March 20, 2025


CHICAGO, Mar. 20, 2025 (GLOBE NEWSWIRE) — Pathos AI, (www.pathos.com), a clinical-stage biotechnology company focused on re-engineering drug development through artificial intelligence, announced the first patient has been dosed in the Company’s Phase 1b/2a clinical trial evaluating pocenbrodib, a CBP/p300 inhibitor, alone and in combination with abiraterone acetate, olaparib or 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC), (P300-02-001, NCT06785636). Pocenbrodib is Pathos’ first clinical-stage asset in its pipeline.


“The clinical promise of pocenbrodib, our potential best-in-class CBP/p300 inhibitor, lies not only in its remarkable efficacy in resistant prostate cancer models, but also in our sophisticated biomarker strategy that identifies patients most likely to benefit,” said Dr. Jens Renstrup, Chief Medical Officer. “Our precision medicine approach allows us to target the underlying resistance mechanisms to AR-targeted therapy through CBP/p300 inhibition, addressing a significant area of high unmet need for patients with advanced prostate cancer. By integrating multiomic data tied to real-world outcomes to identify specific molecular signatures, our PathOSTM platform enables us to select the right patients for treatment, potentially improving outcomes in a disease with limited therapeutic options as resistance develops. This study builds on the previously reported data from COURAGE study (NCT04575766) in metastatic castration-resistant prostate cancer and reinforces our confidence in pocenbrodib’s potential to improve outcomes for these patients.”


Study P300-02-001 is a multicenter, open-label, dose-finding Phase 1b/2a clinical trial to confirm the safety, pharmacokinetics (PK), preliminary antitumor activity, and pharmacodynamics (PD) of pocenbrodib alone or in combination with abiraterone acetate, olaparib or 177Lu-PSMA-617, in adults with metastatic castration-resistant prostate cancer (mCRPC). The study is expected to enroll approximately 203 patients with mCRPC who have progressed despite prior therapy and have been treated with at least one anti-androgen therapy (enzalutamide, apalutamide, abiraterone acetate, or darolutamide). The primary objectives of the study are to assess the safety, objective response rate, and PSA decline of pocenbrodib alone and in combination with abiraterone acetate, olaparib or 177Lu-PSMA-617, and to define a preliminary recommended Phase 2 dose (RP2D) of pocenbrodib in combination with abiraterone acetate, olaparib or 177Lu-PSMA-617.



About Pocenbrodib


Pocenbrodib is an oral, small molecule inhibitor that has the potential to provide clinical benefit for patients with advanced prostate cancer, either alone or in combination with other treatments. Pocenbrodib works by inhibiting CREBBP/EP300 (also known as CBP/p300), which are proteins that activate genes that promote cancer cell growth and proliferation. Inhibiting these proteins impacts the expression of key cancer drivers, including the androgen receptor (AR) and its variants, making pocenbrodib relevant not only to advanced prostate cancer, but also to other cancer indications, either alone or in combination with other treatments.



About Pathos AI

Pathos is a clinical-stage biotechnology company powered by advanced AI that is re-engineering drug development by optimizing patient selection strategies in phase 2 clinical trials. Through partnerships with pharmaceutical companies, Pathos leverages AI-driven computational approaches across multimodal real-world data and patient-derived biological models to accelerate precision medicine development. Pathos has raised over $100 million to expand its AI platform and bring targeted treatments to patients faster. Additional information can be found at www.pathos.com.

