Adaptimmune

Afami-cel/TECELRA (MAGE-A4)

2025

Melanoma-associated antigen A4: A cancer/testis antigen as a target for adoptive T-cell receptor T-cell therapy
Knafler, Gabrielle; Ho, Alan, et al., Cancer Treatment Reviews
DOI: 10.1016/j.ctrv.2025.102891
Long-Term Survival of Patients With Advanced/Metastatic Synovial Sarcoma or Myxoid/Round Cell Liposarcoma Who Received the T-Cell Receptor T-Cell Therapy, Afamitresgene Autoleucel, in the Phase 2 SPEARHEAD-1 Trial
Tandem 2025 meeting in Honolulu, Hawaii
Nursing Considerations for Cell Therapy With Afamitresgene Autoleucel (Afami-cel) in Patients With Solid Tumors
Terry Downey-Freiman, Patricia McLaughlin, et al.
50th Annual Oncology Nursing Society (ONS) Congress; Denver, CO April 14, 2025

2024

Translational Analyses Reveal Mechanisms of Afami-cel’s Anti-Tumor Activity in Synovial Sarcoma
Primary Analysis of the Pivotal IGNYTE-ESO Trial of Lete-cel in Patients With Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Impact of Afami-cel on the Health State of Patients With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma: Cohort 1 of SPEARHEAD-1
Translational Analyses Reveal Mechanisms of Afami-cel’s Anti-Tumor Activity in Synovial Sarcoma
C. Dupont, et al., Society for Immunotherapy of Cancer 39^th annual meeting, 2024
Brief Communication on MAGE-A4 and Coexpression of Cancer Testis Antigens in Metastatic Synovial Sarcomas: Considerations for Development of Immunotherapeutics
Vanacker, Hélène; Connacher, Robert, et al., Journal of Immunotherapy 10.1097/CJI.0000000000000541, September 3, 2024. | DOI: 10.1097/CJI.0000000000000541
Identifying MAGE-A4-positive tumors for TCR T cell therapies in HLA-A*02-eligible patients
T. Wang, JM Navenot, D. S. Hong, G. R. Blumenschein, et al., Molecular Therapy: Methods & Clinical Development Vol. 32, June 2024, doi:10.1016/j.omtm.2024.101265
SPEARHEAD-1: a single-arm phase 2 trial of afamitresgene autoleucel (afami-cel) in advanced synovial sarcoma and myxoid/round cell liposarcoma, S. D’Angelo et al., The Lancet (2024), DOI:10.1016/S0140-6736(24)00319-2
Health state impacts of Afamitresgene Autoleucel therapy (Afami-cel) in Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma: SPEARHEAD-1 Cohort 1 analysis, M. Wagner et al, ESMO Sarcoma and Rare Cancers annual congress, 2024

2023

Development, Validation, and Concordance of Two MAGE A4 Immunohistochemistry (IHC) Assays to Establish Prognostic Value of MAGE-A4 Expression in Synovial Sarcoma, Society for Immunotherapy of Cancer, 2023, R. Connacher et al.
Enrollment of Pediatric Participants With MAGE-A4-Positive Solid Tumors in a Phase 1/2, Open-Label, Basket Trial of Afami-cel, Connective Tissue Oncology Society, 2023, T. O’Donohue, A. Armstrong, et al.
Outcomes of Patients with Advanced Synovial Sarcoma Treated with Afami-cel, Connective Tissue Oncology Society, B. Van Tine et al.
Modulation of Single-Cell Gene Expression and Cell Function in Evolving Manufacturing Processes for Clinical Trials With Enhanced-Affinity T-Cell Receptor T-Cell Therapy Targeting the MAGE-A4 Antigen in Solid Tumors, American Society of Cell and Gene Therapy, 2023, Davis, S., et al.
Mechanistic Characterization of afami-cel, American Society of Cell and Gene Therapy, 2023, Hudson, L., et al.
Afamitresgene Autoleucel (Afami-cel) Demonstrates Durable Clinical Responses by Inducing Broad Immune Engagement With Anti-Tumor Activity, American Association for Cancer Research (AACR) 2023, C. McAlpine, M. Isabelle et al.
Autologous T cell therapy for MAGE-A4+ solid cancers in HLA-A*02+ patients: a phase 1 trial.
Nat Med (2023). https://doi.org/10.1038/s41591-022-02128-z
Hong, D.S., Van Tine, B.A., Biswas, S. et al.
The SPEARHEAD-1 Trial of Afamitresgene Autoleucel (“Afami-cel" [Formerly ADP-A2M4]): Analysis of Overall Survival in Advanced Synovial Sarcoma, B. Van Tine et al, American Society of Medical Oncology annual meeting, Chicago 2023

