thyroid gland poorly differentiated carcinoma

AffyImmune Therapeutics said Thursday its autologous CAR-T cell therapy AIC100 is the first to achieve a complete response in a patient with a solid tumour. The Phase I trial data, shared ahead of a presentation at the American Society of Clinical Oncology (ASCO) annual meeting, suggest the cell therapy could be a tolerable and efficacious option to treat thyroid cancer.The study is enrolling patients with either anaplastic thyroid cancer (ATC), the most aggressive form of the disease, or poorly differentiated thyroid cancer (PDTC) to receive one of three dose levels of AIC100 – either 1x 107, 1 x 108, or 5 x 108 cells – which is an ICAM-1 targeting and affinity-tuned LFA-1 binder CAR-T.In six evaluable patients who received either the second or third dose levels, the cell therapy led to an overall response rate (ORR) of 33%. The figure comprises a partial response in a patient with ATC who received the medium dose, and a durable metabolic complete response in a patient with ATC who received the high CAR-T dose and was able to go off all chemotherapy.The disease control rate, defined as ORR plus stable disease, was 67% in the six patients.Across all 10 evaluable patients, 60% developed grade 1/2 cytokine release syndrome. No patients experienced immune effector cell-associated neurotoxicity syndrome or another serious adverse event related to AIC100.“We believe AIC100 has the potential to overcome current barriers to CAR T, and ultimately establish a new paradigm for patients with solid tumour cancers,” AffyImmune CEO Matt Britz said.ASCO Daily Digest – your go-to-source for the key developments emerging from this year's American Society of Clinical Oncology (ASCO) annual meeting. Exclusively for PLUS subscribers – sign up here!

NATICK, MA, USA I May 25, 2023 I AffyImmune Therapeutics, Inc., a clinical stage biotechnology company finding safe, effective ways to use CAR T cells against solid cancers , today announced positive safety and early efficacy results from a Phase 1 study of affinity tuned and trackable AIC100 CAR T cells in ICAM-1 positive relapsed and/or refractory advanced poorly differentiated and anaplastic thyroid cancers, which will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, on June 5, 2023. "We are very encouraged by the early data, as it marks a groundbreaking CAR T patient response in aggressive and difficult to treat anaplastic thyroid cancers," said Matt Britz, Chief Operating Officer at AffyImmune. "This is an important clinical milestone for AffyImmune as we continue to develop AIC100 in the clinic and explore additional solid tumor indications with high unmet need." The current Phase 1 study is exploring three dose levels (DL) of AIC100 CAR T cells, which are developed using AffyImmune's proprietary Tune & Track CAR T cell platform. To date, AIC100 CAR T cells demonstrated excellent safety and encouraging efficacy in anaplastic (ATC) and poorly differentiated (PDTC) thyroid cancers. As of May 1, 2023, seven patients (4 ATC; 3 PDTC) were infused with AIC100: three patients (2 ATC, 1 PDTC) in DL1 and four patients (2 ATC, 2 PDTC) in DL2. Early results from the Phase 1 study include: "The objective partial response in DL2 for a patient with metastatic ATC who failed multiple lines of therapy is unprecedented and very encouraging," said Samer Ali Srour, MB ChB, MS, assistant professor of Stem Cell Transplantation & Cellular Therapy at The University of Texas MD Anderson Cancer Center. "AIC100 demonstrated an excellent safety profile with no DLTs in patients with ATC and PDTC, and the antitumor activity is promising, especially these responses were observed at the low dose levels 1 and 2." Details of the poster presentation: Abstract Title : Safety and early efficacy results of phase 1 study of affinity tuned and trackable AIC100 CAR T cells in ICAM-1 positive relapsed and/or refractory advanced poorly differentiated and anaplastic thyroid cancers Session Title : Head and Neck Cancer Date and Time: Monday, June 5, 1:15 PM-4:15 PM CDT Location: McCormick Place Convention Center, Exhibit Hall A, Poster Board 87 Presenter : Samer Ali Srour, MBChB, MS, Assistant Professor, Department of Stem Cell Transplantation, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX About AffyImmune Therapeutics, Inc. AffyImmune is realizing the potential of cancer immunotherapy by extending the anti-cancer activity of CAR T cell therapy to solid tumors. AffyImmune's Tune & Track platform finely tunes the affinity of CAR T cells to reduce toxicity and increase CAR T cell longevity while allowing in vivo monitoring through a proprietary tracking system. The company was founded in 2016 and is enrolling patients in its Phase 1 trial to treat advanced thyroid cancers. SOURCE: AffyImmune Therapeutics

