BioNTech Reports Positive Phase 2 Outcomes for mRNA Therapy BNT111 in Advanced Melanoma Patients

BioNTech SE revealed favorable preliminary results from the current Phase 2 clinical study involving individuals with unresectable stage III or IV melanoma whose condition had worsened after receiving anti-PD-(L)1 treatment.

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The randomized trial investigates the clinical effectiveness and safety of the novel mRNA cancer therapy BNT111 when used in conjunction with Libtayo (cemiplimab), an anti-PD-1 monoclonal antibody from Regeneron, and also evaluates the effectiveness of each agent alone.

The primary efficacy endpoint of the trial was achieved, showing a significant increase in ORR for patients treated with the combination of BNT111 and cemiplimab, compared to historical controls for the same condition and treatment parameters. Both single-agent arms showed clinical effectiveness. The ORR for cemiplimab monotherapy aligned with the historical control data for anti-PD-(L)1 or anti-CTLA-4 treatments in these patients.

The combination therapy was well tolerated, and the safety profile of BNT111 with cemiplimab was consistent with previous trials of BNT111 with anti-PD-(L)1-based treatments. The Phase 2 trial will proceed as planned to assess the secondary endpoints, which were immature at the time of the primary analysis.

"These Phase 2 results are a critical advancement towards our goal of personalized cancer medicine. We see mRNA as central to future cancer treatments, addressing unmet needs such as anti-PD-(L)1 refractory or resistant melanoma," noted Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech.

In 2021, the FDA granted Fast Track designation to the combination of BNT111 and cemiplimab for treating anti-PD-1-refractory/relapsed, unresectable Stage III or IV melanoma. The same year, BNT111 also received Orphan Drug designation from the FDA for treating stage IIB through IV melanoma.

BNT111 is an mRNA-based, off-the-shelf cancer immunotherapy designed for intravenous use and encodes a set of four fixed, non-mutated melanoma-associated antigens in a uridine mRNA-lipoplex formulation. Over 90% of patients with cutaneous melanomas express at least one of these antigens.

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According to the data provided by the Synapse Database, As of August 5, 2024, there are 14 investigational drugs for the CD4 and CD8 targets, including 31 indications, 14 R&D institutions involved, with related clinical trials reaching 19, and as many as 47382 patents.

RB-0003 is a personalized antigen mRNA vaccine, targeting CD4 and CD8 cells for the treatment of unresectable melanoma. The drug has reached Phase 2 of clinical development and has received regulatory designations such as Fast Track and Orphan Drug. Its innovative approach to cancer treatment and potential to address unmet medical needs make RB-0003 a promising candidate in the field of biomedicine.