PCS11T

Providing Patients with an Improved Alternative to Irinotecan

PCS11T Targets Various Types of Cancer

Processa Pharmaceuticals is developing PCS11T as a novel prodrug alternative to irinotecan, a second-line therapy for many types of cancer (e.g., metastatic colorectal, small cell lung, and pancreatic). Irinotecan is widely recognized as a potent anti-cancer agent, but it comes with significant drawbacks, including a narrow therapeutic window and severe, dose-limiting side effects like bone marrow suppression and severe diarrhea. PCS11T combines SN-38, the active, anti-cancer moiety in irinotecan, with an additional moiety that slows the release of SN-38 and allows it to preferentially accumulate in tumor cells, capturing them in their vulnerable S phase for eradication.

License Agreement

In May 2020, we entered into an exclusive License Agreement with Aposense, Ltd. (Aposense) in which we acquired a contingent license in Aposense's patent rights and know-how to develop and commercialize PCS11T. The license was conditioned on approval from the Israel Innovation Authority, and successful up-listing to Nasdaq—conditions that have been met.

A Novel Anti-cancer Pro-drug of SN-38

Clinical Development

Previous History

Previous History

In preclinical studies, PCS11T eradicated tumors at much lower doses than irinotecan across various tumor xenograft models. In vitro studies show that PCS11T did not affect acetylcholine esterase (AChE) activity in human or rat plasma, suggesting PCS11T presents fewer of the dose-limiting cholinergic side effects seen with irinotecan.

Current Status & Clinical Trials

Current Status & Clinical Trials

We plan to begin a Phase 1B study of PCS11T in solid tumor cancer patients in 2022, after completing the required toxicology studies.

Benefits of PCS11T

PCS11T uses the same tumor-fighting moieties as existing therapies but with more stable drug levels and fewer side effects.

  • A next-generation irinotecan cancer drug.
  • A pro-drug of SN-38, the active molecule that accumulates in the membrane of tumor cells and the tumor core.
  • Targets cancers where irinotecan is widely used (e.g., small cell lung, metastatic colorectal, and pancreatic).
  • Has an efficacy advantage over irinotecan as demonstrated by tumor eradication at much lower doses than irinotecan across various tumor xenograft models.
  • Pre-IND FDA meeting completed with agreement on IND requirements.

Market Landscape

$1 Billion Market Opportunity With Room to Grow

Despite the severe adverse effects of irinotecan therapy, including bone marrow suppression and severe diarrhea, irinotecan remains a second-line therapy for several cancers. Annual sales of irinotecan sales peaked at over $1 billion. PCS11T is a promising new therapy that aims to make irinotecan's potent cancer-fighting agents more stable, targeted, and well-tolerated by patients.

More than $1,000,000,000

Peak annual sales of commercially marketed irinotecan products for the treatment of metastatic colorectal cancer and other cancers prior to generics.1

Publications

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  • Overview
    • Bailly C. Irinotecan: 25 years of cancer treatment. Pharmacol Res. 2019;148:104398. doi:10.1016/j.phrs.2019.104398
    • Kciuk M, Marciniak B, Kontek R. Irinotecan-Still an Important Player in Cancer Chemotherapy: A Comprehensive Overview. Int J Mol Sci. 2020;21(14):4919. Published 2020 Jul 12. doi:10.3390/ijms21144919
    • Palakurthi S. Challenges in SN38 drug delivery: current success and future directions. Expert Opin Drug Deliv. 2015;12(12):1911-1921. doi:10.1517/17425247.2015.1070142
    • Stein A, Voigt W, Jordan K. Chemotherapy-induced diarrhea: pathophysiology, frequency and guideline-based management. Ther Adv Med Oncol. 2010;2(1):51-63. doi:10.1177/1758834009355164