Seven and Eight Biopharmaceuticals Inc. Announces the First Patient Treated in a First-in-Human Clinical Trial of the TLR7/8 dual agonist BDB018 in Advanced Solid Tumors

On June 23, 2021 Seven and Eight Biopharmaceuticals Inc., a clinical stage biotechnology company focused on developing proprietary novel immuno-oncology therapies to activate the immune system against cancer, reported that the first patient was treated in a First-in-Human Phase 1 clinical trial evaluating BDB018 in advanced solid tumors at Florida Cancer Specialists & Research Institute in Sarasota, FL (Press release, Seven and Eight Biopharmaceuticals, JUN 23, 2021, View Source [SID1234584279]).

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BDB018 is a next-generation intravenously administered Toll-Like Receptor 7 and 8 (TLR 7/8) dual agonist specifically designed to further enhance immune activation against cancer, while maintaining a favorable safety profile similar to its analogue, BDB001. BDB001 has shown to be well tolerated as monotherapy and in combination with an anti-PD-1 mAb, with responses seen in multiple advanced solid tumor types (SITC, 20201; ASCO (Free ASCO Whitepaper), 20212).

BDB018-101 (NCT04840394) is an open-label, dose escalation Phase I clinical trial evaluating the safety and tolerability of BDB018 in patients with advanced solid tumors that have relapsed or are refractory to standard treatments.

"We are excited to bring our next generation program with an intravenously administered TLR 7/8 dual agonist to the clinic, building on our success with BDB001," said Dr. Robert H.I. Andtbacka, Chief Medical Officer, Seven and Eight Biopharma, "The dosing of the first patient with BDB018 will begin to provide us with essential safety information needed to guide the future development of BDB018."

"Initiation of the BDB018-101 Phase I trial is another important milestone for Seven and Eight Biopharma in our mission to develop novel treatments for cancer and expand immuno-oncology treatments beyond targeting PD-1, PD-L1, and CTLA-4." said Dr. Walter Lau, Chief Executive Officer, Seven and Eight Biopharma.