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Adaptimmune (ADAP) Presents Data on Liver Cancer Candidate
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Adaptimmune Therapeutics plc recently announced updated data from its phase I study on ADP-A2AFP for patients with liver cancer at the International Liver Cancer Association.
The phase I, open-label, dose escalation clinical study was designed to evaluate the safety and anti-tumor activity of ADP-A2AFP in patients with liver cancer (hepatocellular carcinoma) or other AFP-expressing tumors. These patients are not amenable to transplant, resection, or loco-regional therapy, and have failed or are intolerant to or refused standard-of-care treatment.
Per the data, 13 patients with advanced hepatocellular carcinoma (HCC) received ADP-A2AFP in Cohort 3 and expansion. The best overall responses in Cohort 3 and expansion (per RECIST v1.1) included 1 complete response (reported in 2020), six stable disease and four progressive disease. Two patients did not have scan results at the time of the data cut-off.
The disease control rate for patients with at least one scan was 7/11 (64%) and two patients had stable disease lasting beyond 16 weeks.
ADP-A2AFP has an acceptable safety profile without any reports of significant T-cell-related hepatotoxicity and any protocol-defined dose limiting toxicities.
The significant antitumor activity with this first-generation product targeting AFP is encouraging for the potential of cell therapy for the treatment of liver cancer in these heavily pre-treated patients with late-stage disease.
The dose escalation portion of the study is complete, and it is intended to treat up to 25 patients with doses up to 10 billion transduced cells in the expansion phase.
Shares of the company have declined 8.4% year to date against the industry’s growth of 2.7%.
Image Source: Zacks Investment Research
Adaptimmune is focused on the development of novel cancer immunotherapy products for cancer. The company’s cell therapy candidates include Specific Peptide Enhanced Affinity Receptor (SPEAR) T-cells, which use genetically engineered T-cell receptors; next generation T-cell Infiltrating Lymphocytes (TiLs) where a patient’s T-cells are co-administered with its next generation technology, and HLA-independent TCRs (HiTs) where surface proteins are targeted independently of the peptide-HLA complex.
The SPEARHEAD-1 phase II study with afamitresgene autoleucel is underway in synovial sarcoma and myxoid round cell liposarcoma (MRCLS) indications in which the MAGE-A4 antigen is expressed. This data is intended to support the filing of a Biologics License Application (BLA) in 2022. A phase II study combining afamitresgene autoleucel with Merck’s (MRK - Free Report) Keytruda in patients with head and neck cancer expressing the MAGE-A4 antigen is underway in the United States.
The company also has a collaboration agreement with GlaxoSmithKline (GSK - Free Report) for the development, manufacture, and commercialization of TCR therapeutic candidates.
Regeneron’s earnings per share estimates for 2021 have increased from $49.96 to $54.15 in the past 30 days. The stock has rallied 40.7% in the year so far.
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Adaptimmune (ADAP) Presents Data on Liver Cancer Candidate
Adaptimmune Therapeutics plc recently announced updated data from its phase I study on ADP-A2AFP for patients with liver cancer at the International Liver Cancer Association.
The phase I, open-label, dose escalation clinical study was designed to evaluate the safety and anti-tumor activity of ADP-A2AFP in patients with liver cancer (hepatocellular carcinoma) or other AFP-expressing tumors. These patients are not amenable to transplant, resection, or loco-regional therapy, and have failed or are intolerant to or refused standard-of-care treatment.
Per the data, 13 patients with advanced hepatocellular carcinoma (HCC) received ADP-A2AFP in Cohort 3 and expansion. The best overall responses in Cohort 3 and expansion (per RECIST v1.1) included 1 complete response (reported in 2020), six stable disease and four progressive disease. Two patients did not have scan results at the time of the data cut-off.
The disease control rate for patients with at least one scan was 7/11 (64%) and two patients had stable disease lasting beyond 16 weeks.
ADP-A2AFP has an acceptable safety profile without any reports of significant T-cell-related hepatotoxicity and any protocol-defined dose limiting toxicities.
The significant antitumor activity with this first-generation product targeting AFP is encouraging for the potential of cell therapy for the treatment of liver cancer in these heavily pre-treated patients with late-stage disease.
The dose escalation portion of the study is complete, and it is intended to treat up to 25 patients with doses up to 10 billion transduced cells in the expansion phase.
Shares of the company have declined 8.4% year to date against the industry’s growth of 2.7%.
Image Source: Zacks Investment Research
Adaptimmune is focused on the development of novel cancer immunotherapy products for cancer. The company’s cell therapy candidates include Specific Peptide Enhanced Affinity Receptor (SPEAR) T-cells, which use genetically engineered T-cell receptors; next generation T-cell Infiltrating Lymphocytes (TiLs) where a patient’s T-cells are co-administered with its next generation technology, and HLA-independent TCRs (HiTs) where surface proteins are targeted independently of the peptide-HLA complex.
The SPEARHEAD-1 phase II study with afamitresgene autoleucel is underway in synovial sarcoma and myxoid round cell liposarcoma (MRCLS) indications in which the MAGE-A4 antigen is expressed. This data is intended to support the filing of a Biologics License Application (BLA) in 2022. A phase II study combining afamitresgene autoleucel with Merck’s (MRK - Free Report) Keytruda in patients with head and neck cancer expressing the MAGE-A4 antigen is underway in the United States.
The company also has a collaboration agreement with GlaxoSmithKline (GSK - Free Report) for the development, manufacture, and commercialization of TCR therapeutic candidates.
Currently, Adaptimmune is a Zacks Rank #3 (Hold) stock. A better-ranked biotech is Regeneron Pharmaceuticals (REGN - Free Report) which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings per share estimates for 2021 have increased from $49.96 to $54.15 in the past 30 days. The stock has rallied 40.7% in the year so far.