Epitopoietic Research Corporation

Last updated
Epitopoietic Research Corporation
Industry Biotechnology
Founded2006
Headquarters
Belgium
Key people
Apostolos Stathopoulos
(CEO)
Vince Dell (Co-Founder and USA CFO)
Thomas Chen (Chief Medical Officer)
Virgil Schijns (Chief Scientific Officer)
Joseph Elliot (Managing Director, ERC-USA)
ProductsERC1671 (Gliovac/Sitoiganap (EU))
Website www.erc-immunotherapy.com

Epitopoietic Research Corporation (ERC) is a Belgian Pharmaceutical company that is specialized in the development of ERC1671 (Gliovac, Sitoiganap (EU)), a treatment for Glioblastoma multiforme, which is the most aggressive form of brain cancer. In 2019 ERC provided treatment under the US Federal Right-to-try law. [1] [2] [3] [4] [5] [6]

Contents

History

Over the years, the company achieved various milestones, including obtaining Advanced Medical Therapy Product status, Orphan Drug status, and initiating Phase II trials.

2006

Stathopoulos conducts a proof-of-concept study on rats. The study finds that the combination of Syngeneic and allogeneic glioma cells injected into rats with growing tumors reduces the size, eradicates the existing tumors, and prevents the formation of new tumors. Stathopoulos patents the technique and founds ERC to develop the treatment for humans. [7] [8] [9]

2009

ERC obtains Advanced Medical Therapy Product status for Gliovac/ERC1671 from the European Medicines Agency. It creates a tissue bank for proliferative tumors and a Good Manufacturing Practice-compliant production facility in Schaijk, Netherlands. [10] [11]

2011

Gliovac obtains Orphan Drug status from the US FDA. Glioblastoma multiforme is the most common and deadly brain tumor in adults, but only affects 10,000-17,000 people in the US. By definition, an orphan disease affects under 200,000 people in the USA. [12]

Glioblastoma on an MRI AFIP-00405558-Glioblastoma-Radiology.jpg
Glioblastoma on an MRI

2012

First patients are treated with Gliovac/ERC1671 under a doctrine of compassionate use. In September, the first patient reached total remission. [13] [14]

2013

Phase II trials of Gliovac/ERC1671 begins in partnership with the University of California, Irvine. [15]

2018

Interim phase II trial results show that patients treated with Gliovac/ERC1671 and the commonly prescribed anti-cancer drug bevacizumab(Atavan) survived almost five months longer on average than those treated with bevacizumab alone. [16]

2019

At the request of a patient, Gliovac/ERC1671 is the first medication prescribed under the US Federal Right-to-try law passed by the Trump Administration. Despite being prescribed under Federal law, the treatment follows the protocols of California’s state Right-To-Try laws. ERC makes Gliovac available at free or reduced cost for Right-To-Try patients. [17] [18]

2020

ERC submits a European Medicines Agency marketing application authorization for ERC1671 under the brand name Sitoiganap. [19] A second trial site opens at Harvard’s Dana Farber Center For Immuno-Oncology. ERC begins development of a COVID-19 vaccine called COVIDVAC based on Gliovac technology. [20] [21]

Leadership

The leadership team includes Apostolos Stathopoulos, Thomas Chen, Virgil Schijns, and Joseph Elliot.

Thomas Chen (Co-Founder, CMO) is a neurosurgeon and professor at the University of Southern California. He is one of the few fellowship trained spinal surgeons focused on spine cancer. [22] Virgil Schijns (Chief Scientific Officer) is the Registered Qualified Person for Gliovac/ERC1671 in the EU. [23] [24] Joseph Elliot is the Managing Director of ERC-USA, ERC's US Subsidiary. [25]

