Processa Pharmaceuticals announces acceptance of three abstracts for ASCO 2025, showcasing advancements in cancer therapies.
Quiver AI Summary
Processa Pharmaceuticals, Inc., a clinical-stage company specializing in next-generation cancer therapies, announced the acceptance of three abstracts for presentation at the 2025 American Society of Clinical Oncology Annual Meeting from May 30 to June 3 in Chicago. The abstracts focus on the company’s drug candidates, including PCS6422 (eniluracil combined with capecitabine) and PCS11T, detailing preclinical and clinical advancements. Notably, Dr. David Young will present findings from a Phase 2 trial evaluating the safety and efficacy of the eniluracil combination in metastatic breast cancer patients. Additional publications include data on the safety and efficacy of eniluracil plus capecitabine and a preclinical approach for PCS11T aimed at optimizing therapeutic dosing while minimizing toxicity. Dr. Young emphasized the importance of these presentations in showcasing Processa's oncology pipeline and their commitment to improving cancer treatment outcomes.
Potential Positives
- Three abstracts were accepted for presentation at the prestigious 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting Processa's commitment to advancing cancer therapy research.
- The abstracts showcase significant data regarding the safety and efficacy of Processa's drug candidates, including the adaptive design trial of PCS6422 combined with capecitabine, indicating ongoing innovation in their clinical pipeline.
- Results from the Phase 1b study demonstrate an improved safety profile and anti-tumor activity for NGC-Cap compared to standard capecitabine, suggesting potential benefits for patients.
- The inclusion of preclinical work on the tumor-targeted pro-drug PCS11T emphasizes Processa's comprehensive approach towards developing next-generation cancer drugs focused on optimizing treatment efficacy and minimizing toxicity.
Potential Negatives
- There is a reliance on forward-looking statements, indicating potential risks and uncertainties that could impact future performance and undermine investor confidence.
- Despite showcasing abstracts and trials, the company does not provide detailed results from the Phase 1b trial, which may lead to skepticism regarding their claims about safety and efficacy.
- The focus on modified existing therapies raises questions about the originality and competitive edge of their drug candidates in a rapidly evolving market.
FAQ
What abstracts did Processa Pharmaceuticals present at ASCO 2025?
Processa presented three abstracts highlighting the efficacy and safety of their NGC drug candidates, PCS6422 and PCS11T.
When and where is the ASCO Annual Meeting 2025?
The ASCO Annual Meeting 2025 takes place from May 30 to June 3, 2025, in Chicago, Illinois.
Who is presenting at the ASCO meeting for Processa?
Dr. David Young, the Founder and President of Research & Development at Processa, will be presenting at the meeting.
What is the focus of the Phase 2 trial for PCS6422?
The trial focuses on the safety and efficacy of PCS6422 combined with capecitabine in advanced or metastatic breast cancer patients.
What is the goal of Processa's NGC drug development?
Processa aims to develop Next Generation Cancer drugs with improved safety and efficacy, addressing critical unmet needs in oncology.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$PCSA Insider Trading Activity
$PCSA insiders have traded $PCSA stock on the open market 4 times in the past 6 months. Of those trades, 4 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $PCSA stock by insiders over the last 6 months:
- DAVID YOUNG (Pres. Research & Development) purchased 124,500 shares for an estimated $99,288
- GEORGE K NG (Chief Executive Officer) purchased 87,200 shares for an estimated $69,542
- PATRICK LIN (Chief Business - Strategy Off) purchased 43,500 shares for an estimated $34,691
- JUSTIN W YORKE purchased 12,400 shares for an estimated $9,889
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$PCSA Hedge Fund Activity
We have seen 5 institutional investors add shares of $PCSA stock to their portfolio, and 4 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- ARMISTICE CAPITAL, LLC added 56,000 shares (+inf%) to their portfolio in Q1 2025, for an estimated $20,720
- VIRTU FINANCIAL LLC added 43,229 shares (+inf%) to their portfolio in Q1 2025, for an estimated $15,994
- HRT FINANCIAL LP removed 31,971 shares (-100.0%) from their portfolio in Q1 2025, for an estimated $11,829
- GEODE CAPITAL MANAGEMENT, LLC added 12,431 shares (+56.6%) to their portfolio in Q1 2025, for an estimated $4,599
- UBS GROUP AG removed 7,852 shares (-99.3%) from their portfolio in Q1 2025, for an estimated $2,905
- ALLWORTH FINANCIAL LP removed 85 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $75
- BANK OF AMERICA CORP /DE/ added 12 shares (+48.0%) to their portfolio in Q1 2025, for an estimated $4
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
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
[email protected]
Investor Relations:
Dave Gentry
RedChip Companies, Inc.
1-407-644-4256
[email protected]
