Modern medicine has helped find solutions to complex health problems, cancer being one of them. What was incurable once, today, under certain conditions can be successfully treated, cured, and controlled, giving patients and their families new hope.
From radiation and chemotherapy, to immune and cell-based therapy, to the first-in-class development of small molecule therapy PCLX-001 by Pacylex Pharmaceuticals that exploits a new target in cancer for which drugs have never been previously developed, cancer therapy continues to evolve and improve
“Through this development, we aspire to cure hematologic malignancies, leukemia, lymphomas, and myelomas, dramatically improving patient outcomes in serious cancers,” says Dr. Michael Weickert, the CEO.
He further adds, “We value strong science, teamwork, and execution. What keeps us moving ahead through every challenge is knowing we have a rare privilege of potentially making a genuine difference in the lives of patients, their families, and their caregivers.”
Cancer care with convenience
Established in 2012, Pacylex has set itself apart by being the first to address a new cancer target with a new first-in-class therapy. There are many cancer therapies currently in practice or in development. However, developing a cancer therapy is about more than whether someone has another molecule against the same target.
When talking about PCLX-001 therapy, it differentiates with the following characteristics:
- Convenience – PCLX-001 is a once-per-day pill.
- Potency – PCLX-001 is approximately 10-times more potent in vitro than the lymphoma drug Imbruvica which had revenues of $8.1 billion in 2019.
- Tumor killing – in all animal models of hematologic cancers, PCLX-001 regressed/killed tumors or cancer cells.
- Synergy – PCLX-001 works through a new mechanism of action not targeted by other therapies. Thus, it can potentially work even better when combined with other treatments that work differently.
This potential of the drug has already intrigued several large pharma companies with mature oncology franchises.
Leadership dynamics
Behind innovations and strategies taking place at Pacylex, is an expert Dr. Weickert who entered the healthcare industry in 1992 as a Senior Scientist straight from 3 years at the National Cancer Institute of NIH, after receiving a Doctorate in Genetics from the University of Wisconsin.
Within two years he was reassigned from laboratory management to project management. Over the next 13 years, Dr. Weickert worked in public companies, Somatogen, Ligand, and Nektar, where he guided preclinical and clinical-stage product development programs for biologics, small molecules, and drug-device combinations including for the Phase 3/NDA program for Targretin for Cutaneous T-cell Lymphoma at Ligand.
At Nektar, Dr. Weickert was entrusted with setting up an internal business unit for anti-infectives for pulmonary delivery which eventually led to 4 development programs.
After being an intrapreneur at Nektar, Dr. Weickert decided in 2007 to work with startups before coming to Pacylex in 2017. He also served as interim CEO at illumisonics and COO or CBO at multiple startups including Therashock, Ohm Oncology, and currently Greenfire Bio.
Dr. Weickert currently serves as Executive Chairman for Chelation Partners, another Canadian Pharmaceutical Company. He seeks life science diamonds in the rough, game-changing medical discoveries and innovations that are emerging from places outside the mainstream marquee ecosystems, and thus, are struggling for traction.
From his home in the San Francisco Bay area, Dr. Weickert helps assemble development plans and teams and tells compelling stories to potential investors and corporate partners for the diamonds in the rough.
Facing the pandemic of challenges
The ongoing pandemic has impacted every sector more or less including medicinal research and development. The lack of preparation and unfortunate policy decisions have strained healthcare delivery and some supply chains to the breaking point in many countries.
Dr. Weickert talked about the impact of the ongoing pandemic on Pacylex Pharmaceuticals operations, “the impact on supply chains affected our company, Pacylex, because our drug substance is manufactured in India and the manufacturing plant was shut down for more than a month due to the pandemic.”
This delayed the manufacturing of the company’s clinical supplies and therefore the filing of a regulatory application that requires the analysis and certification of the final drug product, which is the capsules the company plans to dose to patients.
“Because we are largely virtual, other operations were relatively unaffected. Though the medical and investor conferences we ordinarily attend each year all were virtual, we still had about the same number of meetings, we just didn’t have to travel to have them,” says Dr. Weickert.
Advice for the aspirants
“Healthcare values experience,” said Dr. Weickert while advising aspirants, “if you have a great idea and some initial data, get some experience on your team to help execute. Execution is where most great ideas fail,” he says.
He further suggests, “Value the capital and experience required for execution; many budding entrepreneurs think the idea is all the value. Ideas are a dime a dozen. What distinguishes an idea from a product is hard work, great execution, and the talent and capital necessary to pull that off.”
Transition to a clinical-stage company
Now that the vaccination drives have helped curb the COVID-19 situations in several countries it has brought new hope to the global market. “2021 is an important transition year for the company,” says Dr. Weickert, “in March, we received authorization from Health Canada to begin clinical studies in Diffuse Large B-cell Lymphoma and solid tumor cancer patients for our lead compound, PCLX-001.”
The company expects these studies to begin in late June or July. Further, the company will go from a pre-clinical stage company to a clinical-stage company with three clinical sites conducting the initial clinical program – Princess Margaret Hospital in Toronto, Cross Cancer Institute in Edmonton, and BC Cancer Agency in Vancouver.
The company also hopes to initiate a second program in a different cancer population, Acute Myeloid Leukemia, at MD Anderson Cancer Center in the US late this year. “Though we will transition to a clinical-stage company, we will remain a modest operation for now. Our expanded effort in drug production and clinical operations is largely an expansion of the work of our partners who we have been engaged to oversee those efforts,” says Dr. Weickert.
