Tessa Therapeutics Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to its CD30 CAR-T Cell Therapy for the Treatment of Relapsed or Refractory CD30-positive Classical Hodgkin Lymphoma

PR83070

SINGAPORE, Feb. 27, 2020 /PRNewswire=KYODO JBN/ --

RMAT designation follows positive proof-of-concept data from two independent

Phase I/II clinical studies conducted by Baylor College of Medicine and

University of North Carolina Lineberger Comprehensive Cancer Center for the

autologous T cell therapy

Designation includes early interactions with the FDA to facilitate development

and discuss potential for expedited review

Tessa expects to initiate Pivotal Phase II multi-site trial in 4Q 2020

Tessa Therapeutics (Tessa), a clinical-stage cell therapy company developing

next-generation cancer treatments, today announced that the Company's

investigational CD30-directed autologous chimeric antigen receptor T cell (CD30

CAR-T) therapy has been granted Regenerative Medicine Advanced Therapy (RMAT)

designation by the U.S. Food and Drug Administration (FDA) for the treatment of

patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma

(cHL). Tessa expects to initiate its pivotal Phase II multi-site trial in the

fourth quarter of 2020.

"The RMAT designation speaks to the strength of the data in two independent

Phase I/II trials, which show promising efficacy and a strong safety profile of

the therapy in Hodgkin lymphoma patients whose disease had failed to respond to

other available therapies," said Ivan D. Horak, M.D., President of Research and

Development at Tessa Therapeutics. "We look forward to working closely with the

FDA as we advance our trial at multiple sites in North America and work to

bring this potentially transformative treatment option to patients."

The RMAT designation is supported by clinical data from two independent CD30

CAR-T Phase I/II studies in patients with relapsed or refractory CD30-positive

classical Hodgkin lymphoma conducted by Baylor College of Medicine

(NCT02917083) and University of North Carolina Lineberger Comprehensive Cancer

Center (NCT02690545). Both studies demonstrated objective response rates of

more than 70%, with 18 patients achieving complete response out of 27 patients

treated with CD 30 CAR-T with lymphodepleting chemotherapy as of November 2019.

Dr Horak added: "As part of our longer-term R&D program, we are also developing

an allogeneic CD30-CAR Epstein-Bar Virus-Specific T cell (CD30-CAR EBVST)

therapy product that combines the unique properties of VSTs and CD30 CARs, in

an effort to develop off-the-shelf cell therapies intended to treat a range of

hematologic malignancies and solid tumors."

RMAT designation is designed to facilitate development and expedite review of

cell therapies and other qualifying regenerative medicines intended to treat a

serious or life-threatening disease or condition; and preliminary clinical

evidence indicates that the drug has the potential to address unmet medical

needs for such disease or condition. Advantages include all the benefits of the

FDA's Fast Track and Breakthrough Therapy Designation programs, such as early

interactions with the FDA that may be used to discuss potential surrogate or

intermediate endpoints to support accelerated approval and satisfy

post-approval requirements.

More information on Tessa's CD30 CAR-T therapy pivotal Phase II clinical trial

is available at: https://clinicaltrials.gov/ct2/show/NCT04268706.

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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 fast-growing clinical pipeline includes two investigational autologous

cell therapies in late-stage clinical development for nasopharyngeal cancer and

classical Hodgkin lymphoma. Combining the unique properties of Virus-Specific T

cells (VSTs) and CD-30 Chimeric Antigen Receptors (CD30-CARs), Tessa is also

emerging with a new approach to cancer cell therapy through the development of

a novel, allogeneic platform technology. The platform holds potential for the

creation of off-the-shelf cell therapies against a variety of hematologic

malignancies and solid tumors.

Tessa's strategic partnerships with leading US academic centers and

manufacturing and supply chain capabilities across Asia and the United States,

have enabled the company to successfully deliver cell therapies on a global

scale, creating a fully integrated approach to the treatment of cancer.

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

SOURCE:  Tessa Therapeutics