Adaptimmune (ADAP) Gets Orphan Drug Status for T-cell Therapy

Shares of Adaptimmune Therapeutics plc ADAP rose about 8% after the company announced that the FDA has granted Orphan Drug Designation (ODD) to SPEAR T-cells targeting MAGE-A4 (ADP-A2M4 program) for the treatment of soft tissue sarcomas. 

Notably, the Orphan Drug designation is granted to drugs capable of treating rare diseases that affect less than 200,000 people in the United States. This designation also makes the company entitled to certain other benefits, including tax credits related to clinical trial expenses and an exemption from the FDA user fee.

Shares of the company have plunged 70.4% year to date compared with the industry’s decline of 2.7%.

Adaptimmune’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 currently investigating its ADP-A2M4 SPEAR T-cells in two types of sarcoma: synovial sarcoma and myxoid/round cell liposarcoma (MRCLS). The company is conducting three studies for the same.

In July 2019, the company initiated phase II SPEARHEAD-1 study with ADP-A2M4 SPEAR T-cells to treat patients with synovial sarcoma and myxoid/round cell liposarcoma (MRCLS), with the aim to launch ADP-A2M4 in 2022. This apart, the company is  conducting a low–dose radiation sub-study to enhance antitumor activity  and  a pilot study is also underway for ADP-A2M4. Both radiation sub-study and pilot study 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 study.

Zacks Rank & Stocks to Consider

Currently, Adaptimmune is a Zacks Rank #3 (Hold) stock.

Some better-ranked stocks in the biotech sector are Amgen Inc. AMGN, Acorda Therapeutics Inc. ACOR and Celcuity Inc. CELC All of these carry a Zacks Rank #1 (Strong Buy), at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Amgen’s earnings per share estimates have increased from $13.90 to $14.30 for 2019 and from $14.78 to $15.42 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, the average beat being 6.72%.    

Acorda’s loss per share estimates for the current year narrowed from $3.59 to $2.74 in the past 60 days. The company delivered a positive earnings surprise in the last four quarters, the average beat being 69.68%.    

Celcuity’s loss per share estimates narrowed from 81 cents to 70 cents for 2019 and from 96 cents to 71 cents for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, the average beat being 25.76%.    

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