Wikipedia

Epitopoietic Research Corporation

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]

Epitopoietic Research Corporation
IndustryBiotechnology
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))
Websitewww.erc-immunotherapy.com

History edit

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

2006 edit

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 edit

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 edit

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[clarification needed]

2012 edit

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

2013 edit

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

2018 edit

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 edit

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 edit

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 edit

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 edit

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

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 edit

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

References edit

  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. ^ a b 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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