As autoimmune appetite for CAR-Ts grows, TG nabs rights to Precision’s ‘off-the-shelf’ programme

09 Jan 2024
firstwordpharma.com
Cell TherapyImmunotherapyLicense out/in
The potential of CD19-targeted CAR-T cell therapies in autoimmune diseases has prompted pivots from several large pharmas already this year. Now TG Therapeutics is joining the pack after gaining worldwide rights Tuesday to develop an allogeneic CAR-T from Precision BioSciences in multiple autoimmune indications.
TG expects to file an investigational new drug application  for azercabtagene zapreleucel (azer-cel), a CD19-targeted CAR-T, around the middle of 2024.
Under the deal, Precision will receive $7.5 million upfront, plus a $2.5-million equity investment within a year. The company is also eligible for $295.5 million in clinical, regulatory, and commercial milestones, as well as high single-digit to low double-digit royalties.
Last year, Precision out-licensed worldwide rights to Imugene to develop azer-cel for cancer. The latter also gained options to three other cancer research programmes.
Lupus data turns heads, pipelines
The licensing deal comes as the autoimmune space attracts more cell therapy developers.
Last week, Allogene unveiled a new strategy for its lead CAR-T programme, cemacabtagene ansegedleucel (cema-cel). Studies of the allogeneic CD19-targeted cell therapy in later-line settings for non-Hodgkin lymphoma will be wound down, and instead, Allogene will pursue early-line cancer treatment options – and launch a Phase I study next year in lupus.
The CAR-T autoimmune approach has gained significant momentum since a team of scientists in Germany showed that CD19 CAR-T therapy resulted in a 100% complete response rate in eight patients with systemic lupus erythematosus (SLE).
At the JP Morgan healthcare conference on Monday, FDA’s Peter Marks said the sentiment is strong for the CAR-T pivot into autoimmune diseases, despite questions lingering over a higher safety bar for the less severe diseases that could stop the cell therapies in their tracks. “The risk benefit is still going to be favourable to move forward in those development plans,” he said, calling out settings like lupus nephritis and lupus cerebritis as potentially lethal diseases.
Other pharma and biotech players that have also committed to evaluating CAR-Ts in the autoimmune field include Novartis, AstraZeneca, Autolus, and most recently, Bristol Myers Squibb. CEO Christopher Boerner said at JPM the company plans to develop a next-generation anti-CD19 CAR-T cell therapy to treat lupus and potentially other autoimmune conditions.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
Drugs
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.