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Status update: Local bio making headway with Covid-19 programs


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Altimmune Inc. is making progress on its Covid-19 vaccine more than four months after jumping into that arena.

The Gaithersburg biopharma said Monday it has emerged from preclinical trials with positive results, positioning the clinical-stage company to start manufacturing the candidate, called AdCovid, in the third quarter of this year and start a phase 1 clinical trial in the fourth quarter.

Specifically, the studies Altimmune ran with the University of Alabama at Birmingham showed the candidate induced an antibody response in the respiratory tract that could be critical in blocking the infection and preventing the virus’ spread, according to Altimmune.

We have reached out to the company and will update this story as we hear back.

Altimmune’s candidate, administered through the nose, uses the same technology as the company’s influenza vaccine candidate, NasoVax, which recently completed phase 2 clinical trials. The firm tout's the technology's broad immune response, which is “why we think this is such a good approach to this disease,” Chief Scientific Officer Scot Roberts said in a March interview.

Now, it’s advancing with some support. Monday’s announcement came just a few days after Altimmune teamed up with Frederick, Maryland-based DynPort Vaccine Co., part of General Dynamics Information Technology, which develops vaccines and therapeutics for the government. That partnership will support the federal government’s funding efforts for AdCovid and, if successful, would expand to include program management, drug development and regulatory guidance for the candidate, Altimmune said July 9.

It’s one of more than 160 coronavirus vaccine programs now underway, according to the World Health Organization, including a handful in Montgomery County: Novavax is one of more than 20 now in clinical trials; Emergent BioSolutions is helping Novavax and others to advance, while working on its own treatment; and other private companies, such as Bethesda’s PepVax and Rockville’s Immunomic Therapeutics are developing their own programs.

Altimmune is separately working on a coronavirus treatment, called T-Covid, a single-dose therapy for patients in the early stages of the disease for which Altimmune earned the Food and Drug Administration’s authorization June 1 to initiate clinical trials. It’s developing that candidate under a $4.7 million contract with the U.S. Army Medical Research & Development Command — expected to cover the cost of its phase one and two clinical trials. Altimmune’s preclinical studies showed the candidate helped decrease inflammation in response to the infection. It’s now planning a clinical trial to evaluate the treatment's ability to prevent the disease from worsening and requiring hospitalization, with data from that early-stage clinical trial expected in the fourth quarter.

Altimmune is also developing intranasal anthrax vaccine candidate NasoShieldTM under a contract worth up to $133.7 million with the Biomedical Advanced Research and Development Authority, or BARDA. That, too, uses the same platform as AdCovid.

Altimmune’s stock was trading up more than 19% by 2 p.m. Monday, at $26.59 per share, a huge jump first catalyzed by its DynPort news late last week. For reference, the company’s share price sat at around $3 to $4 a pop back in March when it first announced its progress with its coronavirus vaccine program.

At the end of March, the company had $33 million in cash, cash equivalents and short-term investments, according to its first quarter financial report.

Editor’s Note: This story first appeared in the Washington Business Journal. See the original post here.


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