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

Initial results of a first in human dose-escalation study of KIR-CAR in patients with advanced mesothelin-expressing solid tumors (AACR 2026) - P1 | "Patients in dose cohorts 1-3 received a single intravenous dose of 1, 3, or 10 × 107 transduced SynKIR-110 T cells/m2, respectively, following lymphodepletion (LD) with cyclophosphamide and fludarabine; follow-up was for 12 months or until disease progression. MTD was not reached and dose-escalation enrollment is ongoing in this phase 1 FIH trial. Funding: Verismo Therapeutics"

Clinical • First-in-human • IO biomarker • Metastases • P1 data • Biliary Cancer • Cholangiocarcinoma • Mesothelioma • Oncology • Ovarian Cancer • Solid Tumor • HAVCR2 • IFNG • MSLN • PD-1 • TNFA

Verismo Therapeutics…announced a new preclinical KIR-CAR program targeting the clinically validated Claudin 6 (CLDN6) antigen to treat CLDN6-expressing solid tumors via a novel binder developed at the University of Pennsylvania Perelman School of Medicine (Penn) through a Verismo-sponsored research agreement. (PRNewswire) - "The new CLDN6 novel binder is the second binder discovered in collaboration with Penn....Verismo's KIR-CAR pipeline now spans two solid tumor antigens: mesothelin, targeted by the clinical-stage SynKIR-110 in the STAR-101 Phase 1 trial, and CLDN6, targeted by a new preclinical program."

Pipeline update • Oncology

Trio of Phase I Studies Investigates Mesothelin-Directed CAR T-Cell Therapies. (PubMed, Cancer Discov) - "At the American Association for Cancer Research Annual Meeting, researchers presented data from three separate phase I studies investigating distinct mesothelin-targeted chimeric antigen receptor T-cell therapies: SynKIR-110, UCMYM802, and M28z1XXPD1DNR."

Journal • P1 data • Oncology • MSLN

Verismo Therapeutics' Initial Clinical Data from STAR-101 Phase 1 Trial of SynKIR-110 KIR-CAR Presented at AACR 2026 Plenary Session (PRNewswire) - "The initial data showed on-target biologic activity based on KIR-CAR T cell expansion and persistence in patients and serum cytokine changes after SynKIR-110 infusion. Anti-tumor activity was observed at increased dose levels, with 1 of 3 patients at dose level 3 achieving a partial response per RECIST criteria that was ongoing after 3+ months at the interim data cut-off for this dataset, which was September 2025. The trial remains ongoing, with continued enrollment to evaluate safety and determine the recommended Phase 2 dose."

Late-breaking abstract • P1 data • Cholangiocarcinoma • Mesothelioma • Ovarian Cancer

Penn Medicine Showcases Breakthrough Research at AACR Annual Meeting 2026 (Bioengineer.org) - "Further into the meeting, riveting clinical data will be disclosed from the STAR-101 Phase 1 Clinical Trial, a pioneering study investigating KIR-CAR T cells in patients who have advanced mesothelin-expressing solid tumors such as ovarian cancer and cholangiocarcinoma."

First-in-human • P1 data • Cholangiocarcinoma • Ovarian Cancer

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