Shots:
- The US FDA has granted FT designation for PBCAR0191 to treat advanced B-ALL. FT designation facilitates the expedited development and review of a new drug, whether alone or in combination with another drug addressing the unmet medical needs and treats a serious or life-threatening disease
- Under the agreement with Servier, Precision will solely lead early-stage research activities and P-I execution for PBCAR0191 along with clinical supply for P-II clinical trials. Servier has an exclusive right to opt in for late-stage development and commercialization while Precision has the right to participate in the process of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the US
- PBCAR0191 is an allogenic CART cell therapy, currently being evaluated in a P-I/IIa study evaluating PBCAR0191 in adult patients with r/r B-ALL and r/r NHL
Click here to read full press release/ article | Ref: Precision BioSciences | Image: StraitTimes
