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.
SurgiMab will attend the 8th “CHIP / HIPEC meeting” that will take place in Montpellier on May 23rd, 2014.
On the occasion of the 8th annual meeting of the European Society for Molecular Imaging in Torino (26 to 28 May, 2013) Françoise Cailler, CEO of SurgiMab, will present the company’s R&D programs during the “Intra-Operative Imaging” session, Monday May 27th at 3:00 pm in a short oral presentation. A poster will also be presented Tuesday May 28th from 9:00 to 10:30 (Framery et al, Intraoperative near-infrared immuno photodetection of advanced ovarian tumors with the use of a novel specific conjugate targeting AMHRII. Poster n°177.)
On the occasion of the Grenoble EuroMedtech meeting that took place between May 31st and June 1st 2012, Françoise Cailler, SurgiMab’s president, answered BioPharmInsight’s questions (the Financial Times group). She describes the next steps for SurgiMab in terms of development.
Read the article: SurgiMAB to sign a deal with French CMO…
OSEO, a public institution promoting the innovation and growth of SMEs, awarded SurgiMab the status of Innovative Enterprise and its FCPI certification (Mutual Funds for Innovation) in April.
Convinced by the development program that was launched by the young start-up and by the dynamic team that was installed, and following the obtention of a 450 000 € aid from Oseo / Languedoc-Roussillon Region, SurgiMab’s investors decided to consolidate their initial engagement, allowing the company to seure its R&D program up to the start of the clinical trials for its first molecule.
The realization of this investment demonstrated the capacity of the founding team to federate all necessary actors for a quick development of SurgiMab’s fluorescent conjugates. “These seeding funds, added to the institutional help and the initial investment from our partners allows to foresee the first clinical assays in 2013, to propose our technology to patients as quickly and directly as possible” says Françoise Cailler, President of SurgiMab.
In order to finalize the clinical studies that are compulsory for the development of its products, the company will prepare a new funds raising at the beginning of 2013.
Read the article published in “Biotech Finances” on February 20th, 2012.
Read the Press Release (French)
Following its creation in July 2011, the company now anounces a first round of financing of 500 000 Euros. If the conditions are filled, this first round will be completed at the begining of 2012 following conditions that were defined with the present financial partners : Cathey World Investment Ltd., and ABALIS Finances AG.
This financing will allow SurgiMab to finalize the pre-clinical development of its first conjugate targeting digestive tumors and to set up the first clinical assays that should take place within Montpellier’s Val d’Aurelle Regional Anti-Cancer Center. SurgiMAb was assisted for this operation by the Law Firm Brunswick and by Biotech Developement Conseil.
Link to the Press Release (in French)