Products

Sitoiganap (EU)/Gliovac/ERC1671 is an immunotherapy vaccine that trains the body’s immune system to attack a Glioblastoma (brain tumor) using cells taken from the patient’s own tumor, along with tumor cells from three other donors.ERC1671 is an immunotherapy vaccine designed to train the body’s immune system to attack a Glioblastoma using cells from the patient’s own tumor and cells from three other donors. The vaccine has undergone trials to assess its potential, or proteins, minimizing the chance that tumor cells might escape from the body’s defenses. It also is believed this approach will trigger a stronger cytotoxic T-lymphocyte (CTL, or a “cell-killing” T-cell) response against the TAA on the patient’s tumor. [26] In the first group of nine patients treated under the compassionate use doctrine, 100% survived for six months compared to only 33% in the control group. At ten months, 77% survived, compared to 10% in the control group. [14]

Killer T Cells surrounding a cancer cell Killer T cells surround a cancer cell.png
Killer T Cells surrounding a cancer cell

ERC1671 is currently in Phase II trials in the US, as well as being available under compassionate use protocols and right-to-try laws. According to the Innovation Observatory of the UK’s National Health Service:

The key principle underlying this particular vaccination approach is the use of a broad set of tumour antigens, derived from freshly resected whole tumour tissue – not only from the patient under treatment, but expanded to include the same from three independent GBM tissue donors. This multivalent array of autologous and allogeneic antigens is expected to reduce the chance of immune escape, which can emerge from antigenic loss or active major histocompatibility complex (MHC) downregulation and is more likely to occur when using a single- or limited-antigen targeted immunotherapy. The future promise of this treatment might also rest in the ability to combine it with bevacizumab, and potentially with immune checkpoint inhibitors – an option that will allow more powerful immune activation in the periphery as well as more aggressive local tumour immunological targeting and destruction. [27] [28]

In April 2020, ERC began development on COVIDVAC, a vaccine for COVID-19 based on ERC1671’s underlying technology. [29] [30]

Recent Developments

n 2020, ERC began the development of a COVID-19 vaccine called COVIDVAC, based on the technology underlying ERC1671.

Related Research Articles

<span class="mw-page-title-main">Glioma</span> Tumour of the glial cells of the brain or spine

A glioma is a type of tumor that starts in the glial cells of the brain or the spine. Gliomas comprise about 30 percent of all brain tumors and central nervous system tumours, and 80 percent of all malignant brain tumours.

<span class="mw-page-title-main">Glioblastoma</span> Aggressive type of brain cancer

Glioblastoma, previously known as glioblastoma multiforme (GBM), is the most aggressive and most common type of cancer that originates in the brain, and has very poor prognosis for survival. Initial signs and symptoms of glioblastoma are nonspecific. They may include headaches, personality changes, nausea, and symptoms similar to those of a stroke. Symptoms often worsen rapidly and may progress to unconsciousness.

<span class="mw-page-title-main">Cancer immunotherapy</span> Artificial stimulation of the immune system to treat cancer

Cancer immunotherapy (immuno-oncotherapy) is the stimulation of the immune system to treat cancer, improving the immune system's natural ability to fight the disease. It is an application of the fundamental research of cancer immunology and a growing subspecialty of oncology.

An oncolytic virus is a virus that preferentially infects and kills cancer cells. As the infected cancer cells are destroyed by oncolysis, they release new infectious virus particles or virions to help destroy the remaining tumour. Oncolytic viruses are thought not only to cause direct destruction of the tumour cells, but also to stimulate host anti-tumour immune system responses. Oncolytic viruses also have the ability to affect the tumor micro-environment in multiple ways.

Northwest Biotherapeutics is a development-stage American pharmaceutical company headquartered in Maryland that focuses on developing immunotherapies against different types of cancer. It was founded in 1996 by Alton L. Boynton.

<span class="mw-page-title-main">Cancer immunology</span> Study of the role of the immune system in cancer

Cancer immunology (immuno-oncology) is an interdisciplinary branch of biology and a sub-discipline of immunology that is concerned with understanding the role of the immune system in the progression and development of cancer; the most well known application is cancer immunotherapy, which utilises the immune system as a treatment for cancer. Cancer immunosurveillance and immunoediting are based on protection against development of tumors in animal systems and (ii) identification of targets for immune recognition of human cancer.

