SynKIR-110 / University of Pennsylvania, HLB Bio Group - LARVOL DELTA

Verismo Therapeutics Presents Promising Preclinical Data at SITC 2025 for SynKIR-110 in Solid Tumors (PRNewswire) - "Key Findings: (i) Enhanced Tumor-Specific Serial Killing: In vitro, SynKIR-110 showed sustained killing of MSLN-expressing tumor cells while minimizing off-target activation and cytokine release; (ii) Improved Anti-Tumor Activity: In NSG mouse models of mesothelioma, SynKIR-110 induced deep and prolonged regression of implanted tumors and metastatic spread."

Preclinical • Mesothelioma

Verismo Therapeutics to Announce Upcoming Presentations at SITC and ASH Annual Meetings (PRNewswire) - "The company will present new preclinical and translational data supporting the advancement of its clinical pipelines, SynKIR-110 and SynKIR-310."

Preclinical • Cholangiocarcinoma • Hematological Malignancies

Histopathologic analysis of mesothelin expression in cholangiocarcinoma supports inclusion in biomarker-targeted clinical trials (SITC 2025) - P1 | "SynKIR-110 is a MSLN-targeted KIR-CAR T cell therapy in a Phase 1 clinical trial treating patients with CCA, ovarian cancer, and mesothelioma (#NCT05568680).Acknowledgements Verismo Therapeutics would like to thank all patients who contributed to this study and those currently enrolled in the Phase 1 trial. We are also very thankful to the staff members of Tumor Tissue and Biospecimen Bank (TTAB), Pathology Clinical Service Center (PCSC) at the University of Pennsylvania for their help with sourcing tissue samples and conducting staining.Ethics Approval This study was approved by the University of Pennsylvania's Ethics Board and informed consent was obtained from all patients."

Biomarker • Clinical • IO biomarker • Biliary Cancer • Cholangiocarcinoma • Hematological Malignancies • Mesothelioma • Oncology • Ovarian Cancer • Solid Tumor • MSLN

A Novel NK-cell based Split-Signaling Killer Immunoglobulin Receptor (KIR)-Based CAR T Targeting Mesothelin, SynKIR-110, Shows Increased Safety Profile and Increased Efficacy in vitro and in vivo (SITC 2025) - "SynKIR-110 cell products also showed reduced activation and exhaustion markers expression at baseline.Conclusions SynKIR-110 T cells demonstrate superior anti-tumor activity and reduced non-specific activation and exhaustion compared to conventional 41BB-CD3z CAR T cells, both in vitro and in vivo. These results findings support SynKIR-110 as a promising candidate with improved safety and efficacy for targeting MSLN+ tumors."

Preclinical • Oncology • Solid Tumor • MSLN

A novel NK-cell based split-signaling killer immunoglobulin receptor (KIR)-based CAR T targeting mesothelin, synKIR-110, shows increased safety profile and increased efficacy in vitro and in vivo (SITC 2025) - "SynKIR-110 cell products also showed reduced activation and exhaustion markers expression at baseline.Conclusions SynKIR-110 T cells demonstrate superior anti-tumor activity and reduced non-specific activation and exhaustion compared to conventional 41BB-CD3z CAR T cells, both in vitro and in vivo. These results findings support SynKIR-110 as a promising candidate with improved safety and efficacy for targeting MSLN+ tumors."

Preclinical • Oncology • Solid Tumor • MSLN

The company will highlight STAR-101, an ongoing Phase 1 clinical trial of Verismo's lead pipeline SynKIR-110 in patients with advanced mesothelin-expressing cancers, including mesothelioma. (PRNewswire) - "STAR-101 (NCT05568680) is a multicenter, open-label, Phase 1 study designed to evaluate the safety, feasibility, and preliminary efficacy of SynKIR-110 in patients with advanced mesothelin-expressing tumors. The trial is the first to bring Verismo's multi-chain KIR-CAR platform into the clinic for solid tumors."

