AIC100 / AffyImmune Therap - LARVOL DELTA

Top 5 MD Anderson abstracts at AACR 2025 (MD Anderson Press Release) - "The American Association for Cancer Research (AACR) Annual Meeting showcases exciting new cancer therapies that help link translational science and clinical trials. MD Anderson researchers will be presenting more than 200 studies at AACR this year."

Clinical data • Non Small Cell Lung Cancer • Solid Tumor • Thyroid Gland Carcinoma

AffyImmune Announces Plenary Oral Presentation on ICAM-1 Directed CAR T Therapy AIC100 at AACR 2025 (PRNewswire) - "AffyImmune Therapeutics, Inc....announced an abstract detailing its affinity-tuned CAR T therapy AIC100 will be presented at the American Association for Cancer Research (AACR) Annual Meeting, held April 25-30, 2025 at McCormick Place Convention Center in Chicago, IL."

P1 data • Thyroid Gland Carcinoma

Establishing a multi-modal, cell therapy characterization workflow to identify cell subsets with heightened cytotoxicity (AACR 2025) - P1 | "We leveraged TALL-104 cells before validating compatibility with clinical-stage cell therapies with AIC100 - a Phase 1 CAR-T product targeting thyroid cancer (NCT04420754). We are continuing to identify the optimal CD4:CD8 compositions for greater potency. We envision multi-modal characterization of clinical products with our platform, pre and post-patient infusion, will inform efforts to advance cell therapies for solid tumors."

IO biomarker • B Cell Lymphoma • Endocrine Cancer • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Thyroid Gland Carcinoma • CD4 • CD8 • LAMP2

ICAM-1 directed chimeric antigen receptor (CAR) T cells (AIC100) in patients with advanced thyroid cancers: Clinical and translational data from the phase 1 dose escalation study (AACR 2025) - P1 | "AIC100 was infused intravenously 48 hours after completing lymphodepletion (Fludarabine/Cyclophosphamide x 3 days). AIC100, a first-in-human ICAM-1 directed CAR T-cell therapy, demonstrated an acceptable safety profile in patients with relapsed/refractory ATC and PDTCs. The observed durable responses in DL2 and DL3 are encouraging and provide a proof of concept for potential role of AIC100 in aggressive thyroid cancer patients and other advanced cancers. DL3 is determined as the RP2D."

Clinical • Metastases • P1 data • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • ICAM1 • SSTR • SSTR2

Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer (clinicaltrials.gov) - P1 | N=70 | Active, not recruiting | Sponsor: AffyImmune Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • BRAF • ICAM1

AIC100 CAR T cells show clear potential for the treatment of ICAM-1 positive non-small cell lung cancer (SITC 2024) - P1 | "Conclusions TMA results show a significant proportion of NSCLC are ICAM-1 positive. Given AIC100 successfully eliminated NSCLC tumors in vivo with survival benefit, there is clear potential significant treatment benefit in the ICAM-1 positive population of NSCLC patients."

CAR T-Cell Therapy • Endocrine Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Thyroid Gland Carcinoma • ICAM1

AffyImmune Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for AIC100 in Recurrent Anaplastic Thyroid Cancer (Businesswire) - "AffyImmune...announced today the designation of Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration (FDA) for its CAR T-cell product candidate, AIC100 as a potential treatment for patients with recurrent anaplastic thyroid cancer (ATC), the most aggressive form of the disease....RMAT designation was granted following the FDA’s review of safety and efficacy data from the first ten patients dosed with AIC100 in our Phase 1 study."

FDA event • Thyroid Gland Anaplastic Carcinoma

Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: AffyImmune Therapeutics, Inc. | N=30 ➔ 70 | Trial completion date: Dec 2024 ➔ Aug 2030 | Trial primary completion date: Jun 2024 ➔ Aug 2026

CAR T-Cell Therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • BRAF • ICAM1

Safety and efficacy of AIC100 chimeric antigen receptor (CAR) T-cell therapy in patients with advanced thyroid cancers: Results from the phase 1 study. (ASCO 2024) - P1 | "AIC100 was infused intravenously at least 48 hours after completing lymphodepletion (Fludarabine/Cyclophosphamide x 3 days). This first-in-human ICAM-1 targeted CAR T-cell study demonstrated an excellent safety profile and promising antitumor activity for AIC100 in patients with PDTC and ATC. These favorable outcomes, including a PR in DL2 and a CR in DL3, provide a proof-of-concept and support further exploration of AIC100 to optimize the RP2D and to expand for other ICAM-1-positive neoplasms."