<span class="mw-page-title-main">Epithelioid sarcoma</span> Medical condition

Epithelioid sarcoma is a rare soft tissue sarcoma arising from mesenchymal tissue and characterized by epithelioid-like features. It accounts for less than 1% of all soft tissue sarcomas. It was first definitively characterized by F.M. Enzinger in 1970. It commonly presents itself in the distal limbs of young adults as a small, soft mass or a cluster of bumps. A proximal version has also been described, frequently occurring in the upper extremities. Less commonly, cases are reported in the pelvis, vulva, penis, and spine.

Vaccine therapy is a type of treatment that uses a substance or group of substances to stimulate the immune system to destroy a tumor or infectious microorganisms such as bacteria or viruses.

Active immunotherapy is a type of immunotherapy that aims to stimulate the host's immune system or a specific immune response to a disease or pathogen and is most commonly used in cancer treatments. Active immunotherapy is also used for treatment of neurodegenerative disorders, such as Alzheimer's disease, Parkinson's disease, prion disease, and multiple sclerosis. Active immunotherapies induce an immune response through direct immune system stimulation, while immunotherapies that administer antibodies directly to the system are classified as passive immunotherapies. Active immunotherapies can elicit generic and specific immune responses depending on the goal of the treatment. The categories of active immunotherapy divide into:

Asunercept is a soluble CD95-Fc fusion protein which is in clinical development for the treatment of glioblastoma multiforme (GBM) and myelodysplastic syndromes (MDS). Asunercept has been granted orphan drug status for the treatment of GBM and MDS in the EU and the US. It has also received PRIME designation by the European Medicines Agency (EMA) for the treatment of GBM.

<span class="mw-page-title-main">Temozolomide</span> Cancer medication

Temozolomide, sold under the brand name Temodar among others, is an anticancer medication used to treat brain tumors such as glioblastoma and anaplastic astrocytoma. It is taken by mouth or via intravenous infusion.

ALECSAT technology is a novel method of epigenetic cancer immunotherapy being used by the company CytoVac. It uses a patient's own immune system to target tumor cells in prostate cancer, glioblastomas, and potentially pancreatic cancer. ALECSAT research, directed by Alexei Kirken and Karine Dzhandzhugazyan, has led to several clinical trials.

John Howard Sampson is an American neurosurgeon who was formerly chief of the department of neurosurgery at Duke University where he serves as a professor of surgery, biomedical engineering, immunology, and pathology.

The dendritic cell-based cancer vaccine is an innovation in therapeutic strategy for cancer patients.

Neoepitopes are a class of major histocompatibility complex (MHC) bounded peptides. They represent the antigenic determinants of neoantigens. Neoepitopes are recognized by the immune system as targets for T cells and can elicit immune response to cancer.

Marcela V. Maus is an associate professor of medicine at Harvard Medical School and director of the Cellular Immunotherapy Program at Massachusetts General Hospital. She works on immunotherapy for the treatment of cancer, using genetically engineered T cells to target malignancies (cancer).

Donald M. O'Rourke is an American neurosurgeon and the John Templeton, Jr., MD Professor of Neurosurgery at the Perelman School of Medicine at the University of Pennsylvania. He graduated from Harvard University with an A.B. in Biochemistry and Molecular Biology in 1983, and attended medical school at the University of Pennsylvania where he also completed neurosurgical residency training. He established the institution's human brain tumor tissue bank in 2001. An elected member of the American Academy of Neurological Surgery, his research at the Translational Center of Excellence in the Abramson Cancer Center focuses on Glioblastoma Multiforme, especially the design and investigation of Chimeric Antigen Receptor immune therapies.

Individualized cancer immunotherapy, also referred to as individualized immuno-oncology, is a novel concept for therapeutic cancer vaccines that are truly personalized to a single individual.

<span class="mw-page-title-main">Duane Mitchell</span> American physician and research scientist

Duane A. Mitchell is an American physician-scientist and university professor. He is currently employed at the University of Florida College of Medicine, in Gainesville, Florida as the Assistant Vice President for Research, Associate Dean for Translational Science and Clinical Research, and Director of the University of Florida (UF) Clinical and Translational Science Institute. He is the Phyllis Kottler Friedman Professor in the Lillian S. Wells Department of Neurosurgery. and co-director of the Preston A. Wells Jr. Center for Brain Tumor Therapy. Mitchell is also the founder, President, and Chairman of iOncologi, Inc., a biotechnology company in Gainesville, FL specializing in immuno-oncology.

