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While not accounting for possible compassionate use of the combination, that trial was used to determine the preferred formula for DCVax-l in GBM and Grade III Glioma patients. Poly-ICLC is an adjuvant. There is enough safety data on it to fill the library of congress. Nobody other than UCLA has ten year safety data on DCVax-l + poly-iclc. By itself poly-iclc is ineffective against GBM. As an adjuvant with checkpoint inhibitors, poly-iclc is ineffective against GBM. However, with DCVax-l, this adjuvant formula is safe and appears to increase efficacy.
In that small trial, the DCVax-l + Poly-ICLC arm showed:
100% unmethylated GBM (idh wildtype) patients lived over two years. (n = 4)
100% methylated GBM (idh wildtype) patient lived over four years. (n = 1)
100% Grade III brain tumor patients are still alive. (Between eight and twelve years). (n = 4)
https://www.researchsquare.com/article/rs-3287211/v1
Yes, the trial did not power itself for survival, but the results in that arm are nonetheless stunning.
So I’m not certain people realize what’s going on. A few once promising immune approaches
are dropping by the wayside. Gilead’s program, using an antibody targeting a protein (cd47) on both healthy cells (whoops) and cancer cells was discontinued in blood cancers and all solid tumor cancers. Additionally, Standard Car-T therapy against proteins (bcma and cd19) expressed by healthy cells and blood/lymph B cell cancers received a black box (April 18, 224) warning because it can cause multiple other cancers and/or stay in the body, as transgenes, causing other mutations for decades. Similarly, Infiltrating lymphocyte therapy, which first uses chemotherapy to destroy the immune system cells, was halted a few months ago and restarted due to grade 5 adverse reactions. Also, Company after company going after one or a limited subset of cancer antigens are not able to avoid tumor escape. Most of them readily admit this.
The new head of engineering and manufacturing at Advent is not most recently from Roche, he is from Autolous (six years) a Car-T company hit hard by the scientific outcome of Car-T therapy. Through no fault of his own, the Car-T therapy industry is dealing with very serious safety issues.
All of the strategies employed by big pharma above knew going into it that they were risking either safety, tumor escape or both, but economics, intellectual property and/or other hurdles pushed them into questionable or outright poor and very expensive risks/decisions.
Essentially, Gilead’s cd-47 program was shut down by the company due to overwhelming safety concerns. That’s not surprising, the protein they were seeking to block, the “”don’t eat me” molecule, is found on healthy cells throughout the body, not just cancer cells.
* Gilead gives up on $4.9B antibody as solid tumor plan unravels
https://qtx.omeclk.com/portal/wts/ue%5EcmQ6fDTqbb7gFaA2TyqmveE4b6dzMN9fA7fPsTa
April 18, 2024 Car-T FDA Black Box warning now required.
Wormhole.
May 1: Defendant’s new MTD due.
May 6: “Several” month gap from February 6th (or earlier) begins. Time (minimum) from when NWBO assigned contractor to make GMP grade Eden.
May 10: 10q due.
May 24: Estimated 80 + (possible 60 possible rfi) = 140th day since validation. Cemented?
May 31: Plaintiff’s response to MTD due.
Clown. Try looking in the filings before you make accusations.
It’s in the amended 10k asshole. I’m amazed how you make unfounded accusations when you don’t bother to read SEC filings.
I would imagine, and did about a decade ago, that any buyout should be done as a wholly owned subsidiary, and I guessed that any BP would want LP and LG bought out (Upper management), (I didn’t think about Dr. Boynton) but for age purposes it makes sense.
Maybe that’s what’s going to happen.
Pat Sarma owned 12,535,165 shares (1.0%) before he joined the company as director.
Nice to see you don’t know the difference between zero shares and well over twelve million shares. 🥸
Exwannabe said:
Why do you think posting your quotes without comment is a “got ya?”
If any timing games were played, and I’m not saying they were or were not, those games ended when the MAA was filed. One doesn’t f__ around with an MMA under review. Instead, one clearly answers any regulator questions promptly and accurately. That’s it.
FeMike: January 16, 2024
ChatGPT
Legal Short interest is 4.24%. Not exactly cause for concern.
Not true. Instead:
This is from the March 28, 2024 MHRA Newsletter.
Combination trial. DCVax-l + Pembro
Estimated Primary Completion Date :
August 1, 2024
https://classic.clinicaltrials.gov/ct2/show/NCT04201873
Does this mean I’ll need to upgrade my Apple Watch again?🥸
Not true. Instead, the timing of an MAA announcement by the MHRA is dictated by when they complete their assessment.
And, Flaskworks and Advent cooperatively work on advancing Eden.
May is interesting.
May 1: Defendant’s new MTD due.
May 6: “Several” month gap from February 6th (or earlier) begins. Time (minimum) from when NWBO assigned contractor to make GMP grade Eden.
May 10: 10q due.
May 24: Estimated 80 + (possible 60 possible rfi) = 140th day since validation. Cemented?
May 31: Plaintiff’s response to MTD due.
Amazing how fast devices move from patent application to patent allowance. The application date for the duty cycle patent was in October 2022.
I am not ATL.
Three weeks ago was 90 days from (estimated) validation — not 110.
I don’t think the King took DCVax-l. That’s been my position all along, but I was just asking if something had come out about what he was taking. I don’t watch the Royal family every day.
Did the King ever release which therapy he took for his particular form of cancer?
Untrue.
Found this old article interesting.
https://www.medicalnewstoday.com/articles/272092
I didn’t invest in pphm.
Wrong board.
The Plan (PIP) developed by the sponsor must go through a series of stages of regulatory review and comment to reach a final approval by regulators. This process can typically take more than a year.
However, for NWBO it only took half a year.
The trials were allowed to be deferred.
The SAP was not lost in space after it was submitted.
Pretty certain I asked Attila.
When did you last speak with them about their stating they are currently working their tails off to get this approved?
Reasons?
It’s the safest oncology therapy they’ve ever reviewed. IMO.
They’ve had it in the UK for compassionate treatment for a decade.
The Advent facility was recently certified separately for clinical, compassionate and commercial manufacturing using DCVax-l as their example process, and Advent was recertified for HTA on the day NWBO submitted their maa.
MHRA and NICE recently made major strides since Brexit in increasing their efficiency with national reviews, partly because their international recognition program reduced the case load for national reviews, and partly due to new priorities like proportionate review. We are literally in MHRA’s and NICE’s biggest efficiency improvement window in the current year.
NWBO used two editors to prepare their MAA. They spent about a year preparing for maa review inspections by conducting mock inspections with prior UK regulators.
So yeah, there’s a chance it gets done a little early.
Essentially, Gilead’s cd-47 program was shut down by the company due to overwhelming safety concerns. That’s not surprising, the protein they were seeking to block, the “”don’t eat me” molecule, is found on healthy cells throughout the body, not just cancer cells.