2022

Final Analysis from SPEARHEAD-1 Cohort 1 of Afamistresgene Autoleucel (“Afam-cel” [Formerly ADP-A2M4] in Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma.
PDF poster. 2022 CTOS Annual Meeting, November 16-19 2022.
Brian A. Van Tine et all.
Identifying MAGE-A4-Positive Tumors for SPEAR T-Cell Therapies in HLA-A*02—Eligible Patients
PDF poster. American Association for Cancer Research (AACR), April 8-13, 2022
Tianjiao Wang, PhD, et al.
Identification of Response Stratification Factors from Pooled Efficacy Analyses of Afamitresgene Autoleucel (“Afami-cel” [Formerly ADP-A2M4]) in Metastatic Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Phase 1 and Phase 2 Trials
PDF poster. American Society of Clinical Oncology (ASCO). June 3-7 2022.
Sandra P. D’Angelo, MD, et al.
Identifying New Therapeutic Indications for Afamitresgene Autoleucel (“Afami-cel” [Formerly ADP-A2M4]) in Adult and Pediatric Sarcomas Using MAGE-A4 Immunohistochemistry
PDF poster. AACR Special Conference: Sarcomas. May. 9-12, 2022. Montreal, Canada and virtual.
Caddie Laberiano, MD, et al.
Enrollment of pediatric and adolescent MAGE-A4+ advanced synovial sarcoma patients into Cohort 2 of SPEARHEAD-1: a Phase 2 trial of afamitresgene autoleucel (“afami-cel” [formerly ADP-A2M4])
PDF Poster. AACR Sarcomas. May 9-11 2022.
Sandra P. D’Angelo, MD, et al.
Identifying MAGE-A4-Positive Tumors for SPEAR T-Cell Therapies in HLA-A*02—Eligible Patients
PDF poster. American Association for Cancer Research (AACR), April 8-13, 2022
Tianjiao Wang, PhD, et al.
Real World Treatment Patterns and Outcomes of Metastatic Synovial Sarcoma over the Last Decade in England
PDF poster. European Society for Medical Oncology (ESMO) Congress. September 9-13, 2022. Sandra J. Strauss et al.

2021

SPEARHEAD-1: A phase 2 trial of afamitresgene autoleucel (formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma
PDF presentation. CTOS Annual Meeting. Nov. 10-13, 2021. Virtual.
Brian van Tine, MD, et al.
SPEARHEAD-1: Preliminary translational insights from a phase 2 trial of afamitresgene autoleucel (formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma
PDF poster. CTOS Annual Meeting. Nov. 10-13, 2021. Virtual.
Sandra P. D’Angelo, MD, et al.
Radiation sub-study to characterize safety and tolerability of low-dose radiation in combination with afami-cel in patients with advanced cancers
PDF poster. SITC Annual Meeting. Nov. 10-14, 2021. Washington, DC and virtual
James Welsh, MD, et al.
SPEARHEAD-1: A phase 2 trial of afamitresgene autoleucel (afami-cel, formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma.
PDF presentation. ASCO Annual Meeting, Jun. 4-8, 2021. Chicago, IL and Virtual.
Sandra D’Angelo, MD, et al.
Nursing considerations for the use of MAGE-A4-targeted SPEAR T-cells in patients with synovial sarcoma PDF poster. ONS Conference. Apr. 20, 22, 27, and 29, 2021. Virtual
Erica Elefant, MS, et al.

