Clinical Developments

1- Litenimod as a locally-immunostimulating agent in glioblastoma

Based on promising preclinical data with local injections, and because the blood-brain barrier would impede any diffusion of CpG-ODN into the brain, our clinical program for CpG-ODN initially favored intratumoral administration of Litenimod in glioblastomas (GBM).
In a phase I trial conducted on 24 GBM patients, local administration of CpG-ODN within the tumor was achieved by convection–enhanced delivery (CED) around the tumor mass which was left unresected. This study showed a good clinical tolerance. The median of survival was 7.2 months, greater than would have been expected in these patients (Carpentier et al, 2006).

In a subsequent phase II trial, 31 patients with recurrent glioblastoma received similarly 20 mg Litenimod locally by CED. Using the recursive partitioning analysis (RPA) classification for recurrent glioblastoma the median survival for RPA class 7 patients (68 % of the patients in our study) was 6 months, higher than the 4.9 months that should have been expected (Carpentier et al, 2010).
A multicentre randomized phase II trial in newly diagnosed GBM after surgical resection has been completed. Patients underwent large surgical resection and Litenimod was administrated (or not, depending on the arm) locally around the surgical cavity. The patients were then treated with concomitant radiotherapy and temozolomide. Eighty patients with histologically documented glioblastoma were enrolled in 7 French centers (Ursu et al, 2017).

2- Litenimod, extended application to other areas of cancer

A phase I trial in carcinomatous meningitis has been conducted in 29 patients. Neoplastic meningitis is a devastating disease, with no efficient therapy available. The primary objective of this dose-escalating trial was to assess tolerance of intrathecal and sub-cutaneous Litenimod injections, combined or not with chemotherapy and/or other anticancer treatments. This study showed a good clinical tolerance. Clinical responses were seen in a few patients concomitantly treated with Bevacizumab (Carpentier et al, 2015).

3- Litenimod as a vaccine adjuvant

In addition to the development strategy of Litenimod as a stand-alone approach in cancer, Oligovax is currently expanding its development as a vaccine adjuvant that can be applied in anti-cancer immunotherapy and in anti-infectious diseases:
- Oligovax is a partner of the IMI/PEVIA "Innovative Approach to Ebola Vaccine" European project for developing a second-generation “Ebola vaccines”, based on the proteins found on the surface of the virus. Oligovax is in charge to provide the Litenimod, selected as a vaccine adjuvant for the clinical trial starting in 2020.
- Oligovax is also conducting preclinical studies using Litenimod combined to selected antigens to trigger anti-tumor immunity.
The company is actively seeking partnerships with other pharmaceutical companies for the development and commercialisation of Litenimod as an immune adjuvant for vaccines and/or monoclonal antibodies.


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