BNT3212 / BioNTech - LARVOL DELTA

A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=375 | Recruiting | Sponsor: BioNTech SE | Trial completion date: Mar 2028 ➔ Aug 2028

First-in-human • Monotherapy • Trial completion date • Oncology • Solid Tumor

Discovery of an asymmetric IgG-like bispecific ADC targeting EGFR/HER3 (AACR 2024) - "A bispecific ADC targeting EGFR x HER3 was discovered, named PM1300, which has an asymmetric 1+1 IgG-like structure and optimized affinity. This allows for preferential binding to EGFR/HER3 double-positive cancer cells, rather than EGFR single-positive cells. This may significantly contribute to minimizing safety risk that is common for EGFR-targeting agents."

ADC • Bispecific • Cervical Cancer • Genito-urinary Cancer • HER2 Positive Breast Cancer • Melanoma • Oncology • Prostate Cancer • Solid Tumor • EGFR • ERBB3 • ERBB4 • HER-2

In the last quarter, BioNTech initiated several signal-seeking clinical trials to evaluate pumitamig with the Company’s proprietary assets (GlobeNewswire) - "(i) In August, the first patient was dosed in a Phase 1/2 clinical trial (NCT07079631) to evaluate...BNT314/GEN1059 in combination with pumitamig and chemotherapy in patients with advanced CRC; (ii) Also in August, the first patient was dosed in a Phase 1/2 clinical trial (NCT07070232) to evaluate pumitamig in combination with...BNT326/YL202 and BNT326/YL202 as monotherapy in advanced solid tumors; (iii) In September, the first patient was dosed in a Phase 1/2 clinical trial (NCT07147348) to evaluate BNT3212...as monotherapy and in combination with pumitamig in patients with advanced solid tumors; (iv) In October, the first patient was dosed in a Phase 1/2 clinical trial (NCT07111520) to evaluate...BNT326/YL202 in combination with pumitamig in advanced NSCLC."

Trial status • Colorectal Cancer • Non Small Cell Lung Cancer

In September, the first patient was dosed in a Phase 1/2 clinical trial (NCT07147348) to evaluate BNT3212, a novel bispecific ADC candidate targeting EGFR and HER3, as monotherapy and in combination with pumitamig in patients with advanced solid tumors. (The Manila Times)

Trial status • Solid Tumor

A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=375 | Recruiting | Sponsor: BioNTech SE | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Monotherapy • Solid Tumor