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.
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
With satisfactory safety results, 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.
Upcoming clinical trials
SGM-101 is currently tested in an ongoing trial in LUMC (Netherlands)
- 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.”
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
Surgimab is currently preparing a phase III multicentric clinical trial that will involve around 10 clinical centers in both the US and Europe. First patients shall be recruited in 2018.
Image guided surgery has entered a new era in which real applications in practice are within reach. Our combined effort of surgical oncologists with a world class drug development group as CHDR is unique in the world and opens enormously exciting visions that bring important medical interventions closer to the clinicDr. Alexander Vahrmeijer, principal investigator of the study.