Marker Therapeutics Inc (MRKR)

[bar1080]

Of course MRKR is right back down and on almost no volume, while the broad stock market is doing super well. .

[Buckboard]

Thanks. I am much more optimistic about the company now!

[jobynimble]

Marker Therapeutics Receives Approval from United States Adopted Name (USAN) Council and International Nonproprietary Names (INN) Expert Committee for “Neldaleucel” as Nonproprietary Name for MT-601
January 22, 2024 07:30 ET
| Source: Marker Therapeutics

HOUSTON, Jan. 22, 2024 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors, announced today that the United States Adopted Names (USAN) Council, and the World Health Organization (WHO) International Nonproprietary Names (INN) expert committee has approved “neldaleucel” as the nonproprietary (generic) name for MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell product candidate for the treatment of patients with lymphoma.

The USAN Council in close collaboration with the WHO established INN expert committee select and assign a single unique name of worldwide acceptability for each active substance that is to be marketed as a pharmaceutical, ensuring clear identification, safe prescription and dispensing of medicines to patients. Nonproprietary names are intended for use in pharmacopoeias, labelling, product information, advertising and other promotional material, drug regulation and scientific literature, and as a basis for product names, e.g. for generics. Their use is normally required by national and international legislations. The adoption of the name neldaleucel is a step forward for continued advancements of multiTAA therapies Marker is developing. The Company recently provided a clinical update on the Phase 1 study investigating MT-601 in CAR relapse patients with lymphoma, demonstrating clinical safety and durability in the first study participant, suggesting the clinical benefit of neldaleucel (Press Release, Dec 11, 2023).

“The assignment of the nonproprietary name to MT-601 represents a significant milestone as we advance this potential treatment for patients with lymphoma,” said Juan Vera, M.D., President and CEO of Marker Therapeutics. “The INN and USAN naming process meticulously evaluates proposed drug names for adherence to nomenclature guidelines and potential conflicts, followed by expert consensus and public review. The USAN and WHO INN approval of neldaleucel allows us to establish a universally recognized and conflict-free nonproprietary drug name for MT-601 and represents an important step in our path to ultimately market the drug.”

[jobynimble]

https://www.globenewswire.com/en/news-release/2024/01/22/2812937/0/en/Marker-Therapeutics-Receives-Approval-from-United-States-Adopted-Name-USAN-Council-and-International-Nonproprietary-Names-INN-Expert-Committee-for-Neldaleucel-as-Nonproprietary-Nam.html

[microcapbiotech]

Thank You, I guess that news is better than a sharp stick in the eye.
Now just let it lead to something meaningful and profitable.

[learningcurve2020]

Well, it looks like Mr. Wilson connected with the right company anyway.

[InvestorCpt]

Doesn't seem like Monday premarket PR material.... that they are spending money with no meaningful communicated progress

[jobynimble]

You’re welcome…

[Buckboard]

Thanks

[jobynimble]

8-K filing: https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/1094038/000110465924027293/tm247177d1_8k.htm

ITEM 1.01. ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT

On February 22, 2024, Marker Therapeutics, Inc. (the “Company”) entered into a Master Services Agreement for Product Supply (the “Agreement”) with Cell Ready LLC (“Cell Ready”). Cell Ready, which is owned by one of the Company’s directors and shareholders, Mr. John Wilson, is a contract development and manufacturing organization (CDMO).

Pursuant to the Agreement, the Company may contract with Cell Ready for the provision of various products and services from time to time by entering into work orders with Cell Ready. If the services involve the supply of product, Cell Ready is required to supply such product in conformance with the product requirements set forth in the applicable work order(s). The Agreement contains customary representations, warranties and indemnification provision. The initial term of the Agreement is three years and may be extended upon the mutual written agreement of the parties. Either party may terminate the Agreement (a) for material breach by the other party if such breach has not been cured within 30 days following notice of termination or (b) if the other party is the subject of an insolvency event.

Also on February 22, 2024, the Company entered into Work Order #1 under the Agreement, pursuant to which Cell Ready will provide the Company with GMP drug product for Marker MT-401 and/or MT-601. The services include the delivery of final drug product and quality control testing. The Company also requested Cell Ready to provide general support services in connection therewith. The total projected sum (inclusive of taxes) for the services under Work Order #1 are not anticipated to exceed $750,000. The services will cover the anticipated manufacturing costs for the first quarter of 2024. Additional Work Orders are expected to be generated for the remainder of 2024.

[learningcurve2020]

Looks to be another round of legacy shareholders, I'm afraid.

