BioNTech Bags Fast-Track Status for Melanoma Treatment

BioNTech_Boris Roessler/picture alliance via Getty

Boris Roessler/picture alliance via Getty

BioNTech is on the Fast Track. In an announcement this morning, the company said the U.S. Food and Drug Administration (FDA) gave its cancer immunotherapy candidate, BNT111, a Fast Track Designation.

Germany-based BioNTech is developing BNT111 as a potential treatment for advanced melanoma. The company aims to use its mRNA technology to harness the immune system’s power against cancer and infectious diseases. BioNTech is, of course, riding high off the success of its COVID-19 vaccine, developed in partnership with Pfizer. The company is hoping BNT111, which used a fixed combination of mRNA-encoded, tumor-associated antigens to target the cancer cells, will demonstrate the same kind of success as the COVID-19 vaccine.

BNT111 is the lead product candidate from BioNTech’s own FixVac platform and is currently being assessed in a Phase II study in patients with anti-PD-1-refractory/relapsed unresectable Stage III or IV melanoma. Melanoma is the deadliest form of skin cancer, which, on average, takes the lives of more than 63,000 people around the world each year.

In the ongoing Phase II study in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma, BNT111 is paired with Libtayo, a checkpoint inhibitor developed by Regeneron and Sanofi. Libtayo, a monoclonal antibody, has previously been approved to treat metastatic cutaneous squamous cell carcinoma, advanced basal cell carcinoma, and patients with advanced non-small-cell lung cancer whose tumors have high PD-L1 expression.

The companies forged a collaboration pairing the assets last year. The first patients were dosed in the Phase II study this past summer. The study will include 120 patients and will evaluate the effects of the combination and single agents alone. 

The FDA granted the Fast Track designation based on data from the Phase I program and preclinical data. Data from an exploratory analysis of the ongoing Phase 1 Lipo-MERIT monotherapy dose-escalation trial, the company has shown that BNT111 induces novel antigen-specific anti-tumor immune responses. Also, the trial data revealed that BNT111 enhanced pre-existing immune responses against the encoded melanoma-associated antigens. According to BioNTech, those antigens are expressed in more than 90% of cutaneous melanomas. The interim data were previously published in Nature.

The company believes the designation will accelerate the development of immunotherapy and, if the data is strong enough, potential regulatory approval.

“The Fast Track Designation underlines the potential of our FixVac platform to address current treatment challenges of pre-treated and immune checkpoint blocker experienced melanoma with limited standard of care therapy options left. This is an important step to pave the way for this versatile new treatment approach in a high medical need setting,” Dr. Özlem Türeci, co-founder and chief medical officer of BioNTech said in a statement.

Türeci added that BioNTech aims to expedite further development of the BNT111 program to offer a new therapeutic option for this hard-to-treat and life-threatening form of cancer.

Other developmental FixVac assets include NY-ESO-1, MAGE-A3, tyrosinase, and TPTE.

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