With new name and fresh funds, Cullinan dives into autoimmune diseases

2024-04-16

交易

细胞疗法临床1期免疫疗法IPO临床2期

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.

Formerly Cullinan Oncology, the biotech said it has ended a Phase I trial assessing its CD19xCD3 bispecific T cell engager in B cell non-Hodgkin lymphoma (B-NHL), and will instead launch a new study of the compound, CLN-978, to treat systemic lupus erythematosus (SLE). It plans to submit a trial application to the FDA in the third quarter.

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.

Joining the CD19 crowd

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.

Most recently, Eliem Therapeutics acquired Tenet Medicine and its anti-CD19 antibody that’s Phase II-ready for SLE, the same day that Century Therapeutics announced it would also test its CD19-targeting iNK cell therapy – currently in the clinic for B-cell malignancies – in patients with SLE.

Last month, Nkarta deprioritised development of its CAR-NK cell therapy NKX019 in acute myeloid leukaemia (AML), and will instead prioritise an upcoming trial in lupus nephritis (LN).

Caribou Biosciences and Allogene both announced plans this year to study their respective allogeneic CD19-directed CAR-T programmes 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.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构