SAN DIEGO, June 26, 2017 -- NewVac, LLC today announced detailed primary results of Phase II clinical trial of quisinostat, a novel selective oral histone deacetylase (HDAC1) inhibitor, in advanced ovarian cancer. Results were presented at the ASCO 2017 Annual Meeting. The clinical trial demonstrated quisinostat's safety profile and high efficacy against platinum-resistant ovarian cancer in combination with paclitaxel and carboplatin. NewVac licensed quisinostat from Janssen Pharmaceutica NV.
The primary efficacy endpoint of the study - the objective response rate - was 51.6% and greatly exceeded the value of 30%, expected by the study protocol. Median duration of response was 5 months (4,2-5,7) with median progression free survival of 7 months (95%CI 4.8 - 9.2). SAE were observed in 16,1% of patients, mostly caused by background chemotherapy. The most frequent adverse events during the study were nausea and neutropenia.
As shown in previous preclinical studies, quisinostat amplifies HDAC-repressed expression of E-cadherin, leading to a reversal of epithelial to mesenchymal transition (EMT). The latter is associated with platinum-based chemotherapy resistance.
NewVac is preparing to study indications for quisinostat in combination with proteasome inhibitors to treat translocation-associated sarcomas in adolescents and young adults; and combination with checkpoint inhibitors to increase efficacy in solid tumors (gynecologic cancers and NSCLC).
About Phase II Trial
A multicenter, open-label study of safety and efficacy of quisinostat in combination with paclitaxel + carboplatin chemotherapy in patients with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to first line platinum and paclitaxel-based chemotherapy. The study consists of a screening period of 3 weeks before the start of quisinostat administration, followed by the treatment period of approximately 18 weeks (up to 6 cycles and 21 days for each cycle), a safety follow-up of 4 weeks after the last administration of the study therapy and post-treatment follow-up aimed at the determination of progression-free survival, time to disease progression and overall survival rate in the study population.
About Ovarian Cancer
Ovarian cancer is one of the leading causes of death from malignant tumors amongst women in USA and Europe. With only 36.3% survival rate ovarian cancer takes more lives per year than any other female reproductive system cancer. The efficacy of the standard platinum- and paclitaxel-based chemotherapy is halted by a very high risk of recurrence with a very poor outcome. There is an urgent need to develop new and better treatment options both for first-line patients and those that relapse. The populations of patients who progress within 1-6 months are considered to be platinum-resistant patients. For these patients, re-treatment with the same chemotherapy regimen is futile (<10% response rate). However, by adding a potential resistance modifier, such as quisinostat, a re-treatment with the original regimen in combination with the experimental agent is the best test of proof of concept.
NewVac, LLC, a ChemRar company, focuses on novel approaches to diagnosing and treating cancer. NewVac, is a private development stage biotech, a member of Skolkovo bio-cluster in Moscow, Russia.
NewVac Reports Primary Endpoint Met in the Phase II Clinical Trial of Quisinostat in Combination with Paclitaxel and Carboplatin in Platinum-Resistant Ovarian Cancer
SAN DIGEO, CA, January 3, 2017 – NewVac LLC reported meeting all primary endpoints in the Phase II Clinical Trial of quisinostat, novel selective oral histone deacetylase (HDAC1) inhibitor, which NewVac licensed from Janssen Pharmaceutica NV. The clinical trial is evaluating the efficacy and safety of Quisinostat in Platinum-Resistant Ovarian Cancer in combination with Paclitaxel and Carboplatin. The detailed results will be presented in an upcoming clinical research meeting in 2017.
The main advantage of Quisinostat – its unique PK properties, particularly the ability to selectively accumulate in target tissues, providing high potential in treatment of solid tumors, which has been demonstrated in the Phase II trial. Quisinostat may present a safe and effective therapeutic solution to patients by restoring sensitivity to chemotherapy in platinum-resistant cases. The efficacy and safety of Quisinostat will be further explored in clinic.
In 2016 CMC activities were initiated to support a Phase III clinical trial.
Results of a Quisinostat Phase Ib clinical trial were recently presented at the European Society for Medical Oncology (ESMO) 2016 scientific congress in Copenhagen, Denmark. Quisinostat demonstrated good safety profile and promising efficacy in metastatic platinum-resistant ovarian cancer, showing the highest ORR among other patient groups within the trial.
Preclinical studies have shown that Quisinostat amplifies HDAC-repressed expression of E-cadherin, leading to a reversal of epithelial to mesenchymal transition (EMT). The latter is associated with platinum-based chemotherapy resistance.
Quisinostat has been investigated in six clinical trials conducted by NewVac or Janssen Pharmaceutica in Europe and the US. Overall it has been tested in more than 200 patients with hematological and solid malignancies.
NewVac is preparing to study additional indications of Quisinostat in combination with proteasome inhibitors to treat translocation-associated sarcomas in adolescents and young adults; and in combination with check-point inhibitors to increase efficacy in solid tumors (gynecologic cancers and NSCLC).
