Telomelysin (suratadenoturev) / Oncolys BioPharma, Medigen Biotech - LARVOL DELTA

Virotherapy for Spinal and Spinal Cord Tumors: Current Evidence and Future Perspectives. (PubMed, Microorganisms) - "We discuss the telomerase-specific oncolytic adenovirus OBP-301 and its derivatives, whose hTERT-driven replication provides histology-agnostic tumor selectivity, while sparing the telomerase-silent spinal cord...We also discuss delivery and safety within the confined spinal canal, combination strategies, and future directions, such as extracellular vesicle-mediated delivery and biomarker-guided patient selection. Although clinical translation to the spine will require dedicated preclinical and early-phase studies, virotherapy represents a promising, mechanistically grounded modality for these therapeutically challenging tumors."

IO biomarker • Journal • Review • Astrocytoma • Brain Cancer • Diffuse Intrinsic Pontine Glioma • Glioma • Herpes Simplex • Meningioma • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

NRG-GI007: Testing the Addition of the Anti-cancer Viral Therapy Telomelysin to Chemoradiation for Patients With Advanced Esophageal Cancer and Are Not Candidates for Surgery (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: NRG Oncology | Trial completion date: Oct 2026 ➔ Oct 2030

Trial completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • Squamous Cell Carcinoma

Phase II study of telomelysin (OBP-301) in combination with pembrolizumab in gastroesophageal (GEA) adenocarcinoma. (ASCO 2023) - P2 | "OBP-301 viral particle injection into the tumor is feasible and safe. OBP-301 with pembrolizumab has encouraging activity in GEA, with durable responses and demonstration of activity in immunotherapy refractory disease. Single Cell RNA Sequencing data of the pre- and post-injection immune effects of OBP-301 will be presented."

Combination therapy • IO biomarker • P2 data • Anemia • Diabetes • Esophageal Cancer • Fatigue • Gastric Cancer • Hematological Disorders • Metabolic Disorders • Oncology • PD-L1 • TERT

Japan Becomes First Country in the World to Launch Viral Therapy for Esophageal Cancer (NEWS.am) - "Telomelysin is intended for patients with esophageal cancer who are not eligible for curative surgery or combined chemotherapy and radiation therapy."

Launch Japan • Esophageal Cancer

Initial safety assessment of the endoscopically injected oncolytic virus OBP-301 in medically inoperable esophageal cancer: NRG-GI007. (ASCO-GI 2024) - P1 | "The NRG/RTOG 0436 study of cisplatin/paclitaxel and RT (+/- cetuximab) as definitive therapy showed that about half of Pts have locally persistent disease...OBP-301 was previously studied with RT in Japanese esophageal cancer Pts and shown to be safe and has promising activity.1 In NRG-GI007, a phase 1 study (NCT04391049), OBP-301 is added to weekly carboplatin/paclitaxel and RT (50.4 Gy/28 fractions) for Pts with medically inoperable EC... No DLTs in the 6 evaluable Pts were observed and it is concluded that the initial OBP-301 dose level is safe. NRG-GI007 was reopened on August 7, 2023 to the expansion cohort. Full toxicity and treatment data will be presented."

Clinical • Oncolytic virus • Esophageal Cancer • Gastrointestinal Cancer • Oncology • TERT

NRG-GI007: Secondary endpoints of safety assessment and clinical complete response (cCR) of chemoradiation with endoscopically injected oncolytic virus OBP-301 in medically inoperable esophageal cancer. (ASCO-GI 2025) - P1 | "The NRG/RTOG 0436 study of cisplatin/paclitaxel and RT (+/- cetuximab) as definitive therapy showed that 58% of control arm Pts have locally persistent disease... In NRG-GI007, a phase 1 study (NCT04391049), OBP-301 was added to weekly carboplatin/paclitaxel and RT (50.4 Gy/28 fxs) for medically inoperable EC Pts with pathologically proven adenocarcinoma or squamous cell carcinoma (SCC) of the esophagus or Siewert Type I/II gastroesophageal junction... OBP-301 + CRT is safe and the preliminary cCR rate compares favorably to the historical control from NRG/RTOG 0436. Updated safety and cCR data will be presented. A randomized study is being planned."

