SynKIR-310 / HLB Bio Group - LARVOL DELTA

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 | "These results should provide insights into the correlation between in vitro and in vivo potency of SynKIR-310, building upon the mechanism for prolonged anti-tumor response observed in SynKIR-110, and supporting clinical development of SynKIR-310 for patients with relapsed/refractory B-NHL in a Phase 1 clinical trial (NCT06544265). Disease Focus of Abstract:Cancer Hematologic"

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

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 Announces First Patient Infused in Phase 1 CELESTIAL-301 Clinical Trial of SynKIR-310 (PRNewswire) - "Verismo Therapeutics...announced that it has dosed the first patient in its CELESTIAL-301 Phase 1 clinical trial. The patient was infused at Sarah Cannon Research Institute (SCRI) at Colorado Blood Cancer Institute (CBCI) in Denver, Colorado. CELESTIAL-301 aims to assess safety, tolerability, and preliminary efficacy of SynKIR-310 in patients with 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). The Phase 1 multicenter clinical trial is enrolling patients who previously received CAR T therapy but who have since relapsed or become refractory to it as well as patients who never received CAR T therapy."

Trial status • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma

Verismo Therapeutics Announces Strategic Partnership with IFLI to Support SynKIR-310 Development in Follicular Lymphoma (PRNewswire-Asia) - "Verismo Therapeutics...announced a strategic investment from the Institute for Follicular Lymphoma Innovation (IFLI), a global non-profit foundation dedicated to advancing treatment options for follicular lymphoma (FL). This partnership aims to enhance Verismo's SynKIR-310 pipeline and provide catalytic investment for the pipeline's FL arm, accelerating the development of next-generation cell therapies that address high unmet medical needs. The investment from IFLI will help advance Verismo's SynKIR-310 pipeline, which aims to treat FL along with other non-Hodgkin lymphoma (NHL) subtypes....Verismo will receive up to $4.05 million USD in investments from the Institute for Follicular Lymphoma Innovation (IFLI)."

Licensing / partnership • Follicular Lymphoma

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

Verismo Therapeutics Announces the Activation of its CELESTIAL-301 Clinical Trial at Colorado Blood Cancer Institute (PRNewswire) - "CELESTIAL-301 will assess safety, tolerability, and preliminary efficacy of SynKIR-310 in patients with 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)."

Trial status • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma

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

SynKIR-310 for Relapsed/Refractory B-NHL (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Verismo Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • BCL2

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-310 for Relapsed/Refractory B-NHL (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Verismo Therapeutics

New P1 trial • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • BCL2

Verismo announces non-clinical research results for ‘blood cancer CAR-T’ at the US ASGCT [Google translation] (HIT News) - "Verismo Therapeutics...attended the '2024 American Society of Gene & Cell Therapy' held in Baltimore, Maryland, USA from the 7th to the 11th (local time). It was announced on the 14th that major non-clinical research results related to blood cancer treatment were presented orally at 'ASGCT 2024)'....In the research presentation, the results of measuring the efficacy of SynKIR-310 on CD19 positive cells were introduced. First, as a result of evaluating the ability of SynKIR-310 to kill CD19 positive cells at various ratios (from 1:1 to 30:1), the lysis rate of SynKIR-310 clearly increased as the ratio of target cells increased. In addition, excellent anti-tumor effects were confirmed compared to the control group."

Preclinical • Hematological Malignancies • Oncology

Verismo Therapeutics Receives IND Clearance from the FDA for SynKIR-310 in Relapsed/Refractory B-cell NHL (PRNewswire) - "Verismo Therapeutics...announced that it has received a notification from the US Food and Drug Administration (FDA) that the Phase 1 clinical trial of SynKIR-310 for the investigation of NHL may proceed. The Phase 1 trial, named CELESTIAL-301, will assess safety, tolerability, and preliminary efficacy of SynKIR-310 in patients with 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)....Verismo plans to initiate the CELESTIAL-301 clinical trial in the second half of 2024."

