As previously posted : "Oncolytic viruses represent a new class of therapeutic agents that promote anti-tumour responses through a dual mechanism of action that is dependent on selective tumour cell killing and the induction of systemic anti-tumour immunity."
This dual action mechanism has been demonstrated in clinical studies using Reolysin and has been described recently by Oncolytics Biotech CEO Brad Thompson.
June 30, 2016
"Bristol-Myers Squibb (seeks) to optimize therapeutic combinations for future clinical studies, develop next-generation immuno-oncology drugs, and identify new biomarkers to differentiate responders and non-responders in lung cancer."
Activity across epithelially derived solid tumors, which typically have unmet needs even after checkpoint inhibitor treatment is where oncolytic viruses, such as Reolysin, are demonstrating their potential.
This "partnership deal' is the start of further partnering / M&A activity in the oncolytic virus space. Just a matter of the right time/company for Oncolytics Biotech.
June 30, 2016
Bristol-Myers squibb and psioxus therapeutics announce immuno-oncology clinical collaboration to evaluate the combination of opdivo and enadenotucirev.
“This collaboration continues to expand our clinical development of Opdivo and explores how oncolytic viruses may provide a complementary mechanism to address tumors that are resistant to I-O therapy,” said Dr. Jean Viallet, Global Clinical Research Lead in Oncology at Bristol-Myers Squibb, said in a statement.
'Every patient will have metastasized disease to the liver. And we're also throwing in a checkpoint inhibitor, in this case Merck's product Keytruda. And this is basically the home-run study, if you want to think of it that way.'
irRECIST criteria are based on irRC criteria adapted for unidimensional measurements, as outlined in Nishino
et al., 2013.
From May 19, 2016 IND 210 press release:
Colorectal Cancer Clinical Program: Next Steps
Based on these results, Oncolytics has filed for a U.S. Phase II run–in study examining the treatment of female patients with metastatic colorectal cancer with FOLFOX-6, bevacizumab, REOLYSIN®, and the checkpoint inhibitor pembrolizumab (KEYTRUDA®). Subject to confirmation of overall responses, liver metastases-specific responses, and immune marker analyses, the Company intends to conduct a registration study using the modified therapeutic regime including pembrolizumab.
Evaluation of the results will be conducted using iRECIST analysis:
irRECIST criteria introduces the needed clarifications and adjustments to irRC
criteria and Nishino et al., 2013 publication to allow for treatment evaluations that better meet both
investigators’ and patients’ needs and with that better reflect sponsors’ demands for more reliable
and reproducible study data in targeted immunotherapy in oncology studies. The main adaptation of
the existing immune-response criteira lies in the assessment of all detected lesions. Unequivocal
and substantial increase of non-target and new non-measurable lesions prevents irCR and may also
lead to irPD. Reduction of the tumor burden in patients in an adjuvant setting may lead to irPR and
such patients may therefore be enrolled in studies with response endpoints.
Further to June 20, 2016 presenation given at the Richmond Club in Toronto Canada
Slide 17 - Time 15;53 - Verbatim: Brad Thompson
"We expect this to be a final study in this area ... its a Phase 2 size, its 32 patients but if we see the same response rates that we have seen in the Canadian study, this will be the registration study, that's all we will have to do. We're treating female patients because they have the best response rates, every patient will have metastases (inaudible 'disease') against the liver and we are also throwing in a checkpoint inhibitor. in this case Merck's product Keytruda, this basically is the homerun study, if you want to think of it that way If we just confirm the response rate that we saw before then that will be enough for product registration. And we are very excited about that as you might imagine."
ONCY/ONCYf issues a June 29, 2016 Press Release announcing filing of the above referenced Phase 2 study which in its fullest will be the registration study for Reolysin approval.
As previously observed .. " The logic that comes from armedescapade appears to be from a poorly coded artifical intelligence (AI) program that cannot compute or keep up with unprecedented events." ERO his irrationality and facile posts.
First Scotland .. then N. Ireland .. then London. Thank you David Cameron, George Osborne, Boris Johnson and the (de facto) British feudal system.
armedescapade once claimed he was from Wisconsin ... so you say Ann Arbor. ..some say potato and others say potatoe (GWB sic).
Their Australian promoters election attack strategy and now BREXIT has left a party and country both divided and leader less ... once powerful now defeated. You go armedescapade .. keep up your attack dogma .. your history lesson has just begun.