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Seven and Eight Biopharmaceuticals Inc. Announces the First Patient Treated in a Phase 2 Clinical Trial of the TLR 7/8 dual agonist BDB001 in anti-PD-1 / anti-PD-L1 Refractory Solid Tumors

EDISON, N.J.--(BUSINESS WIRE)--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, announced today that the first patient has been treated in a Phase 2 clinical trial evaluating BDB001 in advanced solid tumors at The University of Texas MD Anderson Cancer Center in Houston, TX.

BDB001 is an intravenously administered Toll-Like Receptor 7 and 8 (TLR 7/8) dual agonist specifically designed to enhance immune activation against cancer. 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, 20212).

BDB001-201 (NCT04819373) is an open-label, multi-arm Phase 2 clinical trial evaluating the efficacy, safety and tolerability of BDB001 in patients with advanced solid tumors that have progressed on anti-PD-1 or anti-PD-L1 mAb treatment.

“There is significant unmet need for effective treatment options for patients with anti-PD-1 / anti-PD-L1 refractory tumors,” said Dr. Robert H.I. Andtbacka, Chief Medical Officer, Seven and Eight Biopharma. “In our BDB001 Phase 1 clinical trial there was evidence of response in these tumors. We are excited to further explore the role of BDB001 in anti-PD-1 / anti-PD-L1 refractory tumors in a Phase 2 setting.”

“As an intravenously administered TLR 7/8 agonist, BDB001 has the potential to become a cornerstone of cancer immunotherapy. This Phase 2 program is an important milestone in our mission at Seven and Eight Biopharma, to develop novel treatments for cancer that expand immuno-oncology beyond PD-1, PD-L1, and CTLA-4,” said Dr. Walter Lau, Chief Executive Officer, Seven and Eight Biopharma.

About Seven and Eight Biopharma

Seven and Eight Biopharmaceuticals Inc. is an Edison, New Jersey based, clinical stage biotechnology company focused on the development and commercialization of novel immunotherapies for cancer. The company specializes in TLR 7/8 programs to treat cancer and has built a comprehensive global intellectual property portfolio in the category of toll-like receptor modulators. Managed by a seasoned team of professionals, the company is progressing a proprietary pipeline of cancer therapeutics in the U.S., with the lead product BDB001 in Phase I and Phase II clinical trials in monotherapy and in combination with both anti-PD-1 and anti-PD-L1 monoclonal antibodies.

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1 J Immunother Cancer 2020;8 (Suppl 3) A324
2 J Clin Oncol 39, 2021 (suppl 15; abstr 2512)


Robert Andtbacka, MD, CM
Chief Medical Officer
Seven and Eight Biopharmaceuticals Inc.
+1 (848) 300-0086

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Last Updated: 07-Sep-2021