Clinical • Oncolytic virus • Esophageal Cancer • Gastrointestinal Cancer • Oncology • TERT

NRG-GI007: Phase I study of OBP-301, an oncolytic virus, and definitive chemoradiation in locally advanced esophageal cancer. (PubMed, Int J Radiat Oncol Biol Phys) - "OBP-301 administration before and during CRT is feasible and safe, resulting in a very promising cCR rate. A randomized study is being planned to further evaluate safety and efficacy."

Journal • P1 data • Esophageal Cancer • Gastrointestinal Disorder • Hematological Disorders • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • TERT

Tokyo-based biotech Oncolys BioPharma said on December 15 that it has filed for Japan approval of its oncolytic virus telomelysin, also known as OBP-301, for the treatment of esophageal cancer. (Pharma Japan)

Japan filing • Esophageal Cancer

Oncolys BioPharma has secured full marketing approval in Japan for Telomelysin, an oncolytic adenovirus injection for esophageal cancer patients who are not candidates for curative surgery or chemoradiotherapy (TipRanks)

Japan approval • Esophageal Cancer

Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma (clinicaltrials.gov) - P2 | N=27 | Recruiting | Sponsor: Weill Medical College of Cornell University | Trial completion date: Apr 2028 ➔ Apr 2030 | Trial primary completion date: Apr 2026 ➔ Apr 2028

Trial completion date • Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • PD-L1

Mitochondrial inhibition enhances the sensitivity of pancreatic ductal adenocarcinoma cells to oncolytic adenovirus. (PubMed, Mol Ther Oncol) - "We demonstrated the cytopathic activity of telomerase-specific, replication-competent oncolytic adenoviruses OBP-301 and p53-armed OBP-702 against PDAC cells. Our results suggest that non-glycolytic PDAC cells are refractory to oncolytic adenoviruses. CPI-613 is a promising reagent for overcoming virotherapy resistance in PDAC tumors."

Journal • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Combination of CDK4/6 inhibitor promotes the antitumor effect of oncolytic adenovirus against canine breast cancer cells (AACR 2024) - "The combination of palbociclib and OBP-301 showed a more profound antitumor effect compared with monotherapy against CMT-U27 and AZA-CB cells. Our results suggest that telomerase-specific oncolytic adenoviruses have cytopathic effect against canine breast cancer cells via virus infection and replication. Furthermore, combination of CDK4/6 inhibitor may be a promising strategy for promoting the antitumor effect of oncolytic adenovirus against canine breast cancers."

Oncolytic virus • Breast Cancer • Oncology • Solid Tumor • TP53

Utility of oncolytic virus as an immunostimulants and potential for combination therapy with ICIs (AACR 2024) - "Among our oncolytic adenoviruses (OVs), OBP-301, in which the human telomerase reverse transcriptase (hTERT) promoter element drives the expression of the viral E1A and E1B genes, is currently undergoing clinical trials. The OVs showed potent and long-term immune activation by inducing CD8 and TRM in tumors as well as direct anti-tumor effects, and synergistic effects with ICI."

Combination therapy • IO biomarker • Oncolytic virus • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD44 • CD8 • TERT • TP53

A novel systemic delivery approach for oncolytic adenovirus therapy using tumor-homing mesenchymal stem cells (AACR 2025) - "We previously developed a telomerase-specific OV, Telomelysin (OBP-301), which utilizes the hTERT promoter to drive the expression of E1A and E1B. When MSCs loaded with OBP-702 (MSC-OBP-702) were intraperitoneally injected into an MC38-bearing peritoneal metastasis model, they effectively migrated to metastatic sites, significantly suppressing tumor growth and improving overall survival compared to OBP-702 alone. These findings demonstrate that MSC-OBP-702 has significant potential to overcome the challenges of systemic OV therapy through the tumor-homing capability of MSCs, providing a foundation for future clinical applications."