Clinical • Metastases • P1 data • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • ICAM1 • SSTR • SSTR2

AffyImmune Announces Confirmed Complete Response in Patient with Anaplastic Thyroid Cancer (Businesswire) - P1 | N=30 | NCT04420754 | Sponsor: AffyImmune Therapeutics, Inc. | "AffyImmune Therapeutics...announced early results from a Phase 1 study evaluating the safety and efficacy of AIC100, an ICAM-1 targeting and affinity-tuned LFA-1 binder chimeric antigen receptor (CAR) T-cell therapy, in patients with advanced thyroid cancer...As of the data cutoff date, 10 patients (6 ATC; 4 PDTC) were infused with AIC100 at 3 dose levels (DLs). No dose-limiting toxicities were observed across all dose levels, and the maximum tolerated dose was not reached...For evaluable patients in DL2 (100 million CAR T cells) and DL3 (500 million CAR T cells) (n=6), the ORR was 33%, with one patient at DL2 achieving a durable partial response (PR) and another patient at DL3 achieving an ongoing durable mCR allowing the patient to be off all chemotherapy. DCR was 67%."

P1 data • Oncology • Solid Tumor • Thyroid Gland Carcinoma

AffyImmune Announces Presentation on Affinity-Tuned CAR T Therapy AIC100 at ASCO 2024 (Businesswire) - "AffyImmune Therapeutics, Inc...today announced an abstract detailing its affinity-tuned CAR T therapy AIC100 will be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, held May 31-June 4, at McCormick Place Convention Center in Chicago, IL....'We look forward to presenting our preliminary data at ASCO, and to provide initial safety and efficacy results from our Phase 1 trial evaluating AIC100 CAR T therapy in patients with advanced thyroid cancers,'...'"

P1 data • Oncology • Solid Tumor • Thyroid Gland Carcinoma

AffyImmune Therapeutics Announces Clinical and Regulatory Advisory Board to Support Development of AIC100 in Solid Tumors (Yahoo Finance) - "'Having seen the data supporting the first milestone in cell therapy - safety in initial cohorts of patients in a phase I clinical trial, it is exciting to observe the next-stage in the development of CAR T-cell therapy that is applicable to patients with solid tumors,' said Prasad S. Adusumilli, MD...Members of the AffyImmune Clinical and Regulatory Advisory Board are: Prasad S Adusumilli, MD..."

Announcement

AIC100 CAR-T cells targeting ICAM-1 are efficacious against solid tumors in xenograft mouse models of non-small cell lung cancer (NSCLC) and cervical cancer (CC) (AACR 2024) - "AIC100 has significant treatment benefit in NSCLC and CC tumors with ICAM-1 expression in in vivo preclinical studies."

CAR T-Cell Therapy • IO biomarker • Preclinical • Cervical Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • ICAM1 • SSTR • SSTR2

AffyImmune Presents Preclinical Data on AIC100 Affinity-Tuned CAR T Targeting ICAM-1 in Additional Solid Tumor Types at AACR 2024 (Businesswire) - "AffyImmune...presented preclinical data on new indications for its lead program, AIC100, at the American Association for Cancer Research (AACR) Annual Meeting 2024....The preclinical studies demonstrated that AIC100 exhibited potent cytotoxic activity against ICAM-1-positive NSCLC and cervical cancer cell lines in vitro, resulting in 100% cell death within 72 hours. The investigational affinity-tuned CAR T candidate AIC100 also demonstrated remarkable efficacy in NSCLC and cervical cancer xenograft models, with the active arm showing a significant reduction in tumor size and an increase in survival compared to placebo."

Preclinical • Cervical Cancer • Non Small Cell Lung Cancer

AffyImmune Therapeutics Announces Clinical and Regulatory Advisory Board to Support Development of AIC100 in Solid Tumors (Businesswire) - "AffyImmune Therapeutics, Inc...announced the formation of a Clinical and Regulatory Advisory Board (CRAB), comprised of distinguished experts in cancer research, immunology, and CAR T therapy. The CRAB will provide strategic counsel and expertise as AffyImmune advances its affinity-tuned CAR T therapeutics in clinical development....'As our lead program AIC100 advances as a potential therapy for solid tumors in non-small cell lung and thyroid cancers, their combined expertise in drug development will be invaluable as we advance our clinical programs to develop trackable, affinity-tuned CAR T cell therapies'..."

Commercial • Endocrine Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma

AffyImmune Therapeutics to Present Poster at 2024 American Association for Cancer Research Annual Meeting (Businesswire) - "AffyImmune Therapeutics...announced today that it will present an abstract in a poster session at the 2024 American Association for Cancer Research (AACR) Annual Meeting, held April 5-10, 2024, in San Diego, California. Presented findings will highlight research applying the affinity-tuned, trackable, ICAM-1 targeting CAR T cell therapy AIC100 to additional solid tumor types where there is significant unmet medical need."

