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

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 2,400+ scientific posters on ePosters
  • More than 3,700+ 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 TechnologyNetworks.com 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’s Antibody Mixtures Highlighted in Three Peer-Reviewed Journals
Pioneering and novel approach to Anti-EGFR and Pan-HER antibodies validated in clinical and pre-clinical research papers.
Thursday, May 28, 2015
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 Announces the Appointment of Annika Espander Jansson
Appointment of Annika as Non-Executive Director of the Board.
Monday, December 23, 2013
Symphogen Receives Milestone Payment in Merck KGaA Sym004 Collaboration
Payment enhances the financial position of Symphogen.
Wednesday, June 26, 2013
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’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
Scientific News
Long Telomeres Associated with Increased Lung Cancer Risk
Genetic predisposition for long telomeres predicts increased lung adenocarcinoma risk.
Expanding the Brain
A team of researchers has identified more than 40 new “imprinted” genes, in which either the maternal or paternal copy of a gene is expressed while the other is silenced.
Identifying a Key Growth Factor in Cell Proliferation
Researchers discover that aspartate is a limiter of cell proliferation.
Study Uncovers Target for Preventing Huntington’s Disease
Scientists from Cardiff University believe that a treatment to prevent or delay the symptoms of Huntington’s disease could now be much closer, following a major breakthrough.
The Genetic Roots of Adolescent Scoliosis
Scientists at the RIKEN Center for Integrative Medical Sciences in collaboration with Keio University in Japan have discovered a gene that is linked to susceptibility of Scoliosis.
A Gene-Sequence Swap Using CRISPR to Cure Haemophilia
For the first time chromosomal defects responsible for hemophilia have been corrected in patient-specific iPSCs using CRISPR-Cas9 nucleases
New Tool Uses 'Drug Spillover' to Match Cancer Patients with Treatments
Researchers have developed a new tool that improves the ability to match drugs to disease: the Kinase Addiction Ranker (KAR) predicts what genetics are truly driving the cancer in any population of cells and chooses the best "kinase inhibitor" to silence these dangerous genetic causes of disease.
Understanding the Molecular Origin of Epigenetic Markers
Researchers at IRB Barcelona discover the molecular mechanism that determines how epigenetic markers influence gene expression.
New Tech Enables Epigenomic Analysis with a Mere 100 Cells
A new technology that will dramatically enhance investigations of epigenomes, the machinery that turns on and off genes and a very prominent field of study in diseases such as stem cell differentiation, inflammation and cancer has been developed by researchers at Virginia Tech.
Access Denied: Leukemia Thwarted by Cutting Off Link to Environmental Support
A new study reveals a protein’s critical – and previously unknown -- role in the development and progression of acute myeloid leukemia (AML), a fast-growing and extremely difficult-to-treat blood cancer.
Skyscraper Banner

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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!