AB Science SA, of Paris, disclosed the publication of preclinical study results with masitinib in COVID-19. Research led by scientists from the Institute of Human Virology in Guangzhou, China, has been published in mBIO, a journal of the American Society for Microbiology. The article reports results of an independent study describing development of a replicon system that has been used for high-throughput screening of antiviral drugs. Replicon systems permit convenient and safe simulation of virus replication to analyze the effects of various SARS-CoV-2 genes, the effects of pandemic SARS-CoV-2 gene variants, and the antiviral activities of small compounds, the company noted.
Achilles Vaccines Srl, of Siena, Italy, disclosed the successful industrial development of a novel monoclonal antibody to treat COVID-19. The company said the treatment could greatly improve access to COVID-19 treatment and has several advantages compared to conventional monoclonals, insofar as it can be administered intramuscularly, avoiding the risks of hospitalization. It’s also highly potent, and the low dosage treatment offers significant health and cost benefits, Achilles said.
Atyr Pharma Inc., of San Diego, is presenting a poster the Virtual Keystone Symposia: Tumor Metabolism and the Microenvironment this week. The poster presents preclinical findings demonstrating that neuropilin-2 was highly expressed on key immune cells implicated in regulating cancer progression, including myeloid derived suppressor cells (MDSCs), tumor associated macrophages (TAMs) generated from triple-negative breast cancer cell lines, mature dendritic cells and inducible T regulatory cells. Further research showed that MDSCs and TAMs suppressed T-cell proliferation and activation.
Biovaxys Technology Corp., of Vancouver, British Columbia, commenced the clinical development program for BVX-0918A, its haptenized tumor antigen vaccine for ovarian cancer. The company plans to seek a compassionate use approval in the EU for stage III and stage IV ovarian cancer, followed by submitting an IND in the U.S. Biovaxys is in discussions with its designated contract manufacturing organization and anticipates the execution of a manufacturing contract in the first quarter of this year.
Elasmogen Ltd., of Aberdeen, Scotland, said it has identified next-generation protein-based drugs potentially capable of stopping COVID-19 infections. The approach was achieved through a partnership with the University of Minnesota. The newly identified anti-COVID-19 spike protein VNARs block infection of the virus in live viral assays at doses as low as 200 pM, equivalent to the best reported antibodies and much better than many. Elasmogen’s drug panel features molecules a tenth the size of large and complex-to-manufacture human antibodies, the company said.
Emergent Biosolutions Inc., of Rockville, Md., and Humanigen Inc., of Burlingame, Calif., entered a contract development and manufacturing services agreement to manufacture lenzilumab, an anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody designed to prevent and treat cytokine storm. Emergent will provide CDMO services for the manufacturing of drug product batches to support Humanigen’s efforts to increase supply of lenzilumab in anticipation of an emergency use authorization in the first quarter of 2021. They said they plan to negotiate a commercial manufacturing services agreement that could include future fill batches for a BLA. Lenzilumab is in a phase III trial evaluating patients hospitalized with COVID-19.
Evozyne LLC, of Chicago, signed a collaboration and license agreement with Takeda Pharmaceutical Co. Ltd., of Tokyo. Under the agreement, Evozyne's evolution-based protein design technology will be used to research and develop proteins that could be incorporated into next-generation gene therapies for genetic disorders within the inborn errors of metabolism and lysosomal storage disease areas of research. Evozyne is eligible to receive an up-front payment and additional research, development and regulatory milestone payments, as well as royalties.
GB Sciences Inc., of Las Vegas, executed a sponsored research agreement with Michigan State University to obtain proof-of-concept data to support the use of its cannabinoid containing complex mixtures (CCCM) for the treatment of cytokine release syndrome (CRS) and associated hyperinflammatory conditions such as macrophage activation syndrome (MAS) and acute respiratory distress syndrome (ARDS) in COVID-19 patients. CRS, MAS and ARDS are the leading causes of deaths in COVID-19 patients, and GB’s CCCMs were designed to reduce the life-threatening levels of specific cytokines and pro-inflammatory processes triggered by SARS-CoV-2 infections while preserving those immune functions and cytokines that are necessary for fighting the viral infection.
Novavax Inc., of Gaithersburg, Md., said it finalized an agreement with the government of Canada to supply up to 76 million doses of NVX-CoV2373, the company’s recombinant protein-based COVID-19 vaccine. Canada has committed to purchase 52 million doses of the vaccine with the option for up to an additional 24 million doses. NVX-CoV2373 is in phase III development for COVID-19 prevention and Novavax said it expects initial efficacy in the first quarter of 2021. Novavax also said it expects to supply NVX-CoV2373 to Canada beginning as early as the second quarter of 2021, following authorization by Canada’s regulatory agency.
Nyrada Inc., of Sydney, reported preclinical data providing further evidence of a dose-response in an in vivo cholesterol efficacy study involving a mouse model that has been genetically modified to mimic human-like characteristics concerning cholesterol metabolism and cardiovascular health. Results also confirm that NYX-PCSK9i dramatically reduces LDL cholesterol. The company said its next step is to test the combination of NYX-PCSK9i and a statin in the same mouse model.
Ose Immunotherapeutics SA, of Nantes, France, said it received a €1.3 million (US$1.58 million) from Bpifrance related to its collaborative program, EFFIMab, evaluating interleukin-7 receptor antagonist OSE-127/S95011. The payment was triggered by achieving key steps including reinforcement of preclinical and translational data in ulcerative colitis, completion of the phase I trial, obtaining the phase II regulatory authorization as well as specific manufacturing steps. The phase II study aims to assess the efficacy and safety of OSE-127/S95011 vs. placebo in patients with moderate to severe active ulcerative colitis who have previously failed or lost response or are intolerant to previous treatment.
