Edmonton, Alberta, Canada/May 18, 2023- Pacylex Pharmaceuticals, a clinical-stage company developing PCLX-001, a first-in-class oral investigational small molecule for leukemia, lymphoma, and solid tumor cancers, today announced the first patient has been dosed in a Phase 2a expansion study in patients with relapsed/refractory B-cell Non-Hodgkin Lymphoma (R/R NHL).

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Key Takeaways:

• The first patient has been dosed with PCLX-001 monotherapy, a first-in-class, oral small molecule N-myristoyltransferase (NMT) inhibitor, in a Phase 2a expansion study.
• The expansion study will enroll up to 20 patients to assess the preliminary clinical activity of PCLX-001.
• The maximum tolerated dose has not yet been reached in the ongoing multiple ascending dose study, therefore dose escalation of PCLX-001 will continue in patients with advanced solid tumors.

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About PCLX-001PCLX-001 is a first-in-class, oral, small molecule N-myristoyltransferase (NMT) inhibitor being developed to treat patients with leukemia and lymphoma. PCLX-001 selectively kills cancer cells in vitro and have been shown to regress hematologic malignancies and inhibit the growth of lung and breast cancer tumors in animal models. PCLX-001 appears to be particularly effective against Acute Myeloid Leukemia (AML) stem cells in animal disease models. The Phase 1/2a study (NCT04836195) is an open-label study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of PCLX-001 in patients with R/R NHL and advanced solid malignancies who have progressed on all available standard therapies.

About Pacylex PharmaceuticalsPacylex is a clinical-stage pharmaceutical company headquartered in Edmonton, Alberta, Canada, targeting hematologic and solid cancers with a first-in-class, oral, once daily investigational therapeutic, PCLX-001. Pacylex has a US Subsidiary in the San Francisco Bay area. 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 is conducting a multi-center Phase 1 multiple ascending dose study in Canada in patients with R/R NHL and advanced solid tumors, and a Phase 2a dose expansion in patients with R/R NHL. The US Department of Defense is supporting the initial clinical investigation of PCLX-001 in patients with AML. The FDA has granted PCLX-001 both Orphan Drug Designation and Fast Track Designation for AML. Pacylex received 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.

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

Contacts:Pacylex Pharmaceuticals: 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, #NH

Contacts:

Michael Weickert Ph.D

650-218-1840

[email protected]

Source: Pacylex

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