Edmonton, Alberta, Canada September 27, 2024. Pacylex Pharmaceuticals Inc. (Pacylex) is a clinical-stage pharmaceutical company developing small-molecule N-myristoyltransferase inhibitors (NMTis) as targeted therapies for the treatment of hematologic cancers and as payloads for antibody drug conjugates (ADCs) for solid tumors treatment. Today, Pacylex Pharmaceuticals announced that it has been recognized as BioAlberta’s company of the year. The 2024 Achievement Awards are in recognition of the outstanding contributions of the individuals and companies whose innovation and achievements have contributed to the growing success of Alberta's life sciences sector. The awards were presented in Calgary on September 26th at BioAlberta’s Annual Health and Life Sciences Showcase & Awards Ceremony. The Company of the Year award acknowledges a company that has shown significant achievement within the marketplace and Alberta’s business community through strong performance or a leadership role.
Accepting this award, Co-founder and CSO, Dr. Luc Berthiaume said “Pacylex Pharmaceuticals has been nurtured by the Alberta investor and philanthropy community and their support allowed us to reach this threshold of beginning to help patients and being recognized as BioAlberta‘s 2024 Company of the Year. We are grateful for that support and as we move our clinical program beyond Canada, we will bring the fruits of our Alberta life sciences ecosystem to cancer patients across the world."
"We are excited to recognize Pacylex, a long-time member of BioAlberta, as BioAlberta's Company of the Year for 2024.” Said BioAlberta. “Pacylex is a true Alberta success story. They have proven that an Edmonton company, powered by talent from the University of Alberta, supported by the Alberta investment community, can grow and succeed in Alberta. The best part is that they aren't finished yet, and we look forward to their future success".
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For more information:
Pacylex Pharmaceuticals Contact: Michael J. Weickert
CEO, Pacylex Pharmaceuticals, Inc.
E: michael.weickert@pacylex.com
P: 650-218-1840
Twitter @Pacylex (https://twitter.com/pacylex)
LinkedIn (www.linkedin.com/company/pacylex-pharma)
Facebook (https://www.facebook.com/pacylex)
About zelenirstat (aka PCLX-001 or DDD86481)
Zelenirstat (formerly identified as PCLX-001 or DDD86481) is a first-in-class, oral, small-molecule NMTi being developed to treat patients with leukemia, lymphoma, and for the treatment of solid tumors when used as a payload for ADCs. Zelenirstat selectively kills cancer cells in vitro and has been shown to regress hematologic malignancies and inhibit the growth of lung and breast cancer tumors in animal models.
Pacylex completed and published a
Phase 1 multiple ascending dose safety, tolerability, and pharmacokinetics study on zelenirstat in patients with relapsed/refractory lymphoma and refractory solid tumors (
NCT04836195). 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 in patients with relapsed/refractory B-cell non-Hodgkin Lymphoma (NHL) and in a separate Phase 1 / 2 study in AML patients is about to start.
About NMTis as ADC payloads
The effect of NMTis on cancer cells is pleiotropic. Across multiple cancer types, NMTis interfere with pathways essential to proliferation and survival including: Receptor tyrosine kinases (e.g. EGFR and VEGFR)/SFK pathways, Wnt pathway, PI3K/AKT/mTOR signaling pathway, Notch signaling, TLR4 inflammatory responses, B-cell and T-cell receptor signaling pathway, Flt3/c-Kit signaling, ferroptosis, ER-Golgi trafficking via ADP-ribosylation factors (Arfs), AMPK signaling, autophagy and mitochondrial respiratory complex 1 assembly and function. NMTis induce ER stress and apoptosis in cancer cells. The preferential toxicity of NMTis towards cancer cells makes them an exciting new class of ADC payload. In animal models, NMTi-ADCs have regressed solid cancer tumors.
Pacylex has exclusive rights to 503 small molecules NMTis, including 27 high potency compounds (IC50 <10nM) against human NMT1. Zelenirstat has advantages as an NMTi-ADC payload: 1) clinical validation of safety, 2) clinical validation of anti-cancer activity, 3) multiple mechanisms of anti-cancer activity that disrupt novel cancer signaling and survival pathways as well as metabolism, 4) activity in models of drug-resistant cancer, 5) limited acquired resistance despite long-term drug exposure. The investigation of the potential of zelenirstat and its analogs as ADC payloads has begun.
About Pacylex Pharmaceuticals
Pacylex is a clinical-stage pharmaceutical company headquartered in Edmonton, Alberta, Canada, which targets hematologic cancers with orally bioavailable NMTi zelenirstat and solid tumor cancers with NMTis used as ADC payloads. Zelenirstat is the lead drug in a new class of NMTis, enabling Pacylex to exploit NMTs as new clinical targets for cancer treatment and a new class of ADC payloads. Pacylex is conducting a multi-center Phase 2a studies in Canada in patients with relapsed/refractory NHL and the IND for a Phase 1 multiple ascending dose study in 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 AML patients. The Cure Cancer Foundation, Alberta Cancer Foundation, and Alberta Innovates supported the initial clinical studies. For additional information, please visit
www.pacylex.com.
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.
