California biotech Bluejay Therapeutics has secured a megaround to continue developing its treatment candidates for chronic hepatitis D and B.
The $182 million Series C, disclosed Thursday morning, will bankroll testing of seven programs, including former Novartis and Exicure assets.
The biotech’s lead hepatitis asset, BJT-778, derives from Novartis and goes against the hepatitis B surface antigen, or HBsAg, with the goal of easing immune cell exhaustion so that the body can control the infection. The monoclonal antibody is in a Phase 1/2 test in Australia, New Zealand and other countries.
Keting ChuThe Series C is expected to fund multiple trials, including a potential global Phase 3 in hepatitis D, for which there are no FDA-approved treatments, CEO Keting Chu told Endpoints News. Gilead’s bulevirtide was approved in Europe but was rejected by the FDA in the fall of 2022.
“The goal is to restore T cell and B cell functions to get immune control and achieve a functional cure,” Chu said at the time of the biotech’s $41 million Series B in August 2022.
Earlier this year, the startup also bought the license to a nucleic acid therapy from Exicure. Bluejay plans to test the former clinical-stage oncology asset, a spherical toll-like receptor 9 agonist dubbed cavrotolimod, as a combination with BJT-778 in hepatitis B.
“Unlike a lot of other TLR agonists that have been tested in hepatitis B, this one is very safe. It’s gone through healthy volunteers and cancer patients,” Chu said of cavrotolimod. She also highlighted its immune activation.
The 14-employee biotech also has an oral HBV transcript inhibitor in the preclinical stages. Bluejay describes the liver-targeted BJT-628 as an “effective combination partner for BJT-778,” according to the biotech’s website.
Investors are betting on a tough field of drug R&D. While multiple hepatitis B vaccines exist, “not everyone has access,” Chu previously said. Chronic infection can lead to serious damage to the liver, including cancer.
Chronic HBV is a “very difficult area to work in” and is “one of those areas of sciences that’s moving so fast,” Melanie Paff, a GSK medicines development leader, told Endpoints when GSK inked a deal for an experimental hepatitis B drug last fall. Multiple biotechs have run into setbacks in the space.
For hepatitis D, which can occur in people who have hepatitis B, biopharmas have also run into snags. After Gilead’s CRL in 2022, the biopharma made further bets in the space with its Assembly Biosciences pact last fall.
In chronic HDV, Bluejay secured “priority medicine,” or PRIME, designation from the European Medicines Agency two months ago.
“There’s about 100,000 patients in the US and more in Europe,” Chu said. “The disease is much more severe than hepatitis B. About 70% of patients with hepatitis delta will progress into liver cirrhosis, liver failure and liver cancer in five to 10 years. So it’s almost as severe as cancer.”
Frazier Life Sciences co-led the Series C with an undisclosed life sciences investor. RA Capital Management, T. Rowe Price, Wellington Management, Novo Holdings, RiverVest Venture Partners, Octagon Capital, Arkin Bio Ventures, HBM Healthcare Investments and Unicorn Capital also took part in the round.
The financing came in $32 million above Bluejay’s initial target, Chu said.
Bluejay started operations in June 2021, Chu said, with with programs from Novartis, where Chu had worked in the 1990s before she moved on to Five Prime Therapeutics, the Leukemia & Lymphoma Society, Apple Tree Partners and Lyfe Capital.
Editor’s note: This story was updated to include information from an interview with Bluejay CEO Keting Chu.