Simcha IL-18, Inc.

Studies will assess ST-067 in acute myeloid leukemia or myelodysplastic syndrome and in multiple myeloma Preclinical data to be presented at the 2024 American Society of Hematology (ASH) Annual Meeting & Exposition support the potential therapeutic use of ST-067 in hematologic cancers SOUTH SAN FRANCISCO, CA & NEW HAVEN, CT, USA I December 05, 2024 I Simcha Therapeutics (“Simcha”), a clinical-stage immunobiology company pioneering first-in-class cytokine treatments in cancer, today announced the opening of two clinical studies assessing the use of ST-067, Simcha’s decoy-resistant IL-18, in hematological indications. One study (ClinicalTrials.gov ID NCT06492707 ) will assess ST-067 in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), while the other study (ClinicalTrials.gov ID NCT06588660 ) will test ST-067 in combination with teclistamab (TECVAYLI®) in patients with multiple myeloma. “These two studies, both of which may rapidly generate clinical proof-of-concept data in indications where there is significant need for better therapies, represent a very exciting opportunity for us to explore additional therapeutic areas that have great potential to respond well to treatment with IL-18,” said Sanuj Ravindran, M.D., chief executive officer of Simcha. “Emerging data, including those included in our preclinical poster to be presented at ASH, are generating signals that serve as proof-of-concept and point to the therapeutic potential of IL-18 across various hematological cancers, so we are pleased to partner with leading hematologic cancer experts on these trials.” The AML/MDS study, under principal investigator Elizabeth Krakow, M.D., of Fred Hutch Cancer Center, is enrolling patients over 18 years of age who have persistent or recurrent AML or MDS after hematopoietic cell transplantation (HCT), also known as a bone marrow transplant. While HCT is the only curative therapy for most forms of AML or MDS, relapse occurs in approximately one-third of patients and is the most common cause of death following HCT. The Phase 1, open-label, dose-escalation study will primarily assess dose limiting toxicities and the number of clinical trial subjects who complete four consecutive weeks of treatment with ST-067. Secondary endpoints will assess response rates, overall survival and whether graft-versus-leukemia effects can be elicited without the accompanying graft-versus-host disease. The study assessing ST-067 in combination with teclistamab, a bi-specific antibody with T cell engagement activity, in patients 18 years of age or older with relapsed or refractory multiple myeloma is occurring under the direction of Rahul Banerjee, M.D., of the University of Washington and Fred Hutch Cancer Center. This open-label Phase 1b study will primarily assess dose-limiting toxicities of ST-067 alone and in combination with teclistamab, as well as optimal dosing and the incidence of adverse events. Secondary endpoints will include overall response rate, duration of response, progression-free survival, overall survival and measurable residual disease negativity. T-cell directed therapeutics, like teclistamab, other bi-specific antibodies or CAR Ts, have become standards of care for the treatment of relapsed/refractory multiple myeloma. However, they are not curative, as not all patients respond to teclistamab, and relapse can occur in those that do. The multiple myeloma study is based on the hypothesis that ST-067 in combination with teclistamab will promote T-cell fitness and persistence, which could increase the number of patients who respond to teclistamab and lengthen durations of response. Data to be highlighted at ASH in a poster presentation demonstrate the therapeutic activity of decoy-resistant IL-18 in multiple mouse models of hematological tumors including B-cell lymphoma, acute myeloid leukemia and plasma cell myeloma. The poster, entitled “Preclinical Efficacy of Decoy-Resistant IL-18 in Hematological Malignancies” will be presented during poster session 802 on Monday, December 9 from 6:00 PM to 8:00 PM. In addition, a trials in progress poster describing the AML/MDS study will be presented at ASH. The poster, entitled “Trials in Progress: Decoy-Resistant Interleukin-18 (DR-18) for Relapse or Pre-Emptive Treatment of Measurable Residual Disease after Allogeneic Hematopoietic Cell Transplantation in Patients with AML and MDS: DR. DREAM, a Phase I Trial (NCT06492707)” will be presented Monday, December 9 from 6:00 PM to 8:00 PM in poster session 701. About Simcha Therapeutics Simcha Therapeutics is a clinical-stage immunobiology company pioneering the development of first-in-class engineered cytokine therapeutics with transformational promise for patients. The company is built on a foundation of scientific rigor to overcome biological challenges in clinically translatable pathways, exemplified by the first decoy-resistant interleukin-18 (IL-18). By unlocking the potential of IL-18, Simcha is developing its lead program (ST-067) as monotherapy and in combination with other anticancer agents. ST-067 is currently being studied both as a monotherapy and in combination with KEYTRUDA® (pembrolizumab) in Phase 1/2 clinical trials, in patients with solid tumors and who have progressed on other immunotherapeutic agents. Simcha is exploring additional modalities for IL-18-based therapeutics to capture the full potential of this best-in-class cytokine. For more information, please visit www.simchatherapeutics.com . SOURCE: Simcha Therapeutics

