Lead Program

SPV Therapeutics’ CDK4/6/9 program represents a next-generation approach to cyclin-dependent kinase inhibition designed to address the biological limitations of first-generation CDK4/6 therapies. While selective CDK4/6 inhibitors have demonstrated clinical benefit, their durability is frequently constrained by adaptive resistance mechanisms involving cell-cycle bypass and transcriptional rewiring.

The program integrates balanced inhibition of CDK4, CDK6, and CDK9 to simultaneously regulate G1 cell-cycle progression and transcriptional programs that sustain tumor survival. This multi-node strategy is intended to address resistance pathways that emerge when cell-cycle control alone is insufficient.

Built on enantiopure, precision small-molecule design, the CDK4/6/9 program is orally bioavailable, development-ready, and supported by an established, scalable synthetic process. The program architecture includes backup and follow-on molecules to support continuity and risk mitigation, along with exploration of emerging modalities such as PROTAC-based approaches derived from the same platform.

Preclinical studies indicate activity in both RB-positive and RB-negative cancer models, including aggressive subtypes such as triple-negative breast cancer (TNBC), where first-generation CDK4/6 inhibitors have shown limited activity. Together, these features position the CDK4/6/9 program as a differentiated, next-generation platform designed to deliver more durable cancer control.