Phase II Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in PD-L1-Negative or Immunotherapy-refractory Esophagogastric Adenocarcinoma

The goal of this study is to learn about of the research study drug, telomelysin (OBP-301), in combination with pembrolizumab in advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. The main question it aims to answer is whether this combination is safe and effective in this type of cancer.
Participants will receive 5 injections of OBP-301, approximately every 2 weeks. OBP-301 will be injected directly into the tumor during an esophagogastroduodenoscopy (EGD). At the same time as the injection, a tumor biopsy will be taken. Participants will also receive pembrolizumab infusions every 6 weeks until disease progression or for a maximum of two years. Pembrolizumab infusions will occur on different days than OBP-301 injections.

Start Date25 Apr 2024

Sponsor / Collaborator

Weill Medical College of Cornell University

[+2]

NCT04391049

/ Active, not recruitingPhase 1IIT

Phase I Trial With Expansion Cohort of OBP-301 (Telomelysin™) and Definitive Chemoradiation for Patients With Locally Advanced Esophageal and Gastroesophageal Cancer Who Are Not Candidates for Surgery

This phase I trial studies the side effects of OBP-301 when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with esophageal or gastroesophageal cancer that invades local or regional structures. OBP-301 is a virus that has been designed to infect and destroy tumor cells (although there is a small risk that it can also infect normal cells). Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving OBP-301 with chemotherapy and radiation therapy may work better than standard chemotherapy and radiation therapy in treating patients with esophageal or gastroesophageal cancer.

Start Date02 Dec 2021

Sponsor / Collaborator

NRG Oncology

[+1]

NCT04685499

/ TerminatedPhase 2IIT

Phase 2 Study of OBP-301 (Telomelysin ™) in Combination With Pembrolizumab and Stereotactic Body Irradiation in Patients With Head and Neck Squamous Cell Carcinoma With Inoperable, Recurrent or Progressive Disease

The purpose of this study is to test the effects, of the research study drug Telomelysin (OBP-301) in combination with pembrolizumab in subjects with inoperable, recurrent, or progressive squamous cell carcinoma of the head and neck. Telomelysin is an investigational treatment, while pembrolizumab and SBRT are approved standard treatments. The combination of these three treatments is also considered investigational.

Start Date03 May 2021

Sponsor / Collaborator

Weill Medical College of Cornell University

[+1]

100 Clinical Results associated with Suratadenotureb

100 Translational Medicine associated with Suratadenotureb

100 Patents (Medical) associated with Suratadenotureb

Literatures (Medical) associated with Suratadenotureb

01 Jun 2026·INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS

NRG-GI007: Phase I study of OBP-301, an oncolytic virus, and definitive chemoradiation in locally advanced esophageal cancer

Article

Author: Miller, Eric David ; Frakes, Jessica M ; Winter, Kathryn ; Hong, Theodore S ; Wu, Abraham ; Williams, Terence M ; Ku, Geoffrey Y ; Moughan, Jennifer ; Nishimura, Makoto ; Yock, Adam D ; Mehta, Rutika J ; Adusumilli, Prasad S ; Biran, Talia ; Ilson, David ; Klempner, Samuel J

INTRODUCTION:

Definitive chemoradiation (CRT) is standard for patients with medically inoperable esophageal cancer. OBP-301 is a modified adenovirus that adds a human telomerase reverse transcriptase gene promoter, replicating only in tumor cells to cause lysis.

METHODS:

In this phase 1 study, OBP-301 was added to carboplatin/paclitaxel and RT (50.4 Gy). Patients received intra-tumoral OBP-301 via endoscopy 3 days prior to and then at Days 12 and 26 of RT. The primary endpoint was protocol-defined dose-limiting toxicity (DLT). Secondary endpoints included clinical complete response (cCR) rate, number alive and alive without progression at 1 year.

RESULTS:

From June 2020 to July 2024, 15 evaluable patients were enrolled. Fourteen patients (93%) received all planned OBP-301 injections and 50.4 Gy RT. No DLTs were observed. The most common treatment-related grade 3/4 toxicities were neutropenia (40%) and lymphopenia (33%). Two patients died prior to restaging: 1 patient developed grade 5 respiratory failure 6 weeks after CRT (suspected RT pneumonitis), while a second patient had unrecognized airway involvement at baseline, which led to a tracheoesophageal fistula during Week 3 of CRT. The cCR rate for patients undergoing restaging (n=13) was 100% (95% CI: 77, 100), and 87% (95% CI: 62, 96) for all 15 patients. At 1 year, 9 (60%) out of 15 patients are still alive and 8 (53%) are alive without progression.

