Vaccines

After sitting through the full presentation on the Phase 3 INTerpath-001 trial at the ESMO Congress over the weekend, analysts are more keen on the personalized mRNA cancer vaccine data that last week spurred a stock selloff for both partners.

A combination of the personalized cancer vaccine intismeran autogene and Merck’s Keytruda just barely cleared analysts’ expectations for recurrence-free survival, leaving questions as to its applicability to tumor types beyond melanoma.

After Abogen Biosciences’ COVID shot missed the commercial window, the big question was whether its mRNA technology could create value beyond vaccines. Novartis’ $575 million upfront commitment is the clearest external validation yet of that broader therapeutic potential.

VAX-31 beat Pfizer and Merck’s established pneumococcal conjugate vaccines in a Phase 3 trial, exceeding investors’ most ambitious scenario and setting Vaxcyte up to challenge the Big Pharmas in a market worth $8 billion.

Manufacturers are redesigning their processes to balance both better future emergency vaccine mobilization and the more demanding work of maintaining flexible, commercially viable manufacturing networks.

GSK is consolidating its vaccine manufacturing operations to one site—located in Canada—amid the pharma’s recent $2.5 billion savings campaign.

A year to the day after the Trump administration slashed $500 million in funding from mRNA-based programs, the FDA approved Moderna’s flu vaccine based on the technology. Weeks later, Moderna and Merck revealed positive Phase 3 results for their personalized mRNA-based cancer vaccine. In the words of one mRNA specialist, “science won.”

After mastering mass-market mRNA production during the pandemic, the industry now needs to achieve the timely delivery of individualized vaccines to thousands of patients.

Novartis hits pause on several CAR T trials after three patient deaths, followed by Bristol Myers Squibb after separate safety signals; Revolution Medicines scores early FDA approval for groundbreaking pancreatic cancer drug; BioNTech suspends a mid-stage trial of its mRNA cancer immunotherapy after a futility analysis; and nine mid-sized biopharma companies join their big pharma peers in President Donald Trump’s Most Favored Nation drug pricing scheme.

GSK’s vaccine—which targets two primary flu antigens—elicited higher immune responses in both younger and older adults in a mid-stage study. The Phase 3 launch, planned for September, follows the FDA’s recent approval for Moderna’s mRNA flu vaccine.