Sym013 / Servier - LARVOL DELTA

First-in-human trial exploring safety, antitumor activity, and pharmacokinetics of Sym013, a recombinant pan-HER antibody mixture, in advanced epithelial malignancies. (PubMed, Invest New Drugs) - P1a | " During the conduct of the study, management of frequent infusion-related reactions, skin toxicities, and mucosal disorders, which are indicative of HER inhibition, necessitated multiple protocol amendments. The investigators, in concert with the Sponsor, agreed that achieving a tolerated regimen with acceptable target saturation was unlikely."

Journal • P1 data • PK/PD data • Colorectal Cancer • Dental Disorders • Dermatitis • Dermatology • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Immunology • Mucositis • Oncology • Solid Tumor • Stomatitis • HER-2

Anti-tumoral activity of the Pan-HER (Sym013) antibody mixture in gemcitabine-resistant pancreatic cancer models. (PubMed, MAbs) - "Finally, we demonstrated that the Pan-HER and gemcitabine combination has an additive effect in vitro and in mice xenografted with the gemcitabine-sensitive or resistant pancreatic models. The mixture of anti-EGFR, HER2 and HER3 antibodies is a good candidate therapeutic approach for gemcitabine-sensitive and -resistant pancreatic cancer."

Journal • Preclinical • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • ERBB3

Sym013, novel pan-HER monoclonal antibody mixture, augments radiation response in human lung and head and neck tumors (AACR 2014) - Presentation time: Tuesday, Apr 08, 2014, 1:00 PM - 5:00 PM; Abstract #4495; “...Sym013 augments radiation response via the induction of cell cycle arrest followed by the induction of apoptosis and cell death, likely reflecting inhibitory effects on DNA damage repair."

Preclinical • Head and Neck Cancer • Non Small Cell Lung Cancer • Oncology

Symphogen presents new pan-HER data at annual AACR meeting (Symphogen, AACR 2013) - "The ability to simultaneously inhibit EGFR, HER2 and HER3 in cancer cells in vitro also translates into broad and efficacious tumor growth suppression in vivo... all three target specificities contribute to the efficacy of Sym013 in vivo, and there is a clear synergistic effect of combining HER family target specificities compared to single-receptor targeting"

Preclinical • Oncology

Symphogen presents new pan-HER data at annual AACR meeting (Symphogen, AACR 2013) - "The ability to simultaneously inhibit EGFR, HER2 and HER3 in cancer cells in vitro also translates into broad and efficacious tumor growth suppression in vivo... all three target specificities contribute to the efficacy of Sym013 in vivo, and there is a clear synergistic effect of combining HER family target specificities compared to single-receptor targeting"

Preclinical • Oncology

Sym013 (Pan-HER) in Patients With Advanced Epithelial Malignancies (clinicaltrials.gov) - P1a; N=32; Terminated; Sponsor: Symphogen A/S; N=134 ➔ 32; Trial completion date: May 2020 ➔ Jun 2019; Active, not recruiting ➔ Terminated; Trial primary completion date: May 2020 ➔ Jun 2019; Business reasons

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination