Citius Pharmaceuticals (NASDAQ: CTXR) Advances Oncology Asset, Paving Way For Spin Out Of Advanced T-cell Lymphoma Treatment

April 18, 2024 at 08:45 AM EDT

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By Meg Flippin, Benzinga

Chemotherapy and radiation are proven ways to treat cancer, but for the patients, they usually mean untold suffering. Finding effective alternatives, especially for people with rare cancers, can seem impossible. For rare cancers, there often isn’t a lot of information to help develop treatments, enough animal or cell models to test, or tumor samples to research. As a result, rare cancers account for 25% of all cancer deaths in the U.S.

Immunotherapy To Kill Cancer Cells

One alternative treatment that seems to be getting attention is immunotherapy. It’s a treatment that uses the patient’s immune system to seek and kill cancer cells. Immunotherapy treatments are designed to boost a patient’s immune system so the body can work harder to destroy cancer cells. It is proving effective with companies including Citius Pharmaceuticals Inc. (NASDAQ: CTXR) advancing oncology treatments through an innovative immuno-oncology approach.

Citius’ lead asset aims to leverage the body's own defense mechanisms to destroy malignant tumors. The therapy targets the interleukin-2 receptors found on malignant T-cells regulatory T-cells (Tregs), opening the potential for new therapeutic approaches to the treatment of cutaneous T-cell lymphoma (CTCL). This innovation could be transformative for individuals with rare cancers like CTCL, potentially enhancing their quality of life significantly. Additionally, Citius highlights compelling market opportunities that the company says are poised for growth. Broadly, the global cancer therapy market is forecast to grow at a CAGR of 9.12% from now until 2027, while the immuno-oncology market is projected to grow at a CAGR of 22.94%, hitting $396.07 billion by 2034.

LYMPHIR Poised to Make Inroads

The company’s lead immunotherapy, LYMPHIR, is under review by the U.S. Food and Drug Administration (FDA) for the treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin lymphoma. In Japan, the formulation is approved and marketed for the treatment of CTCL and peripheral T-cell lymphoma (PTCL).

Just last month, the U.S. FDA accepted the resubmission of a Biologics License Application (BLA) for LYMPHIR for the treatment of patients with relapsed or refractory CTCL after at least one prior systemic therapy. According to the company, the FDA has assigned a PDUFA goal date of August 13, 2024, the company said.

"We believe there remains a critical unmet need for an additional viable treatment option for patients with relapsed or refractory CTCL as current therapies are non-curative,” said Leonard Mazur, Chairman and CEO of Citius.

“We are grateful for the FDA's vital support for rare disease drug development as we work to expand treatment options for patients with cutaneous T-cell lymphoma. We look forward to the FDA's decision and the potential benefit LYMPHIR may provide patients with relapsed or refractory CTCL,” continued Mazur. Citius believes the market for LYMPHIR for CTCL will exceed $400 million and is particularly attractive because it is underserved by existing treatments.

The Proof Is In The Results

LYMPHIR is a recombinant engineered fusion protein that combines interleukin-2 and diphtheria toxin. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. Notably, malignant T-cells and immunosuppressive regulatory T-cells share a common marker, the IL-2 receptor. Consequently, LYMPHIR targets both malignant T-cells and transiently eliminates Tregs, supporting the potential to unleash potent immune responses by the patient’s immune system against their tumors.

In recent preclinical studies, denileukin diftitox has demonstrated the ability to deplete murine Tregs in-vivo and human Tregs ex vivo. In addition, the combination of denileukin diftitox with anti-PD1 showed improved tumor response and very significant improvement in survival in the combination groups relative to either therapy alone in a syngeneic mouse solid tumor model.

Based on this data, two investigator-initiated trials are underway to evaluate the potential safety and efficacy of LYMPHIR in combination with Pembrolizumab (anti-PD1) in patients with recurrent or metastatic solid tumors and LYMPHIR given prior to lymphodepletion (LD) chemotherapy and CAR-T therapies for the treatment of relapsed/refractory B-cell lymphomas. The results of these preclinical trials will determine if the company will develop these treatments further.

The Path To Commercialization

In addition to inroads on the regularity front, the company is making strides to commercialize LYMPHIR. A spinout to form Citius Oncology is in the works. The company announced plans to form a standalone public oncology company a few months ago. In a recent press release, Citius mentioned the transaction will improve the company’s access to the public equity markets and help facilitate the commercialization of LYMPHIR.

"We believe this transaction will allow us to unlock the value of LYMPHIR, and solidly position Citius Pharma to advance our diversified pipeline,” said Mazur at the time.

“This transaction will enable Citius Oncology, with access to the broader capital markets, to better support the successful commercialization of LYMPHIR, if approved, and explore additional potential targeted oncology therapies. Our majority ownership position and shared services agreement ensures that the Citius Pharma management team will remain fully engaged with the development and commercialization efforts at Citius Oncology.”

Featured photo by the National Cancer Institute on Unsplash.

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