contacts

Business Development: bd@pathos.com

Press Inquiries: press@pathos.com

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October 23, 2026
Tempus to build a de-identified dataset from hundreds of thousands of patients with neurological conditions; Pathos to license the dataset under a five-year, $55 million agreement Pathos’s AI expertise and agentic AI platform, Foundry, combined with Bristol Myers Squibb’s (BMS) neuroscience drug development expertise to be applied to understanding disease progression and advancing new therapies BMS leads Pathos’s Series E financing and gains non-exclusive strategic access to Pathos’s AI platform, Pathos Foundry, across its broader portfolio, along with three-year exclusive rights to support its neuroscience development programs NEW YORK, October 23, 2026 — Pathos AI, a clinical-stage AI and technology company advancing its own therapeutic pipeline, today announced multi-year strategic collaborations with Bristol Myers Squibb (NYSE: BMY, “BMS”) and Tempus AI, Inc. (NASDAQ: TEM, “Tempus”) to build a specialized, curated dataset and agentic AI capabilities for Alzheimer’s disease and other neurological conditions. BMS also leads Pathos’s Series E financing and gains access to Pathos Foundry across its broader R&D portfolio. Tempus will apply the infrastructure and expertise it has built in oncology to create a comprehensive, de-identified, longitudinal dataset from hundreds of thousands of patients with neurological conditions, designed to track outcomes over time and accelerate biological insight. Pathos will license the data from Tempus under a five-year, $55 million agreement. Pathos will apply its AI platform, Pathos Foundry, to interrogate the dataset at scale, generate and test hypotheses on disease biology, and inform the design of more targeted, adaptive clinical trials. Pathos built and validated this approach in oncology, where it guides decisions across the company’s clinical-stage pipeline, including adapting trial design in real time to improve its projected probability of success. The collaboration builds on BMS's broader strategy to combine advanced AI with deep scientific and disease-area expertise to make faster, higher-confidence decisions that drive innovation for patients. BMS is helping expand the application of Pathos Foundry into neuroscience, securing three-year exclusive rights in an area where the company brings deep research, clinical-development expertise and a growing portfolio of programs in Alzheimer’s disease and other neurological conditions. Through multi-year access to the platform across its broader portfolio and the specialized dataset developed through the definitive agreements, BMS aims to generate deeper insights into disease progression, identify patients most likely to benefit from potential therapies and design more precise clinical trials. “Neurological diseases demand more than any one company can bring on its own: the best longitudinal data, AI that can reason over it at scale, and the drug development expertise to turn insight into medicines,” said Iker Huerga, CEO of Pathos AI. “Intelligence alone does not bring a therapy to market. These collaborations bring all three together. We are thrilled to deepen our work with Tempus and proud to have BMS leading our Series E as we build a self-learning drug development system designed to adapt clinical trials and improve the likelihood of success.” “AI has the greatest potential when it is grounded in high-quality data and applied by scientists with deep understanding of diseases and drug development,” said Simon Davies, SVP, Head of Data and Quantitative Sciences, Bristol Myers Squibb. “Our investment in Pathos reflects our commitment to applying advanced AI and data science across research and development to accelerate innovation for patients. By combining AI-driven insights with our neuroscience expertise, we hope to deepen our understanding of disease progression, improve clinical-trial design and ultimately advance new treatment options. Collaborating with Pathos and Tempus allows us to interrogate Alzheimer’s and other neurological diseases at scale, strengthening our pipeline and advancing precision medicine for patients in need.” “Making meaningful progress against a disease as devastating as Alzheimer’s requires unprecedented data scale and computing power,” said Eric Lefkofsky, Founder and CEO of Tempus. “These collaborations unite BMS’s deep expertise, Pathos’s drug development agentic AI and Tempus’ data infrastructure. Together, we have a unique opportunity to uncover novel insights and accelerate much-needed treatments for Alzheimer’s patients.” About Pathos AI Pathos AI is an AI and technology company developing drugs. The company redesigns drug development from first principles: identifying clinical assets, making portfolio decisions with continuously updated probability-of-success calculations, and guiding clinical trials with AI-native monitoring. Pathos’s pipeline includes clinical-stage programs in metastatic castration-resistant prostate cancer, multiple myeloma, MET-altered non-small-cell lung cancer, ER+/HER2‐ breast cancer, and TROP2/HER3-expressing solid tumors. The company is based in New York City. For more information, visit pathos.com .
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