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PIQUR Therapeutics AG today announced that the company and its academic collaborators will present five posters highlighting preclinical as well as clinical data on its lead compound, PQR309, at the American Association for Cancer Research (AACR) Annual Meeting, which will take place in Philadelphia, Pennsylvania, April 18-22, 2015. Initial results from the first-in-man phase 1 trial indicate that PQR309 is safe and well-tolerated with no significant side effects. „In addition to the good safety data, PQR309 has also shown the first encouraging signs of clinical activity in solid tumors. With these promising initial clinical results of PQR309, we are making an important step towards our vision to help patients to survive cancer”, commented Dr. Vladimir Cmiljanovic, CEO of PIQUR Therapeutics AG.

The discovery of TOR was not only a major milestone in basic research but also proved to be of clinical relevance. “TOR has also been implicated in aging and in a wide variety of diseases such as diabetes, cancer and cardiovascular disease,” says Hall. “I am eager to see whether newly developed TOR inhibitors are effective and will provide better treatment options for cancer patients.”

The results of this study will be presented at ASCO, May 29 to June 2, 2015:

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Financing for the preclinical development has been secured in seed funding in October 2012 from private investors and the Swiss Innovation Promotion Agency KTI/CTI. In addition to that PIQUR is enjoying unique support by its hosting University of Basel, both in terms of IP funding and the use of laboratories and support. These funds will be spent for the preclinical pharmacology and regulatory toxicology studies and the operational set-up of the company.

The aim of PIQUR’s activities is to turn cancer into a manageable disease. Given the relatively small number of effective cancer treatments available today, there is an unmet medical need for new therapeutic approaches. One in every two men and one in every three women, living in the developed world, will develop cancer at some stage in their lives. PIQUR targets the PI3K (phosphoinositide 3-kinase) and mTOR (mammalian target of rapamycin) pathways.

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Dr. Vladimir Cmiljanovic, CEO and co-founder of PIQUR commented: “This is excellent news for PIQUR. Based on these results no special safety monitoring appears to be necessary during Phase I clinical studies planned to start in Q1/2014. Our compound has a benefit to risk ratio that is anticipated to be superior to other PI3K inhibitor front-runners. This makes PQR309 an excellent candidate to treat cancer patients.” The protocol for Phase I study with PQR309 is being submitted to regulatory authorities and ethics committees for approval to start in January 2014. Phase I will run in four centers in Switzerland, one center in Spain and one center in England. The study focus is on safety and the identification of the maximum tolerated dose.

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Basel, Switzerland – PIQUR Therapeutics AG, focusing on the discovery and the development of innovative anti-cancer drugs, announces today that it has successfully completed preclinical profiling and the GLP toxicology studies with its most advanced compound PQR309. The preclinical studies confirm that the compound is a highly selective brain penetrant dual PI3K/mTOR inhibitor, which displays potent anti-proliferative in vitro and in vivo antitumor efficacy. The standard GLP 4-week toxicology studies, which have been successfully completed, will allow PIQUR to start its clinical trials with PQR309 in selected cancer patients.

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To turn cancer into a manageable disease
The aim of PIQUR’s activities is to turn cancer into a manageable disease. Given the relatively small number of effective cancer treatments available today, there is an unmet medical need for new therapeutic approaches. One in every two men and one in every three women, living in the developed world, will develop cancer at some stage in their lives. PIQUR targets the PI3K (phosphoinositide 3-kinase) and mTOR (mammalian target of rapamycin) pathways.

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In addition PIQUR was recently awarded a substantial grant from Eurostars for the further development of its front-runner compound PQR309. The Eurostars Programme is a European Joint Programme dedicated to the R&D performing small and mid-sized enterprises, and co-funded by the European Communities and 33 EUREKA member countries. PIQUR applied for the Eurostars project jointly with WIL Research Europe (the Netherlands). In Switzerland the project will be funded by the State Secretariat for Education, Research and Innovation and in the Netherlands by the NL Agency. Cmiljanovic commented: “This is an excellent and encouraging result and another confirmation for our vision to develop PQR309 to an important cancer treatment”.

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PIQUR has received approval from the authorities in Switzerland and UK to conduct the clinical Phase I study with PQR309. This study will assess the safety in cancer patients, and will help determine the ideal dosage. On January 2, 2014, PQR309 was administered to the first patient at the University Hospital in Basel. “For PIQUR, the very first administration of PQR309 represents an important milestone in clinical development. First results of the study are expected to be released before the end of 2014,” said Prof. Dr. Richard Herrmann, Chief Medical Officer of PIQUR.

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In addition, Gianni Gromo, Venture Partner with Versant Ventures, will act as an observer in PIQUR’s Board of Directors and will give strategic advice to the company. He was previously the Global Head of the Cardio Metabolic Disease Area at Roche Pharmaceuticals. Currently, he serves on the Board of Novira Therapeutics and on scientific advisory boards of a number of academic institutions and biotechs.

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With the prize from the Gairdner Foundation, Hall once again receives one of the highest acknowledgments for his excellent and comprehensive research, reaching from the discovery to the elucidation of the importance of TOR for cell growth and metabolism and further to providing answers to medical issues. “There is no greater reward for a scientist than to have his work recognized by his peers – and this is what the Gairdner Award is,” says Hall clearly excited by the distinction. The formal prize presentation will take place on 29 October 2015, at a ceremony in Toronto, Canada.

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