Oncolytics Biotech

Oncolytics Biotech


Oncolytics Biotech Inc.
Type Public
Traded as TSX: ONC NASDAQ: ONCY
Industry Biopharmaceutical
Founded 1998 Calgary, Alberta, Canada
Headquarters Calgary, Alberta, Canada
Key people Brad Thompson Ph.D. - President, and Chief Executive Officer; Doug Ball C.A. - Chief Financial Officer; Matt Coffey Ph.D. - Chief Operating Officer; George Gill M.D. - Senior Vice President, Clinical & Regulatory Affairs and Chief Medical Officer; Mary Ann Dillahunty J.D., M.B.A. - Vice President, Intellectual Property; Alan Warrander Ph.D. - Senior Vice President, Global Licensing & Business Development
Products Reolysin, a potential therapeutic for human cancers
Website www.oncolyticsbiotech.com

Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) is a Canadian company headquartered in Calgary, Alberta, that focuses on the discovery and development of pharmaceutical products for the treatment of human cancers. The Company’s product, Reolysin, harnesses the oncolytic capabilities of naturally-occurring reovirus (Respiratory Enteric Orphan virus), which has been shown to replicate specifically in cells with an activated Ras pathway. Ras pathway mutations are found in approximately two thirds of all tumours, including most metastatic disease, which makes Reolysin a potential therapeutic for a variety of cancer types.

Contents

History

Oncolytics Biotech Inc. was founded in Calgary in 1998 in response to discoveries made on the oncolytic potential of reovirus made at the University of Calgary during the 1990s.[1][2] From 1999 to 2000 the Company transitioned from private to public ownership. In June 2000, it began trading on the Toronto Stock Exchange (TSE) and began trading on the NASDAQ in 2001.

Since its inception, Oncolytics Biotech Inc. has worked to take Reolysin, its proprietary formulation of human reovirus, through the development and regulatory requirements necessary to develop it as a potential cancer therapeutic. In 2000, Oncolytics Biotech Inc. received permission to conduct its first phase I clinical trial, which was designed to test the safety of Reolysin in human patients. The positive results[3] of this first study led to the rapid and continuous expansion of Oncolytics’ clinical trial program, with phase II studies beginning in Canada in 2001, U.S. and subsequent cross-border studies beginning in 2002, and enrollment in a multi-site phase III trial beginning in 2010.[4]

Oncolytics Biotech Inc. has also worked to secure its intellectual property as Reolysin has progressed as a potential therapeutic agent. The Company was issued its first Canadian patent in August 2000, and currently holds more than 200 patents worldwide, including 38 U.S. and 11 Canadian patents.

Products

Reolysin was developed from pre-clinical research done at the University of Calgary[1][2] Matt Coffey and Jim Strong led this research, and as Oncolytics’ Chief Operating Officer, Coffey continues to play a pivotal role in the product’s development.[citation needed]

Reolysin is a proprietary formulation of human reovirus, which is naturally found in mammalian respiratory and bowel systems.[5] Most people have been exposed to reovirus by adulthood, but the infection does not typically produce symptoms.[6] Reovirus was noted to be a potential cancer therapeutic when early studies suggested it reproduces well in certain cancer cell lines.[7][8] It has since been shown to replicate specifically in cells that have an activated Ras pathway with very little effect in cells that do not have active Ras pathways.[9] Activating mutations of the Ras protein and upstream elements of the Ras protein may play a role in more than two thirds of all human cancers, including most metastatic disease, which suggests that Reolysin may be an effective therapeutic for many Ras-activated tumor types and potentially for some cell proliferative disorders.[10][11][12]

Research and Development Collaborations

Oncolytics Biotech Inc. has collaborative agreements with the National Cancer Institute,[13] the University of Leeds,[14] and the Cancer Therapy & Research Centre at the University of Texas Health Science Center in San Antonio[15] to conduct multiple phase I/II and phase II trials in the United States and United Kingdom. There are currently multiple active trials[16] in the Company’s clinical program and these ongoing studies, along with the ones Oncolytics has successfully completed, are producing interim and final data that indicate positive clinical responses in multiple types of primary and metastatic disease.[17][18][19][20][21][22]

On September 2, 2010, the Company announced that the Gynecologic Oncology Group (GOG) would be pursuing a new phase II study of Reolysin in combination with weekly paclitaxel in patients with persistent or recurrent ovarian, fallopian, or primary peritoneal cancer.[13] The National Cancer Institute (NCI) in the United States has approved and will sponsor the study.

