ENV-501 / Hummingbird Biosci, Endeavor BioMed - LARVOL DELTA

A Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ENV-501 in Patients With HER3-Expressing Solid Tumors (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Endeavor Biomedicines, Inc.

New P1/2 trial • Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Endeavor BioMedicines Raises $132.5 Million Oversubscribed Series C Financing to Advance Pipeline of Transformational Medicines (Businesswire) - "Endeavor BioMedicines, Inc...announced the closing of a $132.5 million Series C financing, including the conversion of a $5 million convertible instrument....Endeavor will use the financing proceeds to advance the clinical development of ENV-101, its lead candidate for...to advance ENV-501, a human epidermal growth factor 3 (HER3) antibody-drug conjugate (ADC) for the treatment of HER3-positive solid tumors through clinical proof-of-concept studies....Endeavor intends to initiate a Phase 1/2 trial of ENV-501 in 2024."

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

Endeavor BioMedicines Enters License Agreement with Hummingbird Bioscience for Worldwide Rights to HMBD-501, a Next Generation HER3-Targeted Antibody-Drug Conjugate (ADC) (Businesswire) - "Hummingbird Bioscience...and Endeavor BioMedicines...announced that Endeavor has acquired exclusive worldwide rights to Hummingbird Bio’s antibody-drug conjugate (ADC), HMBD-501. The license agreement provides Endeavor with exclusive rights to HMBD-501, a next-generation HER3-targeted ADC with an exatecan payload that has been optimized for safety and efficacy. Under the terms of the license, Hummingbird Bio will be eligible to receive upfront and milestone payments up to $430 million, plus royalties on net sales....Investigational New Drug (IND) application planned in first half of 2024."

IND • Licensing / partnership • Oncology

HMBD-501 - a novel Fc engineered, exatecan-based next generation HER3 targeting antibody drug conjugate shows robust efficacy and tolerability in pre-clinical solid tumor models (AACR 2023) - "Patritumab-Deruxtecan (U3-1402), a HER3-targeting ADC, showed clinical response in a subset of EGFR mutant and TKI resistant lung cancers in a Phase 1 study, albeit with toxicities including severe interstitial lung disease (ILD) and high grade cytopenias. In conclusion, HMBD-501 represents a next generation HER3 targeting ADC that has a potentially best-in-class efficacy and tolerability profile. Our findings strongly support the development of HMBD-501 as a promising candidate in the treatment of HER3 expressing solid tumors."

Preclinical • Colorectal Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • EGFR • FCGR2A • NRG1

Hummingbird Bioscience to Present Two Posters on HER3-Targeting Therapeutics at American Association for Cancer Research (AACR) Meeting 2023 (PRNewswire) - "Hummingbird Bioscience...announced two upcoming poster presentations at the American Association for Cancer Research (AACR) Meeting 2023....Presentations highlight the robust tumor growth inhibition in preclinical models for its HER3-targeting programs HMBD-001 (HER3 mAb) and HMBD-501 (HER3 ADC). HMBD-001 used as monotherapy or in combination with cetuximab effectively inhibits tumor growth in preclinical squamous cell carcinoma models. HMBD-501 shows superior preclinical efficacy and tolerability compared to other HER3 ADCs across a range of preclinical models, presenting a potentially best-in-class profile."

Preclinical • Oncology • Solid Tumor • Squamous Cell Carcinoma