We don't know if they have enough information and deals take time. They may want to follow the trial longer. Based on the CP slide, the combo trial clearly trounces the monotherapy arm, based on that current information.

They are not the swiftest at updating that site. No mention of partial hold.

"...Merck has not stepped up to strike anything with ADXS."

As of yet.

I would think AXAL would be a good treatment to combine with Keytruda instead of shelving it assuming Merck wants to make a deal.

Thanks, James. I have a pretty good feeling about the PSA data, based on the CP slide. I know it's a small sample size but hope it's enough to interest Merck.

So, where are those "expected" multiple catalysts for this quarter?

PROGRAM ANTICIPATED MILESTONES TARGET

ADXS-HPV (axalimogene filolisbac)
•Announce planned Investigator Sponsored Trial in Head and Neck Cancer Q1 2019

ADXS-PSA
•Metastatic Prostate Ph1/2 Combination with pembrolizumab--Part B Monotherapy Combination Therapy Data (12-mo PFS and OS) Q1 2019

ADXS-NEO
•Data from initial clinical cohort (safety, immune response)Q1 2019

WISHLIST
FDA approves mod to SPA AIM2CERV and releases partial hold

This should be mandatory viewing for all here. Dr. Mason should get The Nobel Pooch Prize!

Not so, "Combined Worldwide Estimated Market Opportunity of ~$500M"

dawson, I am sorry to hear that and I wish you the best.

There was mention, in an article (link below), that a study like this was being planned and they had gotten quite a bit of funding. Looks like it got off the ground.

https://www.americanveterinarian.com/news/canine-osteosarcoma-vaccine-awarded-huge-grant-for-new-clinical-trial

Found this on Aratana's website. Google dated it 2/4/2019. Excuse the ring if this was already posted.

"Therapy Dog Provides Greater Service: Helping Define Osteosarcoma Treatment

Denali, a therapy dog, inspires patients in hospitals, but is also an inspiration himself. Diagnosed with osteosarcoma, Denali is part of an ongoing clinical study using the ADXS-cHER2 immunotherapy (AT-014). The study is being conducted at the University Of Pennsylvania School Of Veterinary Medicine by Dr. Nicola Mason. Watch the news story from the CBS affiliate in New York City.

The current standard of care for dogs with osteosarcoma is amputation of the affected leg followed with chemotherapy. Some dogs are not good candidates for limb amputation, however, and these dogs are treated with palliative radiation therapy, which helps to reduce the pain associated with the tumor. Denali is participating in a study that examines whether the addition of ADXS-cHER2 immunotherapy to radiation therapy helps to prolong survival of these dogs. This study is currently enrolling participants.

An earlier clinical study examined ADXS-cHER2 immunotherapy (AT-014) in 21 client-owned dogs with osteosarcoma. In this study, dogs were treated with ADXS-cHER2 immunotherapy after the standard of care (amputation and follow up chemotherapy). So far, there has been a statistically significant prolonged overall survival benefit (p = 0.003) compared with dogs that received standard of care without ADXS-cHER2. The median survival time for dogs that did not receive ADXS-cHER2 immunotherapy was eight months, whereas the median survival time for those dogs treated with ADXS-cHER2 has not yet been reached. There were no short- or long-term complications associated with the immunotherapy and only low-grade, transient toxicities were reported in the study"

FWIW, I found this on the Global BioPharma website. The bolded parts here are also in bold on the website:

Lung Caner (sic)
"In China, Taiwan and around the world, lung cancer deaths are the main reason. At present, China is the world's first lung power, if not effectively controlled, lung cancer patients in China is expected to reach one million in 2025. Since China and Taiwan lung cancer patients are HPV (+) ratio is relatively higher than other countries. GBP will be a priority in this year's independent development ADXS-HPV vaccine to treat HPV (+) patients with lung cancer."

Cervical Cancer
"Cervical cancer is the second most common cancer, only next to breast cancer, of women. Asian race each year with the number of cervical cancer is much greater than in Western World. At present, in addition to radiotherapy, outside the surgery, is the traditional chemotherapy. ADXS-HPV vaccine may be found in patients with advanced providing effective immunotherapy. GBP and Advaxis plans to execute the multi-center treatment of cervical cancer advanced Phase III clinical trials in 2014. GBP will continue to develop in Asia with Advaxis ADXS-HPV vaccine to treat head and neck cancer, anal cancer."

And have you a link to this data?

I consider any treatment that more than doubles OS time to be outstanding. "Canines vaccinated with ADXS31-164 had a median survival time of 956 days, and 56% were still alive three years after chemotherapy, compared to a historical control of 423 days and 22%, respectively [84]." This can't be spun in any other way other than to say it was a success. Yet, here we sit sub-dollar land. That is what boggles my mind. And, yes, there are some very sane people here.

Dr. Mason rocks!

I think canine gets full approval and PSA is good or better.

I think they can do it anytime but I would ask someone else to weigh on that. If they do decide to go forward with it, I hope they wait for some good news first.

Well, supposedly, a few things coming this month.

I've got about 6 years and I feel your pain.

There's also the possibility of the FDA being on-board with the modification of the SPA for AIM2CERV. That, coupled with good or better than ADXS-PSA data, and we may find ourselves over a dollar.

