The therapeutic regimen of esophageal/gastroesophageal junction tumors has not changed over the last 30 to 40 years worldwide and basically there are three different options for treating them: surgery, chemotherapy and radiation therapies. In the US the therapy consists primarily of chemotherapy and radiotherapy while surgical resection is the standard for patients with early-stage esophageal cancer in Japan. The latter patients often have insufficient organ functions including heart, lung, liver and kidney because of advanced age, therefore the operation could be very difficult due to its high invasiveness while the chemotherapy could be intolerable. In such cases, the only remaining option is radiotherapy for these patients.
We see large unmet medical needs there. We believe that our oncolytic adenovirus immunotherapy Telomelysin may have the potential to alter the standard of care in this field and contribute to improve patients’ quality of life (QOL).

<CURRENT STATUS>

• 1) Telomelysin (OBP-301) + Radiation

  • ①Investigator-initiated clinical study at Okayama University

    Subject: patients intolerable to surgery and chemotherapy

    Status: completed

  • ②Clinical trial in Japan

    Subject: patients intolerable to surgery and chemotherapy

    Status: Phase 1 completed by Oncolys, Phase 2 in progress by Chugai Pharmaceuticals

• 2) Telomelysin + Pembrolizumab

  • ①Investigator-initiated clinical study at National Cancer Center Hospital East (NCCHE)

    Subject: advanced solid tumors (mainly esophageal and gastric cancer)

    Status: Phase 1/a completed, Phase 1/b in progress.

  • ②Investigator-initiated clinical study at Cornell University

    Subject: advanced esophageal or esophagogastric junction cancer

    Status: Phase 2 in progress.

Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and most often it occurs in people with cirrhosis caused by hepatitis B or hepatitis C infection. HCC is now the 3rd leading cause of cancer deaths worldwide, and its incidence is highest in Asian and African countries. Sorafenib, a multikinase inhibitor, is a typical systemic molecular targeting drug for HCC approved in 2009. It is such a big challenge for sure as many pharmaceutical companies have tried and failed in this area. However, we believe that our oncolytic adenovirus immunotherapy Telomelysin in combination with immune checkpoint inhibitors may have the potential to bring a new therapeutic option to meet unmet medical needs here.

<CURRENT STATUS>

• 1) Telomelysin monotherapy

  • - Clinical trial in cooperation with Medigen Biotechnology Corp (3176:TT)

    Subject: advanced HCC after treatment failure

    Status: Phase 1 completed by Oncolys

• 2) Telomelysin + Atezolizumab + Bevacizumab

  • - Clinical trial in Japan

    Subject: Locally advanced or metastatic and/or unresectable HCC

    Status: Phase 1 in progress by Chugai Pharmaceuticals

Among all types of cancer, head and neck cancer is known to be the one which could significantly deteriorate QOL of patients because it involves the organs directly related to chewing, eating, breathing and talking. With malignant tumors developing in or around the throat, larynx, nose, sinuses, and mouth, surgery may change patients' appearance. We believe that our oncolytic adenovirus immunotherapy Telomelysin in combination with immune checkpoint inhibitor has potent loco-regional oncolytic effect and systemic immuno-enhancing effect which contribute to improve not only patients' quality of life (QOL) but also PFS/OS.

<CURRENT STATUS>

• 1) Telomelysin + Pembrolizumab + Radiation

  • - Clinical trial in US

    Subject: advanced head and neck squamous cell cancer

    Status: Phase 2 (investigator-initiated trial) in progress

• 2) Telomelysin + Atezolizumab + Chemoradiotherapy

  • - Clinical trial in Japan

    Subject: chemoradiotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck Cancer

    Status: Phase 1 in preparation by Chugai Pharmaceuticals