Trial status • Cholangiocarcinoma • Mesothelioma • Ovarian Cancer

SynKIR-CAR T Cell Advanced Research (STAR)-101 Phase 1 Clinical Trial for Patients with Advanced Mesothelin-expressing Mesothelioma, Ovarian Cancer, or Cholangiocarcinoma (IMIG 2025) - P1 | "Subjects will receive non-myeloablative lymphodepletion (NMA-LD) with cyclophosphamide and fludarabine, followed by a single intravenous infusion of SynKIR-110. Based upon our preclinical studies, SynKIR-110 represents a promising approach to overcoming the limitations of CAR T cells in mesothelioma and other solid tumors. References: 1. Beatty GL et al."

CAR T-Cell Therapy • Clinical • IO biomarker • Metastases • P1 data • Biliary Cancer • Cholangiocarcinoma • Hematological Malignancies • Mesothelioma • Oncology • Ovarian Cancer • Peritoneal Mesothelioma • Solid Tumor • MSLN

HLB Innovation to Present CAR-T Treatment Clinical Trial Progress at ASCO 2025 [Google translation] (HIT News) - "HLB Innovation's US subsidiary Verismo Therapeutics announced on the 5th that it had presented the progress of the phase 1 clinical trial (STAR-101) of the next-generation CAR-T treatment 'SynKIR-110' for solid cancer at the 'American Society of Clinical Oncology (ASCO) 2025' that closed on the 3rd (local time). The presentation was conducted in the form of a poster presentation in the 'Trials in Progress' session...The presentation was led by Professor Janos L. Tanyi of the Perelman School of Medicine at the University of Pennsylvania, who is leading the STAR-101 clinical trial. He introduced SynKIR-110’s mechanism of action, clinical design, patient selection criteria, and safety evaluation indicators on-site."

Trial status • Solid Tumor

SynKIR-CAR T cell advanced research (STAR)-101 phase 1 clinical trial for patients with advanced mesothelin-expressing ovarian cancer, mesothelioma, or cholangiocarcinoma. (ASCO 2025) - P1 | "Participants receive non-myeloablative lymphodepletion with cyclophosphamide and fludarabine, followed by a single intravenous infusion of SynKIR-110...2015 Jul; 3(7):815-26. PMID: 25941351."

CAR T-Cell Therapy • Clinical • Metastases • P1 data • Biliary Cancer • Cholangiocarcinoma • Gastroenterology • Hematological Malignancies • Mesothelioma • Oncology • Ovarian Cancer • Peritoneal Mesothelioma • Solid Tumor • MSLN

SynKIR-310 Provides a Novel Split-Signal CAR T Platform (KIR-CAR) Based upon Natural Killer Cell Signaling to Prolong Anti-Tumor Treatment in B-NHL (ASGCT 2025) - P1 | "Previously, we developed a multi-chain specific killer immunoglobulin-like receptor (KIR)-derived CAR T cell therapy, SynKIR-110, targeting mesothelin on solid tumors with enhanced anti-tumor function in a murine xenograft model of a CAR-resistant patient-derived mesothelioma, compared to 2nd generation (gen) CD3-based CAR T2. Wang, E. Cancer Immunol Res 3, 815-826 (2015) 3. Yucel, N. Molecular Therapy Vol 32 No 4S1 (April 2024) Abstract #189 Disease Focus of Abstract:Cancer Hematologic"

B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Mesothelioma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • IFNG • IL2 • LAMP1 • MSLN • TNFA

Improved Tumor Specificity of Mesothelin (MSLN)-Specific Killer Immunoglobulin Receptor (KIR)-Based Chimeric Antigen Receptor (CAR) T Cell Therapy SynKIR-110 (IMMUNOLOGY 2025) - "Overall SynKIR-110 demonstrates improved tumor specificity without the constitutive activation seen in SS1-41BBz. Further studies will explore the molecular pathways linked to enhanced tumor specificity, potency and exhaustion resistance of SynKIR-110.Keywords: Cells T Cells T Cells, Cytotoxic; Molecules Antigens/Peptides/Epitopes T Cell Receptors; Techniques/Approaches Gene Therapy"

IO biomarker • Gene Therapies • Oncology • Solid Tumor • MSLN

Verismo Therapeutics Announces Poster Presentation at ASCO 2025 (PRNewswire) - "Verismo Therapeutics...today announced a Trials in Progress poster presentation at the American Society of Clinical Oncology (ASCO), being held from May 30 – June 3, 2025 in Chicago, IL. Poster details are below."

