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November 24, 2022 /eMedClub News/-- Marker Therapeutics, a T-cell immunotherapy development company focused on the development of indications for the treatment of hematologic malignancies and solid tumors, announced that The U.
S.
Food and Drug Administration (FDA) has approved the company's IND application
for MT-601 in combination with first-line chemotherapy in patients with locally advanced unresectable or metastatic pancreatic cancer.
.
Previously, the therapy had been granted orphan drug designation by the FDA for the treatment of pancreatic cancer patients
.
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According to Marker's official website, the MultiTAA platform is a non-GMO modified cell therapy technology, unlike CAR-T therapy, the technology does not need to artificially add CAR to T cells, but screens T cells from the patient's blood, selects T cells that recognize a variety of tumor-related antigens, expands them in vitro, and obtains a powerful T cell mixture that can target a variety of cancer cells in a single tumor, and finally infused back into the patient
。
▲MultiTAA platform (Image source: Marker official website)
T cell therapy based on the MultiTAA platform can kill tumors more effectively than single antigen-specific methods, reducing the possibility of
tumor immune escape 。 At the same time, because it does not need to be genetically engineered, Marker Therapeutics believes that its product candidates have the advantages of easier preparation, lower cost, lower toxicity, and no serious adverse effects commonly associated with adoptive cell therapy, such as cytokine release syndrome or neurotoxicity, and can be used in an outpatient setting without hospitalization
.
Currently, Marker Therapeutics has developed multiple product candidates using the MultiTAA platform for hematological and solid tumors
.
Among them, the fastest progress is MT-401, which is currently in the clinical phase II trial stage
.
In February 2022, Marker Therapeutics announced preliminary results from a Phase II clinical trial in which patients treated with MT-401 were well tolerated and no dose-limiting toxicity, cytokine release syndrome, or neurotoxicity were observed; One of these patients had minimal residual lesion (MRD) resolution at week 32 and MT-401 induced epitope spread
on multiple AML-associated antigens.
Top-line readings
for Group 2 active disease are expected in the second quarter of this year.
Meanwhile, Marker Therapeutics is developing MT-401-OTS, a scalable, off-the-shelf product candidate with the potential to successfully match patients to treatment within 3 days, with the potential to be applied to the first patient
in 2023.
Today, Marker is using a new simplified manufacturing process
for the MT-601.
The new manufacturing process, which can be produced in 9 days, marks an important manufacturing improvement
compared to the previous 36- and 20-day manufacturing processes.
At the same time, the new process reduces the number of interventions in the production process by 90%, and the final T cell product is an improvement over the original product in previous trials, which will greatly improve the tumor killing power
of the candidate.
Resources:
1.
marker-therapeutics-announces-fda-clearance-of-ind-for-mt-601-its-six-antigen-t-cell-therapy-for-the-treatment-of-pancreatic-cancer/
2.
https://markertherapeutics.
com/
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On December 1, ICH Q5A revised new biosafety testing strategy
