BNT221 / BioNTech - LARVOL DELTA

Clinical & Translational Learnings of BNT221, a neoantigen-specific adoptive T-cell therapy and next steps for future product iterations with gene knock-out approaches (CIMT 2025) - No abstract available

Clinical • Tumor-specific neoantigens

A Clinical Study of the Safety and Activity of the Investigational Cell Therapy NEO-PTC-01 in Patients With Advanced Melanoma (clinicaltrials.gov) - P1 | N=22 | Terminated | Sponsor: BioNTech US Inc. | Trial completion date: Dec 2029 ➔ Mar 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2029 ➔ Mar 2025; Sponsor decision

Trial completion date • Trial primary completion date • Trial termination • Melanoma • Oncology • Solid Tumor • BRAF

Personalized, autologous neoantigen-specific T cell therapy in metastatic melanoma: a phase 1 trial. (PubMed, Nat Med) - P1 | "We designed BNT221, a personalized, neoantigen-specific autologous T cell product derived from peripheral blood, and tested this in a 3 + 3 dose-finding study with two dose levels (DLs) in patients with locally advanced or metastatic melanoma, disease progression after ICB, measurable disease (Response Evaluation Criteria in Solid Tumors version 1.1) and, where appropriate, BRAF-targeted therapy...Our results provide key insights into this neoantigen-specific adoptive T cell therapy and demonstrate proof of concept for this new therapeutic approach. ClinicalTrials.gov registration: NCT04625205 ."

IO biomarker • Journal • P1 data • Melanoma • Oncology • Solid Tumor • BRAF • CD4 • CD8

A Clinical Study of the Safety and Activity of the Investigational Cell Therapy NEO-PTC-01 in Patients With Advanced Melanoma (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: BioNTech US Inc. | Trial completion date: Oct 2025 ➔ Dec 2029 | Trial primary completion date: Oct 2025 ➔ Dec 2029

Metastases • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF

NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: BioNTech US Inc. | N=72 ➔ 22

Enrollment change • Metastases • Melanoma • Oncology • Solid Tumor • BRAF

NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: BioNTech US Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Melanoma • Oncology • Solid Tumor • BRAF

BioNTech to Present Clinical and Preclinical Data Updates Across Multiple Immuno-Oncology Programs at 2023 SITC Annual Meeting (BioNTech Press Release) - P1 | N=72 | NCT04625205 | Sponsor: BioNTech US Inc. | "Highlights of BioNTech’s clinical stage programs to be presented at SITC Annual Meeting 2023...As a follow-up to the data recently presented at ESMO, BioNTech will give an update on the first-in-human Phase 1 study with BNT221 (NCT04625205), a personalized, autologous neoantigen-specific T cell therapy, which is being evaluated in patients with anti-PD-1- and anti-CTLA-4-pretreated advanced or metastatic melanoma. The data update includes nine patients. Seven of these patients have stable disease with shrinkage of tumor lesions in four of these patients. The initial results show a manageable safety profile with no dose limiting toxicities. In addition, preliminary translational data show multiple functional neoantigen-specific T cell responses in all evaluable patients."

P1 data • Melanoma • Oncology • Skin Cancer • Solid Tumor

Interim clinical and translational data from NTC-001, a phase I study to evaluate the non-engineered neoantigen-specific T cell product BNT221 in patients with advanced or metastatic melanoma (SITC 2023) - P1 | "Translational analysis shows that the generated products contain multiple highly functional tumor-specific T-cell populations against neoantigens. Further clinical investigation of BNT221 in combination with anti-PD-1 is warranted and currently underway."

