The contract manufacturer (Nasdaq: CDMO) will play a role in expanding production capacity for lenzilumab, Humanigen’s late-stage monoclonal antibody therapeutic, which is currently in Phase 3 clinical trials and expected to be filed for emergency use authorization this quarter.
“It’s nice to feel we might play a small part in saving lives or making people’s lives more comfortable,” Nick Green, chief executive of Avid, told the Business Journal.
Avid’s stock is up 25% since the beginning of the month to about $18.50 a share and a $1.1 billion market cap at press time.
Lenzilumab is intended to prevent and treat “cytokine storm,” a severe immune response to COVID-19 that can lead to tissue and organ damage. About 89% of hospitalized patients with COVID-19 are at risk of this response, according to National Institute of Allergy and Infectious Diseases data.
Lenzilumab could be the third monoclonal antibody therapeutic for COVID-19 authorized by the U.S., behind Eli Lilly’s bamlanivimab and Regeneron’s casirivimab and imdevimab antibody cocktail.
Preliminary data showed Lenzilumab led to 37% more recoveries than standard care alone in hospitalized patients, according to Humanigen.
Avid, which has transitioned from making its own drugs to manufacturing drugs for other companies in the last two years, has seen its share price more than triple since the beginning of its fiscal 2021 in May.
“I’m extraordinarily impressed with how the pharmaceutical industry as a whole has responded to COVID-19,” Green said, noting the high success rate of currently approved COVID-19 vaccines and the expectation that at least three more vaccines will receive U.S. approval this year. “It’s had an impact on the entire manufacturing supply chain, from CDMOs to equipment manufacturers and others.”
The firm in August struck CDMO agreements with San Carlos-based Iovance Biotherapeutics Inc. (Nasdaq: IOVA), Tampa, Fla.-based Oragenics Inc. (NYSE: OGEN), and San Diego-based Mapp Biopharmaceutical Inc.
Oragenics is developing a COVID-19 spike protein vaccine candidate, Terra CoV-2, while Mapp Biopharmaceutical is working on a monoclonal antiviral antibody that could present an alternative to convalescent plasma therapy.
Increased demand for CDMO services led Avid to kick off the first phase of its internal expansion plans at its Tustin headquarters on Myford Avenue in December. The first phase of the project is expected to increase the company’s annual revenue-generating capability up to $170 million.
“With the pedigree Avid has in terms of its history as a commercial manufacturer, we’re in a good position to attract new business, and we’re executing in a very interesting and attractive marketplace with good demand for biologics,” Green said.
Avid has set its revenue guidance for its fiscal 2021 between $84 million and $88 million, up from $59.7 million in 2020. Analysts expect $86 million in 2021.
Avid Bioservices Nabs New COVID Contract
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