[ATLdoogie]

LOL, as a Hofstra English major alum fifty years ago the dribble reference has always driven me crazy. Two other common pet peeves of mine.....So many say "It's a hard road to hoe". Yes, I imagine putting a hoe to asphalt would be difficult. The correct saying is "a hard ROW to hoe", as in a row of crops. The other is when a person listens to a good speaker or reads a good post and writes HERE! HERE!........NO! NO!. The correct saying is HEAR! HEAR!, as in listen to this speaker, they have something valuable to say. Anyone else admit to these mistakes for many years?

[microcapbiotech]

A MRKR cancer competitor (but not much) IOVA got an early FDA approval today, good box label, (posted here 2 days ago and before).

[microcapbiotech]

P.S. - after almost 7 decades, you taught me something,
I never knew the word was drivel or seen it spelled out.
I always thought it was dribble. Thanks
P.P.S. I miss all them potato fields and chicken farms from our youth on L.I. (and everything that went with them),
with all of our modern technology, it seems like this world just gets worse and worse, I liked it better when neighbors and people actually cared about each other, and we were allowed to have freedom of speech and our own opinions without cancel culture.

[learningcurve2020]

AlloVir is getting kicked off NASDAQ. I'm surprised they haven't put something together with Marker yet.

[microcapbiotech]

Howdy ATL. GO MRKR - GO METS

[ATLdoogie]

No dribble sir, but lots of drivel.

[bar1080]

This is really ugly especially in a roaring bull market. .



"Doesn't seem like Vera is winning them over"

[microcapbiotech]

I haven't seen any of his posts because I have barchild blocked, but I'm guessing that he is still babbling on with his assinine dribble.

[learningcurve2020]

Doesn't seem like Vera is winning them over.

[AntiMarv]

Go away bar we don’t need your comments on mrkr. We understand this hasn’t worked out. I have excellent returns on all my other mutual funds and stocks. Probably better than you

[microcapbiotech]

MRKR just kind of hanging out here.
10 days left before IOVA date for FDA PDUFA approval.

[bar1080]

How are insiders going to unload at this low volume?

[bar1080]

Compare the dead MRKR with the soaring S&P

[learningcurve2020]

993 at noon. LOL

[learningcurve2020]

71 shares traded. Doesn't even feel like a company anymore.

[bar1080]

Slobbering penny gamblers will ride these bios all the way to zero often averaging down and down. And there have been penny stock suicides.

Buy Quality and Diversify Sensibly © Bar1080

[learningcurve2020]

Five years ago this thing was $80. Can't make it up.

[microcapbiotech]

New T cell therapy for Lymphoma ... clinical trials still a few years away.
https://www.msn.com/en-us/health/other/new-technique-could-make-human-t-cells-100-times-more-potent-at-killing-cancer-cells/ar-BB1hVKbW?ocid=msedgdhp&pc=U531&cvid=7a02c55157864e2ba3eef48328824d64&ei=17

"a gene fusion, CARD11–PIK3R3, found in a CD4 cutaneous T cell lymphoma, that augments CARD11–BCL10–MALT1 complex signalling and anti-tumour efficacy of therapeutic T cells in several immunotherapy-refractory models in an antigen-dependent manner."
https://www.nature.com/articles/s41586-024-07018-7

[microcapbiotech]

ditto

[AntiMarv]

Well I still own and still am keeping the faith. It probably makes sense with our current cash position to just concentrate on lymphoma. I like our six antigen solution. I increased my stake last year. Whatever happened to Marc? Lol

[microcapbiotech]

Here's a new one. Drink milk, cure cancer.
https://www.msn.com/en-us/health/other/calcium-could-be-key-to-cancer-cure-as-scientists-create-ultra-powerful-antitumor-drug/ar-BB1hw5iB?ocid=msedgdhp&pc=U531&cvid=22b3ff3432bf41ad9b257775f23422a3&ei=22

[microcapbiotech]

Thank You. I hope MRKR can report some very positive news soon, with all these new treatments, we don't want to get left in the dust. We have a bit of a head start, lets take advantage of it while we still have it.

[Phantom Lord]

I don't believe that has anything to do with hypomethylating agents that MRKR is going to be using in combination with MT-401. Just one of many studies on new treatments.

