BioNTech Halts Further Development of Cancer Vaccine in Advanced Melanoma Setting

BioNTech, the German biotechnology company known for its mRNA technology, has announced it will not proceed with further development of its BNT111 cancer vaccine candidate in a specific late-stage refractory melanoma setting. This decision, revealed by a company spokesperson, aligns with BioNTech's strategy to focus on other programs from its FixVac mRNA platform.

Phase 2 Trial Results and Implications

The announcement follows the presentation of results from a phase 2 study at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin. The trial investigated BNT111 in combination with Regeneron's checkpoint inhibitor Libtayo in patients with unresectable stage 3 or 4 melanoma who had previously tried PD-1 or PD-L1 therapy.

Key findings from the study include:

• An objective response rate (ORR) of 18.1% for patients treated with the BNT111 and Libtayo combination
• Median progression-free survival of 3.1 months at a median follow-up of 15.7 months
• 24-month progression-free survival rate of 24.9%
• Median overall survival of 20.7 months
• 24-month survival rate of 47.8%

Lead study author Paolo Ascierto, M.D., described the trial as "positive," noting that BNT111 monotherapy also demonstrated "clinical activity" and a manageable safety profile.

Strategic Shift and Future Focus

Despite these encouraging results, BioNTech has decided to deprioritize BNT111 in this specific setting. The company spokesperson stated, "In line with our strategy, we are currently not planning further clinical trials with BNT111 in this late-stage, refractory disease setting."

BioNTech's development priorities now center on:

1. BNT116 and BNT113, two other FixVac candidates
2. mRNA cancer immunotherapies
3. An individualized cancer therapy program called iNeST
4. Immuno-oncology molecules and antibody-drug conjugates

The company's collaboration with Regeneron, initiated in 2020, aimed to overcome checkpoint inhibitor resistance in melanoma patients. While BNT111 remains listed as a phase 2 "priority program" on BioNTech's virtual pipeline, the focus has shifted to other candidates within the FixVac platform.

Broader Context in Melanoma Vaccine Development

BioNTech's decision highlights the ongoing challenges in developing effective cancer vaccines, particularly for melanoma. Other companies in this space include:

• Evaxion, a Danish vaccine developer, which recently reported a 75% ORR for its personalized melanoma vaccine prospect, though the trial's low enrollment prevented statistical significance determination.
• Moderna, which is advancing an mRNA candidate targeting PD-L1 and IDO antigens, focusing on melanoma patients with PD-L1 positive tumors.

As the landscape of cancer immunotherapy continues to evolve, the pharmaceutical industry remains committed to exploring innovative approaches to address the unmet needs of patients with advanced melanoma and other challenging oncological conditions.