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ERC’s vision, mission and strategy, and letters to shareholders.
The big picture
- ERC has a unique patented cell-based immunotherapy approach which treats tumours by directly stimulating the patient’s immune system, using whole cells and lysates of autologous (from the patient him/herself) and allogeneic tumour cells (from other patients).
- This therapeutic technology has been patented at the international level under the reference PCT/EP2007/050807 (WO/2007/085648).
- The vaccine has shown breakthrough performance on compassionate patients suffering from aggressive brain tumours (Glioblastoma Multiforme - GBM). Several patients have shown a regression of the tumour and some, a total disappearance.
- Our product outperforms any known standard medical treatment.
Facts
- +45 Patients treated
- Most have exceeded the survival expectancy under recurrent tumors of 6.5 months average under standard treatment
- Orphan drug status from EMA and FDA
Our vision
We develop, produce and market ERC’s innovative therapeutic vaccine for GBM based on our patented immunotherapy for the treatment of all types of solid tumours.
Our ultimate objective being to provide generic cell therapy treatments against all solid tumour cancers. The strategic planning of ERC over the next 10 years has a primary objective to enlarge the therapeutic solutions and therefore the portfolio of the company.
We expect to dominate the market in the treatment of GBM becoming the first in its class with worldwide leadership by 2019.
The Ambition of its management is broader than simply the completion of the GBM’s ERC-1671 clinical trials and of the subsequent commercialisation of the vaccine. Therefore, ERC’s BoD works on the expansion of the therapeutic solutions portfolio of the company not only onto other types of cancer such as the Lung Cancer (SCLC – Small Cell Lung Cancer), the Pontine Glioma and Pancreas but also on other more business oriented actions. Ultimate objectives of such endeavours are activity expansion through a more versatile business model that should enhance the company’s activity diversification resulting to greater value creation for the shareholders.
Our ultimate objective being to provide generic cell therapy treatments against all solid tumour cancers. The strategic planning of ERC over the next 10 years has a primary objective to enlarge the therapeutic solutions and therefore the portfolio of the company.
We expect to dominate the market in the treatment of GBM becoming the first in its class with worldwide leadership by 2019.
The Ambition of its management is broader than simply the completion of the GBM’s ERC-1671 clinical trials and of the subsequent commercialisation of the vaccine. Therefore, ERC’s BoD works on the expansion of the therapeutic solutions portfolio of the company not only onto other types of cancer such as the Lung Cancer (SCLC – Small Cell Lung Cancer), the Pontine Glioma and Pancreas but also on other more business oriented actions. Ultimate objectives of such endeavours are activity expansion through a more versatile business model that should enhance the company’s activity diversification resulting to greater value creation for the shareholders.
Our mission for an unmet medical need
Brain tumours represent less than 5% of all diagnosed cancers but are a source of considerable morbidity and mortality. They occur frequently in young men and women, in the middle of the most active period of their lives with devastating private and professional consequences.
Over 60% of primary brain tumours are gliomas. Glioblastoma Multiforme (GBM) is the most common and most malignant of all gliomas with 75% of patients dying within 18 months of diagnosis. GBM cannot be cured by surgery, radiation therapy, chemotherapy, or any other available treatment modality. Without treatment, patients with glioblastoma usually die within 3 months of diagnosis.
Yearly incidence of GBM 3-5/100.000
Over 60% of primary brain tumours are gliomas. Glioblastoma Multiforme (GBM) is the most common and most malignant of all gliomas with 75% of patients dying within 18 months of diagnosis. GBM cannot be cured by surgery, radiation therapy, chemotherapy, or any other available treatment modality. Without treatment, patients with glioblastoma usually die within 3 months of diagnosis.
Yearly incidence of GBM 3-5/100.000
- 15.000 - 25.000/ year in the EU
- 10.500 - 17.500/ year in the USA
Our vaccines uniqueness outperforms any existing cancer treatment methods
Supported by major Health institutions (Dana Farber Harvard, University of Southern California,…)
- A non intrusive treatment for patients (out-patient status)
- Easy administration (intra-dermal administration performed by a physician)
- Perceptible cancer cell destruction after a minimum of 2 weeks
- Survival expectancy increased, and in a number of cases, total remission has been observed
- Cost efficient production costs and facilities
- First in class solution
- Patented vaccines
Supported by major Health institutions (Dana Farber Harvard, University of Southern California,…)
Therapeutic approach – ERC’s competitive advantage
ERC seeks to eliminate cancer cells completely, leading to a cure through its unique cell-based immunotherapy approach that treats patients suffering from glioma or glioblastoma by directly stimulating the patient’s immune system with whole cancer cells and cell extracts. ERC has developed a unique, patented process using whole cells and lysates of autologous and allogeneic tumour cells.
This unique vaccine involves immunisation with glioma derived cells and cell extracts from two or more individuals (allogeneic) as well as cells derived from the patient’s own tumour (autologous). This unique allogeneic/autologous vaccine triggers a powerful rejection response to the allogeneic antigens as well as the patient’s own tumour cells. A compelling in vivo proof of principle for this innovative approach in a rat model was published by the founders of ERC in Vaccine (2008) 26:1764-1772.2008, demonstrating a quite intense immune response, resulting in complete tumour rejection and prevention of relapse1.