CONCLUSIONS:

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.

01 Jun 2026·Molecular therapy. Oncology

Mitochondrial inhibition enhances the sensitivity of pancreatic ductal adenocarcinoma cells to oncolytic adenovirus

Article

Author: Nishiyama, Takeyoshi ; Urata, Yasuo ; Yamada, Motohiko ; Yoshida, Ryuichi ; Kagawa, Shunsuke ; Kikuchi, Satoru ; Shoji, Ryohei ; Kuroda, Shinji ; Nagai, Yasuo ; Umeda, Yuzo ; Tazawa, Hiroshi ; Hashimoto, Naoyuki ; Kajiwara, Yoshinori ; Fujiwara, Toshiyoshi ; Inoue, Hiroaki

The metabolism of cancer cells is associated with resistance to anticancer therapies. Pancreatic ductal adenocarcinoma (PDAC) cells exhibit glycolytic and non-glycolytic subtypes. Although oncolytic virotherapy is a novel antitumor modality, the relationship between metabolism and virus sensitivity remains unclear. We demonstrated the cytopathic activity of telomerase-specific, replication-competent oncolytic adenoviruses OBP-301 and p53-armed OBP-702 against PDAC cells. Here, we show the role of metabolism in the virus sensitivity of PDAC cells. The virus sensitivity of human PDAC cells of glycolytic (MIA PaCa-2, PK-45H) and non-glycolytic (PK-59, Capan-2) subtypes was assessed by evaluating replication, glycolysis, and glutamine metabolism through exposure to hypoxia and glucose deprivation or treatment with the mitochondrial metabolism inhibitor CPI-613. Glycolytic PDAC cells were sensitive, and non-glycolytic cells were resistant to oncolytic adenoviruses, which was improved by hypoxia and glucose deprivation or CPI-613 treatment to induce glycolytic activation. OBP-702-mediated p53 activation modulated glutamine metabolism to promote virus sensitivity. In vivo experiments demonstrated the antitumor efficacy of combination therapy with CPI-613 and OBP-702, and the utility of positron emission tomography/computed tomography metabolic parameters for assessing glycolytic activity. 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.

01 Apr 2026·ANTICANCER RESEARCH

P53-armed Oncolytic Adenovirus Enhances the Efficacy of PD-1 Blockade in Neuroblastoma by Inducing Immunogenic Cell Death

Article

Author: Noda, Takuo ; Tanimoto, Terutaka ; Kagawa, Shunsuke ; Tazawa, Hiroshi ; Watanabe, Hinako ; Urata, Yasuo ; Kuroda, Shinji ; Tani, Morimichi ; Nouso, Hiroshi ; Oyama, Takanori ; Fujiwara, Toshiyoshi

BACKGROUND/AIM:

Neuroblastoma (NB) is a primary malignant tumor of the peripheral sympathetic nervous system. Although immunotherapy with immune checkpoint inhibitors (ICIs) targeting programmed cell death 1 (PD-1)/PD ligand 1 (PD-L1) has emerged as novel antitumor therapy, high-risk NB tumors are refractory to ICI therapy. Oncolytic virotherapy is expected to potentiate the antitumor immune response by inducing immunogenic cell death (ICD). In the present study, we assessed the therapeutic potential of OBP-301 and OBP-702, telomerase-specific oncolytic adenoviruses, for the induction of ICD and combined effect with PD-1 blockade against NB cells.

MATERIALS AND METHODS:

The cytopathic activity of OBP-301 and OBP-702 was assessed using three human MYCN-amplified NB cell lines (IMR-32, LA-N-5, and NB-1) and a murine non-MYCN-amplified NB cell line (Neuro-2a). Virus-mediated antitumor effect was assessed by analyzing cell viability, secretion of extracellular adenosine triphosphate (ATP) and high-mobility group box protein B1 (HMGB1), apoptosis, autophagy, and PD-L1 levels. A subcutaneous Neuro-2a tumor model was used to evaluate the in vivo antitumor effect of combination therapy with OBP-702 and anti-PD-1 antibody.

RESULTS:

OBP-702 exhibited stronger cytopathic activity, inducing ICD with secretion of ATP and HMGB1, compared to OBP-301 in human and murine NB cells. OBP-301 and OBP-702 increased apoptosis, autophagy, and PD-L1 expression in murine NB cells. Moreover, OBP-702 significantly prolonged the survival of tumor-bearing mice compared to monotherapy with PD-1 blockade.

