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Since we haven't received (and probably will not) an enrollment update on NEO anyone have a guesstimate on where they are. First dosing was announced in June. There are three cohorts of three patients each for three indications with a staggering of dosing by at least four weeks for the first cohort (safety protocol?). So is it reasonable that all three should be dosed in the first cohort? And how hard could it possibly be to send out a blurb that dosing is proceeding as expected unless Amgen has a qualm with that.
Actually, your post is not a rant. You raise questions that most of us would like to have answered. Status of AXAL, PSA update, plan for paying the HOT trial(s), enrollment updates, status of old partnerships. I would love to hear any updates on these. I don't believe Ken is lying when he says we're in discussions with multiple parties for HOT but it sure doesn't seem like any progress is being made. I know deals take time but someone has to have some interest in us.
"Chairperson and Managing Director of Biocon, Kiran Mazumdar-Shaw said, “Biocon is committed to finding solutions for women’s health issues. This partnership will enable us to develop ADXS–HPV a novel immunotherapy to combat cervical cancer in women. It is a promising technology that has the ability to suppress the tumor inside the micro-environment, and can be leveraged for developing several other novel therapeutics to address various unmet medical needs of patients in India and other emerging markets.”
I don't see any other mention of AXAL on the Biocon website. For all we know, the "partnership" could have been dropped or dissolved and no one told. Other than the initial filing to get AXAL approved in India (denied), I don't see anything else being done.
Advaxis and Merck could start a PIII for prostate with NEO, HOT and/or a CI. The more targets, the more effective the trial could be. Identifying biomarkers may help determine who could be helped the most ensuring a better chance of success. I'd like to see a PII designed as a registrational trial to save time and money, hopefully with the minimal number of patients acceptable to the FDA.
Too much money has been wasted and I hope it's not too late to turn this company around.
NEO data, if good to great, should increase the value of a HOT deal but no reason a smaller deal couldn't be struck now to get adequate funding without further dilution.
No, I doubt it will help anything but I wouldn't say the science has shown no benefit.
No, I think payments to Advaxis will be minimum. Based on the verbiage below, I doubt we'll see any money soon though we may see some commercial milestones.
"Under the agreement, Aratana made a one-time upfront payment to Advaxis of $1 million and an additional $1.5 million equity investment in Advaxis common stock and warrants. Aratana agreed to pay up to an additional $6 million in clinical and regulatory milestones for each of the four products, assuming approvals in both cats and dogs in both United States and the European Union. In addition, Aratana agreed to pay up to $28.5 million in commercial milestones. Upon regulatory approval and commercialization of the immunotherapies, Aratana agreed to pay Advaxis a tiered royalty ranging from mid-single digit to 10% on net sales."
Umm...the canine osteosarcoma vaccine more than doubled the OS of dogs in the trial. I would call that a benefit. It has conditional approval and, hopefully, full approval soon. If you don't believe the GOG results, which was proof of efficacy to me, you may want to watch some of the videos available from patients who believe AXAL contributed to their survival.
I also expected an update on the call. How much of a limited time-frame did he mean. 3 months? 6 months?
I'm inclined to agree with you about the silence. I think some here believe AXAL, in total, is being shelved. I know the head and neck cancer portion is being pursued either externally or internally. There is competition out there to treat HPV associated H&N cancer so Berlin, I hope, steps up the game. An investigator sponsored trial is due to be announced this quarter, also.
Full approval for canines will come before any approval for people. While not an ideal situation, it will, validate the science once and for all (IMHO). That's one small step for man, one giant leap for dogkind.
Not to mention, we have heard NOTHING on their early "partnerships" Biocon, Knight, etc. for a long, long time.
AZ is still mentioned on slide 4 and both AZ and BMY are mentioned on the website, so who knows what's really going on.
https://www.advaxis.com/partners-2/?pagelink=clincialpartners
https://ir.advaxis.com/press-release/business-development/advaxis-and-bristol-myers-squibb-announce-clinical-collaboration
I think you are right about another trial involving a CI, also.
https://www.precisionvaccinations.com/isa-pharmaceuticals-vaccine-isa101-combined-bms-nivolumab-demonstrated-safety-and-efficacy-resulting?s=en&utm_source=newsletter&utm_campaign=pv-consumer-general&utm_medium=email&utm_content=[%20_currentdayname]
HPV-16 is one of the targets of AXAL. Advaxis was going to combine it with nivolumad as ADXS-DUAL. That could have been our name in that article. Another missed opportunity?
