SVV-001 / Seneca Therap - LARVOL DELTA

A Phase 1 Trial of the Oncolytic Virus SVV-001 with Nivolumab and Ipilimumab in Patients with High Grade Neuroendocrine Neoplasms. (ESMO 2026) - No abstract available

Clinical • Oncolytic virus • P1 data • Endocrine Cancer • Neuroendocrine Neoplasm • Oncology • Solid Tumor

A phase 1 trial of the oncolytic virus SVV-001 with nivolumab and ipilimumab in patients with high-grade neuroendocrine neoplasms. (ASCO 2026) - P1 | "Additional exploratory analyses will characterize the tumor immune microenvironment and gut microbiome markers in the dose-expansion cohort. ClinicalTrials.gov Identifier: NCT06889493."

Clinical • IO biomarker • Oncolytic virus • P1 data • Endocrine Cancer • Neuroendocrine Carcinoma • Neuroendocrine Neoplasm • Neuroendocrine Tumor • Solid Tumor

A Phase 1 Trial of the Oncolytic Virus SVV-001 with Nivolumab and Ipilimumab in Patients with High Grade Neuroendocrine Neoplasms. (NANETS 2025) - P1 | "NCT06889493 RESULTS This Phase 1 trial is active at University of Miami and plans to expand the trial to other cancer centers in the US. CONCLUSIONS N/A"

Clinical • IO biomarker • Oncolytic virus • P1 data • Endocrine Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Solid Tumor

A phase 1 trial of the oncolytic virus SVV-001 in combination with nivolumab and ipilimumab in patients with poorly differentiated neuroendocrine carcinomas or well-differentiated grade 3 neuroendocrine tumors. (ASCO-GI 2026) - P1 | "Following dose escalation, an expansion cohort will further evaluate safety and preliminary signals of activity. Tumor endothelial marker 8 (TEM8), a potential biomarker of SVV-001 sensitivity, will be assessed as part of correlative studies."

Clinical • Combination therapy • IO biomarker • Oncolytic virus • P1 data • Gastrointestinal Cancer • Oncology • Solid Tumor

Clinical trial tests virus-immunotherapy combination for neuroendocrine tumors (Medical Xpress) - "The ongoing study has completed its first three dose levels with no severe treatment-related side effects reported to date. It looks at escalating doses of a drug combination that may benefit patients with high-grade neuroendocrine tumors....In the next phase of the study, participants will receive up to six doses of SVV-001 injections followed by immunotherapy. After completion, the study will expand at the optimal dose level. Researchers are continuing to enroll patients as the trial advances through early study phases."

P1 data • Trial status • Neuroendocrine Tumor

A clinical trial for patients with high-grade neuroendocrine tumors is now open for enrollment at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine. (Medical News) - "In the new trial, Chauhan will combine immunotherapy drugs called checkpoint inhibitors with SVV-001 (Seneca Valley Virus-001), an oncolytic virus that has been tested for safety in previous trials....The new phase 1 trial will enroll about 36 people whose tumors have become resistant to or failed previous lines of therapy."

Trial status • Neuroendocrine Carcinoma • Neuroendocrine Tumor

A phase I trial of the oncolytic virus svv-001 with nivolumab and ipilimumab in patients with high-grade neuroendocrine neoplasms (ENETS 2026) - P1 | "The interim data demonstrate an acceptable safety profile and encouraging signs of efficacy in a disease represen - ting a significant unmet medical need. NCT06889493"

Clinical • IO biomarker • Oncolytic virus • P1 data • Anorexia • Dental Disorders • Endocrine Cancer • Hepatology • Neuroendocrine Carcinoma • Neuroendocrine Neoplasm • Neuroendocrine Tumor • Solid Tumor • Xerostomia

A phase 1 Trial of the Oncolytic Virus SVV-001 in Combination with Nivolumab and Ipilimumab in patients with high grade neuroendocrine neoplasms (SITC 2025) - "The Clinical Trial Identifier is NCT06889493Trial Registration Clinical Trial Identifier: NCT06889493Ethics Approval The study was approved by the institutional review boards and conducted in accordance with International Conference on Harmonization Good Clinical Practice Guidelines (ICH-GCP) and the Declaration of Helsinki. Study participation is voluntary and all enrolled patients have signed a consent form before taking part in the trial."

Clinical • Combination therapy • IO biomarker • Oncolytic virus • P1 data • Endocrine Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Solid Tumor

A phase I trial of the oncolytic virus SVV-001 in combination with nivolumab and ipilimumab in patients with poorly differentiated neuroendocrine carcinomas or well-differentiated grade 3 neuroendocrine tumors (ESMO 2025) - P1 | "Following dose escalation, an expansion cohort will further evaluate safety and preliminary signals of activity. Tumor endothelial marker 8 (TEM8), a potential biomarker of SVV-001 sensitivity, will be assessed as part of correlative studies."

