Pacylex Pharmaceuticals
Pacylex Pharmaceuticals is a clinical stage biotech company focused on developing first-in-class, oral cancer therapies targeting myristoylation. They are advancing a novel N-myristoyltransferase (NMT) inhibition therapy, zelenirstat, which has shown promising safety, efficacy, and biological activity across multiple cancer types, including solid tumors, lymphoma, and leukemia. The company is actively engaged in clinical trials, seeking partnerships and funding to expand its innovative cancer treatment portfolio.
Industries
Nr. of Employees
small (1-50)
Patents
Products
Clinical‑stage oral N‑myristoylation inhibitor (investigational small molecule)
An orally administered small‑molecule inhibitor of protein myristoylation developed for oncology indications; characterized preclinically for tumor regression in hematologic and solid tumor models and advanced into Phase 1/2a clinical studies.
Clinical‑stage oral N‑myristoylation inhibitor (investigational small molecule)
An orally administered small‑molecule inhibitor of protein myristoylation developed for oncology indications; characterized preclinically for tumor regression in hematologic and solid tumor models and advanced into Phase 1/2a clinical studies.
Services
Design and execution of Phase 1 dose-escalation studies and Phase 2a expansion cohorts for investigational oral oncology agents, including multi-site enrollment, safety monitoring, and PK/PD assessments.
Execution of in vitro, ex vivo and in vivo studies to characterize efficacy, mechanism-of-action, and predictive biomarkers, including development of gene-expression sensitivity signatures.
Preparation and management of regulatory filings and interactions including IND submissions and pursuit of Orphan Drug and accelerated/expedited pathways.
Design and execution of Phase 1 dose-escalation studies and Phase 2a expansion cohorts for investigational oral oncology agents, including multi-site enrollment, safety monitoring, and PK/PD assessments.
Execution of in vitro, ex vivo and in vivo studies to characterize efficacy, mechanism-of-action, and predictive biomarkers, including development of gene-expression sensitivity signatures.
Preparation and management of regulatory filings and interactions including IND submissions and pursuit of Orphan Drug and accelerated/expedited pathways.
Expertise Areas
- Clinical trial management (Phase 1/Phase 2a)
- Targeted small‑molecule oncology drug development
- Biomarker discovery and predictive signatures
- Translational preclinical models and PDX/ex vivo testing
Key Technologies
- Myristoylation (N‑myristoyltransferase) inhibition
- Oral small‑molecule therapeutics
- Gene expression–based sensitivity signatures
- In vitro cytotoxicity and ex vivo patient tissue assays
News & Updates
CEO Michael Weickert will present Phase 1 safety and efficacy results for zelenirstat in AML at the World Orphan Drug Congress USA 2024, highlighting the drug's potential in this serious indication.
The first patient has been dosed in a Phase 2a study of zelenirstat in refractory metastatic colorectal cancer, with promising signs of prolonged stable disease and tumor reduction.
The FDA has granted orphan drug designation to PCLX-001, a first-in-class NMT inhibitor, for AML, supporting its potential as a targeted therapy for this aggressive cancer.
The FDA has cleared the IND application for PCLX-001, enabling Phase 1/2 clinical trials in AML at The University of Texas MD Anderson Cancer Center.
Series A funding from Greenfire Bio will support initial clinical trials of PCLX-001 in lymphoma and solid tumors, marking a key milestone in the company's development.
CEO Michael Weickert was featured in The Silicon Review as a top healthcare innovator, highlighting Pacylex's groundbreaking approach to cancer therapy.
CEO Michael Weickert will present Phase 1 safety and efficacy results for zelenirstat in AML at the World Orphan Drug Congress USA 2024, highlighting the drug's potential in this serious indication.
The first patient has been dosed in a Phase 2a study of zelenirstat in refractory metastatic colorectal cancer, with promising signs of prolonged stable disease and tumor reduction.
The FDA has granted orphan drug designation to PCLX-001, a first-in-class NMT inhibitor, for AML, supporting its potential as a targeted therapy for this aggressive cancer.
The FDA has cleared the IND application for PCLX-001, enabling Phase 1/2 clinical trials in AML at The University of Texas MD Anderson Cancer Center.
Series A funding from Greenfire Bio will support initial clinical trials of PCLX-001 in lymphoma and solid tumors, marking a key milestone in the company's development.
CEO Michael Weickert was featured in The Silicon Review as a top healthcare innovator, highlighting Pacylex's groundbreaking approach to cancer therapy.