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Post by JHam on Mar 17, 2016 10:44:44 GMT
ir.oncosec.com/press-releases/detail/1860Here is the abstract:
Abstract Title: Intratumoral electroporation of plasmid IL-12 can prime response to anti-PD1/PD-L1 blockade in patients with Stage III/IV-M1a melanoma (Abstract #CT134)
Session Title: Early Clinical Trials Evaluating Cell-based Checkpoint Inhibitors and Novel Immunotherapeutics
Date and Time: April 19, 2016 at 3:45 - 4:00 PM
Location: Room 343, Morial Convention Center
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Post by furbush87 on Mar 17, 2016 13:12:16 GMT
ir.oncosec.com/press-releases/detail/1860Here is the abstract:
Abstract Title: Intratumoral electroporation of plasmid IL-12 can prime response to anti-PD1/PD-L1 blockade in patients with Stage III/IV-M1a melanoma (Abstract #CT134)
Session Title: Early Clinical Trials Evaluating Cell-based Checkpoint Inhibitors and Novel Immunotherapeutics
Date and Time: April 19, 2016 at 3:45 - 4:00 PM
Location: Room 343, Morial Convention Center If this was the combination trial they would hold it back for ASCO. Expect this to be biomarker data only. Should have read it first. Looks like they took patients who had completed IL-12 mono therapy and gave them 1 dose of PD1 as an experiment not as an actual study . So this would be an indicator, but not a clinical trial result. |
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Post by JHam on Mar 17, 2016 13:18:00 GMT
ir.oncosec.com/press-releases/detail/1860Here is the abstract:
Abstract Title: Intratumoral electroporation of plasmid IL-12 can prime response to anti-PD1/PD-L1 blockade in patients with Stage III/IV-M1a melanoma (Abstract #CT134)
Session Title: Early Clinical Trials Evaluating Cell-based Checkpoint Inhibitors and Novel Immunotherapeutics
Date and Time: April 19, 2016 at 3:45 - 4:00 PM
Location: Room 343, Morial Convention Center If this was the combination trial they would hold it back for ASCO. Expect this to be biomarker data only. Should have read it first. Looks like they took patients who had completed IL-12 mono therapy and gave them 1 dose of PD1 as an experiment not as an actual study . So this would be an indicator, but not a clinical trial result. Exactly. They are apparently separate from the P2b trial. That's a surprise. |
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Post by furbush87 on Mar 17, 2016 13:24:24 GMT
If this was the combination trial they would hold it back for ASCO. Expect this to be biomarker data only. Should have read it first. Looks like they took patients who had completed IL-12 mono therapy and gave them 1 dose of PD1 as an experiment not as an actual study . So this would be an indicator, but not a clinical trial result. Exactly. They are apparently separate from the P2b trial. That's a surprise. PD-1 is an approved drug, so administering it without FDA approval would not be a problem because it is done after the fact. Merck would have a vested interest in providing PD1 for say 6 patients, wait 6 months and present data. This would go along with what Punit said to me of "eventually you have to prove your point", well, this isn't proof, but an indicator. I expect the results will be decent, but with such a small number of patients that it will be clinically irrelevant. Again, an indicator but nothing more. Will give me, and likely others, more confidence to take a larger position after reading the data. |
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Post by JHam on Mar 17, 2016 14:37:38 GMT
Exactly. They are apparently separate from the P2b trial. That's a surprise. PD-1 is an approved drug, so administering it without FDA approval would not be a problem because it is done after the fact. Merck would have a vested interest in providing PD1 for say 6 patients, wait 6 months and present data. This would go along with what Punit said to me of "eventually you have to prove your point", well, this isn't proof, but an indicator. I expect the results will be decent, but with such a small number of patients that it will be clinically irrelevant. Again, an indicator but nothing more. Will give me, and likely others, more confidence to take a larger position after reading the data. I know they can easily give a patient Keytruda since it is already on the market. The part I bolded is where I feel a bit differently. In this day and age, no one really want to see inconclusive data (see AVXL). If the data is only "decent" then it could be a blood bath for the pps. And if it is spectacular, ONCS will probably get accused of touting inconclusive data. At this point, and knowing ONCS' history of transparency, I'd rather see them keep it to themselves, be patient, and give us the whole enchilada when they have interim P2b data available. Oh well. If it were to take a dump, I'd likely add more. |
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Post by alcalde on Mar 17, 2016 15:22:50 GMT
A poster on seeking alpha brought up a good point. Since no one was expecting this "teaser" data, if it were bad ONCS could have just kept it quiet and waited on true combo interim data. That fact combined with the clearly positively framed abstract title and I think it will be good results. Perhaps it can be used to get a head start on any partnership negotiations.
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Post by furbush87 on Mar 17, 2016 16:02:41 GMT
A poster on seeking alpha brought up a good point. Since no one was expecting this "teaser" data, if it were bad ONCS could have just kept it quiet and waited on true combo interim data. That fact combined with the clearly positively framed abstract title and I think it will be good results. Perhaps it can be used to get a head start on any partnership negotiations. To paint a rosy picture. Lets say it is 5 of 6 responded. Statistically that is insignificant, however if they present it as biomarkers and not response, then it is not pumping insignificant data, it is presenting supporting data. Ultimately it won't be relevant to value, but is a very nice indicator. |
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Post by lincoln2424 on Mar 17, 2016 16:07:27 GMT
Yes, this is interesting. We don't know if the patients treated with Anti-PD-1/PD-L1 were pre-screened and classified as non-responders or were actually non-responders in the past (my hunch is they were not). If this is the case it is a little different than the hypothesis of turning non-responders into responders...it may just be data showing that this cohort of patients responded more favorably to Anti-PD-1/PD-L1 than patients who are not pre-treated with Immunopulse (I.e. ORR higher than the 30-40% typically seen by the treatment).
If this is the case it would support the theory that they are turning some non-responders into responders. The caveat being that depending on size this will likely be scrutinized as not statistically significant and can only be taken as a potential indication of future success on the combo trial data.
It's an exciting development though! It would be great to see a number north of 70%...that would be a pretty significant development.
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Post by furbush87 on Mar 17, 2016 17:15:35 GMT
Lincoln, little known fact. Every patient in all Phase 2 trials have had biopsies with the PDL1 biomarker recorded. So the "subset" that they did this with is most likely ones that previously were tested to meet current P2b requirements, or fairly close. They may not have ever received PD1 before, but there tests most likely indicated they wouldn't respond.
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Post by lincoln2424 on Mar 18, 2016 0:22:56 GMT
Good to know, thank you!
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