Edmonton, Alberta – January 3, 2024 – Pacylex Pharmaceuticals, a clinical-stage oncology innovator, is closing out a pivotal year with a string of accomplishments that validate its first-in-class oral cancer therapy, zelenirstat. This momentum positions Pacylex perfectly for a Series B funding round or strategic partnership to fuel the next stage of its exciting journey.
Zelenirstat shines in Phase 1, exceeding expectations:
- No Dose Limiting Toxicities (DLTs) up to the target drug exposure. In an all-comer Phase 1 study in refractory/relapsed lymphoma and solid tumor patients, there were no zelenirstat DLTs at doses ranging from 20 mg - to 210 mg.
- Evidence of Efficacy. Even in heavily pre-treated patients with resistant cancers like ovarian, colorectal, bile duct, lung, and appendiceal, zelenirstat at the highest dose significantly improved both progression-free and overall survival.
- Clinical Advancements. Phase 2a is underway in B-cell NHL (non-Hodgkin lymphoma) at the 210 mg dose. Similar studies are planned for solid tumors and acute myeloid leukemia, further amplifying the potential of zelenirstat across multiple cancer indications.
Beyond Phase 1: Additional achievements solidify zelenirstat's potential:
- Orphan Drug and Fast Track designations for AML. Regulatory recognition validates zelenirstat's promise in this challenging cancer.
- Potent Radiosensitization in Brain Cancer. zelenirstat outperformed standard-of-care treatments in preclinical models, opening doors for combination therapies.
- Capital Efficiency and De-risking: Pacylex has progressed to Phase 2 on less than $20 million, demonstrating an ability to deliver results with lean operations.
Investing in the future of cancer treatment:
With zelenirstat demonstrating safety and efficacy in patients who have failed all available therapeutic options, Pacylex presents a compelling investment opportunity. We offer:
- A first-in-class therapy with ibrutinib-like potential: zelenirstat targets a novel pathway, potentially surpassing existing treatments in efficacy and tolerability.
- Multiple expansion avenues: Solid tumors, AML, and autoimmune disorders represent future growth opportunities.
- Experienced and dedicated team: Our team of scientific and commercial leaders possesses a proven track record of success.
Join us in shaping the future of cancer care:
Pacylex is actively seeking Series B funding and strategic partnerships to fuel the next chapter of zelenirstat's development. We invite investors to connect with us at Biotech Showcase during JPM Week to learn more about this groundbreaking therapy and participate in a truly disruptive force in the oncology landscape.
Meet us through the BIO Partnering. https://bpjw.bio.org/
Meet us through the BTS Partnering. https://informaconnect.com/biotech-showcase/partnering/
Schedule a casual coffee or reception meeting! michael.weickert@pacylex.com
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.
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.
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.
