NEW YORK – Ideaya Biosciences on Monday said it is advancing a B7H3/PTK7 topo-I-payload bispecific antibody-drug conjugate, dubbed IDE034.
The drug came to South San Francisco, California-based Ideaya under an exclusive worldwide option and license agreement signed with Biocytogen earlier this year for its preclinical B7H3/PTK7 bispecific program. The firms have now nominated a development candidate within the program, IDE034 (BCG034), to move into clinical studies.
Under the terms of the agreement, Biocytogen will receive upfront, option exercise, and milestone payments from Ideaya totaling $406.5 million and is eligible to receive up to an additional $100 million in development and regulatory milestone payments. Ideaya plans to submit an investigational new drug application for IDE034 in 2025.
B7H3 is an immune checkpoint protein that can play a stimulatory or inhibitory role on the immune system, and PTK7 is a transmembrane receptor involved in tissue homeostasis. B7H3 and PTK7 are co-expressed in several tumor types, including in 30 percent of lung cancers, 46 percent of colorectal cancers, and 27 percent of head and neck cancers in the Human Protein Atlas database, according to Ideaya.
"We are excited to nominate our sixth development candidate in IDE034, and this program achieves several strategic objectives for Ideaya, including the potential for monotherapy activity, application in multiple priority solid tumor types of lung and colorectal cancer, and the ability to enable wholly owned rational combinations with our internal pipeline," Ideaya CEO Yujiro Hata said in a statement, adding that IDE034 has the potential to be combined with its PARG inhibitor IDE161.
The firm is also developing the PKC inhibitor darovasertib in tumors with GNAQ or GNA11 mutations, the MAT2A inhibitor IDE397 in MTAP-null tumors, the PARG inhibitor IDE161 in tumors harboring homologous recombination deficiencies, and a Werner helicase inhibitor IDE275 in microsatellite instability-high tumors.