2020

Durable responses in patients with synovial sarcoma in the phase 1 trial of ADP-A2M4 (MAGE-A4)
PDF presentation. CTOS Annual Meeting. Nov. 18-21, 2020. Virtual
Brian Van Tine, MD, et al.
SPEARHEAD-2 trial design: a phase 2 pilot trial of ADP-A2M4 in combination with pembrolizumab in patients with recurrent or metastatic head and neck cancer
PDF poster. ESMO Congress. Sep. 19-21, 2020. Virtual
Ezra Cohen, MD, et al.
SPEARHEAD-1: A phase 2 trial of ADP-A2M4 SPEAR T-cell in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma.
PDF Poster. ASCO Annual Meeting. May 29- Jun. 2, 2020. Virtual.
Dejka Araujo, MD, et al.
Phase 1 dose escalation and expansion trial to assess safety and efficacy of ADP-A2M4 in advanced solid tumors.
PDF Presentation. ASCO Annual Meeting. May 29- Jun. 2, 2020. Virtual.
David Hong, MD, et al.

2019

ADP-A2M4 (MAGE-A4) in patients with synovial sarcoma
PDF presentation. ESMO congress. Sep. 27-Oct. 1, 2019. Barcelona, Spain.
Brian Van Tine, MD, et al.
The synovial sarcoma subset analysis of the multi-histology phase I trial of ADP-A2M4 (MAGE-A4)
PDF presentation. CTOS Annual Meeting. Nov. 13-16, 2019. Tokyo, Japan.
Brian Van Tine, MD, et al.
SPEARHEAD-1 trial design: A phase 2, single-arm, open-label clinical trial of ADP-A2M4 SPEAR T-cells in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma
PDF poster. SITC Annual Meeting. Nov. 6-10, 2019. National Harbor, MD
Dejka Araujo, MD, et al.
Case reports: Correlates of response following adoptive transfer of ADP-A2M4, affinity-enhanced T-cells targeting MAGE-A4, in synovial sarcoma
PDF poster. SITC Annual Meeting. Nov. 6-10, 2019. National Harbor, MD
Svetlana Fayngerts, PhD, et al.

2018

Initial safety assessment of MAGE-A4 Specific Peptide Enhanced Affinity Receptor (SPEAR) T-cells
PDF poster. ESMO congress. Oct. 19-23, 2018. Munich, Germany.
David Hong, MD, et al.
Specific Peptide Enhanced Affinity Receptor (SPEAR) T-cells targeting MAGE-A4
PDF poster. AACR Annual Meeting. Apr. 14-18, 2018. Chicago, IL.
Joana Senra, PhD, et al.

2017

Study design: Phase 1 dose escalation, multi-tumor study to assess safety, tolerability and antitumor activity of genetically engineered MAGE-A4 SPEAR T-cells in HLA-A2+ subjects with MAGE-A4+ tumors (NCT03132922)
PDF poster. SITC Annual Meeting. Nov. 8-12, 2017. National Harbor, MD.
David S. Hong, MD, et al.

Uza-cel (MAGE-A4)

2024

Identifying MAGE-A4-positive tumors for TCR T cell therapies in HLA-A*02-eligible patients
T. Wang, JM Navenot, D. S. Hong, G. R. Blumenschein, et al., Molecular Therapy: Methods & Clinical Development Vol. 32, June 2024, doi:10.1016/j.omtm.2024.101265
New Phase 1 SURPASS Trial Cohort: Early-Line ADP-A2M4CD8 T-Cell Receptor T-Cell Therapy Plus Pembrolizumab in Urothelial Carcinoma
D. Aggen et al, ASCO Genitourinary Cancers Symposium 2024
First-Line ADP-A2M4CD8 T-Cell Receptor T-Cell Therapy Plus Pembrolizumab in Head and Neck Cancers: An Additional Cohort of the Phase 1 SURPASS Trial
A. Ho et al, Multidisciplinary Head & Neck Cancers Symposium 2024.
GOG-3084: A Phase 2 Trial of ADP-A2M4CD8 TCR T-Cell Therapy, Alone or in Combination With Nivolumab, in Patients With Recurrent Ovarian Cancers
K. Moore et al, Society of Gynecologic Oncology Annual Meeting on Women’s Cancer, 2024

