Versant Ventures invests CHF 11 million in PIQUR and brings further industry expertise to the Board

On April 8, 2014 PIQUR Therapeutics AG and Versant Ventures jointly reported the investment of the California-based venture capital firm of CHF 11 million (USD 12M) in PIQUR (Press release, PIQUR Therapeutics, APR 8, 2014, View Source [SID1234527277]). The pharmaceutical company focused on the discovery and development of novel, small molecules for the treatment of cancer, has closed a Series A extension round of CHF 18 million (USD 20M). This round brings the total funding of the Series A to CHF 32 million (USD 36M). Versant Ventures led the extension round, which also included new as well as existing private shareholders. Since the start of the company PIQUR has raised total proceeds of over CHF 37 million (USD 42M).

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Versant Ventures, specializing in life sciences investments, has more than USD 1.6 billion in assets under management. Versant Ventures has recently established an industry-leading biotech-focused team in Basel, Switzerland. Concurrent with the closing of the transaction, Guido Magni, Venture Partner with Versant Ventures in Basel, has joined PIQUR’s Board of Directors. Guido previously served as a Managing Director of EuroVentures, a Versant incubator, where he was intimately involved in several biotech investments including Synosia (sold to Biotie Therapies), Flexion (IPO) and Okairos (sold to GSK). Prior to that he was the Head of the Medical Science Department of Roche Pharmaceuticals and oversaw the development and the registration of a large number of key oncology drugs.

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.

"We would like to thank our existing investors for their strong confidence in PIQUR. We welcome the new private shareholders and Versant Ventures as new investors and look forward to working with Guido Magni and Gianni Gromo," commented Vladimir Cmiljanovic, CEO of PIQUR Therapeutics AG. "Their experience and network in drug development, profound expertise in oncology as well as in the investment sector, nicely complements PIQUR’s other Board members’ perspectives. We plan to use the funds to advance development of our lead compound PQR309 to reach Phase II and deliver proof-of-concept in the clinic, as well as the discovery of additional drug candidates for oncology and non-oncology indications."

"This is an exciting time to become involved with PIQUR. The company’s innovative dual-acting PI3K/mTOR inhibitors and highly experienced team made this an attractive investment for Versant. In recent months we have conducted a detailed due diligence of the company and its assets and were impressed by PIQUR’s overall IP and the lead compound PQR309. We are excited to bring in our management and industry expertise into a great management team and to support the development of novel anti-cancer therapeutics," said Guido Magni, Venture Partner of Versant Ventures.

To turn cancer into a manageable disease
PIQUR aims to help turn cancer into a manageable disease. Despite significant advances in the fight against cancer, there remains a high unmet medical need for therapies that not only prolong patients’ survival but also significantly improve quality of life. PIQUR targets both PI3K (phosphoinositide 3-kinase) and mTOR (mammalian target of rapamycin), two key signaling molecules that are vital to several essential biological processes, such as cell proliferation and survival, making inhibition of the target attractive for cancer therapy.

PIQUR’s differentiation is the level of innovation with its unique, proprietary fragment and scaffold libraries, as well as cellular technology platforms, and their excellent products with novel, dual-acting ‘strong PI3K plus fine-tuned mTOR’ inhibitors that address the given challenges, meeting therapeutic, tolerance and galenic needs.

Supplemental New Drug Application for IMBRUVICA™ (ibrutinib) Submitted to the U.S. FDA

On April 8, 2014 Janssen Research & Development reported the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc (Press release Johnson & Johnson, APR 8, 2014, View Source [SID:1234500380]). This regulatory submission is based on data from the Phase 3 RESONATE study in relapsed or refractory chronic lymphocytic leukemia (CLL). IMBRUVICA is being jointly developed and commercialized by Janssen and Pharmacyclics.
In February 2014, IMBRUVICA received FDA approval to treat patients with CLL who have received at least one prior therapy. This indication is based on an overall response rate (ORR) from Phase 2 data and an improvement in survival or disease-related symptoms has not been established. The current approval was granted under the FDA’s Accelerated Approval regulations and required the completion of an additional, larger Phase 3 trial to verify clinical benefit.
The Phase 3 PCYC-1112 (RESONATE) study is a randomized, multi-center, open-label study, which compares once-daily oral IMBRUVICA versus intravenous ofatumumab in 391 patients with CLL or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. The RESONATE trial was halted early in January 2014 based on the recommendation of an Independent Data Monitoring Committee (IDMC) at the formal pre-planned interim analysis, which found IMBRUVICA was associated with a significant improvement in progression-free survival (the primary endpoint of the study) versus ofatumumab, and in overall survival (a key secondary endpoint of the trial). Data from this study were accepted and will be presented at the upcoming 50th annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

Ambit Announces Initiation Of Quizartinib QUANTUM-R Phase 3 Trial

On April 8, 2014 Ambit Biosciences reported the initiation of the QUANTUM-R Phase 3 clinical trial (NCT02039726) comparing quizartinib as monotherapy to chemotherapy regimens in relapsed/refractory acute myeloid leukemia (AML) patients with the FMS-like tyrosine kinase-3 (FLT3)-ITD mutation (Press release Ambit Biosciences, APR 8, 2014, View Source [SID:1234500376]).
The trial will be conducted in FLT3-ITD positive AML patients over the age of 18 who have relapsed from, or are refractory to, frontline chemotherapy, including those patients relapsing following hematopoietic stem cell transplantation (HSCT). Patients will be dosed continually until disease progression or intolerable toxicity. Patients who proceed to HSCT after quizartinib treatment will be able to reinitiate treatment with quizartinib following the transplant.
The trial is expected to enroll approximately 326 patients in the United States, Western Europe, Canada and Australia. The primary endpoint for the Phase 3 clinical trial will be overall survival. An interim analysis will be conducted and will include an adaptive design component that will allow the Data Safety Monitoring Board (DSMB) to increase the number of patients, if warranted. Enrollment is expected to be completed in the second half of 2015, assuming there is no increase in the number of patients following the interim analysis.
The Phase 3 trial follows completion of the Phase 2 and Phase 2b clinical trials, which demonstrated the key clinical benefits of quizartinib as a monotherapy, including a high response rate in relapsed/refractory FLT3-ITD positive patients; a substantial number of patients who were bridged to a potentially curative HSCT; and median overall survival in FLT3-ITD positive patients which compared favorably to historical survival data reported for FLT3-ITD positive and negative AML patients. Results from these studies were presented at medical conferences in 2012 and 2013.

20-F/A [Amend] – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

Theratechnologies has filed a 20-F/A [Amend] – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Press release Theratechnologies, APR 7, 2014, View Source [SID1234500375]).

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(Press release Lion Biotechnologies, APR 7, 2014, View Source [SID:1234501577])

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