I think data from NEO and HOT will accrue quicker than AXAL. Based on what I've read NEO/HOT show a fairly rapid immune response. Now, if that can equate to efficacy somebody might be interested in partnering, especially to pharma with PD-1 and PD-L1 inhibitors. IMHO

And yet, here we all remain, not moving on, hoping for a miracle.

Sane words.

It must have been a difficult decision but I think Advaxis has chosen the right path. This decision saves millions of dollars. Some here will just look upon the closing of the trial and say Advaxis cannot complete a trial to fruition but I believe NEO and HOT are the future. If the AIM2CERV data is good, you may be right in the company being able to move forward without an SPA.

Portend definition: If something portends something, it indicates that it is likely to happen in the future

In this case, it may be good.

This may portend well for HOT:

https://immuno-oncologynews.com/2019/06/18/colorectal-cancer-vaccine-candidate-induces-potent-immune-responses-interim-trial-results-show/?utm_source=IO+News&utm_campaign=fef89f09a2-RSS_WEEKLY_EMAIL_CAMPAIGN_US&utm_medium=email&utm_term=0_f04c303b86-fef89f09a2-72345901

LOL! My enthusiasm on what this company can achieve is waning but I still think the science can trump the management missteps that have brought us to these levels. I do think the stock has been manipulated to a degree but that doesn't absolve management of their responsibility to bring one P3 to a successful conclusion. At least, Aratana received conditional approval for canine osteosarcoma and it could be the first full approval.y

I'm not getting excited over these job openings but, given the limited amount of cash on-hand, I would hope these listings are based on something concrete that is coming. The PT opening is interesting. It could indicate they have something that needs to be done soon.

I dashed off an email to Ms. Miller to ask if the "updated results" from the IO Combinations 360° event would be PR'd. I also asked if Dr. Petit is still on the management team as the website implies. I'll share whatever I receive...if I receive a response.

I don't think they would present bad data at an event but I HOPE they would PR good data.

If the results were truly bad, I would think there would have been a sell-off after hours. I'm sure there were enough people there to spread the word. Maybe we see a PR tomorrow.

So, there was a presentation today at IO Combinations 360° on NEO with updated results and we hear...nothing? What's the point of even including the event in an earlier PR?

My thought, also.

I'm surprised no PR for yet for updated NEO results.

Combos are the way to go now. Yes, a partial response or two would be most welcome!

James, while I also think it's important we get FDA nod, I don't see it as holding up other deals. Ken said they were in discussions with Merck for a path forward for PSA as well as other potential partners. I would, however, rest easier if the FDA would give their blessing. It seems to be taking an inordinate amount of time.

Tomorrow we get updated results on NEO, I doubt that it will be earth-shattering but maybe it will give the stock a little boost.

IO Combinations 360°

Date and Time: June 20-21, 2019 at 12:00pm ET
Venue: Wyndham Historic District Hotel, Philadelphia, Pennsylvania
Presenter: J. Randolph Hecht M.D., Professor of Clinical Medicine, David Geffen School of Medicine at UCLA and Director of the UCLA Gastrointestinal Oncology Program
Presentation: A Phase 1 Dose-Escalation Study of ADXS-NEO Expressing Personalized Tumor Antigens in Subjects with Advanced Solid Tumors: Updated Results

RE: canine it IS in a study for full approval!.

AXAL, by itself, has been shown as a safe, effective therapy for cervical cancer. I imagine a triple combo with chemo, an anti-PD-1 agent and AXAL would have a synergistic effect. Merck seems to want throw Keytruda at every cancer and has already been approved for cervical in a second-line setting. It would take little money on Mercks part to license this application from Advaxis. They could possibly move from a PI (if promising) to a P3 fairly quickly. I am puzzled they have not, as yet, done so. IMHO

On the CC, term sheets were not mentioned BUT KB did refer to interest in the platform. Now, there is a BIG difference between interest and a deal but we are available at bargain prices. There is updated NEO data to be presented shortly. Let's see what we have.

They updated his title.

On slide 33, Petit is still shown as on the management team, now the Chair of Scientific Advisory Board. So, all the hullabaloo over his leaving was for naught?

Let's see if any of the stable disease becomes a PR.

