Tessa Therapeutics Announces Results from Two Independent Phase 1/2 Trials of Autologous CD30 CAR-T Cell Therapy in Patients with Relapsed or Refractory Hodgkin Lymphoma

SINGAPORE,Aug. 6,2020 --Tessa Therapeutics (Tessa),a clinical-stage cell therapy company developing next-generation cancer treatments,today announced the publication of results in the Journal of Clinical Oncology from two investigator-sponsored Phase 1/2 trials led by Baylor College of Medicine and the University of North Carolina Lineberger Comprehensive Cancer Center.

Results of the trials,which evaluated the safety and efficacy of CD30 CAR-T cell therapy in patients with relapsed/refractory ("R/R") Hodgkin lymphoma,showed a high rate of durable complete responses and very favorable safety profile using autologous CD30 CAR-T cell therapy.

"These data are significant,as they demonstrate that CAR-T cell therapy may be a safe and effective treatment option for patients with Hodgkin lymphoma and potentially other lymphomas expressing the CD30 antigen," said Dr. Natalie Grover,study co-first author,assistant professor in the UNC Department of Medicine and a UNC Lineberger member. "The highest dose treatment led to the complete disappearance of tumors in the majority of patients,and almost all subjects had clinical benefit. As such,we believe further study of this treatment approach is warranted," said Dr. Carlos Ramos,professor at the Center for Cell and Gene Therapy at Baylor College of Medicine,Houston Methodist Hospital and Texas Children's Hospital.

The trials enrolled 41 adult patients with relapsed/refractory Hodgkin Lymphoma who received CD30 CAR-T cell therapy following lymphodepletion with chemotherapy. Overall,94 percent of the treated patients were still alive a year after treatment. Of the patients who had a complete response,61 percent still had no evidence of recurrence a year later. None of the patients experienced the serious,life-threatening complications that have been seen with several CD19 CAR-T cell trials. The overall response rate in the 32 patients with active disease who received fludarabine-based lymphodepletion was 72%,including 19 patients (59%) with complete response.

"We have been working with Baylor and the University of North Carolina to confirm these impressiveresults further in a Tessa-sponsored regulatory Phase 2 trial,which we aim to initiate this year," said Ivan D. Horak,M.D.,President of Research and Development at Tessa Therapeutics. "Longer term,we seek to explore the potential of this therapy beyond Hodgkin's lymphoma to CD30+ expressing Non-Hodgkin lymphomas,where there is a demonstrated unmet need."

University of North Carolina has granted Tessa an exclusive license to its patents,data and know-how,and Baylor College of Medicine has granted Tessa the rights to use its data and know-how,for the further development and commercialization of this therapy. "We are excited to collaborate with Tessa. Their ability to run multi-center cell therapy clinical trials will be invaluable for the further development of this therapy," said Helen Heslop,director of the Center for Cell and Gene Therapy and Dan L Duncan Chair at Baylor.

About Tessa Therapeutics

Tessa Therapeutics is a clinical-stage biotechnology company focused on the development of cell therapies for a broad range of cancers.

Tessa's clinical pipeline derives from two innovative cell therapy platforms: CD30 Chimeric Antigen Receptors (CD30-CARs) and Virus-Specific T cells (VSTs). Our lead candidate comprises autologous CD30 CAR-T cell therapy targeting classical Hodgkin lymphoma (cHL) and CD30+ non-Hodgkin lymphomas.

Tessa,in collaboration with Baylor College of Medicine,is also developing a novel,allogeneic platform technology,as a new approach to traditional cell therapy. By combining the unique properties CD30-CARs and VSTs,the platform holds potential for the creation of next-generation off-the-shelf cell therapies against a variety of hematologic malignancies and solid tumors.

Tessa's state-of-the-art GMP cell therapy manufacturing facility will open in early 2021 and will substantially enhance in-house production capabilities. Tessa is focused on rapidly and reliably providing safe,effective treatment options for patients.

For more information on Tessa,please visit www.tessatherapeutics.com.