After a summer of stasis, Hemogenyx Pharmaceuticals is one step closer to finally getting its CAR-T therapy into the clinic after the FDA accepted its plan to get a clinical hold lifted.
The London-based company first revealed in June that the regulator had put a planned early-phase trial of HEMO-CAR-T on hold. Hemogenyx later explained that the FDA had taken issue with “a splicing that occurs during the manufacturing process of the lentivirus that is used to produce CAR-T cells.”
The biotech said back in July that it had identified the source of the lentivirus splicing deficiency and developed a method to mitigate the problem. Now, the company has announced that a “detailed plan, supported by laboratory tests” submitted in August “satisfactorily addresses” the FDA’s comments.
“We are pleased that the FDA has agreed to our plan and preliminary test results to address their concerns regarding our HEMO-CAR-T IND application,” CEO Vladislav Sandler, Ph.D., said in the Sept. 14 release. “We are now working hard to complete the schedule of work set out in the plan and to re-submit the IND as expeditiously as possible in order to move forward with clinical trials of HEMO-CAR-T.”
HEMO-CAR-T is in development as a treatment for acute myeloid leukemia. Getting the drug candidate, which is the biotech’s main focus, to the IND stage was (PDF) “more complex and hence longer and more intensive” than expected, the company revealed back in May, but management said then that “any possible delays” had likely been mitigated for the filing.
Hemogenyx can take some consolation from the fact it’s not the only company to have a CAR-T placed on pause this summer. 2seventy bio’s CD33-targeted cell therapy was put on hold last month over a patient death, while that same week Arcellx’s Gilead-partnered CAR-T was released from a two-month hold also instigated after a death.