- Objective response observed in 9/10 patients and complete response observed in 7/10 patients
- No patients proceeded to autologous stem cell transplant (ASCT) as of data cut-off
- Well tolerated safety profile - no Grade 3 or above CRS, no neurotoxicity
SINGAPORE, June 16, 2023 (GLOBE NEWSWIRE) -- Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, today presented encouraging safety and efficacy data from a combination study of its autologous CD30 CAR-T therapy (TT11) with Bristol Myers Squibb’s nivolumab at the 17th International Conference on Malignant Lymphoma taking place from June 13-17, 2023, at Lugano, Switzerland.
TT11 is an autologous CD30 chimeric antigen receptor T-cell (CAR-T) therapy that harvests the patient’s own T-cells and modifies them to target cancer cells expressing the CD30 protein, a well-validated lymphoma target. TT11 is currently being investigated in combination with Nivolumab in Phase 1B (ACTION) study targeting R/R classical Hodgkin Lymphoma (cHL) patients after frontline therapy failure (NCT05352828).
ACTION is a single arm multi-centre Phase 1b study. Study protocol involves patients being treated with 2 cycles of Nivolumab, followed by a single infusion of CD30.CAR-T preceded by lymphodepletion (LD) chemotherapy. An additional 2 cycles of Nivolumab are then given, followed by response assessment by PET/CT per Lugano 2014 criteria. Patients without progressive disease may undergo either autologous stem cell transplant (ASCT) or continue Nivolumab up to 6 additional cycles per physician and patient preference.
A total of 15 patients were enrolled of which 13 were treated with Nivolumab + CD30 CAR-T therapy. 10 patients reached End of Treatment (Post-Nivo Cycle 4) and were evaluable for response. Of the 10 patients 9 responded to the treatment with complete disappearance of tumor observed by PET/CT in 7 patients and partial reduction in tumor size observed in 2 patients. One patient had stable disease. Of note, no patients proceeded to receive autologous stem cell transplant (ASCT) as of the data cut off. All 10 patients reaching EOT (Post-Nivo Cycle 4) proceeded to additional Nivo cycles.
The therapy was well tolerated with no grade 3 or higher Cytokine Release Syndrome (CRS) and no neurotoxicity. Two patients experienced grade 1 CRS, which resolved without use of steroid or tocilizumab.
CD30.CAR-T expansion and persistence was observed post infusion. CAR-T cells continued to persist until data cut-off for the results (day 77 post infusion) with peak expansion observed in peripheral blood at 8 days post infusion.
“CD30 CAR-T therapy in combination with Nivolumab has demonstrated promising anti-tumor efficacy with a very good safety profile in r/r cHL patients after primary treatment,” said Sairah Ahmed, M.D., lead presentation author, and Associate Professor, The University of Texas MD Anderson Cancer Center. “The results are quite encouraging and warrant further development of this combination therapy among r/r cHL patients.”
Circulating tumor ctDNA-MRD (minimum residual disease) was assessed with PhasED-Seq (Foresight Diagnostics) in 3 patients with complete responses at End of Treatment (EOT). All 3 patients (100%) had undetectable ctDNA-MRD demonstrating deep molecular response. Additional patient samples are currently under assessment.
“We are very encouraged by the exciting results demonstrated by the ACTION study. These results offer the potential to re-define Hodgkin lymphoma treatment paradigm, offering a second line treatment alternative free of transplant and high dose chemotherapy to patients who fail frontline therapy,” said Thomas Willemsen, President and CEO, Tessa Therapeutics. He added, “The well tolerated safety profile is especially meaningful for older patients with poor tolerability and young adolescents with risk of long-term sequelae from current standard of care.”
About Tessa Therapeutics
Tessa Therapeutics is a clinical-stage biotechnology company developing next-generation cell therapies for the treatment of hematological cancers and solid tumors. Tessa’s autologous CD30 CAR-T therapy TT11, is currently being investigated as a potential treatment for relapsed or refractory classical Hodgkin lymphoma as both a monotherapy (Phase 2) and combination therapy (Phase 1b). TT11 has been granted RMAT designation by the FDA and access to the PRIME scheme by European Medicine Agency. Tessa is also advancing an allogeneic “off-the-shelf” cell therapy platform targeting a broad range of cancers in which Epstein Barr Virus Specific T Cells (EBVSTs) are augmented with CD30-CAR. This platform is currently the subject of a Phase 1 clinical trial in CD30-positive lymphomas. Tessa has its global headquarters in Singapore, where the company has built a state-of-the-art, commercial cell therapy manufacturing facility. For more information on Tessa, visit www.tessacell.com.
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This press release contains forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, to the fullest extent applicable) including, without limitation, with respect to various regulatory filings or clinical study developments of the Company. You can identify these statements by the fact that they use words such as “anticipate,” “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, “may”, “assume” or similar expressions. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the Company’s financial results, the ability to raise capital, dependence on strategic partnerships and licensees, the applicability of patents and proprietary technology, the timing for completion of the clinical trials of its product candidates, whether and when, if at all, the Company’s product candidates will receive marketing approval, and competition from other biopharmaceutical companies. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made, and disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The Company’s products are expressly for investigational use pursuant to a relevant investigational device exemption granted by the U.S. Food & Drug Administration, or equivalent competent body.
Tessa Therapeutics Investor Contact
Wilson W. Cheung
Chief Financial Officer
wcheung@tessacell.com
Tessa Therapeutics Media Contact
Tiberend Strategic Advisors, Inc.
Bill Borden
+1-732-910-1620
bborden@tiberend.com
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