Clinical • IO biomarker • Metastases • P1 data • Tumor-specific neoantigens • Melanoma • Oncology • Solid Tumor • CD4 • CD8

NTC-001: A phase I study to test safety and efficacy of BNT221, a non-engineered neoantigen-specific T cell product, in patients with advanced or metastatic melanoma (ESMO 2023) - P1 | "Conclusions In this first in human study, BNT221 as a single infusion therapy demonstrated a tolerable safety profile, product persistence, prolonged stable disease, and tumor regressions in patients with checkpoint inhibitor-resistant metastatic melanoma. Additional study is warranted and BNT221 combination with anti-PD-1 is currently underway."

Clinical • IO biomarker • Metastases • P1 data • Tumor-specific neoantigens • Melanoma • Oncology • Solid Tumor • CD4 • CD8

BioNTech to Present Multiple Program Updates Across Modalities at ESMO Congress 2023 (GlobeNewswire) - "BioNTech SE...will present data across its oncology pipeline, covering multiple solid tumor types and novel mechanisms of action, at the European Society for Molecular Oncology ('ESMO') Congress 2023 in Madrid, Spain from October 20-24, 2023....BioNTech will present new data of its investigational autologous Claudin-6 (CLDN6)-directed CAR-T cell therapy BNT211 (NCT04503278), including data showing the potential of combining these CAR-T cells with a CLDN6-encoding CAR-T cell amplifying mRNA vaccine ('CARVac'). Initial data from BioNTech's first-in-human Phase 1 study with BNT221 (NCT04625205), a personalized, autologous neoantigen-specific T cell therapy, will be presented. The initial results show a manageable safety profile and tumor regression in several patients with anti-PD-1 and anti-CTLA4 pretreated advanced or metastatic melanoma."

P1 data • P1/2 data • Melanoma • Oncology • Skin Cancer • Solid Tumor

NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: BioNTech US Inc. | N=52 ➔ 72

Enrollment change • Metastases • Melanoma • Oncology • Solid Tumor • BRAF

NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: BioNTech US Inc. | Trial primary completion date: Nov 2023 ➔ Oct 2025

Metastases • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF

NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: BioNTech US Inc. | Trial completion date: Nov 2023 ➔ Dec 2025

Trial completion date • Melanoma • Oncology • Solid Tumor • BRAF

BNT221, an autologous neoantigen-specific T-cell product for adoptive cell therapy of metastatic ovarian cancer (SITC 2021) - "Efforts are ongoing to upscale the manufacturing process and move this into a phase I study. BNT221, the neoantigen-specific T cell product generated from this process, is a potent adoptive cell therapy targeting multiple immunogenic neoantigens in patients with metastatic ovarian cancer."

Tumor-specific neoantigens • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • CD4 • CD8

BioNTech to Present New Clinical and Preclinical Data Across Multiple Immuno-Oncology Programs at 36th SITC Annual Meeting (GlobeNewswire) - "BioNTech SE....announced that new clinical and preclinical data will be presented in six posters and one presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held both in person and virtually from November 10 - 14, 2021."

Clinical data • Preclinical • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov) - P1; N=52; Recruiting; Sponsor: BioNTech US Inc.; N=32 ➔ 52

Clinical • Enrollment change • Melanoma • Oncology • Solid Tumor • BRAF • MRI

[VIRTUAL] BNT221, an autologous neoantigen specific T cell product for adoptive cell therapy of metastatic melanoma (CIMT 2021) - "Conclusions NEO-STIM is a novel platform that is capable of generating ex vivo T cell responses to high-quality neoantigen- targets. A first in human study with this adoptive cell therapy, BNT221, in patients with metastatic melanoma is now underway."

Tumor-specific neoantigens • Melanoma • Oncology • Solid Tumor • CD4 • CD8

BioNTech Announces Full Year 2020 Financial Results and Corporate Update (GlobeNewswire) - “BNT312/GEN1042 – We expect first data disclosure from the Phase 1/2a trial of BNT312 in solid tumors in the second half of 2021…BNT211…We expect a data update for this trial in the second half of 2021…BNT221 (NEO-PTC-01) – Dosing of the first patient in a Phase 1 dose escalation trial for the treatment of metastatic melanoma in patients who are refractory or unresponsive to checkpoint inhibitors is expected in the first half of 2021…BNT411…We expect a data update from this trial in the second half of 2021.”

