On December 21, 2016 BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the dosing of the first patient in a Phase I clinical trial of BGB-290, a potent and selective PARP inhibitor, in Chinese patients with advanced solid tumors (Press release, BeiGene, DEC 21, 2016, View Source [SID1234517156]).

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"We are pleased to announce the start of clinical development for BGB-290 in China, and we look forward to its rapid development following this Phase I study. BGB-290 entered clinical evaluation in Australia in July 2014, and proof of principle data were presented at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting in 2015. We look forward to developing BGB-290 for patients in China, where this class of agents is still not available," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman.

The Phase I open-label, multi-center dose escalation and expansion study of BGB-290 is designed to investigate the safety, pharmacokinetics, and antitumor activity of BGB-290 in Chinese patients with advanced solid tumors and to determine the recommended Phase II dose in these patients. Professor Binghe Xu from The Chinese Academy of Medical Sciences Cancer Hospital is the principal investigator of the study.

About BGB-290

BGB-290 is a potent and highly selective inhibitor of PARP1 and PARP2. BGB-290 is being developed as a monotherapy and in combination with other therapies for the treatment of several cancers including ovarian cancer, prostate cancer, breast cancer, glioblastoma multiforme, small cell lung cancer, and gastric cancer.

On December 21, 2016 Incyte Corporation (NASDAQ:INCY) and Merus N.V. (NASDAQ:MRUS) reported that they have entered into a global, strategic collaboration agreement focused on the research, discovery and development of bispecific antibodies utilizing Merus’ proprietary Biclonics technology platform (Press release, Incyte, DEC 21, 2016, View Source [SID1234517155]). The Collaboration and License Agreement grants Incyte the exclusive rights for up to eleven bispecific antibody research programs, including two of Merus’ current preclinical immuno-oncology discovery programs.

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Biclonics retain the IgG format of antibodies that are produced naturally by the immune system and, by binding to two targets, enable multiple modes of action that cannot otherwise be obtained with conventional monoclonal antibodies.

"By virtue of a unique ability to simultaneously engage multiple protein targets, we believe bispecific antibodies have the potential to play an important role in the future of biotherapeutics," said Reid Huber, Ph.D., Incyte’s Chief Scientific Officer. "This collaboration with Merus expands our large molecule discovery capabilities into an innovation-rich area of research, creating additional opportunities for us to deliver on our commitment to improving and extending the lives of patients with cancer and other serious diseases."

"This transformative, global collaboration further underscores the potential of Merus’ Biclonics technology platform and establishes a strong relationship with Incyte, a leader in innovative drug development," said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. "We look forward to expanding our pipeline under this agreement, as we efficiently exploit our preclinical discovery engine and progress our most advanced, proprietary assets in the clinic."

Terms of the Collaboration
Under the terms of the collaboration, Incyte has agreed to pay Merus an upfront payment of $120 million. In addition, Incyte has agreed to purchase 3.2 million shares of Merus stock at $25 per share, for a total equity investment of $80 million.

The parties have agreed to collaborate on the development and commercialization of up to 11 bispecific antibody programs. For one current preclinical program, Merus will retain all rights to develop and commercialize approved products in the United States, and Incyte will develop and commercialize approved products arising from the program outside the United States. Following any regulatory approval of a product candidate for this particular pre-clinical program, each company has agreed to pay the other tiered royalties ranging from 6 to 10 percent on net sales of products in their respective territories.

Merus also has the option to co-fund development of product candidates arising from two other programs. For any program for which Merus exercises its co-development option, Merus would be responsible for 35 percent of global development costs in exchange for a 50 percent share of U.S. profits and losses and tiered royalties ranging from 6 to 10 percent on ex-U.S. sales by Incyte for these programs. Merus also has the right to elect to provide up to 50 percent of detailing activities for product candidates arising from one of these programs in the United States.

For each of the other eight programs, Incyte has agreed to independently fund all development and commercialization activities. For these programs, Merus will be eligible to receive potential development, regulatory and sales milestone payments of up to $350 million per program, which could result in an aggregate milestone opportunity of approximately $2.8 billion if all development, regulatory and sales milestones are achieved across all such eight other programs in all territories. Merus will also be eligible to receive tiered royalties ranging from 6 to 10 percent on global sales of any approved products under these eight programs.

