On January 13, 2014, arGEN-X reported the initiation of a new pilot research agreement with Boehringer Ingelheim (Press release arGEN-X, JAN 13, 2014, View Source [SID:1234500576]). No further details are being disclosed at this stage.

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On January 9, 2014 FORMA Therapeutics reported the achievement of several discovery milestones in their alliance with Boehringer Ingelheim (BI) for the discovery of novel drug candidates against protein-protein interactions (PPI) for the treatment of cancer (Press release, Forma Therapeutics, JAN 9, 2014, View Source [SID:1234509339]).

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"Targeting PPIs is highly attractive for therapeutic intervention because they play a vital role in virtually all cellular processes. FORMA’s discovery engine has garnered critical insights into PPIs, which now instruct and guide our drug discovery initiatives."

"Our recent successes within the BI partnership, an agreement originally announced in January 2012, demonstrate FORMA’s ability to execute and deliver on challenging goals," said Steven Tregay, Ph.D., President and CEO, FORMA Therapeutics. "Targeting PPIs is highly attractive for therapeutic intervention because they play a vital role in virtually all cellular processes. FORMA’s discovery engine has garnered critical insights into PPIs, which now instruct and guide our drug discovery initiatives."

As part of the PPI alliance, BI has formally internalized novel compounds for an oncology-relevant PPI program from FORMA. Further, FORMA will continue to conduct screening within the alliance, has expanded chemistry resourcing to prosecute validated scaffolds, and will continue to further interrogate additional targets named within the agreement. FORMA will receive undisclosed payments as part of these recent scientific advancements.

Kenneth W. Bair, Ph.D., Chief Scientific Officer and Head of Research and Development, FORMA Therapeutics noted, "The combination of our cell-based screening technology (MAPPIT) and biochemical assay platforms provides a rapid way to screen for PPI inhibitors in two parallel formats, each offering distinct advantages. Further, integrating data from FORMA’s X-ray crystallography efforts across product pipeline targets with CS-Map technology interrogation of the surfaces for all human proteins in the Protein Data Bank (PDB) (~16,000) enabled the design and synthesis of shape-directed compound libraries biased toward shapes of druggable pockets on protein surfaces. The conformational flexibility of these novel molecules has proven essential to identify potential chemical starting material for PPIs of interest."

On January 9, 2014 the Avillion Group reported that it has entered into an exclusive collaborative development agreement with Pfizer Inc. to conduct a global Phase 3 clinical trial of Pfizer’s BOSULIF (bosutinib) (Press release, Avillion, JAN 9, 2014, View Source [SID:1234502188]).

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The trial, which will be conducted across multiple sites in the United States, Asia and Europe, will evaluate BOSULIF, administered at a starting dose level of 400 mg daily, as a first-line treatment for patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML).

Under the terms of the agreement, Avillion will provide the funding for and will conduct the trial to generate the clinical data necessary to potentially support a registration dossier for marketing authorization of BOSULIF by regulatory authorities for an indication as first-line treatment of patients with chronic phase Ph+ CML. If approved for this indication, Avillion will be eligible to receive milestone payments from Pfizer upon regulatory approval of the drug. Pfizer will retain all rights to commercialize BOSULIF globally.

"We are delighted to announce Avillion’s agreement with Pfizer, a global leader in the biopharmaceutical industry, and we look forward to working with them with the goal of advancing the development of BOSULIF and expanding its availability to a broader range of CML patients," said Lewis Cameron, CEO of Avillion. "Avillion offers pharmaceutical and biotech companies a compelling option to partner late-stage drug development projects. We have an experienced team focused on global drug development and regulatory approval, with the capability to optimise contract research organization (CRO) management."

"Chronic myelogenous leukemia remains a difficult disease to treat despite recent advances," said Garry Nicholson, president and general manager, Pfizer Oncology. "Today, the distinct tolerability profile of BOSULIF offers physicians an important therapeutic choice for their patients with Ph+ CML, as has already been shown in patients who are resistant or intolerant to prior therapy. Through our collaboration with Avillion, we plan to expand the development of BOSULIF by exploring its potential benefit as a first-line therapy for patients with CML."

