There are some coverage in our broker/analyst reports regarding this ONTY and its primary product Stimuvax.
--In the Southern Cross report in May--
PRR owns 100% of the technology, without intellectual property issues and with only a modest royalty payable. In March 2004 PRR licensed the CVac technology for use outside Australia and New Zealand to a Canadian company called Biomira, which was developing a similar technology to PRR15. That agreement was altered in February 2007 with PRR taking back the international rights in return for a modest royalty on sales. This helped clear up the intellectual property space around MUC-1 and consequently we have no concern about patent litigation in the event of CVac’s clinical trial success. Biomira is now Oncothyreon, a company we profile below.
Oncothyreon. This company, which used to be called Biomira (mentioned above regarding CVac’s IP position), is currently in Phase III with its MUC-1 immunotherapy, called Stimuvax, in non-small-cell lung cancer and in breast cancer. Oncothyreon partnered Stimuvax to Merck KGaA20 in 2001, which was converted to a full license in 2007, while manufacturing rights were granted to Merck KGaA in late 2008. In March 2010 the FDA placed a clinical hold on the Stimuvax trials due to a trial subject developing encephalitis. The non-small cell lung cancer hold was lifted in June 2010, but the hold remains for breast cancer.
With regard to PRR we think Oncothyreon is particularly worth paying attention to:
• The data for lung cancer has been favourable – In a 171 patient Phase IIb trial for which final survival results were announced in April 2006 median survival for treated patients was 30.6 months versus 13.3 months for the controls.
• We understand Phase III data will be available close to the end of 2011(now reported to be mid-2012) - Success for Merck KGaA and Oncothyreon in this trial will also be favourable for PRR given the validation it will provide for.
--In the latest Nomura report in November--
Oncothyreon (ONTY US, not rated): is based in Seattle, Washington, and is a biotechnology company dedicated to the development of oncology products. ONTY are currently developing multiple therapeutic candidates designed to target cancer. ONTY’s pipeline includes both synthetic vaccines and small molecules for a variety of cancer indications. ONTY’s relevant clinical trials are around Stimuvax (a BLP25 liposome vaccine). Currently in Phase 3 Trials, Stimuvax is a cancer vaccine designed to induce an immune response to cancer cells that express Mucin-1 (MUC1). Stimuvax works by stimulating the body's immune system to identify and destroy cancer cells expressing MUC1. Stimuvax is being developed by Merck KGaA (MRK GY, BUY, EUR 67.60) of Darmstadt, Germany under a license agreement with Oncothyreon. Merck is currently conducting two Phase 3 trials of Stimuvax, called: 1) START – Stimulating Targeted Antigenic Responses to Non Small Cell lung Cancer and 2) INSPIRE (Stimuvax trial In Asian NSCLC Patients: Stimulating Immune Response) a trial of Stimuvax in Asian patients with advanced non-small cell lung cancer (NSCLC).
-----------------------------------------------------------The upcoming Phase3 result of Stimuvax will give a strong validation reference on our Cvac as they are very similar MUC-1 based technology. And given that we are expecting the interim result from our Phase2b trial at around the same period, 2012 could be a very interesting/pivot year for PRR. And so far, things are pointing to the right direction with regards to Cvac and Stimuvax in terms of effectiveness and safety.
H2 2011 has been red for PRR due to our 'big brother' DNDN's non-technology slip over the market turmoil, hopefully 2012 will be a green and strong year for PRR.
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