Bourbon, you're asking the question that is on all our minds.

I think the most interesting info came in the Q&A:

Andres Gutierrez (on NEO combo portion):

"We’re expecting that, that particular cohort is going to enroll faster. Actually, we have received several requests to be – for patients to be enrolled in that particular study arm. So we’re thinking that we are going to be able to proceed with Part B very quickly."

KB (on partner(s)/collaboration(s)):

"I think the only thing to say is, we’ve seen a high level of interest, both from big pharma and small companies, as well as from folks looking for regional deals, say in Asia, we just came out of a very heavy meeting agenda at Bio, where we had over 40 meetings, many of which were pretty substantive and have follow ups."

"NEO could take many different flavors in terms of partnership. People can partner on certain aspects of NEO."

"...we have another asset that that’s early in development in the vet space, where we are utilizing the optimized construct that we’ve developed for HOT and NEO, where we put multiple antigens in there. And now we – we’re able to do that in the vet space like we did successfully with our HER2 construct that’s on the market today."

"And so, we think there’s a nice monetization opportunity, very intriguing opportunity in the vet space to monetize through partnerships. We obviously have a partner today that’s getting acquired, so that would be the first place we would go to, to have a conversation. But just to point out that there are many different ways that we can monetize the science as we already have monetized HER2, both for vet use and for use in humans for pediatric osteosarcoma."

"And yes, we’re in discussions with Merck about what to do next, because I think as we’ve seen, they’ve seen some nice synergies between KEYTRUDA and our PSA construct.

And so, once we conclude those discussions, we’ll determine the best path forward. And other people have expressed interest in the PSA construct itself, because it’s a nice indication right now in late-stage metastatic prostate cancer, where there is an unmet need for these patients who have failed chemotherapy and have failed the novel hormone agents. And so there’s some interest in the PSA construct, both in the U.S. and outside the U.S."

Here is a link to the transcript from SA: https://seekingalpha.com/article/4269697-advaxis-inc-adxs-ceo-kenneth-berlin-q2-2019-results-earnings-call-transcript?part=single

I believe they are working with an outside firm. Apparently, there are also follow-up talks to discussions held at the recent BIO International Convention but the only thing that will propel the PPS upward is a deal with upfront cash. There was no concrete bad news on the call today but the lack of any real, substantive news prevented any kind of run-up. I will say Ken sounded positive and upbeat but just sounding that way will do nothing to move the PPS. Make a deal, Ken. Time and cash are running out.

You heard correctly. They are still talking regarding an earlier interim look.

Technically, no bad news but no new news. They're still trying for an earlier interim look. That should have been done a while ago. IST should have been announced by now also. We'll see what Ken says shortly and it shouldn't be how much he saved on car insurance.

If we don't hear anything tomorrow, I doubt it.

An announcement of...?

Financial news released after hours on Monday. Call on Tuesday. I feel better than if they scheduled it on a Friday but we'll see.

Genocea currently has one P1/2a running and the share price is approx. $8 and change. We're in a P3 under an SPA and we're...let's just say ADXS is undervalued here.

Are you talking about Scammy? I've had him on ig for some time.

I'm hoping at least one of those term sheets lead to a deal. Too much money has been wasted on too many trials at once, interrupted, discontinued trials and completed trials (check clinicaltrials.gov) that have never published results. I still have a little hope that something positive comes of all this.

And, let's see what the "updated" NEO results are. Things are moving fast in immunotherapy. Advaxis HAS to get it's act together and partner. What happened to all those term sheets? SOMEBODY must realize the LM platform has value.

June is Cancer Immunotherapy Month. What better time to get a partner or deal?

Yes, free trial is good. Do you attach any significance to the HOT construct no longer having "in discussions with multiple partners" attached to it on the presentation or we haven't heard back about an earlier interim peek (AIM2CERV)? The interim peek, I would think, should have been decided by now but who knows with the FDA.

Since there's already an on-going trial, ADXS 11-001 Vaccination Prior to Robotic Surgery, HPV-Positive Oropharyngeal Cancer, I would hope the new one would involve a CI or, maybe better, a CI, chemo and AXAL. Seems to be the way of the future. The Ken and Molly Show takes stage next week. Let's make a deal!