About Phase II trial
This is a multicenter, open-label study of safety and efficacy of Quisinostat in combination with Paclitaxel + Carboplatin chemotherapy in patients with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to first line platinum and Paclitaxel based chemotherapy. The study is consisted of screening period of 3 weeks before the beginning of Quisinostat administration, followed by the treatment period of approximately 18 weeks (up to 6 cycles and 21 days for each cycle), a safety follow-up of 4 weeks after the last administration of the study therapy and post-treatment follow-up aimed at determination of progression-free survival, time to disease progression and overall survival rate in the study population.
About Ovarian cancer
Ovarian cancer ranks 5th in the world list of causes of death of women from malignant tumors. Among the countries are USA, West and North Europe. Ovarian cancer is also a leading cause of death from tumors of gynecological nosologies, i.e. it causes more deaths per year than any other type of female reproductive system cancer. The average age at diagnosis is 58 years, and 90% of diagnoses are established in women who are older than 40 years. In the case of ovarian cancer the median 5-year survival rate is 36.3%. After debulking surgery, the standard of care for first line diagnosed ovarian cancer is platinum- and paclitaxel based chemotherapy. However, there is still a very high risk of recurrence, with a very poor outcome. There is an urgent need to develop new and better treatment options both for first line patients and those that relapse. The populations of patients who progress within 1-6 months are considered to be platinum-resistant patients. For these patients, retreatment with the same chemotherapy regimen is futile (<10% response rate). However, by adding a potential resistance modifier such as Quisinostat, a re-treatment with the original regimen in combination with the experimental agent is the best test of proof of concept.
NewVac LLC, a ChemRar Group company, focuses on novel therapeutic and diagnostic approaches to detecting and treating cancer. NewVac, a privately owned biotech, is a member of Skolkovo innovative biocluster in Moscow, Russia.
NewVac signs license and co-development agreement with Janssen to advance novel drug for treatment of solid tumors
San Francisco, CA, January 07, 2013 - NewVac LLC (a ChemRar company, resident of the Skolkovo Innovation Center in Russia) announced today that it has entered into a co-license agreement with Janssen Pharmaceutica, NV (Janssen). Under the terms of the agreement Janssen grants NewVac the exclusive rights for the development and commercialization of Janssen’s quisinostat an innovative next generation Histone Deacetylase Inhibitor (HDACi) program - in Russia and several other Eastern European countries. Quisinostat will be investigated for the treatment of patients with solid tumors in combination with standard of care agents.
Under the arrangement, NewVac will develop quisinostat including R&D support to clinical trials. Janssen will provide its expertise in external global clinical trials.
The agreement with Janssen is an important component of NewVac’s strategy, which is designed to create value for the Russian people through progressive partnerships aimed at the modernization of the pharmaceutical industry, accelerating the development of medical innovations, and to contribute to the extension of life expectancy and improvement of quality-of-life for Russian patients.
Nikolay Savchuk, Chairman of the Board of NewVac, noted: "Our goal is to create an innovative world-class biomedical platform for the treatment of oncologic diseases based on molecularly targeted compounds including but not limited to immunological cancer therapies in Russia. We were looking very hard for a next generation HDAC compound which has potential to demonstrate clinical activity in solid tumors and especially with potential for clinically meaningful improvement of outcomes in resistant or refractory disease. NewVac will initiate solid tumor combination therapy studies which are accompanied by translational efforts. We are honored to commit our research organization to such a noble cause and we plan to start and conduct those clinical studies in Russia in 2013. NewVac will continue to help making innovative and highly efficacious cancer therapies more easily accessible to Russian patients."
About NewVac LLC
NewVac LLC is a subsidiary of ChemRar High Tech Center, the top Russian non-governmental research and development center for life sciences. NewVac's major objective is development, manufacturing and advancement of combination medicines and personalized research to treat cancer. NewVac became one of the first residents of Skolkovo innovation cluster in Russia in 2010 and continues to develop and manufacture personalized oncovaccines, small molecule adjuvants and diagnostics.
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Phone: + 7(926)-206-78-71
Oleg Kouzbit, Online News Managing Editor — In a new international technology transfer success story, Russian biotech company NewVac announces future Russian-based, GMP-standardized production and marketing of a new licensed drug. Originally developed by the U.S.’ Agenus, the Oncophage therapeutic vaccine is expected to make a substantial difference for non-metastatic kidney patients both in Russia and the neighboring states.
Khimki, February 06, 2012 - Under a license, development and manufacturing technology transfer agreement, Agenus grants NewVac an exclusive right to produce and sell the innovative vaccine to the Russian and CIS markets. The Russian firm is also reportedly licensed to do further Oncophage testing and carry out development programs using its own co-adjuvant technology.
