Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.

Achilles Therapeutics is betting that its clonal neoantigen-targeting T cell (cNeT) products, combined with an industrial scale advanced manufacturing capability and predictive bioinformatics platform, will have a transformational impact on patients with solid tumors and metastasized cancer.

Public Company Edition: After an initial hit to valuations from COVID-19, massive amounts of money have been raised by drug developers, such as argenx with a $862.5m stock sale. However, only two IPOs launched in the US in May, including ADC with a $267m offering.

AACR highlighted Gracell’s allogeneic CAR-T targeting CD7, Iovance’s TIL therapy in lung cancer, Gilead’s Yescarta/PD-L1 combination and the NCI’s bispecific CAR-T therapy.