Processa Pharmaceuticals Announces Presentation and Publication of Three Abstracts at 2025 ASCO Annual Meeting

Rhea-AI Summary

Processa Pharmaceuticals announced the acceptance of three abstracts for presentation at the 2025 ASCO Annual Meeting. The presentations focus on their Next Generation Cancer drug candidates PCS6422 and PCS11T. The main presentation features their Phase 2 adaptive design trial of PCS6422 (eniluracil) combined with capecitabine for advanced/metastatic breast cancer. Two additional online-only abstracts cover: (1) Phase 1b trial results defining MTD and RP2DR for NGC-Cap, showing improved safety and anti-tumor activity, and (2) preclinical Project Optimus dose escalation study of PCS11T, a tumor-targeted SN-38 pro-drug designed to increase tumor drug concentration while reducing systemic toxicity.

Insights

Oncology Clinical Trial Specialist

Processa's ASCO abstracts demonstrate clinical progress with their next-gen cancer therapies, showing encouraging early safety and efficacy signals.

Processa Pharmaceuticals has secured three abstract spots at the prestigious 2025 ASCO Annual Meeting, signaling meaningful progress in their oncology pipeline. Their lead program, PCS6422 (eniluracil) combined with capecitabine (NGC-Cap), has advanced to Phase 2 testing in metastatic breast cancer following successful Phase 1b results. The Phase 1b data established both the Maximum Tolerated Dose and Recommended Phase 2 Dose Range, with the abstract highlighting improved safety and anti-tumor activity compared to standard capecitabine.

The company is employing an adaptive design for their Phase 2 trial, which represents a sophisticated approach allowing for dose optimization during the study rather than using a fixed protocol. This flexible methodology, combined with their stated personalized medicine approach, suggests they're working to identify patient subgroups who may respond particularly well to treatment – a critical factor in oncology drug development success.

Their second candidate, PCS11T (NGC-Iri), shows thoughtful development aligned with FDA's Project Optimus initiative, which emphasizes finding optimal therapeutic dosing rather than simply the maximum tolerated dose. The compound functions as a tumor-targeted pro-drug of SN-38 (the active metabolite of irinotecan), designed to concentrate drug delivery at tumor sites while reducing systemic exposure and toxicity – a mechanism that addresses key limitations of current chemotherapeutics.

The presentations reflect Processa's strategic focus on improving existing chemotherapy agents through novel delivery approaches and combinations, rather than pursuing entirely new molecular targets.

HANOVER, Md., May 30, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage pharmaceutical company focused on developing the next generation cancer therapies with improved efficacy and safety, today announced the acceptance of three abstracts for the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 to June 3, 2025, at McCormick Place in Chicago, Illinois. The abstracts highlight Processa’s pipeline of Next Generation Cancer (NGC) drug candidates, including PCS6422 (NGC-Cap) and PCS11T (NGC-Iri), showcasing both preclinical and clinical advances.

Trials in Progress Poster Presentation and Abstract Publication

• Abstract Title: Adaptive Designed Eniluracil + Capecitabine Phase 2 Trial in Advanced or Metastatic Breast Cancer Patients
• Abstract Number: TPS1133 | Poster Board Number: 105b
• Session Title: Breast Cancer—Metastatic
• Date & Time: June 2, 2025 | 9:00 AM–12:00 PM CDT
  Dr. David Young, Founder and President of Research & Development at Processa, will be presenting an overview of Processa’s ongoing Phase 2 adaptive design trial evaluating the safety and efficacy of PCS6422 (eniluracil) combined with capecitabine in patients with advanced or metastatic breast cancer. The study explores optimal dosing regimens and a personalized medicine approach to improve outcomes and tolerability.

Abstract Publications

1.   Abstract Title: Safety and Efficacy of Eniluracil + Capecitabine (6422 + Cap) in Phase 1b Trial

Abstract Number: e15152

This online-only abstract provides data from the Phase 1b study that defined the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose Range (RP2DR) for NGC-Cap (eniluracil + capecitabine or 6422 + Cap), highlighting its improved safety profile and anti-tumor activity compared to standard capecitabine.

2.   Abstract Title: Preclinical Project Optimus Dose Escalation of SN-38 Pro-Drug PCS11T

Abstract Number: e15023

This online-only abstract outlines a Project Optimus-aligned approach to define the optimal therapeutic window of PCS11T, a tumor-targeted pro-drug of SN-38. PCS11T is designed to increase drug concentration in tumors while reducing systemic toxicity.

“These ASCO presentations and publications reflect the breadth of our oncology pipeline and the progress we’re making across multiple programs,” said Dr. David Young. “From our Phase 2 clinical program in metastatic breast cancer to preclinical innovations with PCS11T, we are leveraging our Regulatory Science Approach and deep oncology expertise to address critical unmet needs.”

About Processa Pharmaceuticals, Inc.

Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path.

For more information, visit our website at www.processapharma.com.

Forward-Looking Statements

This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements.

Company Contact:
Patrick Lin
(925) 683-3218
plin@processapharma.com

Investor Relations:
Dave Gentry
RedChip Companies, Inc.
1-407-644-4256
PCSA@redchip.com

FAQ

What will Processa Pharmaceuticals present at ASCO 2025?

Processa will present three abstracts: a Phase 2 trial of PCS6422 with capecitabine for metastatic breast cancer, Phase 1b results of NGC-Cap, and preclinical data on PCS11T dose escalation.

What is PCS6422 and how is it being studied by PCSA?

PCS6422 (eniluracil) is being studied in combination with capecitabine in a Phase 2 adaptive design trial for advanced or metastatic breast cancer patients, focusing on optimal dosing and personalized medicine approaches.

What are the key findings from Processa's Phase 1b trial of NGC-Cap?

The Phase 1b trial established the Maximum Tolerated Dose and Recommended Phase 2 Dose Range for NGC-Cap, demonstrating improved safety profile and anti-tumor activity compared to standard capecitabine.

What is PCS11T and what are its potential advantages?

PCS11T is a tumor-targeted pro-drug of SN-38 designed to increase drug concentration in tumors while reducing systemic toxicity, currently being studied in preclinical Project Optimus dose escalation studies.

When and where will Processa's ASCO 2025 presentation take place?

The poster presentation will take place on June 2, 2025, from 9:00 AM to 12:00 PM CDT at McCormick Place in Chicago, during the Breast Cancer-Metastatic session.