New job opening. This may be a re-listing of a previously listed position.
Scientist - Process Development
Job Locations US-Princeton
Posted Date 5 minutes ago(9/28/2018 12:14 PM)
ID
2018-1129
# of Openings
1
Category
Biotech/Pharmaceuticals
Overview
Advaxis is a growing clinical-stage biotechnology company developing cancer immunotherapies based on its proprietary platform that redirects the immune system to identify and destroy cancer cells.
We are seeking an individual with technical experience in process development and process analytical development of biotechnology products. This individual will provide perform experiments for the design of the manufacturing processes, technology transfer, process validation, and new product commercialization. This individual will also support the ongoing development and GLP/GMP manufacturing/testing activities.
Of course, anything can happen but it would come as a surprise to me if, after having best ever GOG results, the data was bad. Again, what you outlined could be a possibility.
It should be over soon, though.
According to this HER2 was started, has 12 patients and estimated primary completion was in August.
https://clinicaltrials.gov/ct2/show/NCT02386501?term=advaxis&rank=5
I would hope not.
"Setting an eligibility criteria for AXAL treatment of AA T <3.5 may increase 12 month survival from 38% to 49% and median survival from 6.2 months to 10.3 months in advanced cervical cancer".
Now, imagine using that criteria combined with a CI and/or HOT or NEO.
H&N is set to be an investigator sponsored trial, announced 4th quarter. Don't know if it will happen but it's on the CP.
Hear from a satisfied customer.
https://www.advaxis.com/wp-content/uploads/2018/08/Corporate-Presentation-September-2018.pdf
abuhafsa, thank you for taking the time to post your email conversation with Ranja. I've tried with no success to reach her by phone, glad you reached her by email and got a response.
Hov, with the albeit early data for PSA combo, median OS had not been reached in the combination arm after 13 months of follow-up and was 7.79 months in the monotherapy arm, wouldn't seem to be in Merck's interest to strike a deal now? It seems the almost doubling of median OS is pretty damn good.
AXAL can be combined with different therapies and could still retain value as an adjuvant.
I remember him well. R.I.P., Terry.
Apparently nobody knows how to access the call. Do you have that information?
Well, at least they didn't report any truly terrible news.
From the 10-Q, regarding ADXS-PSA. I'd say it's positive:
? Median overall survival had not been reached in the combination arm after 13 months of follow-up (95%CI 7.16-NR), and was 7.79 months (95%CI 3.52-11.9) in the monotherapy arm.
? 56.8% of patients on combination therapy and 38.5% of patients on monotherapy did not experience disease progression.
? The percentage of patients with PSA declines from baseline in the combination therapy arm was 40.5%, and 15.4% in the monotherapy arm.
? In all treated patients, an improvement in survival was observed in patients with PSA declines from baseline of 50% or greater vs. those with PSA declines of less than 50%. There were 7 (18%) patients in the combination arm with 50% or greater declines in PSA from baseline, and none in the monotherapy arm.
Third quarter results out. Didn't see a mention of a CC, though.
https://ir.advaxis.com/press-release/financial-news/advaxis-reports-fiscal-2018-third-quarter-business-highlights-and
Called Ranja's # to ask about the CC supposedly tomorrow. Got her mailbox which, of course, was full. A lot of fans must be calling.
So, how involved is our new CFO in these efforts to secure funding?
" In her over twenty years of financial experience, Ms. Henderson brings to Advaxis a demonstrated set of skills that includes operational efficiency, fund raising, M&A evaluation, investor relations, accounting and financial controls."
Well said.
I hope we get an update on enrollment in the NEO trial. I believe three months could allow enough time to see some results. I don't know that they'd PR the data for one patient, even with a CR but who knows.
There's probably other deals I didn't find, too. It's sad, that with all those agreements, we are where we are. What wasted time, opportunity and money. At least Aratana, received a conditional (maybe full, soon) approval.
I seem to be known here by my unbridled optimism for our success. That's fallen by the wayside. I had great hopes (maybe I have a little hope left) that we would all reap the rewards of the company that could make cancer as manageable as a chronic disease. This has been one disappointment after another. Still holding but my expectations are now practically zilch. I'm a big enough person to admit when I've been wrong. But, it ain't over till it's over.