Adimab spinout aims for neutralizing mAbs more effective than coronavirus vaccines

Adagio launches with $50M to pursue broadly neutralizing mAbs with bi-annual dosing potential

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Adagio spun out of Adimab Thursday with neutralizing antibodies against a conserved epitope of the SARS-CoV-2 spike protein that it believes are potent enough to yield a bi-annual prophylaxis with better efficacy than vaccines. The start-up, co-founded by Adimab co-founder and CEO Tillman Gerngross, also thinks the therapies could protect against future coronaviruses.

Adagio Therapeutics Inc. has raised $50 million in a series A round led by Polaris Partners and Mithril Capital with a near-term goal of advancing the first neutralizing mAb program into the clinic by year-end. Longer term, the newco aims to produce up to 60 million doses per year from one 100,000-liter reactor. Fidelity Management & Research Co., OrbiMed, M28 Capital and GV also participated in the venture round.

Gerngross told BioCentury that the company is the first spinout from Adimab LLC, a prolific mAb platform company that has more than 70 partners using its yeast-based human mAb platform. The New Hampshire-based parent company out-licenses its tech and/or runs discovery programs on behalf of development partners.

Gerngross said an internal team led by Adagio’s CSO Laura Walker has for years worked on developing mAb-based countermeasures for infectious diseases such as Zika virus and Ebola. “This was a natural progression,” he said.

The team started working on SARS-CoV-2 in March, and so far has created a series of neutralizing mAbs that target a highly conserved epitope of the spike protein across beta-coronaviruses. In preclinical assays, the mAbs show an ability to target SARS-CoV-1, SARS-CoV-2 and several bat coronaviruses that are a risk to jump to humans in the future.

“In the past 20 years there have been three major pandemic spillovers of coronaviruses, so we thought let’s look at this in a more systematic way, as a class,” Gerngross said. “Why don’t we come up with a solution that basically covers that for perpetuity.”

Gerngross said Adagio has one series of mAbs that are broadly neutralizing and shouldn’t allow for viral escape. If early clinical data show viral escape might be an issue, the biotech has two other mAb programs being developed in parallel that target completely different, undisclosed epitopes of the spike protein that could be given as part of a cocktail.

He said using a single neutralizing mAb would be the most efficient approach in terms of formulation and manufacturing vs. a cocktail strategy.

According to Gerngross, having a broadly neutralizing mAb is also how Adagio expects to differentiate itself from other mAb approaches. Recent studies of antibody titers from convalescent serum make him skeptical that vaccines in development for COVID-19 will be able to provide an adequate and durable immune response.

“If you look at the abysmal response of antibody titers, people that had the live infection -- what do you think a vaccine is going to do?” he said. “Tell me one instance where a vaccine has outperformed a live viral infection in eliciting an immune response. The answer is none.”

The company’s hypothesis is that a prophylactic mAb-based therapy may be the best option for returning society to normal.

Gerngross said given the high potency of Adagio’s mAbs, the biotech may be able to administer a large enough dose that could allow for a twice-yearly dosing schedule given as an intra-muscular injection.

“The vision for the product is that you’re an elderly person that wouldn’t necessarily respond well to vaccination, so you get two shots a year and you’re protected 90% vs. a vaccine where, given the responses we are seeing, you may have to receive it every two or three months,” he said. “In this particular situation, I think antibodies are moving into an area that used to be reserved for vaccines.”

Adagio plans to submit an IND for its lead neutralizing mAb program by year-end, with the first patient dosed in December or January.

Gerngross said the biotech has an undisclosed global manufacturing partner in place during development of its antibodies. In terms of broader capacity, he said Adagio will work with manufacturing partners in different regions to add capacity. But he said based on an estimated prophylactic dose for Adagio’s neutralizing mAb, making the mAb broadly available should be within reach if it works in clinical trials.

The series A round will carry Adagio to Phase I data, which is expected next year. The company already plans to raise its next round of financing in the fall.

Gerngross said Chair Rene Russo, CEO of cancer play Xilio Therapeutics Inc., has pulled together a drug development team for Adagio that has experience across the infectious disease drug development landscape. Adagio’s CMO is Lynn Connolly, who was previously SVP of clinical research and medical affairs at fellow COVID-19 mAb developer Vir Biotechnology Inc. (NASDAQ:VIR).

In connection with the financing, Polaris’ Terry McGuire, M28’s Marc Elia, Mithril’s Ajay Royan and Adimab’s Phillip Chase will join Adagio’s board.

COMPANY PROFILE

Adagio Therapeutics Inc.

Waltham, Mass.

Technology: Neutralizing antibodies against SARS-CoV-2 and other coronaviruses

Origin of technology: Adimab LLC

Disease focus: Infectious

Clinical status: Preclinical

Founded: 2020 by Tillman Gerngross, Rene Russo and Laura Walker

Corporate partners: Adimab LLC

Funds raised: $50 million

Investors: Polaris Partners, Mithril Capital, OrbiMed, M28 Capital and GV

CEO: Tillman Gerngross

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