In a bold strategic move, small-cap biotech Cullinan Oncology is transforming into an autoimmune disease company and rebranding as Cullinan Therapeutics. The Massachusetts company announced the major pivot alongside a $280 million private placement financing that extends its cash runway into 2028.
Cullinan is staking its future on the emerging potential of CAR-T cell therapies to treat autoimmune conditions like systemic lupus erythematosus (SLE). The company plans to advance its lead candidate CLN-978, a bispecific T cell engager originally developed for lymphoma, into SLE. An Investigational New Drug (IND) filing is targeted for the third quarter of 2024, with additional autoimmune indications likely to follow.
The strategic refocusing comes as preliminary data from small academic studies hint that CAR-T cells could induce durable remissions in autoimmune patients by depleting pathogenic B cells and modulating the immune system. In February, researchers reported that 8 out of 15 SLE patients achieved remission for over 1 year after CAR-T treatment, allowing them to discontinue all other medications.
“The unmet need in autoimmune diseases is vast, with most patients cycling through treatment after treatment without achieving remission,” said Cullinan CEO Alejandra Carvajal. “CAR-T cell therapy represents a potential paradigm shift, with an entirely novel mechanism to re-educate the immune system.”
Cullinan is one of the first movers in the autoimmune CAR-T space, but it won’t be alone for long. Peers like Kyverna, Cabaletta, Allogene and Arbor have all initiated programs or partnerships in the last year to develop similar cell therapies.
Cullinan has stopped enrolling patients in CLN-978’s lymphoma study to fully transition to autoimmune disorders. But the company is retaining its existing oncology pipeline, including lead asset zipalertinib in non-small cell lung cancer.
To fund the new autoimmune endeavors, Cullinan raised $280 million through the sale of shares and convertible securities to institutional investors. The private placement was led by venBio Partners and included Cullinan’s existing investors.
“This successful financing provides Cullinan with the resources to rapidly advance our CLN-978 program in SLE and beyond,” stated Carvajal. “We’re excited to lead the way into this new frontier at the intersection of cell therapy and autoimmune disease.”
Cullinan is making a high-risk, high-reward bet on still-unproven science. CAR-T’s efficacy in autoimmune conditions has only been explored in small patient numbers so far. But if the approach proves transformative, Cullinan could be at the vanguard of disrupting the large autoimmune drug market.
The hefty $280 million raise buys Cullinan plenty of runway to generate data from larger trials evaluating CLN-978 and shaping its future autoimmune portfolio. For autoimmune disease patients in need of new options, all eyes will be on Cullinan’s pioneering role in the promising CAR-T space.