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ADAP (Adaptimmune): We are blowing the whistle to the FDA on this suspicious

patient death (PT: $1)


Part 1 in a Multipart Series on ADAP (SHORT) by Art Doyle

In memory of a truly brave patient (M) who died trying to advance the cause of fighting cancer. He
posted this photo the day he received his Adaptimmune experimental MAGE-A10 TCR cells. He was put
on life support two weeks later and died less than two weeks after that. Adaptimmune management
claims his death has nothing to do with the treatment. Art vehemently disagrees and so should you.

Note: Art intends to protect the identity of this patient and his family. His posts are/were public as
he was an outspoken warrior in his battle with cancer. The death itself has been written about
publicly here. The proof of identity of this patient has been submitted to the FDA.

Summary of this Report


1. Adaptimmunes solid tumor TCR programs are a disaster and they know it.
2. Adaptimmune is already reeling from patient deaths in its MAGE program and
knows it cant sustain another hit.
3. Adaptimmune investors might forget that the conditioning regimen for ADAP
TCRs now contains FLU (fludarabine) again.
4. The patients own published data will show his health and regimen leading up to
and through the Adaptimmune trial, shutting down managements attempts to
claim this had NOTHING TO DO WITH THE TREATMENT.
5. Art has initiated formal whistleblower proceedings with the FDA against
Adaptimmune through the Division of Communication and Consumer Affairs for
CBER (FDAs Center for Biologics Evaluation & Research).

ADAPTIMMUNE MANAGEMENT MUST BE HELD ACCOUNTABLE FOR


DISREGARDING THE OBVIOUS SAFETY ISSUES PRESENTED IN THEIR TRIALS
JUST TO AVOID ANOTHER CLINICAL HOLD.
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Art really doesnt like his job sometimes. He is very certain that Adaptimmunes (ADAP) solid
tumor TCR programs are complete garbage and will never work. Single antigen solid tumor T-
cell therapy is just plain stupid. It is like trying to destroy a mountain with a ball peen hammer.
Good luck. So when he heard there were some problems on an Adaptimmune trial, he looked
up from his 500 bottlecaps jigsaw puzzle he had been saving for the holidays and figured that
the dang things just didnt work. Because they wont in the long run and Adaptimmune
management knows it. Which is why they are SLOOOOOOOWWWW playing everything after
NY-ESO (which also doesnt really work but who really cares). However, what they have
appeared to do in their MAGE-A10 trial is truly atrocious. They appear to have simply stepped
over a highly suspicious patient death of a young father of three and said NOT RELATED TO
TREATMENT. This, despite overwhelming evidence that it is at least POSSIBLY related to
treatment. Did they tell you about this death? No, a reporter did. So herein Art will do what
Adaptimmune refuses to do and provide the FDA and investors with the information they need
to make an informed decision about this patient death. As Art says earlier, he is protecting the
identity of this patient despite the fact that they have posted everything publicly. Here is all
you need to know:
Timeline Summary (again, all information obtained from publicly available sources):
1) Late September/Early October 2017: Patient M undergoes leukaphereis at a major
cancer center in the southern US
2) Early October 2017: Patient M undergoes lymphodepletion at same center
3) October 17, 2017: Patient M receives infusion of engineered Adaptimmune MAGE-A10
TCRs.
4) October 27, 2017: Patient M is discharged home
5) October 28, 2017: Patient M is rushed to the hospital via ambulance
6) October 29, 2017: Patient M is admitted to the ICU and put on life support including
ventilator
7) November 13, 2017: Patient M dies, having never been taken off life support

