SurgiMab is currently working on the development of two products, with ongoing external collaborations on additional candidates.
SGM-101 is a tumor-specific antibody conjugated to a near-infrared fluorochrome. It selectively binds a specific marker overexpressed in gastrointestinal and breast tumors.
SGM-201 similarly targets ovarian cancer. Both allow surgeons to visualize tumors in real-time with a near-infrared camera, helping them to perform more radical cytoreductive surgery, thus automatically improving surgical outcomes.
Phase III study
Based on the compelling results from the Phase 2 study, SurgiMab is now advancing SGM-101 into a Phase 3 trial.
The randomized Phase 3 trial, designed following discussions with the FDA and other regulators, aims to enroll 300 CRC patients in ten clinical centers in Europe and US, and will assess the clinical benefit of using FGS with SGM-101 as the intraoperative imaging agent to identify cancer lesions during the surgical procedure. Patients will be injected with 10mg of SGM-101 fourdays prior to the scheduled CRC surgical procedure.
Preliminary clinical data of the Phase 3 trial is expected in 2020.
Phase I/II Study
With satisfactory safety results in the first-in-human study, SurgiMab decided to evaluate SGM-101 efficacy in pancreatic and rectal cancers, as surgery is the cornerstone of the treatment for these patients. An exploratory patient group, consisting of patients with a recurrence or metastasis of colorectal cancer and rising CEA- levels was also included to the trial.
Near Infrared Surgery (NIRS).
Omroep Brabant/Catharina Hospital Eindhoven
Near-infrared fluorescence detection of retroperitoneal lymph node metastases.
Supplementary video from the article by Boogerd L.S.F. et al., 2018 The Lancet Gastroenterology & Hepatology 3(3): 181-191. DOI: https://doi.org/10.1016/S2468-1253(17)30395-3
SGM-101 has been tested in an phase I/II trial in the Netherlands, with patients operated at Leiden University Medical Center, Catharina Ziekenhuis (Eindhoven) and Erasmus MC (Rotterdam). 75 patients undergoing surgery for colorectal cancer or pancreatic cancer were included in the trial, that is now complete.
- Title : Study on the detection of cancer during surgery for rectal cancer or pancreatic cancer with the fluorescent agent SGM-101.
- Primary outcome : Safety and tolerability
- Secondary outcome : Performance of SGM-101
Preliminary results for this trial were published in the Lancet Gastroenterology & Hepatology (Boogerd L.S.F. et al. 2018). It was shown that “in the expansion cohort, 19 (43%) of 43 lesions were detected using fluorescence imaging and were not clinically suspected before fluorescent detection, which changed the treatment strategy in six (35%) of 17 patients.”
80% of cancer patients are treated with surgery as first intention. Up to 40% relapse within 2 years because surgeons left some tumor in place, due to their inability to clearly distinguish tumor from normal tissue with only vision or palpation.
SGM-101 safety was demonstrated in a first-in-human study in Montpellier Cancer Institute.
- Title : Phase I Study assessing safety of SGM-101, a fluorochrome-labeled anti-CEA agent monoclonal antibody … in patients with peritoneal carcinomatosis from CEA-expressing digestive cancer.
- Primary outcome : Maximum Tolerated Dose, Recommended phase II dose
- Secondary outcome : Safety profile, Pharmacokinetic profile
“Fluorescence-guided surgery (FGS) is an exciting new approach that allows the surgeon in real-time to differentiate between tumortissue and healthy tissue, enabling detection of even small metastatic nodules that areinvisible to the eye. With more than 400,000 new cases of CRC diagnosed every year in Europe, new approaches that can facilitate the detection of malignant tissue and potentially improve patient outcomes are greatly needed. We look forward to further evaluating the potential of SGM-101 …”Dr. Alexander Vahrmeijer, coordinating investigator of the Phase III study.