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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Enzon has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, Enzon, MAR 5, 2015, View Source [SID1234502196]).

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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Dynavax Technologies has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, Dynavax Technologies, MAR 5, 2015, View Source [SID1234502194]).

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

ArQule has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, ArQule, MAR 4, 2015, View Source [SID1234502178]).

arGEN-X Expands Preclinical Pipeline with ARGX-115: A Novel Simple Antibody™ for Cancer Immunotherapy

On March 4, 2015 arGEN-X N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, reported that it has exercised its option to exclusively license a first-in-class, preclinical therapeutic antibody candidate, now ARGX-115, to target GARP, a novel immune checkpoint with potential in cancer immunotherapy (Press release, arGEN-X, MAR 4, 2015, View Source [SID:1234511350]). ARGX-115 was discovered under arGEN-X’ Innovative Access Program with de Duve Institute / Université Catholique de Louvain (UCL) / WELBIO (BE).

"Cancer immunotherapy continues to be one of the most exciting approaches to treating cancer, but also one that is rapidly evolving. Application of immune checkpoint inhibitors have come more into focus, specifically in combination regimens in order to achieve the best possible patient outcomes. Preclinical results illustrate the exciting potential of ARGX-115 as a first-in-class antibody targeting GARP, a novel immune checkpoint and a target we believe to play a key role in the ability of tumors to escape the patient’s immune system," commented Tim Van Hauwermeiren, CEO of arGEN-X. "Combining the expertise of the de Duve Institute/UCL/WELBIO in cancer immunology with arGEN-X’s proprietary SIMPLE AntibodyTM platform and antibody know-how creates a powerful partnership that is ideally positioned to lead the discovery of differentiated antibodies in immune oncology. We expect to initiate further preclinical studies of ARGX-115 in the near-term to illustrate its potential as future cancer immunotherapy."

ARGX-115 RE-ACTIVATES IMMUNITY TO CANCER
In cancer patients, tumors grow as they escape from immune surveillance. Tumors can suppress the immune system by co-opting different immunosuppressive cells such as regulatory T-cells (Tregs), which exert contact-dependent inhibition of immune cells through the production of active TGF-β. On Treg cell surface, the membrane protein GARP regulates the production of active TGF-β. Preclinical studies completed at de Duve Institute/UCL/WELBIO show ARGX-115 can inhibit the immunosuppressive activity of human Tregs by binding to GARP-inactive TGF-β complex and preventing release of active TGF-β.

EXCLUSIVE LICENSE FOR GARP PROGRAM
ARGX-115 results from a collaboration between arGEN-X and de Duve Institute/UCL/WELBIO, initiated in November 2013, leveraging the SIMPLE AntibodyTM platform and the experience of de Duve Institute/UCL/WELBIO in cancer immunology, in order to create and validate functional leads and druggable targets in oncology. Under the collaboration, arGEN-X has exercised its option to exclusively in-license the GARP program for further development and commercialization as part of arGEN-X’ proprietary product pipeline.

ABOUT THE INNOVATIVE ACCESS PROGRAM
arGEN-X’ Innovative Access Program leverages the proven power of the SIMPLE Antibody platform in creating highly differentiated antibodies across multiple therapeutic areas. Through collaboration with academic centers of excellence and emerging biotech companies, arGEN-X will provide access to its antibody discovery technologies and offer technical support and proprietary know-how where needed. Deal structures are designed to be flexible.

Eisai and Merck Enter Collaboration to Explore Novel Combination Regimens of Anti-PD-1 Therapy with Multi-targeting RTK Inhibitor and Microtubule Dynamics Inhibitor in Multiple Types of Cancer

On March 4, 2015 Eisai Co., and Merck reported on a clinical trial collaboration to evaluate the safety, tolerability and efficacy of Merck’s anti-PD-1 therapy, pembrolizumab (marketed in the U.S. under the brand name KEYTRUDA), in combination with Eisai oncology compounds
lenvatinib mesylate (a multi-targeting RTK inhibitor marketed in the U.S. under the brand name LENVIMA, “lenvatinib”) and eribulin mesylate (a microtubule dynamics inhibitor marketed in
nearly 60 countries including Japan, the U.S., and Europe under the brand name HALAVEN, “eribulin”) in multiple clinical trials (Press release, Eisai, MAR 4, 2015, View Source [SID:1234502182]).

The planned studies include a multicenter, open-label Phase 1b/2 study of lenvatinib plus pembrolizumab in select solid tumors and an open-label, single-arm, multicenter Phase1b/2 study to evaluate the efficacy and safety of eribulin in combination with pembrolizumab in metastatic triple-negative breast cancer. Eisai and Merck will establish a Joint Development Committee to oversee clinical development activities. The studies are expected to begin in
the second half of 2015. Financial terms of the agreement were not disclosed.

“This collaboration could be a major step in the direction of developing combination regimens in different types of cancer, potentially maximizing the value of eribulin and lenvatinib,” said
Kenichi Nomoto, PhD, president, oncology product creation unit, Eisai Product Creation Systems. “Together, Eisai and Merck seek to explore combination regimens that have the potential to create synergistic effects between lenvatinib and pembrolizumab as well as between eribulin and pembrolizumab. Our hope is that we will bring treatments to market that make a difference in the lives of people battling cancer.”

“Cancer is a complex disease that often requires different approaches to help patients achieve the best possible outcome,” said Dr. Eric Rubin, therapeutic area head, oncology early-stage development, Merck Research Laboratories. “The collaboration with Eisai exemplifies Merck’s focus on advancing breakthrough science in immuno-oncology. We look forward to evaluating pembrolizumab in combination with eribulin and also with lenvatinib in different tumor types.”

The combinations of lenvatinib and pembrolizumab, and eribulin and pembrolizumab, are investigational. The efficacy and safety of these combinations have not been established.