A first report of ERC-1671TM vaccine use in glioblastoma patients with recurrent disease has been presented in the Neuro-Oncology symposium (SNO Washington – November 2012) and published in Neuro-Oncology14: vi43-vi49, 2012. The company has filed patents and maintains a geographically consistent and comprehensive patenting strategy to ensure adequate protection of this proprietary technology.
This unique vaccine involves immunisation with glioma derived cells and cell extracts from two or more individuals (allogeneic) as well as cells derived from the patient’s own tumour (autologous). This unique allogeneic/autologous vaccine triggers a powerful rejection response to the allogeneic antigens as well as the patient’s own tumour cells. A compelling in vivo proof of principle for this innovative approach in a rat model was published by the founders of ERC in Vaccine (2008) 26:1764-1772.2008, demonstrating a quite intense immune response, resulting in complete tumour rejection and prevention of relapse1.
A first report of ERC-1671TM vaccine use in glioblastoma patients with recurrent disease has been presented in the Neuro-Oncology symposium (SNO Washington – November 2012) and published in Neuro-Oncology14: vi43-vi49, 2012. The company has filed patents and maintains a geographically consistent and comprehensive patenting strategy to ensure adequate protection of this proprietary technology.
Since 2012, this innovative therapeutic treatment is confirmed through the compassionate use of a certain number of patients and notably in the US upon the relative FDA Phase I approvals. These developments increased the interest towards compassionate use in several institutions and hospitals in Europe, USA, South Africa, and Australia whereas ERC with the local collaborators currently conduct all the necessary preparatory work for the respective market authorisations.
Recent progress in immunology has made it possible to stimulate lymphocytes to identify and selectively target tumour cells expressing tumour associated antigens (TAA). The field of cancer immunotherapy has become highly active recently with a number of companies developing cancer vaccines based on dendritic cell protocols, where a person’s own extracted immune cells are primed in a test tube with purified tumour antigens or patient’s own tumour cells. These approaches have had limited success; for example, Dendreon’s dendritic cell vaccine, Provenge®, received US marketing approval after demonstrating a 4-month increase in the survival for prostate cancer patients.
Recent progress in immunology has made it possible to stimulate lymphocytes to identify and selectively target tumour cells expressing tumour associated antigens (TAA). The field of cancer immunotherapy has become highly active recently with a number of companies developing cancer vaccines based on dendritic cell protocols, where a person’s own extracted immune cells are primed in a test tube with purified tumour antigens or patient’s own tumour cells. These approaches have had limited success; for example, Dendreon’s dendritic cell vaccine, Provenge®, received US marketing approval after demonstrating a 4-month increase in the survival for prostate cancer patients.
Strategic & clinical roadmap
1
Q4 2014
Ethical exception principally accepted by the Phase II centers.
2
Q1 2015
Acquiring technology and experience to develop a test to determine patients response to vaccine by buying a small Dutch company with currently about 750K in yearly revenue (close to a deal).
3
Q2 2015
Capital increase, which allows ERC to finance itself and stay totally independent.
Selective emergency treatment invoicing and commercial/distribution expansion.
Selective emergency treatment invoicing and commercial/distribution expansion.
4
Q3 2015
Approval of the tissue bank in the Netherlands.
On boarding additional recruitment centers.
On boarding additional recruitment centers.
5
Q4 2015
Phase II for the Minnesota vaccine for Pontine Glioma. (same remark as for Gliovac/ERC1671/SITOIGANAP)
6
Q1 2016
Expansion of relationships with top treatment centers around the world.
7
Q2-2016
Agreement with University of Sothern California to set up immunotherapy centre.
8
Q4-2016
GMP certification of the production site in Schaijk, The Netherlands.
9
Q4-2017
Significant Clinical trial Phase II results.
10
Q1-2018
Meeting with EMA(Europe) to prepare Gliovac commercialization.
11
Q3-2018
Set up of a new production site in Canada.
12
Q1-2019
First patient treated in the USA under the right to try law.
13
Q2/Q3 – 2019
Further patients treated under right to try law (California/New York)
14
Q1-2020
Commercialization request to NICE in the United Kingdom.
15
Q2-2020
- Fast track commercialization request to the FDA in the USA.
- Filing of a patent against virus SARS-CoV-2 (COVID-19 coronavirus) for a vaccine called COVIDVAC.
- 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/SITOIGANAP.
16
Q2-2022
Successful Phase II 2022. FDA suggested to stop the clinical trial Phase II after revision of the data by the FDA. Fast Track approval July 2022.
Interesting facts about ERC
- We will move production facility to USA by end of 2024.
- We operate our own production facility in the Netherlands.
- We run our own fully authorised tissue bank.
- Our current production facility has the capacity to treat 14000 patients/year.