P1 data • Trial status • Cholangiocarcinoma • Mesothelioma • Ovarian Cancer

A Long-Term Follow-Up Basket Study for Participants Treated with SynKIR Chimeric Antigen Receptor (CAR) T Cell Product (clinicaltrials.gov) - P=N/A | N=60 | Enrolling by invitation | Sponsor: Verismo Therapeutics | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Oncology

Verismo Therapeutics Completes Merger to Accelerate Clinical Development (PRNewswire) - "Verismo Therapeutics...today announced the completion of a merger in which the company has become a wholly-owned subsidiary of HLB Innovation...a publicly traded company in South Korea and a member of the HLB Group. The merger certificate is expected to be filed shortly...The merger will accelerate the clinical development of SynKIR-110 and SynKIR-310 for solid tumor and blood cancer patients, respectively, solidifying Verismo's and HLB Group's collective mission to advance its innovative KIR-CAR platform for patients worldwide....This merger aligns with HLB Group's strategic commitment to expanding its capabilities in next-generation cell therapies."

M&A • Hematological Malignancies • Solid Tumor

A Long-Term Follow-Up Basket Study for Participants Treated with SynKIR Chimeric Antigen Receptor (CAR) T Cell Product (clinicaltrials.gov) - P=N/A | N=60 | Not yet recruiting | Sponsor: Verismo Therapeutics

New trial • Pan tumor • Oncology

Long-Term Follow-Up Safety Study of Subjects Treated with SynKIR-110 in Cancer Studies (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Verismo Therapeutics | N=100 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Oncology

The people who invested in HLB Verismo range from pharmaceutical company owners to construction companies. [Google translation] (PRESS9) - "It has been confirmed that Verismo Therapeutics, a biotech company under the HLB Group, has attracted several investors in addition to affiliates of the HLB Group in Korea...HLB Innovation plans to invest approximately KRW 156.3 billion in the US corporation (HLBI USA) and provide it to Verismo shareholders. Verismo shareholders will use this fund to participate in a paid-in capital increase, acquire HLB Innovation new shares, and transfer Verismo shares to HLBI USA. After HLBI USA merges with Verismo in early November and disappears, Verismo will remain a 100% subsidiary of HLB Innovation....According to the evaluation opinion written by Shinwha Accounting Corporation, Verismo is expected to start generating full-scale sales from 2029, turn to operating profit and turn to positive corporate free cash flow (FCFF) in 2030. This figure is based on only the estimated sales of SynKIR-110 and SynKIR-310, which are currently in clinical trials."

Commercial • M&A • Hematological Malignancies • Oncology • Solid Tumor

HLB Innovation Acquires US CAR-T Developer Verismo as 100% Subsidiary [Google translation] (HIT News) - "HLB Innovation has begun the process of incorporating Verismo Therapeutics, a U.S. CAR-T treatment developer, as a wholly owned subsidiary...HLB Innovation announced on the 5th through a public disclosure on the 4th that its 100% US subsidiary HLBI USA will be conducting a triangular stock exchange and merger with Verismo. The transaction method is that HLB Innovation will participate in HLBI USA’s paid-in capital increase, and HLBI USA will then participate in HLB Innovation’s paid-in capital increase, and the common stocks of HLB Innovation acquired through this will be distributed to Verismo’s existing shareholders....After HLBI USA and Verismo complete the merger process, HLB Innovation will acquire a 100% stake in Verismo."