Whole-cell vaccines are a type of vaccine that has been prepared in the laboratory from entire cells. Such vaccines simultaneously contain multiple antigens to activate the immune system. They induce antigen-specific T-cell responses.

References

  1. ↑ "Epitopoietic Research Corporation". ERC. 2020-04-09. Retrieved 2020-07-02.
  2. ↑ "k8fT0MoqyMcug16mplqDtQ2". S&P Global Market Intelligence. 2019-11-26. Retrieved 2020-07-02.
  3. ↑ ERC-USA (2019-11-19). "ERC-USA Sponsors Ancillary Meeting to Discuss Outcomes from Its Clinical Trial and Right To Try Patient Experience of ERC1671 in Recurrent Glioblastoma". GlobeNewswire News Room. Retrieved 2020-07-02.
  4. ↑ Bota, Daniela A; Alexandru-Abrams, Daniela; Pretto, Chrystel; Hofman, Florence M; Chen, Thomas C; Fu, Beverly; Carrillo, Jose A; Schijns, Virgil EJC; Stathopoulos, Apostolos (2008-06-26). "Use of ERC-1671 Vaccine in a Patient with Recurrent Glioblastoma Multiforme after Progression during Bevacizumab Therapy: First Published Report". The Permanente Journal. 19 (2): 41–6. doi: 10.7812/TPP/14-042 . PMC   4403580 . PMID   25785641.
  5. ↑ "ERC Belgium Submits Marketing Authorization Application to European Medicines Agency (EMA) for Glioblastoma Immunotherapy, SITOIGANAP". Yahoo Finance. 2018-08-26. Retrieved 2020-07-02.
  6. ↑ Michelle Fay Cortez (2019-01-10). "Brain Cancer Patient Is First to Get Untested Treatment Under Trump-Backed Law". www.bloomberg.com.
  7. ↑ Stathopoulos, Apostolos; Samuelson, Christian; Milbouw, Germain; Hermanne, Jean Philippe; Schijns, Virgil E. J. C.; Chen, Thomas C. (2008-03-25). "Therapeutic vaccination against malignant gliomas based on allorecognition and syngeneic tumor antigens: proof of principle in two strains of rat". Vaccine. 26 (14): 1764–1772. doi:10.1016/j.vaccine.2008.01.039. ISSN   0264-410X. PMID   18336964.
  8. ↑ WO 2007085648,Stathopoulos, Apostolos,"Tumour vaccine comprising allogeneic or xenogeneic tumour cells",published 2007-08-02
  9. ↑ www.erc.eu. "ERC - Epitopoietic Research Corporation". erc.konnu.be. Retrieved 2020-07-02.
  10. ↑ "ERC: Epitopoietic Research Corporation Netherlands". Rhumbline Consultancy (in Dutch). 2015-04-12. Retrieved 2020-07-02.
  11. ↑ Schijns, Virgil E. J. C.; Pretto, Chrystel; Strik, Anna M.; Gloudemans-Rijkers, Rianne; Devillers, Laurent; Pierre, Denis; Chung, Jinah; Dandekar, Manisha; Carrillo, Jose A.; Kong, Xiao-Tang; Fu, Beverly D. (2018-08-27). "Therapeutic Immunization against Glioblastoma". International Journal of Molecular Sciences. 19 (9): 2540. doi: 10.3390/ijms19092540 . ISSN   1422-0067. PMC   6163986 . PMID   30150597.
  12. ↑ Lassen, Ulrik; Mau-Sørensen, Morten; Poulsen, Hans Skovgaard (2014-11-14). "Orphan drugs in glioblastoma multiforme: a review". Orphan Drugs: Research and Reviews. Retrieved 2020-07-02.
  13. ↑ "Gliovac (ERC1671)". Immuno-Oncology News. Retrieved 2020-07-02.
