Atossa Therapeutics Advances Innovative Cancer Treatment Strategies at Research Conference

Atossa Therapeutics, Inc., a company leading the charge in clinical-stage biopharmaceutical development, recently underscored its progress in the RECAST™ trial during the Early Detection Research Conference in Portland, Oregon. Dr. Laura J. Esserman, a prominent figure in the field and Professor at the University of California, San Francisco, spearheads discussions focused on active-surveillance strategies and groundbreaking endocrine agents in the treatment of ductal carcinoma in situ (DCIS).

The RECAST trial is a multi-arm, Phase 2, randomized study aimed at determining the best treatment pathways for patients diagnosed with hormone receptor-positive DCIS, an often non-invasive form of breast cancer that carries the potential to become invasive in certain cases. This trial marks a significant step towards understanding patient demographics that may benefit from a non-surgical treatment option.

The Objectives of the RECAST Trial

The primary goal of RECAST is to identify which DCIS patients can be suited for long-term active surveillance using novel endocrine therapies rather than immediate surgery. The trial evaluates both standard therapies—like tamoxifen or aromatase inhibitors—and innovative agents, such as (Z)-Endoxifen, elacestrant, and Hav-088. The assessment of efficacy involves state-of-the-art imaging techniques, including mammography and breast MRI, as well as biomarker discovery designed to enhance quality of life for participants.

Enrollment began in January 2024, and so far, 50 patients have joined out of a targeted 400 participants across 17 active clinical sites, with more sites opening in the near future. This comprehensive enrollment strategy emphasizes the trial's mission to address a market need by guiding patients away from unnecessary surgical procedures.

Understanding Market Needs

DCIS is frequently treated similarly to invasive breast cancer, which typically involves surgery, radiation, and endocrine therapy. However, there exists a pressing need for evidence supporting a non-surgical, biomarker-guided approach. Should this approach prove effective, it could not only alter the standard of care for DCIS but also broaden the application of oral endocrine agents in early-stage disease management.

The RECAST trial's design facilitates parallel testing of multiple agents, generating comparative data to inform registration strategies, which further enhances the trial's potential impact. Additionally, early imaging responses and biomarker correlations will provide interim data that can help to de-risk later-stage programs while populating crucial health-economic modeling that insurers and healthcare providers will rely on.

The Collaboration Factor

The RECAST initiative is sponsored by the Quantum Leap Healthcare Collaborative, with essential support from the National Institutes of Health (NIH) and several industry allies. This collaborative framework allows for faster patient enrollment, improved site access, and maximized capital efficiency, creating a conducive environment for pioneering cancer research.

Steven Quay, CEO and Chairman of Atossa Therapeutics, accentuates the trial's significance, stating that, "RECAST is purpose-built to answer the question that payers, physicians, and patients care most about: who truly needs surgery and who does not?" The trial serves as a capital-efficient platform to demonstrate the potential of (Z)-Endoxifen in a meaningful patient group, generating relevant biomarkers while guiding future developments.

Future Aspirations

As the RECAST trial progresses, its objectives remain clear: increase the number of DCIS patients eligible for active monitoring, explore how risk correlates with therapy response, and discover biomarkers predicting treatment outcomes and resistance mechanisms. Furthermore, it aims to analyze participants' quality of life in comparison to traditional treatments.

Atossa Therapeutics continues to forge ahead, developing innovative solutions in oncology. As such, it aims to improve outcomes for patients navigating the complexities of breast cancer treatment. For more information about Atossa Therapeutics and the RECAST trial, visit Atossa Therapeutics.