The number or prior failed treatments is not known in advance. Both trials required for eligible subjects to have failed at least one line of treatment. RAC released that information when they presented the trial data, and I expect the same from CHM.
At @Beaza79 's statement is correct, RAC's results were excellent. Median number of prior treatments however was 4, with treatments ranging from 3-9: https://www.listcorp.com/asx/rac/race-oncology-limited/news/impressive-bisantrene-phase-2-aml-clinical-results-2952479.html "Weeks away from death" - yes, inclusion criteria was "Life expectancy ≥ 3 months." Whilst there is no reference to life expectancy in CHM's trial, it does mention "Participants will be eligible if they have either refused standard treatment regimens or if there is no standard approach to curative salvage therapy per National Comprehensive Cancer Network (NCCN) guidelines in the setting of relapsed/refractory disease." I would consider that to be in line with Dr Smith's statement of "a patient group that [...] clinicians have give up by now", no?
It is also worth noting, that RAC's trial excluded malignancies other than "Relapsed or Refractory Acute Myeloid Leukemia (AML)", while this particular CHM trial (not funded by CHM), also includes:
Add that to the previous Phase 1a trial patient: "The third subject (subject 12) had recurrent AML presenting with extramedullary disease in the form of myeloid sarcoma of the breast. At the time of enrollment, this subject had experienced another breast cancer relapse after her second haploidentical donor HCT. [...] At postinfusion day 28, subject 12 was found to have no change in size of the extramedullary AML in the breast and no new sites of disease." https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9489303/
And the conclusion of that P1a trial? "The observed clinical responses could be enhanced by administration of exogenous cytokine support, as well as complementary approaches that promote NK cell function in the tumor microenvironment."
That's why now: "Researchers at University Hospitals Seidman Cancer Center and the Case Comprehensive Cancer Center at Case Western Reserve University are launching a first-ever, investigator-initiated clinical trial to study universal donor NK cells in combination with IL-2 and vactosertib as a potential treatment for colorectal cancer and hematological malignancies. Vactosertib is a clinical drug candidate that inhibits TGF-β signaling, a pathway that is known to inhibit the therapeutic effect of immunotherapy. By modulating the tumor microenvironment, vactosertib is thought to play a synergistic role in improving the response of various drugs and suppressing the proliferation and metastasis of cancer cells." https://www.uhhospitals.org/for-clinicians/articles-and-news/articles/2022/02/seidman-to-launch-1st-trial-of-nk-therapy-and-vactosertib-in-treating-colo-ca-hematological-malig
I'm looking forward to the next CR (Complete Response, not Capital Raise, although both are equally possible at the moment).
CHM Price at posting:
1.4¢ Sentiment: Buy Disclosure: Held
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