Supposedly, Q1 for ADXS-PSA, ADXS-NEO and start of the IST in H&N. HOT data by end of Q2. I still like the look of the PSA trial so far (slide 15) on the CP. Part A: N=12, Events=9, Median=7.79. Combo Part B (both PSA drop of <50%/>50%): N=36, Events=7, Median=NR. Broken down, the >50% is better.

I believe they said there had been interest, by party or parties unknown, in NEO before Amgen signed on. Perhaps there is a deal in the works with some upfront cash. I certainly agree with your timeline to do something.

mmiller@lhai.com is still listed.

http://app.quotemedia.com/data/downloadFiling?ref=12749015&type=HTML&symbol=ADXS&companyName=Advaxis+Inc.&formType=8-K&formDescription=Report+of+unscheduled+material+events+or+corporate+changes.&dateFiled=2019-03-01

If it gets full approval, it's worth the wait. I think it also may trigger a milestone payment, if memory serves.

It's about the time they should be winding down their extended field study. Maybe we'll hear they submitted for full approval.

Gregory T. Mayes appointed to the BOD of AVEO Oncology. If you recall Greg left Advaxis and founded Engage Therapeutics.

Number 3 is also my pick. Again, these are just things I just THINK could happen, not predictions.

With much talk of an impending R/S and dilution, which could very well happen at any time, here is what I think MAY happen between now and the end of the quarter.

1) The FDA approves a second interim look into AIM2CERV. Nothing should be taken for granted, though. The FDA works in strange and mysterious ways.
2) The investigator sponsored trial in head and neck cancer gets under way.
3) The data from the combo prostate trial is good or better. Looking at the slide 15, it would appear Part B of the combo trial MAY beat the median of Part A. As Hov pointed out to me it is a small sample size but looks encouraging. Will it look good enough for Merck to take a position? That remains to be seen but I would think that Merck would want to acquire anything that would increase the efficacy of pembro.
$) Preliminary data for NEO looks good. I think this is a wildcard as the trial is not that far along. We'll see.

These are in no way predictions but reflects the Q1 catalysts reflected on the CP. Advaxis is notorious for missing timelines so I wouldn't be surprised if one or more are pushed out. Could any or all of these forestall the R/S? Who knows.

It was withdrawn, I believe. as the EMA (or the company felt) would not approve it as is and requested more info. That's the short answer. I'm sure more can elaborate.

Thanks, hov. Much appreciated. I suppose the <50% drop in the Part B is encouraging, also. Still a small number (29) but, again, median has not reached. I'm hoping the correlative biomarker analysis will shed light on who might best respond to the treatment. Supposedly we'll know this quarter but met timelines are hit and miss with Advaxis.

Hov, on the CP (slide 15), the median for the Part A ADXS-PSA (PSA drop <50%) is 7.79 months. Part B (PSA drop <50%) is approx. at 14 months, without having reached the median and Part B (PSA drop >50%) is approx. at 11 - 12 months without having reached the median and has had no events, at least at the time this slide was prepared. I would assume that, with no events so far in the Part B (PSA drop >50%), the median for this group could easily be double the Part A? I'm sure the answer is more complicated than I think it is but I'm always interested in your views.

Looks like Keytruda may be a good fit for the HOT NSCLC trial...

https://immuno-oncologynews.com/2019/02/19/european-panel-favors-keytruda-chemo-combo-therapy-nsclc/?utm_source=IO+News&utm_campaign=4355e9138c-RSS_WEEKLY_EMAIL_CAMPAIGN_US&utm_medium=email&utm_term=0_f04c303b86-4355e9138c-72345901

http://app.quotemedia.com/data/downloadFiling?ref=12728869&type=HTML&symbol=ADXS&companyName=Advaxis+Inc.&formType=8-K&formDescription=Report+of+unscheduled+material+events+or+corporate+changes.&dateFiled=2019-02-22

I'm on the side of Ig, Hov and others who believe Amgen bailing was not due to the science. We may all be proven wrong at the end (things happen) but for now, I look at the CR's that have prolonged life with a better quality of being. Certainly the anal cancer trial was a success and, even if used as an adjuvant, AXAL is of value. Slide 15 on the CP tells me SOMETHING appears to be improving OS in the combo trial. And there just wasn't enough data either way (IMO) to definitively prove NEO was effective or not. I think the cost of production was listed as a mitigating factor as well as Amgen moving in a different direction.

I certainly like the odds of having more targets. If we see the FDA is on-board with the SPA mod and the prostate data is good (slide 15 on the CP looks interesting), we may get to a dollar but I'm curtailing my normal optimism as this is, well, Advaxis.

I agree with your comment on MINE being profitable if the same company takes both. I think 80% response rate is a little too optimistic (depending on the stage of cancer). We have achieved CR's in some patients and I certainly hope we see more with NEO/HOT. I'm very curious to see the updated prostate data due this quarter.

None were for futility. Enrollment problems, yes but not for a failure of the science.

The decision of KB saying they may shelve AXAL, no doubt pissing off Stendhal (no one saw that coming at Advaxis?), and then saying they're going forward was a fiasco, IMO. Trying to modify the SPA to get another interim look seems a good decision.