CONCLUSION:

OBP-702 is a promising antitumor strategy to promote the antitumor effect of ICIs by inducing ICD against NB tumors.

News (Medical) associated with Suratadenotureb

04 Feb 2026

·www.prnewswire.com

Oncolytic Virus Clinical Trial Landscape Gains Momentum: 100+ Companies Lead the Charge in Pioneering New Treatments | DelveInsight

The oncolytic virus therapy landscape has expanded steadily over the past decade, with over 100 companies worldwide pursuing clinical or preclinical programs. A few leaders, such as Candel Therapeutics, Binhui Biopharmaceutical, Oncolytics Biotech, EpicentRx, Hangzhou Converd, and others, anchor the mid and late-stage pipeline. LAS VEGAS, Feb. 4, 2026 /PRNewswire/ -- DelveInsight's Oncolytic Virus Competitive Landscape 2026 report provides comprehensive global coverage of pipeline oncolytic virus therapies across various stages of clinical development. The report offers an in-depth analysis of key trends, emerging therapies, and the competitive landscape, highlighting the strategies of major pharmaceutical companies to advance their pipelines and capitalize on future growth opportunities. In addition, it provides critical insights into clinical trial benchmarking, partnering and licensing, and regulatory pathways with the FDA and EMA, enabling stakeholders to make informed decisions and optimize development strategies in the oncolytic virus domain. Oncolytic Virus Clinical Trial Analysis Summary DelveInsight's oncolytic virus pipeline report highlights a robust landscape, with 100+ active players developing 110+ oncolytic virus drugs. Key oncolytic virus companies such as Oncolytics Biotech, SillaJen, Candel Therapeutics, Binhui Biopharmaceutical, Oryx GmbH, Oncolys Biopharma, EpicentRx, Theriva Biologics, Lokon Pharma, DNAtrix, Surv BioPharma Inc., Treovir, Immvira Pharma, Virogin Biotech, OrienGene Biotechnology, Apices Soluciones, Vyriad, Transgene, BioEclipse Therapeutics, Imugene, CG Oncology, Istari Oncology, Akamis Bio, Elicera Therapeutics, and others are evaluating new oncolytic virus drugs to improve the treatment landscape. Promising pipeline oncolytic virus therapies, such as Pelareorep, Pexa-Vec, CAN-2409, BS001, ParvOryx, Telomelysin, AdAPT-001, VCN-01, LOAd 703, DNX-2401, Surv.m-CRA-1, G207, MVR-T3011, VG161, OrienX010, AloCelyvir, Voyager-V1, TG6002, CRX-100, CF33-hNIS, CG0070, PVS-RIPO, NG-350A, ELC-201, and others, are in different phases of oncolytic virus clinical trials. Request a sample and discover the recent advances in oncolytic virus drugs @ Key Factors Driving the Oncolytic Virus Therapy Market Growing Cancer Incidence: The global rise in cancer prevalence, especially in hard-to-treat solid tumors, has intensified demand for novel, effective treatment modalities. Conventional therapies such as chemotherapy and radiation often have significant side effects and limited long-term efficacy, motivating the adoption of immunotherapeutic alternatives like oncolytic virus therapies. Increasing Understanding of Cancer Biology: Growing knowledge of cancer biology has enabled the development of oncolytic virus therapies that selectively target and destroy cancer cells while sparing healthy cells. Advancements in Viral Engineering: These advances are enabling more precise, targeted oncolytic virus therapies, significantly expanding the global oncolytic virus therapy market. Rising Adoption of Personalized Medicine: Oncolytic virus therapies align closely with personalized treatment approaches by enabling tailored viral constructs and immunomodulatory payloads based on tumor genomics. What is Oncolytic Virus Therapy? Oncolytic virus therapy is an innovative form of cancer treatment that uses genetically engineered or naturally occurring viruses to selectively infect and destroy cancer cells. These viruses replicate inside tumor cells, causing them to burst while leaving healthy cells largely unharmed. As the cancer cells break apart, they release tumor antigens that help activate the body's immune system, enhancing its ability to recognize and attack remaining cancer cells. This dual action, direct tumor destruction and immune stimulation, makes oncolytic virus therapy a promising approach in modern oncology, often used alongside other treatments such as immunotherapy or chemotherapy. Applications of Oncolytic Virus Therapy Oncolytic virus (OV) cancer therapies can be used for both diagnosis and treatment of cancer. OVs can function as cancer vaccines by boosting tumor-specific T-cell responses. Oncolytic viruses can be engineered with immunostimulatory molecules to enhance immune activation. OVs show strong synergy