SOUTH SAN FRANCISCO, Calif. & NEW HAVEN, Conn.--( BUSINESS WIRE )-- Simcha Therapeutics (“Simcha”), a clinical-stage immunobiology company pioneering first-in-class cytokine treatments in cancer, today announced the opening of two clinical studies assessing the use of ST-067, Simcha’s decoy-resistant IL-18, in hematological indications. One study (ClinicalTrials.gov ID NCT06492707 ) will assess ST-067 in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), while the other study (ClinicalTrials.gov ID NCT06588660 ) will test ST-067 in combination with teclistamab (TECVAYLI®) in patients with multiple myeloma. “These two studies, both of which may rapidly generate clinical proof-of-concept data in indications where there is significant need for better therapies, represent a very exciting opportunity for us to explore additional therapeutic areas that have great potential to respond well to treatment with IL-18,” said Sanuj Ravindran, M.D., chief executive officer of Simcha. “Emerging data, including those included in our preclinical poster to be presented at ASH, are generating signals that serve as proof-of-concept and point to the therapeutic potential of IL-18 across various hematological cancers, so we are pleased to partner with leading hematologic cancer experts on these trials.” The AML/MDS study, under principal investigator Elizabeth Krakow, M.D., of Fred Hutch Cancer Center, is enrolling patients over 18 years of age who have persistent or recurrent AML or MDS after hematopoietic cell transplantation (HCT), also known as a bone marrow transplant. While HCT is the only curative therapy for most forms of AML or MDS, relapse occurs in approximately one-third of patients and is the most common cause of death following HCT. The Phase 1, open-label, dose-escalation study will primarily assess dose limiting toxicities and the number of clinical trial subjects who complete four consecutive weeks of treatment with ST-067. Secondary endpoints will assess response rates, overall survival and whether graft-versus-leukemia effects can be elicited without the accompanying graft-versus-host disease. The study assessing ST-067 in combination with teclistamab, a bi-specific antibody with T cell engagement activity, in patients 18 years of age or older with relapsed or refractory multiple myeloma is occurring under the direction of Rahul Banerjee, M.D., of the University of Washington and Fred Hutch Cancer Center. This open-label Phase 1b study will primarily assess dose-limiting toxicities of ST-067 alone and in combination with teclistamab, as well as optimal dosing and the incidence of adverse events. Secondary endpoints will include overall response rate, duration of response, progression-free survival, overall survival and measurable residual disease negativity. T-cell directed therapeutics, like teclistamab, other bi-specific antibodies or CAR Ts, have become standards of care for the treatment of relapsed/refractory multiple myeloma. However, they are not curative, as not all patients respond to teclistamab, and relapse can occur in those that do. The multiple myeloma study is based on the hypothesis that ST-067 in combination with teclistamab will promote T-cell fitness and persistence, which could increase the number of patients who respond to teclistamab and lengthen durations of response. Data to be highlighted at ASH in a poster presentation demonstrate the therapeutic activity of decoy-resistant IL-18 in multiple mouse models of hematological tumors including B-cell lymphoma, acute myeloid leukemia and plasma cell myeloma. The poster, entitled “Preclinical Efficacy of Decoy-Resistant IL-18 in Hematological Malignancies” will be presented during poster session 802 on Monday, December 9 from 6:00 PM to 8:00 PM. In addition, a trials in progress poster describing the AML/MDS study will be presented at ASH. The poster, entitled “Trials in Progress: Decoy-Resistant Interleukin-18 (DR-18) for Relapse or Pre-Emptive Treatment of Measurable Residual Disease after Allogeneic Hematopoietic Cell Transplantation in Patients with AML and MDS: DR. DREAM, a Phase I Trial (NCT06492707)” will be presented Monday, December 9 from 6:00 PM to 8:00 PM in poster session 701. About Simcha Therapeutics Simcha Therapeutics is a clinical-stage immunobiology company pioneering the development of first-in-class engineered cytokine therapeutics with transformational promise for patients. The company is built on a foundation of scientific rigor to overcome biological challenges in clinically translatable pathways, exemplified by the first decoy-resistant interleukin-18 (IL-18). By unlocking the potential of IL-18, Simcha is developing its lead program (ST-067) as monotherapy and in combination with other anticancer agents. ST-067 is currently being studied both as a monotherapy and in combination with KEYTRUDA® (pembrolizumab) in Phase 1/2 clinical trials, in patients with solid tumors and who have progressed on other immunotherapeutic agents. Simcha is exploring additional modalities for IL-18-based therapeutics to capture the full potential of this best-in-class cytokine. For more information, please visit www.simchatherapeutics.com .