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Marengo Therapeutics Progresses STARt-002 Trial for Metastatic Breast Cancer

Marengo Therapeutics, Inc., a pioneering biotechnology firm known for its innovative strategies in precision immunotherapy, has announced a significant milestone in its ongoing clinical research. The company has successfully completed the Phase 1b safety run-in for the STARt-002 clinical trial and established the recommended Phase 2 dose (RP2D) for its investigational drug, invikafusp alfa. This study is particularly focused on patients suffering from unresectable metastatic breast cancer, specifically targeting those with hormone receptor-positive, HER2-negative (HR+/HER2−) and triple-negative (mTNBC) tumors.

Significance of STARt-002 Trial

The STARt-002 trial, which combines invikafusp alfa with TRODELVY® (sacituzumab govitecan-hziy), a well-established TROP2-directed antibody-drug conjugate from Gilead, represents an ambitious attempt to tackle breast cancer - a disease that continues to pose enormous challenges in treatment. According to Dr. Erika Hamilton, the Director of Breast Cancer Research at Sarah Cannon Research Institute, there remains a significant unmet need for advanced therapies aimed at these specific types of breast cancer. She expressed optimism about the potential of combining invikafusp with a proven ADC, which may expand the therapeutic options available to patients who have been historically limited in their choices.

The early phases of the trial have shown promising outcomes, with reports of confirmed partial responses (PR) and some tumor regressions. This evidence of early anti-tumor activity suggests that the combination therapy may elicit a favorable immune response.

Noteworthy Insights from the Research

Marengo’s Chief Medical Officer, Dr. Kevin Chin, highlighted that invikafusp has previously demonstrated notable activity as a standalone treatment, particularly in PD-1 resistant cases, including breast cancer. Moving into the Phase 2 expansion cohorts marks a vital step in confirming invikafusp’s role as a foundational therapy for immunotherapies, especially when paired with ADCs for treatment-resistant tumors like breast cancer. The forward momentum in trial enrollment reflects both the scientific ambition of the project and the community’s hope for effective breast cancer treatments.

The trial, noted as NCT06827613, is currently open for patient recruitment at several leading North American cancer treatment centers, including Massachusetts General Hospital and Princess Margaret Cancer Centre, among others. This expansive enrollment strategy aims to include a broad demographic of participants to enhance the validity of the trial outcomes.

About Marengo Therapeutics and Their STAR™ Platform

Founded with a purpose to innovate therapeutic options in the oncology space, Marengo Therapeutics concentrates on developing advanced treatments that can selectively activate T cells to combat various cancers effectively. Their STAR™ Platform, which stands for Selective T Cell Activation Repertoire, forms the basis for their investigational therapies. This innovative technology aims to manipulate T cell responses with the goal of achieving durable immunity against tumors.

Invikafusp alfa, the leading candidate from this platform, employs a unique mechanism that combines T cell receptor (TCR) activation with a co-stimulatory signal. This innovative approach has been shown to facilitate the proliferation of memory T cells that can adaptively respond to cancer cells, enhancing overall anti-tumor immunity.

Conclusion

As Marengo Therapeutics moves forward with the STARt-002 trial, the combination of invikafusp alfa and TRODELVY represents a beacon of hope for the breast cancer community. With continued support from the research community and enrollment from patients, there is optimism that these efforts could lead to breakthrough treatments for some of the most challenging forms of breast cancer today. The hope is that by harnessing the power of the immune system, the fight against breast cancer will become more manageable and ultimately victorious.

For more information about ongoing trials and developments regarding this initiative, interested parties are encouraged to visit the clinical trials registry at clinicaltrials.gov for updates.