Citius Pharma collaborates with University of Pittsburgh for phase 1 investigator-initiated study to evaluate I/ONTAK in combo with pembrolizumab in solid tumours

Citius Pharmaceuticals, Inc., a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, announced a collaboration with Dr. Haider Mahdi at the University of Pittsburgh in an investigator-initiated trial to evaluate I/ONTAK (denileukin diftitox or E7777) in combination with pembrolizumab in the treatment of recurrent or metastatic solid tumours. "We are honoured to support Dr. Mahdi and his team at the University of Pittsburgh in this phase 1 investigator-initiated study to evaluate I/ONTAK as a combination therapy in the treatment of solid tumours. This study will expand the body of knowledge about I/ONTAK's unique mechanism-of-action targeting the CD25 component of the IL-2 receptor which is present on both malignant T-cells (T-cell leukaemias and lymphomas) and immunosuppressive regulatory T-cells (T-regs)," stated Dr. Myron Czuczman, Chief Medical Officer of Citius. "Preclinical research in a syngeneic solid tumour mouse model shows that E7777 (denileukin diftitox) enhances anti-tumour activity and significantly extends survival benefit of anti-PD-1 therapy. This data provides a positive signal of denileukin diftitox's potential in the immuno-oncology space. There remains a significant ongoing need for innovative, effective, and well-tolerated treatments for cancer patients with solid tumours, and we are excited that I/ONTAK may provide meaningful antitumor activity in combination with the PD-1 inhibitor pembrolizumab (Keytruda)," added Dr. Czuczman. "Encouraging clinical data emerging in the field of tumour immunotherapy have demonstrated that therapies focused on enhancing T-cell responses against cancer result in a significant survival benefit in patients with advanced malignancies. Overexpression of PD-L1 on tumour cells has been reported to impede anti-tumour immunity, resulting in immune evasion. The interruption of the PD-1: PD-L1 pathway combined with diminishing the suppressive effect by T-regs may represent an attractive strategy for restoring tumour-specific T-cell immunity. This first in human I/ONTAK plus anti-PD-1 combination immunotherapy study is a significant step towards advancing a T-cell-based therapeutic approach to treating solid tumours," stated Dr. Haider Mahdi, University of Pittsburgh, Assistant Professor, Department of Obstetrics, Gynaecology & Reproductive Sciences. Education & Training. Additionally, Citius is collaborating with an investigator-initiated study at the University of Minnesota (UMN). This phase 1 dose-finding study to evaluate I/ONTAK prior to tisagenleucel (Kymriah) CAR-T therapy in patients with diffuse large B-cell lymphoma (DLBCL) enrolled its first patient in May 2021. The investigator-initiated trial at UPMC is an open label, phase I/Ib study to evaluate T-reg cell depletion with I/ONTAK (E7777) in combination with pembrolizumab in recurrent or metastatic solid tumours. The study consists of two parts. Part I is a dose escalation study of four cohorts (3,6,9,12 mcg of I/ONTAK) and is expected to enroll 18-30 patients. Part II is a dose expansion study of approximately 40 patients to evaluate the safety and tolerability of the recommended combination dose of I/ONTAK and pembrolizumab. The study will also investigate the alteration of the immune microenvironment within tumours and peripheral blood. Secondary endpoints include the objective response (complete response plus partial response), progression-free survival, and overall survival. I/ONTAK is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK. ONTAK was marketed in the US from 1999 to 2014, when it was voluntarily withdrawn from the market. Manufacturing improvements resulted in a new formulation, which maintains the same amino acid sequence but features improved purity and bioactivity. The new formulation received regulatory approval in Japan in 2021 for the treatment of CTCL and PTCL. In 2011 and 2013, the FDA granted orphan drug designation (ODD) to I/ONTAK for the treatment of PTCL and CTCL, respectively. Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies

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