On June 24, 2014 Johnson & Johnson Innovation, Boston and Janssen Biotech, Inc. reported a three-year immuno-oncology lung cancer collaboration with the Dana-Farber Cancer Institute (Press release Johnson & Johnson, JUN 24, 2014, View Source [SID:1234501614]). Through the collaboration, Janssen scientists will work with the research team at Dana-Farber’s Belfer Institute for Applied Cancer Science to determine the clinical setting for certain immuno-oncology agents in Janssen’s lung cancer discovery pipeline.

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"We are thrilled to be working with the scientists at the Belfer Institute," said Peter Lebowitz, Janssen Global Therapeutic Area Head, Oncology. "Their excellence in lung cancer translational research, which incorporates both tumor genetics and immunotherapy, will be critical to the development of personalized treatment options for patients in need."

Utilizing the Belfer Institute’s proprietary immuno-oncology lung platform and lung cancer disease expertise, the research teams will also seek to identify rational immuno-oncology drug combination strategies and biomarkers, and to characterize mechanisms of resistance. The collaboration will also identify and validate novel targets for lung cancers.

"There is a growing recognition of the potential importance of immuno-oncology agents directed at a variety of cancers," said Robert G. Urban, PhD, Head of Johnson & Johnson Innovation, Boston. "Through our collaboration with the Dana-Farber Cancer Institute, we will be able to increase the probability of success and decrease development times for our important immuno-oncology pipeline in the critical area of lung cancer."

Lung cancer is one of three focus areas for Janssen Oncology based on its high unmet need. According to the American Cancer Society, lung cancer is the leading cause of cancer death among both men and women. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined. Overall, the chance that a man will develop lung cancer in his lifetime is about 1 in 13; for a woman, the risk is about 1 in 16.

On June 24, 2014 Mersana Therapeutics and Merck KGaA (EMD Serono) reported an agreement to collaboratively develop next-generation antibody-drug conjugates (ADCs) (Press release Mersana Therapeutics, JUN 24, 2014, View Source [SID:1234500605]). ADCs are composed of an antibody linked to cytotoxic drugs, whereby the antibody specifically targets and delivers the cytotoxic drug to cancer cells, which could lead to higher drug levels at the tumor site.

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Mersana and the biopharmaceutical division of Merck KGaA will leverage Mersana’s Fleximer technology to generate ADCs for multiple undisclosed targets. Both parties have agreed to test a variety of ADCs by utilizing Mersana’s platform technologies and several cytotoxic agents as conjugates.

"This new collaboration provides an exciting opportunity to expand our oncology drug discovery and development portfolio into the evolving ADC space," said Dr. Andree Blaukat, head of the Translational Innovation Platform Oncology at Merck Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany. "We have a long-standing commitment to improving oncology care, and we aim to deliver the best benefit possible to patients. Partnering with Mersana allows us to incorporate cutting-edge research and technical excellence to enrich our pipeline."

"We look forward to working with Merck in Darmstadt, Germany, to apply our proprietary platform technologies to rapidly develop and demonstrate preclinical proof-of-concept of several customized, novel Fleximer-ADC candidates," said Timothy B. Lowinger, Ph.D., Mersana’s Chief Scientific Officer.

Under the agreement, Merck KGaA will provide monoclonal antibodies to Mersana, which will generate the Fleximer-ADCs and conduct drug discovery and preclinical development activities. Merck KGaA will be responsible for clinical development and commercialization of any products under an exclusive license from Mersana. In addition to an upfront payment, Mersana is eligible to receive milestones plus royalties on worldwide net sales of products.

(Press release, Ligand, JUN 24, 2014, View Source [SID:1234502817])

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(Press release, PeptiMed, JUN 23, 2014, View Source;newsId=20140623005412&newsLang=en [SID:1234503455])

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On June 20, 2014 Celsion reported the completion of the acquisition by Celsion of substantially all of the assets of EGEN, Inc. (EGEN), a privately-held biopharmaceutical company focused on the development of nucleic acid-based therapeutics for the treatment of cancer and other difficult to treat diseases (Press release Celsion, JUN 20, 2014, View Source [SID:1234501826]). The acquisition includes EGEN’s Phase Ib DNA-based immunotherapy product candidate EGEN-001 and its therapeutic platform technologies, TheraPlas for delivery of DNA and mRNA, TheraSilence for delivery of RNA, and RAST for Cell Enabled Expression and Secretion of RNA.

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"Completing the acquisition of EGEN marks a defining event for Celsion, as it brings together leading-edge assets and capabilities with the opportunity to not only advance medicine and patient care in cancer and other serious diseases, but create long-term value for our shareholders," said Michael H. Tardugno, Celsion’s President and Chief Executive Officer. "Now, all at once a fully integrated development company with assets and capability from feasibility to commercialization, we look forward to advancing our pipeline of chemotherapies, immunotherapies and DNA or RNA-based therapies in the lab and in ongoing or planned Phase III, II and I studies. Our strong balance sheet provides us with an impressive internal development runway, as well as allows us to develop collaborative partnerships leveraging the power of our multiple platforms."

Under the terms of the agreement, CLSN Laboratories, Inc., a wholly-owned subsidiary of Celsion (CLSN Laboratories), acquired substantially all of the assets and assumed certain specified liabilities of EGEN. At the closing, Celsion issued $8.5 million worth of common stock, representing approximately 15.8% of its outstanding shares, paid approximately $3.0 million in cash to EGEN, and holds back $2.1 million worth of common stock until August 2, 2016 for expense adjustment and certain indemnification claims of Celsion. In addition to the upfront payment, a total of $30.4 million in future milestone obligations are payable to EGEN based on the successful completion of certain clinical development and licensing milestones.

The combination of Celsion and EGEN will create a fully-integrated, oncology-focused research and development company with a multi-phase clinical pipeline, platform technologies for the discovery of novel, nucleic acid-based immunotherapies and other anti-cancer DNA/RNA therapies, and expertise from bench to bedside. The transaction brings to Celsion EGEN’s lead, Phase Ib clinical candidate, EGEN-001, an IL-12 plasmid immunotherapy encased in a nanoparticle delivery system, as well as three technology platforms, TheraPlas, TheraSilence, and RAST for Cell Enabled Expression and Secretion of RNA.

The transaction complements Celsion’s lead development candidate, ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in a pivotal, double-blind, placebo-controlled, global Phase III trial (the OPTIMA Study) in primary liver cancer.

CLSN Laboratories has retained all EGEN employees and will be based in Huntsville, Alabama, where Celsion also plans to consolidate all of its analytical service and laboratory functions.

Cantor Fitzgerald & Co. acted as the financial advisor to Celsion. Sidley Austin LLP and O’Melveny & Myers LLP acted as legal counsel to Celsion for this transaction.