Clinical • Combination therapy • IO biomarker • Oncolytic virus • P1 data • Endocrine Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Solid Tumor

SVV-001 + Ipi-Nivo in Patients With Poorly Differentiated NEC or Well-Differentiated High-Grade NET (YouTube) - "Dr. Aman Chauhan...discusses SVV-001 + Ipi-Nivo in Patients With Poorly Differentiated (NEC) or Well-Differentiated High-Grade (NET) tumors."

Video

SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET) (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Aman Chauhan, MD | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

SVV-001 with Nivolumab and Ipilimumab in Patients with Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET) (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Aman Chauhan, MD

New P1 trial • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Dr. Paul Hallenbeck, CSO and President of Seneca Therapeutics to Present at World Vaccine Congress November 28, 2023 (GlobeNewswire) - "Seneca Therapeutics, Inc., announced today Dr. Paul Hallenbeck will present a talk...during the World Vaccine Congress in Santa Clara, CA on November 28, 2023. In his talk, Dr. Hallenbeck will present data on the development of multiple IV technology for SVV-001, a clinical stage oncology product."

Clinical • Oncology

Seneca Therapeutics Announces Publication of TEM8 Review Article “TEM8 in Oncogenesis” in Cells Journal (Businesswire) - "Seneca Therapeutics, Inc., announced today the publication of 'TEM8 in Oncogenesis' in Cells....'In the article, we underline TEM8’s prognostic and predictive abilities in various solid tumors by highlighting its association with more aggressive disease biology and poor clinical outcomes and assessing its associated clinical trial landscape'...This review article provides an excellent update on both TEM8, ANTXR1 - the gene that encodes TEM8 - and SVV-001 which targets TEM8."

Clinical • Oncology • Solid Tumor

mNTX-250, a novel multimodal HPV-16 mRNA-based therapeutic, induces potent anti-tumor responses and establishes HPV-16 specific immune memory (SITC 2023) - "Methods In this study, we studied in vivo efficacy, pharmacodynamics and the establishment of antigen-specific immune memory against HPV-16 antigens of mNTX-250 (a murine surrogate of NTX-250), in comparison with NTX-010 (consisting of noncoding mRNA, murine IL-12 and murine LIGHT) in C3. Conclusions mNTX-250 demonstrated significant antitumor efficacy in the C3. 43 tumor model and generated HPV-16 antigen specific immune memory that was sufficient to protect the host from re-challenge with another HPV-16 driven tumor."

Cervical Cancer • Oncology • Solid Tumor • IL12A

Oncolytic virotherapies for pediatric tumors. (PubMed, Expert Opin Biol Ther) - "We reviewed seven virus types that have been investigated in past or ongoing pediatric tumor clinical trials: adenovirus (AdV-tk, Celyvir, DNX-2401, VCN-01, Ad-TD-nsIL-12), herpes simplex virus (G207, HSV-1716), vaccinia (JX-594), reovirus (pelareorep), poliovirus (PVSRIPO), measles virus (MV-NIS), and Senecavirus A (SVV-001). However, the antitumor effects of OVT remain variable depending on tumor type and viral agent used. Although the widespread adoption of OVT faces many challenges, we are optimistic that OVT will play an important role alongside standard chemotherapy and radiotherapy for the treatment of malignant pediatric solid tumors in the future."

Journal • Oncolytic virus • Review • Herpes Simplex • Infectious Disease • Measles • Oncology • Pediatrics • Solid Tumor

Targeting GBM with an Oncolytic Picornavirus SVV-001 alone and in combination with fractionated Radiation in a Novel Panel of Orthotopic PDX models. (PubMed, J Transl Med) - "A panel of 17 clinically relevant and molecularly annotated PDOX modes of GBM is developed, and SVV-001 exhibited strong anti-tumor activities in vitro and in vivo."

Combination therapy • IO biomarker • Journal • Oncolytic virus • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Infectious Disease • Oncology • Solid Tumor • Transplantation

Progress of oncolytic virotherapy for neuroblastoma. (PubMed, Front Pediatr) - "Furthermore, clinical trials on some OVs (Celyvir, Pexa-Vec (JX-594) and Seneca Valley Virus (NTX-010)) have reported great results. This review summarizes the latest evidence in the therapeutic application of OVs in NB, including those generated in cell lines, animal models and clinical trials."

