On February 24, 2025 Halda Therapeutics, a clinical-stage biotechnology company developing a novel class of cancer therapies called RIPTAC (Regulated Induced Proximity TArgeting Chimeras) therapeutics, reported that the first patient has been dosed in the first-in-human Phase 1/2 clinical trial (NCT06800313) to evaluate the safety and tolerability of HLD-0915 in the treatment of metastatic castration-resistant prostate cancer (mCRPC) (Press release, Halda Therapeutics, FEB 24, 2025, View Source [SID1234650497]).

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"We are very pleased to have initiated the clinical evaluation of HLD-0915 to address the unmet needs of cancer patients with mCRPC," said Christian Schade, President and CEO of Halda Therapeutics. "Initiation of this study marks a significant step in advancing our novel small molecule RIPTAC modality as an important new approach for the treatment of cancer."

The Phase 1/2 open label, multi-center clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of orally administered, single-agent HLD-0915 in mCRPC patients. The study will include an initial Phase 1 dose escalation portion to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion of HLD-0915 as monotherapy and a Phase 2 expansion cohort to further evaluate the efficacy and safety of HLD-0915. The Phase 1/2 clinical study could enroll up to 80 mCRPC patients.

About HLD-0915

HLD-0915 is an innovative bifunctional small molecule therapy designed to selectively target prostate cancer tumors cells by holding together, with defined orientation and purpose, androgen receptor (a tumor-specific intracellular targeting protein) and a protein with essential function (effector protein). The ternary complex drives the formation of new, or neomorphic, protein-protein interactions, abrogating an essential function within cancer cells which results in an antitumor effect. HLD-0915 is designed to drive specific interactions between selected proteins to achieve optimal activity and pharmacology, as demonstrated in Halda’s preclinical studies. In preclinical prostate cancer models, orally delivered HLD-0915 treatment resulted in tumor shrinkage and declines in prostate-specific antigen (PSA), while delivering a favorable therapeutic index including in models of drug resistance.