IND • New P1 trial • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Verismo Therapeutics Announces Upcoming Presentation at ASGCT 2024 (PRNewswire) - "Verismo Therapeutics...announced that an abstract has been accepted for oral presentation at the upcoming American Society of Gene & Cell Therapy 2024 (ASGCT 2024), to be held in Baltimore on May 7-11, 2024....We will present preclinical data on the in vitro and in vivo studies of the novel KIR-CAR T cell therapy, SynKIR-310 with the new proprietary CD19 binder (DS191). The preclinical study data demonstrates that high CD19 antigen sensitivity, specificity, and potency of the novel binder DS191 combined with KIR-CAR supports SynKIR-310 as a promising T cell therapy against CD19-positive malignancies."

Preclinical • Oncology • Solid Tumor

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 announces next-generation CAR-T research results that increase lymphoma treatment response rate [Google translation] (HIT News) - "Verismo Therapeutics...an affiliate of HLB Group, presented the results of research on the lymphoma of CAR-T treatment developed using its CAR-T treatment platform 'KIR-CAR' by the American Association for Cancer Research. It was announced on the 9th that the poster will be presented at (AACR 2024)...The research results presented by Verismo at this AACR suggest the possibility of overcoming the limitations of existing CAR-T treatments....According to the published research abstract, Verismo demonstrated the anti-tumor function against blood cancer that appears when the new CD19 binder is combined with the KIR-CAR platform, along with basic experimental results such as the affinity and functional binding capacity of the newly discovered CD19 binder. We present the results of evaluation using a leukemia mouse model."

Preclinical • Hematological Malignancies • Leukemia • Lymphoma • Oncology

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 and University of Pennsylvania Discover Two Novel Binders Targeting CD19; Enter Licensing Agreement (PRNewswire) - "Verismo Therapeutics...announced that it had entered into a licensing agreement with the University of Pennsylvania for worldwide exclusive rights for two newly discovered anti-CD19 binders. The newly discovered binders are a result of the sponsored research agreement between Verismo and the University of Pennsylvania that was executed in 2022....Verismo will utilize one of these binders, DS191, as the basis for its SynKIR-310 product, a KIR-CAR T cell immunotherapy therapeutic for blood cancer, while reserving both binders for potential future partnering....Verismo plans to submit an IND for its SynKIR-310 product, which utilizes the DS191 binder, by the end of 2023 and to seek collaborations with key industry partners."

IND • Licensing / partnership • Hematological Malignancies • Oncology

Verismo Therapeutics Announces $17 million in a Second Pre-Series A with DongKoo Bio, HLB Innovation, and HLB as Lead Investors (PRNewswire) - "Verismo Therapeutics...today announced it has raised $17M in a second pre-Series A financing round. The financing will support continued advancement of the clinical trial for SynKIR™-110, a first-in-class KIR-CAR T cell immunotherapy candidate for solid tumors, and pre-clinical development of SynKIR™-310, a KIR-CAR T cell immunotherapy therapeutic for blood cancers...The funding will be used to advance multiple programs targeting solid and liquid tumors. With this $17M investment Verismo will have secured a total of $50M in financing since launching in 2020."

Financing • Biliary Tract Cancer • Cholangiocarcinoma • Diffuse Large B Cell Lymphoma • Gastrointestinal Cancer • Gynecologic Cancers • Hematological Malignancies • Lung Cancer • Lymphoma • Mesothelioma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor • Thoracic Cancer

Verismo Therapeutics Announces $7 Million Pre-Series A with BRV Capital Management as Lead Investor (PRNewswire) - "Verismo Therapeutics...announced a $7M pre-Series A financing round. The financing will support continued advancement of the clinical trial for SynKIR-110™, a first-in-class KIR-CAR T cell immunotherapy candidate for solid tumors, and pre-clinical development of SynKIR-310, a KIR-CAR T cell immunotherapy therapeutic for blood cancer....The funding round was led by BRV Capital Management (BRV Capital), a renowned institutional investment firm known for investing in blue chip biopharmaceutical companies such as Arvelle Therapeutics BV and ST Pharmaceutical."

Financing • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Gynecologic Cancers • Mesothelioma • Oncology • Ovarian Cancer • Solid Tumor