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I think the company is closely watching this data. CI's have not shown much, if any, activity in prostate cancer. If the combo proves effective, I suspect we'll see some kind of deal and a good one at that.
That must be why Amgen pulled out of the NEO deal. Oh...wait...they didn't...
I agree Raja. I don't blame Tony for the sins of Dan. I want him to put his stamp on the company and moves us forward asap.
You have no clue as to whether or not Advaxis has received any buyout offers so it's your opinion.
Wow, that article was quite a read!
If you're familiar with the GOG study, OS hadn't exceeded 30%. I don't know if they have or have not applied for AA but you could always direct that to IR.
As for $30, I'd love to have the option of getting that.
GOG PII: "Among 18 (69%) patients who received all 3 per-protocol doses, median OS exceeded 1 year (12.1 months) and 12-month survival was 55.6%"
Nothing would surprise me with the way this stock is manipulated. Your hypothesis is as valid as anyone's. Now, we wait and see what happens as the year moves forward. I would love to see Advaxis going for accelerated approval for as many indications as possible. The FDA seems more receptive to granting them.
My recollection of talking with her is they met with all the big tutes and reiterated that the science was sound and there were no reasons for the selling that the knew of. Obviously, the company has no say as to who sells and it sounded to me as though they were reassuring the tutes that, despite the changes, the company was still on track. Now, it's time to add a great CMO.
Steven?
Not sure what day the portal is open but sure would like to see a deal announced.
I have ADXS. It's been a roller-coaster ride over five years but I think 2018 will be the defining year. The science is sound. The clinical hold, the shorting and missteps by management all contributed to where we are now but, once the MAA is filed, we could turn the corner.
fbg, we've all taken a hit on this stock, but I believe we could see north of $30, just maybe not as soon as we thought. We have a (conditionally) approved product. Just to get that seemed a major hurdle but we did it. If the company aggressively pursues a BTD or an AA, that could certainly help. The collaboration with Sellas looks good but will take time to bear fruit. If the MAA is submitted on that one day in January that the portal is open, that could get us off to a good start. Announcing a (good) partnership at that time would be most welcome. Combo prostate data is coming and, if really good, we're off to the races.
The clinical hold, shorting and, yes, missteps caused by the company have brought us here but here, I believe, we will not stay. 2018 will make or break us. As for competition, well someone's always going to build a better mouse-trap but there's no reason we can't build it. I try not to be a company cheerleader here but I just see the good that can come from our treatments to help cancer patients and I believe we will see it.
Looking to add a few of this next year to my holdings. Hopefully, one or two may prove to be a winner. The PPS is low and I hope the upside is high.
ATNM, BLRX, CLSN, HTBX, MEIP, ONCS, RNN TPIV
Would like to hear from others who know or hold any of these stocks and your sentiment, bullish or bearish. Thanks in advance and a Happy, Healthy and Prosperous New Year to all!
I saw that. I was sorry to see Greg go. He checked the FB posts on a regular basis.
From a new article by Zach Hartman, "PD-1/PD-L1 antibodies are being combined with everything under the sun, so it wouldn't shock me to see big companies like Roche or Bristol-Myers Squibb (NYSE:BMY) scoop up a current partner if they demonstrate something promising."
I expect some smaller oncology companies will be scooped up in the coming year. Link below.
https://seekingalpha.com/article/4133976-zach-hartman-phd-positions-2018-oncology-immunotherapy-focus?app=1&uprof=45&isDirectRoadblock=false
For anal cancer, it may work better in the adjuvant setting. In the Brown University study, the patients who completed treatment all achieved a CR. Historical 3-year recurrence rate in similar patient populations is ~45%. I believe the SOC works well for these patients but this is still impressive. Would be nice to see an update of how these patients are doing now.
The way conditions are now at the FDA, they seem more open to approve oncology drugs faster. I did ask IR about going for conditional approval and they said they are looking at all avenues open to them. Maybe after submitting the EU application, they'll consider going for it here, too. I think Biocon should try for India approval again, also.
The reason the anal cancer trial was cancelled is, that due to the very small market size for Anal cancer, the company is not going to use internal funding for anal cancer. Instead they are looking for a partner to fund this study.
If you have any concerns, you should contact IR.
