On the heels of U.S. FDA approval of its first T-cell therapy, Adaptimmune Therapeutics plc reported positive results from a pivotal study for its second candidate, letetresgene autoleucel, expected to support a rolling BLA submission in 2025 that could bolster the firm’s offerings as it narrows its focus on the rare sarcoma space.
A T-cell therapy from Adaptimmune Therapeutics plc has received accelerated approval from the U.S. FDA to treat advanced synovial sarcoma (SS). Tecelra (afamitresgene autoleucel), a CAR T targeting MAGE-A4, is the first engineered T-cell therapy for solid tumors and the first treatment option for the indication in more than a decade.
ESMO late breakers were released Sept. 8, and scientifically at least, a key theme of the meeting will be that cell therapies, at long last, are capable of besting solid tumors.
Likely to garner attention at the upcoming European Society of Medical Oncology meeting are the MAGE-A4 and PRAME antigens which, although well-known and validated, have proved evasive for drug developers – a situation that may soon change.
A new deal between Adaptimmune Therapeutics plc and Roche Holding AG's Genentech Inc. aims to develop allogeneic cell therapies for up to five shared cancer targets. Should the agreement win regulatory clearance, still pending, Adaptimmune will receive $150 million up front and additional payments of $150 million over five years. In addition, it could be eligible for development, regulatory and commercial milestones payments from Roche exceeding $3 billion, plus royalties.
With the FDA approval of Keytruda (pembrolizumab, Merck & Co. Inc.) in the front-line setting of metastatic or unresectable, recurrent head and neck cancer squamous cell carcinoma, the space has become a race to develop drugs using a variety of mechanisms of action to improve the efficacy of the anti-PD-1 monoclonal antibody.
DUBLIN – Even by any normal measure of European biotechnology investment, the first two quarters of 2020 were memorable. If it maintains the present momentum, Europe’s drug development sector is on course for a record-breaking year, having already raised $5.034 billion in publicly disclosed equity investments. That puts it well ahead of any other year – the sector edged to a new high in 2019 when it raised $7.739 billion over the full 12 months – but, of course, comparisons with any other year seem irrelevant. This year is like no other. The COVID-19 pandemic has changed everything.
Overall, data presented at the American Society of Clinical Oncology virtual meeting over the weekend appear to have garnered investor approval, with the BioWorld Cancer index advancing 3%, by market close Monday, and a further 1.7% by the closing bell today.
Shares of Adaptimmune Therapeutics plc (NASDAQ:ADAP) rocketed to $11.07 Friday, up $127% or $6.21, on updated data rolled out at the American Society of Clinical Oncology (ASCO) meeting, held virtually this year.
While companies have seen plenty of success treating blood cancers with T-cell therapies, solid tumors have largely remained the holy grail for T cells. But Adaptimmune Therapeutics plc has early data from its Specific Peptide Enhanced Affinity Receptor T-cell platform suggesting it may be on the right path for a platform with a wide breadth.
