Monday, July 15, 2024

Ovarian Cancer Treatment Advances with FDA Fast Track Designation for Tubulis’ TUB-040

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Tubulis announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead antibody-drug conjugate (ADC), TUB-040, for the treatment of patients with platinum-resistant ovarian cancer. TUB-040 is a next-generation NaPi2b-targeting Exatecan ADC, leveraging Tubulis’ proprietary P5 technology. This innovative treatment has demonstrated superior biophysical properties and effective, durable responses in various preclinical models, including ovarian cancer.

TUB-040 is currently being evaluated in a multicenter Phase I/IIa study (NAPISTAR 1-01, NCT06303505) involving patients with platinum-resistant high-grade ovarian cancer (PROC) or relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC). The Fast Track designation is based on promising preclinical data that highlight TUB-040’s effectiveness and durable responses across a range of models. This status allows for increased interaction with the FDA to support the development of TUB-040 and expedite regulatory review, facilitating faster access for patients in need.

Ovarian cancer is the leading cause of death among women diagnosed with gynecological cancers. Platinum-resistant ovarian cancer, characterized by disease recurrence during or within six months after completing platinum-based chemotherapy, is associated with poor outcomes and low response rates to subsequent treatments. The median survival for these patients is 12-16 months, underscoring the urgent need for new therapeutic options. Dr. Günter Fingerle-Rowson, Chief Medical Officer of Tubulis, emphasized the significance of the FDA’s Fast Track designation, stating, “This designation is a crucial step in the development of TUB-040, offering new hope for women with platinum-resistant ovarian cancer. We are grateful for the FDA’s support in advancing TUB-040 efficiently.”

Ovarian Cancer Targeted by TUB-040 with FDA Fast Track Status for Innovative Treatment

TUB-040 targets NaPi2b, an antigen highly overexpressed in ovarian cancer and lung adenocarcinoma. It combines an IgG1 antibody with the Topoisomerase I inhibitor Exatecan, connected through a cleavable linker system using Tubulis’ proprietary P5 technology. This technology allows for unprecedented linker stability and biophysical properties, resulting in efficient payload delivery to the tumor while minimizing off-site toxicities. The ongoing Phase I/IIa trial is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of TUB-040 as a monotherapy. This trial is being conducted in multiple countries, including the US, UK, Spain, Belgium, and Germany.

The FDA’s Fast Track status is designed to facilitate the development and expedite the review of new therapies intended to treat serious conditions and address unmet medical needs. Programs granted Fast Track designation are subject to more frequent interactions with the FDA during clinical development and may be eligible for accelerated approval and/or priority review if certain criteria are met. The Fast Track status granted to TUB-040 highlights the urgency and importance of developing new treatments for patients with platinum-resistant ovarian cancer, who have limited options and face poor prognoses.

Ovarian Cancer

Tubulis Advances ADCs with FDA Fast Track Designation for TUB-040, Pioneering New Therapies for Ovarian Cancer

Tubulis specializes in creating uniquely matched protein-drug conjugates by combining novel proprietary technologies with disease-specific biological insights. The company aims to expand the therapeutic potential of ADCs by overcoming the limitations of toxicity, efficacy, and indication. Tubulis continues to collaborate with industry partners to deliver better outcomes for patients and usher in a new era of ADCs. The ongoing research and development efforts at Tubulis, supported by the FDA’s Fast Track designation, reflect the company’s commitment to advancing innovative treatments for challenging diseases.

In summary, the FDA’s Fast Track designation for TUB-040 represents a significant milestone in the development of new therapies for platinum-resistant ovarian cancer. By providing a pathway for accelerated development and review, this designation brings hope to patients who urgently need effective treatments. Tubulis’ innovative approach to ADCs, coupled with the support of the FDA, promises to make a substantial impact on the treatment of ovarian cancer and potentially other challenging diseases.


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Resource: Tubulis, June 27, 2024

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