More than a year and a half into Cullinan Therapeutics’ pivot from an oncology company to a hybrid autoimmune player, the biotech is parting ways with a pair of cancer programs.
The move balances the number of candidates from each branch of Cullinan’s pipeline, which now encompasses four named assets across autoimmune and cancer indications.
Specifically, Cullinan has canned work on CLN-619, a phase 1 anti-MICA/B antibody in development for multiple myeloma and solid tumors, and the IL-12 cytokine fusion protein CLN-617, which had been engaged in an early-stage trial in solid tumors.
“[A]fter reviewing emerging clinical data, we have decided not to pursue further development of CLN-619 and CLN-617,” Cullinan CEO Nadim Ahmed said in a Nov. 6 press release.
“Notably, our core pipeline is now focused on T cell engagers applied to well-validated targets with transformative potential in immunology and oncology,” he said, adding that the leaner pipeline is expected to extend the company’s cash runway into 2029.
The decision comes after the drug developer rebranded from Cullinan Oncology to Cullinan Therapeutics last April, a move meant to reflect the company’s foray into autoimmune disease.
Under the new focus, Cullinan redirected development of its CD19xCD3 T-cell engager CLN-978 away from B-cell non-Hodgkin lymphoma over to systemic lupus erythematosus. The asset is now in phase 1 testing in rheumatoid arthritis and Sjögren’s disease, as well.
The decision to jettison two of its former oncology drugs aligns with the strategy for the revamped Cullinan that CEO Ahmed laid out in an interview with Fierce Biotech earlier this year.
The company is now exploring the potential of its pipeline in hematology, solid tumors and autoimmune diseases with a “modality-agnostic” mindset, he said.
To grapple with that expansive focus, Cullinan must first “start off with multiple molecules” and then “generate data as quickly as possible,” the CEO explained. The biotech then weds those data with what Ahmed deemed a “thriller or killer experimentation approach,” which he defined as maintaining a high bar to move assets forward, while swiftly scrapping programs that fail to impress.
That approach played out in August of last year, when Cullinan returned full rights to a bispecific immune activator from Harbour BioMed after glimpsing lackluster phase 1 results on the asset. At the time, Ahmed framed the move as a way to “focus our resources on our most promising programs."
Cullinan’s most advanced asset is the EGFR ex20ins inhibitor zipalertinib, currently in a trio of non-small cell lung cancer (NSCLC) trials, including one in phase 3.
The biotech’s partner, Taiho Pharmaceutical, plans to kick off a rolling FDA submission for the candidate in NSCLC “by year-end,” Cullinan said Thursday.