Moderna reveals Claudin18.2 ambitions via cancer vaccine, solid tumor CAR-T combo plans

What could be hotter than Moderna getting in the Claudin18.2 race? How about pairing up a newly disclosed mRNA therapeutic cancer vaccine with a solid-tumor-targeting CAR-T?

That sounds like the plan, according to CARsgen Therapeutics. The Chinese biotech is developing CT041, also known as satricabtagene autoleucel, as a Claudin18.2-focused CAR-T for the potential treatment of gastric, pancreatic and other digestive system cancers. Despite being an autologous—as opposed to an allogeneic or “off-the-shelf” therapy—the Shanghai-based company claims that CT041 is the “most advanced solid tumor CAR-T in development” on account of it having entered a “pivotal” phase 2 trial.

The biotech said it has initiated a collaboration agreement with Moderna for the two companies to “contemplate conducting preclinical studies and a phase 1 clinical trial to evaluate CT041 in combination with Moderna’s Claudin18.2 mRNA cancer vaccine.”

Claudin18.2 is a hot cancer target, with Amgen, Astellas and Legend Biotech having thrown a wide spectrum of biologic modalities at it in the belief targeting the tight junction molecule can tackle tumors in the gastrointestinal tract. AstraZeneca has also doubled down on Claudin18.2 this year, paying KYM Biosciences $63 million upfront for the global rights to an early-phase antibody-drug conjugate 10 months after handing over $25 million to Harbour BioMed for a CLDN18.2xCD3 bispecific antibody aimed at the same target.

When it comes to mRNA therapies, Moderna won’t be the first player in the Claudin18.2 space. BioNTech already has a Claudin18.2 inhibitor called BNT-141 in a phase 1/2 trial for gastric, pancreatic, ovarian and biliary tract tumors.

“Claudin18.2 is a promising therapeutic target to potentially treat multiple cancer types with high unmet medical need,” Moderna’s chief scientific officer of external research ventures Lin Guey, Ph.D., said in this morning’s release.

“We are pleased to partner with CARsgen to explore the potential synergy of CAR-T with an investigational mRNA cancer vaccine that encodes for the Claudin18.2 protein,” Guey added.

Combining Moderna’s “off the shelf” cancer vaccine with a CAR-T therapy “could potentially provide greater clinical benefit to patients” with tumors, CARsgen CEO and Chief Scientific Officer Zonghai Li, M.D., Ph.D., said in the same release.

Last month, Moderna stirred up interest in another cancer vaccine combo trial when it unveiled details for how it would test a Merck-partnered personalized cancer vaccine with Keytruda in a phase 3 trial for post-surgery treatment of patients with resected melanoma. If eventually successful, Merck and Moderna could open up an entirely new area of cancer treatment.