Angiochem, a clinical stage biotechnology company developing drugs that are uniquely capable of crossing the blood-brain barrier (BBB), today announced the presentation of data for its lead drug candidate, ANG1005, a novel paclitaxel-peptide drug conjugate, at the American Society of Clinical Oncology 50th Annual Meeting in Chicago, IL. Phase 1 and Phase 2 clinical studies demonstrated promising signs of both CNS and peripheral anti-tumor activity of ANG1005 in patients with brain metastases including breast cancer patients. Based on these data, Angiochem also announced today that the company has initiated a Phase 2 clinical trial with ANG1005 designed to confirm this anti-tumor activity as a potential new approach to treating HER2+ breast cancer.
"The data being presented on our lead product candidate, ANG1005, underscores its potential utility in treating brain and peripheral metastases from breast cancer and other solid tumors," said Jean Paul Castaigne, M.D., President and CEO of Angiochem. "Effective management of patients with brain metastases continues to be a major clinical challenge. By actively penetrating the blood-brain barrier and cancer cells through LRP-1 receptor, ANG1005 elicits both CNS and peripheral tumor responses and provides a potential new treatment option for this difficult to treat patient population."
The data to be presented at ASCO includes results from a Phase 1 and initial Phase 2 clinical studies of ANG1005 in HER2+ and HER2- breast cancer patients and solid tumors with brain metastases in which promising signs of anti-tumor activity were observed both in CNS and at the periphery. These studies support the advancement of the newly-initiated comprehensive Phase 2 clinical study for ANG1005 in HER2+ breast cancer patients with brain metastases.
ANG1005 represents a first-in-class oncology product that leverages the low density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier (BBB) and enter cancer cells. In addition to the newly-initiated comprehensive Phase 2 clinical study in patients with progressive or recurrent brain metastases from HER2+ breast cancer, ANG1005 is also being evaluated in an ongoing Phase 2 clinical study in patients with primary brain cancers such as recurrent glioblastoma multiforme (GBM) and anaplastic glioma.
In a poster presentation entitled "Evaluation of CNS and peripheral antitumor activity of ANG1005 in patients with brain metastases from breast tumors and other advanced solid tumors," Nancy U. Lin, M.D., Clinical Director Breast Oncology at the Dana Faber Cancer Institute will present Phase 1 and Phase 2 clinical data which demonstrated the anti-tumor activity of ANG1005 on CNS tumors and peripheral metastases, providing additional patient benefit.
- In a Phase 1 dose escalating (30 to 700 mg/m2) clinical study of ANG1005 in solid tumors with progressive brain metastases 21 patients dosed with ANG1005 at ≥ 420 mg/m2 were evaluated for response including overall tumor response (CNS and peripheral).
- CNS: Four (22%) achieved partial responses (PR) and ten (56%) achieved stable disease
- Peripheral: Four (25%) achieved partial responses and 7 (44%) achieved stable disease
- In a Phase 2 open-label, single arm study with two cohorts (HER2+ and HER2-) breast cancer patients with brain metastases 61 and 32 patients were evaluated for CNS and peripheral tumor response, respectively, at the dose of ANG1005 at 550 mg/m2 or 650 mg/m2
- CNS: 15 (25%) achieved partial responses and 34 (56%) achieved stable disease
- Peripheral: 8 (25%) achieved partial responses and 16 (50%) achieved stable disease