SGM-101 has the potential to be the first tumor-targeted fluorescent probe to be marketed for fluorescence-guided surgery (FGS).
Montpellier, France, 16 July 2019 – SurgiMab today announces that the first surgical procedure was carried out in a pivotal Phase 3 clinical trial of the Company’s lead product, SGM-101, in a patient with colorectal cancer (CRC).
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 four days prior to the scheduled CRC surgical procedure. Preliminary clinical data of the Phase 3 trial is expected in 2020.
Press Release 16 July 2019
Dr. Alex Vahrmeijer’s team in Leiden publishes first results of the clinical use of SGM-101.
Montpellier, France 31st Jan 2018 – SurgiMab is very proud to announce that Dr. Alex Vahrmeijer’s team in Leiden University Medical Center (LUMC) published their clinical results in the Lancet Gastroenterology & Hepatology after using SGM-101 in patients undergoing surgery for colorectal cancer. The study demonstrates the safety of SGM-101 and shows it can influence clinical decision making during the surgical procedure for patients with colorectal cancer.
This publication illustrates an extremely important part of the work that has been done by SurgiMab to prepare the phase III clinical trial that is currently in preparation.
Click here to get to the abstract of the article.
Click here to get to Pubmed
SurgiMab sponsors the Molecular Guided Surgery conference that will take place during the SPIE Photonics West in San Francisco, 27-28 Jan 2018.
Montpellier, France Jan 2018 – SurgiMab is proud to be a sponsor of the Molecular Guided Surgery conference that will take place during the SPIE Photonics West Meeting on Saturday 27 and Sunday 28 January, 2018. The conference will gather together the best specialists of Molecules, Devices and Applications. Results will be presented for our SGM-101 compound in colorectal cancer surgery. Come and meet us there!
Click here for the detailed program of the conference.
SurgiMab and Quest Medical Imaging enter a Collaboration Agreement for the 1st Phase III multicenter clinical trial on Fluorescence Guided Surgery for Digestive Cancers.
Montpellier, France and Middenmeer, Holland – 18 sept 2017 – SurgiMab and Quest Medical Imaging, a leader in the market for multispectral cameras, announced today that they have entered into a collaboration agreement for the upcoming Phase III clinical trial of Surgimab’s SGM-101 in fluorescent guided colorectal cancer surgery.
Under the terms of the agreement, Quest Medical Imaging has received an undisclosed lump sum payment to provide 12 Spectrum™ platforms to the centers that will participate in the Phase III pivotal trial sponsored by SurgiMab. The Quest Spectrum™ Fluorescence Imaging Platform is designed and developed for open and minimally invasive fluorescence image-guided surgery with the capability for multiple wavelengths in a single system. It demonstrated high sensitivity and ease of use in a previous phase I/II clinical trial in conjunction with SGM-101. The preliminary results of this trial have been presented by the clinical teams at the World Molecular Imaging Congress that took place in Philadelphia in September ( http://www.wmis.org/2017-world-molecular-imaging-congress/ ).
Françoise Cailler, CEO of SurgiMab, said “We are looking forward to working with Quest for the pivotal trial of our lead compound SGM-101 Indeed, SGM-101’s cancer targeting properties give it the potential to facilitate the detection and visualization of malignant tissue when used during image guided surgery. Our hope is that this real-time visualization of tumor tissue by surgeons will lead to higher rates of total resection and therefore significant benefits to patients. The use of a CE-marked / FDA approved device shall simplify the regulatory requirements and we are confident that the quality of the data that we will generate will help us accelerate the development of SGM-101 and ensure a quick access to the market..”
Click here to get to the complete press release.
SurgiMab is an Entrepreneur Sponsor of the first Boston-Paris Biotechnology Summit and as such, we will present our latest clinical developments during the Entrepreneurs Forum.
The Boston-Paris Biotechnology Summit is a novel catalyst event aiming to provide facilitative leadership for talents in both cities in order to foster energies and synergies, to spark new projects and to generate funding opportunities. It will bring together biotechnology professionals, investors, experts and stakeholders with a rich program. The event will take place at Institut Pasteur on May 18th, 2017.