Reolysin Clinical Progress

Reolysin has successfully completed a number of phase I and II clinical trials across a variety of cancer types. The Company is currently conducting a phase III trial examining Reolysin in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. The phase III trial is being conducted in multiple jurisdictions:

  • On October 2, 2009, the Company announced that it had reached an agreement with the U.S. Food and Drug Administration (FDA) regarding the study design, making Oncolytics one of the first companies to reach an agreement with the FDA on a phase III trial design for an intravenously-administered oncolytic virus under the Special Protocol Assessment (SPA) process[23]
  • On February 16, 2010, the Company announced that it has received a letter of approval to conduct the trial from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA)[24]
  • On June 1, 2010, the Company announced that it had received approval to conduct the trial from the Belgian Federal Agency for Medicines and Health Products (FAMHP)[25]
  • On July 19, 2010, the Company announced that it had received a no-objection letter to conduct the trial from Health Canada[26]

The Company is currently conducting phase II trials in a range of indications including squamous cell carcinoma of the lung, non-small cell lung cancer, pancreatic cancer, and ovarian cancer. The Company is also conducting a phase I trial in colorectal cancer.

References

  1. ^ a b Strong, JE; Tang, D; Lee, PW (1993). "Evidence that the epidermal growth factor receptor on host cells confers reovirus infection efficiency". Virology 197 (1): 405–11. doi:10.1006/viro.1993.1602. PMID 8212574. 
  2. ^ a b Coffey, MC; Strong, JE; Forsyth, PA; Lee, PW (1998). "Reovirus therapy of tumors with activated Ras pathway". Science 282 (5392): 1332–4. doi:10.1126/science.282.5392.1332. PMID 9812900. 
  3. ^ Thirukkumaran, CM; Nodwell, MJ; Hirasawa, K; Shi, ZQ; Diaz, R; Luider, J; Johnston, RN; Forsyth, PA et al. (2010). "Oncolytic viral therapy for prostate cancer: efficacy of reovirus as a biological therapeutic". Cancer research 70 (6): 2435–44. doi:10.1158/0008-5472.CAN-09-2408. PMID 20215509. 
  4. ^ "ONCOLYTICS BIOTECH INC. | Oncolytics Biotech(R) Inc. Announces Opening of Enrollment in Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers". Newswire.ca. 2011-06-20. http://www.newswire.ca/en/releases/archive/May2010/25/c6268.html. Retrieved 2011-08-08. 
  5. ^ Nirbert, M. L.; Schiff, L. A.; Fields, B. N. (1996). "Reoviruses and their Replication". In Fields, Bernard N.; Knipe, David Mahan; Howley, Peter M.. Fundamental Virology (3rd ed.). Philadelphia: Lippincott-Raven. ISBN 978-0-7817-0284-3. [page needed]
  6. ^ White, CL; Twigger, KR; Vidal, L; De Bono, JS; Coffey, M; Heinemann, L; Morgan, R; Merrick, A et al. (2008). "Characterization of the adaptive and innate immune response to intravenous oncolytic reovirus (Dearing type 3) during a phase I clinical trial". Gene therapy 15 (12): 911–20. doi:10.1038/gt.2008.21. PMID 18323793. 
  7. ^ Hashiro, G; Loh, PC; Yau, JT (1977). "The preferential cytotoxicity of reovirus for certain transformed cell lines". Archives of virology 54 (4): 307–15. doi:10.1007/BF01314776. PMID 562142. 
  8. ^ Duncan, MR; Stanish, SM; Cox, DC (1978). "Differential sensitivity of normal and transformed human cells to reovirus infection". Journal of virology 28 (2): 444–9. PMC 354293. PMID 214572. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=354293. 
  9. ^ Strong, JE; Coffey, MC; Tang, D; Sabinin, P; Lee, PW (1998). "The molecular basis of viral oncolysis: usurpation of the Ras signaling pathway by reovirus". The EMBO journal 17 (12): 3351–62. doi:10.1093/emboj/17.12.3351. PMC 1170673. PMID 9628872. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1170673. 
  10. ^ Duursma, AM; Agami, R (2003). "Ras interference as cancer therapy". Seminars in cancer biology 13 (4): 267–73. doi:10.1016/S1044-579X(03)00040-3. PMID 14563121. 
  11. ^ Bos, JL (1989). "Ras oncogenes in human cancer: a review". Cancer research 49 (17): 4682–9. PMID 2547513. 
  12. ^ Norman, KL; Lee, PW (2005). "Not all viruses are bad guys: the case for reovirus in cancer therapy". Drug discovery today 10 (12): 847–55. doi:10.1016/S1359-6446(05)03483-5. PMID 15970267. 
