Edmonton, Alberta, Canada, November 2, 2022 Pacylex, a clinical-stage NMT inhibitor company developing first-in-class therapies for leukemia, lymphoma, and solid tumor cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PCLX-001 for the treatment of acute myeloid leukemia (AML). The open IND enables a Phase 1/2 clinical study to start in the coming months at The University of Texas MD Anderson Cancer Center, which was recently awarded a US Department of Defense (DOD) grant for this purpose.

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Key Takeaways:

• Pacylex seeks to improve treatment outcomes in leukemia and lymphoma patients with PCLX-001, a first-in-class N-myristoyltransferase (NMT) inhibitor which inhibits myristoylation in cancer cells where this process is fundamental for cancer cell proliferation and survival.
• Pacylex plans to start its second clinical program in AML; PCLX-001 is currently in clinical studies at 4 hospitals in Canada in Non-Hodgkin Lymphoma and solid tumor patients.
• The company received FDA Orphan Drug Designation for PCLX-001 in AML and will launch its Phase 1 study in the next quarter.

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PCLX-001

PCLX-001 (aka DDD86481) is a first-in-class, small molecule NMT inhibitor originally developed by the University of Dundee Drug Discovery Unit as part of a program to treat African sleeping sickness, funded by Welcome Trust. Pacylex is developing PCLX-001 in the form of a once-a-day pill initially to treat leukemia and lymphoma. PCLX-001 has also been shown to inhibit the growth of lung and breast cancer tumors in animal models. In leukemia, lymphoma and breast cancer patients, the levels of NMT2 are correlated with survival, suggesting an important biological role in these cancers.

About Pacylex

Pacylex is a pharmaceutical company headquartered in Edmonton, Alberta, Canada, targeting hematologic and solid cancers with a new first-in-class therapeutic, PCLX-001. Pacylex's technology combines new insights from Dr. Luc Berthiaume of the University of Alberta connecting myristoylation to cancer with a family of high quality myristoylation inhibitors Pacylex licensed from the University of Dundee. PCLX-001 is the lead drug in a new class of NMT inhibitors, enabling Pacylex to exploit NMTs as new clinical targets for cancer treatment. Pacylex initiated clinical studies in Canada in the fall of 2021 in non-Hodgkin lymphoma and solid tumors. Pacylex is also receiving support from an Alberta Innovates AICE grant in 2020, and the research leading to this breakthrough was supported in part by the Alberta Cancer Foundation and the Cure Cancer Foundation. The US Department of Defense is supporting the initial clinical investigation of PCLX-001 in AML patients.

For more information:Pacylex Pharmaceuticals Contact: Michael J. WeickertCEO, Pacylex Pharmaceuticals, Inc.E: [email protected]P: 650-218-1840Twitter @Pacylex (https://twitter.com/pacylex) LinkedIn (www.linkedin.com/company/pacylex-pharma)Facebook (https://www.facebook.com/pacylex)Reportable page: (https://pacylex.reportablenews.com/)#cancer, #lymphoma, #leukemia, #albertacancer, #Pacylex, #PCLX001, #UAlberta; #UAlberta_FoMD; #Worldslongestgame, #ASH22, #MDACC, #AML

Contacts:

Michael Weickert Ph.D

650-218-1840

[email protected]

Source: Pacylex

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