2023

Clinical and Translational Data from the Phase 1 SURPASS Trial of ADP A2M4CD8 T Cell Receptor (TCR) T Cell Therapy Alone or Combined With Nivolumab in Solid Tumors V. Moreno et al., European Society for Medical Oncology annual congress 2023
A Phase 2 Study (GOG-3084) of ADP-A2M4CD8 TCR T Cell Therapy, Alone or in Combination With Nivolumab, in Patients With Recurrent Ovarian Cancers Dr. Kathleen Moore, poster presentation, European Society of Gynaecological Oncology, September 2023
Preliminary results of the Phase 1 SURPASS trial of ADP-A2M4CD8, a next-generation SPEAR T-cell therapy, in patients with head and neck cancer, Hong., D., et al, AHNS 11th international conference on head & neck cancer, Monteral, QC, Canada, 2023
Modulation of Single-Cell Gene Expression and Cell Function in Evolving Manufacturing Processes for Clinical Trials With Enhanced-Affinity T-Cell Receptor T-Cell Therapy Targeting the MAGE-A4 Antigen in Solid Tumors, American Society of Cell and Gene Therapy, 2023, Davis, S., et al.
Enhancing Efficacy of TCR-engineered CD4+ T Cells Via Coexpression of CD8α Journal of Immunotherapy, February 2023, DOI: 10.1097/CJI.0000000000000456.
V. Anderson et al.
Preliminary Clinical Outcomes of ADP-A2M4CD8, a Next-Generation Autologous T-Cell Receptor T-Cell Therapy, in Patients With Advanced Urothelial Cancer
American Society of Clinical Oncology (ASCO), Genitourinary Cancer Symposium, February 16-18 2023.
Dr David Aggen et al.
Safety and Efficacy From the Phase 1 SURPASS Trial of ADP-A2M4CD8, a Next-Generation T-Cell Receptor T-Cell Therapy, in Patients With Advanced Esophageal, Esophagogastric Junction, or Gastric Cancer
American Society of Clinical Oncology (ASCO), Gastrointestinal Cancer Symposium Jan 19–21, 2023
Dr Mariela Blum Murphy et al.

2022

Preliminary Clinical Outcomes of ADP-A2M4CD8, a Next-Generation Autologous T-Cell Receptor T-Cell Therapy, in Patients With Advanced Epithelial Ovarian Cancer, European Congress on Gynaecological Oncology, October 28-30 2022
Dr Kathleen Moore et al.
Identifying MAGE-A4-Positive Tumors for SPEAR T-Cell Therapies in HLA-A*02—Eligible Patients
PDF poster. American Association for Cancer Research (AACR), April 8-13, 2022
Tianjiao Wang, PhD, et al.
SURPASS 2 trial design: A phase 2, open label study of ADP-A2M4CD8 SPEAR T-cells in advanced esophageal or esophagogastric junction cancers
PDF poster. ASCO GI Cancers Symposium. Jan. 20-22, 2022. San Francisco, CA
David S. Hong, MD, et al.
Dr Hong SURPASS Update ESMO 2022
PDF presentation.

2021

Enhancement of TCR-engineered T-cells targeting MAGE-A4 antigen by co-expression of CD8α and inhibition of AKT signaling during ex vivo T-cell expansion
PDF poster. SITC Annual Meeting. Nov. 10-14, 2021. Washington, DC and virtual.
Emily Schmidt, PhD, et al.
Safety and efficacy from the SURPASS trial with ADP-A2M4CD8, a SPEAR T-cell therapy incorporating a CD8α co-receptor and an affinity optimized TCR targeting MAGE-A4
PDF poster. ESMO Congress. Sep. 16-21, 2021. Virtual. David Hong, MD, et al.

