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FDA’s ODAC bind; plus NK cell engagers and company creation in Europe: a BioCentury podcast

May 4, 2021 | 1:41 AM GMT

After three days on trial at ODAC last week, FDA’s accelerated approval pathway awaits the agency’s verdict on six labels for checkpoint inhibitors that were discussed at the meeting. On the latest BioCentury This Week podcast, BioCentury’s editors assess whether the meeting outcomes will prompt FDA to revise the paradigm for accelerated approval of cancer therapies, as well as why NK cell engagers are gaining traction, and what’s the state of play for Europe’s newcos amid a banner year for money raising.

The integrity of the accelerated approval pathway was under the microscope at last week’s FDA’s Oncologic Drugs Advisory Committee. FDA presented justifications that could lead to the withdrawal of all six accelerated approvals. ODAC disagreed, recommending four be maintained.

FDA is in a difficult position, Washington Editor Steve Usdin explains. The agency could disregard some or all of ODAC’s recommendations, a decision that might infuriate patients. But if FDA complies with the recommendations, sponsors could conclude that they should decline agency suggestions to voluntarily withdraw accelerated approvals and press for the opportunity to make their case to ODAC. Usdin also explains why he does not believe FDA’s actions will read through to other disease areas.

Senior Editor Lauren Martz discusses why a growing number of biotechs are betting on the NK cell engager structure as a safer way to redirect immune cells to tumors than T cell engagers. She also gives a primer on how the leading companies working in the space are approaching the technology. 

Turning to Europe, Editor in Chief Simone Fishburn says that company creation is slowing in the region even as the U.K. and the Continent joined in last year’s global funding bonanza for new biotechs. Fishburn says the trends suggest that Europe has still not solved its translational problem — the discrepancy between the high level of academic research and the region’s ability to convert innovative science into new companies.

In this week’s Deal in Focus, Executive Editor Jeff Cranmer zeroes in Danish antibody-drug conjugate company Adcendo ApS, which last week raised the largest-ever series A round by a biotech from Denmark. Cranmer notes that the company ticks a lot of the right boxes for a venture company in Europe: a spinout from an academic institution, formative years at an incubator, brand name investors in Novo Seeds and Ysios Capital and  a strong management team led by former Santaris Pharma A/S CEO Henrik Stage.

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