Merus will retain rights to both of its clinical candidates and MCLA-158, as well as its technology platform and future programs emerging from Merus’ platform that are outside the scope of this agreement.

The transaction is expected to close in the first quarter of 2017, subject to the early termination or expiration of any applicable waiting periods under the Hart-Scott Rodino Act and customary closing conditions.

On December 21, 2016 BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on the discovery and development of novel immuno-regulatory antibodies to treat cancer, reported that it has entered into a cancer immunotherapy research collaboration and license agreement with Pfizer Inc. ("Pfizer") (NYSE: PFE) to develop antibodies targeting tumour-associated myeloid cells (Press release, BioInvent, DEC 21, 2016, View Source [SID1234517154]).

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Under the terms of the deal, Pfizer will pay BioInvent approximately $10 million in early payments, including an upfront payment, early research funding, and a $6 million equity investment in new shares of BioInvent at a subscription price of SEK 2.56 per share, which corresponds to an approximately 30% premium to the average volume weighted price for the share during the 10 trading days prior to 21 December 2016.

Assuming five antibodies are developed through to commercialization, BioInvent would be eligible for potential future payments related to certain development milestones, which could amount to more than $0.5 billion through the term of the deal, as well as up to double digit royalties related to any potential products that may result from the collaboration. Pfizer will have the right to develop and commercialize any antibodies generated to an undisclosed number of tumour-associated myeloid cell targets.

Commenting on the agreement, Michael Oredsson, CEO of BioInvent said: "We are very pleased to announce this discovery and development collaboration with Pfizer which will leverage our cancer antibody biology and immuno-oncology expertise. We are looking forward to working with Pfizer to deliver a number of first-in-class antibodies to potentially treat a range of cancer indications addressing unmet patient needs."

BioInvent will leverage its cancer biology expertise, combined with its unbiased translational drug discovery approach ("F.I.R.S.T"), to identify novel oncology targets and therapeutic antibodies that inhibit cancer growth either by reversing the immunosuppressive activity of tumour-associated myeloid cells or by reducing the number of tumour-associated myeloid cells in the tumour.

"We believe co-targeting of tumour-associated myeloid cells has the potential to significantly improve the efficacy of currently available checkpoint inhibitor therapies, and may help activate anti-cancer immunity in currently non-responding patients and cancer types" said Björn Frendéus, CSO of BioInvent.

"We look forward to collaborating with BioInvent, as we believe that modulating the activity of tumour-associated myeloid cells presents an opportunity to help us expand our portfolio in oncology and ultimately deliver on our mission to bring innovative new medicines to cancer patients," said Robert Abraham, Ph.D., Senior Vice President and Head of Pfizer’s Oncology Research & Development Group, Pfizer.

Directed Share Issue
As part of the agreement, the Board of Directors of BioInvent on 21 December 2016 resolved, based on the authorization of the annual general meeting on 12 May 2016, on a directed issue of 21,973,594 new shares to Pfizer at a subscription price per share of SEK 2.56, corresponding to a total investment of $6 million. The subscription price corresponds to an approximately 30% premium to the average volume weighted price for BioInvent’s share during the 10 trading days prior to 21 December 2016. The reason for the derogation from the shareholders’ preferential right is that the investment, in addition to providing BioInvent with new capital, brings Pfizer as a new strategic partner, in alignment with shareholders’ interests as a new shareholder.

As a result of the new share issue, the number of shares in BioInvent will increase from 282,721,619 shares to 304,695,213 shares, and the share capital will increase from 22,617,730 to 24,375,617. The new shares are expected to be registered with the Swedish Companies Registration Office and admitted for trade on Nasdaq Stockholm on 28 December 2016. Pfizer have undertaken, on customary terms and conditions, not to sell or otherwise dispose of the shares of the investment during a period of 90 days from the share issue. Following the directed share issue, Pfizer will own approximately 7,2% of BioInvent’s share capital.