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..”
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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
SurgiMab is happy to be part of the sponsors for the one-day Optical Surgical Navigation Seminar that is organized on september the 2nd during the World Molecular Imaging Congress in Hawaï. SurgiMab will also present its latest results on September 3rd during the WMIC (12h05, room 302 – Emalani Theatre).
SurgiMab, a French company founded in 2011 in Montpellier, is developing antibody-fluorochrome conjugates as in vivo diagnostic agents in oncology. “Today we are pleased to announce that Montpellier Cancer Institute (ICM) has started patient inclusion in a phase I clinical trial for our most-advanced product, SGM-101.”
SGM-101 is a fluorescent conjugate comprised of a tumor-specific monoclonal antibody and a near-infrared emitting fluorochrome. With this molecule the goal is to provide oncology surgeons with an intraoperative imaging tool that will allow them to visualize tumors overexpressing carcinoembryonic antigen – colorectal, gastric, pancreatic, non-small cell lung and breast carcinomas for example. As a first indication, SGM-101 is being tested for the real-time visualization of infra-clinical size tumors during the surgical resection of peritoneal carcinomatosis originating from digestive malignancies.
The primary objective of this study is to evaluate the safety of SGM-101 in patients suffering from peritoneal carcinomatosis and determine the recommended dose for the phase II clinical trials that should follow.
Among the exploratory objectives, however, is the assessment of the feasability of detection of neoplastic lesions for patients with peritoneal carcinomatosis from digestive cancer.
Currently surgeons rely on visual appearance and palpation to discriminate between tumor and normal tissue, which may lead to incomplete resection of malignant tissue or unnecessary removal of healthy tissue. Since complete resection is a crucial factor in the prognosis of a patient, intraoperative imaging technologies are currently studied leading to the development of real-time image-guided surgery. SGM-101 should allow surgeons to visualize tumors in patients in order to more effectively delineate surgical margins and detect microscopic tumors to improve long-term outcomes. Thanks to its capacity to target several tumor types, SGM-101 should improve patient care in a variety of cancer pathologies among which colorectal, pancreas or gastric cancers.
More details on SurgiMab and ICM here.
SurgiMab is happy to announce that it is part of the 15 laureates – selected among 87 young innovative companies – of the NETVA program.
NETVA (NEw Technology Venture Accelerator) is a unique program of preparation and exposure to high-tech U.S. markets for young innovative French companies, which responds to the need for international expansion faced by young French startups in high technology.
The candidates went through two selection processes to determine this year’s laureates, the first taking place in Paris, and the second, in one of the three NETVA cities in the United States: Boston, San Francisco, and Washington DC.
The selected laureates will benefit from a cycle of preparation and exposure to the realities of the American high technology markets. The first phase consists of preparatory training and coaching, and will take place in Paris on June 30th at the headquarters of Microsoft France, a partner of the initiative. Each laureate will be paired with one or more American mentors to prepare them for their arrival to the United States, which could be in September or October of 2014, depending on which center is hosting them. In their week of intense immersion, the laureates will network with American academic and technological partners and will profit from an additional series of training workshops focused about how to approach and enter American markets.
This selection comes right on time for SurgiMab, which is currently preparing the development of SGM-101 in the US and anticipates the launching of clinical assays after the phase I assay that is to take place in Montpellier Cancer Institute in 2014.