SOCS1

Phase 1/2 clinical study will evaluate the safety and preliminary efficacy of KSQ-004EX in advanced solid tumorsLEXINGTON, Mass., Sept. 24, 2024 (GLOBE NEWSWIRE) -- KSQ Therapeutics, Inc. (KSQ), a clinical-stage biotechnology company developing novel treatments for solid tumors, in collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) and the Cell Therapy Manufacturing Center (CTMC), today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for a Phase 1/2 clinical study of KSQ-004EX, KSQ’s second engineered tumor-infiltrating lymphocyte (eTIL®) program. KSQ-004EX consists of TIL in which the genes encoding SOCS1 and Regnase-1 are inactivated using CRISPR/Cas9 gene editing. KSQ’s CRISPRomics® platform identified SOCS1 and Regnase-1 as key regulators of anti-tumor potency and persistence of TIL in preclinical models, providing KSQ-004EX with best-in-class potential in the treatment of advanced solid tumor indications. “As we continue to learn more about the biology of our eTIL candidates, we gain confidence that they can redefine the treatment of solid tumors, including difficult-to-treat cancers. We’re excited to bring an additional therapy into the clinic with the experts at MD Anderson, where this study will be initiated,” said Qasim Rizvi, Chief Executive Officer of KSQ. “Solid tumor treatment continues to be a significant challenge in oncology. The ability to offer patients a novel cell therapy is encouraging,” said Rodabe Amaria, M.D., professor of Melanoma Medical Oncology at MD Anderson and principal investigator of the KSQ-004EX study. “The preclinical KSQ-004EX data is promising, and we look forward to exploring the potential of KSQ’s dual-edited TIL.” Phase 1/2 Trial Design The Phase 1/2 clinical trial is an open-label, dose-escalation study for patients with select advanced solid tumors. The primary objective of the Phase 1 portion of the trial is to evaluate the safety and tolerability of KSQ-004EX. The primary objective of Phase 2 is to evaluate anti-tumor activity in multiple indication-specific cohorts. About KSQ-004EX KSQ-004EX, an eTIL® cell therapy in which TIL are edited to inactivate the genes encoding SOCS1 and Regnase-1, has the potential to revolutionize the treatment of solid tumors. In preclinical studies, KSQ-004EX demonstrated enhanced anti-tumor function in solid tumor models refractory to PD-1 inhibition. KSQ-004EX is manufactured by CTMC using KSQ’s ExPRESS™ process using patient tumor samples, including core biopsies, as starting material. About KSQ Therapeutics KSQ Therapeutics is advancing a pipeline of tumor- and immune-focused drug candidates to treat cancer across multiple drug modalities, including targeted therapies, adoptive cell therapies, and immunotherapies. KSQ's proprietary CRISPRomics® discovery engine enables genome-scale, in vivo validated, unbiased target discovery across broad therapeutic areas. For more information, please visit www.ksqtx.com and follow us on LinkedIn and X. KSQ Media Contact: Cory Trombleecory@scientpr.com

June 12, 2024 -- KSQ Therapeutics, Inc. (KSQ), a clinical-stage biotechnology company developing treatments for solid tumors, today announced the first patient dosed in the Phase 1/2 clinical study of KSQ-001EX, a novel edited TIL therapy. KSQ-001EX consists of TIL in which the SOCS1 gene is inactivated by CRISPR/Cas9 gene editing, giving it the potential to be a best-in-class treatment for a variety of solid tumor indications. KSQ's CRISPRomics® platform identified SOCS1 as a key gene inhibiting T cell growth, survival, and differentiation by negatively regulating cytokine signaling in the tumor microenvironment. "TIL have emerged as a powerful new treatment modality, and we believe both of our eTIL® programs, KSQ-001EX and KSQ-004EX, have the potential to significantly advance the field by improving the potency of TIL therapy for the treatment of a variety of solid tumor types. In preclinical studies, KSQ-001EX demonstrated enhanced anti-tumor activity, polyclonality, persistence, and memory formation in multiple solid tumor models compared to unmodified TIL. We also saw robust anti-tumor activity in models insensitive to PD-1 inhibition,” said Qasim Rizvi, Chief Executive Officer of KSQ. “We look forward to evaluating KSQ-001EX in patients with difficult-to-treat solid tumors, including melanoma, head and neck squamous cell carcinoma, and non-small cell lung cancer.” The first patient treated with KSQ-001EX was enrolled by Rodabe Amaria, M.D., professor of Melanoma Medical Oncology and principal investigator of the study at The University of Texas MD Anderson Cancer Center. The Phase 1/2 clinical trial is an open-label, safety lead-in study for patients with melanoma, head and neck squamous cell carcinoma (HNSCC), and non-small cell lung cancer (NSCLC). The primary objective of the Phase 1 portion of the trial is to evaluate the safety and tolerability of KSQ-001EX. In the safety lead-in portion, a cohort of patients will be initially dosed without IL-2. The primary objective of Phase 2 is to evaluate antitumor activity in indication-specific cohorts. KSQ’s lead eTIL® cell therapy program, KSQ-001EX, in which TIL are edited to inactivate the SOCS1 gene, has the potential to revolutionize the treatment of solid tumors. In preclinical studies, KSQ-001EX demonstrated enhanced anti-tumor function in solid tumor models refractory to PD-1 inhibition, as well as enhanced persistence and memory formation. KSQ Therapeutics is advancing a pipeline of novel drug candidates to treat cancer across multiple drug modalities, including targeted therapies, adoptive cell therapies, and immunotherapies. KSQ's proprietary CRISPRomics® discovery engine enables genome-scale insights driving novel therapeutic discovery. For more information, please visit the company's website at www.ksqtx.com. The content above comes from the network. if any infringement, please contact us to modify.

