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BARDA takes steps to secure supply chain as more companies look to scale up manufacturing

HHS agency closes $354M deal to manufacture APIs in the U.S.; plus updates from Dynavax, Abivax, NantKwest

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HHS is taking steps to shore up the U.S.’s national supply chain and manufacturing capabilities after global disruptions in the early days of the COVID-19 crisis. The agency’s BARDA has closed a four-year, $354 million deal with Phlow Corp. to manufacture medicines needed during the pandemic and future public health emergencies.

Manufacturing continues to be a rate-limiting factor for COVID-19 countermeasures. Abivax S.A. (Euronext:ABVX) and NantKwest Inc. (NASDAQ:NK) have secured funding and materials to scale up manufacturing for their therapies as they near the clinic. Dynavax expects clinical testing to begin in July for a vaccine developed with its adjuvant.

The supply chain, along with manufacturing, were priorities for a March COVID-19 spending package, which provided $3.5 billion to the Biomedical Advanced Research and Development Authority, a portion of which can be used to construct or renovate U.S.-based next-generation manufacturing facilities. An additional $1.5 billion was allocated to contract the National Academies of Sciences, Engineering and Medicine to report on the security of the U.S. medical product supply chain (see “Revamped Senate Stimulus Bill”).

Phlow will produce APIs needed for COVID-19 medicines at U.S. facilities, including a new site that will be built in Virginia. With its continuous manufacturing infrastructure, Phlow aims to expand U.S. capacity to produce finished generic drugs.

The deal can be extended for up to 10 years, for a total of $812 million.

Dynavax adjuvant closer to clinic

Dynavax Technologies Corp. (NASDAQ:DVAX) gained $1.65 (34%) to $6.51 Tuesday after the company disclosed in an SEC filing that it expects one or more of its COVID-19 vaccine partners to begin a Phase I trial by July.

Dynavax has provided its TLR9 agonist adjuvant, CpG 1018, to vaccine developers identified via its partnership with the Coalition for Epidemic Preparedness Innovations (CEPI). Its partners include the University of Queensland, Sichuan Clover Biopharmaceuticals Inc. and Valneva SE (Euronext:VLA; VSE:VLA), as well as Sinovac Biotech Ltd. (NASDAQ:SVA), which began a Phase I/II trial of its chemically inactivated virus vaccine in April.

The CpG 1018 adjuvant is used in Dynavax’s marketed HBV vaccine, Heplisav-B.

Funding for Abivax, more manufacturing for NantKwest

Abivax S.A. (Euronext:ABVX) said it received €36 million ($39.4 million) in non-dilutive funding from Bpifrance to fund clinical testing and manufacturing of its autoimmune therapy ABX464 for COVID-19.

The offering comprises a €20.1 million grant and a €15.9 million loan, which Abivax would repay after ABX464 reaches the market.

Last week, France cleared the start Abivax’s randomized, double-blind, placebo-controlled Phase IIb/III miR-AGE trial of ABX464, which will enroll 1,034 high-risk COVID-19 patients (see “Repurposed Autoimmune Therapies Head for Controlled Studies”).

ABX464, which was initially developed for HIV, is in a Phase IIb trial for ulcerative colitis. The small molecule blocks viral replication by binding CBC, and also upregulates miR-124, which in turn downregulates inflammatory cytokines.

Be The Match BioTherapies will provide cryopreserved donor stem cell material for NantKwest Inc. (NASDAQ:NK) to accelerate manufacturing of its mesenchymal stem cell therapy as it moves towards a Phase Ib study in COVID-19 patients with acute respiratory distress syndrome (ARDS).

FDA has cleared an IND for BM-Allo.MSC, an allogeneic cell therapy derived from human bone marrow.

Targets

CBC - Cap binding complex

miR-124 - MicroRNA-124

TLR9 - Toll-like receptor 9

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