Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.
After the closing bell on Thursday, the biotech put out word that Bayer is washing its hands of the worldwide license “following Bayer’s strategic review and asset-level prioritization of its pipeline, including cell and gene therapy,” according to a statement from Atara R&D chief Jakob Dupont.
Cell and gene therapy has been a major focus for Bayer’s R&D group, and the pharma player tells me they are definitely pushing ahead with “BlueRock Therapeutics and their platform, we have also recently opened two cell therapy development labs (one in Berkeley CA and another in Wuppertal Germany) and our first cell therapy launch facility is under construction at our Biotech campus in Berkeley.”
Their statement to me:
We regularly review our pharmaceutical development projects. Following the latest evaluation, we decided not to pursue further development of the Atara mesothelin-targeting CAR-T cell therapy program. This includes both the autologous ATA2271 and the allogeneic ATA3271 CAR-T programs. We remain committed to pursuing disruptive innovation, such as cell and gene therapies, to the benefit of patients.
Atara stock $ATRA slid 15% Thursday evening, adding to a year-to-date plunge that has wiped out 70% of its market cap.
Bayer had been mightily attracted to Atara’s approach of developing the armored off-the-shelf CAR-T ATA3271 and its autologous — or personalized — version ATA2271. Both are designed to target tumors expressing high levels of mesothelin.
ATA2271 is in an Atara-sponsored Phase I at Memorial Sloan Kettering, home to much of the original research that went into Juno and CAR-T 1.0. That study will continue, while Atara says it will now postpone the IND filing on its allogeneic program in order to reserve funds for the other drugs that were prioritized following the Bayer pact.
Both of the drugs Atara had partnered on included the “novel inclusion of armoring in the form of a PD-1 DNR construct to overcome checkpoint inhibition and a 1XX costimulatory domain on the CAR to enhance expansion and functional persistence of the CAR T-cells.”
Durability and impact are key issues in this second wave of CAR-T work, with safety remaining as a constant threat.
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