[microcapbiotech]

Phantom, Does the following have anything similar to do with the hypomethylating agent that MRKR was doing with MT-401?
Kobayashi and his team discovered a gene named NLRC5 that controls the levels of MHC class I. They also realized that in cancers, this gene gets suppressed when certain molecular switches on DNA are turned off.
This turning off, called DNA methylation, reduces the levels of MHC class I, helping cancer cells hide.
Their new method, TRED-I (Targeted Reactivation and Demethylation for MHC-I), can reverse the DNA methylation of the NLRC5 gene and activate it again.
Doing this increases the levels of MHC class I in cancer cells without causing serious side effects. It's like flipping a switch to make the immune system see and fight against cancer cells more effectively.
https://www.msn.com/en-us/health/other/crispr-just-made-it-easier-for-the-immune-system-to-destroy-cancer/ar-BB1hvBML?ocid=msedgdhp&pc=U531&cvid=e0b4244c642c47efb86149d7bf22b334&ei=33

[Epicare]

FDA Requests Class-Wide Boxed Warning for CAR T-Cell Agents Regarding Secondary T-Cell Malignancy Risk
Jan 25, 2024
By Kyle Doherty

[microcapbiotech]

Negative CAR-T information report:
The FDA has received numerous reports from doctors and researchers linking CAR T to the development of secondary cancers, specifically cancers involving T cells.
The FDA has sent letters to six makers of CAR T products telling them to include a new boxed warning detailing the possible risk in their products’ labeling.
https://www.msn.com/en-us/health/other/groundbreaking-cancer-treatment-may-actually-raise-risk-of-secondary-cancers/ar-BB1hceQt?ocid=msedgdhp&pc=U531&cvid=98b233a6100d4af3b2fdab890a8604f9&ei=48
LET'S GO MULTI-TAA.

[microcapbiotech]

After the recent AML news, and pretty much everything riding on Lymphoma, I think MRKR is a case of ...
hope for the best but prepare for the worst.
But I'll still click on the green bull for now.

[ATLdoogie]

Neldalleucel is a popular boys name in da hood.

[GMA13]

It’s all GIBBERISH! AML is a big disappointment & MRKR is back on tract with more excuses/delays!

[Epicare]

I googled "Nelda-" with the following. I guess it is not bad with something like shining and champion. Well, I hope the dim MRKR is getting shining soon.

Nelda Meaning: Shining light; Torch; Sun ray; Champion; From the alder trees

Nelda is a girl’s name with multiple possible meanings and origins. It may derive from the French name Eleanor of unknown meaning, or the Greek name Helen meaning “torch,” “shining light,” or “sun ray.” Some believe it originated as a feminine form of the Irish name Niall, anglicized as Neil, which is thought to mean “champion.” Alternatively, it may be an Old English name meaning “from the alder trees.” Whichever meaning you prefer, Nelda is a lovely, less common alternative to the charmingly vintage Nell, which has come back in fashion recently.

[Buckboard]

It's a loose translation from the old midwest saying "whatthehelld'dyousay?"

[Epicare]

Neldalleucel? ? What the heck is that? I can understand the latter half "-leucel" for white blood cells with a combination of "leuke + cell). But what do the "nel" and dal" really mean?

[jobynimble]

You’re welcome…

[Buckboard]

Thanks. You're always helpful.

[jobynimble]

💥Breaking News!

The #USAN Council and the #WHO INN expert committee approved “neldaleucel” as the nonproprietary name for MT-601, our #multiTAA product candidate for the treatment of #patients with #lymphoma.

More information: https://t.co/L4WbEPPSBa

#immunotherapy #cancer pic.twitter.com/2C4j3OefA3

— Marker Therapeutics, Inc. (@MRKRTherapeutic) January 22, 2024

[bar1080]

True: "All we can do is hang in_there." Since Jan 1, 2024 selling or lightening up on a disappointing stock is prohibited.

"and all we can do is hang in there, hurry up and wait ... and hope."

[microcapbiotech]

and all we can do is hang in there, hurry up and wait ... and hope.

[Flyingj]

I've been a stock holder in mrkr since it was formED. It's been so long I can't even remember when that was. LOL

[microcapbiotech]

No, It seemed to me that MRKR took a very long time to enroll in AML but that was kind of halted because of Covid. They don't have that excuse anymore and since the Lymphoma trial is open, all I can say is, the sooner the better. I think one problem MRKR has all along for any trials is awareness. If Doctors and patiants don't know about your company or trials, it's hard to sign them up for it. I hate to say this ... but ... how much of this recuiting for trials has to do with both Hospital competition and greed. In other words if MRKR contacts M.D. Anderson or Mayo Clinic and says: "we have this therapy for patients "X", you might want to enroll them in our trial. Will those Hospitals and Doctors recommend that their patients go elsewhere for treatment because they would both no longer be able to charge the Insurance companies for any treatments that they themselves would have given and billed for?? I would hope not, but people are people.