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Pacylex Pharmaceuticals Discusses its Broad-Spectrum Anti-Cancer Drug Zelenirstat at 2024 BIO International Convention

Zelenirstat inhibits multiple cancer mechanisms underpinning anti-cancer activity in different solid tumor types in a completed Phase 1 study
Key Takeaways
  • Zelenirstat is a first-in-class inhibitor of myristoylation now in two Phase 2a studies for patients who have exhausted standard cancer therapies.
  • In the completed Phase 1, 57% of heavily pre-treated solid tumor cancer patients had stable disease or better for six months or longer, including colorectal, ovarian, and appendiceal cancers.
  • Zelenirstat inhibits myristoylation of multiple oncogenic targets, including mitochondrial energy production, and validated targets EGFR and VEGFR signaling.

Edmonton, Alberta, Canada May 15, 2024. Pacylex Pharmaceuticals Inc. (Pacylex) is a clinical-stage pharmaceutical company developing N-myristoyltransferase (NMT) inhibitors as targeted therapies for the treatment of hematologic cancers and solid tumors. Today Pacylex announced that it will be attending the Biotechnology Innovation Organization (BIO) International Convention taking place June 3-6, 2024, at the San Diego Convention Center, in San Diego, California, USA. The BIO Convention is the premier life sciences networking conference in the world, bringing together leaders, innovators and investors from the pharmaceutical, biotech and medical device industries.

Pacylex’s Chief Executive Officer, Dr. Michael Weickert, will be attending the conference and participating in the BIO One-on-One Partnering™ system. He will be available to review Pacylex’s recent clinical progress with zelenirstat currently being dosed in patients in two Phase 2a studies, in refractory and relapsed B-cell non-Hodgkin’s lymphoma and in advanced refractory colorectal cancer patients, at 4 clinical sites in Canada. He will also share new data describing how zelenirstat works in different cancers by inhibiting the myristoylation required for assembly, translocation, and/or function of validated targets like B-cell receptor, EGFR, and VEGFR. Zelenirstat also blocks Complex I formation in mitochondria of cancer cells which shuts down oxidative phosphorylation, especially critical for metastasis and cancer stem cells. 

“We are learning from laboratory and clinical studies that inhibiting myristoylation appears to be an efficient way to turn off many cancer-critical processes with one switch”, said Dr. Michael Weickert, CEO of Pacylex. “That may explain why Phase 1 zelenirstat patients with heavily pretreated and refractory ovarian, appendiceal, and colorectal cancer had 6 to 15 months of stable disease when treated with our recommended phase 2 dose. “

Registered attendees can discuss investment and licensing opportunities with Dr. Weickert by scheduling a meeting using the BIO One-on-One Partnering™ system. If there are no compatible time slots available, please contact Dr. Weickert directly to schedule a meeting.

For more information:

About zelenirstat (PCLX-001)

Zelenirstat (formerly identified as PCLX-001) is a first-in-class, oral, small molecule NMTi being developed to treat patients with leukemia, lymphoma, and solid tumors. Zelenirstat selectively killed cancer cells in vitro and in animal models has been shown to fully regress hematologic malignancies and inhibit the growth of lung and breast cancer tumors. In AML models, zelenirstat preferentially killed leukemic stem enriched cell populations and reduction of the leukemic burden directly in the bone marrow.

About zelenirstat Phase 1 and 2 studies 

Pacylex completed the dose escalation phase of a Phase 1 multiple ascending dose safety, tolerability, and pharmacokinetics study on zelenirstat in people with relapsed/refractory lymphoma and refractory solid tumors (NCT04836195). A recommended Phase 2 dose was determined. Zelenirstat demonstrated an acceptable safety and tolerability profile, pharmacokinetics consistent with once daily oral dosing, and early signs of efficacy.

Zelenirstat is currently being studied in a Phase 2a open-label study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of zelenirstat in patients with relapsed/refractory B-cell non-Hodgkin Lymphoma (NHL) and a separate Phase 2a cohort in patients with refractory metastatic colorectal cancer that has progressed despite all available standard therapies. 

About Pacylex Pharmaceuticals

Pacylex is a clinical-stage pharmaceutical company headquartered in Edmonton, Alberta, Canada, targeting hematologic and solid cancers with orally bioavailable NMT inhibitors. Zelenirstat is the lead drug in a new class of NMT inhibitors, enabling Pacylex to exploit NMTs as new clinical targets for cancer treatment. Pacylex is conducting two multi-center Phase 2a studies in Canada in patients with relapsed/refractory NHL and refractory metastatic colorectal cancer. The IND for a Phase 1 multiple ascending dose study in acute myeloid leukemia (AML) has been cleared and the FDA has granted zelenirstat both Orphan Drug Designation and Fast Track Designation for AML. The US Department of Defense is supporting the initial clinical investigation of zelenirstat in patients with AML. The Cure Cancer Foundation supported initial clinical studies through its World’s Longest Games. 

For additional information, please visit www.pacylex.com.



Key Takeaways
  • Zelenirstat is a first-in-class inhibitor of myristoylation now in two Phase 2a studies for patients who have exhausted standard cancer therapies.
  • In the completed Phase 1, 57% of heavily pre-treated solid tumor cancer patients had stable disease or better for six months or longer, including colorectal, ovarian, and appendiceal cancers.
  • Zelenirstat inhibits myristoylation of multiple oncogenic targets, including mitochondrial energy production, and validated targets EGFR and VEGFR signaling.
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We are learning from laboratory and clinical studies that inhibiting myristoylation appears to be an efficient way to turn off many cancer-critical...
Dr. Michael Weickert — CEO of Pacylex
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Contacts
Michael Weickert Ph.D
michael.weickert@pacylex.com
650-218-1840
Chief Executive Officer