VET3-TGI / KaliVir - LARVOL DELTA

Mechanisms of synergy between TGF-beta inhibitor and IL12 expression from the systemically deliverable clinical oncolytic immunotherapy VET3-TGI (ASGCT 2025) - "This data led to the selection of VET3-TGI as a lead clinical candidate and clinical testing has begun. Disease Focus of Abstract:Cancer Solid Tumors"

Clinical • IO biomarker • Oncolytic virus • Oncology • Solid Tumor • IFNG • IL12A • TGFB1 • TGFBI

KaliVir Immunotherapeutics Announces Completion of First Cohort of STEALTH-001 Study Evaluating VET3-TGI in Patients with Advanced Solid Tumors (Businesswire) - "KaliVir Immunotherapeutics...announced the successful completion of the first cohort in its STEALTH-001 study, a Phase 1/1b clinical trial of VET3-TGI for patients with incurable, advanced solid tumors....The Data Safety Committee, charged with monitoring the safety and overall risk-benefit of treatment on the STEALTH-001 (NCT06444815) clinical study, convened following dosing of the first cohort in the dose-escalation portion of the study, and approved continuation of dosing for the next intratumoral (IT) and intravenous (IV) infusion cohorts....The STEALTH-001 trial is a dose escalation and expansion study evaluating VET3-TGI administered through direct IT injection and IV infusion. The trial is evaluating VET3-TGI as a monotherapy and in combination with a checkpoint inhibitor in patients with pathologically confirmed, advanced, unresectable or metastatic solid tumors."

Trial status • Solid Tumor

Mechanisms of synergy between TGF-beta inhibitor and IL12 expression from the systemically deliverable clinical oncolytic immunotherapy VET3-TGI (AACR 2025) - "In addition, toxicity studies demonstrated the safety of VET3-TGI in mouse models. This data led to the selection of VET3-TGI as a lead clinical candidate and clinical testing has begun."

Clinical • IO biomarker • Oncolytic virus • Oncology • Solid Tumor • IFNG • IL12A • TGFB1 • TGFBI

KaliVir Immunotherapeutics Announces Details of Presentation at 2025 American Association for Cancer Research (AACR) Annual Meeting (Businesswire) - "KaliVir Immunotherapeutics...announced the upcoming presentation of a poster at the American Association for Cancer Research (AACR) Annual Meeting....The presentation will focus on the company’s clinical oncolytic immunotherapy, VET3-TGI, for patients with incurable, advanced solid tumors. VET3-TGI is a novel oncolytic immunotherapy which is designed to systemically target and selectively kill tumor cells while also expressing an immuno-stimulatory transgene payload consisting of interleukin-12 and a TGFbeta inhibitor."

Clinical • Oncology • Solid Tumor

KaliVir Immunotherapeutics Strengthens Innovation Portfolio with Issuance of Three New U.S. Patents Covering Its VET Product Candidates (GlobeNewswire) - "-KaliVir Immunotherapeutics...announced the expansion of its patent portfolio with the addition of three new patents recently issued by the United States Patent and Trademark Office. The patents (No. 11,963,990, 12,016,893 and 12,036,257) cover novel modifications to enhance tumor targeting, immune modulation and systemic delivery of oncolytic viruses....The newly patented technologies are being applied to KaliVir's pipeline of oncolytic virus candidates, including VET3-TGI..."

Patent • Oncology • Solid Tumor

Matica Biotechnology Establishes CDMO Partnership with KaliVir Immunotherapeutics (Businesswire) - "Matica Biotechnology Inc...announced the signing of a Letter of Intent (LOI) with KaliVir Immunotherapeutics...KaliVir is at the forefront of developing novel cancer therapies using its proprietary Vaccinia Enhanced Template (VET) platform. This platform allows for the expression and systemic delivery of multiple therapeutic transgenes. KaliVir’s lead clinical candidate, VET3-TGI, expresses interleukin-12 and a TGFbeta inhibitor. Under this new partnership, Matica Bio will utilize its proprietary cell line, MatiMax, to explore a new manufacturing process for KaliVir’s oncolytic virus product."

