BioNTech and Regeneron Expands Cancer Vaccine Collab, Adds Lung Cancer Indication

BioNTech and Regeneron have been combining the former’s mRNA-based FixVac platform with the latter’s PD-1 immune checkpoint inhibitor, Libtayo, to generate cancer vaccines. Now, the two companies are adding a third tumor type – advanced non-small cell lung cancer (NSCLC) – to their collaboration. 

NSCLC is one of the most common forms of lung cancer, making up about 85% of all lung cancers.

Under the deal, the companies will start evaluating BioNTech’s candidate BNT116 with Libtayo as a first-line treatment for patients with advanced NSCLC. The companies will equally share development costs for the trials. Separately, BioNTech wll conduct a Phase 1 called LuCa-MERIT-1 assessing the BNT116/Libtayo combo in other NSCLC subpopulations. Full financial details of the deal have not been disclosed, similar to previous agreements. 

“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 Israel Lowy, Senior Vice President of Clinical Development, Oncology, at Regeneron. “Combining PD-1 inhibition with mRNA-based vaccines is an exciting, yet still emerging, approach in oncology.”

Related article: New Research on Neoantigens and Tumor-targeting T-cells Marks Paradigm Shift in Countering Solid Tumors

FixVac and Cancer Vaccine Candidates

BioNTech’s FixVac selects combinations of mRNA encoding for known cancer-specific antigens expressed by many cancerous cells. In the case of BNT116, the mRNA vaccine candidate encodes for a cluster of antigens frequently seen on NSCLC cells. 

Besides NSCLC, BioNTech has ongoing partnerships with Regeneron to develop cancer vaccines against advanced melanoma and prostate cancer. The experimental shots also use a combination of FixVac candidates and Libtayo.

Outside the partnership, BioNTech’s FixVac pipeline includes a Phase 2 asset for HPV-positive head and neck cancers and a Phase 1 drug for ovarian cancer. 

“Advancing the sixth FixVac product candidate based on uridine mRNA into clinical development underlines the versatility and potential of this platform,” said Özlem Türeci, Co-Founder and Chief Medical Officer at BioNTech.

The five-year survival rate of advanced NSCLC is only 25% leaving patients, and there are few 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,” said Türeci.

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Joy Lin

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