Cellectis, Immatics On COVID-19's Impact
By Erin Harris, Editor-In-Chief, Cell & Gene
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In Life Science Leader’s upcoming annual Outlook issue, I contributed an article featuring Cellectis’ CEO André Choulika and Immatics’ Director, Global Site Operations, Michael Mehler about their take on the future of gene therapy and cell therapy respectively. In addition to the forward-looking insight included in that article, I also asked them how COVID-19 has impacted their companies, which I will share with you here. Here’s what they had to say about how the pandemic has affected their companies. And, watch your mailbox for the December 2021 issue of Life Science Leader magazine for the full-length outlook article featuring Choulika and Mehler.
How has COVID-19 impacted Cellectis?
Choulika: As we know the COVID-19 crisis caused significant disruptions to various public and commercial activities. Disruptions to global and regional supply chains affected global and regional economic conditions. One of the most unexpected challenges from the COVID-19 was dealing with the impact of manufacturing and supply chains throughout the world. Cellectis experienced disruption from the COVID-19 crisis on several fronts that impacted the company’s day-to-day activities. To combat this disruption, we conducted daily meetings to assess potential bottlenecks, monitor real time consumption, and we grasped opportunities to slightly stockpile some of our critical consumables.
Despite these issues, Cellectis experienced limited delays in operations, and we were able to complete construction of both manufacturing facilities during COVID. We were able to accomplish this because of our close relationships with vendors/suppliers and leveraging of both our cross-Atlantic positioning sharing materials between our Paris, NY and Raleigh sites when necessary.
Before the COVID-19 crisis, Cellectis made the pivotal decision to invest in its manufacturing capabilities. In March 2019, we announced the start of construction on an 82,000 square foot GMP manufacturing facility in Raleigh, NC for clinical and commercial production of the company’s leading allogeneic UCART products. We concurrently announced construction for a 14,000 square foot manufacturing facility in Paris, to produce a series of critical starting material supplies for UCART clinical studies and our .HEAL platform. Construction was completed on both facilities during the COVID-19 crisis; 2020 in Paris and 2021 in Raleigh, NC, despite numerous challenges with availability of materials and tradespeople crews. Cellectis accomplished this by having close communication with construction management firms and their subcontractors.
Due to successful completion of our manufacturing facilities, we can move swiftly from an innovative idea at the R&D stage, to clinical trials with the potential to produce commercial-level supplies in the future. In the cell and gene therapy space, product is defined by process. Therefore, mastering all manufacturing processes from A-to-Z and delivery to the patient - all in-house- is a critical factor for success. Cellectis has full control of its manufacturing schedules, from starting materials to finished product including electroporation devices.
Despite the lockdowns and restrictions due to COVID-19, our team became stronger as we worked together to overcome those limitations, while remaining passionate about developing innovative therapies that address unmet medical needs. We shifted to flexible work arrangements to ensure that site and project-essential personnel were present in the facilities. This ensured continuity of projects and operational readiness while protecting the health and productivity of the site-essential personnel.
From the beginning of the COVID-19 crisis, Cellectis made it a priority to continue all our operations. We enrolled patients throughout our three Phase 1 trials, advanced preclinical programs and remained on schedule with the construction of our in-house GMP manufacturing facilities.
By working together to face these challenges over the last year and half, we have doubled our employee base and international leadership team, expanded our robust pipeline, outlined four new UCART preclinical programs targeting solid tumors, launched our .HEAL platform for rare genetic diseases, opened our UCART manufacturing facilities in Raleigh, NC and further broadened our partnerships and international leadership team.
Finally, the success of mRNA-based vaccines has induced tremendous demand on worldwide supply of nucleic acids, DNA, as well as mRNA. Our TALEN® gene editing platform is mRNA-based, and plasmid DNA is at the basis of most of our technologies. Having newfound manufacturing independence has given Cellectis more freedom and less dependance on outside suppliers, directly and positively impacting our current planning and capabilities. Due to COVID, and the impact it has had on the supply chain, we have been inspired to internalize the manufacturing of our raw materials.
How has COVID-19 impacted Immatics?
Mehler: While the COVID-19 pandemic has been difficult, Immatics has been able to create innovative solutions to these challenges. As the clinical sites were seeing fewer patients, Immatics was able to maintain screening and enrollment by deepening the support our clinical sites needed and finding ways to screen or pre-identify patients when and where possible. Immatics has mastered remote trainings and onboarding procedures for the convenience of our partners and clinical sites while in-person visits were limited. Additionally, we have become experts at strengthening our partnerships remotely through telemedicine and telecommunications on a global level. We keep our challenges and benefits close, meaning that everything we learn from our challenges directly results in a benefit to patients and creating a best-in-class product.