Citius Pharmaceuticals Co-Founder and CEO Discusses the Recently Accepted Biologics License Application of Lymphir for the Treatment of Relapsed/Refractory CTCL

PE: The FDA recently accepted the BLA for Lymphir as a treatment for patients with relapsed/refractory CTCL after at least one prior systemic therapy. How has the company addressed the concerns raised by the FDA in the complete response letter issued in July 2023?

Mazur: That occurred last July. There was a test on the finished product that we passed, but the validation procedure hadn’t been completed. It was going to run several months past the PDUFA date, and we worked on that. That application was actually worked on a lot by Eisai Pharmaceuticals, who we have the license with. I think everybody thought that the agency would give us an approval condition upon completing that validation test and not go to market until that could happen, but the agency chose to go the other way. So, we received the Complete Response Letter, and we finished the validation procedure. We then resubmitted it to them and they accepted. We have a PDUFA date of August 13th, 2024. We’ve engaged in a process with the agency and hopefully, we'll see an approval in at that time frame. Shortly after, we’ll go to the market. It's a small market throwing 3000 patients out there, so this is an orphan drug, and it's not going to require a giant sales force to cover the market.

PE: Are there any other investigational products in the Citius pipeline that you wish to highlight?

Mazur: First of all, there are two INDs out for Lymphir, and one is at the University of Pittsburgh. The investigator is an OBGYN/oncologist and he’s looking at a combination of Lymphir and Keytruda. This is because Lymphir has a very unique mechanism of action. It lowers the T-regs in the microenvironment of a cancer cell, which has a tremendous impact when it comes to PD1 inhibitors such as Keytruda, because the overall efficacy of a PD1 inhibitor is impacted by a higher number of T-regs. The high the number, the less efficacy. If you can bring it down, you'll have greater effort.

We had an animal trial that was published last winter in Frontiers Immunology that showed that the combination of our drug with the PD1 inhibitor was better than monotherapy. We’re going to see that there’s a real scientific rationale for this combo.

The way that he’s administering it, the patient starts out on Lymphir, they get their T-regs lowered, and then the patient is given Keytruda or a PD1 inhibitor. We’re very excited about it but we don’t know yet, because it’s early. The investigator has indicated that he’s applied to present a paper at a conference in November, so we should have some data starting in the fall. We'll start to see what the impact of that combo is.

The other one is early on, and it’s with the University of Minnesota. It combines Lymphir with Cart-T another well-known therapy for cancer. It’s really interesting for us to see this happen, because we truly can expand the number of lifesaving situations for the company.