Iovance shares hammered on TIL therapy filing delay — although analysts aren't as bothered
Iovance won’t be able to file for its first-ever approval by the end of this year after all.
At issue is the potency assays Iovance is using to define what would be the first-ever tumor-infiltrating lymphocyte (TIL) therapy. Regulators want to have more data on the current assays, or potentially see different assays in the BLA, the biotech suggested.
All of that work would push the BLA submission in metastatic melanoma to 2021, when Iovance has completed the required clinical follow-up and finished refining its assays as well as developing alternative ones. That means a launch won’t happen until 2022 at the earliest, with cervical cancer to follow in the same year.
Chemistry, manufacturing and control issues have loomed large among late-stage developers of cell therapy since the FDA slammed Bristol Myers and bluebird with a surprise refuse-to-file letter citing a faulty section on CMC. The companies still managed to sort it out and secure priority review for the BCMA CAR-T, ide-cel, but not after five months of Celgene investors fretting about the fate of their $7 billion CVR payout.
Analysts suspected it was also a key reason why J&J-partnered Legend Biotech pushed back their EMA filing — to prepare a strong CMC package and stay on the safe side.
For Iovance the delay triggered a steep drop in stock price, as investors traded shares $IOVA down 20.46% to $25.50.
Most analysts, though, appear to echo Chardan analyst Geulah Livshits’ assessment that “this is a solvable (but not trivial) issue.”
“In our view, the key word is ‘refine,’ which does not suggest the requirement for additional clinical studies or substantive work,” Mizuho analyst Mara Goldstein wrote in a note. “However, this does raise the uncertainty profile as the exact point of concern is unknown to us.”
Unlike CAR-T, TILs are non-engineered and more heterogeneous; measuring the potency is thus more complex. Iovance is also going after solid tumors with lifileucel, CEO Maria Fardis noted in a statement.
Biren Amin of Jefferies expects a delay between four and six months. While he previously predicted 2021 and 2022 sales of $61 million and $458 million, respectively, he’s now dialing down those estimates to $211 million for 2022.