On January 9, 2014 APEIRON Biologics reported the signing of two transactions as part of the worldwide commercialization of APN311, an antibody-based immunotherapy in development for the treatment of children suffering from high-risk neuroblastoma (Press release, Apeiron Biologics, APR 9, 2014, View Source [SID:1234502250]).

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Medison Pharma ("Medison"), Israel’s leading marketing group for innovative niche healthcare solutions, and Gen İlaç ve Sağlık Ürünleri ("Gen Ilac"), a leading supplier of orphan drugs for the treatment of rare diseases in Turkey, entered into license agreements with Apeiron, under the terms of which they receive the exclusive rights to market and sell APN311 in Israel and Turkey, respectively.

Today Apeiron announced the signing of license agreements with Medison and Gen Ilac. The two deals grant Medison and Gen Ilac exclusive rights to market and sell APN311 in Israel and Turkey, respectively. These transactions are part of Apeiron’s ongoing activities for worldwide commercialization of its immunotherapy portfolio against high-risk neuroblastoma. APN311 is the most advanced biologic in Apeiron’s development pipeline that focuses on immunologic therapies of cancer. Further details or financial terms of the transaction were not disclosed.

Hans Loibner, PhD, CEO of Apeiron, commented, "Based on very positive clinical data and the advanced development status of APN311 we are actively engaged in discussions with potential partners around the world for commercialization of this immunotherapy. After a first agreement with Paladin Labs we are pleased to now close these two deals with Medison and Gen Ilac. This represents a further important step in Apeiron’s efforts and commitment to improve therapeutic options for children suffering from life-threatening high-risk neuroblastoma."

Meir Jakobsohn, Medison’s Founder & CEO, commented, "We are proud of the new agreement with Apeiron that reflects Medison’s continuous ambition to provide breakthrough and lifesaving treatments for today’s most urgent medical needs. One of Medison’s main focuses is providing medications in the field of pediatric oncology, in niches with unmet need. Apeiron’s treatment fits exactly to Medison’s mission."

Abidin Gülmüs, CEO of Gen Ilac, added, "We are proud of our reputation as one of Turkey’s leading specialty pharma companies, but even more important to us is the difference we make to the lives of people with life-threatening conditions. We look forward to a successful partnership with Apeiron, together providing oncologists with the opportunity to treat high-risk neuroblastoma patients. We aspire to make APN311 available for Turkish patients as soon as possible."

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.

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).

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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On April 7, 2014 Myriad Genetics reported that it has submitted the first module of a premarket approval (PMA) application to the Food and Drug Administration (FDA) for the use of BRACAnalysis testing as a companion diagnostic with olaparib (Press release Myriad Genetics, APR 7, 2014, View Source [SID:1234500382]). Olaparib is an investigational, orally active poly-ADP ribose polymerase (PARP) inhibitor being developed by AstraZeneca.
In 2012, Myriad made strides in developing BRACAnalysis as a companion diagnostic by retrospectively genotyping patients in a previously completed Phase 2 study of olaparib.

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