Baili Announces Clinical Trial Collaboration to Evaluate SI-B001, an EGFR x HER3 bispecific Antibody, in Combination with Tagrisso® in Patients with Non-Small Cell Lung Cancer

Rhea-AI Summary

Baili-Biopharmaceutical and SystImmune announced a collaboration with AstraZeneca to conduct a Phase 2a clinical trial assessing the efficacy of SI-B001, a bispecific antibody targeting EGFR and HER3, alongside AstraZeneca's TAGRISSO® (osimertinib) for treating non-small cell lung cancer (NSCLC). Initial Phase 1 results of SI-B001 indicated good tolerability and early efficacy signs. The financial details of the agreement remain undisclosed. This partnership aims to enhance treatment options for patients with NSCLC, a prevalent cancer type worldwide.

Positive

• Collaboration with AstraZeneca to evaluate SI-B001's efficacy in a Phase 2a trial.
• SI-B001 demonstrated good tolerability and preliminary efficacy in Phase 1 trials.
• Potential for SI-B001 and TAGRISSO® combination to improve treatment outcomes for NSCLC patients.

Negative

• None.

CHENGDU, China and SEATTLE and LONDON, May 13, 2022 /PRNewswire/ -- BAILI-BIOPHARMACEUTICAL CO., LTD. ("Baili") and its wholly owned subsidiary, SystImmune, Inc ("SystImmune"), announced today that it has entered into a clinical trial collaboration and supply agreement with AstraZeneca (LSE :AZN) (STO: AZN) (NASDAQ : AZN) to evaluate the combination of Baili's cancer therapy, SI-B001, an EGFR x HER3 bispecific antibody, in combination with AstraZeneca's third-generation, irreversible epidermal growth factor receptor ("EGFR") TKI, TAGRISSO® (osimertinib), in a new Phase 2a study, sponsored and conducted by Baili, for patients with non-small cell lung cancer ("NSCLC").

Dr. Yi ZHU, Founder, Chairman, and CEO of Baili commented, "SI-B001 has demonstrated good tolerability and early sign of efficacy during Phase 1 trial in China. We are excited about the collaboration with AstraZeneca to investigate the combination of SI-B001 and a leading third-generation EGFR TKI for patients with NSCLC. By combining SI-B001 with Osimertinib, we believe it has the potential to provide more effective treatment options for patients with NSCLC."

The financial terms of the non-exclusive collaboration have not been disclosed.

About SI-B001

SI-B001 is a bispecific antibody designed with the proprietary platform technology developed by Baili and SystImmune. It can bind to EGFR and HER3, and simultaneously inhibits the ligand induced EGFR×EGFR homodimers, the formation of EGFR×HER3 heterodimers and the activation of its downstream signal pathway. SI-B001 can also induce endocytosis of EGFR and HER3, and down-regulate the levels of EGFR and HER3 tumor cells. In preclinical studies, SI-B001 has demonstrated superior tumor killing activities. SI-B001 Phase 1 trials have shown good safety and preliminary efficacy.

About NSCLC and EGFR

Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.  More than a third of the world's lung cancer patients are in China. Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC. The majority of NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis. For patients with resectable tumors, the majority of patients eventually develop recurrence despite complete tumor resection and adjuvant chemotherapy.

Approximately 10-25% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR-mutated NSCLC. These patients are particularly sensitive to treatment with an EGFR TKI which blocks the cell-signaling pathways that drive the growth of tumor cells.

About Baili

Baili is a biopharmaceutical company focusing on the research and development, manufacturing, and commercialization of medicines for cancer and other diseases. With strong R&D teams in both China and US, it has developed fully integrated proprietary platforms in bispecific, multi-specific antibodies and antibody-drug conjugates. Its highly differentiated platforms have generated a pipeline of six clinical stage anti-cancer drug candidates. The Company also has state-of-the-art manufacturing capability designed and built to meet cGMP standards.

With multiple in-house proprietary platforms for innovative biopharmaceuticals, Baili has built a robust pipeline to benefit cancer patients around the world.

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SOURCE SystImmune Inc.

FAQ

What is the purpose of the clinical trial involving AZN?

The trial aims to evaluate the efficacy of SI-B001 combined with AstraZeneca's TAGRISSO® for patients with non-small cell lung cancer.

When was the collaboration between Baili and AZN announced?

The collaboration was announced on May 13, 2022.

What are the initial results of SI-B001 in clinical trials?

The initial Phase 1 trials indicated good tolerability and early signs of efficacy for SI-B001.

What is SI-B001 and its significance?

SI-B001 is a bispecific antibody targeting EGFR and HER3, designed to enhance treatment efficacy for NSCLC patients.

How does the collaboration with AZN impact shareholders?

The collaboration represents a strategic partnership that could lead to enhanced treatment options, potentially impacting the market perception positively.