- We have the possibility to outsource to an additional production facility in France to cover an extra 4.000 patients/ year if necessary. We are looking to collaborate with an additional production facility in North America.
- During Q2-2020 and after recruiting +/- 40 patients in the Phase II clinical trial, ERC intends to initiate the request for getting a fast track authorisation approval for the USA.
- ERC expects controlled commercialisation of Gliovac/ERC1671/SITOIGANAP starting mid-2021.
- During Q2- 2020, ERC is developing a clinical study for its product “COVIDVAC” against SARS-CoV-2 (COVID-19 coronavirus) in the USA
Prominent cancer specialists talk about erc
“It is in my opinion that the current study using your product – Gliovac/ERC1671/SITOIGANAP – holds a potentially greater promise than any of the other recurrent GMB studies currently being conducted. The initial results on recurrent glioblastoma patients, treated with ERC1671/SITOIGANAP under compassionate use agreements are more than impressive. A 6-month overall survival(OS-6) of 100 % is unheard of in this patient group. Although a small number, this data is highly significant, and makes a convincing case for the future of your treatment”
Daniela Bota, 3rd of October 2016 – University of Southern California
~
"...As you know, the effectiveness of most cancer vaccines that have been evaluated until recently is limited…"
"...Your approach with ERC1671/SITOIGANAP incorporating whole killed cells as well as cell lysates obtained from patient-specific tumours as well of those of allogeneic donors with the same diagnosis, represents a highly innovative and very promising strategy for the immunotherapy of glioblastoma as well as other cancers…"
"...Thus, I wish to confirm my enthusiasm for the Center for Neuro-Oncology at the Dana-Farber Cancer Institute to join as a collaborative site for your clinical trial, for the Treatment of recurrent Glioblastoma Multiforme..."
Reardon David A, 31 january 2015 - Harvard University
~
…we here at the Brain Tumor Program at the University of Pittsburgh Cancer Institute are very interested in working with ERC on the on both ERC1671/SITOIGANAP and the GBM6 vaccine..."
Okada Hidaho, 14 december 2012 - University of Pittsburgh
~
Daniela Bota, 3rd of October 2016 – University of Southern California
~
"...As you know, the effectiveness of most cancer vaccines that have been evaluated until recently is limited…"
"...Your approach with ERC1671/SITOIGANAP incorporating whole killed cells as well as cell lysates obtained from patient-specific tumours as well of those of allogeneic donors with the same diagnosis, represents a highly innovative and very promising strategy for the immunotherapy of glioblastoma as well as other cancers…"
"...Thus, I wish to confirm my enthusiasm for the Center for Neuro-Oncology at the Dana-Farber Cancer Institute to join as a collaborative site for your clinical trial, for the Treatment of recurrent Glioblastoma Multiforme..."
Reardon David A, 31 january 2015 - Harvard University
~
…we here at the Brain Tumor Program at the University of Pittsburgh Cancer Institute are very interested in working with ERC on the on both ERC1671/SITOIGANAP and the GBM6 vaccine..."
Okada Hidaho, 14 december 2012 - University of Pittsburgh
~
Erc’s added value
During the years since incorporation, ERC Belgium SA developed a strong network with medical companies, research institutions and universities across Europe and the USA in order to manage the clinical research and reach sufficient number of patients. Moreover, the company continues to work on building strong reputation and relationships with the regulatory authorities and agencies.
The strategic planning of ERC over the next 10 years has a primary objective to enlarge the therapeutic solutions portfolio of the company. Ambition of its management is broader than simply the completion of the GBM’s ERC- 1671 clinical trials and of the subsequent commercialisation of the vaccine. Therefore, ERC’s BoD works on the expansion of the therapeutic solutions portfolio of the company not only onto other types of cancer such as the Lung Cancer (SCLC – Small Cell Lung Cancer), the Pontine Glioma and Pancreas but also on other more business oriented actions. Ultimate objectives of such endeavours are activity expansion through a more versatile business model that should enhance the company’s activity diversification resulting to greater value creation for the shareholders.
The strategic planning of ERC over the next 10 years has a primary objective to enlarge the therapeutic solutions portfolio of the company. Ambition of its management is broader than simply the completion of the GBM’s ERC- 1671 clinical trials and of the subsequent commercialisation of the vaccine. Therefore, ERC’s BoD works on the expansion of the therapeutic solutions portfolio of the company not only onto other types of cancer such as the Lung Cancer (SCLC – Small Cell Lung Cancer), the Pontine Glioma and Pancreas but also on other more business oriented actions. Ultimate objectives of such endeavours are activity expansion through a more versatile business model that should enhance the company’s activity diversification resulting to greater value creation for the shareholders.
During the years since incorporation, ERC Belgium SA developed a strong network with medical companies, research institutions and universities across Europe and the USA in order to manage the clinical research and reach sufficient number of patients. Moreover, the company continues to work on building strong reputation and relationships with the regulatory authorities and agencies.
The strategic planning of ERC over the next 10 years has
The strategic planning of ERC over the next 10 years has
Financial statements and news
Financial statements, CEO statements and general meeting notices are published in News.