Already approved in Russia for the treatment of renal cell carcinoma in patients at intermediate risk of recurrence, the US-originated vaccine will be manufactured on the premises of Moscow-based ChemRar High Tech Center, NewVac’s parent company. The new production line is being set up, the licensee says; NewVac CEO Sergei Bugrov emphasized that first patients would receive Oncophage therapy “…this year already.”
According to Agenus, Oncophage is an advanced therapeutic cancer drug in a family of the developer’s proprietary Prophage Series vaccine candidates, “tested in more than 850 patients in multiple cancers in more than 15 Phase 1, 2 and 3 clinical trials.” In Russia, there’s an estimated 2.5 million cancer patients, with about 500,000 new cases added on an annual basis.
Located in the town of Khimki just outside Moscow, NewVac is a biomed start-up established to focus on the development of innovative technology for cancer immunotherapy. According to Mr. Bugrov, the company’s mission is “the creation of a Russian-based innovative, world-class biomed platform for cancer treatment centered on patient-specific immunotherapy.” It is a resident of the Skolkovo innovation hub outside Moscow.
In addition to realizing the Oncophage program NewVac is currently moving to clinical trials of its new low-molecular compounds that could be used as co-adjuvant and are expected to dramatically improve the company’s own therapeutic anti-tumoral vaccine technology.
ChemRar, its parent firm and the Oncophage production site, is one of Russia’s largest private biomed R&D centers with a presence in the US, European and South-East Asian pharma markets.
Set up in 1994 in Lexington, MA, Agenus has been dedicated to developing and commercializing cutting-edge immunotherapies for cancer and infectious diseases.
Hot on the trail of foes
Unlike many existing broad-acting cancer treatments like chemotherapy or radiation therapy that typically cause toxicities and leave other side effects, Oncophage is designed to exclusively attack cancerous cells, reportedly keeping healthy tissues intact.
Tumor antigens, caused by gene mutations, are assumed to be very often unique to the tumor of an individual patient. This premise that reportedly took Agenus almost twenty years to corroborate has formed the basis of its vaccine development.
The heat shock protein (also referred to as ‘stress protein’) and associated peptides are purified directly from a patient’s own tumor. These ‘building blocks’ of the new drug bear what some call ‘the antigen imprint’ of one’s cancer cells and therefore elicit cancer-specific immunity, the developers claim. Aided by the innovative vaccine, the patient’s immune system (particularly its T-cells) generates a targeted immune response and assails the neoplasm-specific antigens it pinpoints as ‘reflecting’ the imprint. In the process, tumor regression has been observed, Agenus says.
The innovation’s primary application in the Russian and CIS markets will be treatment of renal cell carcinoma. However, clinical trials conducted in Russia, the U.S. and Europe have also reportedly proved Oncophage’s validity for a range of multiple cancers, including melanoma, glioma, colorectal cancer, pancreatic cancer, gastrointestinal tract cancer, and non-Hodgkin’s lymphomas.
Russia’s innovative biotech company and a Skolkovo resident, NewVac, is developing cutting-edge cancer immunotherapy technology and has recently completed some tests, Rusnanonet Russian National Nanotech Network reports. The company is reportedly working on new low-molecular compounds that could be used as co-adjuvant to dramatically improve the effect of therapeutic antitumoral vaccines, and moving to clinical trials of new cancer immunotherapy techniques.
Khimki, December 05, 2011 - The fundamental idea of blocking protective mechanisms cancer cells employ against the human body’s immune response is said to have been first formulated by Dr. Mikhail Sitkovsky from the New England Inflammation and Tissue Protection Institute (NEITPI), Boston, the U.S. Earlier this year NewVac scientists developed and tested a number of new synthetic A2A inhibitors for use with oncovaccines and are assumed to have patented their IP.
The work done has reportedly resulted in the development of clinical trials protocols. The Russian researchers have plans to perform clinical trials over the course of next year to see if the new cancer treatment method is safe and efficient. According to NewVac CEO Sergei Bugrov, the company is supported by the Skolkovo Foundation. NewVac’s goal is “the creation of a Russian-based innovative, world-class biomed platform for cancer treatment centered on immunotherapy, personalized medicine and other modern approaches.”
NewVac is an innovative biomed company located in the town of Khimki just outside Moscow. It is a subsidiary of Russia’s largest private biomed R&D center, ChemRar.
Contacts for media:
Phone: + 7(926)-206-78-71
SAN DIEGO, June 26, 2017 -- NewVac, LLC today announced detailed primary results of Phase II clinical trial of quisinostat, a novel...
SAN DIGEO, CA, January 3, 2017 – NewVac LLC reported meeting all primary endpoints in the Phase II Clinical Trial of quisinostat, novel selective...
San Francisco, CA, January 07, 2013 - NewVac LLC (a ChemRar company, resident of the Skolkovo Innovation Center in Russia) announced today that it...