Moderna has touted the possibility of an accelerated approval for its Merck-partnered cancer vaccine by 2025. But according to executives, three things need to happen first.

Merck and Moderna made news in December 2022 when they unveiled Phase II data suggesting their individualized neoantigen therapy, or INT, reduced the risk of cancer recurrence or death in melanoma patients when used with Merck’s Keytruda. The data reinvigorated a field that has frustrated scientists for years. The therapy is now in two Phase III trials in adjuvant melanoma and non-small cell lung cancer.

But Moderna said Thursday that it wants to see more progress on enrollment before it considers filing for an accelerated approval.

“We have to substantially enroll the confirmatory Phase III study,” the company’s president Stephen Hoge said on a fourth-quarter earnings call Thursday. “For an accelerated approval in this space, we do believe we have to show we’ve really already done the diligence to allow that confirmatory data to come in.”

Moderna plans on launching additional clinical studies for INT this year, including “additional Phase III and confirmatory studies,” Hoge said. That also includes “some potential metastatic indications,” though Moderna declined to comment on the new tumor types it plans to pursue.

Hoge also said the company wants proof of durability, something it saw signs of in Phase IIb results released in December. At a three-year analysis, patients who took INT and Keytruda saw a 49% reduction in the risk of recurrence or death compared to patients on Keytruda alone. Hoge said the company is “incredibly encouraged by that.”

But the final box he wants to tick is going to take a bit more time. Hoge’s third criteria for approaching regulators will be an established manufacturing facility. Without that, he added, “There isn’t really a product here to talk about.”

Moderna is currently building an estimated $322 million site in Marlborough, MA for that purpose, roughly 30 miles west of its Cambridge headquarters. A spokesperson said the site is slated for completion this year.

“We’re making progress on all three,” Hoge said. “The durability of the benefit we’ve been seeing really causes us to lean into working hard to complete the enrollment of that confirmatory study, criteria two, and finish the build-out of that Marlborough facility.”

Source:
https://endpts.com/moderna-wants-an-accelerated-approval-for-its-cancer-vaccine-but-its-waiting-on-three-things/
GMP mRNA
Check out our mRNA service to expedite your vaccine research
About PackGene

PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.

Related News

Scientists develop potential stealth cancer therapy

Credit: ACS Central Science (2024). DOI: 10.1021/acscentsci.4c00559Sneaking by cancer's defenses, by disguising tumor-fighting antibodies inside the molecules cancer uses to nourish tumor growth, is the basis of a novel therapy from Yale Cancer Center researchers at...

read more

Related Services

Plasmids GMP Services

Multiple scales & grade of solutions of various kind of plasmids suitable for multiple treatments in a fast and cost effective way.
READ MORE

AAV GMP Services

Ranging from small-scale AAV production, to large-scale AAV cGMP manufacturing for animal studies.
READ MORE
aav icon

Technology Platforms

PackGene’s proprietary π-Alpha™ 293 AAV High-yield Platform increases AAV production by 3 to 8 times that of traditional platforms.
READ MORE