Anavex Life Sciences Corp., of New York, was awarded a research grant of $995,862 from The Michael J. Fox Foundation for Parkinson’s Research to develop ANAVEX2-73 (blarcamesine) for the treatment of Parkinson’s disease. The award will explore utilization of PET imaging biomarkers to enable measurement of target engagement and pathway activation of the sigma-1 receptor with clinically relevant doses in people with Parkinson’s disease. The foundation previously awarded Anavex a research grant, which fully funded a preclinical study that established ANAVEX2-73 as a potentially disease-modifying treatment.
Baxter Biopharma Solutions, of Deerfield, Ill., said it agreed to provide sterile manufacturing services for NVX-CoV2373, Gaithersburg, Md.-based Novavax Inc.’s COVID-19 recombinant nanoparticle vaccine candidate. The agreement, the company said, is to advance commercial-scale manufacturing essential for production and distribution of NVX-CoV2373, which contains a full-length, prefusion spike protein, in the U.K. and Europe. Novavax’ COVID-19 vaccine candidate is in phase III studies.
Biogen Inc., of Cambridge, Mass., and Apple will collaborate to study the role the Apple Watch and iPhone could play in monitoring cognitive performance and screening for decline in cognitive health, including mild cognitive impairment (MCI). The multiyear, observational research study begins in 2021 and will enroll participants including young and aging adults with a range of cognitive performance. The study’s primary objectives are to develop digital biomarkers to help monitor cognitive performance over time and identify early signs of MCI, according to Biogen.
Bioinvent International AB, of Lund, Sweden, said it restructured a clinical development agreement with Cancer Research UK for its anti-FcγRIIB antibody, BI-1206. In exchange for a one-time payment, the revised deal provides Bioinvent with more flexibility to carry out development and partnering activities with BI-1206, the company said. Cancer Research UK conducted and funded a phase I/IIa trial to evaluate BI-1206 for treating non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia. Bioinvent is conducting a phase I/II trial of BI-1206 in combination with rituximab to treat NHL. Given the overlap between the two trials, Cancer Research UK ended the trial being conducted in the U.K. after the single-agent part of the study.
Cohbar Inc., of Menlo Park, Calif., said it signed a nonclinical evaluation agreement with the U.S. National Institute of Allergy and Infectious Diseases to evaluate CB-5064 analogues for treating COVID-19-associated acute respiratory distress syndrome (ARDS). The program has shown positive results in models of acute lung injury, Cohbar added, including reduced levels of fluid accumulation, neutrophil infiltration and cytokine secretion.
New preclinical data from Curevac NV, of Tübingen, Germany, demonstrated the induction of antibody and T-cell responses of its COVID-19 vaccine candidate, CVnCoV, in nonhuman primates. Rhesus macaques were shown to be protected from challenge infection with SARS-CoV-2 following vaccination with 8 µg of CVnCoV, the company said. The data provided important evidence on the immunogenicity and protective efficacy of CVnCoV at low doses, Curevac added, supporting an ongoing international phase IIb/III efficacy study applying a 12-µg dose.
Cyclolab Kt., of Budapest, and Epipharma LLC, of Szeged, Hungary, said they formed a joint venture, Targetrin Therapeutics LLC, a biopharmaceutical services and peptide drug development company, to develop and commercialize conjugated cyclodextrin-peptide drug candidates to treat CNS and pulmonary diseases. Both companies will own 50% interest in the joint venture.
Dyne Therapeutics Inc., of Waltham, Mass., reported preclinical data from its myotonic dystrophy type 1 program, demonstrating robust RNA knockdown of toxic human nuclear DMPK, the genetic basis of the disease. The new data build on previous results showing significant reduction in cytoplasmic wild-type DMPK RNA in a mouse model that expresses human TfR1(hTfR1). To assess the ability of its lead DM1 candidate to reduce toxic human nuclear DMPK RNA, Dyne developed an hTfR1/DMSXL mouse model that expresses human TfR1 and carries a human DMPK gene that represents a severe DM1 phenotype with more than 1,000 CTG repeats. In that model, two doses (2 x 10 mg/kg) of Dyne’s candidate resulted in significant toxic human nuclear DMPK knockdown at 14 days: 60% in the heart; 56% in the diaphragm; 54% in the tibialis anterior and 39% in the gastrocnemius.