when combined with other immunotherapies, such as checkpoint inhibitors. Oncolytic Viruses in Combination with Chemotherapy Chemotherapy works systemically, unlike surgical resection or radiotherapy. It remains essential for treating patients with disseminated (widespread) cancer. Because chemotherapy is systemic, it is often combined with oncolytic viruses (OVs), which typically require localized delivery to achieve a strong antitumor effect. Systemically administered OVs have shown limited therapeutic benefit in several clinical trials. Delivering OVs effectively to metastatic sites remains a major challenge. Therefore, using chemotherapy as a systemic adjuvant to localized OV therapy is of significant clinical interest and is currently being actively investigated. Oncolytic Virus Market Analysis: Drug Profile IMLYGIC: Amgen IMLYGIC (talimogene laherparepvec), developed by Amgen, is a first-of-its-kind oncolytic viral therapy for melanoma that cannot be surgically removed. It combines direct tumors destruction with immune system stimulation. The therapy is based on a genetically engineered herpesvirus engineered to preferentially infect and destroy cancer cells, releasing GM-CSF to trigger a broader anti-tumor immune response. In the Phase III OPTiM trial, IMLYGIC produced durable responses in about 16% of patients, compared with 2% with GM-CSF alone, and overall responses in roughly 26%. Patients at earlier disease stages achieved better outcomes, with some achieving long-term control. The treatment is usually well tolerated, with most adverse effects being mild and resembling flu symptoms. Although its independent effect on survival and deep organ metastases is modest, its value is most evident when combined with checkpoint inhibitors. Early data show response rates approaching 56%, and ongoing studies aim to further define these synergistic benefits. As the first FDA-approved oncolytic virus in the West, IMLYGIC has validated the broader concept of viral immunotherapy and is now being explored as a component of combination immuno-oncology approaches. Oncorine: Shanghai Sunway Biotech Oncorine, also known as H101, is a genetically engineered adenovirus with an E1B gene deletion developed by Shanghai Sunway Biotech in China. It is administered alongside chemotherapy to treat nasopharyngeal carcinoma and head and neck cancers. Its approval and effective clinical use have significantly advanced oncolytic virus–based cancer immunotherapy. Marketed as Recombinant Human Adenovirus Type 5 Injection, Oncorine became the first oncolytic virus approved for cancer treatment by the Chinese State Food and Drug Administration (CFDA) in November 2005. Since its introduction, it has demonstrated a favorable safety profile and notable antitumor activity across various cancers and malignant pleural effusions. Exploratory clinical studies have also evaluated Oncorine for treating liver cancers, pancreatic cancer, cervical cancer, malignant melanoma, and metastatic liver tumors. Find out more about oncolytic virus cancer drugs @ Oncolytic Virus Analysis A snapshot of the Pipeline Oncolytic Virus Drugs mentioned in the report: Learn more about the emerging oncolytic virus therapies @ Oncolytic Virus Clinical Trials Recent Developments in Oncolytic Virus Treatment Space In November 2025, Imugene Ltd and JW Therapeutics announced a co-development collaboration to evaluate the combination of Imugene's oncolytic virus CF33-CD19 (onCARlytics) and JW's Carteyva®, a CD19-directed autologous CAR-T cell therapy, for patients with advanced solid tumors. This collaboration includes preclinical in vitro and in vivo studies, followed by a Phase I investigator-initiated trial to be conducted exclusively in China at premier CAR-T clinical centers. The approach utilizes Imugene's CF33-CD19 virus to induce CD19 expression on tumor cells, rendering them susceptible to targeting by CD19 CAR-T therapies, a transformative "mark and kill" strategy. In July 2025, Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, announced that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for CLD-201 (SuperNova), the company's allogeneic adipose stem-cell loaded oncolytic virus for the treatment of soft tissue sarcoma. In June 2025, Oncolytics Biotech presented a poster demonstrating the role of pelareorep in activating anti-tumor immunity in PDAC. In May 2025, Candel Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted Regenerative Medicine Advanced Therapy (RMAT) designation to CAN-2409 (aglatimagene besadenovec), the Company's biological immunotherapy lead candidate, for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. CAN-2409 