Pacylex Discusses new oncology target and drug candidate at Biotech Showcase: PCLX-001 is getting ready to enter clinical trials

Presenting at the Biotech Showcase Monday, January 13, 2020, 4 pm PST at the Hilton San Francisco Union Square in San Francisco, California.

Key Takeaways

Pacylex is developing PCLX-001, a first-in-kind, small molecule with a novel mechanism of action believed to play a significant role in the development of certain types of blood cancers and solid tumors.
Data from four different preclinical models suggest that PCLX-001 has robust efficacy in leukemia and lymphoma.
Rapid development - on path for IND filing within 6-9 months.

Edmonton, Alberta, Canada, Jan. 9, 2020 – PACYLEX PHARMACEUTICALS, INC. a pre-IND-stage pharmaceutical company targeting hematologic cancers with a new first-in-class therapeutic, announced today that its chief executive officer, Michael Weickert, will present at the Biotech Showcase 2020 conference being held January 13-15, 2020 at the Hilton San Francisco Union Square in San Francisco, California.

Pacylex is developing an oral small molecule drug, PCLX-001, to treat cancers deficient in N-myristoyltransferase 2 (NMT2), a myristoylation enzyme associated with higher mortality in leukemia and lymphoma. PCLX-001 selectively kills cancer cells and completely regresses (eliminates) tumors in animal models of Acute Myeloid Leukemia (AML), Diffuse Large B-cell Lymphoma (DLBCL), and Burkitt’s Lymphoma (BL). It also inhibits the growth of Lung and Breast cancer tumors in animal models. In tests using cultured cancer cells in vitro, PCLX-001 is at least 10-times as potent as Ibrutinib (Imbruvica) and Dasatinib (Sprycel), two multi-billion-dollar drugs for hematologic malignancies. Pacylex is completing GLP toxicology in January and will file its IND and commence clinical studies in 2020.

Details of the presentation are as follows:

About PACLYEX

Pacylex is a Canadian oncology company headquartered in Edmonton, Alberta. It combines new insights from Dr. Luc Berthiaume of the University of Alberta, connecting myristoylation to cancer, with a family of myristoylation inhibitors developed for African sleeping sickness by the University of Dundee in a program funded by Wellcome Trust. PCLX-001 is the lead drug in a new class of NMT inhibitors, exploiting this new clinical target for cancer treatment. Animal dosing for IND-enabling toxicology in 2 species will finish in January 2020. Pre-IND meeting feedback from the FDA in 2019 defines a clear path to IND filing and clinical start later this year. The Phase 1 protocol is complete and principal investigators are in place at three clinical sites in Canada. Pacylex plans to close a Seed Note round of $5M USD early in 2020 and is looking to raise a $25M Series A in late 2020 to fund clinical development through Phase 2.

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Key Takeaways

Pacylex is developing PCLX-001, a first-in-kind, small molecule with a novel mechanism of action believed to play a significant role in the development of certain types of blood cancers and solid tumors.
Data from four different preclinical models suggest that PCLX-001 has robust efficacy in leukemia and lymphoma.
Rapid development - on path for IND filing within 6-9 months.

Contacts

Michael Weickert Ph.D

michael.weickert@pacylex.com

650-218-1840

Chief Executive Officer

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Michael J. Weickert

CEO

Michael has been in biotech and pharmaceuticals for over 26 years, as CEO of illumiSonics, Sonescence, and SEA Medical Systems, CBO of Strategent Life Sciences, Corium, and Therashock, COO of Ohm Oncology, VP of development at SciDose and Auspex, and Senior Program Executive or Manager at Nektar and Ligand. Key roles included raising capital, establishing and maintaining business partnerships, building teams, and developing new products. He raised Seed through Series C capital and established partnerships worth more than $175 Million.

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Luc G. Berthiaume

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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Ryan Heit

Chief Operations Officer

Ryan has a diverse 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 position at TEC Edmonton and as an independent consultant. Additionally, he has helped multiple Alberta companies in obtaining financing in his role with the angel investing network, Valhalla Angels.

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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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