29 November 2016 : The collaboration will explore the expression of OAcGD2 antigen in tumors from patients with glioblastoma and the potential of anti-OACGD2 monoclonal antibodies to treat a panel of resistant glioblastoma tumors, alone or in combination with standard treatments such as temozolomide and irradiation. Pr. Weller’s team will first conduct efficacy studies in preclinical models with anti-OAcGD2 monoclonal antibodies, with the perspective of initiating a first-in-human clinical trial for relapsing glioblastoma patients.
“As detailed in our recent strategic update, OGD2 Pharma continues exploring the potential of therapies targeting the OAcGD2 antigen in various cancers. This collaboration follows a first proof of concept study conducted in animal models and published in 2016 (Fleurence et al, 2016)” said Jean Marc Le Doussal, President at OGD2 Pharma.
Press Release : ogd2-university-of-zurich-pr-2016-11-29-release
6 September 2016 : This collaboration agreement will explore the potential of targeting chemotherapeutic drugs using anti-OAcGD2 ADCs in the treatment of difficult-to-treat solid tumors. The ADCs will be designed to release the cytotoxic drug both within tumor cells and in the tumor microenvironment.
“Thanks to this collaboration, OGD2 Pharma accelerates the development of its anti-OAcGD2 ADC platform. Syndivia’s versatile linker technology will allow depicting the best way to specifically deliver ADC payloads to tumors using the unique cellular biology of the OAcGD2 membrane glycolipid” said Jean-Marc Le Doussal, President at OGD2 Pharma. “Syndivia’s technology should result in ADCs that are highly stable in patient’s blood, in line with our strategy to develop safer anti-cancer therapies leveraging the highly tumor-specific tissue distribution of the OAcGD2 antigen. OGD2 Pharma will continue building such strategic partnerships with academic groups and private companies in other ADC technologies.” he added.
Press release : OGD2 SYNDIVIA PR 2016 09 06 release
22 June 2016 : With this collaboration, OGD2 Pharma and GCLC will explore the potential of targeting NK-cells to the OAcGD2 antigen using humanized antibody and chimeric antigen receptors (CAR) for fighting against solid tumors.
“Thanks to this collaboration OGD2 Pharma speeds-up the development of its anti-OAcGD2 CAR platform. We highly value Green Cross leadership in allogenic NK-cell therapy and their proven ability to develop and to market cell therapy products” said Jean-Marc Le Doussal, President at OGD2 Pharma. “OGD2 Pharma will continue building strategic partnerships with academic groups and private companies in other fields of cell therapies.” he added.
Press release: OGD2 GCLC PR 2016 06 22 release
27 May 2016 : In our efforts to fight brain cancer we are proud to annonce the publication of new data supporting the therapeutic activity of our antibody in brain tumors. Research was performed in collaboration with Centre de Recherche Contre le Cancer de Nantes Angers (CRCNA) and supported by Agence Nationale de la Recherche (ANR).
Fleurence 2016 Oncotarget – Targeting GBM
Abstract: There are still unmet medical needs in the treatment of glioblastoma, the most common and the most aggressive glioma of all brain tumors. Here, we found that O-acetyl GD2 is expressed in surgically resected human glioblastoma tissue. In addition, we demonstrated that 8B6 monoclonal antibody specific for O-acetylated GD2 could effectively inhibit glioblastoma cell proliferation in vitro and in vivo. Taken together, these results indicate that O-acetylated GD2 represents a novel antigen for immunotherapeutic-based treatment of high-grade gliomas.
On 2 March 2015 the European Medicines Agency published its public summary of opinion on orphan designation for OGD2 Pharma chimeric monoclonal antibody to O-acetyl-GD2 antigen for the treatment of neuroblastoma granted by the European Commission on 15 January 2015 (EU/3/14/1416).
“The sponsor has provided sufficient information to show that chimeric monoclonal antibody to O-acetyl-GD2 antigen might be of significant benefit for patients with neuroblastoma because it works in a different way to currently authorised treatments by specifically targeting tumour tissue. In addition, early studies in experimental models showed improved anti-tumour activity. These assumptions will need to be confirmed at the time of marketing authorisation, in order to maintain the orphan status.
Chimeric monoclonal antibody to O-acetyl-GD2 antigen is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific structure (an antigen) called O-acetyl-GD2. O-acetyl-GD2 is a substance that is present in high amounts on the surface of neuroblastoma cells, but not normal cells. When the medicine attaches to the neuroblastoma cells, it marks them out as a target for the body’s immune system, which is then expected to attack the cancer cells and thereby reverse or slow down the progression of the disease.”
“Neuroblastoma is a cancer of nerve cells which is usually seen as a lump in the abdomen or around the spine. Symptoms may include weakness, bone pain, loss of appetite and fever. Neuroblastoma is the most common solid tumour outside the brain in children. In many cases it is present at birth but is diagnosed later when the cancer has spread to other parts of the body and the child begins to show symptoms of the disease. Neuroblastoma is a long-term debilitating and life-threatening disease that is associated with poor long-term survival.
At the time of designation, neuroblastoma affected approximately 1.1 in 10,000 people in the
European Union (EU). This was equivalent to a total of around 56,000 people*, and is below the ceiling for orphan designation, which is 5 people in 10,000. This is based on the information provided by the sponsor and the knowledge of the Committee for Orphan Medicinal Products (COMP).
At the time of designation, several medicines were authorised in the EU for the treatment of
neuroblastoma. Treatments for neuroblastoma included surgery, chemotherapy (medicines to treat cancer) and radiotherapy (treatment with radiation).”
For more information: European Medicine Agency
OGD2 Pharma SAS has been incorporated in Nantes on 28 October 2014 with the mission to research, develop and commercialize with pharma partners innovative cancer immunotherapies against the O-acetylated form of the GD2 ganglioside (OAcGD2).
As its first cousin GD2, the OAcGD2 glycolipid is highly expressed at the cell membrane of orphan pediatric cancers (e.g. neuroblastoma), adult cancers (e.g. glioma, sarcoma, melanoma), and at the surface of cancer stem cells (e.g. in breast cancers) that are thought to be the chemo- and radio-resistant cells initiating cancer recurrences.
Anti-GD2 immunotherapies – monoclonal antibodies, immunocytokines, chimeric antigen receptor (CAR cells) – have been shown highly promising, but unfortunately also quite toxic (dose-limiting pain and neuropathies) since GD2 is also expressed on the surface of normal nerves and brain cells.
By contrast to GD2, OAcGD2 is not expressed on normal nerves and brain cells. Thus, with anti-OAcGD2 therapies, toxicity to the nervous system is not observed in animal models and is not expected in human.
Thanks to this exquisite tumor-specificity of the OAcGD2 antigen, OGD2 Pharma develops safe and efficacious cancer immunotherapies to meet the medical needs of pediatric and adult cancer patients in both orphan and major indications.