Sym004 Advances into Two New Clinical Trials and Receives Milestone Payments - Gilde Healthcare

Sym004 Advances into Two New Clinical Trials and Receives Milestone Payments

August 7, 2014

COPENHAGEN, Denmark 7 – Symphogen, a private biopharmaceutical company developing recombinant antibody mixtures, announced today that its collaborative partner, Merck KGaA, Darmstadt, Germany, through its biopharmaceutical division, Merck Serono has initiated two 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).  Symphogen also reports that it is eligible to receive two milestone payments from Merck for achieving certain agreed goals in the collaboration, related to the bi-weekly dosing study and the mCRC study.

“There is a high unmet need for patients with EGFR-resistant mCRC and NSCLC cancers as patients currently have limited therapeutic options,” said Kirsten Drejer, Chief Executive Officer of Symphogen. “We are pleased by the advancement of Sym004 into these new studies, and the Phase 1 dose-finding study in Japan of Sym004 that was initiated in late 2013, and we look forward to generating clinical data with this compound.”

Out-licensed worldwide by Symphogen to Merck in September 2012, Sym004 was the subject of data presentations at the 2013 and 2014 ASCO Annual Meetings in Chicago, IL. At these meetings, Sym004 reported Phase 2 proof-of-concept data in squamous cell carcinoma of the head & neck (SCCHN) and in metastatic colorectal cancer that signaled clinical activity and were supportive of the proposed mechanism of action, respectively.

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 out-licensed to Merck KGaA in 2012 following phase 2 clinical data in late stage cancer patients.

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. In total, the company has raised € 249 million in equity capital from premier international investors including Novo, Essex Woodlands Health Ventures and PKA, and employs 100 people, most of who are based at Symphogen’s facilities in Copenhagen.

For additional information, please contact:

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

Annes Associates
Shari Annes
Phone: 650-888-0902
E-mail: sannes@annesassociates.com

Consilium Strategic Communications
Mary-Jane Elliott, Amber Bielecka, Lindsey Neville
Phone: +44 20 3709 5702
E-mail: symphogen@consilium-comms.com

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