United States Orphan Drug Designation for Treatment of Soft Tissue Sarcomas Granted to SPEAR T-cells Targeting MAGE-A4
PHILADELPHIA and OXFORDSHIRE, United Kingdom, Sept. 09, 2019 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to SPEAR T-cells targeting MAGE-A4 (Adaptimmune’s ADP-A2M4 program) for the treatment of soft tissue sarcomas. Orphan Designation by FDA was created to encourage the development of drugs for rare diseases, such as sarcomas.
“We recently started SPEARHEAD-1 treating patients with synovial sarcoma and myxoid/round cell liposarcoma (MRCLS), with the aim to launch ADP-A2M4 in 2022,” said Elliot Norry, Adaptimmune’s interim Chief Medical Officer. “This orphan drug status is another key milestone in achieving our goal of providing this much-needed therapy to people living with these rare and deadly cancers, for which there are few other treatment options.”
About soft tissue sarcomasSoft tissue sarcomas can develop from soft tissues like fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues. There are approximately 50 types of soft tissue sarcomas. Adaptimmune is currently investigating its ADP-A2M4 SPEAR T-cells in two types of sarcoma: synovial sarcoma and MRCLS.
Synovial sarcoma is a cancer of the connective tissue around joints. The most common locations are the hip, knee, ankle, and shoulder. Synovial sarcoma accounts for approximately 6% to 10% of all soft tissue sarcomas. Approximately one third of synovial sarcomas occur in childhood and the peak incidence is in the third decade of life.
Liposarcomas are another type of sarcoma, which are malignant tumors of fat tissue. Myxoid/round cell liposarcoma (MRCLS) is a malignant fat tissue sarcoma that is found predominantly in the limbs. One third of MRCLS cases will become metastatic with tumors spreading to bone and soft tissue locations. MRCLS commonly presents at an age ranging from 35-55 years and has a poor prognosis because it recurs locally and tends to metastasize quickly and widely.
About Adaptimmune’s ADP-A2M4 program in sarcomaAdaptimmune’s ADP-A2M4 (MAGE-A4) SPEAR T-cell therapy is directed to a member of the MAGE family of cancer testis antigens expressed in a number of solid tumor cell types. The MAGE- A4 antigen is among the most commonly expressed cancer testis antigens. Adaptimmune is evaluating its affinity-enhanced SPEAR T-cells in synovial sarcoma and MRCLS in three trials: (1) the recently initiated Phase 2 trial SPEARHEAD-1 in sarcoma; (2) a radiation sub-study to enhance antitumor activity; and, (3) the ongoing pilot trial. Both the radiation sub-study and pilot trial include sarcoma as well as multiple other solid tumor indications. Adaptimmune is also evaluating a next-generation SPEAR T-cell (ADP-A2M4CD8) in sarcoma as well as other solid tumor indications in the SURPASS trial.
About AdaptimmuneAdaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for cancer patients. The Company’s unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T‑cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. For more information, please visit http://www.adaptimmune.com.
Adaptimmune Forward-Looking StatementsThis release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 1, 2019, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.
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