BioNTech announced an expansion on its collaboration with Regeneron to continue advancing mRNA technology and develop novel treatments for a variety of cancers.
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As the most financially invested in the research of mRNA-based cancer therapies, one might think that next-generation immunotherapy pioneer BioNTech would be short on new goals. But on Monday, the company announced an expansion of its collaboration with Regeneron Pharmaceuticals to continue advancing mRNA technology and develop FixVac candidate BNT116 in combination with Regeneron and Sanofi’s shared pharmaceutical product Libtayo (cemiplimab) for non-small cell lung cancer (NSCLC).
This is in addition to current collaborative efforts to evaluate the efficacy of Libtayo in combination with BNT111 and BNT122, candidates for the treatment of advanced melanoma and prostate cancer. The first is presently undergoing investigation in a randomized Phase II trial that began in June 2021 as a result of an encouraging interim analysis of the ongoing phase I Lipo-MERIT study combining BNT111 with PD-1 blockade. This earned it a Fast Track Designation from the U.S. Food and Drug Administration last November.
Now, BioNTech and Regeneron are expanding cooperation to the joint financial sponsorship, responsibility and clinical evaluation of BNT116 in tandem with Libtayo as a treatment for NSCLC, marking the third category of cancer to be conspired against by this partnership.
“We are delighted to expand our collaboration with BioNTech to a third tumor type – advanced NSCLC – and investigate whether combining Libtayo with BNT116 will further enhance the efficacy and safety we’ve demonstrated with Libtayo in this cancer as both a monotherapy and in combination with chemotherapy,” said Regeneron Senior Vice President of Translational and Clinical Sciences, Oncology, Israel Lowy, M.D., Ph.D.
Together, BioNTech and Regeneron intend to develop phase I and II clinical trials for which the combined research will target first-line treatment for patients with NSCLC, weaponizing tumor-associated antigens to bolster the endogenous immune response
“Advancing the sixth FixVac product candidate based on uridine mRNA into clinical development underlines the versatility and potential of this platform. Advanced NSCLC still has a five-year survival rate of only 25% leaving patients with very limited treatment options. We believe that a potent vaccine that induces strong T cell responses against shared tumor-associated antigens combined with PD-1 blockade that further enables the activated T cell repertoire will help to address the high unmet medical need in this indication,” elaborated BioNTech Co-Founder and Chief Medical Officer Özlem Türeci, M.D., mirroring the sentiment at Regeneron. “We look forward to further building on our successful collaboration with Regeneron to accelerate the clinical development of BNT116 in our growing mRNA oncology pipeline.”
Even so, BioNTech seems to be going the extra mile under a separate agreement with Regeneron by sponsoring and conducting a phase I clinical trial investigating the BNT116-Libtayo combination therapy across a greater number of NSCLC patient subpopulations than the shared trial. BioNTech is additionally sponsoring and conducting yet another separate phase I clinical trial studying the effectiveness of combining FixVac candidate BNT112 with Libtayo in treating prostate cancer.
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