Milestones

ERC Netherlands re-certified GMP Facility

Complete application to the EMA for conditional approval.

FDA suggestion for stoping phase II clinical trial and going for registraztion trial Phase III, apply for Fast tract designation and avoid a double blind clinical trial design.

First clinical trial patient at Dana Farber Cancer Institute

ERC receives a positive Opinion to commence a paediatric investigation plan(clinical trial) from the European Medicines Agency for treatment of children between 3 and 18 years of age with relapsing malignant glioma with its product Gliovac/ERC1671.

Dana Farber (Harvard) is expected to enter as the second site starting its contribution to the Phase II clinical trial.

ERC Worldwide today announced the launch of the Company’s development program for its therapeutic and prophylactic vaccine against the new coronavirus SARS-CoV-2. The technology is based on ERC’s Gliovac/ERC1671 glioblastoma vaccine platform currently in an FDA approved clinical trial in the US.

In Q2 2020 after enrolling about 40 patients in the Phase II clinical trial, ERC will submit its request for commercialization in the USA.

Filing of a patent against virus SARS-CoV-2 (COVID-19 coronavirus) for a vaccine called COVIDVAC.

Thanks to the optimization of Gliovac, exceptional results to date.

Introduction of the commercialization request to UK.

Single Technical Appraisal of ERC1671 for treating recurrent glioma by NICE (UK).

Patients expressed interest for “Right to try” and the first vaccines were administered.

“Right to try”. Gliovac can be prescribed and invoiced in Southern California, USA.

Preparation of the commercialization request at the FDA for Gliovac.

GMP certification of the production site in the Netherlands.

Agreement with USC (University of Southern California) for a future set-up of an immunotherapy centre.

Support of Dana Farber / Harvard to ERC’s approach and agreement for later participation in the Phase II.

Projects : International studies
Submission of a phase II in EU - first line for patient unresponding to TMZ.
Submission of a phase I in Australia - first line combined with RT.

« Seal of excellence » in project development from European Commission.

ERC own GMP facilities (the Netherlands) and tissue bank.
Acquisition of the patent: PCT/US11/57654
Vaccine, Therapeutic Composition and Methods for Treating or Inhibiting Glioblastoma

Phase II FDA Approval in recurrent patients - recruiting.
Orphan Drug Status granted by EMA.

Submission of application for EMA orphan drug designation.
Compassionate use in Canada considered by approval authorities. (Health Canada)
Confirmation for NID protocol meeting (FDA) schedule on January 9th, 2013.

First patient reaching total remission.

Single patient INDs 15022 and 15087 granted by US FDA.

Second patient vaccinated in Belgium also for compassionate use.

The company has designed and initiated a 15 month pre-clinical development plan which will allow it to apply for a Phase I/II clinical trial in glioblastoma patients.
First vaccination of patients under compassionate use.

The company obtained Orphan Drug status for Gliovac/ERC1671 from the US FDA.
The company obtained the status SME from the EMA which offers significant advantages in terms of fee waivers for EMA guidance and assessments of marketing authorization applications.
The company has put into place a scientific team with experience in cell culture and set up two scientific advisory boards, one in Europe and one in the United States.

Published article on the successful and statistically significant preclinical animal tests (conducted in rats having two strains of malignant gliomas); e.g. Anit-cancer Agents in Medicinal Chemistry, 2010, Vol. 10, No. 6; Hofman et al.

The company obtained Advanced Medical Therapy Product status for Gliovac/ERC1671 from the EMA. (classification: somatic cell therapy)

Erc settled in its main office in Isnes. (Belgium)
Implementation of a "cleanroom" at the Hospital of South of Luxembourg in Arlon (Belgium) with the set-up of tissue bank, whereby the clinical trials of the company can be compliant with EU standards.

Creation of ERC.

Patent. PCT/EP2007/050807 (WO/2007/085648)
Tumor Vaccine Comprising Allogeneic or Xenogeneic tumor cells.

Proof-of-Concept
Stathopoulos, A., C et al. (2008) Therapeutic vaccination against malignant gliomas based on allorecognition and syngeneic tumor antigens proof of principle in two strains of rat.