M&A • Cholangiocarcinoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Gastrointestinal Cancer • Gynecologic Cancers • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Mesothelioma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor

SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Verismo Therapeutics | Trial completion date: Mar 2026 ➔ Dec 2027 | Trial primary completion date: Mar 2026 ➔ Dec 2027

Metastases • Trial completion date • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Mesothelioma • Oncology • Ovarian Cancer • Solid Tumor • MSLN

Long-Term Follow-Up Safety Study of Subjects Treated With SynKIR-110 in Cancer Studies (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Verismo Therapeutics

New trial • Oncology

Preclinical Specificity and Potency Evaluation of a Novel CD19-Specific KIR-CAR T Cell Therapy (SynKIR-310) (ASGCT 2024) - P1 | "Previously we developed a multi-chain mesothelin-specific killer immunoglobulin-like receptor (KIR)-CAR T cell therapy, SynKIR-110, with enhanced anti-tumor function and durability in a murine xenograft model of human mesothelioma [1, 2]. Journal for ImmunoTherapy of Cancer, 2023. 11(Suppl 1): p. A365-A365."

CAR T-Cell Therapy • IO biomarker • Preclinical • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Mesothelioma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • CD19 • MSLN

Verismo Therapeutics Announces Submission of IND Application to the FDA for SynKIR-310 in Relapsed/Refractory B-cell NHL (PRNewswire) - "Verismo Therapeutics...announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its Phase 1 clinical trial of SynKIR-310, for the treatment of relapsed/refractory (r/r) B-cell Non-Hodgkin Lymphomas (B-cell NHL), including Diffuse Large B Cell lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL)....Pending regulatory approval, the company plans to initiate the clinical trial (named CELESTIAL-301) in 2024....Verismo's leading pipeline, SynKIR-110, is currently undergoing investigation in Phase 1 clinical trial (STAR-101) [NCT05568680] at two sites with plans to open two additional sites in Q2 2024."

IND • New P1 trial • New trial • Trial status • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Gastrointestinal Cancer • Gynecologic Cancers • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Mesothelioma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor

Verismo Therapeutics Announces Opening of Second Clinical Site for STAR-101 Phase 1 Trial (PRNewswire) - "Verismo Therapeutics...announced that it has activated a second clinical site for its STAR-101 Phase 1 clinical trial at The University of Texas MD Anderson Cancer Center. STAR-101 is a multi-center clinical trial designed to evaluate Verismo Therapeutic's lead candidate, SynKIR-110, for the treatment of mesothelin-overexpressing ovarian cancer, malignant pleural mesothelioma, and cholangiocarcinoma....Verismo achieved clearance from the FDA to initiate this multi-center clinical trial for SynKIR-110 and has partnered with the Hospital of the University of Pennsylvania as the first clinical site."

Trial status • Cholangiocarcinoma • Malignant Pleural Mesothelioma

Preclinical potency assessment of SynKIR-110, a mesothelin-specific KIR-CAR T cell therapy for mesothelioma (SITC 2023) - P1 | "These data support further clinical development of SynKIR-110 in patients with advanced solid tumors. SynKIR-110 is currently being investigated in a Phase I clinical trial STAR-101 (NCT05568680)."

CAR T-Cell Therapy • Preclinical • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Lung Cancer • Mesothelioma • Oncology • Ovarian Cancer • Solid Tumor • MSLN

Verismo Therapeutics Announces Upcoming Presentation at SITC 2023 (PRNewswire) - "Verismo Therapeutics...announced that it will be presenting at the upcoming Society for Immunotherapy of Cancer 38th Annual Meeting (SITC 2023)....We conducted in vivo potency studies to assess the impact of the engineered T cell dose of the first mesothelin (MSLN)-specific KIR-CAR T cell therapy (SynKIR-110) in an NSG mouse xenograft model of human mesothelioma. Our data demonstrate for the first time that anti-tumor efficacy of SynKIR-110 is dose-dependent with greater potency compared with MSLN-41BBz CAR T cells previously evaluated in the clinic. This enhanced potency of SynKIR-110 was observed both at the primary tumor site and metastatic sites as demonstrated by histopathologic analysis."

Preclinical • Mesothelioma