AVZO-103 / VelaVigo, Avenzo Therap - LARVOL DELTA

AVZO-103-1001: Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors (clinicaltrials.gov) - P1/2 | N=355 | Recruiting | Sponsor: Avenzo Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

AVZO-103-1001: Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors (clinicaltrials.gov) - P1/2 | N=355 | Not yet recruiting | Sponsor: Avenzo Therapeutics, Inc.

First-in-human • New P1/2 trial • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Avenzo Therapeutics Announces $60 Million Series B Financing (Businesswire) - "The proceeds will be used to support the advancement of Avenzo’s pipeline of potential best-in-class oncology drug candidates."

Financing • Hormone Receptor Positive Breast Cancer • Non Small Cell Lung Cancer • Urothelial Cancer

Avenzo Therapeutics Initiates Phase 1/2 Clinical Study of AVZO-103, a Potential Best-in-Class Nectin4/TROP2 Bispecific Antibody-Drug Conjugate (Businesswire) - "The Phase 1/2 first-in-human, open-label clinical study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-103 as a single agent and in combination therapy in patients with advanced solid tumors."

Trial status • Solid Tumor • Urothelial Cancer

Avenzo Therapeutics Announces FDA Clearance of Investigational New Drug Application for AVZO-103, a Potential Best-in-Class Nectin4/TROP2 Bispecific Antibody-Drug Conjugate (Businesswire) - "Under the IND, the company plans to initiate a Phase 1/2 first-in-human, open-label clinical study later this year. The Phase 1 portion will assess the safety, tolerability, and preliminary clinical activity of AVZO-103 as a single agent and in combination therapy in patients with advanced solid tumors."

IND • New P1/2 trial • Solid Tumor

VelaVigo Announces Exclusive Option Agreement with Avenzo to License a Potential First-in-Class Nectin4/TROP2 Bispecific Antibody-Drug Conjugate (PRNewswire) - "VelaVigo will maintain rights for Greater China and plans to collaborate with Avenzo in global development....Under the terms of the agreement, VelaVigo will receive an upfront fee and potential near-term milestones upon option exercise by Avenzo of up to $50 million. In addition, VelaVigo is eligible to receive future potential development, regulatory, and commercial milestone payments of up to approximately $750 million in total, as well as tiered royalties on sales in Avenzo's territory. An Investigational New Drug application is planned for submission to the U.S. Food and Drug Administration (FDA) and Chinese National Medical Products Administration (NMPA) in 2025."

Licensing / partnership • New trial • Solid Tumor

VBC103: An innovative Trop2/Nectin4 targeted bispecific antibody drug conjugate (ADC) in bladder urothelial carcinoma (UC), triple-negative breast cancer (TNBC) and beyond (AACR 2024) - "The therapeutic potential of targeting Trop2 or Nectin4 has been demonstrated through the approval of Trodelvy™ (Sacituzumab govitecan; SG) and Padcev™ (Enfortumab Vedotin; EV). VBC103 also exhibited excellent developability based on plasma stability and other stress test data, which suggests it a good candidate in future CMC development.In summary, VBC103, with its unique bispecific design and differentiated features in affinity, valency, linker-payload, has shown promising potential as a first-in-class ADC candidate. Discovery studies have revealed favorable efficacy and toxicity profiles, supporting advancing VBC103 into clinical trials."

Late-breaking abstract • Bladder Cancer • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer • NECTIN4 • TACSTD2