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RuiYi (formerly Anaphore) and arGEN-X Announce Exclusive Worldwide License Agreement for ARGX-109, a Novel anti-IL-6 Antibody

On October 4, 2012 RuiYi (formerly Anaphore) and arGEN-X BV reported that arGEN-X has granted a worldwide exclusive license to RuiYi to develop and commercialize ARGX-109, a novel anti-IL-6 monoclonal antibody discovered and developed by arGEN-X (Press release arGEN-X, OCT 4, 2012, View Source [SID:1234500574]).

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Under the agreement, RuiYi will make an upfront payment to arGEN-X consisting of cash and equity. arGEN-X is also eligible to receive additional payments based on the achievement of certain clinical, regulatory and commercialization milestones and royalties based on worldwide net sales of therapeutic products.

"The arGEN-X SIMPLE Antibody technology enables novel antibodies with outstanding features of potency, human composition and manufacturability," said Paul Grayson, President and CEO of RuiYi. "ARGX-109 was carefully selected based on its physical and biologic attributes and its range of potential clinical applications in both inflammatory diseases as well as oncology indications. Furthermore, the addition of this molecule accelerates our growth as an early development stage company in China."

"We are excited to partner our first preclinical program so early in our lifetime as a therapeutic antibody company," added Tim Van Hauwermeiren, Chief Executive Officer of arGEN-X. "We believe RuiYi’s development strategy of first developing ARGX-109 in China is a highly innovative approach to drug development and will maximize the clinical and commercial potential of ARGX-109."

ABLYNX COLLABORATES WITH MERCK TO DEVELOP THERAPEUTIC NANOBODY CANDIDATES

On October 2, 2012 Ablynx reported a collaboration with Merck & Co to develop and commercialise Nanobody candidates directed towards a voltage gated ion channel with the option to develop and commercialise a Nanobody to a second target (Press release Ablynx, OCT 2, 2012, View Source [SID:1234500455]).
Under the terms of the agreement, Merck gains exclusive global rights to Nanobodies against the selected target, with an option for similar rights to a second target. Upon signing, Merck will pay Ablynx a €6.5 million upfront payment and a €2 million fee for research funding. In addition, Ablynx will be eligible to receive up to €448 million in research, regulatory and commercial milestone payments associated with the progress of multiple candidates as well as tiered royalties on any products derived from the collaboration. Ablynx will be responsible for the discovery of Nanobody candidates and Merck will be responsible for the research, development, manufacturing and commercialisation of any Nanobody product resulting from the collaboration.

(Press release, Cannabis Science, SEP 24, 2012, View Source [SID:1234506799])

Dyax Corp. and Kadmon Sign Strategic Licensing Agreement for DX-2400

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.

"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.

MacroGenics and Servier Enter Broad Strategic Alliance to Develop and Commercialize Three Anti-Cancer DART™ Products

On September 20, 2012 MacroGenics and Servier reported that they have entered into an option agreement for the development and commercialization of Dual-Affinity Re-Targeting (DART) products directed at three undisclosed tumor targets (Press release MacroGenics, SEP 20, 2012, View Source [SID:1234500770]). MacroGenics’ DART technology is a proprietary, bi-specific antibody platform in which a single recombinant molecule is able to target two different antigens. These DART proteins can be used to redirect the body’s cell-destroying, immune effector cells against tumor cells.

"We are very pleased to be expanding our existing relationship with MacroGenics. Servier partnered with MacroGenics in late 2011 on MGA271, a monoclonal antibody that recognizes B7-H3, a novel member of the B7 family of immune regulators. We believe bi-specific antibodies are an important new frontier in medicine. MacroGenics is well positioned to be a leader in this exciting area, given the robustness and versatility of their DART platform. Furthermore, they have a proven track record in successfully integrating their powerful antibody discovery and bi-specific platforms," said Stéphane Depil, M.D., Ph.D., in charge of Oncology Research & Development at Servier. "Today’s announcement further underscores Servier’s commitment to develop novel targeted therapies that address significant unmet medical needs for cancer patients," added Emmanuel Canet, M.D., Ph.D., President Research & Development at Servier. "We continue to look forward to building a long-term strategic collaboration with MacroGenics, a pioneer in developing next-generation antibody therapeutics."

Under the terms of the agreement, MacroGenics will receive a $20 million upfront payment. MacroGenics retains full development and commercialization rights to the three pre-clinical DART programs in the U.S., Canada, Mexico, Japan, Korea and India, while Servier has the option to obtain an exclusive license covering the rest of the world for each of the programs. Prior to the exercise of Servier’s option, both parties will fund and conduct specified research and development activities. Servier may exercise its option for one of the programs prior to IND submission, and for each of the other two programs upon completion of an initial Phase 1 clinical trial. If Servier exercises such options, MacroGenics will receive option exercise fees, which, when combined with preclinical milestones, would total an additional $80 million. MacroGenics could also receive up to an additional $1 billion in clinical, regulatory and commercialization milestone payments for the three programs. Both parties will share the clinical development costs for each program following the exercise of such option. Finally, MacroGenics may receive tiered, double-digit royalties on future net sales.

"We are delighted to enter into our second collaboration with Servier and our third major pharmaceutical partnership around our DART platform," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Servier has been an extraordinary partner with significant global capabilities in developing and delivering novel cancer treatments to patients. They will enable us to significantly broaden and accelerate our pipeline of innovative DART-based product candidates."