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29 Jan 2015

Symphogen Regains Rights to Sym004 And Announces Organizational Changes

COPENHAGEN, Denmark 29 January 2015: Symphogen, a private biopharmaceutical company developing recombinant antibody mixtures, announced today several new corporate initiatives that reposition the company to focus on its proprietary pipeline of clinical oncology programs. The announcements addresses the regained rights to Sym004, a novel antibody mixture currently in a Phase 2b program, and a prioritization of the company’s discovery activities in immuno-oncology.

Symphogen’s collaborative partner, Merck KGaA, is conducting an ongoing assessment of its pipeline assets and has decided to return the rights of Sym004 to Symphogen for further development. The decision to return the rights is not related to any new safety or efficacy findings regarding Sym004.

The regained Sym004 product rights provides Symphogen with a valuable opportunity to retain the value of this attractive clinical candidate, an investigational antibody mixture targeting the epidermal growth factor receptor (EGFR), currently in Phase 2b and 1b trials.

In addition to Sym004, Symphogen expects to bring its pan-HER multi-targeting antibody mixture into clinical development in 2015. Pan-HER is a mixture of six humanized full-length monoclonal antibodies targeting EGFR, HER2 and HER3, all validated targets for cancer treatment that effectively induces simultaneous down-modulation of all three targets and prevents compensatory receptor up-regulation. Symphogen’s research has demonstrated that simultaneous targeting of three receptors provides broader efficacy, than targeting a single receptor or any combination of two receptors in the HER family. Symphogen also has, in late preclinical development, a mAb mixture program against the receptor tyrosine kinase c-MET, which is expected to enter the clinic in 2016. Symphogen’s early discovery activities will now be focused on the development of multi-targeting programs in the immuno-oncology area.

“We are pleased to have regained the rights to this attractive product candidate and look forward to rapidly moving forward its clinical development in areas of high unmet medical needs. The return of this mature program allows Symphogen, effectively and efficiently, to transition into a clinical company. With more than €70 million in cash to execute its strategy, the rights to an advancing clinical program, and several pipeline programs being readied for development, we can harvest the productivity of our research efforts and move the company forward with an eye toward commercial oncology opportunities,” said Kirsten Drejer, PhD, Chief Executive Officer of Symphogen.

Organizational Changes
Symphogen also announced today that Symphogen Inc. is opening a Clinical Development Unit in New Jersey, US, under the leadership of Head of Corporate R&D, Chief Medical & Scientific Officer Dr. Ivan Horak.

Additionally, Dr. Esper Boel has joined the company as Chief Technology Officer to lead Symphogen’s antibody discovery activities in Denmark, including Immuno-Oncology projects.
Prior to joining Symphogen, Dr. Boel served as Corporate Vice President for the Biotechnology unit in Novo Nordisk’s international R&D organization. Dr. Boel has extensive experience in biopharmaceutical R&D management, and has served as Board member/consultant for high-profile antibody based companies including Xencor Inc. and Innate Pharma SA, and he has (co)authored more than 70 original research articles and reviews.

About Sym004
Sym004 is comprised of two antibodies that are not only designed to block ligand binding, receptor activation and downstream signaling but are also thought to elicit removal of the EGFR receptors from the cancer cell surface by inducing EGFR internalization and degradation.
Sym004 was the subject of data presentations at the 2013 and 2014 ASCO Annual Meetings in Chicago, IL. At these meetings, reported Phase 2 proof-of-concept data in squamous cell carcinoma of the head & neck (SCCHN) and in metastatic colorectal cancer signaled clinical activity and were supportive of the proposed mechanism of action. Merck KGaA, through its biopharmaceutical business, Merck Serono, initiated new clinical studies evaluating Sym004, an investigational antibody mixture targeting the epidermal growth factor receptor (EGFR). The trials are a Phase 2b study in patients with metastatic colorectal cancer (mCRC) and a Phase 1b study in patients with Non-Small Cell Lung Cancer (NSCLC). In addition, a Japanese Phase 1 study, which started in 2013, is currently recruiting patients with Esophageal Cancer. Also in 2014, Symphogen received three milestone payments from Merck for achieving certain agreed goals in the collaboration, including the initiation of new mCRC and NSCLC clinical trials.

About Symphogen A/S
Symphogen is developing next-generation antibody therapeutics for the treatment of cancer and is dedicated to bringing truly innovative oncology products to the market. The company has advanced the frontier of antibody discovery by creating well-characterized antibody mixtures that address multiple oncology targets in a single drug product. The company has matured its pipeline and has currently brought two product candidates into the clinic. The company’s productive technology suite – capable of identifying, selecting and manufacturing optimal antibody mixtures – fuels Symphogen’s innovative pipeline.

For additional information, please contact:

Kirsten Drejer
Chief Executive Officer
Phone: + 45 22 10 99 59
E-mail: kd@symphogen.com

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