2020

Inhibition of AKT signaling during expansion of TCR-engineered T-cells from patient leukocyte material generates SPEAR T-Cells with enhanced functional potential in vitro
PDF poster. SITC Annual Meeting. Nov. 9-14, 2020. Virtual.
Katerina Mardilovich, PhD, et al.
Initial safety, efficacy, and product attributes from the SURPASS Trial with ADP-A2M4CD8, a SPEAR T-cell therapy incorporating an affinity optimized TCR targeting MAGE-A4 and a CD8α co-receptor
PDF poster. SITC Annual Meeting. Nov. 9-14, 2020. Virtual.
David S. Hong, MD, et al.

2019

SURPASS trial design: A phase 1 dose escalation trial to assess safety and efficacy of ADP-A2M4CD8 in HLA-A2+ patients with MAGE-A4+ tumors
PDF poster. SITC Annual Meeting. Nov. 6-10, 2019. National Harbor, MD.
Paula M. Fracasso, MD, PhD, et al.
Enhanced activity of second-generation MAGE-A4 SPEAR T-Cells through co-expression of a CD8α homodimer
PDF presentation. AACR Annual Meeting. Mar. 29-Apr. 3, 2019. Atlanta, GA.
Victoria Anderson, PhD, et al.

Lete-cel (NY-ESO-1)

2025

Letetresgene Autoleucel in Advanced/Metastatic Myxoid/Round Cell Liposarcoma
S. D’Angelo et al., Journal of Clinical Oncology

2024

Primary Analysis of the Pivotal IGNYTE-ESO Trial of Lete-cel in Patients With Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
S. D’Angelo et al., Connective Tissue Oncology Society annual meeting, 2024
Lete-cel in Patients With Synovial Sarcoma or Myxoid/Round Cell Liposarcoma: Planned Interim Analysis of the Pivotal IGNYTE-ESO Trial
S. D’Angelo et al., American Society of Clinical Oncology (ASCO) Annual Meeting 2024.

2023

Primary Analysis of Efficacy and Safety of Letetresgene Autoleucel (Lete-cel) as First-Line Treatment for Unresectable or Metastatic Synovial Sarcoma (SyS); Substudy 1 of IGNYTE-ESO, Connective Tissue Oncology Society, 2023, M. Burgess et al.

2019

Manuscript Long‐term safety and activity of NY-ESO‐1 SPEAR T cells after autologous stem cell transplant for myeloma.
Blood Advances 2019;3:2022-2034.
Stadtmauer EA, et al.

2018

Manuscript Antitumor activity associated with prolonged persistence of adoptively transferred NY-ESO-1c259T cells in synovial sarcoma.
Cancer Discovery 2018;8(8):944-957.
D'Angelo SP, et al.

2015

Manuscript NY-ESO-1-specific TCR-engineered T cells mediate sustained antigen-specific antitumor effects in myeloma.
Nature Medicine 2015;21(8):914-921.
Rapoport AP, et al.

Pre-clinical

2024

Development and Preclinical Characterization of an Engineered T-Cell Therapy Targeting PRAME-Expressing Solid Tumors, G. Pope et al., ASGCT 27th annual meeting 2024
Presented at the ASGCT 27th Annual Meeting, Baltimore, MD, May 7–11, 2024

2022

A Novel Flow Cytometry Method for Rapid Assessment of Lentiviral Detection
PDF poster. ASGCT Annual Meeting. May 16-19, 2022. Washington, DC and virtual
Fraser Wilkes, MS, et al.
Next-Generation, Inducible IL-7–Expressing, Tumor-Infiltrating Lymphocytes by Lentiviral Vector Genetic Modification for Clinical Application
PDF poster. ASGCT Annual Meeting. May 16-19, 2022. Washington, DC and virtual
Michael Douglas Crowther, PhD, et al.
IL-7 and CCL19 Expression in Specific Peptide Enhanced Affinity Receptor T-cells Targeting MAGE-A4 Display Improved Survival and Ability to Induce Migration of Immune Cells
PDF poster. ASGCT Annual Meeting. May 16-19, 2022. Washington, DC and virtual
George R. Pope, PhD, et al.

