FDA grants oncosec immunopulse IL-12 fast channel designation

Source: Sina Pharma 2017-2-28 photo source: Oriental IC, Inc on February 27, San Diego time, oncosec company, which focuses on DNA-based intratumoral cancer immunotherapy, said that the U.S FDA granted the company's asset, immunopulse ® IL-12 fast channel status, for pembrolizumab or nivolumab Treatment of metastatic melanoma after treatment of disease progression Among them, immunopulse ® is an immunotherapy platform developed by oncosec, which adopts intratumoral immunotherapy to improve the tumor microenvironment of immunosuppression Using the immunopulse ® platform, interleukin-12 (IL-12) DNA is introduced into tumor cells, driving the immune system to recognize cancer cells and attack solid tumors "At present, more and more melanoma patients use pembrolizumab or nivolumab as the first-line or second-line treatment For such patients, a large part of them will not respond to drugs, so such patients still need effective treatment that can alleviate the disease," said punit Dhillon, CEO and President of oncosec According to the interim data of our ongoing clinical trial combined with pembrolizumab for the treatment of patients with no response to PD-1 drugs, we have high confidence that the company's immunopulse ® IL-12 can bring safe and effective efficacy to patients with no response " Dr Sharron gargosky, chief clinical and affairs officer of the company, said: "the fast track designation of FDA shows the unanimous recognition of oncosec clinical development project With the upcoming phase 2B clinical trial Pisces, we very much hope to work with FDA to smoothly promote the clinical trial process." Pisces test, full name of anti-PD-1 IL-12 stage III / IV combination electricity study, is a multicenter, non control, single arm, bid opening, single arm study for intravenous injection of immunopulse ® IL-12 combined with anti-PD-1 mAb for the treatment of advanced local advanced or metastatic stage III and stage IV melanoma The patients in the group should be stage III / IV patients with metastatic melanoma who showed disease progression after evaluation with RECIST v1.1 standard or within 24 weeks after treatment with pembrolizumab or nivolumab The primary end point of this clinical study was the overall response rate (ORR) after 24 weeks, and the secondary end point was the optimal overall response rate (Borr), response duration (DOR), progression free survival (PFS) and total survival (OS) The study is expected to start in the first half of 2017 FDA's fast track identification aims to accelerate the development and evaluation of drugs that can effectively treat serious and life-threatening diseases For drugs that are granted fast track designation, it also shows the potential of the drug to further meet clinical needs in the future For the drugs entering the fast track, FDA will make early intervention, and provide guidance on which tests should be done and which tests can not be done, the use of biomarkers and the data standards to be achieved in the future market, which can speed up the whole research and development process In addition, on the premise of meeting certain standards, pharmaceutical companies can also submit application materials for future BLA applications in a rolling way, and may speed up the review time.