German plays deliver on data, plus accelerated approval on trial: a BioCentury podcast
By Jeff Cranmer, Executive Editor
April 27, 2021 1:10 AM UTC
A pair of biotechs have endured the rocky financing landscape in their home country of Germany for over a decade to deliver standout data this month. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the evolution of Affimed and Adrenomed over the years, plus how ODAC’s meeting on checkpoint inhibitors could affect the future of accelerated approval, as well as Vertex’s most recent deals.
Associate Editor Stephen Hansen charts the journey of Affimed N.V. (NASDAQ:AFMD) from platform technology creation to clinical proof of concept, explaining how the company found the best settings and combinations for its innate immune cell engagers.
Turning to fellow German biotech Adrenomed AG, Hansen explains how the company is charting a path into Phase III testing for what could be the first precision medicine for sepsis.
He also discusses how the companies navigated a decade in which there was very little capital available for German biotechs across the financing spectrum.
On the regulatory front, the integrity and future of FDA’s accelerated approval pathway will be on trial at this week’s Oncologic Drugs Advisory Committee meeting, says Washington Editor Steve Usdin. The FDA advisory committee will be making recommendations about retaining or withdrawing six accelerated approvals for three PD-1 and PD-L1 inhibitors; however, Usdin explains why the deliberations could have consequences that go well beyond the fates of the specific drugs, the patients diagnosed with the indications and the therapies’ manufacturers. The meeting begins Tuesday and concludes Thursday.
Usdin also details what he is looking for from President Joe Biden’s upcoming address to Congress and the state of play in the drug pricing debate.
In this week’s Deal in Focus, Executive Editor Jeff Cranmer checks in on the most recent deals by Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), which included expanding a deal with CRISPR Therapeutics AG (NASDAQ:CRSP) and a partnership with Obsidian Therapeutics Inc. Both deals highlight how Vertex continues to build its future beyond cystic fibrosis by branching out into new indications and new modalities including gene editing and mRNA therapies.
TARGETS PD-1 (PDCD1; CD279) – Programmed cell death 1 PD-L1 (B7-H1; CD274) – Programmed cell death 1 ligand 1
