Pathos AI Initiates Phase 1b/2a Trial of Pocenbrodib for Metastatic Castration-Resistant Prostate Cancer
Key Insights
Pathos AI has dosed the first patient in a Phase 1b/2a trial evaluating pocenbrodib, a CBP/p300 inhibitor, alone and in combination with established therapies for metastatic castration-resistant prostate cancer.
The multicenter trial will enroll approximately 203 patients who have progressed despite prior therapy, with primary objectives to assess safety, response rates, and determine recommended Phase 2 dosing.
Pocenbrodib targets underlying resistance mechanisms to AR-targeted therapy through CBP/p300 inhibition, addressing a significant unmet need in advanced prostate cancer treatment.
Pathos AISearch company announced today that the first patient has been dosed in its Phase 1b/2a clinical trial evaluating pocenbrodibSearch drug, a CBP/p300Search term inhibitor, for the treatment of metastatic castration-resistant prostate cancerSearch disease (mCRPCSearch disease). The trial will assess pocenbrodib both as monotherapy and in combination with established treatments including abiraterone acetateSearch drug, olaparibSearch drug, or 177Lu-PSMA-617Search drug.
The Chicago-based biotechnology company, which specializes in AI-driven drug development, is advancing pocenbrodibSearch drug as its first clinical-stage asset. The compound targets the CREBBP/EP300Search term proteins that activate genes promoting cancer cell growth and proliferation.
"The clinical promise of pocenbrodibSearch drug, our potential best-in-class CBP/p300Search term inhibitor, lies not only in its remarkable efficacy in resistant prostate cancerSearch disease models, but also in our sophisticated biomarker strategy that identifies patients most likely to benefit," said Dr. Jens Renstrup, Chief Medical Officer at Pathos AISearch company.
Trial Design and Patient Population
The multicenter, open-label, dose-finding study (P300-02-001, NCT06785636View clinical trial) aims to enroll approximately 203 patients with mCRPCSearch disease who have progressed despite prior therapy and have received at least one anti-androgen therapy, such as enzalutamideSearch drug, apalutamideSearch drug, abiraterone acetateSearch drug, or darolutamideSearch drug.
Primary objectives include:
- Assessing safety and tolerability
- Measuring objective response rates
- Evaluating PSA decline
- Determining the recommended Phase 2 dose of pocenbrodib in combination with other therapies
The trial builds upon previously reported data from the COURAGE study (NCT04575766View clinical trial) in metastatic castration-resistant prostate cancerSearch disease, which provided initial evidence of pocenbrodibSearch drug's potential efficacy.
Addressing Unmet Needs in Advanced Prostate Cancer
Metastatic castration-resistant prostate cancerSearch disease represents a significant clinical challenge, as patients often develop resistance to existing therapies. According to the American Cancer Society, prostate cancerSearch disease is the second leading cause of cancer death in American men, with more aggressive forms like mCRPCSearch disease having limited treatment options once resistance develops.
Dr. Renstrup emphasized the significance of their approach: "Our precision medicine approach allows us to target the underlying resistance mechanisms to ARSearch term-targeted therapy through CBP/p300Search term inhibition, addressing a significant area of high unmet need for patients with advanced prostate cancerSearch disease."
AI-Driven Patient Selection
A distinguishing feature of Pathos AISearch company's development strategy is its use of artificial intelligence to optimize patient selection. The company's PathOS™ platform integrates multiomic data with real-world outcomes to identify specific molecular signatures that may predict response to treatment.
"By integrating multiomic data tied to real-world outcomes to identify specific molecular signatures, our PathOS™ platform enables us to select the right patients for treatment, potentially improving outcomes in a disease with limited therapeutic options as resistance develops," Dr. Renstrup explained.
Mechanism of Action
PocenbrodibSearch drug is an oral, small molecule inhibitor designed to block the activity of CREBBP/EP300Search term (CBP/p300Search term) proteins. These proteins play a crucial role in activating genes that drive cancer cell growth and proliferation. By inhibiting these proteins, pocenbrodib impacts the expression of key cancer drivers, including the androgen receptorSearch term (ARSearch term) and its variants.
This mechanism makes pocenbrodibSearch drug potentially relevant not only for advanced prostate cancerSearch disease but also for other cancer indications, either as monotherapy or in combination with other treatments.
About Pathos AI
Pathos AISearch company is a clinical-stage biotechnology company that leverages advanced artificial intelligence to re-engineer drug development, with a particular focus on optimizing patient selection strategies in phase 2 clinical trials. The company partners with pharmaceutical companies to accelerate precision medicine development through AI-driven computational approaches across multimodal real-world data and patient-derived biological models.
The company has raised over $100 million to expand its AI platform and accelerate the development of targeted treatments. This funding supports Pathos AISearch company's mission to bring innovative therapies to patients faster through more efficient clinical development pathways.
As the trial progresses, Pathos AISearch company will continue to leverage its AI capabilities to refine patient selection and potentially improve outcomes for patients with metastatic castration-resistant prostate cancerSearch disease, a disease with significant unmet medical needs.