was also previously granted FDA Fast Track designation for the same indication. In May 2025, Elicera Therapeutics AB announced that it had entered into a Material Transfer Agreement (MTA) with University Hospital Tübingen in Germany. Under the agreement, the company's oncolytic virus candidates ELC-100 and ELC-201 will be included in tests aimed at developing a new type of companion diagnostic to predict the potential success of a novel neuroendocrine neoplasm (NEN) therapy, immuno-virotherapy. In April 2025, Hangzhou ConVerd Co., Ltd. announced that the first Phase IIa clinical study of hV01, ConVerd's first oncolytic vaccinia virus product, had successfully completed first patient dosing, with the subject in good condition. This phase IIa clinical study investigates the administration of a single dose of recombinant human IL-21 oncolytic poxvirus injection (hV01) per cycle for the treatment of patients diagnosed with advanced sarcoma and cervical cancer. It is important to note that the indication is for advanced sarcoma and recurrent or metastatic cervical cancer for which there is no standard of care available at this stage of the treatment process, or where standard of care has failed. Scope of the Oncolytic Virus Pipeline Report Coverage: Global Key Oncolytic Virus Companies: Oncolytics Biotech, SillaJen, Candel Therapeutics, Binhui Biopharmaceutical, Oryx GmbH, Oncolys Biopharma, EpicentRx, Theriva Biologics, Lokon Pharma, DNAtrix, Surv BioPharma Inc., Treovir, Immvira Pharma, Virogin Biotech, OrienGene Biotechnology, Apices Soluciones, Vyriad, Transgene, BioEclipse Therapeutics, Imugene, CG Oncology, Istari Oncology, Akamis Bio, Elicera Therapeutics, and others Key Oncolytic Virus Pipeline Therapies: Pelareorep, Pexa-Vec, CAN-2409, BS001, ParvOryx, Telomelysin, AdAPT-001, VCN-01, LOAd 703, DNX-2401, Surv.m-CRA-1, G207, MVR-T3011, VG161, OrienX010, AloCelyvir, Voyager-V1, TG6002, CRX-100, CF33-hNIS, CG0070, PVS-RIPO, NG-350A, ELC-201, and others Dive deep into rich insights for new oncolytic Virus treatments, visit @ Oncolytic Virus Drugs Table of Contents Related Reports Oncolytic Virus Therapies Market Oncolytic Virus Therapies Market Size, Target Population, Competitive Landscape, and Market Forecast – 2034 report deliver an in-depth understanding of the market trends, market drivers, market barriers, and key oncolytic virus therapies companies including Targovax, Genelux, Imugene, EpicentRx, Replimune, Genelux Corporation, Candel Therapeutics, DNAtrix, SillaJen, Treovir, Lokon Pharma AB, Istari Oncology, CG Oncology, Amgen, Daiichi Sankyo, and others. Melanoma Market Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key melanoma companies including IO Biotech, Merck Sharp & Dohme, Eisai, Regeneron Pharmaceuticals, Iovance Biotherapeutics, Highlight Therapeutics, Linnaeus Therapeutics, Spring Bank Pharmaceuticals, Taiga Biotechnologies, Inc., Aivita Biomedical, Inc., Genentech, Inc., Dana-Farber Cancer Institute, BioMed Valley Discoveries, Inc, Amgen, Checkmate Pharmaceuticals, Astellas Pharma Inc, Galectin Therapeutics Inc., Eucure (Beijing) Biopharma Co., Ltd, Mologen AG, Ultimovacs ASA, Seagen Inc., MedImmune LLC, OnKure, Inc., Syntrix Biosystems, Inc., Anaveon AG, iOx Therapeutics, Portage Biotech, ModernaTX, Inc., Nektar Therapeutics, BioNTech SE, Sapience Therapeutics, HUYABIO International, LLC., Provectus Biopharmaceuticals, Inc., Cantargia AB, Turnstone Biologics, Corp., Aura Biosciences, F-star Therapeutics, Inc., Day One Biopharmaceuticals, Inc., Kinnate Biopharma, Xencor, Inc., HiFiBiO Therapeutics, and others. Colorectal Cancer Market Colorectal Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key colorectal cancer companies, including Mirati Therapeutics, Exelixis, Enterome, Arcus Biosciences, Lyell Immunopharma, AstraZeneca, Novartis Pharmaceuticals, Surgimab, Numab Therapeutics, SOTIO Biotech, Amgen, Sichuan Baili Pharmaceutical, Qilu Pharmaceutical, Bristol-Myers Squibb, NGM Biopharmaceuticals, Takeda, PureTech, Pfizer, Kezar Life Sciences, Salubris, Biotherapeutics , and others. Pancreatic Cancer Market Pancreatic Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pancreatic cancer companies including FibroGen, OSE Immunotherapeutics, Lokon Pharma, Oncotelic Inc., Tesaro, Inc., Helix BioPharma Corporation, Theradex, Tvardi Therapeutics, Incorporated, AIM ImmunoTech Inc., BioNTech SE, Prestige Biopharma Limited, HCW Biologics, Cantex Pharmaceuticals, XBiotech, Inc., Lumicell, Inc., CARsgen Therapeutics Co., Ltd., Panbela Therapeutics, Inc. , and others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

