Friday, December 12, 2014 8:41:09 PM
Read http://seekingalpha.com/article/2355835-amgen-amgn-ceo-bob-bradway-on-q2-2014-results-earnings-call-transcript
You will see Amgen is taking Tvec very seriously.
With similar/superior efficacy/toxicity profile to Tvec, this should be a giant clue that Immunopulse+PD1 is going to blow it out of the water. Note the 50% ORR that Tvec achieved was with Yervoy, not PD1.
Tvec+PD1 should even be better than 50% ORR (based on Yervoy monotherapy 10% vs PD1 20-30%). We could see ORRs approaching 80%, with CRs approaching 50%. The key point is you can take these numbers and reasonably extrapolate them to Immunopulse.
Furthermore, I suspect Immunopulse+PD1 efficacy will be be slightly better than Tvec (given the intrinsic advantages of the electroporation/DNA plasmid approach)
1) constant, continuous secretion IL12
2) acute inflammation / danger signals
3) direct tumor kill and mechanical compromising of tumor defenses
If this proves out, then it is just a matter of time. Merck will need Immunopulse to position against Amgen's Tvec. 80% response rates is what CAR-Ts can offer for CD19+ blood cancers. Look at how excited that's got the industry. Blood cancers are "easier" to treat than solid tumors. So, achieving 80% ORRs for solid tumors will be nothing short of revolutionary.
The important advantage Immunopulse + PD1 has is it will be much safer than CAR-T. CAR-T has a big problem where patients have died violent deaths (when the CAR-Ts attack healthy cells that express the intended target in small amounts).
Secondly advantage: Immunopulse + PD1 is much much cheaper and logistically much easier to administer than CAR-T. CAR-T requires collection of white cells, complex genetic engineering, culturing, shipping cells etc etc. Much more expensive than simple antibody infusions of PD1 + roll-into office device (Immunopulse). DNA plasmids Immunopulse uses are also very cheap and easy to make in comparison to genetic engineering of CAR-Ts.
Witness the hysteria around CAR-T companies now. KITE market cap at $2B. Juno ipo said to be coming out at $3B. But there are already 8 of more players in the space. There is risk of investors losing a lot of money in that space if CAR-Ts do not work for solid tumors. Like the early dot com days. In the beginning, web mail portals attracted huge, huge valuation. After a very short time, every company had it's own web mail portal. Similar thing will happen to CAR-T space. The general approach is public domain knowledge as it was discovered by NIH and other country/government scientists.
ONCS has seen the light. They have made a course adjustment to go after head & neck cancer. I see this as a sign they need to push hard and fast to position themselves for other solid tumor indications, not just the crowded melanoma space.
I suspect worst case scenario is we get bought by Merck for 4-5x today's market cap. Best case, we get to chart our own future and grow into a multi-billion platform standalone company.
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