treatment for schizophrenia and related pathologies. The project, which has an initial global budget of €1,129,716 (US$1.3 million), will be pursued in collaboration with the Group of Psychiatry, Mental Health and Addictions of the Research Institute of Vall d’Hebrón in Barcelona. The project is expected to last a maximum of 39 months, with a start scheduled for Oct. 1. The partners earlier worked to show that vafidemstat reduced agitation and aggression in psychiatric patients with borderline personality disorder, autism and attention deficit hyperactivity disorder.
Rezolute Inc., of Redwood City, Calif., reported preclinical data in Investigative Ophthalmology & Visual Science showing that RZ-402, a plasma kallikrein inhibitor in development for diabetic macular edema, demonstrated excellent ADME (absorption, distribution, metabolism and excretion) profile, with moderate renal clearance.
Sernova Corp., of London, Ontario, said it completed an acquisition of cellular local immune protection technology from Converge Biotech Inc., gaining all IP associated with Converge’s conformal coating cell encapsulation technology. Sernova has also completed a $1 million unsecured convertible debenture financing, with the proceeds used to fund the acquisition, it said.