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Msg  29167 of 30753  at  8/16/2022 4:55:19 PM  by

2abetteryear


TCRT post from Frank on Yahoo board

Yes Yahoo boards tend to be trashy, but a few gems always emerge.

Frank posted yesterday...

Background on delay of trials. Drawing a parallel in timing, it took about five years for the Kite's CRADA (Collaboration and Research Development Agreement) with the NCI to develop the promising science of CAR-T therapy into blood cancers. For Alaunos' CRADA utilizing the NCI's promising science targeting solid cancers ... has already exceeded five years in timing. IMO, The reasons for the lack of progress are three-fold. First is the delay in creating the legal review and approvals for what was first announced in 2017. From their Alaunos 2019 annual report --

On May 28, 2019, we entered into a patent license agreement, or the Patent License, with the National Cancer Institute, or the NCI. Pursuant to the Patent License, we hold an exclusive, worldwide license to certain intellectual property to develop and commercialize patient-derived (autologous), peripheral blood T-cell therapy products engineered by transposon-mediated gene transfer to express TCRs reactive to mutated KRAS, p53 and EGFR neoantigens. In addition, pursuant to the Patent License, we hold an exclusive, worldwide license to certain intellectual property for manufacturing technologies to develop and commercialize autologous, peripheral blood T-cell therapy products engineered by non-viral gene transfer to express TCRs, as well as a non-exclusive, worldwide license to certain additional manufacturing technologies. On January 8, 2020, we amended the Patent License to expand the TCR library licensed from the NCI to include additional TCRs reactive to mutated KRAS and TP53 neoantigens.

Second reason -- physical plant. In the fall of 2019, the NCI demolished their outdated facility in order to prepare themselves for the innovative future in various applications of Adoptive Cell Therapy (ACT), of which CAR-T and TCR-T are included. Their new facility opened last spring. Likewise, Alaunos began setting up its own process facility on the campus of MD Anderson -- demo then build new in leased space for TCR-T.

Third reason -- COVID. The pandemic put extraordinary demands on the FDA in both review of the research and in manufacturing process/facility inspections. Roughly thirty months was lost to COVID.

Today in the conference call, we heard that the first patient was safely dosed with five billion TCR-T cells and that Alaunos has the go-ahead to dose a second patient at forty billion TCR-T cells. A third patient is planned for the trial at 100 billion cells. In time, both the NCI trial and the Alaunos trial will be churning out results against all sites of metastatic cancers, an unmet need. In addition, the NCI technology is also being set up at MDA itself.

TCR-T for Alaunos is a bedside, autologous therapy, where the vein-to-vein process will be continually refined to achieve a currently spoken goal to take fifteen days (down from thirty) as an "affordable" solution to the "blueprint for success." against solid cancers.

So we wait ... will it take five years to approval ... or in the hands of MDA as principal investigators, will dramatic results from the NCI blueprint application -- agnostic to cancerous locus of somatic tissue (lung, colon, pancreas, etc.) -- suggest that blueprint is viable to an unmet need? Also worth speculation, in choosing five, forty and one hundred billion cells for infusion, if positive results on all three ... what does this trial design suggest in safety and efficacy? Then finally, as it impacts valuation, if approval for a CAR-T therapy that targets 10% of cancers is worth $11B ... what is the value potential for this promising NCI, TCR-T science targeting 90% percent of cancers?


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