Phase 1/2 clinical study will evaluate the safety, pharmacokinetics, and preliminary efficacy of KSQ-001EX in melanoma, head and neck squamous cell carcinoma, and non-small cell lung cancerLEXINGTON, Mass., Nov. 29, 2023 (GLOBE NEWSWIRE) -- KSQ Therapeutics, Inc. (KSQ), a clinical-stage biotechnology company developing novel treatments for solid tumors, in collaboration with The University of Texas MD Anderson Cancer Center and the Cell Therapy Manufacturing Center (CTMC), today announced the Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for a Phase 1/2 clinical study of KSQ-001EX, KSQ’s lead engineered tumor-infiltrating lymphocyte (eTIL®) program. KSQ-001EX consists of TILs in which the SOCS1 gene is inactivated by CRISPR/Cas9 gene editing. KSQ's CRISPRomics® platform identified SOCS1 as a key gene regulating the anti-tumor potency and persistence of TIL and provides KSQ-001EX with best-in-class potential in the treatment of solid tumors. "Our team has made great progress advancing our KSQ-001EX and KSQ-004EX eTIL® programs. Through our platform insights, we've identified how to enhance the effectiveness of T cells in the treatment of solid tumors. We believe our eTIL® cell therapies have tremendous potential to benefit patients with cancer who have limited treatment options. We look forward to working closely with the clinical experts at MD Anderson, where the study will be initiated,” said Qasim Rizvi, Chief Executive Officer of KSQ. “Our partnership with CTMC has yielded a robust manufacturing process for our eTIL® cell therapy that is derived from patient tumor samples, including core biopsies. The collaborative effort allowed the IND to be submitted in an accelerated timeframe.” “New treatment options are urgently needed in melanoma and other solid tumors, and the potential to improve outcomes and patient experience is very exciting. KSQ-001EX exhibited considerable efficacy in preclinical studies,” said Rodabe Amaria, M.D., professor of Melanoma Medical Oncology at MD Anderson and principal investigator of the KSQ-001EX study. “We look forward to working closely with KSQ as we advance this program.” Phase 1/2 Trial Design The Phase 1/2 clinical trial is an open-label, safety lead-in study for patients with melanoma, head and neck squamous cell carcinoma (HNSCC), and non-small cell lung cancer (NSCLC). The primary objective of the Phase 1 portion of the trial is to evaluate safety and tolerability of KSQ-001EX. In the safety lead-in portion, a cohort of patients will be initially dosed without IL-2. The primary objective of Phase 2 is to evaluate antitumor activity in indication-specific cohorts. About KSQ-001EX KSQ’s lead eTIL® cell therapy program, KSQ-001EX, in which TILs are edited to inactivate the SOCS1 gene, has the potential to revolutionize the treatment of solid tumors. In preclinical studies, KSQ-001EX demonstrated enhanced anti-tumor function in solid tumor models refractory to PD-1 inhibition, as well as enhanced persistence, and memory formation. About KSQ Therapeutics KSQ Therapeutics is advancing a pipeline of novel drug candidates to treat cancer across multiple drug modalities, including targeted therapies, adoptive cell therapies, and immunotherapies. KSQ's proprietary CRISPRomics® discovery engine enables genome-scale insights driving novel therapeutic discovery. For more information, please visit the company's website at www.ksqtx.com. KSQ Media Contact: Cory Trombleecory@scientpr.com