  14. 1 2 Schijns, Virgil E. J. C.; Pretto, Chrystel; Devillers, Laurent; Pierre, Denis; Hofman, Florence M.; Chen, Thomas C.; Mespouille, Pascal; Hantos, Peter; Glorieux, Philippe; Bota, Daniela A.; Stathopoulos, Apostolos (2015-05-28). "First clinical results of a personalized immunotherapeutic vaccine against recurrent, incompletely resected, treatment-resistant glioblastoma multiforme (GBM) tumors, based on combined allo- and auto-immune tumor reactivity". Vaccine. 33 (23): 2690–2696. doi: 10.1016/j.vaccine.2015.03.095 . ISSN   1873-2518. PMID   25865468.
  15. ↑ "ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-02.
  16. ↑ Bota, Daniela A; Chung, Jinah; Dandekar, Manisha; Carrillo, Jose A; Kong, Xiao-Tang; Fu, Beverly D; Hsu, Frank PK; Schönthal, Axel H; Hofman, Florence M; Chen, Thomas C; Zidovetzki, Raphael (2018-07-01). "Phase II study of ERC1671 plus bevacizumab versus bevacizumab plus placebo in recurrent glioblastoma: interim results and correlations with CD4+ T-lymphocyte counts". CNS Oncology. 7 (3): CNS22. doi:10.2217/cns-2018-0009. ISSN   2045-0907. PMC   6200061 . PMID   30157683.
  17. ↑ "Right to Try Program Offers Hope to Brain Cancer Patients". Goldwater Institute. Retrieved 2020-07-02.
  18. ↑ "Glioblastoma patient is first to receive treatment under Right to Try. Our question is Why? – The Cancer Letter". The Cancer Letter – The Cancer Letter is an independent weekly news publication and the leading source for information on the issues that shape oncology. 2019-02-01. Retrieved 2020-07-02.
  19. ↑ "ERC Belgium Submits Marketing Authorization Application to European Medicines Agency (EMA) for Glioblastoma Immunotherapy, SITOIGANAP". finance.yahoo.com. Retrieved 2020-07-14.
  20. ↑ "ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme". Smart Patients.
  21. ↑ Martin, Ulrich (2020-04-10). "The Biologics News and Reports Portal". pipelinereview. Retrieved 2020-07-02.
  22. ↑ "ERC Immunotherapy". tracxn.com. Retrieved 2020-07-02.
  23. ↑ Home"> "Prof.dr. V.E.J.C. (Virgil) Schijns (https://www.narcis.nl)". NARCIS > Home. Retrieved 2020-07-02.
  24. ↑ "Virgil Schijns". WUR. 2012-11-05. Retrieved 2020-07-02.
  25. ↑ Michelle Fay Cortez (2019-01-10). "Brain Cancer Patient is First to Get Untested Treatment Under Trump-Backed Law". www.bloomberg.com. Retrieved 2020-07-14.
  26. ↑ PhD, Ines Martins. "Gliovac (ERC1671) - Immuno-Oncology News" . Retrieved 2020-07-02.
  27. ↑ Bota, Daniela A.; Alexandru-Abrams, Daniela; Pretto, Chrystel; Hofman, Florence M.; Chen, Thomas C.; Fu, Beverly; Carrillo, Jose A.; Schijns, Virgil Ejc; Stathopoulos, Apostolos (2015). "Use of ERC-1671 Vaccine in a Patient with Recurrent Glioblastoma Multiforme after Progression during Bevacizumab Therapy: First Published Report". The Permanente Journal. 19 (2): 41–46. doi:10.7812/TPP/14-042. ISSN   1552-5775. PMC   4403580 . PMID   25785641.
  28. ↑ Innovation Observatory. "ERC1671 (Gliovac) for recurrent grade IV glioma" (PDF). Health Technology Briefing - March 2019. Retrieved 2020-07-02.
  29. ↑ ERC-USA (2020-04-09). "ERC Launches Development Program for Novel Cell-Based Therapeutic and Prophylactic SARS-CoV-2 Vaccine". GlobeNewswire News Room. Retrieved 2020-07-02.
  30. ↑ Martin, Ulrich. "The Biologics News and Reports Portal". pipelinereview. Retrieved 2020-07-02.
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