Pharmadrug Inc., of Toronto, said it entered a definitive agreement in its acquisition of Sairiyo Therapeutics Inc., also of Toronto. Sairiyo is a biotechnology company focused on developing and commercializing controlled-substances and natural medicines such as psychedelics, cannabis and naturally derived approved drugs. Sairiyo is advancing the clinical development of its lead drug candidate, cepharanthine, a repurposed and reformulated naturally derived compound to treat cancer, neurological, inflammatory and infectious diseases.
Piramal Pharma Solutions, of Lexington, Ky., a contract development and manufacturing organization, said it is providing Montreal-based Theratechnologies Inc. GMP manufacturing of sterile fill/finish drug product to support development as it enters a phase I study of TH-1902, a peptide-drug conjugate. The trial design includes a dose-escalation study to evaluate the safety, pharmacokinetics, maximum tolerated dose and preliminary antitumor activity of TH-1902 administered once every three weeks in patients with advanced solid tumors refractory to available cancer therapies.
Quercis Pharma AG, of Zug, Switzerland, said it entered an exclusive, worldwide license agreement for two patents with Beth Israel Deaconess Medical Center, an affiliate of Harvard Medical School, for modulating and reducing thrombotic conditions and events in cancer patients. The patents are related to key thrombotic inhibitor pathways, including P-selectin. The patents cover the inhibition of soluble P-selectin that helps to prevent and/or reduce thrombotic events. Terms of the agreement were not disclosed.
Relief Therapeutics Holding AG, of Geneva, and Acer Therapeutics Inc., of Newton, Mass., said they signed an option agreement providing exclusivity for the right to negotiate a potential collaboration and license agreement for worldwide development and commercialization for ACER-001 (sodium phenylbutyrate). The powder is a taste-masked, immediate-release proprietary formulation in development to treat urea cycle disorders and maple syrup urine disease. Acer will receive a $1 million non-refundable payment in return for exclusivity until June 30 to negotiate and enter a definitive collaboration and license agreement between Acer and Relief for the development of ACER-001. Relief will make a $4 million loan to Acer. If a definitive agreement closes by June 30, Acer will receive $15 million in cash and Relief will pay up to $20 million in U.S. development and commercial launch costs for the indications. Further, Acer will retain development and commercialization rights in the U.S., Canada, Brazil, Turkey and Japan.
Samsung Bioepis Co. Ltd., of Incheon, South Korea, announced the opening of its new headquarters in the nation's Bio Cluster of Songdo, located in the Incheon Free Economic Zone. The 52,000-square-foot site, completed in December 2020, will be the hub of the company's development work, it said. It's slated to house about 1,000 employees.
Saniona AB, of Copenhagen, Denmark, received about $2.9 million in an up-front payment resulting from the now-completed acquisition of Cadent Therapeutics Inc. by Basel, Switzerland-based Novartis AG. Saniona may receive additional milestone payments as well as royalties on any potential products developed and commercialized from the company's SK ion channel program. One such program that originated with Saniona spin-out Ataxion Inc. is CAD-1883, a positive allosteric modulator of SK ion channels now in phase II trials for the potential treatment of movement disorders.
Seneca Biopharma Inc., of Germantown, Md., received notice from Nasdaq on Jan. 22 that it had regained compliance with the minimum bid price requirement for continued listing. Company shares (NASDAQ:SNCA) closed on Jan. 25 at $1.64.
Sonnet Biotherapeutics Holdings Inc., of Princeton, N.J. said it's planning to initiate pilot-scale efficacy trials of its low-dose recombinant fully human interleukin 6 candidate, SON-080, during the second half of this year in both chemotherapy-induced peripheral neuropathy and then diabetic peripheral neuropathy. The plans follows finding from a nonhuman primate (NHP) study of the candidate that found no adverse effects observed at all doses tested. Another preclinical study found that, compared to recombinant human IL-12, the company's fully human interleukin 12 candidate, SON-1010, demonstrated an enhanced pharmacokinetic profile that was similar to IgG antibodies and was well-tolerated at doses far exceeding levels expected in potential future clinical trials. Results from a second phase of the NHP study, which includes a repeat dose regimen in healthy cynomolgus macaques, are expected in the coming weeks. The data will be applied to advance SON-1010 phase I testing in patients with lung cancer and head and neck cancers, with an IND submission anticipated during the second half of 2021.
Therapeutic Solutions International Inc., of Oceanside, Calif., said administration of its umbilical cord-generated dendritic cell immunotherapy candidate, Stemvacs, induced regression of GL261 glioma, CT-26 colorectal cancer and Lewis lung carcinoma tumors grown in mice. Previously, the company reported positive animal data in a 4T1 breast cancer model.
Valneva SE, of Saint-Herblain, France, and Instituto Butantan in Sao Paulo, Brazil, said they signed agreements for the development, manufacturing and marketing of Valneva’s single-shot chikungunya vaccine, VLA-1553, in low- and middle-income countries (LMICs). That finalization follows the signing of a binding term sheet in May 2020. The collaboration falls within the framework of the $23.4 million funding agreement Valneva signed with the Coalition for Epidemic Preparedness Innovations in July 2019. The agreement calls for Instituto Butantan to develop, manufacture and commercialize the vaccine in LMICs as well as to provide certain clinical and phase IV observational studies that Valneva will use to meet regulatory requirements. The agreement includes small up-front and technology transfer milestones.