Pacylex to Meet with Investors at Bio CEO Conference (BCIC) in New York City, February 26-27, 2024.

Pacylex CEO expected to announce updated company and clinical milestones.

Key Takeaways

  • If you are attending BIO CEO & Investors, we would like to talk to you about investing in Pacylex and zelenirstat, a first-in-class oral cancer drug in Phase 2.
  • Zelenirstat has a great safety profile and evidence of benefit in refractory patients with solid and liquid tumors. Activity in vitro is 10x ibrutinib, and zelenirstat is highly synergistic with venetoclax.
  • This capital-efficient company has gotten to Phase 2 on <$20m so this is an excellent opportunity to invest in a significantly derisked FIC oncology pioneer with extraordinary potential.

Edmonton, Alberta – February 23, 2024--Pacylex Pharmaceuticals, a biotechnology company dedicated to developing innovative therapies for cancer and autoimmune diseases, announced that CEO Michael Weickert will attend the upcoming BIO CEO & Investor Conference in NYC and will be meeting with investors regarding the company's Series B funding round. The company's lead candidate, zelenirstat, is a first-in-class, orally bioavailable small molecule myristoylation inhibitor, a new mechanism of action for cancer treatment. Zelenirstat is currently being studied in patients who have failed available treatments (refractory or relapsed; r/r). It is in Phase 2 for patients with r/r B-cell non-Hodgkin lymphoma (NHL) and is about to begin Phase 2a in various r/r solid tumors, especially colorectal cancer, and Phase 1/2 in r/r acute myeloid leukemia (AML). Pacylex recently presented Phase 1 results in gastrointestinal cancers at the ASCO-GI conference in San Francisco in January 2024, including a colorectal patient who had been on therapy for more than 340 days and counting with a reduction in tumor volume and blood cancer marker.

BIO CEO & Investor Conference (BCIC) in New York City, February 26-27, 2024. BCIC is one of the largest investor conferences focused on established and emerging publicly traded and select private biotech companies. The conference brings together institutional investors, industry analysts, and senior biotechnology executives to connect, share insights, and explore promising investment opportunities. Pacylex will be showcasing zelenirstat and seeking partnerships to accelerate the development and commercialization for patients with several different underserved cancers.



About zelenirstat (PCLX-001)

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

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 R/R lymphoma and solid tumor patients (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 potential 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 R/R B-cell non-Hodgkin Lymphoma (NHL). A separate Phase 2a cohort is planned in advanced solid malignancies who have progressed on 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 a multi-center Phase 1/2a study in Canada in patients with R/R NHL and advanced solid tumors. 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. 

Forward-Looking Statements
This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws, such as statements relating to future events or the Company’s future financial and operating performance, as well as the Company’s business plans, growth initiatives, and objectives and prospects. Generally, forward-looking statements and forward-looking information may be identified by the use of forward-looking terminology, including the words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “goal,” “expect,” “strategy,” “future,” “likely,” "proposed,” “scheduled,” “forecast,” “budget,” “could,” “would,” variations of such words of phrases and other similar expressions, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. However, the absence of these words does not mean that a statement is not forward looking. Forward-looking statements and forward-looking information are subject to numerous factors, risks and uncertainties that could cause actual results to differ materially, including, but not limited to, the Company’s ability to successfully execute on its business plans and strategies, avoid delays in planned clinical trials, hire and retain key personnel, obtain appropriate or necessary governmental approvals to market potential products and obtain future funding for product development and working capital on commercially reasonable terms, changes in laws, and  general macroeconomic conditions, including economic slowdowns, recessionary risks, rising inflation and interest rates, and supply chain disruptions. Forward-looking statements and forward-looking information are based on the beliefs of management as well as assumptions made by and information currently available to management as of the date hereof, and none of the Company or its affiliates undertakes any obligation to update or issue revisions to any forward-looking statements or forward-looking information contained herein to reflect any future events or circumstances, except as required by law. The foregoing does not constitute an offer or solicitation to acquire any securities in the Company or any related or associated entity or affiliate. The information contained herein is not intended as legal, tax, financial or investment advice. Furthermore, the information contained herein may not be applicable to or suitable for an individual’s specific circumstances or needs.

Key Takeaways

  • If you are attending BIO CEO & Investors, we would like to talk to you about investing in Pacylex and zelenirstat, a first-in-class oral cancer drug in Phase 2.
  • Zelenirstat has a great safety profile and evidence of benefit in refractory patients with solid and liquid tumors. Activity in vitro is 10x ibrutinib, and zelenirstat is highly synergistic with venetoclax.
  • This capital-efficient company has gotten to Phase 2 on <$20m so this is an excellent opportunity to invest in a significantly derisked FIC oncology pioneer with extraordinary potential.

Quotes

Zelenirstat's impressive performance in Phase 1, combined with its novel mechanism of action and potential for expansion across multiple indication...
Michael J. Weickert, PhDCEO
We are confident that the coming year will see further clinical progress and strategic partnerships, solidifying our position as a leader in precis...
Michael WeickertCEO

Related Bios

Michael J. Weickert, PhD
CEO
Dr. Weickert has been developing drugs at public and private companies for over 30 years. He has been CEO of Fe Pharmaceuticals, illumiSonics, Sonescence, and SEA Medical Systems, CBO of Strategent Life Sciences, Corium, and Therashock, COO of Greenfire Bio and Ohm Oncology, VP of development at SciDose and Auspex, and Senior Program Executive or Manager at Nektar and Ligand. Michael has driven oncology product development including Phase III/NDA for Targretin for Cutaneous T-cell Lymphoma, and business planning for drug delivery versions of the cancer drugs Leuprolide, Paclitaxel and Irinotecan. He obtained Orphan Drug and Fast Track designations for oncology-related products in the US and EU. Prior to joining the pharmaceutical industry, he was at the National Cancer Institute at NIH. He has a PhD in Genetics from the University of Wisconsin, Madison.
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Luc G. Berthiaume, PhD
Chief Scientific Officer
Luc is a professor of cell biology at University of Alberta with 28 years of experience studying protein fatty acylation. He received his PhD from the Université de Sherbrooke and completed his Post-Doctoral Fellowship at the Memorial Sloan-Kettering Cancer Centre. He has more than 40 publications and 3 patents published or pending. Luc is also the founder and president of Eusera, an antibody manufacturing company in Edmonton, AB, which produces and markets many commercially successful antibodies.
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John Mackey, MD
Chief Medical Officer
John is a medical oncologist and Professor of Oncology, University of Alberta, and Chair of the Alberta Pre-Phase I Cancer Program (www.prephaseone.com). As the former Director of Clinical Trials at the Cross Cancer Institute, and the former Executive Director of Translational Research In Oncology (TRIO), a global clinical trial company with its head office in Edmonton, he has experience with clinical trial operations to expedite the clinical evaluation of Pacylex diagnostics and therapeutics.
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Ryan Heit, MSc, MBA
VP Operations
Ryan has a background in research, technology commercialization, business development, and financing early stage companies. Ryan has provided business planning and company development for many early-stage, technology-based ventures in health-related fields in his previous positions as the Director of the Merck Invention Accelerator, with the University of Alberta, TEC Edmonton, and as an independent consultant. He also has nearly a decade of experience in the angel investing space as a Co-Founder and investor in Valhalla Private Capital. He holds a Masters in Experimental Oncology and an MBA from the University of Alberta.
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Contacts

Michael Weickert Ph.D
michael.weickert@pacylex.com
650-218-1840
Chief Executive Officer