Warp Speed makes J&J COVID-19 vaccine program fifth above $1B
BARDA drops funding for IL-6 inhibitors after Phase III misses; plus partnering with Partner
J&J’s manufacturing and delivery deal with HHS and DoD brings to $9.3 billion the amount Operation Warp Speed has committed to COVID-19 vaccines, $1.5 billion of which is now committed to the pharma.
The deal comes a week after Johnson & Johnson (NYSE:JNJ) showed a single shot of Ad26.COV2.S has the potential to generate sterilizing immunity.
HHS’s Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense have pledged $1 billion to J&J for 100 million doses of the vaccine, if FDA grants the adenovirus vector vaccine an Emergency Use Authorization. The U.S. government may also buy 200 million more doses through a subsequent deal.
J&J has not yet disclosed when production of the first 100 million doses will complete; however, HHS Secretary Alex Azar said the agreement increases the likelihood that the U.S. will have “at least one safe, effective vaccine by 2021.”
As with BNT162 from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) -- which have garnered a $1.95 billion Warp Speed contract for 100 million doses -- Americans would receive Ad26.COV2.S at no cost. Healthcare professionals could charge for the cost of administration (see “$2B COVID-19 Vaccine Deal”).
BARDA had already committed $456 million to J&J for R&D related to a COVID-19 vaccine. The pharma is the fifth COVID-19 vaccine developer to have secured over $1 billion dollars for its candidate (see “Warp Speed’s Total”).
J&J’s deal follows a July 30 article published in Nature showing that none of the six monkeys given a single administration of Ad26.COV2.S and challenged with SARS-CoV-2 had detectable viral RNA in lung fluid at any time point. Only one had detectable viral RNA in the nose, which was gone by day four. All 20 control animals had detectable viral RNA in lung and nasal samples.
The study also linked higher titers of neutralizing antibodies against SARS-CoV-2 to lower levels of the virus in the lungs, without a requirement for strong T cell responses (see “Non-human Primate Data Shed Light on Correlates of Protection”).
J&J is evaluating single and prime-boost regimens of Ad26.COV2.S in its clinical trials. The vaccine is in Phase I/II testing, and is slated to begin Phase III in September.
BARDA has stopped supporting development of anti-IL-6 mAbs Actemra tocilizumab from Roche (SIX:ROG; OTCQX:RHHBY) and Kevzara sarilumab from Sanofi (Euronext:SAN; NASDAQ:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) after high profile Phase III misses.
The move follows the July 29 revelation that Actemra failed to improve clinical status or reduce mortality in hospitalized adults patients with severe COVID-19-associated pneumonia and a miss by Kevzara earlier in July in critically ill COVID-19 patients on mechanical ventilation (see “Second IL-6 Failure”; “Data for IL-6 mAb in COVID-19 Disappoint”).
Separately, Partner Therapeutics Inc. will receive up to $35 million from the U.S. government to fund two Phase II trials of Leukine sargramostim in patients with COVID-19 associated acute hypoxemia. The first study of the recombinant human GM-CSF, evaluating oxygenation and the proportion of intubated patients as primary endpoints, is slated to begin this month.
The funds will support expansion of manufacturing capacity and potential submission of an EUA application.
GM-CSF (CSF2) - Granulocyte macrophage colony-stimulating factor
IL-6 - Interleukin-6