CHM (ASX) CLTX-CAR T is a game changer

Originally posted by dalts66: ↑

It is interesting to see that the FDA is willing to give drug approvals, at an early stage of testing, for treatments of conditions where patients have no other choice. This is true even when adverse event rates from the treatment is high. Over the past two years, several Car T drugs have been approved after phase 1 and phase 2 testing.

GBM is one of these conditions. Survival rate is low. "Many factors can affect brain cancer survival rate. Average survival rate is one to two years. There is no cure for brain cancer but there are many treatment options." This statement is copied from a GBM website. Survival rates in younger people (up to 14yrs old 73%) is far better than older people (5% for elderly).

From the CHM prospectus p 22, they state:

"There have been no new glioblastoma drugs
for many years and current drugs only provide
a very short extension of life. Consequently, the
Directors believe that the US FDA would be willing
to consider any glioblastoma drugs showing
even a small survival improvement over existing
treatments."

and

"Due to the severity of
glioblastoma, the Directors
believe that this drug may
qualify for an expedited
approval pathway through
the FDA".

CHM has also developed a new way of administering the CarT (prospectus p25) :

"CLTX-CAR T is also unique in that it constitutes a novel delivery method for the CAR T product.
Approved CAR T therapies, Kymriah®, Tecartus and Yescarta®, are delivered by intravenous
infusion. CLTX-CAR T is being delivered via intracranial intratumoral or intracranial
intraventricular dosing methods.
Glioblastoma is one of the deadliest cancers with a median survival time of 12 to 15 months.
There have been no new glioblastoma drugs for many years and the Directors believe current
drugs only provide a very short extension of life. Consequently the Directors believe that the US
FDA may be willing to consider any glioblastoma drugs showing a small survival improvement
over existing treatments."

So, if CHM can show efficacy and a better than average CR, the approval pathway could be shorter than normal.

Phase 1 testing is primarily a test for safety, and with an increasing dose trial, a test for optimal dose amount. Of the CarT drugs approved so far, Adverse events have been high, due to the drug interaction including, cytokine storm and off target binding. From Prospectus p40:

"COH researchers screened the CLTX peptide on a panel of cells from 23 tumour samples resected from 15
glioblastoma patients. The toxin bound strongly to almost all patient tumours, with more than 80% of the
cells binding CLTX. Only samples from two of the 15 patients revealed binding in less than 40% of total
cells. Similarly, when examining CLTX binding in patient-derived glioblastoma cell lines, the team found
that 21 of 22 cultured cell lines showed greater than 70% binding. In contrast, three other targeting agents
currently being evaluated for CAR T cell therapy, viz. IL13Rα2, EGFRvIII and HER-2, bound less broadly
and less uniformly to cells from the tumour samples and cultured lines demonstrating CLTX’s ability to
address heterogeneity both within and between tumours.
CLTX binding was also demonstrated against the glioblastoma stem-like cells that are thought to seed
tumour recurrence.
One of the potential dangers of CAR T cell therapy is off-target binding, when the CARs cause adverse
effects by killing the wrong cells. To assess the novel CAR’s safety in pre-clinical models, the COH
researchers measured binding in a panel of non-tumour human cells, revealing little to undetectable off-target
recognition.
The findings were verified in mouse models with human tumours where the CAR T cells only targeted
glioblastoma cells, and there were no adverse reactions in the mice when the therapeutic cells were delivered.
The engineered T cells only bound to tumour cells, leaving the surrounding normal brain tissue intact. The
treatment was able to control tumour growth, prolonging the survival of the animals and did not cause
adverse reactions or organ damage in the animals"

A video from 2016 so not using CLTX.

And a video about CLTX

Expand

Great find mate, I hadn't come across that video before. Hopper scooping up all sorts of City of Hope gold in the early stages. I like how CHM is keeping all the research in-house with city of hope, undoubtedly part of the negotiation, meaning the royalties return CHM with clinical progress at each hurdle. Almost feel like CHM is copping a free ride here, to simply hire City of Hope staff, other industry specialists and market a product to either big pharma or fast-way approval pre-phase 2/3.

Phase 1 trials may be traditionally safety trial, but there'll be dosing and effect size data as a result of it too - we'll get an idea if preclinical merit translates to clinical sooner than required, and it's fine tuning from there.

Not expecting resounding material news imminently but price action will definitely say otherwise before then

No.	Vol.	Price($)
6	4612925	0.4¢

No.

Vol.

Price($)

4612925

0.4¢

Price($)	Vol.	No.
0.5¢	18563373	21

Price($)

Vol.

No.

0.5¢

18563373

No.	Vol.	Price($)
6	4612925	0.004
41	27362937	0.003
16	15400505	0.002
12	54600000	0.001
0	0	0.000

No.

Vol.

Price($)

4612925

0.004

27362937

0.003

15400505

0.002

54600000

0.001

0.000

Price($)	Vol.	No.
0.005	18563373	21
0.006	13884684	16
0.007	3100000	2
0.008	8542434	6
0.009	2390797	5

Price($)

Vol.

No.

0.005

18563373

0.006

13884684

0.007

3100000

0.008

8542434

0.009

2390797

(20min delay)
Last 0.4¢		Change 0.000(0.00%)		Mkt cap ! $8.060M

Open	High	Low	Value	Volume
0.4¢	0.5¢	0.4¢	$4.765K	1.178M

CLTX-CAR T is a game changer, page-34

Australia’s gas crisis is here – and dying coal plants aren’t helping

Paradigm adds new oral combo IP to osteoarthritis drug stable with $500K pick-up

Neuren jumps over +11% on patent win for Pitt Hopkins drug treatment

Thursday's HotCopper trends: Paradigm's drug IP buy, MTM placement | June 26

Listen: HotCopper Wire Podcast 015 – Yeah, we're thinking the IPO market is back

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

CLTX-CAR T is a game changer, page-34

Top Stories

Australia’s gas crisis is here – and dying coal plants aren’t helping

Paradigm adds new oral combo IP to osteoarthritis drug stable with $500K pick-up

Neuren jumps over +11% on patent win for Pitt Hopkins drug treatment

Thursday's HotCopper trends: Paradigm's drug IP buy, MTM placement | June 26

Listen: HotCopper Wire Podcast 015 – Yeah, we're thinking the IPO market is back

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News