Bayer terminates $670 million CAR-T partnership with Atara after patient death
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Bayer terminates $670 million CAR-T partnership with Atara after patient death.
Atara Biotherapeutics had to choose to suspend the development of its new CAR-T therapy two months ago after causing the death of a test patient.
A few days ago, the company’s partner Bayer has finally decided to terminate the $670 million cooperation agreement between the two companies on next-generation mesothelin-directed CAR-T cell therapy.
At the end of February this year, Atara reported that it had voluntarily suspended the recruitment of new patients for mesothelin-targeted autologous CAR-T therapy because of a serious adverse event (SAEs) that occurred in a phase I clinical trial of ATA2271 therapy. ).
During treatment, the patient had a history of multiple malignancies and other complications, which complicates the investigation into the cause of death, Atara noted.
According to the latest evaluation data released, Bayer has finally decided not to further cooperate with Atara to develop mesothelin-targeted CAR-T cell therapy programs, including autologous ATA2271 and allogeneic ATA3271 CAR-T therapies.
The cooperation agreement between the two companies will be terminated in September 2022.
According to the cooperation agreement, the rights and licenses previously granted by Atara to Bayer will be returned to Atara, and Atara will still have full rights to continue clinical development and future commercialization projects worldwide.
Bayer’s decision to suspend cooperation also forced Atara to make necessary changes to its pipeline plan for its CAR-T therapy.
The companies’ previous collaboration includes funding and development of ATA3271 (allogeneic T-cell immunotherapy) and autologous ATA2271 therapies for the treatment of mesothelin-high tumors such as malignant pleural mesothelioma and non-small cell lung cancer.
Among them, the ATA3271 therapy mainly uses the EBV-T cell platform of Atara, and is currently undergoing IND (Investigative New Drug) trials. In vitro functional studies showed that ATA2271 has potent antitumor activity after repeated antigen stimulation, with stronger levels of expansion observed in cells with PD1 DNR compared to modified CD3z(1XX) CAR-T cells alone.
Regarding Bayer’s announcement to terminate the cooperation, Atara President and CEO Pascal Touchon said that Atara is still focusing on the interim analysis of the EMBOLD study of ATA1882, which will be announced in June, and looks forward to the continued progress of tab-cel, including the European EMA’s Regulatory review and further collaboration with the US FDA on the appropriate BLA pathway.
Touchon pointed out that the company will re-evaluate the strategy of the mesothelin CAR-T R&D program, so it needs to delay the submission of the expected investigational new drug application for the ATA3271 therapy until after the fourth quarter of 2022. Touchon also said the company will maintain its cash runway guidance through the fourth quarter of 2023.
Affected by the unfavorable news, Atara shares fell 15.4% to $4.34 on Thursday evening, and the company’s market value has shrunk by nearly 70% so far this year.
▶ Previously related reports: ” Bayer and Atara reached a cooperation of up to 670 million US dollars to jointly develop cellular immunotherapy “
In December 2020, Bayer and Atara reached a cooperation of up to 670 million US dollars to jointly develop cellular immunotherapy, mainly involving the cooperative development of mesothelin-directed CAR-T cell therapy for the treatment of solid tumors.
According to the content of the agreement, it mainly includes the development of two drug candidates: ATA3271, an enhanced allogeneic T-cell immunotherapy, and the autologous drug ATA2271, a drug for the treatment of malignant pleural mesothelioma and non-small cell lung cancer and other mesothelioma drugs for high-expressing tumors.
Under the terms of the agreement, Atara will lead the IND and process development for ATA3271, while Bayer will be responsible for the submission of the New Drug Application and subsequent clinical development and commercialization.
In addition, Atara will continue to be responsible for the ongoing Phase I clinical study of ATA2271, which has now submitted an IND application and clinical trials have been initiated.
On the fee payment side of the collaboration, Atara will receive an upfront payment of $60 million, and if Bayer progresses well in development, regulatory and commercialization, Atara will be eligible to receive milestone payments totaling $610 million and up to net sales at a later stage Staged commissions in double-digit percentages.
Reference:
1. Bayer sounds retreat from a $670 million CAR-T pact in the wake of a patient death
2. Bayer to end collaboration with Atara Biotherapeutics to develop CAR T-cell therapies
3. Atara Biotherapeutics Provides Update on Strategic Collaboration with Bayer
Bayer terminates $670 million CAR-T partnership with Atara after patient death
(source:internet, reference only)
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