  13. ^ a b "ONCOLYTICS BIOTECH INC. | Oncolytics Biotech(R) Inc. Announces Randomized Phase II Ovarian Cancer Study to be Conducted by the Gynecologic Oncology Group and Sponsored by the National Cancer Institute". Newswire.ca. 2011-06-20. http://www.newswire.ca/en/releases/archive/September2010/02/c6742.html. Retrieved 2011-08-08. 
  14. ^ "Bulletin Board". Therapy 6 (2): 191. 2009. doi:10.2217/14750708.6.2.191. 
  15. ^ "ONCOLYTICS BIOTECH INC. | Cancer Therapy & Research Center at The University of Texas Health Science Center and Oncolytics Biotech(R) Inc. Announce Multi-Trial Clinical Research Collaboration". Newswire.ca. 2011-06-20. http://www.newswire.ca/en/releases/archive/February2009/04/c5529.html. Retrieved 2011-08-08. 
  16. ^ "Oncolytics". Oncolyticsbiotech.com. http://www.oncolyticsbiotech.com/clinical.html. Retrieved 2011-08-08. 
  17. ^ Sei, S; Mussio, JK; Yang, QE; Nagashima, K; Parchment, RE; Coffey, MC; Shoemaker, RH; Tomaszewski, JE (2009). "Synergistic antitumor activity of oncolytic reovirus and chemotherapeutic agents in non-small cell lung cancer cells". Molecular cancer 8: 47. doi:10.1186/1476-4598-8-47. PMC 2723073. PMID 19594950. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2723073. 
  18. ^ Twigger, K; Vidal, L; White, CL; De Bono, JS; Bhide, S; Coffey, M; Thompson, B; Vile, RG et al. (2008). "Enhanced in vitro and in vivo cytotoxicity of combined reovirus and radiotherapy". Clinical cancer research 14 (3): 912–23. doi:10.1158/1078-0432.CCR-07-1400. PMID 18245555. 
  19. ^ Pandha, HS; Heinemann, L; Simpson, GR; Melcher, A; Prestwich, R; Errington, F; Coffey, M; Harrington, KJ et al. (2009). "Synergistic effects of oncolytic reovirus and cisplatin chemotherapy in murine malignant melanoma". Clinical cancer research 15 (19): 6158–66. doi:10.1158/1078-0432.CCR-09-0796. PMID 19773377. 
  20. ^ Harrington, KJ; Karapanagiotou, EM; Roulstone, V; Twigger, KR; White, CL; Vidal, L; Beirne, D; Prestwich, R et al. (2010). "Two-stage phase I dose-escalation study of intratumoral reovirus type 3 dearing and palliative radiotherapy in patients with advanced cancers". Clinical cancer research 16 (11): 3067–77. doi:10.1158/1078-0432.CCR-10-0054. PMID 20484020. 
  21. ^ Smakman, N; Van Der Bilt, JD; Van Den Wollenberg, DJ; Hoeben, RC; Borel Rinkes, IH; Kranenburg, O (2006). "Immunosuppression promotes reovirus therapy of colorectal liver metastases". Cancer gene therapy 13 (8): 815–8. doi:10.1038/sj.cgt.7700949. PMID 16543920. 
  22. ^ Kottke, T; Thompson, J; Diaz, RM; Pulido, J; Willmon, C; Coffey, M; Selby, P; Melcher, A et al. (2009). "Improved Systemic Delivery of Oncolytic Reovirus to Established Tumors Using Preconditioning with Cyclophosphamide-Mediated Treg Modulation and Interleukin-2". Clinical cancer research 15 (2): 561–9. doi:10.1158/1078-0432.CCR-08-1688. PMC 3046733. PMID 19147761. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=3046733. 
  23. ^ "ONCOLYTICS BIOTECH INC. | Oncolytics Biotech(R) Inc. Reaches Special Protocol Assessment Agreement with the FDA on Design of Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers". Newswire.ca. http://www.newswire.ca/en/releases/archive/October2009/02/c3208.html. Retrieved 2011-08-08. 
  24. ^ "ONCOLYTICS BIOTECH INC. | Oncolytics Biotech(R) Inc. Receives Approval from the U.K. MHRA to Conduct Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers". Newswire.ca. http://www.newswire.ca/en/releases/archive/February2010/16/c9911.html. Retrieved 2011-08-08. 
  25. ^ "ONCOLYTICS BIOTECH INC. | Oncolytics Biotech(R) Inc. Receives Approval from Belgium FAMHP to Conduct Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers". Newswire.ca. 2011-06-20. http://www.newswire.ca/en/releases/archive/June2010/01/c8562.html. Retrieved 2011-08-08. 
  26. ^ "ONCOLYTICS BIOTECH INC. | Oncolytics Biotech(R) Inc. Receives No Objection Letter from Health Canada to Conduct Phase 3 Trial of REOLYSIN(R) in Head and Neck Cancers". Newswire.ca. 2011-06-20. http://www.newswire.ca/en/releases/archive/July2010/19/c5008.html. Retrieved 2011-08-08. 

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