Exuma Biotech Corp., of West Palm Beach, Fla., said it entered a collaboration with Moffitt Cancer Center to develop the company’s rapid point-of-care (rPOC) subcutaneous product for treating B-cell malignancies. Exuma said its product using rPOC technology for targeting CD19 and CD22 has the potential to complete treatment within a six-hour time frame from blood draw to injection, with preparative chemotherapy. Moffitt will provide regulatory support, gene product characterization and analytical testing to support first-in-human studies.
Geovax Labs Inc., of Atlanta, said the National Institute of Allergy and Infectious Diseases, part of the U.S. NIH, awarded the company a Small Business Innovative Research grant to support work on a vaccine against SARS-CoV-2. The grant will support ongoing design, construction and preclinical testing of the firm’s GV-MVA-VLP vaccine candidates in preparation for human clinical trials. The efficacy testing will be performed in collaboration with the University of Texas Medical Branch.
Hoth Therapeutics Inc., of New York, said it entered an agreement with Charles River Laboratories to initiate preclinical studies of HT-001, a topical formulation designed to treat patients with rash and skin disorders associated with initial and repeat EGFR inhibitor cancer treatment. The initial studies will develop the required bioanalytical methods to perform GLP toxicology studies required by the FDA to initiate clinical studies for HT-001.
Humanigen Inc., of Burlingame, Calif., and Eversana, a life sciences services company, said they are partnering to make lenzilumab available to hospitalized and hypoxic COVID-19 patients in the event that an emergency use authorization is issued from the FDA. Lenzilumab, a Humaneered anti-GM-CSF monoclonal antibody, is designed to prevent and treat cytokine storm, a complication considered to be a leading cause of COVID-19 death.
Irisys LLC, of San Diego, said it was awarded a contract valued at $850,000 by the National Cancer for Advancing Translational Sciences (NCATS) to develop a new injectable formulation of drinabant, a selective, high-affinity CB-1 agonist. Opiant Pharmaceuticals Inc., of Santa Monica, Calif., an NCATS collaborator, licensed drinabant from Paris-based Sanofi SA and is developing the drug with the goal of treating individuals who have ingested large amounts of THC and are diagnosed with acute cannabinoid overdose.
Moderna Inc., of Cambridge, Mass., said it is expanding its pipeline of vaccines with three new development programs to develop mRNA vaccine candidates against seasonal flu, HIV and the Nipah virus. Moderna also announced an expansion of its respiratory syncytial virus vaccine program into older adults. The company said the announcement reflects its commitment to accelerating its infectious disease portfolio based on Moderna’s experience with its COVID-19 vaccine. In separate news, the company provided a distribution update for its COVID-19 vaccine in the European Union and EEA member states, including the beginning of deliveries on Jan. 11. Moderna’s vaccine cleared approval in the EU on Jan. 6.
Myeloid Therapeutics Inc., of Cambridge, Mass., and Maxcyte Inc., of Gaithersburg, Md., said they signed a clinical and commercial licensing agreement in which Myeloid will obtain nonexclusive clinical and commercial rights to use Maxcyte’s Flow Electroporation technology and Expert platform to advanced its pipeline programs, including for engineered cell therapies targeting solid tumors, T-cell lymphoma and glioblastoma. In return, Maxcyte is entitled to receive undisclosed development and approval milestones, and sales-based payments, along with other licensing fees.
Navrogen Inc., of Cheyney, Pa., and the National Cancer Institute (NCI), part of the U.S. NIH, said they established a research collaboration aimed at testing mesothelin-targeting therapies for the treatment of cancers where humoral immunity is suppressed. The collaboration is a joint effort to analyze antibody-drug conjugates (ADCs) for in vivo efficacy against human mesothelioma models developed by the Hassan laboratory. Navrogen and NCI will combine their expertise and experimental resources to enable the comprehensive characterization of mesothelin targeting ADCs as agents for future human studies against mesothelin-expressing cancers, including mesothelioma.
Pharmabcine Inc., of Daejeon, South Korea, said it entered a research collaboration agreement with Legochem Biosciences Inc. (LCB), also of Daejeon, in which Pharmabcine will provide PMC-403, a preclinical program, so LCB can conduct combination research using PMC-403 and its antibody-drug conjugate. The study will allow both parties to evaluate the efficacy of the combination therapy in solid tumors.
Resolution Bioscience Inc., of Kirkland, Wash., said it entered a companion diagnostic agreement with Mirati Therapeutics Inc., of San Diego, which will use Resolution Ctdx liquid biopsy technology to help identify non-small-cell lung cancer patients who might benefit from Mirati’s investigational KRAS G12C inhibitor therapy.