Thanks, I think I remember now it being talked about in the Q&A segment of the last call.
Thank you for that link, Dew. I also found this interesting: "In the study on which Hacohen and Wu collaborated, six people with melanoma received vaccines containing as many as 20 neoantigens each. Four of the patients were cancer-free two and a half years later. The tumours also disappeared in the other two patients, but only after treatment with a checkpoint inhibitor.
The other 2017 study, led by Ugur Sahin at Johannes Gutenberg University of Mainz in Germany, involved 13 people with melanoma, whose vaccines each contained a mix of 10 neoantigens. Nine of these people were cancer-free after a follow-up period of 12–23 months: eight had been given the vaccine alone and the other an additional checkpoint inhibitor."
Emphasis added.
And for those who didn't look at the slides on the corporate presentation, it explains why we are targeting Colon Cancer,
Metastatic Squamous Histology Head and Neck Cancer and Metastatic Non-Small Cell Lung Cancer for Neo.
You said, "Lm may not work beyond cervical and even that data hasn’t been YET properly done for approval thus the phase iii." I don't see how this refers to just the anal trial. but okay...
So, the treatment that more than doubled the median survival of dogs with osteosarcoma (Median survival time was 956 days compared to 423 days for a historical control group (p<0.05). from Aratana PR) is bull? Wow, thanks for letting me know. I thought it worked!
Even better!
Dawson, I think it's to Tony's credit that he realized there needed to be some cuts in spending. Anyone who tries to paint a nefarious picture of hiding trial failures is off the mark. HER2, shelved or not, had stellar results in the canine trial. Only an idiot would argue otherwise. I'll still give him some time to try and get a good deal for HER2 or another construct.
Thanks, and now I remember reading earlier that the anal cancer trials were no longer being funded internally but could proceed with a partner, so that is the reason they are not going forward with them at this time.
Unless you look in the rear...
All you had to do is read the 10K: "The Company has decided not to initiate the Stage 2 portion of the trial in order to focus its resources on other clinical priorities at this time. We will continue to evaluate alternative funding sources and collaborations to further develop this program. Axalimogene filolisbac has received FDA and EMA orphan drug designation for anal cancer."
So if you call trying to save precious dollars as hiding failures, then you would be correct.
"Eight of the 9 patients (89%) are progression-free at a median follow-up of 42 months. These data were accepted and published in the International Journal of Radiation Oncology." I like that part.
Sorry, on the road so can't do much research but I think the PI trial was the Brown study, "This non-randomized, open-label, multi-center study will evaluate the safety and effectiveness of ADXS-HPV when combined with standard chemotherapy and radiation treatment for anal cancer. The primary objectives of the trial include the evaluation of adverse events and the evaluation of 6-month clinical response."
•11 patients enrolled; continuing to track 9 patients who completed
treatment and achieved complete responses
•No further enrollment given Phase 3 study plans
Then came the FAWCETT study, "The multi-center, open-label, two-stage study is designed to evaluate the efficacy and safety of AXAL as a monotherapy in patients with HPV-associated metastatic anal cancer who have received at least one prior treatment regimen for the advanced disease. Stage 1 of the trial will enroll 31 patients with anal cancer whose disease recurred after receiving treatment. Patients will receive AXAL 1x109 colony forming unit (CFU) doses every three weeks for up to two years."
I can't seem t find the FAWCETT trial in the clinicaltrial.gov page but I think both PI and PII trials were not recruiting anymore as a PIII was being planned. Please correct me if I'm wrong.
So a 28% control rate is considered a bust? That's not too bad for metastatic cancer, I think.
2017 Financial results...
https://ir.advaxis.com/press-releases/detail/1287
I couldn't agree more with your agreeable post.
In total agreement with you.
We are double the average volume of 800,192, per Yahoo finance, with two hours to go.
Well, Aratana got the expected conditional approval. The GOG has provided the needed info that delayed the EMA (final?) submission. The application should be submitted Q1 (I'm guessing January). New IND(S) and trial(s) will start. Although my thinking may be too simplistic perhaps the shorts realize they had better cover before the real news starts and continues. IMHO.
Just hit $3.50. Let's see where she ends up.
Oddly, PETX up only a few pennies on low volume.