THEO-260 / Theolytics - LARVOL DELTA

Phase I/IIa, open-label, dose finding, safety and exploratory trial of THEO-260: A novel oncolytic immunotherapy, by intravenous delivery in patients with high grade serous or endometrioid ovarian cancer (ESMO 2025) - P1/2 | "Legal entity responsible for the study Theolytics Ltd. Funding Theolytics Ltd."

Clinical • Oncolytic virus • P1/2 data • Endometrial Cancer • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor • CAFs

Theolytics to Present Ongoing Phase I/IIa OCTOPOD-IV Trial of THEO-260 in Ovarian Cancer at ESMO 2025 (The Manila Times)

P1/2 data • Platinum resistant • Ovarian Cancer

OCTOPOD-IP: Trial of THEO-260 (Administered Via Intraperitoneal Route) in Ovarian Cancer Patients (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Theolytics Limited

New P1 trial • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Theolytics Doses First Patient in Phase I/IIa Trial of THEO-260 in Ovarian Cancer (GlobeNewswire) - "Theolytics...has dosed the first patient in its Phase I/IIa multi-centre, open-label first-in-human trial (OCTOPOD - NCT06618235) of THEO-260 in patients with advanced-stage platinum-resistant ovarian cancer (PROC)....The Phase I/IIa clinical trial is designed to investigate the safety and tolerability of THEO-260 administered via intravenous delivery and determine the recommended Phase 2 dose."

Trial status • Ovarian Cancer

Oncolytic immunotherapy THEO-260 enters readiness for first in human clinical trial in ovarian cancer patients (SITC 2024) - "Results THEO-260 was highly efficacious in a panel of OC cell lines (n=8), different stromal rich tumour types (n=9) and a panel of fresh OC patient samples (n=33), killing cancer cells and CAFs. THEO-260 induced immunogenic cell death and T-cell activation (assessed by T-cell proliferation and IFN-"

Clinical • Oncolytic virus • P1 data • Oncology • Ovarian Cancer • Solid Tumor • CAFs

OCTOPOD: Trial of THEO-260 in Ovarian Cancer Patients (clinicaltrials.gov) - P1/2 | N=28 | Recruiting | Sponsor: Theolytics Limited

New P1/2 trial • Oncology • Ovarian Cancer • Solid Tumor

Theolytics Awarded Significant £2M Transforming Cancer Therapeutics Grant from Innovate UK (GlobeNewswire) - "Theolytics...has been awarded £2M from Innovate UK’s prestigious Transforming Cancer Therapeutics grant funding competition to support the clinical development of its lead candidate THEO-260...The grant will primarily support the Company’s upcoming Phase 1 multi-centre, open-label first-in-human trial to evaluate safety and tolerability of THEO-260 in patients with advanced-stage platinum-resistant ovarian cancer and determine the recommended Phase 2 dose. This trial is expected to begin in the coming months."

Financing • New P1 trial • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Theolytics successfully closes latest financing raising total of £19M ($24.5M) and welcomes Sound Bioventures as new investor (GlobeNewswire) - "Theolytics...announced it has successfully closed its latest financing round, raising a total of £19M ($24.5M) with the addition of Sound Bioventures as a new investor. Sound Bioventures joins a strong international syndicate of existing investors participating in the round that includes M Ventures, Taiho Ventures, Epidarex Capital, Oxford Science Enterprises and the University of Oxford. The proceeds from this financing round further strengthen the company’s position as it advances its lead oncolytic adenovirus - THEO-260 - into clinical trials in ovarian cancer. The first trials are planned for this year and will aim to demonstrate safe, effective administration, and provide insight to the candidate’s dual cancer/cancer-associated fibroblast-killing and immunomodulatory mechanism of action when administered by intravenous or intraperitoneal routes in platinum-resistant ovarian cancer patients."

Financing • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Development of an oncolytic virus for the treatment of high grade serous ovarian cancer and other stromal rich tumours (ESMO 2023) - "THEO-260 outperforms SOC chemotherapies including paclitaxel and PARP inhibitors. The genetic and temperature stability of THEO-260 has been confirmed and is currently being GMP manufactured to high yields. Conclusions Our data confirms that THEO-260 is efficacious and safe, supporting the initiation of FIH clinical trials in high grade serous ovarian cancer patients."

Oncolytic virus • Stroma • Breast Cancer • Colorectal Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CAFs

Theolytics Presents Data on THEO-260 for stromal rich carcinomas at ASCO and on THEO-310 for myeloma at EHA (PharmiWeb) - "In ovarian cancer murine models containing human CAFs and cancer cells, THEO-260 shows antitumor efficacy, with a complete reduction in tumour volume in subcutaneous and intraperitoneal systems, and superiority to standard of care. Virus activity is not restricted to ovarian cancer, with cell line data demonstrating killing in additional solid tumour types, including pancreatic, colorectal, lung, and breast cancer.....THEO-310 demonstrates efficacy in >80% of ex vivo bone marrow aspirates, across newly diagnosed, relapsed and refractory myeloma patients. In these experiments, TME immune modulation and superiority to ‘best-in-class’ oncolytic virus strains for myeloma, including the measles virus, was observed."

Preclinical • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Hematological Malignancies • Lung Cancer • Multiple Myeloma • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

Evaluation of THEO-260 as a novel oncolytic virus therapy for treating stromal rich tumours. (ASCO 2023) - "Taken together, we present a preclinical data package for THEO-260 supporting progression to Phase I clinical trials."

Oncolytic virus • Stroma • Breast Cancer • Colorectal Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Refractory Ovarian Cancer • Solid Tumor • CAFs • EGFR • IFNG • PD-L1

Theolytics presents CAF-targeting therapy for stromal rich tumours, and strengthens leadership team as pipeline accelerates into the clinic (PRNewswire) - "Theolytics...will release data on their proprietary systemic therapy for stromal-rich tumours at the 2022 International Oncolytic Virus Conference, and announce executive appointments. THEO-260 is a new oncolytic virus in development that is intrinsically capable of targeted killing of both cancer cells and CAFs....'THEO-260 is a virotherapy that potentially could demonstrate something that neither chemotherapy, nor immunotherapeutic approaches have been capable of to date. This lead programme demonstrates the power of Theolytics' platform to deliver a long-awaited step-change for the oncolytic virus field'....Miriam has led the translational development activities required to start six phase I clinical trials with novel viral therapies across Europe and the United States."

Clinical data • Oncology • Solid Tumor