Hodgkin’s lymphoma is an indication currently dominated by chemotherapy regimens and stem cell transplants. There is a need for new treatments that will prolong remission, namely in the first line, in order to delay the necessity of more toxic treatments such as stem cell transplants.
Currently, both Adcetris and the PD-1 inhibitors Opdivo and Keytruda are expanding within the Hodgkin’s lymphoma market by exploring combination strategies with the goal of achieving this target. However, new approaches are continuously being pursued and a highly anticipated treatment to reach the Hodgkin’s lymphoma market, after having already been approved to treat other haematological malignancies, is chimeric-antigen receptor T-cell (CAR-T) therapies. Among the CAR-T approaches being studied in Hodgkin’s lymphoma is Cellular Biomedicine Group Inc with its CBM-C30.1 and Immune Cells CD30 CAR-T Therapy. However, it was Tessa Therapeutics ’ CD30 CAR-T cell therapy TT11 that received a special designation by the FDA. Though this is an early step, CAR-T cell therapies could soon be making their way to Hodgkin’s lymphoma and revolutionize treatment as they have so far done for other haematological malignancies.
On February 27, the FDA granted the regenerative medicine advanced therapy (RMAT) designation to TT11, which provides the benefits of the FDA’s fast track and breakthrough therapy designations. TT11 becomes the 47th drug to receive this new designation, which the FDA initiated in 2016 to speed the review of novel cell therapies, gene therapies, and other regenerative medicines. To date, only two CAR-T therapies have received this designation, namely Bristol-Myers Squibb ’s Liso-cel and CARsgen’s CT053. The RMAT designation for TT11 followed from positive Phase I / II data where Hodgkin’s lymphoma patients who failed all other lines of therapy achieved a positive response to TT11. The data pooled from both studies, conducted by Baylor College of Medicine and Lineberger Comprehensive Cancer Center, culminated in a total 18 out of 27 (66.7%) patients achieving a complete response. In addition to this, Tessa Therapeutics has a planned pivotal Phase II trial for this drug, expected to initiate in Q4 2020 with an estimated primary completion date of December 2022. Given the RMAT designation, Tessa Therapeutics may look to discuss surrogate endpoints with the FDA for its planned Phase II trial to support a faster approval of TT11. As per the standard clinical trial design for novel treatments in HL, both the Phase I / II trials investigated TT11 in relapsed and refractory (R/R) Hodgkin’s lymphoma patients. GlobalData expects that Tessa Therapeutics may be first to market with its CAR-T therapy in Hodgkin’s lymphoma and soon after, seek to gain approval for pre-transplant R / R patients, positioning TT11 to eventually become an option for first-line treatment.
This news has also served to highlight the importance of academic partnerships and their role in bringing new treatments to indications with a relatively low incidence. Tessa Therapeutics first established a strategic partnership with Baylor College of Medicine in 2015 regarding HPV-specific T cell therapies. In 2016 this partnership was extended to include the development of novel combination therapies to treat liver and lung cancers. Finally, in 2020 this partnership peaked with TT11’s RMAT designation by the FDA. Both Baylor College of Medicine and Lineberger Comprehensive Cancer Center contributed to the development of TT11, and retain an important strategic position, being involved in clinical trials with multiple other CAR-T therapies, accounting for seven out of nine ongoing trials for CAR-T therapies for Hodgkin’s lymphoma in the US.