In year 3 of the pandemic, a new Covid-19 biotech takes flight with an antibody combo and Takeda's ex-vaccines chief at the helm
Year three of the Covid-19 pandemic just began, but this far in, Omega Funds thinks it’s not too late to launch a biotech to fight SARS-CoV-2 just as another subvariant takes flight and cases rise in various regions.
The prolific biotech incubator poached Takeda’s former vaccines leader Rajeev Venkayya and inked research agreements with Swiss universities to create Aerium Therapeutics, named after the Latin word for airborne. With the cover now off, Aerium can put to work two monoclonal antibodies that it says have shown neutralization against Omicron and its subvariants in preclinical testing that is yet to be peer reviewed.
After a decade at Takeda, Venkayya told Endpoints News he wanted a fresh start and “something different” when he was approached by Omega’s Otello Stampacchia last November. Aerium’s goal to go after not just Covid-19 but other viruses and potential future pandemics was also appealing, especially from Venkayya’s vantage point as a board member of the Coalition for Epidemic Preparedness Innovation.
Five months in, he’s assembled a team of almost 20 people across Boston and Lausanne to quickly ramp up for a clinical trial this summer to test the two monoclonal antibodies as a combination prophylaxis treatment, the CEO said.
Helping build out that team is board member John Maraganore, the former founding CEO at Alnylam, which axed its own Covid-19 antiviral last August, citing “highly effective vaccines and alternative treatment options.” The RNAi biotech is also now suing and seeking money from Moderna and Pfizer for their supposed use of its lipid nanoparticles in two of the world’s biggest Covid-19 vaccine cash cows.
But Aerium is getting into the monoclonal race now because it sees the need for Covid-19 treatments extending into the future given the number of immunocompromised patients, as well as the waning immunity of vaccines, Venkayya said.
“We do think that offering those individuals something that can be given over three to six months and give them the equivalent of vaccine protection would be high impact,” Venkayya said of testing the antibody combination in immunocompromised patients who “haven’t derived the benefit of the miraculous vaccine advancements.”
Aerium’s monoclonals came out of the labs of Giuseppe Pantaleo at Centre Hospitalier Universitaire Vaudois and Didier Trono at École Polytechnique Fédérale de Lausanne. Omega teamed up with the scientific founders to seed Aerium and has now led a series A in the biotech. Venkayya declined to offer details on how much is in the bank.
Aerium wants to work “as quickly as possible” with the FDA and European regulators on getting “through clinical development on a very expedited timeframe, hopefully without an efficacy study,” Venkayya said. Eli Lilly’s emergency authorized antibody did not have phase III data, he noted.
To help bankroll the testing, EUA filing and in-licensing of antivirals for other viruses, Aerium will raise a series B in the next two or three months, Venkayya said. He expects the EUA milestone to happen as early as this year.
The company is in discussions with potential large manufacturers about scaling up production, should the therapy get greenlit, as well as Big Pharmas about potential co-development paths, he said.
Beyond Covid-19, the startup will go after other viruses with “commercial potential,” like influenza and Respiratory syncytial virus, Venkayya said. Big Pharmas are in an RSV race, including Pfizer, Sanofi, GlaxoSmithKline, Moderna and AstraZeneca.
Other “more neglected viral diseases” could also be on the docket, Venkayya said, including those on the World Health Organization’s R&D blueprint. That work would be supported by global organizations or governments, he said. Prior to Takeda, Venkayya was director of vaccine delivery at the Bill & Melinda Gates Foundation.