Genmab Enters Commercial DuoBody Technology Agreement with BioNovion in the Field of Immuno-Oncology

On February 19, 2015 Genmab reported it has entered a co-development and commercialization agreement with BioNovion to evaluate a number of DuoBody product candidates targeting immune checkpoints (Press release Genmab, FEB 19, 2015, View Source [SID:1234501754]). Genmab and BioNovion will contribute panels of antibodies for the creation of bispecific antibody products using Genmab’s DuoBody platform technology. If the companies jointly select a product candidate for clinical development, development costs will be shared equally, with each party retaining a 50% share of the product rights. If one of the companies decides not to move a therapeutic candidate forward, the other company is entitled to continue developing the product at predefined licensing terms. The agreement also includes terms which allow the parties to opt out of joint development at key points in each product’s clinical development.

This commercial agreement follows a July 2014 research collaboration between Genmab and BioNovion.

“We are pleased to expand our research collaboration with BioNovion into a full commercial agreement, and utilize our robust and versatile DuoBody technology to create unique differentiated cancer therapeutics in the promising field of immuno-oncology,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

8-K – Current report

On February 19, 2015 Kite Pharma reported that it has entered into a lease agreement for a commercial manufacturing facility in El Segundo, California, which is adjacent to Los Angeles International Airport (Filing 8-K , Kite Pharma, FEB 19, 2015, View Source [SID:1234501710]). Kite also recently secured a lease for a clinical manufacturing facility in Santa Monica, California. The two facilities will not only support the planned clinical trials of Kite’s product candidates, but also will prepare Kite for the commercial launch and supply of its lead product candidate, KTE-C19, anticipated in 2017.

“We are committed to the rapid advancement of KTE-C19, which has the potential to address the significant, unmet needs of patients with aggressive, refractory B cell lymphomas and leukemias,” said Arie Belldegrun, M.D., FACS, Kite Pharma’s President and Chief Executive Officer. “We are initiating pivotal studies for KTE-C19 in multiple indications and believe our new facilities will help ensure the timely completion of these studies as well as our commercial launch. We also expect the facilities to support clinical trials and potential commercialization of our other eACT based product candidates, including both chimeric antigen receptor (CAR) and T cell receptor (TCR) based product candidates.”

The Santa Monica facility has approximately 18,000 square feet and will provide space for clinical manufacturing, research and development, and offices upon completion. In addition, Kite plans to continue to utilize its contract manufacturer to support clinical trials of eACT based product candidates.

The El Segundo facility has approximately 44,500 square feet, and, under the lease agreement, Kite has an expansion option for an additional 17,000 square feet until July 1, 2017. Kite was represented in the negotiation of the lease by Andrew Riley and Jeff Pion of CBRE. Kite anticipates the El Segundo facility will be operational to support the planned commercial launch of KTE-C19 in 2017.

Commenting on the new leases, Cynthia Butitta, Kite’s Chief Operating Officer and Chief Financial Officer, said, “Securing these manufacturing facilities fits strategically with our expansion and is an exciting and necessary step as we advance multiple clinical trials and prepare for commercialization of our product candidates.”

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

NPS Pharmaceuticals 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 .

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

Regulus 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 10-K , Regulus, FEB 18, 2015, View Source [SID1234501712]).

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

Pharmacyclics 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 10-K , Pharmacyclics, FEB 18, 2015, View Source [SID1234501711]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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