Symphogen, a biopharmaceutical company developing recombinant antibody mixtures, published two papers with new clinical data for its lead anti-EGFR antibody mixture, Sym004, in the journals Cancer Discovery and in Cancer Chemotherapy and Pharmacology. In addition, a paper in Clinical Cancer Research described preclinical findings relating to the company’s pan-HER product candidate, Sym013, a mixture of six antibodies targeting each of EGFR, HER2 and HER3 with a pair of synergistic antibodies, according to Symphogen.
This represents strong mechanistic validation for Symphogen’s antibody mixture approach to innovative oncology therapeutics. The clinical efficacy data published provided the basis for advancing Sym004 into a randomized Phase 2b study, currently ongoing in the US and Europe.
In the June issue of Cancer Discovery for the first time there is positive efficacy clinical findings for Sym004’s study in patients with metastatic colorectal cancer (mCRC) and with acquired resistance to anti-EGFR antibody therapies.
The Phase 1 study enrolled a total of 62 patients, of which 20 patients had advanced solid epithelial tumors and were enrolled to the dose-escalation phase of the study. They received different doses of Sym004, ranging from 0.4 mg/kg to 12 mg/kg, administered weekly, notes Symphogen. The remaining 42 enrolled patients had metastatic colorectal cancer and had previously been treated with anti-EGFR antibodies with brief responses, and were enrolled to the dose-expansion phase of the trial. Patients in the dose-expansion cohort received weekly doses of 9 mg/kg or 12 mg/kg of Sym004.
Of the patients in the dose-expansion cohort, five people, representing 13 percent, had a partial response, and overall, 17 or 44 percent, had some degree of tumor shrinkage during treatment with Sym004. The overall disease-control rate, which includes partial responses and stable disease, was 67 percent.