Adverum Biotechnologies Inc., of Redwood City, Calif., disclosed plans for a new GMP facility in Durham, N.C. The company will invest more than $80 million in the 174,000-square-foot facility, located in Research Triangle Park. The site will include four 1,000-liter bioreactors, with space for future expansion and will create more than 200 jobs, Adverum said.
Avidity Biosciences Inc., of La Jolla, Calif., disclosed a research collaboration with Myokardia Inc., a wholly owned subsidiary of Bristol Myers Squibb Co., of New York. The pact is designed to demonstrate the potential utility of Antibody Oligonucleotide Conjugates in cardiac tissue by leveraging Myokardia's genetic cardiomyopathy platform including, among other aspects, its novel target discovery engine and cardiac disease models.
Celularity Inc., of Florham Park, N.J., and GX Acquisition Corp., of New York, signed a definitive merger agreement pursuant to which GX will combine with Celularity. Upon the closing of the transaction, which is expected to occur in the second quarter of 2021, GX will be renamed Celularity Inc., and its common stock and warrants are expected to remain listed on Nasdaq under the new ticker symbols CELU and CELUW. Along with about $292 million held in GX’s trust account (assuming no stockholder redemptions are effected), a group of existing and other institutional investors have committed to participate in a concurrent equity financing through the sale of about $80 million of GX class A common stock at $10 each.
Cevec Pharmaceuticals GmbH, of Cologne, Germany, signed a license agreement with Biogen Inc., of Cambridge, Mass., for the use of Cevec’s Elevecta technology for the manufacturing of adeno-associated virus vectors for gene therapy applications. The deal will afford Biogen the rights to use the technology across its portfolio of gene therapy products. Cevec is eligible for technology access and milestone fees, including clinical development and commercial milestones, as well as royalties on net sales of products.
Integral Molecular Inc., of Philadelphia, and Optimeos Life Sciences Inc., of Princeton, N.J., have partnered to develop antibody therapeutics using long-acting, sustained delivery formulations. The partnership will leverage Integral's industry-leading platform for antibody discovery and include novel targets in cancer and autoimmune diseases. The therapeutics developed using Optimeos' inverse flash nanoprecipitation (iFNP) platform will reduce the frequency of antibody injections for patients.
Novavax Inc., of Gaithersburg, Md., said it finalized its agreement with the Commonwealth of Australia to provide 51 million doses of NVX-CoV2373, Novavax’s COVID-19 vaccine. Novavax is conducting late-stage clinical studies on the vaccine, including two pivotal phase III trials in the U.S./Mexico and the U.K in addition to a phase IIb study in South Africa.
Novozymes A/S, of Copenhagen, said it completed acquisition of Microbiome Labs, of Glenview, Ill., and its portfolio of probiotic and microbiome therapies. Novozymes is acquiring 100% of the equity in Microbiome for DKK780 million (US$125 million) on a cash and debt-free basis. Novozymes said the acquisition will have a negative effect in 2021 of roughly half a percentage point on its EBIT margin and ROIC, including goodwill due to higher amortization and invested capital. The transaction is expected to close in the first half of January.
Oncternal Therapeutics Inc., of San Diego, and Stockholm’s Karolinska Institute will collaborate to research and develop ROR1-targeting cell therapies focused on CAR T cells and CAR-NK cells. Oncternal’s pipeline includes cirmtuzumab, a monoclonal antibody designed to inhibit the ROR1 pathway, a type I tyrosine kinase-like orphan receptor being evaluated in a phase I/II trial in combination with ibrutinib for treating patients with mantle cell lymphoma and chronic lymphocytic leukemia, and also in an investigator-sponsored phase Ib trial in combination with paclitaxel for treating women with HER2-negative metastatic or locally advanced, unresectable breast cancer.
Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany, said results from an in vitro study conducted by Pfizer and the University of Texas Medical Branch showing antibodies from people who have received the Pfizer-Biontech COVID-19 vaccine. While the virus tested in that experiment did not include the full set of spike mutations found on the rapidly spreading strains in the U.K. or South Africa, the companies said, neutralization of virus with the N501Y mutation by the vaccine-elicited human sera is consistent with preserved neutralization of a panel of 15 pseudoviruses bearing spikes with other mutations found in circulating SARS-CoV-2 strains. This indicates that the key N501Y mutation, which is found in the emerging U.K and South Africa variants, does not create resistance to the Pfizer-Biontech vaccine induced immune responses, the companies added.
Sareum Holdings plc, of Cambridge, U.K., said its licensing partner for FLT3 Aurora kinase program decided not to exercise its option to continue development. Worldwide rights to the FLT3 program, as well as data relating to progress made by the licensee, will therefore revert to Sareum. As announced in March 2020, the previously de-prioritized program was licensed to a China-based specialty pharma company for which Sareum received an up-front payment of about £50,000 (US$67,000).
Vincera Pharma Inc., of Palo Alto, Calif., said it has changed its name to Vincerx Inc. The company’s common stock will continue trade under the ticker symbol VINC. Vincerx’s pipeline is derived from an exclusive license agreement with Leverkusen, Germany-based Bayer AG and includes a clinical-stage and follow-on small-molecule drug program and a preclinical-stage bioconjugation/next-generation antibody-drug conjugate platform.
Xlife Sciences AG, of Zurich, said it reached a licensing agreement with Baliopharm AG, of Basel, Switzerland, and will receive 10% of all future licensing income up to a maximum of €300 million (US$366.46 million). That applies to the company's entire line of active ingredients. In December, Baliopharm received approval to start a phase I study of atrosimab for treating nonalcoholic steatohepatitis by the Australian Healthcare Administration.