Preclinical • Cervical Cancer • Non Small Cell Lung Cancer

Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: AffyImmune Therapeutics, Inc.

CAR T-Cell Therapy • Metastases • Trial completion date • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • BRAF • ICAM1

Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: AffyImmune Therapeutics, Inc. | Trial primary completion date: Sep 2023 ➔ Jun 2024

CAR T-Cell Therapy • Metastases • Trial primary completion date • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • BRAF • ICAM1

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. (ASCO 2023) - P1 | "AIC100 is received as a single infusion two days after completing lymphodepletion with Fludarabine/Cyclophosphamide. AIC100 demonstrated an excellent safety profile in DL1/DL2 treated patients with ATC and PDTC with no DLTs observed. The objective and relatively durable partial response in the first evaluable patient in the DL2, a patient with metastatic ATC who failed multiple lines of therapy, is unprecedented and very encouraging. Further investigations of AIC100 are ongoing at DL2 and DL3 to determine the RP2D."

CAR T-Cell Therapy • Clinical • Metastases • P1 data • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • ICAM1 • SSTR • SSTR2

AffyImmune Therapeutics Announces Positive Safety and Early Efficacy Results from Phase 1 Study of AIC100 CAR T Cells in Anaplastic and Advanced Thyroid Cancers at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (PRNewswire) - P1 | N=24 | NCT04420754 | Sponsor: AffyImmune Therapeutics, Inc. | "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)....'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.'"

P1 data • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma

Focused IL-12 cytokine delivery enhances function of affinity-tuned and real-time tracked ICAM-1-specific CAR T cells in solid tumors (AACR 2022) - P1 | "AIC1010 CAR T cells demonstrate superior cancer elimination compared to AIC100 CAR T cells in subcutaneous and IP tumor models in mice. We anticipate that cytokine delivery, paired with our “Tune & Track” technology will be widely adaptable to develop potent and safe affinity-tuned CAR T cells against hard-to-treat solid cancers."

CAR T-Cell Therapy • Breast Cancer • Endocrine Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Triple Negative Breast Cancer • ICAM1 • IL12A • NFATC1 • SSTR • SSTR2

Study of AIC100 in Relapsed/Refractory Thyroid Cancer (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: AffyImmune Therapeutics, Inc. | Trial completion date: Jul 2024 ➔ Dec 2024 | Trial primary completion date: Jul 2023 ➔ Dec 2023

Metastases • Trial completion date • Trial primary completion date • Endocrine Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • BRAF • ICAM1

Phase I study of AIC100 in relapsed and/or refractory advanced thyroid cancer and anaplastic thyroid cancer. (ASCO 2022) - P1 | "Adoptive cellular therapy with ICAM-1 directed CAR T is safe and feasible at dose level 1 in patients with anaplastic thyroid cancer. DOTATATE PET allows visualization of expansion and homing of SSTR2 expressing CAR T cells, while concomitant FDG PET permits correlation with biological activity."

P1 data • Endocrine Cancer • Inflammation • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • BRAF • ICAM1 • SSTR • SSTR2

First-in-human study of ICAM-1-specific affinity tuned CAR T cells against advanced thyroid cancer (AACR 2022) - P1 | "The CAR T cells are engineered to co-express somatostatin receptor 2 (SSTR2), which allows for the tracking of CAR T cells in vivo via PET/CT scan using FDA-approved DOTATATE. AIC100 was generated by affinity tuning the I-domain of LFA-1, the physiological ligand to ICAM-1... We have developed affinity tuned CAR T cells designed to selectively target ICAM-1 overexpressing tumor cells and to spatiotemporally image CAR T cells. Near-synchronous FDG and DOTATATE scans will enhance patient safety by early detection of off-tumor CAR T activity and validation of tumor response. We anticipate that our “tune and track” technology will be widely applicable to developing potent yet safe CAR T cells against hard-to-treat solid cancers."

CAR T-Cell Therapy • P1 data • Breast Cancer • Endocrine Cancer • Gastric Cancer • Gastrointestinal Cancer • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor • Thyroid Gland Carcinoma • ICAM1 • SSTR • SSTR2

Weill Cornell Medicine Becomes First to Test CAR T Cells in Patients With R/R Thyroid Cancer (Targeted Oncology) - "A non-randomized, open-label trial of AIC100, an autologous chimeric antigen receptor T-cell agent for the treatment of relapsed/refractory thyroid cancer, is currently recruiting patients at the Weill Cornell Medical College in in New York, under the supervision of Koen van Besien, MD, PhD."

P1 data