In this editorial, Arnaud Deladeriere and Denis-Claude Roy, Centre for Commercialization of Cancer Immunotherapy (QC, Canada), introduce the center.
Cancer immunotherapy is a form of regenerative medicine
The process of activating, replacing, engineering or regenerating human cells, tissues or organs to restore or establish normal function refers to regenerative medicine. Cancer immunotherapy activates, replaces, engineers or regenerates the immune system in order to fight cancer. In fact, it is the most frequently used and marketed form of regenerative medicine.
Indeed, cancer immunotherapy takes advantage of the intrinsic ability of hematopoietic stem or more mature cells to target and eliminate cancer cells. Such blood cells serve as biological material for further selection, manipulation and/or sensitization to increase their anti-tumor potential. For example, white blood cells can undergo genetic modification to enable binding with CD19, a cancer biomarker present on the surface of acute lymphoblastic leukemia and non-Hodgkin’s Lymphoma, or BCMA, present on multiple myeloma cells.
Alternatively, cells with intrinsic features enabling them to kill cancer cells can be selected, expanded and administered to patients. Whether cells are matured and expanded or undergo genetic addition of chimeric antigen receptors (CAR), these and other forms of cancer immunotherapy show immense promise. Often forgotten is that fact that stem cell transplantation is at the origin of such treatments, as it first identified and still uses the ability of donor stem cells to generate graft-versus-tumor activity.
Although cancer immunotherapy was shown to be very efficient at treating blood cancers, both academia and industry across the globe are now demonstrating the wide potential of these therapies in solid tumors as well. This brings new hopes to patients with cancer previously thought to be incurable.
Who is C3i and what do we do?
C3i is a Montreal-based contract development manufacturing organization specialized in cell and gene therapy. Once working solely on cancer immunotherapy, C3i was recently mandated to work on regenerative medicine as well, and now operates the only cGMP manufacturing unit with commercial capacity in cell and gene therapy in Canada.
Our mission is to accelerate the discovery, commercialization and access to these therapies, by being Canada’s catalyst for cancer immunotherapy and regenerative medicine business development. Located at the heart of Hopital Maisonneuve Rosemont (HMR; QC, Canada), a center specialized in cell therapy since the 80s, C3i was created to accelerate market access to biotech and pharma companies working on cell and gene therapies for cancer immunotherapy and for regenerative medicine. C3i is working around 5 business units as follow:
- A cGMP manufacturing unit: the Centre of Excellence for Cell and Gene Therapy is a 37,000 sq ft facility, with 14 cleanrooms, and its own in-house quality control and quality assurance teams and systems. The cGMP manufacturing unit is staffed with more than 50 highly qualified personnel and is open year round. We are also currently developing our cGMP gene therapy platform in order to meet the needs of our partners in this growing field;
- A Biomarker—Diagnostics Unit: supporting the development of novel analytical tests for cGMP production as well as developing new stand-alone tests at to our state-of-the-art platform (droplet digital PCR, mass cytometry Helios, next generation sequencing);
- A Clinical Research Unit: allowing Phase I to Phase III clinical trials in regenerative medicine and cancer immunotherapy to be managed at our host institution HMR, with a team of highly qualified research staff, and several clinicians bringing experience to the team as key opinion leaders in the field;
- A contract research organization unit, involving highly experienced clinical research associates for the identification of participating centers and management of multicenter clinical studies across Canada and the US;
- An Innovation and Commercialization Unit: accelerating access of breakthrough discoveries to market through its other four units, with special emphasis on cell therapy and regenerative medicine using its cGMP manufacturing unit.
With the strong and close interactions between all of our units, we ensure that our partners benefit from an integrated approach to generate rapid and successful clinical trials. The extensive translational and implementation skills of our personnel at the cGMP Manufacturing Unit results in rapid development of clinical material of the highest standard. The strong quality control and quality assessment teams, efficient and experienced patient recruitment and handling of specimens, and dedicated clinicians are clear assets. There is also a strong vital link between C3i and HMR that allows both entities to grow stronger and faster together. This combination allows new treatments to get to the patient faster than conventional models.
C3i is therefore positioning itself as a key partner for clinical stage companies
In 2018, cGMP manufacturing of cell and gene therapies is in high demand. Indeed, the increase in the number of clinical trials in cancer immunotherapy and regenerative medicine is very steep, and the number of new companies working in the cell and gene therapy field has skyrocketed over the last five years. This led to a shortage of space in cGMP manufacturing units, whether academic or commercial, in North America and in Europe.
In this context, C3i has built on the already established experience of a reference center in the field and brought the business-driven mindset of its team of experts. This makes C3i the perfect partner for young or mature biotech or pharma companies in the field of cell and gene therapy looking for partners with expertise in clinical manufacturing, and in cancer immunotherapy and regenerative medicine clinical trials.