Moderna Launches New Cancer Vaccine Trials, Halts PD-1 Research

Moderna is making significant strides in its solid tumor strategy with the initiation of three new midstage clinical trials. The company's primary focus remains on securing FDA approval for its respiratory syncytial virus (RSV) vaccine, which is anticipated in the near future. However, Moderna is also investing heavily in the development of its late-stage cancer treatments.

In a recent earnings update, Moderna unveiled plans for its personalized neoantigen cancer vaccine, with three phase 2 studies currently underway in collaboration with Keytruda. This treatment, known as mRNA-4157, is being tested in patients with various types of cancer, including neoadjuvant or adjuvant cutaneous squamous cell carcinoma, adjuvant high-risk muscle-invasive bladder cancer, and adjuvant renal cell carcinoma.

Stephen Hoge, M.D., President and R&D Chief of Moderna, explained that the company is leveraging data from a successful phase 2 melanoma study, as well as insights from other cancer types where Keytruda has shown efficacy. "We have been aggressively pursuing adjuvant indications where immuno-oncology (I-O) is approved and where we see an opportunity, and all three of these fit squarely in that space," Hoge stated.

In a strategic shift, Moderna has decided not to advance its own checkpoint inhibitor, a preclinical PD-L1 therapy. The company announced that it will not pursue any additional treatments in this area following a strategic review.

Moderna’s ambitions in the oncology sector are spearheaded by mRNA-4157, which is used in combination with Keytruda for patients with high-risk melanoma and non-small cell lung cancer. Since the beginning of the year, Moderna has been gearing up to submit this therapy for accelerated approval as a treatment for melanoma. This plan hinges on the successful enrollment of the phase 3 melanoma study, which would act as the confirmatory trial, and the expansion of manufacturing capabilities at their Marlborough, Massachusetts facility.

"We're optimistic that both [enrollment] and the facility will be available in short order," Hoge informed investors. He mentioned that Moderna has not yet sought regulatory approval for the accelerated pathway, as they are waiting to meet their internal criteria first. "Our view is that if we're able to get to the point where accelerated approval is appropriate, and regulators are supportive of that, we can't imagine why ourselves and Merck wouldn't want to make the product available to help people suffering from cancer right now," Hoge added.

In conclusion, while Moderna is eagerly awaiting the FDA’s decision on their RSV vaccine, the company is not slowing down in its efforts to advance its cancer treatment portfolio. The initiation of new phase 2 trials and the potential for accelerated approval of mRNA-4157 underscore Moderna's commitment to addressing unmet needs in oncology.