TRIFECTA is an investigator-initiated, single-arm, open-label, clinical trial in which 35 evaluable Squamous Cell Head and Neck Cancer (SCCHN) patients will receive TAVO™, pembrolizumab and epacadostat. The primary endpoint of the study is overall response rate (ORR) by RECIST v1.1 and will be compared to historical data for pembrolizumab and epacadostat. The study is being conducted by the UCSF Helen Diller Family Comprehensive Cancer Center.
Who is Leading the Clinical Trial?
Dr. Chase Heaton, MD, leading oncologic head and next surgeon at UCSF is leading the study and Dr. Alain Algazi, leader of the Head and Neck Medical Oncology Program at UCSF and Clinical Strategic Advisor to OncoSec.
The TRIFECTA study capitalizes on findings from a 2017 plot study of TAVO in head and neck cancer patients. The study demonstrated impressive clinical and biological results including evidence of synergy between TAVO, and PD-1 antibodies in the disease. One of the patients in the 2017 pilot study, was featured in a LA Times article titled: “I have terminal cancer and I know my friends want to ask, ‘Aren’t you dead yet.”
The triple combination of IL-12, IDO1 and anti-PD-1 monoclonal antibody is a first-of-its-kind clinical trial and is seeking to exploit individual anti-tumor properties of each modality. The goal of the study is to evaluate this three-way combination in SCCHN cancer and, if promising, to potentially evaluate the triple combination in other tumor types.
Who makes TAVO™?
OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS) is a late-stage cancer biotechnology company developing intertumoral gene-delivery immunotherapies. OncoSec, the study sponsor, seeks to have its TAVO compound be taken in combination with epacadostat and KEYTRUDA in patients with unresectable squamous cell carcinoma head and neck (SCCHN) cancer.
OncoSec Medical Incorporated, a biotechnology company, focuses on the development of cytokine-based intertumoral immunotherapies to stimulate the body’s immune system to target and attack cancer. Its lead product candidate is ImmunoPulse IL-12 that uses electroporation device to deliver a DNA-encoded interleukin-12 for reversing the immunosuppressive microenvironment in the treated tumor. The company is also developing ImmunoPulse IL-12 with KEYTRUDA in patients with advanced melanoma that is in the Phase IIb clinical trials (PISCES/KEYNOTE-695) and advanced or metastatic triple negative breast cancer (TNBC), which is in the Phase II clinical trials (OMS-141/KEYNOTE-890); ImmunoPulse IL-12 and KEYTRUDA in patients with advanced or metastatic melanoma that has completed Phase II clinical trials; and ImmunoPulse IL-12 monotherapy in patients with metastatic melanoma, which has completed the Phase II clinical trials.
In addition, it undertakes the phase II monotherapy biomarker study in patients with advanced or metastatic TNBC. Further, the company has completed Phase I neoadjuvant clinical trial of ImmunoPulse IL-12 in combination with an anti-PD-1 in surgically resectable melanoma. Additionally, it is developing new DNA-encoded therapeutic candidates and tumor indications. OncoSec Medical Incorporated has clinical trial collaborations with Merck & Co., Inc. and its subsidiary in connection with the PISCES/KEYNOTE-695 and OMS-141/KEYNOTE-890 studies—a collaboration with the GOG Foundation, Inc. to conduct a registration-enabled study of tavokinogene telseplasmid in women with recurrent/persistent cervical cancer, and a collaborative research agreement with Duke University School of Medicine in HER2+ breast cancer. The company was formerly known as NetVentory Solutions Inc. and changed its name to OncoSec Medical Incorporated in March 2011. OncoSec Medical Incorporated was incorporated in 2008 and is headquartered in Pennington, New Jersey.
What is Squamous Cell Head and Neck Cancer?
Head and neck cancer is a group of cancers that starts in the mouth, nose, throat, larynx, sinuses, or salivary glands. Symptoms for head and neck cancer may include a lump or sore that does not heal, a sore throat that does not go away, trouble swallowing, or a change in the voice. There may also be unusual bleeding, facial swelling, or trouble breathing.
About 75% of head and neck cancer is caused by the use of alcohol or tobacco. Other risk factors include betel quid, certain types of human papillomavirus, radiation exposure, certain workplace exposures, and Epstein-Barr virus. Head and neck cancers are most commonly of the squamous cell carcinoma type. The diagnosis is confirmed by tissue biopsy. The degree of spread may be determined by medical imaging and blood tests.