Commercial • Oncology

KaliVir Immunotherapeutics Doses First Patient in Phase 1/1b Trial of VET3-TGI for Incurable, Advanced, Solid Tumors (Businesswire) - "KaliVir Immunotherapeutics, Inc...announced that the first patient has been dosed in its STEALTH-001 study, a Phase 1/1b clinical trial of VET3-TGI for patients with incurable, advanced solid tumors."

Trial status • Oncology • Solid Tumor

STEALTH-001: A Study of VET3-TGI in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: KaliVir Immunotherapeutics | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Cervical Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

KaliVir Immunotherapeutics Announces FDA Clearance of Investigational New Drug (IND) for Oncolytic Immunotherapy VET3-TGI for Solid Tumors (Businesswire) - "KaliVir Immunotherapeutics, Inc...announced that the FDA has cleared the Investigational New Drug (IND) application for the STEALTH-001 study of VET3-TGI in patients with incurable, advanced solid tumors....The Phase 1/1b study (ClinicalTrials.gov ID NCT06444815) will evaluate the safety profile and efficacy of VET3-TGI when administered through intravenous infusion or intratumoral injection in patients with advanced, incurable solid tumors."

IND • Cervical Cancer • Colorectal Cancer • Kidney Cancer • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

STEALTH-001: A Study of VET3-TGI in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: KaliVir Immunotherapeutics

Combination therapy • Metastases • New P1 trial • Cervical Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

The Clinical Oncolytic Virotherapy, VET3-TGI, Displays Potent Therapeutic Activity in Multiple Mouse Tumor Models through Blocking TGF-Beta and Augmenting Type-1 Immune Response (ASGCT 2024) - "This data led to the selection of VET3-TGI as a lead clinical candidate. A human version has been manufactured for clinical use."

IO biomarker • Oncolytic virus • Preclinical • Oncology • Solid Tumor • CXCR3 • IL12A • TGFB1 • TGFBI

KaliVir Announces Opening of GMP Cleanroom Facility, Increasing Manufacturing Capacity for Oncolytic Viruses (Businesswire) - "KaliVir Immunotherapeutics...has unveiled its state-of-the-art GMP cleanroom facility to manufacture its pipeline of oncolytic viruses. KaliVir has already successfully executed the inaugural manufacturing run for its lead clinical candidate, VET3-TGI....KaliVir's GMP manufacturing facility includes a cleanroom spanning over 1,000 square feet. The facility is equipped with the iCellis 500 bioreactor, hyperstack, filtration and chromatography capabilities and is supported by KaliVir’s comprehensive quality, process development and analytical development capabilities."

Commercial • Oncology

Novel oncolytic viral immunotherapy VET3-TGI displays enhanced systemic delivery and inhibits TGFb-signaling while augmenting type-1 immune response in the tumor (SITC 2023) - "Conclusions Altogether, VET3-TGI demonstrated good ability to counter TGFb1 mediated immunosuppression and dramatically enhanced anti-tumor immune responses leading to safe and potent therapeutic activity in multiple mouse tumor models. Based on the above, VET3-TGI was selected as a lead clinical candidate and clinical manufacture and toxicology testing is undergoing with a human version of this virus."

IO biomarker • Oncolytic virus • Oncology • CD8 • CXCR3 • IL12A • TGFB1

KaliVir Immunotherapeutics Announces New In Vivo Data Demonstrating Superior Therapeutic Efficacy of VET3-TGI at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting (PRNewswire) - "KaliVir Immunotherapeutics...announced the presentation of new data on its lead pre-clinical candidate VET3-TGI at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting....The functionality and therapeutic activity of VET3-TGI were tested in multiple models, and the mechanism of action and toxicity profile were assessed. VET3-TGI was compared to control virus in three pre-clinical in vivo tumor models, and demonstrated potent therapeutic activity, including 100% complete responses, even at several logs below equivalent clinical doses and in the presence of pre-existing anti-viral immunity."

Preclinical • Oncology

Novel Oncolytic Therapy VET3-TGI Restricts TGFb1 and Augments Type-1 Immune Response in TME, Leading to Superior Therapeutic Efficacy in Multiple Preclinical Tumor Models (ASGCT 2023) - "Based on the above, VET3-TGI is selected as the lead clinical candidate for upcoming clinical trials. Currently, clinical manufacture and toxicology testing is undergoing with a human version of this virus."

