DB107-FC + DB107-RRV

DB107-FC + DB107-RRV is an investigational gene therapy combination being developed for the treatment of high-grade gliomas (HGG), including glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA). This combination therapy consists of two components that work together to target cancer cells. ## Components and Mechanism of Action The therapy comprises two key components: 1. **DB107-RRV (vocimagene amiretrorepvec)**: A retroviral replicating vector designed to selectively infect and genetically modify cancer cells. It's administered both intracranially during tumor resection and intravenously afterward[8]. 2. **DB107-FC**: An extended-release oral formulation of 5-fluorocytosine (5-FC). When DB107-FC is administered orally, the DB107-RRV in the tumor cells converts it into the potent chemotherapeutic agent 5-fluorouracil (5-FU) directly at the tumor sites[7]. This innovative approach allows for targeted chemotherapy generation within tumor cells, reducing systemic toxicity commonly associated with traditional chemotherapy while potentially improving efficacy against cancer cells that cannot be surgically removed[8]. ## Clinical Development The therapy is currently being evaluated in several clinical trials: - A Phase 1/2a multicenter, open-label study evaluating DB107-RRV in combination with DB107-FC when added to standard of care for newly diagnosed HGG patients. This study began enrolling patients in March 2025, with the first two patients already enrolled[8]. - A Phase 2 biomarker-guided study assessing the combination in DGM7-positive patients with recurrent/progressive HGG. The DGM7 biomarker is present in approximately 20-30% of HGG patients and appears to identify those who may benefit most from the therapy[3]. - A study evaluating the combination in treating glioblastoma multiforme or anaplastic astrocytoma[1]. ## Administration Protocol In clinical trials, the treatment protocol typically involves: 1. Surgical resection of the tumor with administration of DB107-RRV into the tumor cavity walls and intravenously. 2. Patients then take DB107-FC orally three times daily for seven consecutive days (one treatment cycle), followed by a five-week rest period before the next cycle. Treatment with DB107-FC may continue for up to 12 months after surgery[5][6]. 3. The therapy may be combined with standard-of-care treatments such as radiation therapy with or without temozolomide (TMZ), depending on the patient's MGMT methylation status[2]. ## Regulatory Status and Support The therapy has received significant recognition and support: - Fast track and breakthrough therapy designations from the FDA - Orphan drug designations from both the FDA and European Medicines Agency (EMA) - An $11.8 million grant from the California Institute for Regenerative Medicine (CIRM) to support clinical development[7] This combination represents a promising approach to treating high-grade gliomas, which remain among the most challenging cancers with limited treatment options and poor survival rates.

Brand names

Ancotil

Other names

vocimagene amiretrorepvec