EDISON, NJ, USA I November 9, 2020 I 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, today announced interim Phase 1 results evaluating BDB001, its Toll-like receptor 7/8 (TLR7/8) agonist (NCT03486301), at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting to be held virtually November 9 – 14, 2020.

“The potential for BDB001, as an immuno-oncology backbone, in combination with anti-PD-(L)1 therapies is currently being evaluated in several clinical trials, and early findings are promising.”

The interim Phase 1 results show that intravenous administration of BDB001 as monotherapy is well-tolerated and induces robust immune activation resulting in clinical responses in solid tumors, including deep responses in anti-PD-(L)1 refractory tumors. BDB001 is an immune modulator capable of activating dendritic cells to initiate both innate and adaptive immunity against cancer. BDB001 is a first-in-class TLR7/8 agonist delivered intravenously, allowing for broader treatment of solid tumors compared to intratumoral TLR agonists in development.

“These initial data showing that BDB001 can be safely delivered intravenously and produce clinical responses in heavily pre-treated tumors are encouraging,” said Dr. Manish R. Patel, presenter of the BDB001 Phase I clinical trial abstract, and a study investigator.

“The responses seen with BDB001 in anti-PD-(L)1 refractory tumors are notable and will guide our development program in these difficult to treat tumors,” said Dr. Robert H.I. Andtbacka, Chief Medical Officer, Seven and Eight Biopharma. “The potential for BDB001, as an immuno-oncology backbone, in combination with anti-PD-(L)1 therapies is currently being evaluated in several clinical trials, and early findings are promising.”

“We are very excited about the clinical BDB001 monotherapy data as we advance our robust immuno-oncology pipeline in treatments beyond anti-PD-(L)1, including preclinical platform programs in TLR Ligand Antibody Conjugation,” said Dr. Walter Lau, Chief Executive Officer, Seven and Eight Biopharma. “Our assets will help us expand our programs globally.”

Presentation Details:

Title: BDB001, a Toll-Like Receptor 7 and 8 (TLR 7/8) agonist, can be safely administered intravenously ​and shows clinical responses in advanced solid tumors​
Abstract Authors: Manish R. Patel, Drew Rasco, Melissa Johnson, Anthony Tolcher, Lixin Li, Adam Zong, Alexander Chung, Robert H.I. Andtbacka
Abstract #: 324
Presenter: Manish R. Patel
Presentation times: November 9 – 14, 8:00 a.m. – 5:00 p.m. EST
Location: Virtual Poster Hall

The poster presentation will be available for virtual viewing at the SITC meeting website until December 31, 2020 and will also be made available on the Company’s website at www.7and8biopharma.com.

Full abstract:

Background: TLR agonists mediate antitumor activity through dendritic cell (DC) activation. Most TLR agonists in development are administered intratumorally allowing for less than 30% of advanced solid tumor to be treated. BDB001 is an intravenously administered novel TLR7/8 agonist that activates plasmacytoid and myeloid DCs and has shown to have activity in preclinical studies. Here we report on BDB001 administration in patients with advanced solid tumors.

Methods: BDB001-101 is a Phase 1, open label, dose escalation/expansion trial of BDB001 administered intravenously weekly in patients with advanced solid tumors. The primary endpoint was safety and tolerability. Secondary endpoints included efficacy, pharmacokinetics and pharmacodynamic profiling of immune activation.

Results: Thirty-six subjects with 16 different tumor types were enrolled across 5 dose levels. Sixty seven percent were female, median age was 66 years (range, 38-88), median number of prior therapies was 4 (range, 0-12), and 61% of tumors had progressed on prior anti-PD-(L)1 therapy. BDB001 was well tolerated and a maximum tolerated dose was not reached. Eleven (30.5%) subjects had no treatment related adverse events (AEs) and the majority of AEs were Grade 1 or 2. Three (8.3%) subjects had Grade 3 AEs, including 2 with a cytokine release syndrome, both of whom were clinically stable and had symptoms fully resolved within 2 to 5 days. There were no Grade 4 or 5 AEs. The most common AEs included chills/rigor (19.4%), fever (19.4%), fatigue (11.1%), nausea (11.1%) and pruritus (11.1%). Of 32 subjects evaluable for efficacy, best overall response rate was: 6% durable partial response, 56% stable disease, 38% progressive disease, for a disease control rate of 62%. Durable responses were seen in renal cell carcinoma and non-small cell lung cancer. Interestingly, clinical activity favored subjects with tumors that had progressed on prior anti-PD-(L)1 therapy, compared to prior DNA-damaging chemotherapy, within 6 months of BDB001 initiation. Median time on treatment was 12.1 weeks (range, 3.1 – 68.0). Transcriptional profiling showed up-regulation of interferon inducible genes, activation of dendritic cells and macrophages. BDB001 also significantly increased serum levels of interferon gamma and interferon inducible protein-10 (IP-10).

Conclusions: Intravenously administered BDB001 monotherapy was well tolerated. Clinical responses were achieved, supported by BDB001-induced immune activation. Preliminary findings suggest that BDB001 is a promising therapeutic option for patients with tumors that progress on anti-PD-(L)1 therapy. BDB001 is also being evaluated in combination with pembrolizumab (anti-PD-1, NCT03486301) and with atezolizumab (anti-PD-L1, NCT04196530).

About Seven and Eight Biopharma

Seven and Eight Biopharmaceuticals Inc. is an Edison, NJ-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 clinical trials in monotherapy and in combination with both anti-PD-1 and anti-PD-L1 monoclonal antibodies. BDB001 monotherapy Phase II clinical trials in anti-PD-(L)1 refractory tumors will commence in early 2021. For more information, please visit www.7and8biopharma.com.

SOURCE: Seven and Eight Biopharma