Journal • Oncolytic virus • Review • CNS Tumor • Endocrine Cancer • Immunology • Neuroblastoma • Neuroendocrine Tumor • Oncology • Solid Tumor

Targeting GBM with an Oncolytic Picornavirus SVV-001 alone and in Combination with Fractionated Radiation in a Novel Panel of Orthotopic PDX models (SNO 2022) - "A panel of 17 clinically relevant and molecularly annotated PDOX modes of GBM is developed. The strong anti-tumor activities of SVV-001 in vitro and in vivo in GBM models provided experimental rational that support the initiation of clinical trials in GBM patients."

Combination therapy • IO biomarker • Oncolytic virus • Brain Cancer • CNS Tumor • Glioma • Infectious Disease • Oncology • Solid Tumor • Transplantation • CD133

Oncolytic Seneca Valley Virus (SVV-001) Overcomes Checkpoint Inhibitor Resistance and Demonstrates a Systemic Anti-tumor Response in a Syngeneic Tumor Model (NANETS 2022) - "SVV treatment showed marked increases in CD3+ and CD8+ T-cell infiltration of tumors with the combination of SVV+CPIs showing the highest infiltration.CONCLUSIONS These data show that SVV+CPI converted immunologically “cold” tumors to “hot” tumors. These studies serve as a foundation for translating SVV oncolytic virotherapy combined with anti-PD-1 and anti-CTLA4 antibodies in patients with neuroendocrine neoplasms with a clinical trial anticipated to begin in H2, 2022."

Checkpoint inhibition • Preclinical • Endocrine Cancer • Immunology • Neuroendocrine Tumor • Oncology • Solid Tumor • CD8

Seneca Therapeutics Receives FDA Clearance to Begin SVV-001 Phase I/II Clinical Study (Businesswire) - "Seneca Therapeutics, Inc...announced today it had received FDA clearance to begin a Phase I/II clinical study utilizing Seneca Valley Virus ('SVV-001') in combination with a checkpoint inhibitor. This Phase I/II study with SVV-001 is in patients that are TEM8 positive and SVV-001 permissive with neuroendocrine tumors or neuroendocrine carcinomas. The study should begin enrollment early in 2023."

Enrollment status • IND • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Evolving role of seneca valley virus and its biomarker TEM8/ANTXR1 in cancer therapeutics. (PubMed, Front Mol Biosci) - "In this review we will discuss one such promising oncolytic virus called Seneca Valley Virus (SVV-001) and its therapeutic implications. SVV development has seen seismic evolution over the past decade and now boasts of being the only OV with a practically applicable biomarker for viral tropism. We discuss relevant preclinical and clinical data involving SVV and how bio-selecting for TEM8/ANTXR1, a negative tumor prognosticator can lead to first of its kind biomarker driven oncolytic viral cancer therapy."

Biomarker • IO biomarker • Journal • Review • Endocrine Cancer • Immune Modulation • Inflammation • Neuroendocrine Tumor • Oncology • Solid Tumor • ANTXR1

Characterisation of a Seneca Valley virus thermostable mutant. (PubMed, Virology) - "SVV-001 strain has shown promise as an oncolytic virus against tumors with neuroendocrine features...In this study, we isolated a thermostable mutant of SVV by thermal selection assays and we characterized a single mutation located in a capsid protein. The cryo-EM map of this mutant showed conformational shifts that facilitated the formation of additional hydrogen bonds and aromatic interactions, which could serve as capsid stabilizing factors."

IO biomarker • Journal • Neuroendocrine Tumor • Oncology • Solid Tumor

Seneca Therapeutics, Inc. to Present at the World Vaccine Congress in Washington, DC April 18-21, 2022 (Businesswire) - "Seneca Therapeutics, Inc...will be presenting on Wednesday, April 20 at 12:10pm at the World Vaccine Congress in Washington, DC. Seneca Therapeutics’ Senior Immunology Consultant, Michael Lacy, PhD will present a summary of prior research and three clinical trials done utilizing Seneca Valley Virus (SVV-001) delivered intravenously as a monotherapy. These clinical trials demonstrated profound tumor selectivity and safety. Dr. Lacy will also discuss Seneca’s upcoming Phase I/II clinical trial in both Neuroendocrine tumor and carcinoma patients...Finally, data will also be presented demonstrating the utility of SVV to express therapeutic transgenes (armed derivatives) and/or cancer antigens."

Clinical data • Oncology

Oncolytic Seneca Valley virus (SVV-001) overcomes checkpoint inhibitor resistance and demonstrates a systemic anti-tumor immune response in a syngeneic pancreatic cancer murine model (AACR 2022) - "Phenotypic and gene expression analyses of infiltrating cells will be presented. These studies serve as a foundation for translating SVV oncolytic virotherapy combined with anti-PD-1 and anti-CTLA4 antibodies in patients with neuroendocrine neoplasms with a clinical trial anticipated to begin in H1, 2021."

Checkpoint inhibition • IO biomarker • Preclinical • Endocrine Cancer • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor