On September 20, 2012 Dyax and Kadmon reported that they have entered into a strategic licensing agreement in which Kadmon has been granted an exclusive worldwide license for the development and commercialization of the fully human monoclonal antibody DX-2400, a potent and selective antibody inhibitor of matrix metalloproteinase 14 (MMP-14) (Press release Kadmon, SEP 20, 2012, View Source [SID:1234500783]). MMP-14 is a key enzyme in a molecular pathway thought to play a role in tumor blood vessel formation (angiogenesis) in addition to affecting tumor growth and cell migration. Under the terms of the agreement, Dyax will receive an upfront payment, and is eligible for significant development and commercial milestone payments, in addition to tiered royalties on commercial sales up to a double-digit rate. As an exclusive licensee, Kadmon will be responsible for further development and commercialization of DX-2400, which is currently in investigational new drug (IND) application-enabling studies.

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"Kadmon’s management team has a proven track record of successfully developing and commercializing important, new oncology products," stated Gustav Christensen, President and Chief Executive Officer of Dyax. "This strategic agreement further validates Dyax’s capabilities to successfully discover novel antibody drug candidates utilizing our proprietary phage display technology and advance the resulting drug candidates into development."

"This agreement expands on our longstanding relationship with Dyax and their antibody technology platform," stated Samuel D. Waksal, Ph.D. Chairman and CEO of Kadmon. "We believe MMP-14 is an important piece of the puzzle for overcoming cancer’s growth, proliferation and resistance mechanisms. In particular, its role in tumors and ocular disease neovascularization represents a unique target opportunity that may be complementary to other antiangiogenic therapies on the market and in development. We look forward to developing this candidate, and to fully understanding its synergistic potential with our oncology pipeline products."

Targeting MMP-14 has therapeutic potential in multiple oncology indications where human tumor tissue sample analysis has confirmed high levels of active MMP-14. In published work, Dyax has previously demonstrated DX-2400 mediated inhibition of primary tumor growth, metastasis and angiogenesis in preclinical models of breast, melanoma and prostate cancer.

DX-2400 was discovered using Dyax’s "gold-standard" phage display technology where Dyax applied its extensive selection and screening expertise to selectively block catalytic activity of a single protease within a larger and closely related family of enzymes. This antibody is another example of the superior functional selectivity available to validate novel biologic targets using Dyax’s phage display libraries.

(Filing, 10-K, Myrexis, SEP 13, 2012, View Source [SID:1234505685])

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On September 15, 2012 Lundbeck reported that Treanda is approved in Canada in patients with symptomatic chronic lymphocytic leukemia (CLL) who have received no prior treatment and in relapsed indolent B-cell non-Hodgkin lymphoma (iNHL) who did not respond to or progressed during or shortly following treatment with a rituximab regimen (Press release Lundbeck, SEP 13, 2012, View Source [SID:1234500349]).

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On September 7, 2012 CRT, Astex Pharmaceuticals, Inc. (NASDAQ: ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics and The Institute of Cancer Research, London, reported they have initiated a collaboration to discover and develop drug candidates targeting an undisclosed epigenetic target in a blood cancer with high unmet medical need (Press release, Cancer Research Technology, SEP 7, 2012, View Source [SID1234523270]).

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The collaboration combines Astex’s world-renowned fragment-based drug discovery platform and epigenetic* drug development experience with the expertise in blood cancer biology at The Institute of Cancer Research (ICR) and proven success in drug discovery at the Cancer Research UK Cancer Therapeutics Unit at the ICR.

Dysregulated epigenetic mechanisms are now understood to underlie a variety of cancer types, and have been successfully targeted by the first generation of epigenetic anticancer drugs**. In some cases, specific epigenetic mutational events can be linked to disease etiology, providing an opportunity to develop highly targeted personalised medicines and associated companion diagnostics that will ultimately improve survival and reduce side effects.

"We are delighted to be entering into this new collaboration with the ICR and CRT on a key epigenetics target," said Harren Jhoti, PhD, president of Astex Pharmaceuticals. "This new partnership builds on the highly successful collaboration which Astex entered into with the ICR and CRT in 2003 on another cancer target, PKB/Akt. That collaboration led to the discovery of two clinical candidates, the first of which, AZD5363, was taken into Phase I by our partner AstraZeneca in early 2011 and the second of which, AT13148, is being prepared to be taken into Phase 1 under our development partnership with Cancer Research UK. "

Professor Paul Workman, director of the Cancer Research UK Cancer Therapeutics Unit at The Institute of Cancer Research, said: "ICR scientists are pioneers at unravelling blood cancer drug targets, which others have considered challenging to drug effectively. We have a very strong track record of designing drugs to attack challenging biological targets and bringing them into clinical trial, and given Astex’s complementary expertise, we are very excited about the potential of this collaboration."

Dr Phil L’Huillier, director of business management at CRT, said: "Putting in place this collaboration between the Cancer Research UK-funded drug discovery team at the ICR and Astex provides a powerful route to identify drug candidates for this promising new target.

"The deal will ensure that the research programme benefits from the necessary investment to progress the research to its full potential while building on the validation and assay development work that has been carried out at the ICR and funded by Cancer Research UK and others.

"We hope that this research will lead to the development of new drugs to ultimately improve survival for cancer patients."

On September 7, 2012 the SFJ Pharmaceuticals Group entered into a collaborative development agreement with Pfizer Inc. to conduct a Phase III clinical trial of Pfizer’s investigational pan-HER inhibitor, dacomitinib (PF-00299804) (Press release SFJ Pharmaceuticals, SEP 7, 2012, View Source [SID:1234500284]). The trial, which will be conducted across multiple sites in Asia and Europe, will evaluate dacomitinib as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor (EGFR).
Under the terms of the agreement, SFJ will provide the funding and clinical development supervision to generate the clinical data necessary to support a registration dossier on dacomitinib for marketing authorization by regulatory authorities for the indication: First-line treatment of patients with locally advanced or metastatic NSCLC with EGFR activating mutations. If approved for this indication, SFJ will be eligible to receive milestone payments and earn-out payments.
This is the second collaborative agreement between SFJ and Pfizer. SFJ previously entered into an agreement with Pfizer to conduct a Phase 3 trial in Asia of Pfizer’s Inlyta (axitinib) for the adjuvant treatment of patients at high risk of recurrent renal cell carcinoma following nephrectomy.

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