Just been reading about this biotech below... what’s interesting...

Just been reading about this biotech below... what’s interesting is how they are going about there trail phases. Please skip to bold text if you can’t be bothered, it is the weekend after all.

Iovance Biotherapeutics (IOVA) closed up 20.4% on Wednesday upon announcing clinical trial design updates for two pipeline programs. Iovance is among the leading immunotherapy companies focused on tumor-infiltrating lymphocyte (TIL) therapy for the treatment and potential cures for various solid tumor indications

The company announced updates to its clinical programs with TIL therapy in the treatment of cervical cancer and non-small cell lung cancer (NSCLC).

The protocol for innovaTIL-04 (C-145-04), the Phase 2 study in cervical cancer, was amended tincrease the sample size to 59 and to modify the primary endpoint of Objective Response Rate (ORR) to be determined by a Blinded Independent Review Committee (BIRC).

Iovance made changes in anticipation of a meeting with the Food and Drug Administration (FDA) planned for later this year to discuss the registration pathway for LN-145 in cervical cancer. Additionally, the company closed its IOV-LUN-201 study in non-small cell lung cancer (NSCLC) and instead plans to add an arm to the global IOV-COM-202 study for PD-1 naïve NSCLC patients.

By increasing the sample size for the cervical cancer study, the company might be expecting to bypass phase 3 studies and is powering the Phase 2 trial for registration activities. Changes in the NSCLC trial moves the therapy towards earlier lines of treatment. These broad changes to clinical trials probably indicate Iovance's conviction in its pipeline programs.

Reference was ARK investment mgnt