Come and meet us during the Entrepreneurs Forum!
SurgiMab is happy to announce the publication of its manuscript entitled “SGM-101: An innovative near-infrared dye-antibody conjugate that targets CEA for fluorescence-guided surgery” in the peer-reviewed journal Surgical Oncology. This paper describes the Near-Infrared fluorescent CEA-targeting molecule developped by SurgiMab as well as pre-clinical tumor-targeting results in murine tumor models.
Please click on the following link to get a pdf version of the article. Surg Oncol 26 153 Gutowski M Framery B
SurgiMab will attend WMIC 2016 : Bérénice Framery, in charge of the company’s internal R&D programs, will be present in New York.
You can meet her in particular during the “Optical Surgical Navigation” session on Wednesday, September 7, 2016, from 9:00 to 15:30, Room 1E10, Javits Convention Center, New York.
Let’s meet at the Moscone Center in San Francisco, June 6-9 for the BIO International convention!
The company presentation will take place in Room 4 on Wednesday the 8th, 5:00 PM during the Oncology session. Françoise Cailler, CEO of the company, will update the audience on the current fundraising and the clinical trials currently in progress.
The BIO International Convention is hosted by the Biotechnology Innovation Organization (BIO). BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.
SurgiMab is happy to be part of the sponsors for the conference “Molecular Guided Surgery : Molecules, Devices and Applications II”, organized par Brian W. Pogue and Sylvain Gioux as a part of the SPIE photonics West meeting that will take place at the Moscone Center in San Francisco in February 2016.
This two-days conference will gather together the best specialists of the domain to discuss a variety of subjects from the development of new contrast agents to their clinical applications.
Montpellier, France, February 5th, 2016. SurgiMab announces the launch of a phase I clinical trial program evaluating the safety and performance of its fluorescent conjugate SGM-101 in patients with pancreatic or rectal cancer.
SurgiMab, founded in 2011 in Montpellier, France, is developing near-infrared fluorescent conjugates as in vivo diagnostic agents in oncology. “Today we are proud to announce that the Centre for Human Drug Research and the Leiden University Medical Center have started patient inclusion in a phase I clinical trial that will allow to assess both the safety and the efficacy of our tumor-targeted product SGM-101 in patients with pancreatic or rectal cancer.” Dr. Alexander Vahrmeijer, Principal Investigator of this study, is a renowned key-opinion-leader in intraoperative fluorescence imaging. He is confident that “a targeted fluorescent agent such as SGM-101 should allow surgeons to perform more radical resections and subsequently improve surgical outcomes; intraoperative fluorescence guidance could also prevent both under- and over-treatment by providing a clear-cut image of tumors within a normal environment.“
SGM-101 is a fluorescent injectable molecule comprised of a tumor-specific monoclonal antibody and a near-infrared emitting fluorochrome. It binds selectively to carcinoembryonic antigen (CEA), a specific marker overexpressed in a number of tumors of epithelial origin including pancreatic and rectal cancer. Cancer cells can then be visualized with a NIR-fluorescence imaging system, allowing oncologic surgeons to improve intraoperative staging and perform more radical cytoreductive surgery.
SGM-101 is currently being tested in an ongoing first-in-human trial in Montpellier Cancer Institute. As a first indication the conjugate was tested for the visualization of sub-clinical size tumors during surgical resection of peritoneal carcinomatosis originating from digestive malignancies.
With satisfactory preliminary safety results to date, SurgiMab decided to extend its clinical program to pancreatic and rectal cancers, as surgery is the cornerstone of the treatment for these patients. However complete surgical resection, a crucial factor for patient prognosis, is challenging to accomplish, as surgeons have to rely on visual appearance and palpation to discriminate between tumor and normal tissue.
As it allows surgeons to specifically visualize tumors cells with a NIR fluorescence imaging system, SGM-101 will help them delineate tumors, thus increasing the chances of radical resection and improving patient care in a variety of cancers including pancreatic and rectal cancers. Read More