Adaptive Phage Therapeutics Inc., of Gaithersburg, Md., said it was awarded $9.8 million by the U.S. Department of Defense for research and development of multiple bacteriophage-based display vaccine candidates against SARS-CoV-2, initially for testing in phase I trials.
Anavex Life Sciences Corp., of New York, said the Shake It Up Foundation for Parkinson’s Research and its global partners committed to invest in up to 50% of the costs of a study designed to advance the oral formulation of Anavex-2-73 (blarcamesine) for disease-modifying treatment of Parkinson’s disease (PD). The planned study is designed to confirm in humans features of the sigma-1 receptor agonist/muscarinic M1 receptor modulator previously identified in an animal model of PD. Anavex said safety and efficacy will be assessed in people with PD over at least 48 weeks in an appropriately powered placebo-controlled study that includes Anavex-2-73-specific biomarkers. Participants will be eligible to receive the study drug under a voluntary open label extension protocol.
Brainstorm Cell Therapeutics Inc., of New York, said data published in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration confirmed the potential of Nurown, its autologous human bone-marrow-derived, adult mesenchymal stem cell candidate, to induce T and B regulatory cells and IL-10 secretion and to produce immunomodulatory effects. In the preclinical experiments, a significant (p<0.0001) decrease of interferon-g secretion by peripheral blood mononuclear cells (PBMCs) in the presence of Nurown was shown. When co-cultured with PBMCs, Nurown induced CD4+CD25+FoxP3+ T regulatory cells (p<0.001). When co-cultured with B cells, Nurown induced CD24hiCD38hi B regulatory cells and increased IL-10 secretion (p<0.001).
Cytokinetics Inc., of South San Francisco, said it provided a $1 million grant and initiated a four-year partnership with the HCM Registry (HCMR), a global registry of individuals with hypertrophic cardiomyopathy (HCM) focused on improving predictive measures of risk for complications and identifying biomarkers associated with adverse outcomes to inform treatment decisions. The HCMR is a prospective observational study, completed in 2017, that enrolled 2,755 participants with HCM at sites in North America and Europe for follow-up of at least five years and up to 10. As an industry sponsor, Cytokinetics will join the HCMR steering committee in an observational capacity.
Eagle Pharmaceuticals Inc., of Woodcliff Lake, N.J., said preclinical research from an academic study of dantrolene sodium, published in the Journal of Alzheimer’s Disease, showed the calcium channel modulator, administered intranasally, improved memory and cognition in a mouse model of Alzheimer’s disease (AD). The study evaluated plasma and brain dantrolene concentrations, effectiveness and safety when dosed at 5 mg/kg three times weekly, intranasally or subcutaneously, and compared dosing before and after the onset of AD symptoms. Hippocampal-dependent and -independent memory in the early treatment group improved with intranasal and subcutaneous administration, but only intranasal dantrolene improved cognition in the late treatment group. Eagle, which said it did not sponsor the study, markets a formulation of dantrolene sodium branded Ryanodex.
Elicio Therapeutics Inc., of Cambridge, Mass., said preclinical studies of ELI-005, a protein subunit vaccine for COVID-19, showed an ability to elicit high magnitude T-cell response to the coronavirus alongside strong neutralizing antibody induction. Mice dosed with the study drug showed an increase of up to 25-fold in numbers of T cells detected in peripheral blood (>40% of CD8) and sites that provide immune defense against COVID-19, including lung tissue (>70% CD8) and respiratory fluid, compared to benchmark vaccines. In addition, ELI-005 induced 265-fold higher neutralizing antibody responses to coronavirus proteins than those present in convalescent COVID-19 patients. When aged mice were compared to younger animals, antibody and T-cell responses were maintained.
Humanetics Corp., of Edina, Minn., and contract development and manufacturing organization Pharmaceutics International Inc., of Hunt Valley, Md., said they will work together to conduct a trial of BIO-300 (genistein, oral suspension), a selective modulator of inflammation, cell cycle arrest and DNA damage repair, in individuals with COVID-19. The placebo-controlled study will enroll people who were hospitalized for severe COVID-19 and then discharged to recover at home, comparing lung function, exercise capacity and quality of life. The primary endpoint will be assessed at 12 weeks, with participants followed for one year.