IO biomarker • Oncolytic virus • Colorectal Cancer • Oncology • Solid Tumor

Preoperative p53-armed oncolytic virus therapy enhances the efficacy of postoperative adjuvant ICI therapy (AACR 2025) - "We have developed a telomerase-specific oncolytic virus (OV), OBP-301, and its p53 gene-armed derivative, OBP-702. Bulk RNA-seq of OV treated MC38 tumor with reactome pathway analysis revealed the upregulation of pathways associated with enhanced antitumor immunity.Conclusion : OV therapy not only demonstrated direct antitumor effects but also induced tumor-specific systemic immunity and sustained long-term immune activation. These results suggest that preoperative OV therapy can enhance the effectiveness of postoperative ICI therapy."

Clinical • IO biomarker • Oncolytic virus • Colon Cancer • Colorectal Cancer • Microsatellite Instability • Oncology • Pancreatic Cancer • Solid Tumor • CD8 • MSI

P53-armed Oncolytic Adenovirus Enhances the Efficacy of PD-1 Blockade in Neuroblastoma by Inducing Immunogenic Cell Death. (PubMed, Anticancer Res) - "OBP-702 is a promising antitumor strategy to promote the antitumor effect of ICIs by inducing ICD against NB tumors."

IO biomarker • Journal • Neuroblastoma • Oncology • Solid Tumor • HMGB1 • MYCN

Turning pancreatic cancer from cold to hot: the promise of a p53-expressing oncolytic adenovirus (OBP-702). (PubMed, Int J Clin Oncol) - "Of these agents, Telomelysin (OBP-301, Suratadenoturev), a telomerase-specific oncolytic adenovirus, demonstrated clinical safety but limited efficacy in refractory tumors. Given its multifaceted antitumor functions and ability to overcome key barriers in pancreatic cancer, OBP-702 represents a highly promising therapeutic candidate. A first-in-human clinical trial evaluating endoscopic ultrasonography-guided intratumoral injection of OBP-702 is currently in preparation, expected to advance clinical translation of this novel virotherapeutic strategy."

First-in-human • IO biomarker • Journal • Review • Tumor mutational burden • Oncology • Pancreatic Cancer • Solid Tumor • CAFs • CDKN1A • E2F1 • KRAS • TMB • TP53

NRG-GI007: Testing the Addition of the Anti-cancer Viral Therapy Telomelysin™ to Chemoradiation for Patients With Advanced Esophageal Cancer and Are Not Candidates for Surgery (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: NRG Oncology | Trial completion date: Oct 2025 ➔ Oct 2026

Trial completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • Squamous Cell Carcinoma

Announcement of Receipt of Clinical, Nonclinical, and Quality Application Confirmation Documents for Oncolytic Virus OBP-301 [Google translation] (Oncolys BioPharma Press Release) - "We submitted an application for approval of OBP-301 to the Ministry of Health, Labour and Welfare on December 15, 2025. This application is progressing according to the review process envisioned under the Sakigake Comprehensive Evaluation Consultation. We are pleased to announce that we have received application confirmation documents from the Pharmaceuticals and Medical Devices Agency (PMDA) in three categories: clinical, nonclinical, and quality....we plan to have OBP-301 listed on the NHI drug price list and begin selling it in the fiscal year ending December 2026."

Japan filing • Launch Japan • Esophageal Cancer

P53-Armed Oncolytic Virotherapy Promotes the Efficacy of PD1 Blockade in Murine Osteosarcoma Tumors. (PubMed, Anticancer Res) - "Our results suggest that P53-armed OBP-702 is a promising agent for improving the antitumor effect of PD1 blockade in treating invasive OS."

