Editors' (re)View: Cancer vaccine progress; An FTC victory

Dec. 15, 2023
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of December 11

One step closer to a cancer vaccine 

The potential of a cancer vaccine holds immense promise as a transformative breakthrough in oncology. With millions of people globally grappling with the impact of cancer, the urgency to develop effective preventive measures is evident.

Leveraging cutting-edge technologies and understanding the complexities of the immune system, earlier this week, partners Moderna and Merck (MSD) announced they had initiated a phase 3 trial to assess their mRNA cancer vaccine, V940, in combination with Keytruda for adjuvant treatment in patients with non-small cell lung cancer (NSCLC).

V940, an experimental mRNA-based personalized neoantigen therapy, is designed to stimulate an anti-tumor immune response based on the unique mutational characteristics of a patient's tumor. Merck's well-established Keytruda, an immunotherapy, amplifies the immune system's ability to identify and combat tumor cells.

The trial, which has commenced recruitment with initial patients in Australia, aims to involve approximately 868 individuals with completely resected stage II, IIIA, or IIIB NSCLC. Participants will be randomized for either the combination treatment of V940 and Keytruda or Keytruda alone, post-surgery and adjuvant chemotherapy, for up to one year or until disease recurrence.

NSCLC treatment strategies commonly involve surgical resection, followed by adjuvant therapies such as chemotherapy or immunotherapy. Depending on disease stage, prognosis can be guarded.

But Merck and Moderna have hopes for their vax beyond lung cancer. The combination of V940 and Keytruda is also being investigated in INTERPATH-001, a global phase 3 trial with about 1,089 patients focusing on resected high-risk melanoma

Their collaboration underscores a six-year partnership between Moderna and Merck, leveraging their combined expertise in mRNA and immuno-oncology. Despite the complexity of the aim at hand, this effort brings a glimmer of hope to push forward cancer treatments into a new era for patients. — Andrea Corona

Small victory for FTC

This week, we reported that Sanofi is backing out of its Maze Therapeutics licensing agreement after the FTC moved to block the $755 million deal, which was focused on a phase 1 glycogen synthase 1 inhibitor for Pompe disease. 

While Sanofi disagreed with the FTC's monopoly concerns, the drugmaker opted to terminate the deal to avoid the prolonged and costly litigation. 

This marks the first substantial victory for the FTC since its 2021 promise to take a closer look at anticompetitive pharma deals.

But it’s not for lack of trying. The FTC filed a lawsuit early this year to attempt to block Amgen's $27.8 billion buyout of Horizon, but the deal closed in October after Amgen agreed to some of the FTC's settlement terms. The agency also took aim at Pfizer’s $43 billion acquisition of Seagen, but closed this week after Pfizer agreed to donate royalties from sales of Bavencio.

The squashed Sanofi agreement was notably smaller in scale than Pfizer or Amgen — and wasn’t even a merger. However, FTC Chair Lina Khan has noted that these smaller deals can also create monopolies.

"We have, in certain instances, just seen blind spots. Where we've seen a whole set of deals that are below our radar, that are kind of slowly and incrementally consolidating a market, and then five years in, 10 years in, you have two players, three players that have come to dominate," Khan said.

But pharma argues that these types of deals are necessary, given the massive cost of bringing new therapies to market. Back in October, life sciences organizations banned together to oppose the FTC’s new approach to antitrust enforcement, launching the Partnership for the U.S. Life Science Ecosystem — PULSE. The coalition argues that deals are associated with increased R&D and innovation because they enable efficient allocation of funding and resources across the pharma ecosystem.

Remains to be seen how future deals will unfold, but this time it seems the FTC has finally scored some points. —Karen Langhauser

About the Author

Andrea Corona | Senior Editor

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.'