Anabios Corp., of San Diego, is collaborating with the FDA to study adult human primary cardiomyocytes as standards for reference of gene expression and localization of functional proteins. The pair will also explore the ability to use the cells in testing of drugs that affect the strength of cardiomyocyte contractility.
Anticancer Inc., of San Diego, said its methionine-cleaving enzyme, methioninase, in development as a pharmaceutical compound and a supplement, prevented mice from becoming obese while on an ultra-high-fat diet, while untreated mice on the same diet became obese. The study appeared in In Vivo. Oral methioninase also has shown effectiveness against cancer in mouse models, according to the company, and is proposed as a treatment for coronavirus infection.
Aytu Bioscience Inc., of Englewood, Colo., said it concluded an exclusive distribution agreement for the right to commercialize a clinically validated and commercially used coronavirus 2019 (COVID-19) IgG/IgM rapid test licensed from L.B. Resources Ltd., of Hong Kong, which previously licensed North American rights from product developer Zhejiang Orient Gene Biotech Co. Ltd., of Huzhou, China. The point-of-care test, which was validated in a 113-patient trial and received CE marking, is a solid phase immunochromatographic assay used for rapid, qualitative and differential detection of IgG and IgM antibodies to COVID-19 in human whole blood, serum or plasma, delivering results in two to 10 minutes. Sensitivity of the lgM test was 87.9% (87/99) and specificity was 100% (14/14) when compared to RT-PCR, and sensitivity of the lgG test was 97.2% (35/36) and specificity was 100% (14/14) during the convalescence period of trial participants. The agreement grants Aytu the exclusive right to distribute the product in the U.S. for three years, with additional three-year autorenewals. Aytu plans to seek U.S. regulatory clearance under the FDA's emergency use authorization.
Century Therapeutics Inc., of Philadelphia, said it opened an innovation hub in Seattle to develop cell therapy candidates with increased effectiveness in treating solid tumors. The site will advance the company’s induced pluripotent stem cell science and allogeneic cell therapy candidates using data sciences and machine learning, synthetic biology, cancer biology and immuno-oncology. Hy Levitsky, president of R&D, will oversee site operations and integration with the company’s pipeline programs, together with Luis Borges, chief scientific officer, who remains at Century’s headquarters. In July 2019, the company secured $250 million in funding commitments from lead investor Bayer AG, founding investor Versant Ventures and strategic partner Fujifilm Holdings Corp. to develop next-generation allogeneic cell therapies for cancer.
Correvio Pharma Corp., of Vancouver, British Columbia, said it established an exclusive agreement through wholly owned subsidiary Correvio International Sàrl with Hong Kong Teson Pharma Ltd., of Hong Kong, to commercialize Aggrastat (tirofiban hydrochloride) in mainland China (excluding Taiwan and Hong Kong) and Macau. The GP IIb IIIa antagonist is approved to reduce thrombotic cardiovascular events in individuals with acute coronary syndrome. Correvio agreed to a one-time up-front payment of $3 million from Teson and is eligible to receive up to another $500,000 upon Teson's first receipt of product, expected to occur in the third quarter of 2020. Teson gained exclusive rights to commercialize Aggrastat in the territories at its own expense. Additional terms were not disclosed.
Curadigm, a subsidiary of Nanobiotix SA, of Paris, said the NCI’s Nanotechnology Characterization Laboratory (NCL) selected its Nanoprimer technology for a characterization and development collaboration, based on the technology’s potential to improve treatments in multiple indications, including cancer. Prior to delivery of a therapeutic, Nanoprimer is administered intravenously to occupy, specifically and transiently, the liver pathways responsible for clearance and to increase temporarily the therapeutic compound’s bioavailability and subsequent accumulation in target tissue. Nanoprimer can be used in combination with multiple classes of nanomedicines, including nucleic acid and small-molecule therapeutics or gene editing technologies. Under the collaboration, the NCL will perform in-depth preclinical studies to advance toward an IND filing with the FDA and to support the Nanoprimer’s future development. The work also will support collaborations combining the Nanoprimer with other therapeutics across diverse indications. Financial terms were not disclosed.
Emergent Biosolutions Inc. and Novavax Inc., both of Gaithersburg, Md., are collaborating to develop and manufacture Novavax’s vaccine against the coronavirus that causes COVID-19. Emergent will be responsible for manufacturing the vaccine with a goal of starting a phase I trial within the next four months. Financial terms of the agreement weren't disclosed. Separately, Novavax said it was awarded $4 million to support development of the vaccine from the Coalition for Epidemic Preparedness.
GT Biopharma Inc., of Beverley Hills, Calif., and Cytovance Biologics LLC, of Oklahoma City, are collaborating to develop a treatment for COVID-19 using GT's Trike NK cell engager platform. Cytovance will be responsible for manufacturing the product using its E. coli-based Keystone Expression System. Financial terms of the agreement weren't disclosed.
Immunitybio Inc., of Culver City, Calif., reported results from studies evaluating N-803, an IL-15 superagonist, alone and in combination with anti-HIV broadly neutralizing antibodies (bNAbs), in SHIV-infected, antiretroviral therapy-suppressed rhesus macaques at the Conference on Retroviruses and Opportunistic Infections meeting in Boston. Data showed evidence that repeated co-dosing of N-803 in combination with bNABs may facilitate long-term viral remission in the absence of antiretroviral therapy. Two clinical studies have been initiated in patients with HIV.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., said one of the 12 U.S. Regional Biocontainment Labs is scheduled to begin testing brilacidin, which mimics the human innate immune system, as a treatment for COVID-19 during the week of March 16.
Kuur Therapeutics Inc., of Houston, said it launched its new business in partnership with Baylor College of Medicine and Baylor’s Center for Cell and Gene Therapy. Kuur will advance the work of its predecessor, Cell Medica, to develop cancer therapies using a CAR NK T-cell therapy platform. IP Group, Baylor College of Medicine and Schroeder Adveq are investing to support two phase I studies: GINAKIT 2 (autologous CAR-NKT cells in neuroblastoma) and ANCHOR (allogeneic CAR-NKT cells in CD19 malignancy). The funding will also support the preclinical development of an allogeneic CAR-NKT product for treatment of hepatocellular carcinoma, ahead of an IND submission anticipated in the first half of 2021. Kevin S Boyle, Sr, was named CEO of Kuur.
Medicinova Inc., of La Jolla, plans to start development of MN-166 (ibudilast) for severe pneumonia and acute respiratory distress syndrome (ARDS). In a mouse model of ARDS, ibudilast reversed histological changes in ARDS, including inflammation, hemorrhage, alveolar congestion and alveolar wall edema. The drug reduced pulmonary edema (p<0.001) and reduced the levels of inflammatory cytokines, including TNF-alpha (p<0.001), IL-1beta (p<0.001), IL-6 (p<0.001) and MCP-1 (p<0.001).
Mesoblast Ltd., of New York, plans to test remestemcel-L in patients with acute respiratory distress syndrome caused by COVID-19. The company is in talks with various government and regulatory authorities, medical institutions and pharmaceutical companies to start the clinical trial.
Point Biopharma Inc., of Toronto, acquired a family of more than 70 next-generation PSMA radioligands for targeted radiotherapy of prostate cancer from Scintomics GmbH, of Munich, Germany. Scintomics is eligible to receive undisclosed milestone payments and royalties on the drugs.
Trianni Inc., of San Francisco, licensed the use of its Trianni Mouse to Nkarta Inc., of South San Francisco. Nkarta plans to use the model to discover fully human monoclonal antibodies. Financial terms of the deal weren't disclosed.