NIH competition to encourage COVID-19 diagnostic innovation, pad U.S. testing capacity

BeiGene partners to explore differentiated antibody therapy as J&J finds second manufacturing partner

As dozens of leading biopharmas, research institutes and health agencies embrace precompetitive coalitions and master protocols to speed development of COVID-19 therapies and vaccines, NIH has created a competition to accelerate diagnostics.

The organization today launched the Rapid Acceleration of Diagnostics (RADx) Initiative, a national technology development competition to fuel the development of rapid and easy-to-use COVID-19 tests.

The goal of the initiative, which has received $1.5 billion via federal stimulus funding, is to make millions more rapid tests available in the U.S. by late summer or fall.

Participants in the competition -- which NIH Director Francis Collins described in a blog as similar to the TV show Shark Tank -- will vie for a share of a $500 million fund to advance their technologies.

The pool of competitors will go through an initial review to assess their proposals for any technical, clinical, commercial and regulatory issues, such as scalability, and to ensure they would provide a clear advantage over current technologies.

NIH is working with the Biomedical Advanced Research and Development Authority (BARDA), CDC and FDA on RADx.

The initiative follows the launch of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership to coordinate and accelerate the development of medical countermeasures. NIH and the Foundation for the NIH announced the collaboration this month (see “Collaborating to Clobber COVID-19”).

A different tack on antibodies

BeiGene Ltd. (NASDAQ:BGNE; HKEX:6160) partnered with Atreca Inc. (NASDAQ:BCEL) and IGM Biosciences Inc. (NASDAQ:IGMS) to develop IgM and IgA therapies targeting SARS-CoV-2.

IgM and IgA antibodies have 10 and four binding domains, respectively, while IgG antibodies have two. According to the partners, increased binding potential could result in better activity against a broader range of viral variants. Additionally, because IgM and IgA can be actively transported to mucosal surfaces such as the lung mucosa, the trio think these antibody types could provide an a therapeutic advantage for respiratory diseases.

Atreca will generate the antibody sequences based on B cells from COVID-19 patients. IGM will then develop engineered antibodies from those sequences. BeiGene will be responsible for global clinical development; testing could start as soon as 1H21.

J&J’s second manufacturing partner

Johnson & Johnson (NYSE:JNJ) closed a second manufacturing deal for its COVID-19 vaccine, tapping Catalent Inc. (NYSE:CTLT) and its Bloomington, Ind., facility.

The partnership will accelerate rapid scale-up of manufacturing capacity to support dedicated production of J&J’s vaccine.

Catalent plans to hire about 300 staffers at the site starting July to enable round-the-clock manufacturing in January.

Last week, J&J closed a $135 million deal with Emergent BioSolutions Inc. (NYSE:EBS), which will deploy its CDMO services and reserve manufacturing capacity starting this year to prepare for commercial manufacturing of the adenovirus-based COVID-19 vaccine planned for 2021 (see “J&J Picks Emergent as Manufacturing Partner”).

J&J plans to start its trial in September, and could have its vaccine available on an emergency basis as early as 1Q21.

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