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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

EDISON, N.J.–()–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 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.

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, 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.

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 TLR7/8 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.

For more information, please visit http://www.7and8biopharma.com

References

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

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