First clinical patient dosed at Cross Cancer Institute, Edmonton, Alberta, Canada
Dallas, TX, September 14, 2021
Greenfire Bio portfolio company Pacylex Pharmaceuticals, Inc. announced today that it initiated a Phase 1 clinical trial of PCLX-001, a first-in-class, orally bioavailable small molecule inhibitor of N-myristoyltransferase 1 and 2 (NMT1, NMT2), at the University of Alberta Cross Cancer Institute. This open label, dose escalation study will examine the safety and tolerability of PCLX-001 and determine the dose to be used in initial efficacy studies. Pacylex received a No Objection Letter from Health Canada on March 8, 2021, authorizing the Phase 1 Trial of PCLX-001 in relapsed/refractory B-cell Non-Hodgkin’s Lymphoma and advanced solid malignancies. PCLX-001 is believed to be the first NMT inhibitor that will be clinically tested.
PCLX-001 is the first clinical candidate sponsored by Pacylex Pharmaceuticals to reach the clinical stage. “We are excited to see PCLX-001 transition to helping serious refractory cancer patients,” said Michael Weickert, CEO of Pacylex Pharmaceuticals. “Our mission to bring this new potential cancer breakthrough to patients is finally being realized.”
“Pacylex is the first investment based on our strategy of finding game changing assets that are close to initiating clinical studies,” said Ajit Gill, the CEO of Greenfire Bio. “We are delighted to see Pacylex enter the clinic so soon after becoming part of our portfolio and look forward to seeing the benefits we hope this will provide to cancer patients.”
Patient enrollment and dosing will also begin soon at Princess Margaret Hospital in Toronto and the BC Cancer Agency in Vancouver. The study will enroll 20-30 patients in the initial phase. Three principal investigators will oversee the clinical study at the three clinical sites in Canada: Dr. John Kuruvilla at Princess Margaret Cancer Centre in Toronto, Dr. Randeep Sangha at the Cross Cancer Institute in Edmonton, and Dr. Laurie Sehn at the British Columbia Cancer Center in Vancouver.
This study is registered at ClinicalTrials.gov Identifier: NCT04836195.
About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s Lymphoma (NHL) is the most common hematologic malignancy and the eleventh most common cancer worldwide, with nearly 510,000 new cases diagnosed in 2018. It accounted for nearly 249,000 deaths worldwide in 2018. The most prevalent form of NHL, accounting for about 40% of newly diagnosed NHL cases, is an aggressive form called diffuse large B-cell lymphoma (DLBCL), that comes with a life expectancy of weeks or months if left untreated.
PCLX-001 is a small molecule, first-in-class N-myristoyltransferase (NMT) inhibitor, originally developed by the University of Dundee Drug Discovery Unit as part of a program to treat African sleeping sickness funded by Wellcome Trust. Pacylex is developing PCLX-001, which has excellent oral bioavailability, to treat 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 lymphoma (BL). PCLX-001 has also been shown to strongly inhibit the growth of lung and breast cancer tumors in animal models. In leukemia, lymphoma and breast cancer patients, the level of NMT2 is correlated with survival, suggesting an important biological role in these cancers. In tests using cultured cancer cells in vitro, PCLX-001 is at least ten times as potent as ibrutinib (Imbruvica) and dasatinib (Sprycel), two clinically approved drugs currently used to treat hematologic malignancies.
Pacylex is a pharmaceutical company targeting hematologic and solid cancers with a new first-in-class therapeutic, headquartered in Edmonton, Alberta, Canada. Pacylex’s technology combines new insights on N-myritoylation biology in normal and cancer cells from Dr. Luc Berthiaume of the University of Alberta with a family of high quality myristoylation inhibitors Pacylex licensed from the University of Dundee. 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 has received regulatory authorization to begin clinical studies in Canada in the Non-Hodgkin’s lymphoma and solid tumor patients. Pacylex is also receiving 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.
About Greenfire Bio
Greenfire Bio, LLC is a development and investment company, led by a team of experienced biopharma executives, building a diversified product pipeline by developing early-stage assets through proof of concept and investing in unique medical breakthroughs. Greenfire typically licenses, acquires, partners, or invests in differentiated pre-clinical or early clinical stage programs to bridge the translational medicine gap and accelerate development. Greenfire’s first dedicated subsidiary company, Green3Bio Inc., was created for the purpose of developing the salt-inducible kinase (SIK) inhibitor, GRN-300, in ovarian and other cancers. Greenfire recently announced the formation of its second subsidiary, WeaveTech, to research and develop bi-layer silk fibroin (BLSF) scaffolds to repair visceral hollow organ defects. Pacylex is the first external investment by Greenfire expanded the oncology indications in the portfolio.
For more information:
Greenfire Bio Contact: Ajit Gill, President
CEO, Greenfire Bio, Inc.
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