2021

Manuscript Engineering cancer antigen-specific T cells to overcome the immunosuppressive effects of TGF-β.
The Journal of Immunology 2022 Jan 1;208(1):169-180.
Jonathan DS, et al.
PDF upon request.

2020

Manuscript Preclinical evaluation of an affinity-enhanced MAGE-A4-specific T-cell receptor for adoptive T-cell therapy
OncoImmunology. 24 Nov 2019. Joseph P. Sanderson et at.

2018

Development of novel cancer immunotherapy by exploring human immunopeptidome using mass spectrometry
PDF poster. Hupo World Congress. Sep. 30-Oct.3, 2018. Orlando, FL.
Kamila Chughtai, PhD, et al.
Manuscript Fludarabine and neurotoxicity in engineered T-cell therapy
Gene Therapy 2018;25:175-191.
Lowe KL, et al.

2017

Manuscript Human leucocyte antigen class I-redirected anti-tumour CD4+ T cells require a higher T cell receptor binding affinity for optimal activity than CD8+ T cells.
Clinical & Experimental Immunology 2017;187(1):124-137.
Tan MP, et al.

2013

Manuscript Examining the presentation of tumor-associated antigens on peptide-pulsed T2 cells.
Oncoimmunology 2013 September;2(11):e26840.
Bossi G, et al
Manuscript Cardiovascular toxicity and titin cross-reactivity of affinity-enhanced T cells in myeloma and melanoma.
Blood 2013 August;122(6):863-871.
Linette GP, et al.
Manuscript A pharmacologic perspective on newly emerging T-cell manipulation technologies.
British Journal of Clinical Pharmacology 2013 August;76(2):173-187.
Smethurst D.

Allogeneic

2020

Driving ADP-A2M4 SPEAR Expression from an Endogenous Hematopoietic Lineage Promotor for “Off-the-Shelf” T-Cell Therapy for MAGE-A4+ Solid Tumors
PDF poster. ASGCT Annual Meeting. May 12-May 15, 2020. Virtual.
Garth Hamilton, PhD, et al.

2019

Differentiating T-Cells from hiPSCs to create off-the-shelf SPEAR T-Cell therapies.
PDF presentation. ASGCT Annual Meeting. Apr. 29-May 2, 2019. Washington DC
Lee Carpenter, PhD, et al.

CMC

2023

Interview - Ensuring success in working with apheresis centers
Cell & Gene Therapy Insights 2023; 9(2), 141–146 DOI: 10.18609/cgti.2023.019.
Suzanne Kamps

2022

Building an integrated vector supply to support autologous cell therapy for solid tumours
European Pharmaceutical Review Volume 27, Issue 05, November 2022.
James Nanista and Josh Hunt

2019

Assessing the potency of SPEAR T cells: development and validation of a flow cytometry-based cytotoxicity assay
PDF poster. BEBPA EUR Bioassay Conference. Sep. 25-27, 2019. Prague, Czechia.
Rachel Kenneil, PhD, et al.

HLA Independent TCRs (HiTs)

2024

Selection, engineering, and in vivo testing of a human leukocyte antigen–independent T-cell receptor recognizing human mesothelin.
M. Hiscox et al. PLOS ONE 19(4): e0301175. DOI: 10.1371/journal.pone.0301175.

2021

In vitro Selection and Engineering of a Human Leukocyte Antigen-Independent T-Cell Receptor (HiT) Recognizing Human Mesothelin
PDF presentation. ASGCT Annual Meeting. May 11-14, 2021. Virtual.
Martyn J. Hiscox, PhD, et al.