Autologous CD30 CAR-T cell therapy(Tessa Therapeutics Pte Ltd.)

78% Overall Response Rate (14/18 patients), including seven patients exhibiting a complete response to TT11X allogeneic CAR-T therapy Safety data encouraging with no graft-versus-host-disease and no neurotoxicity Updated data highlighted in podium presentation at the 17th International Conference on Malignant Lymphoma expand upon favorable results presented at 2022 Annual Meeting of American Society of Hematology (ASH) Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, today announced promising safety and efficacy data from a study of its off-the-shelf CD30.CAR EBVST therapy (TT11X) in patients with relapsed or refractory (R/R) Hodgkin lymphoma. The results were presented by Tessa collaborators at the Baylor College of Medicine in an oral podium presentation at the 17th International Conference on Malignant Lymphoma (ICML) taking place at Lugano, Switzerland. TT11X, Tessa’s allogeneic “off-the-shelf” cell therapy, is based on Tessa’s proprietary CD30.CAR-modified Epstein-Barr virus-specific T-cell (EBVST) platform. The podium presentation (#47), titled, “Off-the-shelf CD30.CAR EBV-specific T cells provide a safe and effective therapy for HL,” reported data from 18 heavily pre-treated patients with R/R Hodgkin lymphoma who were administered TT11X across four dosing levels (40 × 106 CD30.CAR EBVSTs, 100 × 106 CD30.CAR EBVSTs, 400 × 106 CD30.CAR EBVSTs, and 800 × 106 CD30.CAR EBVSTs). An overall response rate of 78% (14/18 patients) was observed across all four dose levels, including seven complete responses and seven partial responses, with higher doses producing improved clinical responses. Additionally, TT11X was demonstrated to be well tolerated with no dose-limiting toxicities observed, including no evidence of graft-versus-host disease (GVHD) or immune effector cell-associated neurotoxicity syndrome (ICANS). Six episodes of possible cytokine release syndrome were all grade one (mildest of four grades). “The data reported at ICML suggest that allogeneic CD30.CAR EBVSTs provide a potentially safe and efficacious treatment for CD30-positive lymphomas and affirm previously reported data indicating the technology may avert GVHD and immediate rejection even after multiple infusions,” stated Carlos Ramos, M.D., Professor at Center for Cell and Gene Therapy, Baylor College of Medicine, USA. “Importantly, CD30.CAR EBVSTs elicited a clinical response in 14 of 18 patients with R/R Hodgkin lymphoma including seven complete responses. Based on these results, CD30.CAR EBVSTs appear to be a promising platform for off-the-shelf cancer immunotherapy.” Tessa is currently advancing a pipeline of products that utilize CD30.CAR-modified EBVSTs, including its lead allogeneic cell therapy, TT11X, which is being co-developed with the Baylor College of Medicine for the treatment of relapsed or refractory CD30-positive lymphomas. Tessa’s proprietary “off-the-shelf” CD30.CAR EBVST allogeneic cell therapy platform is based on decades-long research and development by researchers at Baylor College of Medicine into the unique properties of virus-specific T-cells (VSTs). These highly specialized T cells have the ability to recognize and kill infected cells while activating other parts of the immune system for a coordinated response. CD30-CAR Allogeneic VSTs without further genetic modification have demonstrated a strong safety profile and efficacy in early trials with minimal risk of GVHD. “The data presented at ICML are very promising and further validate our “off-the-shelf” CD30.CAR EBVST allogeneic cell therapy platform in R/R Hodgkin lymphoma,” stated Ivan Horak, M.D., Chief Medical Officer and Chief Scientific Officer of Tessa Therapeutics. “Tessa is steadfastly focused on advancing the development of TT11X as a potential treatment for CD30-positive lymphomas, while targeting opportunities to extend the EBVST platform to other cancer indications and enhance the cell performance and durability of the technology.” 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. A therapy using 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. The content above comes from the network. if any infringement, please contact us to modify.

Objective response observed in 9/10 patients and complete response observed in 7/10 patientsNo 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 TherapeuticsTessa 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. Cautionary Note on Forward Looking Statements 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 Dave Schemelia +1-609-468-9325 dschemelia@tiberend.com