IO biomarker • Preclinical • Oncology • CD8 • CXCR3 • GZMB • IFNG • IL12A • TGFB1 • TGFBI

KaliVir Immunotherapeutics Announces Presentation at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting (PRNewswire) - "KaliVir Immunotherapeutics, Inc...announced that its Director of Immunology, Ravikumar Muthuswamy, Ph.D., will present...an overview of data on its lead pre-clinical candidate, VET3-TGI, in an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting. The presentation is on Friday, May 19, 2023 at 5:15 PM PST."

Preclinical • Oncology

The oncolytic virus VET3-TGI both blocks TGF-beta signaling and activates type 2 IFN responses, resulting in potent therapeutic responses in multiple mouse models (AACR 2023) - "VET3-TGI demonstrated an ability to reduce immunosuppression and dramatically enhance antitumor immune response leading to safe and potent therapeutic activity in multiple mouse tumor models. This data led to the selection of VET3-TGI as our lead clinical candidate. A human version of the virus is currently undergoing clinical manufacture and toxicology testing."

IO biomarker • Oncolytic virus • Preclinical • Oncology • CD8 • CXCR3 • IFNG • IL12A • TGFB1 • TGFBI

KaliVir Immunotherapeutics Announces New In Vivo Data Demonstrating Potent Therapeutic Activity for Oncolytic Therapy VET3-TGI at the American Association for Cancer Research (AACR) Annual Meeting (PRNewswire) - "KaliVir Immunotherapeutics, Inc...announced the presentation of new data on its lead pre-clinical candidate VET3-TGI presented in a poster session at the American Association for Cancer Research (AACR) in Orlando, Florida....VET3-TGI demonstrated potent therapeutic activity, even at doses several logs below equivalent clinical doses and in the presence of pre-existing anti-viral immunity. Mechanism of action studies confirmed enhanced IL-12 expression and reduced suppression of CD8 T cells mediated through blockade of TGF-β, and indicate that the therapeutic efficacy of VET3-TGI is associated with considerable modification of the tumor microenvironment. The data presented at AACR also includes preliminary toxicity studies demonstrating the safety of VET3-TGI."

Preclinical • Oncology

A novel oncolytic immunotherapy, VET3-TGI, overcomes TGFB1 mediated immunosuppression, augments type-1 immune response, and displays potent therapeutic activity in multiple mouse tumor models. (SITC 2022) - "A human version of the virus is currently undergoing clinical manufacture and toxicology testing. Ethics Approval Animal studies were approved by IACUC, Hilltop animal center"

IO biomarker • Oncolytic virus • Preclinical • Oncology • CD8 • CXCR3 • IFNG • IL12A • TGFB1 • TGFBI

KaliVir Immunotherapeutics Announces Pre-Clinical Data for Oncolytic Therapy VET3-TGI at the Society for Immunology of Cancer (SITC) 37th Annual Meeting (PRNewswire) - "KaliVir Immunotherapeutics...announced the presentation of data on its lead pre-clinical candidate VET3-TGI presented in a poster session at the 37th Annual Meeting of the Society for Immunology of Cancer (SITC)....Using multiple in vivo mouse tumor models, the functionality and therapeutic activity of VET3-TGI were tested and the mechanism of action and toxicity profile were explored....This systemic delivery resulted in between 60 to 90% complete responses in different immunocompetent mouse tumor models."

Preclinical • Oncology

KaliVir Immunotherapeutics to Present at 14th International Oncolytic Virotherapy Conference (IOVC) (PRNewswire) - "KaliVir Immunotherapeutics, Inc...announced that Dr. Stephen Thorne, Co-Founder and CSO, will present data on its product candidate VET3-TGI at the 14th International Oncolytic Virotherapy Conference (IOVC), taking place October 23-26, 2022, in Karuizawa, Nagano, Japan."

Preclinical • Oncology • Solid Tumor

KaliVir Immunotherapeutics to Present Data on its Novel Pre-Clinical Oncolytic Therapy VET3-TGI at the Society for Immunology of Cancer (SITC) Annual Meeting (PRNewswire) - "KaliVir Immunotherapeutics, Inc....today announced that it will be presenting data on its product candidate VET3-TGI at the 37th Annual Meeting of the Society for Immunology of Cancer (SITC), taking place November 8-12, 2022 in Boston, Massachusetts."

Preclinical • Oncology • Solid Tumor