ASCO24: AffyImmune’s CAR-T achieves first complete response in solid tumor

AffyImmune Therapeutics announced on Thursday a significant milestone in cancer treatment. Their autologous CAR-T cell therapy, AIC100, has achieved a complete response in a patient with a solid tumor, marking the first recorded instance of such success. The preliminary data from the Phase I clinical trial, released ahead of their presentation at the American Society of Clinical Oncology (ASCO) annual meeting, indicates that this cell therapy could become a viable and effective treatment for thyroid cancer.

The ongoing study is focused on patients diagnosed with either anaplastic thyroid cancer (ATC), known as the most aggressive form of thyroid cancer, or poorly differentiated thyroid cancer (PDTC). Participants are being administered one of three dosage levels of AIC100, which is an innovative CAR-T cell therapy targeting ICAM-1 and featuring affinity-tuned LFA-1 binders. The doses being tested are 1x10^7, 1x10^8, and 5x10^8 cells.

In the study, six patients who received either the medium or high doses were evaluated, and the therapy demonstrated an overall response rate (ORR) of 33%. This includes a partial response from a patient with ATC who received the medium dose and a prolonged metabolic complete response from another ATC patient who was administered the highest dose. This particular patient has been able to discontinue all chemotherapy treatments. The disease control rate, which combines the ORR and the rate of stable disease, was observed to be 67% among these six patients.

In the larger group of ten evaluable patients, 60% experienced grade 1/2 cytokine release syndrome, a common side effect. Importantly, there were no cases of immune effector cell-associated neurotoxicity syndrome or other serious adverse events directly linked to AIC100.

AffyImmune's CEO, Matt Britz, expressed optimism regarding the therapy's potential, stating, "We believe AIC100 has the potential to overcome current barriers to CAR T, and ultimately establish a new paradigm for patients with solid tumor cancers."

The promising results from this trial highlight AIC100's potential to be both a tolerable and effective treatment for thyroid cancer, potentially offering new hope to patients suffering from these aggressive forms of the disease. This development could signify a major advancement in the use of CAR-T cell therapies for treating solid tumors, a frontier that has been challenging to tackle so far.

Overall, the data presented by AffyImmune Therapeutics suggest that AIC100, with its innovative mechanism of targeting ICAM-1 through affinity-tuned LFA-1 binders, may pave the way for more effective treatments for solid tumors like ATC and PDTC. As the trial progresses, the oncology community will be closely watching for further results, which could validate the early promise shown by this new therapy.