BNT326 / MediLink, BioNTech - LARVOL DELTA

BioNTech Announces Fourth Quarter and Full Year 2024 Financial Results and Corporate Update (GlobeNewswire) - "First clinical data from the ongoing global Phase 1/2 expansion cohorts (NCT05438329) evaluating the combination of BNT327 and BNT325/DB-1305, a TROP2-targeted antibody-drug conjugate ('ADC') candidate, are planned to be published in 2025. Additional clinical trials exploring novel combinations of BNT327 with the ADC candidates BNT323/DB-1303 (trastuzumab pamirtecan) targeting HER2, BNT324/DB-1311 targeting B7-H3 or BNT326/YL202 targeting HER3 are planned to start in 2025."

New trial • P1/2 data • Oncology • Solid Tumor

BioNTech Provides Business and Pipeline Updates at 43rd Annual J.P. Morgan Healthcare Conference (GlobeNewswire) - "A global randomized Phase 3 clinical trial evaluating BNT327/PM8002 in first line triple-negative breast cancer ('TNBC') is on track to start in 2025. Plan to initiate additional clinical trials exploring novel combinations of BNT327/PM8002 with ADCs BNT323/DB-1303 (trastuzumab pamirtecan), BNT324/DB-1311 and BNT326/YL202 in 2025. Plan to present first clinical data from the ongoing global Phase 1/2 expansion cohorts (NCT05438329) evaluating BNT327/PM8002 plus BNT325/DB-1305 in multiple solid tumors in 2025. Plan to present clinical data from the ongoing global Phase 2 dose optimization trials evaluating BNT327/PM8002 plus chemotherapy in advanced TNBC (NCT06449222) and first line SCLC (NCT06449209) in 2025."

New P3 trial • New trial • P2 data • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Active, not recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

A Study of YL202 in Selected Patients with Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Active, not recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • Gastric Cancer • Head and Neck Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • HER-2

A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Subjects With Locally Advanced or Metastatic Breast Cancer Who Are TNBC and HR Positive, HER2 Zero, or HER2 Hypoactive (ChiCTR) - P2 | N=180 | Recruiting | Sponsor: Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center

Metastases • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

YL202-INT-101-01: A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Active, not recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

FDA Lifts Hold on MediLink’s BNT326/YL202 Phase I Trial (Contract Pharma) - "The U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on MediLink Therapeutics (Suzhou) Co., Ltd.’s Phase I trial evaluating BNT326/YL202 (NCT05653752). The decision follows the submission of a comprehensive response by MediLink, addressing the FDA's concerns regarding safety data and incorporating additional risk mitigation measures....The trial will now resume recruitment, focusing on dose levels no higher than 3 mg/kg, where the safety profile was deemed manageable and encouraging clinical activity was observed."

FDA event • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

American Oncology Network Announces the Research Studies Presented at the ASCO 2024 Annual Meeting (GlobeNewswire) - "American Oncology Network...is pleased to announce that several research studies, co-authored by AON physicians and leaders, were accepted at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting."

Clinical data • Breast Cancer • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Non Small Cell Lung Cancer • Oncology • Small Lymphocytic Lymphoma

A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC (clinicaltrials.gov) - P2 | N=180 | Active, not recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | Initiation date: Jul 2024 ➔ Apr 2024

Enrollment closed • Metastases • Trial initiation date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

YL202-INT-101-01: A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer (clinicaltrials.gov) - P1 | N=80 | Active, not recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

A Study of YL202 in Selected Patients With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=200 | Active, not recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • HER-2

YL202/BNT326, a HER3-targeted ADC, in patients with locally advanced or metastatic non-small cell lung cancer and breast cancer: Preliminary results from a first-in-human phase I trial. (ASCO 2024) - P1 | "YL202/BNT326 demonstrated encouraging efficacy in heavily pretreated locally advanced/ metastatic NSCLC and BC. The safety profile showed adequate safety and tolerability."

Clinical • Metastases • P1 data • Alopecia • Anemia • Breast Cancer • Dental Disorders • Fatigue • Febrile Neutropenia • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Immunology • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Stomatitis • Xerostomia • EGFR • ERBB3 • HER-2

A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Metastases • New P2 trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

BioNTech Announces First Quarter 2024 Financial Results and Corporate Update (GlobeNewswire) - "A confirmatory Phase 3 trial (NCT06340568) in this patient population is planned to start in 2024....A multicenter, open-label, first-in-human Phase 1 clinical trial (NCT05653752) evaluating BNT326/YL202 as a later-line treatment in patients with locally advanced or metastatic epidermal growth factor receptor ('EGFR')-mutated non-small cell lung cancer ('NSCLC') or HR+/HER2-negative breast cancer is ongoing in the United States and China. Preliminary data from this study are expected to be presented at the 2024 ASCO Annual Meeting."

P1 data • Trial status • Breast Cancer • Endometrial Cancer • Gynecologic Cancers • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Uterine Cancer

A Study of YL202 in Selected Patients With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • HER-2

A Study of YL202 in Selected Patients With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Metastases • New P2 trial • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ERBB3 • HER-2

MediLink Therapeutics Announces Strategic Collaboration and Worldwide License Agreement with BioNTech to develop next-generation anti-cancer antibody-drug conjugate (PRNewswire) - "MediLink Therapeutics...announced today that it has entered into a strategic research collaboration and worldwide license agreement with BioNTech SE...on the development of a next-generation antibody-drug conjugate candidate ('ADC'), against Human Epidermal Growth Factor Receptor 3 (HER3). Under the terms of the agreement, MediLink will grant BioNTech exclusive global rights for the development, manufacturing, and commercialization of one of MediLink's ADC assets excluding Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region. In exchange, BioNTech will provide MediLink with an upfront payment totaling of $70 million and additional development, regulatory and commercial milestone payments potentially totaling over $1 billion. The completion of the agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino ('HSR') Antitrust Improvements Act."

Licensing / partnership • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Preclinical development of YL202, a novel HER3-targeting antibody-drug conjugate (ADC) with novel DNA topoisomerase I inhibitor for treatment of solid tumors (AACR 2023) - "GLP toxicity studies using cynomolgus monkeys showed that YL202 is well tolerated with calculated therapeutic index (TI, HNSTD/MED) of ~100 for repeat dosing. No lung or platelet toxicity findings were observed at doses up to the maximum tolerated dose (MTD).Based on these preclinical results, it demonstrates that YL202’s advanced ADC design results in an increased therapeutic margin, and YL201 could be further developed in HER3 positive cancer patients."

Preclinical • Oncology • Solid Tumor • EGFR • HER-2

A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Metastases • New P1 trial • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2