Halda Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial Evaluating HLD-0915 in Metastatic Castration-Resistant Prostate Cancer

First-in-human clinical trial to evaluate safety and tolerability of a new class of small molecule medicines for the treatment of cancer, RIPTAC™ therapeutics

NEW HAVEN, Conn.--(BUSINESS WIRE)--Halda Therapeutics, a clinical-stage biotechnology company developing a novel class of cancer therapies called RIPTAC™ (Regulated Induced Proximity TArgeting Chimeras) therapeutics, today announced 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).

“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.

About Halda Therapeutics

Halda Therapeutics is a clinical-stage biotechnology company that has developed a proprietary RIPTAC™ (Regulated Induced Proximity TArgeting Chimeras) modality that works by a novel “hold and kill” mechanism for the precision treatment of cancer. The novel mechanism of action of RIPTAC therapeutics is uniquely designed to address cancer’s ability to evolve bypass mechanisms of resistance, a common limitation of today’s precision oncology medicines. In addition to its lead clinical program in prostate cancer, Halda is developing additional RIPTAC pipeline programs for major solid tumor types and is exploring other therapeutic programs to treat serious disease. For more information, please visit www.haldatx.com and follow us on LinkedIn.