Data show unprecedented CAR T patient response in ICAM-1 positive relapsed and/or refractory advanced poorly differentiated and anaplastic thyroid cancers Of the two patients evaluable for efficacy assessment at day 42 treated with an intermediate dose of CAR T cells, both experienced tumor reductions, with one achieving a partial response with 42 percent reduction in target tumor lesion No dose limiting toxicities reported; two patients had transient grade 1 cytokine release syndrome NATICK, Mass., May 25, 2023 /PRNewswire/ -- AffyImmune Therapeutics, Inc., a clinical stage biotechnology company finding safe, effective ways to use CAR T cells against solid cancers , today announced positive safety and early efficacy results from a Phase 1 study of affinity tuned and trackable AIC100 CAR T cells in ICAM-1 positive relapsed and/or refractory advanced poorly differentiated and anaplastic thyroid cancers, which will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, on June 5, 2023. "We are very encouraged by the early data, as it marks a groundbreaking CAR T patient response in aggressive and difficult to treat anaplastic thyroid cancers," said Matt Britz, Chief Operating Officer at AffyImmune. "This is an important clinical milestone for AffyImmune as we continue to develop AIC100 in the clinic and explore additional solid tumor indications with high unmet need." The current Phase 1 study is exploring three dose levels (DL) of AIC100 CAR T cells, which are developed using AffyImmune's proprietary Tune & Track CAR T cell platform. To date, AIC100 CAR T cells demonstrated excellent safety and encouraging efficacy in anaplastic (ATC) and poorly differentiated (PDTC) thyroid cancers. As of May 1, 2023, seven patients (4 ATC; 3 PDTC) were infused with AIC100: three patients (2 ATC, 1 PDTC) in DL1 and four patients (2 ATC, 2 PDTC) in DL2. Early results from the Phase 1 study include: No DLTs were reported; two patients had transient grade 1 CRS. For the four patients infused in DL2, two patients were evaluable for efficacy assessment at day 42. Both had tumor reductions. One ATC patient achieved partial response (PR) with 42 percent reduction in target tumor lesion and a second PDTC patient had stable disease (SD). "The objective partial response in DL2 for a patient with metastatic ATC who failed multiple lines of therapy is unprecedented and very encouraging," said Samer Ali Srour, MB ChB, MS, assistant professor of Stem Cell Transplantation & Cellular Therapy at The University of Texas MD Anderson Cancer Center. "AIC100 demonstrated an excellent safety profile with no DLTs in patients with ATC and PDTC, and the antitumor activity is promising, especially these responses were observed at the low dose levels 1 and 2." Details of the poster presentation: Abstract Title: Safety and early efficacy results of phase 1 study of affinity tuned and trackable AIC100 CAR T cells in ICAM-1 positive relapsed and/or refractory advanced poorly differentiated and anaplastic thyroid cancers Session Title: Head and Neck Cancer Date and Time: Monday, June 5, 1:15 PM-4:15 PM CDT Location: McCormick Place Convention Center, Exhibit Hall A, Poster Board 87 Presenter: Samer Ali Srour, MBChB, MS, Assistant Professor, Department of Stem Cell Transplantation, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX About AffyImmune Therapeutics, Inc. AffyImmune is realizing the potential of cancer immunotherapy by extending the anti-cancer activity of CAR T cell therapy to solid tumors. AffyImmune's Tune & Track platform finely tunes the affinity of CAR T cells to reduce toxicity and increase CAR T cell longevity while allowing in vivo monitoring through a proprietary tracking system. The company was founded in 2016 and is enrolling patients in its Phase 1 trial to treat advanced thyroid cancers. Contact Information: Matt Britz AffyImmune Therapeutics, Inc. 508-654-3600 x2 [email protected] SOURCE AffyImmune Therapeutics