Atara Biotherapeutics, Kite, and Tmunity
By Erin Harris, Editor-In-Chief, Cell & Gene
Follow Me On Twitter @ErinHarris_1
Atara Biotherapeutics & First-Ever Approved Allo Therapy
The future of cell and gene therapies continues to prove to be very bright. Late last year, the world’s first allogeneic therapy was approved. Atara Biotherapeutics’ Ebvallo (tabelecleucel) received European Commission Approval as the first-ever allogeneic therapy for patients ages two and up with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who’ve tried at least one other drug. Only approved in the E.U., this sets the stage for other allo developers.
Why This Matters
We can hope for additional breakthroughs and approvals in solid tumor oncology, and we should expect advancements in cell therapy beyond oncology (i.e. autoimmune and cardiovascular diseases, etc.). And, COGS and the financial feasibility of generating small-batch CGT products for rare and ultra-rare diseases with limited patient populations will be top coverage areas as well. Will the breakthrough in allogeneic therapy approach come along in 2023? In his recent article, Mark Gergen, CEO of Poseida explained that in order for allogeneic therapies to become a reality, we need to look at multiple factors including up-front efficacy, durability, safety, and access as well as health economics (i.e. cost). The end goal should be to make transformative allogeneic CAR-T cell therapies available to as many patients who can benefit from them as possible. Autologous cell therapies are proven, and all eyes are on allogeneic cell therapies for the foreseeable future.
Dr. Manuel Litchman, CEO, and Dr. Knut Niss, CTO at Mustang Bio state in their article that while the ascendancy of allogeneic CAR-T therapies is no longer a foregone conclusion, they undoubtedly will continue to play a role in addressing an array of unmet needs in patients with cancer. No cell and gene therapy, including autologous and allogeneic CAR-Ts, is suitable for all patient populations and situations. But everyone in our field shares the same goal: to bring safe and innovative treatments to patients who lack meaningful therapeutic options. Kudos to Atara Biotherapeutics for reaching the finish line first.
Kite Acquires Tmunity
Last month, Kite acquired Tmunity Therapeutics, a Philadelphia-based clinical-stage, private biotech company focused on next-generation CAR T-therapies and technologies. The acquisition provides Kite wtih several preclinical and clinical assets, a new platform for “armored” CAR T-cell development, and rapid manufacturing processes.
Why This Matters
When Kite stated that a boon of the acquisition would be a rapid manufacturing processes, what do they mean? Kite’s leadership team believes the best-case scenario is to reduce the current manufacturing process from seven days to two to three days. As an industry, we have been focused on reducing manufacturing time for quite some time. Just last year, I wrote an article about Penn Medicine’s study led by Center for Cellular Immunotherapies researchers Michael C. Milone, M.D., Ph.D., an associate professor of Pathology and Laboratory Medicine and Saba Ghassemi, Ph.D., a research assistant professor of Pathology and Laboratory. They published their pre-clinical study in Nature Biomedical Engineering on generating non-activated CAR-T cells in less than 24 hours. Scenarios vary, and so reducing manufacturing time is dependent on many things: automation, manufacturing at the point of care, capacity planning, the unique manufacturing issues associated with gene therapy, decentralizing the manufacturing process, and more.
Kite’s acquisition of Tmunity will certainly continue to make headlines for various reasons, and I, for one, am very excited and interested to see how they successfully reduce manufacturing processes.