Enrolling patients with unresectable metastatic melanoma who have progressed or are progressing on an anti-PD-1 therapy
Global study in the U.S. and Australia
ImmunoPulse® IL-12 granted Fast Track and Orphan Drug Designation in the U.S.
OncoSec Medical Incorporated (“OncoSec” or the “Company”) (ONCS), a company developing intratumoral cancer immunotherapies, today announced that it has initiated its phase 2b registration directed trial, PISCES/KEYNOTE-695. The PISCES/KEYNOTE-695 study is a global, multicenter phase 2b trial of OncoSec’s investigational therapy, ImmunoPulse® IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or "tavo"] with electroporation), combined with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy marketed by Merck (known as MSD outside the US and Canada), in patients with unresectable metastatic melanoma who have progressed or are progressing on an anti-PD-1 therapy.
“Patients with metastatic melanoma who are progressing or have progressed on anti-PD-1 therapy have limited treatment options. We believe the combination of ImmunoPulse IL-12 and pembrolizumab offers a potentially transformative approach for these patients given the absence of approved therapies,” said Punit Dhillon, CEO and President at OncoSec. “The advancement of the PISCES trial marks an important milestone for the Company.”
The phase 2b, Simon 2-stage multicenter study of intratumoral tavo with electroporation in combination with intravenous KEYTRUDA will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).
“ImmunoPulse IL-12 and pembrolizumab are immunotherapies designed to modulate the patient’s own immune response to fight cancer,” said Sharron Gargosky Ph.D., Chief Clinical and Regulatory Officer at OncoSec. “We are pleased with the progress of the ongoing PISCES trial, which has benefitted from our clinical trial collaboration and supply agreement with Merck.”
The collaboration agreement, which was announced in May 2017, is between OncoSec Medical Incorporated and Merck, through a subsidiary. Under the agreement, OncoSec will sponsor and fund the study and Merck will provide KEYTRUDA.
To learn more about the trial, visit www.oncosec.com. Additional details can also be found at www.clinicaltrials.gov via NCT03132675.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
ImmunoPulse® is a registered trademark of OncoSec Medical Incorporated, San Diego, CA, USA.
About Metastatic Melanoma1
Melanoma is a type of skin cancer that begins in skin cells called melanocytes. As the cancer progresses, melanoma becomes more difficult to treat once it spreads beyond the skin, such as the lymphatic system (metastatic disease). Given its occurrence young individuals, the potential years of life lost to melanoma can be higher when compared with other cancers. Although melanoma is a rare form of skin cancer, it accounts for over 75% of skin cancer deaths. The American Cancer Society estimates that approximately 87,000 new melanoma cases and 10,000 deaths from the disease will occur in the United States in 2017. Additionally, the World Health Organization estimates that approximately 132,000 new cases of melanoma are diagnosed around the world every year.
1 American Cancer Society (https://www.cancer.org/cancer/melanoma-skin-cancer/about/key-statistics.html); World Health Organization (http://www.who.int/uv/faq/skincancer/en/index1.html)
About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study)
PISCES is a global, multicenter phase 2b, open-label trial of intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or “tavo”) delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).