As of today, L.S. still thinks there is a chance NWBO will present something at ASCO, but he is also aware the final dosing and deadline timelines may present a bureaucratic hurdle of sorts. He does believe there will be more releases as the year goes on. I'm simply waiting.
Despite someone's thorough job of trying to persuade many there will be a handful or less Partial responders in the Direct trial, the 2014 article from the Lancet I cited yesterday charted 15% responses in 1st generation dendritic therapies. DCVax-Direct is basically 3.0 dendritic technology. Again, caveat I think most phase I patients have moved onto the phase II/partII dosing regimen. Some might say now that we've come this far, why not let the optimal dosing, cell maturation and frequency get traction. Well, that all depends on where they are -- I know there are some who do not believe that the phase I/II trial is still actively dosing into stage II, but I do.
Anyway, Fox may have a point. The write up in any one of those Journals could very well take precedence. This is big stuff, and while expectations have been lowered on Direct to a point where longterm investors get nervous. The company could probably get out in front of this better, but only those inside the company know what cause and effects this might have on other issues currently on their collective plates. I'm still very encouraged by the data, though sparse, that is available thus far.
If anyone did read the portions of the 2014 Lancet I posted on ORR for older dendritic therapy, it should be encouraging not only for future techs like DCVax-Direct, but it also gives a bit more insight into how DCVax-L -- proven safer than any oncology therapy on the planet over the span of a decade -- might use CIs for potential synergy trials.
Recently we learned a couple things. Car-ts don't work in solid tumors. I've alluded to this previously in prior posts, and Yervoy (CTLA-4) + Opdivo is too toxic for many and fatal for 3%. Keytruda and Opdivo alone have barely enough ORR to obtain approval, and after that, their durability improvement appears modest.
DCVax-L is not just for Brian cancer. It is used right now in Israel on all types of cancers. With the new dosing schedule that includes booster shots, I'm speculating they are getting 20% + ORR for tumor shrinkage. That's a guess folks. It's based on background reading for a couple years, and extrapolated. Of course the impressive numbers for DCVax-L phase III should be related to Overall survival and Progression free survival.
Anyway, suspend your disbelief if you must, but lets imagine taking Opdivo or Keytruda and adding it to DCVax-L. I've discussed this before, more often with DCVax-Direct, but let's consider our therapy that has a ten year old safety track record.
I surmise, again, DCVax-L could be used both as pretreatment and concurrent treatment with said CIs.
Why? Because DCVax-L naturally recovers the immune system, increases t-cell proliferation, activity and efficacy, and, in cases where patients have high tumor burden, can safely stabilize a patient before they are subject to checkpoint inhibitors (which might otherwise induce cytokine storms.)
After pretreatment is complete and concurrent combinational therapy is started, less rescue medicine is likely necessary, the CIs actually have t-cells to "take the breaks off," and those t-cells are directed by DCVax-L to attack all the relevant antigens in the tumors.
Thus the potential advantages from using DCVax-L with CIs are:
1. Improving safety profile for CI by combining it with DCVax-L.
2. Potentially improve efficacy of both CI and DCVax-L.
3. Improving the approval speed for DCVax-L on other indications through ORR as the primary endpoint. Combinational effect on tumor response may be logarithmic.
4. Maintain approval of CI therapy durability because tumor escape is reduced by combinational therapy with DCVax-L.
5. Reduce competition.
The potential disadvantage:
1. Cost to patient.
2. Cut into profit margin for both companies.
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