Clinical ResultPhase 2ImmunotherapyFast TrackPhase 3

22 May 2024

·www.biospace.com

Global Oncolytic Virus Immunotherapy Clinical Trials Landscape

“Currently More Than 180 Oncolytic Virus Immunotherapies Are In Clinical Trials” Conventionally, the management of cancer was predominantly restricted to surgery, radiation therapy, in addition to chemotherapy. Even though these therapies have shown significant abolition of primary tumors, their allied systemic toxicities and the high incidences of relapse are the foremost limitations. The escalation in prevalence of cancer and the curbs of conventional therapies have propelled the demand of novel targeted therapies which can overcome the limitations and have enhanced specificity and target ability towards the disease. One such approach is using the virus as a therapeutic approach to deliver cancer fighting genes to the tumor cell and thereby inducing an immuno modularity response that will aid to cause death in cancerous cell. This led the development of oncolytic virus therapy as a promising treatment to cure rising cancer malignancies. The oncolytic virus therapy clenches long history which can be backpedalled the late 1950s to 1970s epoch in which the multiple clinical trials and studies were ongoing with the wild type viruses in order to understand a novel approach to treat tumor cells. Moreover, oncolytic viral therapy provides enormous advantage such as higher response towards cancer cells owing to the presence of impaired antiviral defense in addition to better delivery of therapeutic payloads to tumor cells as compared to the conventional treatment which aims to reduce or delays the symptoms of cancer. Download Oncolytic Virus Immunotherapies Clinical Trials Landscape Research: The research and development picked up its pace ever since the oncolytic virus therapy called Oncorine was approved by the National Medical Products Administration (NMPA) to treat Head and neck cancer in the year 2005. However, the drug was only accessible in China owing to the strict rules and regulations. Nevertheless, the approval of Oncorine has provided surplus thrust to the research and development across the globe which led to the approval by FDA for the first viral therapy, T- VEC (Imlygic) to treat melanoma. One of the primary impetuses for the growth of oncolytic virus therapy domain was due to the rising ascendancy of these therapies in the clinical studies. Preliminary data from the clinical trial studies demonstrates that more than 150 clinical researches are currently ongoing for the treatment of innumerable seldom and common diseases such as Alzheimer disease, herpes simplex 1, advanced biliary tract cancer, chronic hepatitis b, refractory malignant ascites as well as hepatocellular carcinoma. The clinical pipeline for the domain of viral therapy is mounting at an incredible gait. For instance, a modified human recombinant type 5 adenovirus with genetic modifications H101 is a novel treatment regimen used to provide treatment for patients suffering from advanced biliary tract cancer. The study is lately in the phase I clinical stage which is sponsored and collaborated by Fudan University. To further enhanced in addition to improve the efficacy, novel viral oncolytic therapy are used in combination with other drugs with the purpose to provide improved and advanced treatment regimen to the patients suffering from cancer. For instance, a novel Telomerase-specific Type 5 Adenovirus OBP-301 viral therapy in conjugation with Carboplatin, Paclitaxel as well as radiation therapy is used to cure adenocarcinoma. The clinical studies in lately in the phase I clinical stage which is sponsored and collaborated by NRG Oncology and National Cancer Institute (NCI). Researches believed that the oncolytic virus therapy clench potential as well as long lasting promising therapeutic effects. As a consequence, multiple pharmaceutical companies along with centers such as City of Hope Comprehensive Cancer Center, New York Medical College, Children's Hospital of Pennsylvania, Mayo Clinic in Arizona, Peking University First Hospital as well as Beijing Tiantan Hospital, Capital Medical University are working recklessly for the purpose to develop advanced oncolytic virus therapy that controls the prognosis of cancer diseases along with other indications such as advanced bladder carcinoma, pancreatic cancer, solid tumor and gastrointestinal cancer. All these examples mentioned above demonstrate that the clinical and translational market for oncolytic virus therapy is growing at an absurd pace.