IO biomarker • Journal • Preclinical • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • PD-L2

p53-armed oncolytic adenovirus induces apoptosis in pancreatic cancer-associated stellate cells via macropinocytosis. (PubMed, Cancer Gene Ther) - "We previously demonstrated the therapeutic potential of telomerase-specific oncolytic adenoviruses OBP-301 and p53-armed OBP-702 against human PDAC cells. Co-inoculation of PSCs enhanced the growth of PDAC tumors, an effect that was attenuated by OBP-702-mediated p53 activation in the tumor stroma. Our results suggest that p53-armed oncolytic adenovirus OBP-702 eliminates PDAC-associated PSCs via enhancement of macropinocytosis-mediated virus entry and induction of p53-mediated apoptosis."

Journal • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Serum extracellular vesicles containing adenoviral E1A-DNA as a predictive biomarker for liquid biopsy in oncolytic adenovirus therapy. (PubMed, Sci Rep) - "This study evaluated extracellular vesicle-encapsulated adenoviral E1A-DNA (EV-E1A-DNA) as a minimally invasive biomarker for monitoring responses to telomerase-specific oncolytic adenoviruses OBP-301 and OBP-502...These results demonstrate that EV-E1A-DNA is a sensitive and virus-specific biomarker that enables early assessment of therapeutic efficacy, even in the presence of antiviral immunity. This strategy offers a promising liquid biopsy approach for personalized monitoring of oncolytic virotherapy and may be applicable to other virus-based therapies."

Biomarker • Journal • Liquid biopsy • Oncology

Oncolytic virotherapy with suratadenoturev (OBP-301) injection with radiotherapy alone for esophageal cancer patients: Final results of OBP101JP study (ESMO 2025) - P | "Conclusions OBP-301 combined with RT demonstrated promising efficacy in terms of L-CR rate and overall survival among the EC Pts unfit for surgical resection and CRT, with AEs that were transient and manageable. OBP-301 is considered to provide clinical benefit for this vulnerable population of EC Pts."

Clinical • Oncolytic virus • Esophageal Cancer • Oncology • Squamous Cell Carcinoma

Announcement of OBP-301 presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium [Google translation] (Oncolys BioPharma Press Release) - P1 | N=16 | NCT04391049 | "We are pleased to announce that the results of a Phase 1 investigator-initiated clinical trial of OBP-301...This study enrolled a total of 15 patients, including 12 esophageal cancer patients and 3 gastroesophageal junction cancer patients...Preliminary efficacy was evaluated in 13 patients, as two of the 15 enrolled patients died before the therapeutic effect of this study could be confirmed...Efficacy was assessed by endoscopic findings and pathological biopsy, and the disappearance of tumors at the site of OBP-301 administration (clinical complete response: cCR) was confirmed in all 13 patients....'The results of this study not only show that OBP-301 can be safely combined with radiochemotherapy in the future, but also show an unprecedentedly high therapeutic effect with a 100% response rate. The 5-year survival rate for esophageal cancer is still not high, so we will continue to consider the next step in clinical trials...'"

P1 data • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma

Notification regarding the status of preparations for establishing a logistics system for the oncolytic virus OBP-301 [Google translation] (Nikkei) - "We are pleased to announce that we have established a system that complies with GCTP (Good Gene, Cellular, and Tissue-based Products Manufacturing Practice), a standard for manufacturing and quality control of regenerative medicine products, at the facility of Mitsui-Soko Holdings Co., Ltd. (hereinafter 'Mitsui-Soko HD') in Kobe City, Hyogo Prefecture, which is entrusted with the logistics operations of packaging, storage, and transportation of the oncolytic virus OBP-301 for which we are aiming to apply for approval...OBP-301 has completed the 'Phase 2 clinical trial for esophageal cancer combined with radiation (OBP101JP trial)'....We will continue to work with Mitsui-Soko HD to develop a stable and high-quality logistics system. We will also work hard to apply for approval of OBP-301."

Commercial • Trial completion • Esophageal Cancer