Cullinan Oncology, now renamed Cullinan Therapeutics, is riding the growing wave of interest in autoimmune disorders by refocusing its bispecific T cell-engager CLN-978 for systemic lupus erythematosus.
Cullinan Oncology on Tuesday announced that it is expanding its business focus to include autoimmune diseases. As part of the company’s strategic adjustment, the biotech has also changed its name to Cullinan Therapeutics.
The Massachusetts-based company will now target systemic lupus erythematosus (SLE) as its first autoimmune indication, for which it will advance its investigational bispecific T cell-engager CLN-978. Cullinan is eyeing an Investigational New Drug application for the candidate in the third quarter of 2024 and is also planning to develop CLN-978 for other autoimmune conditions.
Originally designed as a treatment for B-cell non-Hodgkin lymphoma (B-NHL), CLN-978 is a bispecific T cell engager that targets both the CD19 and CD3 proteins. This mechanism of action could potentially achieve the destruction of CD19-expressing cells, according to Cullinan’s website. CLN-978 is also specifically engineered to have a human serum albumin-binding domain, which prolongs its serum half-life.
In a Phase I study in B-NHL, CLN-978 showed clinical activity in three patients, two of whom showed “rapid, deep, and sustained B cell depletion,” according to the company. The candidate also had a favorable safety profile, with two cases of grade 1 cytokine release syndrome and no documented episode of immune effector cell-associated neurotoxicity syndrome.
Cullinan has stopped patient enrollment in the study to reflect its strategic refocus. The company’s existing oncology assets—including its lead candidate Zipalertinib, which is being developed for non-small cell lung cancer—will not be affected.
Concurrent with its shift in business focus, Cullinan has also announced a $280 million private placement, which will help bump up its cash, cash equivalents, short term investments and interest receivables. The company now has a cash runway to support its operations into 2028.
Cullinan’s pivot to the autoimmune space comes after a series of small studies pointed to the potential of CAR-T therapy in autoimmune disorders. In February 2024, a paper published in The New England Journal of Medicine showed that eight SLE patients treated with CAR-T therapies reached disease remission after a median follow-up of 15 months.
Results were similarly positive for patients with systemic sclerosis and idiopathic inflammatory myositis. Eventually, all 15 study participants were able to stop immunosuppressive treatments.
The mounting data in hinting at the efficacy of CAR-T therapies in autoimmune disease has pushed many early industry movers to repurpose their pipelines. This group includes Kyverna and Cabaletta which made the move in early 2023 as well as Allogene and Arbor, which last month partnered to develop off-the-shelf CAR-T treatment for autoimmune conditions.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