- Adaptimmune has two huge reasons to be scared of deaths in this MAGE-A10 TCR trial:
o Their MAGE-A3 TCR trial was involved in two patient deaths related to unexpected
cardiovascular toxicity back in 2011 and 2012.
Cross reactivity (off target effects) is a MAJOR risk factor for solid tumor
T cell therapy. This isnt CD19this is real war. If you hit a healthy cell
with the T cell therapy you are SCREWED. And these Adaptimmune MAGE-
A3 patients were SCREWED.
Art believes that Adaptimmune is so blinded by crossreactivity findings in
this safety study that they are missing out on the other HUGE ISSUE
o The conditioning regimen for the Adaptimmune MAGE-A10 TCR trial is now
enhanced with the great taste of FLU (fludarabine)!!!
This change to add FLU to the conditioning regimen was made to their
protocol on April 4, 2017just a few months before M enrolled:
Why would they do this? Well, because Adaptimmune management
learned that their product doesnt work pretty much at all without it in
another trial (NY-ESO). Recall that Adaptimmune tried to take FLU away
for the NY-ESO program due to the safety concerns raised in the Juno trials,
but had to add it back in when it turns out they needed it to get ANY
efficacy at all (and we dont see much as far as lasting, life changing efficacy
for NY-ESO).
Why does that matter? Well, FLU has a lot of issues and neurotoxicity isnt
the only one. REPEAT AFTER ART: FLUDARABINE CAUSES DIRECT
PULMONARY TOXICITY. Here is one of MANY references. LET ART JUST
GOOGLE IT FOR YOU. So you are going to tell me that you believe
Adaptimmune and their investigators when they tell you that the
treatment had NOTHING TO DO with the patient being put on life support
shortly after he received his treatment. Adaptimmune gives lung cancer
patients FLU and they end up on a ventilator. When asked if this regimen
IN ANY WAY could have led to this outcome, they say NOPE!
- Oh, and one more thing: CYCLOPHOSPHAMIDE ALSO CAUSES LUNG TOXICITY!!!
o Cyclophosphamide is the other agent in the lymphodepleting regimen. It is a
chemo agent with well known lung toxicity. Here is what they tell doctors about
it in a popular decision support tool.
o Wonder if the conditioning regimen took a toll on Patient M? Remember him
from our cover photo? Here is a photo he posted just ONE WEEK after the one on
the cover (YES THAT IS THE SAME GUY!):
o Art failed out of medical school, but Id say that his condition is deteriorating
rapidly. But as Adaptimmune would say, it has nothing to do with the treatment!
- Dont believe what the PIs are telling youthey have NO IDEA WHAT THEY ARE DOING.
o In one of his posts, the patient notes (emphasis and redaction mine): [T]hey
have done around 20 CAR T's on Leukemia patients at [redacted] so far and know
what to look for... but are still very vague since this is their first solid tumor trial.
o The inclusion criteria for this trial includes the following:
ECOG Performance Status 0-1 and anticipated life expectancy >3
months.
o The patient was put on life support less than two weeks after getting his T cell
therapy.
o Bottom line: ask yourself if this particular patient would have died on THIS
PARTICULAR DAY in November if they never met Adaptimmune or their
investigators. Art doesnt see how you can say with a straight face how you could
say that the trial wasnt the cause of this persons death in some direct way, shape
or form.

Either the PI doesnt know how to assess a patient properly for their own
inclusion criteria OR they dont know how to properly assess a patient death for
causality. Because this did NOT look like a guy who was supposed to be on life
support 12 days after getting his treatment.
ADAPTIMMUNE AND THE PI CANT HAVE IT BOTH WAYS!!!

- Lets let the patients own posts speak for themselves. This is what the patient posted
about their health and regimen on a public page prior to joining the trial:
o So what we see here is a guy who had a fairly standard chemo regimen that
appears to have been designed AROUND (not THROUGH) his compromised lungs.
o He was able to walk three miles a day.
o He was deemed by the PI of the Adaptimmune trial to be ECOG 0-1 and to have a
life expectancy greater than three months. This all makes perfect sense given
everything we know about this brave father of three.
o And yet, he died within a month of receiving his Adaptimnune T cell therapy. And
the company claims that the trial had NOTHING TO DO with his death.
- Art has formally blown the whistle to the FDA on Adaptimmune management regarding
what he believes to be an egregious coverup of a highly suspicious patient death. He
believes the company is doing this solely to protect their own interests and are not
providing sufficient communication to patients and shareholders. Here is the mechanism
under which he has filed a complaint and provided the FDA with the sufficient information
they need to hold the company accountable:
Arts summary of the situation:
- Adaptimmune is fumbling its way through what is sure to be failed single antigen solid
tumor T cell therapy programs.
- They have had some major safety issues in the past and are highly defensive about
anything that would appear to be a new safety issue.
- A patient has died under some highly unusual circumstances which appear to be in some
way directly related to the clinical trial that was conducted by Adaptimmuneeither it
was the therapy itself or the conditioning regimen but this person was put on life support
rather suddenly and in direct contrast with the inclusion criteria.
- Rather than communicate this information with shareholders and the FDA, Adaptimmune
management is hiding behind a safety committee which they claim has ruled the death
unrelated to the treatment. This completely flies in the face of reason and common
sense. The patient was given two drugs with known pulmonary toxicity. A previous
version of this TCR killed two patients for cardiac toxicity. Any and all deaths (especially
within weeks of treatment) should at the very least be ruled possibly related to
treatment.
o The committee excuse that Adaptimmune is using is BS and the company isnt
required to accept their recommendation especially if it makes no sense. Would
this father of three have died on this particular day were it not for the intervention
of Adaptimmune? Art thinks not and neither should you. And neither will the FDA.
o Art believes the committee is likely protecting the PI and giving them plausible
deniability. This is nonsense. Common sense says that drugs which hurt the lungs
may kill someone with bad lungs.
- Art has blown the whistle to the FDA on Adaptimmune management utilizing the FDAs
Complaint Reporting Program for Biologic Studies. A redacted copy of our letter can be
found at the back of this report.

Investors have flocked to T Cell therapies for promises of CRs (complete


responses)and what has Adaptimmune given you?
What did patient M have? Apparently, he just died of natural causes?!?
There is NO WAY out of this: either their conditioning regimen is dangerous,
their therapy is INERT (NO response), their therapy is dangerous OR ALL OF
THE ABOVE!!!
Meanwhile Adaptimmune management is happy to whistle past the
graveyard