With FDA clearance of its IND, the company has begun studying the drug's dosing and preliminary activity in previously treated, ALK-positive, advanced NSCLC.
The firm plans to begin a Phase I trial of its autologous, controllable T-cell cell therapy, ACLX-001, for multiple myeloma patients in the second half of 2021.
Following the initial results readout, the firm will expand the Phase I/II SWORD-1 trial and decide on a recommended Phase II dose prior to meeting with regulators.
In a supplemental application, Gilead company Kite submitted data on its CAR T-cell therapy from the Zuma-3 trial in relapsed or refractory B-cell precursor ALL.
The DRP would be used to identify kidney cancer patients likely to benefit from dovitinib, a repurposed TKI for which Allarity plans to file an NDA this year.
The company has previously offered its liquid biopsy tests through an LDT model but sees the timing and the clinical niche as right for a regulatory bid in CSF testing.
The company is planning to commercialize its cancer early detection technology initially in lung cancer and is working with NYU researchers to explore future expansions.
The autologous, anti-BCMA CAR T-cell therapy may be the first to garner FDA approval for multiple myeloma patients but competing products may soon catch up.
The agency has decided not to approve neoadjuvant and adjuvant pembrolizumab in early-stage TNBC based on currently available data from the Keynote-522 trial.
