The FDA accepted an investigational new drug application providing clearance to begin an open-label, single-arm phase 1 clinical trial of ATA2271, a next-generation mesothelin targeting CAR T-cell therapy.
The FDA has accepted the investigational new drug (IND) application providing clearance to begin an open-label, single-arm phase 1 clinical trial of ATA2271, according to Atara Biotherapeutics, the developer of the agent.
ATA2271 is a next-generation autologous CAR T-cell therapy which targets mesothelin for the treatment of advanced mesothelioma. The development of the therapy is supported by the safety and anti-tumor efficacy that was exhibited in prior studies evaluating a mesothelin-directed CAR utilizing a CD28 co-stimulatory signaling domain.
“We are pleased the FDA has cleared the IND for ATA2271 for the treatment of advanced mesothelioma,” Jakob Dupont, global head of Research and Development at Atara Biotherapeutics, said in a press release “This milestone marks an important moment in the advancement of cell and gene immunotherapy for patients, for the field and for Atara. As the first-ever CAR T therapy leveraging the combination of PD1DNR checkpoint inhibition and 1XX CAR signaling technologies to enter the clinic, we are advancing such a unique CAR T program with the goal of developing transformative therapies for patients with solid tumors.”
Preclinical data were presented from ATA2271 IND-enabling studies at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting II, showing the effects of combining multiple novel technologies in this next-gen CAR T-cell therapy. Overall, ATA2271 was associated with less cell exhaustion, improvements in functional persistence, serial cell killing, and enhanced in vivo efficacy when compared with first-generation mesothelin CAR T-cell therapy. Further, these observed effects were maintained through multiple redosings with ATA2271 and are consistent with developing views in the field regarding preferred characteristics of CAR T-cells when targeting solid tumors such as mesothelioma.
Moving forward, this improved profile of ATA2271 will be assessed in a Ph1 clinical trial led by principal investigator, Roisin E. O’Cearbhaill. MD, a medical oncologist at Memorial Sloan Kettering Cancer Center.
Notably, Atara Biotherapeutics has selected mesothelin as the target for both the ATA2271 autologous and the ATA3271 allogeneic programs along with novel CAR T-cell technologies that have the potential to further enhance activity and resulting clinical benefits for patients with mesothelioma. ATA3271, the allogeneic version of ATA2271, leverages an EBV T-cell platform and is currently in IND-enabling studies.
Atara Biotherapeutics Announces FDA Clearance of IND for ATA2271, a Next-Generation Autologous Mesothelin-Targeted CAR T with Novel PD1DNR and 1XX Technologies Combined to Treat Solid Tumors [news release]. South San Francisco, California. Published September 8, 2020. Accessed September 15, 2020. https://www.businesswire.com/news/home/20200908005255/en/Atara-Biotherapeutics-Announces-FDA-Clearance-IND-ATA2271