Phase 1ImmunotherapyDrug ApprovalVaccine

08 Feb 2023

·www.fiercebiotech.com

BIO: Big Pharma offers menu of partnering options, but biotechs want licensing entrée

For the smaller companies attending the Biotechnology Innovation Organization's CEO and Investor Conference in New York, the mission was simple: find enough capital to keep going. Eli Lilly's Renee Williams arrived in New York City this week ready to mix and mingle with dozens of biotechs that had descended on the Big Apple itching to strike a deal. The draw was the Biotechnology Innovation Organization's CEO and Investor Conference, a business development bonanza centered on partnerships and dealmaking. For the smaller companies in attendance, the mission was simple: find enough capital to keep going. In a financing environment that remains perilous for new biotechs, the stakes are high. Even so, Williams, who leads external innovation for Lilly's genetic medicine unit, cautioned against desperation. “I definitely get the sense that people need to find a way to return for their investors, to return their own costs probably out of their pockets,” she said. “It's translating to perhaps maybe not typical business practices.” While big-ticket licensing deals are at the top of the list for smaller biotechs, Williams highlighted Lilly's other offerings, such as data and strategy consulting in exchange for some royalties or commercialization rights. The proposal underscores how much the ball is in Big Pharmas court with respect to dealmaking—and what companies may need to give up in exchange for even a limited relationship with the industry's biggest players. “Having dollars doesn't mean that you run your experiments in a way that necessarily we want to see them,” said Williams. Still, she emphasized the company is open for business, reiterating an often-heard call from pharma executives. But Big Pharmas need the biotech ecosystem just as much to top up their pipelines—hence why people like Williams were there, to meet the small biotech executives who could hold the next big thing. The juxtaposition between Big Pharma's available cash to spend and the sheer volume of potential partnerships sets the scene for a competitive and dogged financing environment. It's been made even more difficult as IPOs have become increasingly difficult to pull off, M&A has not returned to expected volumes and trepidation has crept into private financing, particularly in follow-up raises. Yet the sentiment among conference attendees was largely hopeful. That was certainly Talia Biran’s mood. As president of the U.S. subsidiary of the Japanese biotech Oncolys BioPharma, Biran is shopping for two distinct opportunities. The first is finding a commercial partner for the company’s soon-to-be-submitted oncolytic virus therapy, suratadenoturev, in Japan, with phase 2 data expected before the end of the year and an approval application slated to be submitted in 2024. The other goal is to find a development partner in the U.S., where suratadenoturev is being tested in conjunction with chemoradiotherapy in a phase 1 trial and alongside Merck & Co.'s Keytruda in a phase 2 trial. The company has tried before with no luck. But this time is different, as Biran says Oncolys now has clinical data plus the prospect of bringing in revenue from Japan, bolstering the prospects of landing a coveted licensing deal. “I think the issue was that we didn't have data at the time that Oncolys tried a few years ago,” she said. “Now, four years fast forward, we have more convincing data that was generated in the U.S. that I feel more confident to showcase the virus and to get the licensing deal.” While Biran wishes Oncolys could commercialize the drug by itself, they simply can’t afford it. She guessed that before the end of the year, the company would at least be able to nail down a partner in Japan. Ulrich Dauer, Ph.D., CEO of Vivoryon, finds himself in a similar situation as the company sets its sights on a phase 2 readout for Alzheimer’s disease treatment varoglutamstat in the first quarter of 2024. He says the goal is to find a partner to fund additional clinical development. His pitch comes as Alzheimer’s drug development is at a fever pitch, with Eisai’s lecanemab nabbing accelerated approval and Eli Lilly’s donanemab nearing a phase 3 readout. “Now having kind of the first successes, there seems to be an increasing interest to look on, you know, various approaches in the field and we are experiencing that,” said Dauer. The inspired pursuit for more money that drove most companies at the conference means that the options for people like Williams were in abundance. Her pitch to them was succinct. “People just have to come and ask—everything is not just give me a dollar. We have a lot to offer,” she said.