Ingenza Ltd., of Edinburgh, U.K., said it achieved a milestone in the production of a cost-effective vaccine against COVID-19 infection using engineered yeast of the receptor-binding domain of the SARS-CoV-2 spike protein. When displayed on a novel virus-like particle developed and produced by researchers at Oxford University using a recombinant microbe, the prototype vaccine elicited a strong immunogenic response in mouse studies. Downstream assays are underway to validate and optimize the production technology for preclinical testing that, if successful, could lead to a fully microbial biomanufacturing platform to support rapid scale-up.
Maverick Therapeutics Inc., of Brisbane, Calif., said preclinical data from its lead conditional bispecific redirected activation, or COBRA, programs, reported at the 2nd Annual Cell Engager Summit, showed that CD3/epidermal growth factor receptor (EGFR) modulator MVC-101 reduced established solid tumors expressing EGFR in mice, while CD276 antigen/CD3 modulator MVC-280 degraded established solid tumors expressing B7H3 in mice. Half-life extended COBRAs were cleared more quickly after proteolytic activation, with regression of established solid tumors dependent on tumor-mediated linker cleavage and COBRA activation.
Morphosys AG, of Planegg, Germany, and Incyte Corp., of Wilmington, Del., said Monjuvi (tafasitamab-cxix) was included in the latest National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology for B-cell lymphomas. The humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide, was designated as an option for previously treated adults with relapsed or refractory diffuse large B-cell lymphoma, including disease arising from low grade lymphoma in those ineligible for autologous stem cell transplant.
Roche Holding AG, of Basel, Switzerland, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., are collaborating to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination for COVID-19 infection. The deal is expected to increase supply of REGN-COV2 to at least three and a half times the current capacity, with the potential for even further expansion. REGN-COV2 is being studied in two phase II/III trials for the treatment of COVID-19 and one phase III trial for the prevention of COVID-19 in household contacts of infected individuals.
Sapience Therapeutics Inc., of Harrison, N.Y., was awarded an SBIR grant from the National Cancer Institute of the NIH to investigate ST-101 against breast cancer. The grant will provide $255,240 to support research aimed at characterizing the pharmacokinetic profile and optimal dosing regimen, with a focus on metastatic disease. ST-101 is a peptide antagonist of the transcription factor C/EBPβ, which drives tumor cell proliferation and survival in a variety of human malignancies, Sapience noted.
Surrozen Inc., of South San Francisco, disclosed a peer-reviewed publication describing its platform for the generation of potent and selective R-spondin mimetics. The article, “Tissue-targeted R-spondin mimetics for liver regeneration” was published online in Scientific Reports. It describes Surrozen’s R-spondin-mimetic program, culminating in a hepatocyte-targeted bispecific antibody that potently and selectively enhances the Wnt signaling pathway in the liver. A new approach to the regeneration of hepatocytes is described, and the article highlights the potential for the approach in treating a range of severe liver diseases.
Theralase Technologies Inc., of Toronto, executed a sponsored research agreement with the University of Manitoba (UM) medical microbiology department to commence development of a coronavirus vaccine and therapy utilizing Theralase's patented photodynamic compounds. UM will conduct experiments in conjunction with Theralase for the research and development of a coronavirus vaccine and therapeutic to be further evaluated in animal then human clinical testing in 2021. A multi-institutional consortium will use a research tool called Somascan and next-generation sequencing, to determine how COVID-19 affects large numbers of genes and proteins in human cells, Theralase said.
Tolmar Pharmaceuticals Inc., of Buffalo Grove, Ill., affirmed the full availability of Fensolvi (leuprolide acetate) for injectable suspension in its six-month dose (45 mg) for pediatric patients with central precocious puberty. The company confirmed a complete inventory of product supply and also disclosed a production increase in response to reports of a shortage in the U.S. for a different leuprolide acetate injection product. Tolmar noted that the company has provided a consistent supply of its leuprolide acetate products in the U.S. and across about 89 countries, with no shortages to date.