The oncology-to-autoimmune pipeline gained a new convert on Tuesday. Cullinan Therapeutics is at least the sixth company so far this year to announce plans to test a CD19-directed therapy in lupus – the majority being current or castoff cancer programmes.
Cullinan CEO Nadim Ahmed told FirstWord the move into autoimmune diseases was driven in part by the opportunity to offer a disease-modifying treatment across a range of conditions with unmet need. “More recently, lymphoma has become an area of much more competitive intensity and as such, the unmet need across lymphoma has reduced,” he added.
The company will continue to move forward its pipeline of five clinical immuno-oncology programmes while it brings on autoimmune disease experts. Expanding into the new disease space makes sense for Cullinan, Ahmed said, because “the biology of oncology and immunology has continued to converge. Therefore, expanding our presence into immunology is a very natural adjacency for us as a company and represents an excellent strategic fit.”
To fund the additional disease focus, Cullinan raised $280 million on Tuesday, including the sale of pre-funded warrants for $6 million and a $274 million private placement, both at $19 per share. New and existing investors participated in the PIPE, including Adage Capital Partners, Avidity Partners, Blue Owl Healthcare Opportunities, Boxer Capital, Braidwell, BVF Partners, Foresite Capital Management, an affiliate of Deerfield Management, Invus, OrbiMed, Paradigm BioCapital, Rock Springs Capital, RTW Investments, Surveyor Capital, and Venrock Healthcare Capital Partners.
Encouraged by data published in NEJM this February, which suggested that CD19-targeted cell therapy could lead to sustained remission for patients with several autoimmune diseases, Cullinan joins the ranks of half a dozen other biotechs testing their CD19 mettle in lupus.
And Kyverna Therapeutics, which has already begun Phase II testing of its CD19 CAR-T in lupus nephritis, among other autoimmune diseases, is a prime example of growing investor appetite – the biotech raised a $319-million IPO in February, so far the year’s second-largest. For more insight into the firm’s autoimmune strategy, see ViewPoints: Kyverna CEO outlines next steps for autoimmune CAR-T pipeline.
While the early data supporting a CD19 approach in lupus is based on a CAR-T, Ahmed said its T cell engager could offer safety and dosing advantages over the cell therapy – for which approved treatments carry a class-wide boxed warning for secondary malignancies – while still providing a powerful immune system reset.
“As a potential first-in-class opportunity, CLN-978 is differentiated from CAR-T based on off-the-shelf convenience and patient-friendly subcutaneous administration with the potential to deliver potent disease-modifying effects with a favourable safety profile,” he said.
According to Cullinan, CAR-T therapy may also be a logistically challenging therapy for lupus patients, given its requirement for lymphodepleting chemotherapy and its complex manufacturing processes, which can limit patient access.
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