Citius Pharmaceuticals is eyeing an approval decision and a potential commercial launch for its lead lymphoma therapy Lymphir by September or October 2024, said the company’s CEO Leonard Mazur in an In an exclusive interview with Pharmaceutical Technology.
On 13 February, Citius announced that it had resubmitted its biologics license application (BLA) for Lymphir (denileukin diftitox/E7777) to the US Food and Drug Administration (FDA). The company expects the FDA to issue and package a new Prescription Drug User Fee Act (PDUFA) date within thirty days of the resubmission. Mazur predicts that the new PDUFA date will be set for a six-month timeframe.
Lymphir is an IL-2-based immunotherapy for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The drug binds to IL-2 receptors on the cell surface, leading to the inhibition of protein synthesis and subsequently cell death.
In 2021, Citius acquired a license to develop Lymphir from Dr Reddy’s Laboratories, completing a Phase III trial for the drug in December 2021. In 2022, the company filed a BLA for the drug, but received an FDA complete response letter in July 2023. “We knew there was a small deficiency in that filing, but we felt that we would still get it approved,” says Mazur.
He explains that the rejection was based on a manufacturing test on the final product that had been passed but had not yet been validated by the FDA, and the company has now resolved this issue.
Citius has transferred Lymphir over to a subsidiary company, Citius Oncology, with plans to have the subsidiary acquired through a special purpose acquisition company (SPAC). “This will give us a Nasdaq listing... Once the SPAC acquires the subsidiary, it will be renamed and will start to trade separately on NASDAQ at around May,” says Mazur. He explains that this approach should prevent the dilution of shareholders in Citius Pharmaceutical and allow the company to separately raise finances for the launch of Lymphir.
Citius is also collaborating with Eversana for its post-marketing operations such as warehousing, shipping and billing of the drug.
The New Jersey-based company also completed enrolment for a Phase III trial (NCT02901717) for its antibody lock therapy Mino-lok (edetate disodium + ethyl alcohol + minocycline hydrochloride), as per an announcement on 2 January. Citius is developing this therapy for the treatment of catheter-related blood stream infections.
Mazur now forecasts a topline data readout for the trial in May or June 2024, and further plans will be made following the data readout.