BOSULIF is an oral, once-daily, TKI which inhibits the Bcr-Abl kinase that promotes CML; it is also an inhibitor of Src-family kinases. BOSULIF is currently approved in the U.S. for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy and offers an important treatment option for these patients. In Europe, BOSULIF was granted conditional marketing authorization for the treatment of adult patients with Ph+ CML previously treated with one or more TKIs and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

In January 9, 2014 Five Prime Therapeutics reported a sponsored research collaboration agreement with Adimab (Press release Five Prime Therapeutics, JAN 9, 2014, View Source [SID:1234500859]). Five Prime will provide multiple targets to Adimab for the discovery and optimization of therapeutic monoclonal antibodies initially focused in cancer immunotherapy.

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Under the terms of the collaboration agreement, Adimab will use its proprietary discovery and optimization platform to identify fully-human antibodies for Five Prime. This agreement will grant Five Prime the right to develop and commercialize antibodies generated during the collaboration for potential use as therapeutic products. While financial terms were not disclosed, Adimab will be eligible to receive potential research funding, option payments, milestone payments and royalties.

"Five Prime is in an ideal position to leverage our robust protein discovery platform and our oncology experience to advance new targets and molecules for cancer immunotherapy," said Lewis T. "Rusty" Williams, M.D., Ph.D., President and Chief Executive Officer of Five Prime. "Adimab’s ability to rapidly and effectively generate therapeutic monoclonal antibody candidates should allow us to move quickly from targets to products, as we expand our research and development efforts in this promising therapeutic area."

"We are pleased to be entering into this partnership with Five Prime," said Tillman Gerngross, Co-Founder and Chief Executive Officer of Adimab. "Five Prime’s productive high-throughput protein screening capabilities, in combination with our antibody discovery platform, have the potential to lead to the development of exciting new therapeutic agents and we look forward to collaborating in this effort."

On January 8, 2014 Eddingpharm reported that an asset purchase agreement has been signed with ACT Biotech, Inc. (ACT Biotech), a biopharmaceutical company based in the United States. Eddingpharm acquired worldwide rights to three small molecule drug assets (Telatinib, ACTB1003, and ACTB1010) and other molecules from ACT Biotech (Press release, Eddingpharm, JAN 8, 2014, View Source [SID1234527684]). Eddingpharm made an upfront payment to ACT Biotech upon the closing of the transactions contemplated under the APA. ACT Biotech is also eligible to receive clinical, regulatory, and commercial milestone payments. The total consideration, including the upfront payment, may reach up to U.S. $95 million.

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The lead asset,Telatinib, is a VEGFR inhibitor ready for Phase III development for gastric cancer. The other two programs ACTB1003 (FGFR/VEGFR2 inhibitor) and ACTB1010 (Aurora kinases inhibitor) are in Phase I-ready and preclinical stages, respectively. Eddingpharm plans to initiate trials for Telatinib in China and continue the development that ACT Biotech started in the U.S. Eddingpharm also intends to take the other two assets into clinical development in either the U.S. or China.

Eddingpharm founder and CEO Xin Ni commented, "Eddingpharm is pleased to expand its oncology portfolio by acquiring global rights to these three promising compounds. We look forward to resuming ACT Biotech’s work by advancing these important drugs to the next phase of trials in the U.S., China, and beyond."

This transaction represents the next step in Eddingpharm’s growth strategy and commitment to oncology. Owning the global rights to these innovative products will allow Eddingpharm to optimize its development strategies for China and the rest of the world.

Bernard Peperstraete, MD, Acting President and Chief Executive Officer of ACT Biotech commented, "We believe that this transaction represents an attractive opportunity for ACT Biotech, its stockholders and for cancer patients, and we are delighted that ACT’s promising oncology portfolio will be further developed by such a strong and internationally well-positioned partner." John Costantino, managing partner at NGN Capital, ACT Biotech’s lead investor, noted, "Eddingpharm’s experience in commercializing oncology products promises to accelerate and further unlock the full potential of these potent cancer compounds."

Purchased Assets

Telatinib
Telatinib, is a potent and selective small molecule VEGFR inhibitor ready for Phase III in gastric cancer, a leading cause of cancer-related death in China. Telatinib stands out in the well-validated VEGFR space for its manageable safety profile and promising objective response rates across the 300 patients treated to this point. Telatinib is currently ready for Phase III with trial design supported by the FDA and EMA, and a Special Protocol Assessment (SPA) was granted by the FDA.

ACTB1003
Phase I-ready ACTB1003 inhibits both FGFR and VEGFR2. The asset has a strong pharmacological profile.

ACTB1010
ACTB1010 is an Aurora kinase inhibitor in preclinical development.