New P1 trial • P1/2 data • Lung Cancer • Melanoma • Oncology • Skin Cancer • Small Cell Lung Cancer • Solid Tumor

[VIRTUAL] NEO-PTC-01 (BNT-221), an autologous neoantigen-specific T-cell product for adoptive cell therapy of metastatic melanoma (SITC 2020) - "Conclusions NEO-STIM is a novel platform that generates ex vivo T-cell responses to high-quality neoantigen targets. NEO-PTC-01, the neoantigen-specific T cell product generated from this process, is a potent adoptive cell therapy targeting multiple immunogenic neoantigens in patients with metastatic melanoma."

Tumor-specific neoantigens • Melanoma • Oncology • Solid Tumor • CD8

[VIRTUAL] NEO-PTC-01 (BNT-221), an autologous neoantigen-specific T-cell product for adoptive cell therapy of metastatic melanoma (SITC 2020) - "Conclusions NEO-STIM is a novel platform that generates ex vivo T-cell responses to high-quality neoantigen targets. NEO-PTC-01, the neoantigen-specific T cell product generated from this process, is a potent adoptive cell therapy targeting multiple immunogenic neoantigens in patients with metastatic melanoma."

Tumor-specific neoantigens • Melanoma • Oncology • Solid Tumor • CD8

NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: BioNTech US Inc.

Clinical • New P1 trial • Melanoma • Oncology • Solid Tumor • BRAF

Neon Therapeutics announces acceptance of European Clinical Trial Authorization application for NEO-PTC-01 (GlobeNewswire) - “Neon Therapeutics, Inc…announced the acceptance of its Clinical Trial Authorization (CTA) from the Dutch Health Authority (DHA) for its personal neoantigen-targeted T cell therapy candidate, NEO-PTC-01. Neon’s initial Phase 1 clinical trial of NEO-PTC-01 will be in patients with metastatic melanoma who are not responsive to checkpoint inhibitors. The Phase 1 dose-finding clinical trial in metastatic melanoma will be conducted in collaboration with the Netherlands Cancer Institute and is expected to begin in the third quarter of 2020… Neon is also planning for a second indication for NEO-PTC-01 in metastatic ovarian cancer, as well as for the potential to both expand to other solid tumor types and pursue clinical development in the United States.”

European regulatory • Trial initiation date • Gynecologic Cancers • Melanoma • Oncology • Ovarian Cancer • Solid Tumor

BioNTech to acquire Neon to strengthen global leadership position in T cell therapies (GlobeNewswire, BioNTech SE) - "Further expands BioNTech’s growing CAR-T and TCR therapy pipeline through addition of neoantigen specific cell therapies, including a T cell therapy targeting shared RAS oncogenes...Neon’s most advanced program is NEO-PTC-01, a personalized neoantigen-targeted T cell therapy candidate consisting of multiple T cell populations targeting the most therapeutically relevant neoantigens from each patient’s tumor."

M&A • Tumor-specific neoantigens

Neon Therapeutics submits European Clinical Trial Authorization application for personal neoantigen-targeted T cell therapy NEO-PTC-01 (GlobeNewswire) - "Neon Therapeutics, Inc...announced that it has filed a Clinical Trial Authorization (CTA) with the Dutch Health Authority for the evaluation of NEO-PTC-01 in patients with metastatic melanoma who are refractory to checkpoint inhibitors...Neon plans to initiate a Phase 1 dose escalation clinical trial in metastatic melanoma in collaboration with the Netherlands Cancer Institute in the first half of 2020. The second planned indication for NEO-PTC-01 is metastatic ovarian cancer, with the potential to both expand to other solid tumor types..."

European regulatory • Trial initiation date