Agilis Biotherapeutics LLC, of Cambridge, Mass., and Waisman Biomanufacturing, a Madison, Wis.-based nonprofit gene and cell therapy development and manufacturing group, formed an exclusive partnership agreement for the production of Agilis' gene therapy product, AGIL-FA, for the treatment of Friedreich's ataxia. Under the terms, Waisman will utilize its personnel, facilities and processes to manufacture GLP material for nonclinical studies, cGMP material for nonclinical and clinical studies, and potential future commercial supply should AGIL-FA be successfully developed and approved. Financial terms were not disclosed.

Avrobio Inc., a new Cambridge, Mass.-based company developing cell and gene therapies targeting cancer and rare diseases, said it expected to have phase I programs in the clinic by early to mid-2016 in both acute myeloid leukemia and Fabry disease. AVR-01 is a cancer immunotherapy, while AVR-02 will seek to genetically modify a patient's own cells by adding a functional copy of the faulty gene. The company secured seed funding of an undisclosed amount from Atlas Venture.

Biondvax Pharmaceuticals Ltd., of Ness Ziona, Israel, said the National Authority for Technological Innovation, formerly known as the Office of the Chief Scientist, agreed to fund up to 40 percent of a NIS3.6 million (US$920,392) project toward ongoing development of the company's universal flu vaccine. The nondilutive grant is repayable from royalties generated from future sales of the vaccine, once available on the market. Biondvax said its vaccine, currently in late phase II trials, has shown increased effectiveness against multiple seasonal and pandemic flu strains when compared to existing flu vaccines.

Cancer Moonshot 2020 announced the formation of the Pediatrics Consortium focused on bringing the promise of combined immunotherapy as the next generation of standard of cancer care to children. All founding partners will seek to apply the most comprehensive cancer molecular diagnostic testing available, including integrating whole genomic and proteomic analysis, and will leverage combination immunotherapies and clinical trials through the QUILT (QUantitative Integrative Lifelong Trial) Program. The Cancer Moonshot 2020 program was announced last month. (See BioWorld Today, Jan. 15, 2016.)

Marina Biotech Inc., of Bothell, Wash., said it entered an evaluation and option agreement regarding its Smarticles platform for the delivery of an undisclosed genome editing technology. Further terms were not disclosed.

Nuvo Research Inc., of Mississauga, Ontario, said its shareholders approved the firm's plan to reorganize into two separate publicly traded companies, Nuvo Pharmaceuticals Inc., a revenue and EBITDA-generating commercial health care company, and Crescita Therapeutics Inc., a drug development company.

Portola Pharmaceuticals Inc., of South San Francisco, said the FDA accepted for priority review the company's biologics license application for andexanet alfa, a breakthrough-designated therapy designed to reverse the anticoagulant activity of both direct and indirect factor Xa inhibitors. The PDUFA date is Aug. 17.