From Lab to First-in-Human: How a Novel Cancer Drug Reached the Clinic
For patients with metastatic cancers who have exhausted approved treatments, a Phase I clinical trial is often the last door open to them. Getting a new compound through that door — from a university lab bench to a sterile injectable vial administered in a clinical setting — takes years, and a chain of contributors who rarely share the same spotlight.
CCI-001 is one such compound. Designed computationally at the University of Alberta and now in active Phase I trials at the Cross Cancer Institute in Edmonton, Alberta, it represents the kind of collaboration that moves science forward: a university discovery, a development-stage pharmaceutical company, a clinical trials unit, and a CDMO working together toward a shared goal.
Dalton Pharma Services is proud to have played a role in that chain.
For patients who have run out of approved options, a Phase I trial is often the last door open. Dalton helped open it.
The Science Behind CCI-001
CCI-001 is a microtubule disruptor — a class of agents that interfere with cell division, a hallmark of cancer biology. It was designed computationally in the laboratory of Dr. Jack Tuszynski during his Allard Chair in Oncology at the University of Alberta, and entered structured preclinical development through the Alberta Pre-Phase I Cancer Program, funded by the Alberta Cancer Foundation and established by oncologist Dr. John Mackey.
PharmaMatrix Holdings Ltd., an Alberta-based pharmaceutical company, took on the development program and engaged Dalton Pharma Services to provide aseptic fill-finish manufacturing under cGMP conditions — a critical step in producing a sterile injectable drug product suitable for first-in-human use.
What the Phase I Data Show
Phase I trials are designed primarily to evaluate safety and tolerability, not efficacy. They enroll patients who have exhausted standard therapeutic options — a population for whom even disease stabilization is a meaningful outcome.
The Phase I dose-escalation results for CCI-001, presented at the 2026 American Society of Clinical Oncology (ASCO) general meeting, are encouraging on both fronts. The drug demonstrated acceptable safety and tolerability across escalating doses. Several patients experienced disease stabilization for up to six months. One patient remained on treatment for 14 months.
On the strength of these single-agent results, the Phase I clinical team at the Cross Cancer Institute has now initiated combination testing of CCI-001 with gemcitabine and carboplatin.
One patient remained on treatment for 14 months. On the strength of these results, combination testing with established chemotherapy agents has now begun.
Dalton's Role: Aseptic Fill-Finish for Clinical Supply
Dalton provided aseptic fill-finish manufacturing for CCI-001 under cGMP, supporting PharmaMatrix through the transition from research compound to clinical-grade drug product.
For a novel compound with limited prior data and a patient population with limited remaining options, that manufacturing infrastructure is not a background detail. It is foundational to what the clinical team can do.
Looking Ahead
CCI-001 is now in active combination testing. The path from here — through dose optimization, expanded cohorts, and eventually efficacy trials — is long, and uncertain in the way that all drug development is uncertain.
But it is a path that would not exist without the Phase I data, and the Phase I data would not exist without the manufacturing work that preceded it. Dalton is glad to have contributed to this milestone alongside PharmaMatrix, and we look forward to continuing to support the program as it advances.
About PharmaMatrix Holdings Ltd.
PharmaMatrix Holdings Ltd. is an Alberta-based pharmaceutical company focused on the development of novel oncology compounds. CCI-001 is its lead investigational asset, currently in Phase I clinical development at the Cross Cancer Institute in Edmonton, Alberta.
About Dalton Pharma Services
Dalton Pharma Services is a Toronto-based CDMO specializing in sterile injectable drug products for small-to-mid biotech and specialty pharma companies. Services include API development and manufacturing, aseptic fill/finish (sterile powder and liquid), formulation
development, and analytical/QC — all under one QMS, one site, one accountable partner. Dalton is wholly owned by Seikagaku Corporation.