Pipeline

Clinical Pipeline

Clinical Pipeline

Worldwide, cancer is a leading cause of death and is characterized by the uncontrolled growth of abnormal cells that have the ability to evade the immune system. Our latestage pipeline includes various SPEAR T-cell therapies in clinical trials across multiple solid tumors.

Afamitresgene autoleucel or “afami-cel” (formerly ADP-A2M4) is our first-generation TCR T-cell therapy targeting MAGE-A4. We plan to submit a BLA for afami-cel for people with synovial sarcoma in late 2022. We are also developing next-generation cell therapies and our first clinical candidate is ADP-A2M4CD8, currently being evaluated in the SURPASS family of trials, being investigated in the SURPASS and SURPASS-2 trials. Recently, we closed the Phase 1 ADP-A2AFP trial for people with liver cancer and will continue to focus development on new cell therapies for this disease.

Our Clinical Pipeline

Adaptimmune is developing an industry-leading T-cell therapy pipeline in solid tumors, and has a deep pipeline of identified and proprietary targets for further product development.

ADP-A2AFP Phase 1 clinical trial

This was a Phase 1, open-label, dose-escalation clinical trial designed to evaluate the safety and anti-tumor activity of Adaptimmune's ADP-A2AFP therapeutic candidate. The trial included patients who have advanced hepatocellular carcinoma (liver cancer), which has grown or returned after being treated, and who were HLA-A*02 positive and had adequate AFP protein in blood or tumor, and whose noncancerous liver tissue had very little AFP protein. Patients who did not tolerate or refused other therapies could have also participated. The primary objective of the clinical trial was to evaluate the safety and tolerability of ADP-A2AFP SPEAR T-cell therapy.

This trial has ceased enrollment.

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ADP-A2M4 Phase 1 clinical trial

This was a Phase 1, open-label, dose-escalation clinical trial designed to evaluate the safety and anti-tumor activity of Adaptimmune's ADP-A2M4 therapeutic candidate (now called afamitresgene autoleucel or afami-cel) in patients who were HLA-A*02 positive and had inoperable locally advanced or metastatic melanoma, urothelial cancer, head and neck cancers, ovarian cancer, non-small cell lung cancer (NSCLC), esophageal cancers, synovial sarcoma, myxoid/round cell liposarcoma (MRCLS), and gastric cancers expressing MAGE-A4. The primary objective of the clinical trial was to evaluate the safety and tolerability of ADP-A2M4. Further details are available via the link below.

This trial is now closed for enrollment.

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SPEARHEAD-1 (afamitresgene autoleucel "afami-cel" formerly ADP-A2M4)

This is a Phase 2, open-label, single arm clinical trial to evaluate the anti-tumor activity of afamitresgene autoleucel in patients who are HLA-A*02 positive and have inoperable locally advanced synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) expressing MAGE-A4. Enrollment for Cohort 1 is now closed, enrollment for Cohort 2 remains open.

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SURPASS (ADP-A2M4CD8)

This is a Phase 1, open-label, dose escalation clinical trial to evaluate the safety and anti-tumor activity of next-generation ADP-A2M4CD8 SPEAR T-cells in patients who are HLA-A*02 positive and have inoperable locally advanced urothelial, ovarian, esophageal, esophagogastric junction, gastric, non-small cell lung (NSCLC), or head and neck cancers, expressing MAGE-A4.

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SURPASS-2 (ADP-A2M4CD8)

This is a Phase 2, open-label, clinical trial to evaluate the safety and anti-tumor activity of ADP-A2M4CD8 SPEAR T-cells in HLA-A*02 patients with advanced esophageal or esophagogastric junction (EGJ) cancers expressing MAGE-A4.

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Ongoing/InitiatingCompleted/ceased enrollment Phase 2/3 Phase 1 trial Hepatocellular carcinoma Phase 1 ADP-A2AFP Initiated in Q3 2021 Initiating in 2022 SURPASS-2 Esophageal and EGJ cancers SURPASS-3 Ovarian cancer SURPASS Focus on lung, gastroesophageal, head and neck, bladder, and ovarian cancers Combination with checkpoint inhibitor Initiating in 2022 ADP-A2M4CD8 Therapy AFP MAGE-A4 Program Enrollment in Cohort 1 is complete BLA for synovial sarcoma planned in 2022 afamitresgene autoleucel “afami-cel” (formerly ADP-A2M4) SPEARHEAD-1 Synovial sarcoma, MRCLS Phase 1 trial Multiple tumors* * Bladder, Melanoma, Head and Neck, Ovarian, Non-small cell lung cancer (NSCLC), Esophageal, Gastric, Synovial sarcoma, MRCLS

ADP-A2M4

The ADP-A2M4 (MAGE-A4) SPEAR T-cell therapy is directed to a member of the MAGE family of cancer testis antigen expressed in many solid tumor cell types.

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ADP-A2M4CD8

Our first “next-generation therapy” is the ADP-A2M4CD8 SPEAR T-cell therapy. Unlike the ADP-A2M4CD8 SPEAR T-cells therapy, these cells also express the CD8α co-receptor alongside the engineered TCR that targets MAGE-A4.

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ADP-A2AFP

Our ADP-A2AFP product is being used to treat patients with hepatocellular carcinoma (liver cancer).

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