Pacylex Pharmaceuticals – 16 December
Pacylex Pharmaceuticals is a Canadian company developing an oral small molecule drug, PCLX-001, as a first-in-class therapy for a new target in cancer, myristoylation. PCLX-001:
Induces selective lethality in leukemias and lymphoma cell lines,
Kills patient cancer cells ex-vivo, completely regresses leukemia and lymphoma tumors in mice including those from drug resistant patient tumor cells,
Strongly inhibits growth of solid tumors in mice including breast and certain lung cancers,
Is likely to synergize with most other therapies on the market or in development,
Is at least 10-times as potent in vitro as Ibrutinib (Imbruvica) and Dasatinib (Sprycel), two multi-billion-dollar drugs for hematologic malignancies.
Pacylex has finished GLP tox and is on track to file a CTA (for clinical studies in Canada) and commence studies of PCLX-001 in lymphoma and solid tumour patients early in 2021. There are a tremendous number of other compounds approved or in clinical studies in oncology and PCLX-001 is likely to be synergistic with most of them since it works through a new mechanism of action with does not overlap the targets of most other drugs.
The new field of NMT inhibitors for cancer that Pacylex is pioneering gained traction this fall with two events,
1) the publication of Pacylex’s Lymphoma proof of concept results in Nature Communications. Pacylex’s breast cancer-proof of concept evidence is in the press in “Breast Cancer Research and Treatment”.
2) Experienced life sciences investors, Sofinnova Partners and Brandon Capital Partners, backed a Seed round in November 2020 in a newly formed competitor, Myricx Pharma in the UK showing investors have discovered this target. This company is at least a year behind Pacylex and our studies reveal that PCLX-001 is twice as potent as their lead compound.
Pacylex closed a $5M seed round at the beginning of the year and has finished GLP tox and is on track to file a CTA (for clinical studies in Canada) and commence a Phase 1 trial of PCLX-001 in lymphoma and solid tumour patients at three clinical sites in Canada early in 2021. This fall the PCLX-001 story was featured in Fierce Biotech and Pacylex was featured in CEO/CFO Magazine.
Other than financing, their biggest hurdle is navigating this transition into a clinical stage company. Finishing the Clinical Trials Application and getting approval to launch a clinical study in Canada at three trial sites, getting the sites up, recruiting and dosing patients, and analyzing the results in real time from this open label study will be an important challenge for Pacylex, but also creates tremendous value.
Pacylex is initiating a $12.5M Series A investment round. The Series A proceeds will be used to support the Canadian clinical program in lymphoma and solid tumours early in 2021 and launch an IND and leukemia program with MD Anderson Cancer Center later next year as well.
The initial development of NMT inhibitors was conducted at the University of Dundee under a $6M program funded by Wellcome Trust. The compounds were licensed by Pacylex which was formed as a University of Alberta spinout to develop NMT inhibitors for cancer after nearly $1.5M in research in the lab of Dr Luc Berthiaume. Pacylex has also received ~$1.14M in non-dilutive funding, $5.8M in equity and convertible note investments and has ~1M in additional non-dilutive funding pending. In the future, they expect to hire a US drug development team to include experience in quality, supply chain, clinical operations, and regulatory affairs.
Pacylex is developing an innovative first-in-class cancer therapy for blood cancers first, then solid tumour cancers. The company expects to require significant capital to bring this therapy through clinical studies and regulatory approval and eventually to market. The funding may come from strategic partners like pharma companies, venture investors or the public markets through an IPO. Eventually, the company is likely to partner with a large pharmaceutical company for registration and commercialization of PCLX-001 via licensing or acquisition, though commercializing the drug as a public company is also an option.
Luc Berthiaume, PhD – Founder, CSO, Board co-Chair
World leader in protein fatty acylation and Professor at the University of Alberta; Founder of Eusera and Pacylex; global distribution experience; 3 patents; commercialized antibody design and production.
John Mackey, MD, FRCP – co-Founder, CMO, Board Director
Director of clinical trials at the Cross Cancer Institute; former Director of TRIO (International clinical trial organization, 200 people); practicing oncologist, involved with ~100 clinical trials, founder of 3 companies.
Ryan Heit, MSc, MBA – co-Founder and COO
Technology and business development experience with 20+ companies in early-stage to commercialization; founder/ co-founder of 4 companies; led deal screening for Valhalla Angels.
Michael Weickert, PhD – CEO, Director
CEO of Chelation Partners, Sonescence, and SEA Medical Systems, COO of Greenfire and Ohm Oncology, CBO of Corium, Stratagent Life Sciences and Therashock, VP Development Auspex, Senior Program Executive, Nektar, Ligand, NCI/NIH.
Erwan Beauchamp, PhD – Dir. Discovery Biol.
Protein fatty acylation expert for 15+ years; made the seminal discovery of the sensitivity of hematologic cancers towards PCLX-001, first author on recent Nature Communication paper.
Karen Smith, MD, PhD, MBA, LLM, Board co-Chair
Proven CEO/CMO leader with pharma and biotech depth, Director Acceleron, Sangamo, Antares, prior Director Forward, Sucampo, Eliminate Cancer (CEO), Susan G. Komen, CMO Emergent, former Jazz, Allergan, AZ, BMS.
Mark Huson, PhD – Board Director
Professor of Finance and the Dianne and Irving Kipnes Chair in Finance and Development University of Alberta. is an expert in Corporate finance, Income trusts, Management science and Private enterprise.
Cindy Jacobs, MD, PhD – Board Director
CMO Achieve Life Sciences, CMO OncoGenex, Corixa, executive with Cytran, CellPro, Immunex (inventor and devel. Enbrel). On Board of Renown Pharma.
4000, 10230 Jasper Avenue,
Edmonton, AB, Canada, T5J 4P6