RGT-61159 Phase 1a/b Study (relapsed or refractory ACC and CRC)

Rgenta has an ongoing multi-center, open-label Phase 1a/b clinical trial of RGT-61159 in patients with advanced relapsed or refractory ACC or CRC. The dose escalation and expansion study is designed to evaluate safety, tolerability, pharmacokinetics and target engagement and clinical efficacy of RGT-61159. Additional information on the Phase 1a/1b clinical trial can be accessed at clinicaltrials.gov (NCT06462183). 

About Adenoid Cystic Carcinoma (ACC) 

It is estimated that approximately 200,000 people are living with ACC throughout the world including 11,000 in the US. ^1,2   While it is a rare cancer, ACC is the second most common cancer type arising in the salivary gland³  and is an aggressive malignancy with a tendency to infiltrate surrounding nerves and metastasize to distant sites. Overactivation of the MYB oncogene has been described as a hallmark of ACC and is noted in over 90% of ACC. Treatment for ACC is extremely challenging and may include surgery and/or radiation, which often fails to control local tumor recurrence and distant metastases. There are no effective targeted therapies available for patients with recurrent and/or metastatic disease. New therapeutic targets and treatment strategies for patients with this fatal cancer are urgently needed to fulfill the unmet medical need. 

About Colorectal Cancer (CRC)

CRC is the third most prevalent cancer and the second leading cause of cancer-related mortality worldwide. According to the World Health Organization, more than 1.9 million cases of CRC were diagnosed in 2022.⁴ In Despite improved early detection, approximately 15% - 30% of patients present with metastases and 20% - 50% of patients with initially localized disease will develop metastases.⁵  Patients with relapsed or refractory disease who have exhausted all the available standard of care therapy options have a very poor prognosis. MYB is significantly overexpressed in 80 - 85% of CRC⁶  and has been frequently found to be a predictive biomarker of tumor aggressiveness and poor prognosis. Developing novel therapies to treat patients with metastatic CRC6 remains a major unmet medical need.

About Acute Myeloid Leukemia (AML) 

AML is a blood cancer that starts in the bone marrow, begins to make large numbers of abnormal cells, is characteristically fast growing, and moves quickly into the blood. AML is the most common type of acute leukemia in adults, and it accounts for about 10% of all new blood cancers each year. In the United States, there are about 20,000 new cases of AML per year. The average age of people diagnosed with AML is 68 years old, and while it is uncommon in people under 45, it can occur in adolescents and children.⁷  While complete remission can be achieved in up to 70% of patients with newly diagnosed AML⁸ , prognosis remains poor with only approximately 32% of patients that remain alive 5 years after diagnosis.⁹ Allogeneic hematopoietic cell transplantation (HCT) remains the only potentially curative strategy for most patients. Up to 40% of patients relapse after allogeneic HCT, and 5-year overall survival (OS) rates for these patients are low, approximately 30–40%.¹⁰