Marengo Therapeutics Initiates Clinical Trial with Invikafusp Alfa and Trodelvy for Breast Cancer

Marengo Therapeutics Initiates STARt-002 Clinical Trial

Marengo Therapeutics, a clinical-stage biotechnology firm, has made a significant advancement in the fight against metastatic breast cancer with the initiation of its STARt-002 clinical trial. This innovative study marks the first patient dosing of Invikafusp Alfa, a unique dual T cell agonist, combined with Gilead's TROP2-directed antibody-drug conjugate (ADC), Trodelvy®.

Overview of the Clinical Trial

The STARt-002 trial is a Phase 1b/2 study designed to evaluate the efficacy and safety of this promising combination therapy in patients suffering from metastatic breast cancer. The trial specifically targets populations with hormone receptor-positive, HER2-negative (HR+/HER2−) and triple-negative breast cancer (TNBC).

Initial Focus on Combination Therapy

Currently being conducted at leading cancer centers across North America, the initial phase of the trial will focus on determining the ideal tolerable dosing of Invikafusp Alfa and Trodelvy. Following the run-in phase, the trial will expand into two specific patient cohorts: those with mTNBC and those with HR+/HER2− metastatic breast cancer.

Dr. Steven Isakoff, a prominent Oncologist at Massachusetts General Hospital, expressed optimism regarding the trial, citing the positive data emerging from other studies that combine ADCs with immunotherapies. He emphasized that Invikafusp Alfa's innovative design as a bi-specific immunotherapy could provide new avenues for patients with limited treatment options.

The Mechanism of Action

Invikafusp Alfa operates through a dual T cell activation mechanism, a novel approach that aims to generate a robust immune response against cancer cells. Recent presentations at key oncology conferences have demonstrated its potential effectiveness in addressing tumors resistant to PD-1 inhibitors, opening doors for innovative treatment pathways. With evidence of efficacy in preclinical models of breast cancer, this approach could enhance the immunotherapeutic landscape for selected breast cancer patients.

Collaborations and Future Directions

As Marengo collaborates with renowned clinical research centers such as the Sarah Cannon Research Institute and Princess Margaret Cancer Centre, there’s an ongoing effort to include more sites in the study. Marengo's Chief Medical Officer, Dr. Kevin Chin, noted the exciting potential for Invikafusp to become a foundational element in immunotherapy, especially when paired with ADCs that target tumors lacking effective immune responses.

The STAR™ Platform

Central to the development of Invikafusp Alfa is Marengo’s proprietary STAR™ platform, which facilitates selective activation of T cells in the body. This technology aims to amplify the immune response specifically against cancerous cells while sparing healthy tissue. The STAR™ platform uses multispecific antibody-fusion technology targeting unique T cell regions, enabling a refined approach to anti-tumor therapy.

Conclusion

With the launch of STARt-002, Marengo Therapeutics is positioning itself at the forefront of breast cancer treatment innovation. The combination of Invikafusp Alfa and Trodelvy reflects a promising frontier in precision immunotherapy, potentially transforming the treatment landscape for patients battling metastatic breast malignancies. As the trial progresses, there is significant hope that it will yield valuable insights and pave the way for enhanced therapeutic options where none currently exist.

For more details on this clinical trial and Marengo's ongoing research, visit Marengo Therapeutics.