BNT111 Melanoma mRNA Immunotherapy Clinical Trials, Efficacy, Side Effects
BNT111 Melanoma mRNA immunotherapy (vaccine) candidate is based upon BioNTech's FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens to trigger a strong and precise immune response against cancer. BioNTech's BNT111 is n intravenous therapeutic cancer vaccine candidate encoding for a fixed set of four cancer-specific antigens optimized for immunogenicity and delivered as an RNA-lipoplex formulation. More than 90% of mela omas in patients express at least one of the four tumor-associated antigens encoded in BNT111 (NY-ESO-1, MAGE-A3, tyrosinase, and TPTE).
The ongoing randomized Phase 2 trial (BNT111-01) in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma investigates BNT111 in combination with Libtayo® (cemiplimab), an anti-PD-1 monoclonal antibody being co-developed by Regeneron and Sanofi. On July 30, 204, BioNTech announced the study's primary endpoint was met. Data demonstrated a statistically significant improvement in overall response rate (“ORR”) compared to historical control in patients with anti-PD-(L)1 relapsed/refractory advanced melanoma. The BNT111 program received a Fast Track designation and an Orphan Drug designation from the U.S. Food and Drug Administration (“FDA”) in 2021.
BioNTech retains global commercial rights to BNT111, which is based on BioNTech’s fully owned FixVac platform and proprietary uridine mRNA-LPX technology. FixVac platform candidates consist of a fixed combination of mRNA-encoded non-mutated antigens shared within specific cancer types. In addition, they feature BioNTech's proprietary RNA-lipoplex delivery formulation, designed to enhance the stability and translation of the mRNA cargo and specifically target dendritic cells. Thus, the vaccine candidate aims to trigger a strong and precise innate and adaptive immune response against cancer cells overexpressing the respective antigen.
Mainz, DE-based Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. BioNTech's U.S. headquarters is based in Cambridge, MA.
BNT111 Indication
BNT111, in combination with Libtayo (cemiplimab), is being studied in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma. Melanoma remains one of the deadliest types of skin cancer, with 5-year survival for Stage IV metastatic disease of about 20%.
BNT111 News
July 30, 2024 - “These Phase 2 results mark a significant step towards our vision of personalized cancer medicine. We envision mRNA as a centerpiece in future treatment paradigms for cancer, helping to address unmet medical needs, such as for patients with anti-PD-(L)1 refractory or resistant melanoma,” said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech.
November 19, 2021 - BioNTech S.E. announced that the U.S. FDA granted Fast Track Designation for BNT111, an investigational cancer immunotherapy for the potential treatment of advanced melanoma. The vaccine candidate is currently being investigated in a Phase 2 trial in patients with anti-PD-1-refractory/relapsed unresectable Stage III or IV melanoma.
August 9, 2021 - BioNTech S.E. announced for the six months ended June 30, 2021, total revenues were estimated to be €7,356.9 million compared to €69.4 million for the comparative prior-year period.
June 18, 2021 - BioNTech Announces First Patient Dosed in Phase 2 Clinical Trial of mRNA-based BNT111 in Patients with Advanced Melanoma. This is a randomized, global, three-arm Phase 2 trial evaluating BNT111 in combination with cemiplimab versus both agents as monotherapy in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma. Survival can be as sh rt as six months in the refractory or relapsed setting, depending on risk factors. Up to 50% of patients progress after treatment with checkpoint inhibitors.
August 29, 2020 - The Phase 1 Lipo-MERIT dose-escalation trial demonstrated a favorable safety profile in 89 patients with advanced melanoma. In addition, efficacy analysis of the Lipo-MERIT study in a subset of 42 metastatic melanoma patients previously treated with a checkpoint-inhibitor showed that BNT111 mediated durable responses both as a single agent and in combination with anti-PD-1 antibodies and that durable objective response by BNT111 were associated with activation and strong expansion of tumor-antigen-specific CD4+ and CD8+ T cells.
July 29, 2020 - The journal Nature published a study: An RNA vaccine drives immunity in checkpoint-inhibitor-treated melanoma. 'Our findings indicat that RNA-LPX vaccination is a potent immunotherapy in patients with CPI-experienced melanoma, and suggest the general utility of non-mutant shared tumor antigens as targets for cancer vaccination.'
BNT111 Melanoma Vaccine Clinical Trials
BNT111 is currently conducting clinical trials. A phase 1 clinical t al demonstrated a favorable safety profile in 89 patients with advanced melanoma. In addition, efficacy analysis of the Lipo-MERIT study in a subset of 42 metastatic melanoma patients previously treated with a checkpoint-inhibitor (CPI) showed that BNT111 mediated durable responses both as a single agent and in combination with anti-PD-1 antibodies and that durable objective response by BNT111 were associated with activation and strong expansion of tumor-antigen-specific CD4+ and CD8+ T cells. Results were publishe in Nature in July 2020.
The Phase 2 trial is based on positive results from the Phase 1 Lipo-MERIT trial that demonstrated a favorable safety profile for BNT111 as well as durable objective responses observed in patients with melanoma who had progressed following prior checkpoint blockade.
