Corporate Banner
Satellite Banner
Scientific Community
Become a Member | Sign in
Home>News>This Article

Symphogen Reports New Data on Anti-EGFR Monoclonal Antibody Mixture

Published: Monday, June 03, 2013
Last Updated: Monday, June 03, 2013
Bookmark and Share
ASCO presentation and poster on SYM004 in mCRC and SCCCHN.

Symphogen has announced at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO) the results of two proof-of-concept studies of SYM004, an anti-EGFR monoclonal antibody (mAb) mixture.

Symphogen entered the antibody mixture into the clinic in 2010, and subsequently partnered with Merck KGaA, Darmstadt, Germany, in September 2012.

In sessions this morning, Abstract #3551 provided data on SYM004’s clinical evaluation in patients with anti-EGFR mAb-resistant/refractory KRAS wild-type (wt) metastatic colorectal cancer (mCRC) and Abstract #6002 in patients with advanced squamous cell carcinoma of the head and neck (SCCHN) refractory to anti-EGFR mAb.

Both studies provided data supportive of the anticipated mechanism of action of the antibody mixture.

Professor Jean-Pascal Machiels, Head of Department of Medical Oncology, Université Catholique de Louvain, Clinique Universitaires St-Luc, Brussels, Belgium, lead investigator in the Sym004-02 study who made the oral presentation, commented, "These datasets suggest an anti-tumor effect. The achievement of stable disease and tumor shrinkage in heavily pretreated patient populations is of interest for any potential treatment. The studies are in line with Symphogen’s published data on the mechanism of action. The fact that these patients had progressed on other EGFR mAbs suggest a potentially additive effect against the EGF receptor."

Squamous Cell Carcinoma of the Head and Neck (SCCHN) Phase 2 Open Label Study Results
Weekly doses of 12 mg/kg Sym004 showed clinical response of stable disease in half of the heavily pretreated SCCHN patients resistant/refractory to previous anti-EGFR mAb treatment.
• Tumor shrinkage was observed in 8/26 patients by central and blinded review of CT scans. SD was observed in 13/26 patients.
• Median PFS was 2.7 months (95% CI 1.4-4.7 months).
• The observed safety profile was similar to other anti-EGFR mAbs except for skin related toxicity
• EGFR down-modulation was observed in paired skin and tumor biopsies, supporting the proposed mechanism-of-action.

Metastatic Colorectal Cancer Phase 1 / 2 Results
Weekly doses of Sym004 showed clinical responses in mCRC patients failing previous anti-EGFR mAb treatment. Partial responses were seen at both the 12 mg/kg and 9 mg/kg doses:
• A central and blinded review of CT scans was performed in 27/29 patients treated with 12 mg/kg Sym004 and showed tumor shrinkage >10% in 7/27 (26%) pts. A partial response (PR) PR was observed in 3/27 (11%) and stable disease (SD) in 16/27 (59%).
• A central and blinded review of CT scans was performed in 12/13 patients treated with 9 mg/kg Sym004 and showed tumor shrinkage >10% in 4/12 (33%) pts. A PR was observed in 1/12 (8%) and SD in 8/12 (67%).
• PFS for 9 mg/kg and 12 mg/kg was 14 weeks (95% CI 5.3 - 22.1%) and 14.3 weeks (95% CI 6.0 - 18.6), respectively.
• The observed safety profile was similar to other anti-EGFR mAbs, except for skin related toxicity.
• EGFR down-modulation was observed in paired skin and tumor biopsies supporting the proposed mechanism-of-action.

Symphogen has an exclusive worldwide license agreement with Merck KGaA, of Darmstadt, Germany, for Sym004. Under the agreement, Merck gained exclusive worldwide rights to develop and commercialize Sym004.

Symphogen received from Merck in 2012 an upfront payment of € 20 million.

Symphogen is eligible to receive up to € 225 million for meeting clinical development and regulatory milestones, and € 250 million in potential sales performance milestones and royalties on net worldwide sales.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Symphogen to Report Preliminary Safety Data from a Phase 1 Study of Sym004
Data will be presented at the upcoming 2014 ASCO Annual Meeting in Chicago.
Friday, May 30, 2014
Symphogen Expands Previous Private Equity Round, Reaching a Total of € 141 Million
Novo A/S and PKA led the expansion with investments of €20 million each, while Danica Pension participated with its pre-financing ownership share of the additional financing.
Friday, May 03, 2013
Symphogen Presents Positive Rozrolimupab (SYM001) Phase 2 Trial Results in ITP at ASH
Phase 2 data demonstrate that rozrolimupab induce a rapid increase in blood platelets of ITP patients.
Tuesday, December 13, 2011
Symphogen’s Success Attracts USD 25 Million Investment
The financing will be used to carry out clinical trials of Symphogen’s first product, anti-RhD.
Thursday, January 12, 2006
Symphogen Launches New Website and Marketing Materials
New website is accompanied by several new factsheets detailing the company, technology and products.
Wednesday, December 21, 2005
Scientific News
Genetic Basis of Fatal Flu Side Effect Discovered
A group of people with fatal H1N1 flu died after their viral infections triggered a deadly hyperinflammatory disorder in susceptible individuals with gene mutations linked to the overactive immune response, according to a recent study.
Developing Drug Resistance may be a Matter of Diversity for Tuberculosis
Researchers have probed the bacteria that causes tuberculosis, Mycobacterium tuberculosis, to learn more about how individual bacterial cells change and adapt while in the human body.
Surprising Trait Found in Anti-HIV Antibodies
Scientists at The Scripps Research Institute (TSRI) have new weapons in the fight against HIV.
Some Gut Microbes May Be Keystones of Health
University of Oregon scientists have found that strength in numbers doesn’t hold true for microbes in the intestines. A minority population of the right type might hold the key to regulating good health.
Essential Component of Antiviral Defense Identified
Infectious disease researchers at the University of Georgia have identified a signaling protein critical for host defense against influenza infection.
Single Vaccine for Chikungunya, Related Viruses May be Possible
What if a single vaccine could protect people from infection by many different viruses? That concept is a step closer to reality.
Is Allergy the Price We Pay for Our Immunity to Parasites?
New findings help demonstrate the evolutionary basis for allergy.
Blocking the Transmission Of Malaria Parasites
Vaccine candidate administered for the first time in humans in a phase I clinical trial led by Oxford University’s Jenner Institute, with partners Imaxio and GSK.
Mucus – the First Line of Defence
Researchers reveal the important role of mucus in building a good defence against invaders.
Antibody Targets Key Cancer Marker
University of Wisconsin-Madison researchers have created a molecular structure that attaches to a molecule on highly aggressive brain cancer and causes tumors to light up in a scanning machine.

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos