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Remember the development of the Moderna personalized cancer vaccine?
As the world awaits data from its late-stage Covid-19 candidate, mRNA reader interrupts its most intensively watched program with upbeat early sneak peek at data from its RNA cancer vaccine mRNA-4157 messenger. And the Moderna team is taking the opportunity to introduce a new head for their oncology unit, raided from Bristol’s Myers Squibb cancer group.
When combined with Merck’s Keytruda in the phase I KEYNOTE-603 trial, the researchers report, the vaccine appears to be effective enough at shrinking tumors. Among 10 patients with HPV negative squamous cell carcinoma of the head and neck, the overall response rate is 50%: 2 complete responses and 3 partial responses. And that translates into a huge benefit over PD-1 inhibitor alone:
The median progression-free survival (mPFS) is 9.8 months, which compares favorably with the published ORR and mPFS of 14.6% and 2.0 months, respectively, for Keytruda as monotherapy. Including four patients with stable disease, the disease control rate (DCR) is 90% (9/10). The median duration of response was not reached.
“The data is preliminary and the sample size is small, but it’s promising,” University of Arizona professor Julie Bauman, who presents the preliminary data at the annual meeting of the Society for Immunotherapy of Cancer. “A Phase I trial is all about safety, and we now know this treatment is safe and tolerable. But, we also have a strong signal to encourage us to pursue this study in head and neck cancer.
Jefferies analyst Michael Yee observed that the results compare favorably even with the Keytruda / chemo combo, the standard of care in the first-line treatment, which gives an ORR of 36% and an mPFS of 4.9 months.
“While 4/5 responders reached PR after 2 doses of Keytruda before mRNA-4157, the 4 responses deepened after administration of mRNA-4157 with 2 PR converted to CR”, a- he writes “Add’l, a pt progressed on Keytruda, but started responding after mRNA-4157. “
In the group of stable microsatellite colorectal carcinomas, however, no response was observed in 17 patients.
With its own tolerability so far, Moderna now plans to expand the HNSCC cohort to 40 patients. For each of them, the tailor company makes a vaccine with messenger RNA that encodes up to 20 neoepitopes which, according to its algorithms, stimulate the strongest immune response.
He will do so under the leadership of Praveen Aanur, who left Bristol Myers Squibb to become Moderna’s Therapeutic Area Manager for Oncology Development. Aanur has spent the past 7 years working on the Bristol Myers Immuno-Oncology pipeline. He received an MBBS from the University of Bangalore, an MPH from the University of Alabama and an MBA from Columbia University School of Business.
Cancer vaccines are once again gaining ground among big players in biopharmacy as new biotechnologies emerge following a series of clinical disasters among Gen 1 players. Regeneron is allied with BioNTech – now a name known through its Covid-19 effort in partnership with Pfizer – on a phase II testing a candidate for 4 antigens, while Roche recently disbursed $ 200 million for a neoantigen program.
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