Phase 2

100 Deals associated with Suratadenotureb

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Esophageal Carcinoma	Japan	Oncolys BioPharma, Inc.	10 Jun 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	United States	Oncolys BioPharma, Inc.	03 May 2021
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 2	United States	Oncolys BioPharma, Inc.	03 May 2021
Metastatic gastroesophageal adenocarcinoma	Phase 2	United States	Oncolys BioPharma, Inc.	09 May 2019
Metastatic gastroesophageal adenocarcinoma	Phase 2	United States	Weill Medical College of Cornell University	09 May 2019
Metastatic melanoma	Phase 2	United States	Oncolys BioPharma, Inc.	22 Dec 2016
Unresectable Melanoma	Phase 2	United States	Oncolys BioPharma, Inc.	22 Dec 2016
Non-Small Cell Lung Cancer	Phase 2	Japan	Oncolys BioPharma, Inc.	25 Nov 2013
Stomach Cancer	Phase 2	United States	Medigen Biotechnology Corp.	-
Unresectable Hepatocellular Carcinoma	Phase 1	South Korea	Oncolys BioPharma, Inc.	01 Oct 2014
Unresectable Hepatocellular Carcinoma	Phase 1	South Korea	Medigen Biotechnology Corp.	01 Oct 2014

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


JPRN-jRCT1080225033 (OBP101JP, ESMO2025) Manual	Phase 2	Esophageal Carcinoma	37	OBP-301 + RT	efbpgypodx(qawrfhuaqt) = hxflrxkgpt bdpdnlvtqi (gfqxupoiai ) View more	Positive	17 Oct 2025
NCT04391049 (NRG-GI007, CTgov)	Phase 1	Adenocarcinoma of Esophagus \| Locally Advanced Malignant Neoplasm \| Esophageal Squamous Cell Carcinoma ... View more	16	Radiation Therapy+Telomerase-specific Type 5 Adenovirus OBP-301+Carboplatin+Paclitaxel	fjnugqbjus = hiyyzzlhhw muzrsidtvi (chfpktxnst, pzfmyssopg - xwvfuqyzjs) View more	-	29 May 2025
NCT03921021 (CTgov)	Phase 2	Metastatic gastroesophageal adenocarcinoma \| Gastroesophageal junction adenocarcinoma	17	Telomelysin	ekjgukfpcl = kdtyyawmvp bjrlsaorss (gymqqeasyd, rviopghqty - wcpkfnogzd) View more	-	25 Jun 2024
NCT04391049 (NRG-GI007, ASCO2024) Manual	Phase 1	Esophageal Carcinoma	6	OBP-301	evwzgfrdcx(twzjoxhhel) = None romppvivbw (fzcbwxuxxm ) View more	Positive	17 Jan 2024
NCT02293850 (OBP-301, Pubmed \| Mol Ther)	Phase 1	Liver Cancer PD-L1	20	OBP-301	oodczowqkc(bfmetitpeo) = tparyrkcdk xiqqhmrlpy (cnbesuszzd )	Positive	01 Jul 2023
NCT03921021 (ASCO 12023 \| ASCO 22023) Manual	Phase 2	Metastatic gastroesophageal adenocarcinoma Third line	16	Pembrolizumab+Telomelysin	noaimkiuwg(mmdoxqgqgo) = Toxicity attributed to OBP-301 included grade 2 fatigue/weakness (25%), grade 2 fever (18.7%), and a single incidence each of grade 2 nausea, anemia, grade 3 melena, and grade 4 diabetes mellitus (6.25%). taglmknrfw (ouhokzhfcp )	Positive	31 May 2023
NCT03172819 (EPOC1505, AACR2023) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	22	OBP-301+pembrolizumab	nrtktvaefl(utuvucyytq) = nxevftalvx fyovpnunlz (chmicnqslw ) View more	Negative	14 Apr 2023
NCT04685499 (CTgov)	Phase 2	Recurrent Squamous Cell Carcinoma of the Head and Neck \| Advanced Head and Neck Squamous Cell Carcinoma \| Squamous Cell Carcinoma of Head and Neck	1	OBP-301+pembrolizumab	ybfivojlor(shtppdripf) = dbhmziojys avfkldhfgx (abiptkgdpy, cstgdmgzod - mqjgzfgzhr) View more	-	11 Jan 2023
NCT03213054 (ESMO2021)	Phase 1	Esophageal Carcinoma	6	OBP-301	afqfghezlz(rtkuehptke) = fbvmrqndab wmnjihoklo (enewxndnbv )	Positive	16 Sep 2021
NCT03213054 (Pubmed \| Eur J Cancer Care (Engl)) Manual	Phase 1	Esophageal Carcinoma Last line	13	radiotherapy+OBP-301	clzjdtoxng(njyxnqhhtw) = sgkbvoutoe xvkrudencq (bkunuojsfw )	Positive	01 Aug 2021

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