FDA Clears IND of BAT8006 in Platinum-Resistant Ovarian Cancers

• The FDA has cleared the investigational new drug application for the antibody-drug conjugate (ADC) BAT8006 for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• BAT8006 is an innovative ADC targeting folate receptor α (FRα).
• The agent will now be studied in a phase 2 trial for this patient population.

The investigational new drug application for BAT8006, an innovative ADC targeting FRα, has been cleared by the FDA for a phase 2 study in platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.¹

BAT8006 is under development for the treatment of solid tumors, ovarian cancer, endometrial cancer, non-small cell lung cancer, cervical cancer, and breast cancers. The ADC is being developed based on Bio-Thera's ADC platform technology.

Ovarian cancer: © Dr_Microbe - stock.adobe.com

Preclinical studies of BAT8006 have shown good stability, safety, and strong antitumor activity.

In a phase 1 study (NCT05378737) of BAT8006 that is ongoing in China, the agent elicited responses and had a manageable safety profile when used for the treatment of patients with advanced solid tumors, including ovarian cancer, breast cancer, and cervical cancer.²

Among all evaluable patients irrespective of tumor type (n = 29), the objective response rate (ORR) observed was 31.0%. The disease control rate (DCR) in this group was 86.2%. Twelve patients had ovarian cancer with a tumor proportion score more than 25% and of these patients, the ORR was 58.3% and the DCR was 91.7%. Additionally, there were 2 partial responses seen in patients with breast cancer and endometrial carcinoma.

Of all 15 patients with ovarian cancer, about 75% had a FRα expression of more than 25%, and the majority of patients received more than 3 prior antitumor therapies, including bevacizumab (Avastin) and a PARP inhibitor.

Safety findings showed that the most common treatment-related adverse effects (TRAEs) observed among patients were neutropenia, thrombocytopenia, anemia, nausea, and vomiting. Interstitial lung disease, ocular toxicity, or severe hepatotoxicity were not seen among any of the enrolled patients. Further, no patients stopped treatment due to their TRAEs.

The dose-escalation study has completed and now, the dose-expansion and dose-optimization study is ongoing. Updated findings from this phase 1 study will be presented at future medical meeting.¹

REFERENCES:

1. Bio-Thera solutions receives IND clearance from US FDA to initiate a phase II study for BAT8006, an innovative antibody drug conjugate targeting folate receptor α. News release. Bio-Thera Solutions. March 25, 2024. Accessed March 25, 2024. https://tinyurl.com/2tjw4exr

2. Bio-Thera Solutions announces positive phase 1 clinical data for BAT8006 (folate-receptor-α-ADC) and presents phase 1 dose escalation study at the Bethune Obstetrics and Gynecology Forum. News release. Bio-Thera Solutions. August 13, 2023. Accessed March 25, 2024. https://tinyurl.com/4j2u6vz3