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Boundless Bio and Lilly Announce Clinical Trial Collaboration and Supply Agreement to Evaluate VERZENIO

Wednesday, September 20, 2023

Boundless Bio, a company focused on precision oncology, is partnering with Eli Lilly and Company in a clinical trial collaboration and supply agreement. This collaboration involves the provision of Eli Lilly's CDK4/6 inhibitor, Verzenio® (abemaciclib), to be used alongside BBI-355 in a clinical trial aimed at patients with locally advanced or metastatic solid tumors characterized by oncogene amplifications. BBI-355 is an orally administered inhibitor of CHK1, making it a pioneering therapy directed at extrachromosomal DNA (ecDNA) for oncogene-amplified cancers.

Zachary Hornby, the CEO of Boundless Bio, expressed optimism about the partnership, stating, “We are pleased to enter this supply agreement with Lilly to evaluate the combination of BBI-355 and abemaciclib in patients with ecDNA-driven solid tumors harboring CDK4 or CDK6 amplifications in our ongoing POTENTIATE trial. To date, CDK4/6 inhibitors have only been approved in HR+/HER2- breast cancer. Based on preclinical data, we believe BBI-355 has the potential to disable the underlying ecDNA driving oncogene amplification and unlock synergistic anti-tumor activity when combined with abemaciclib, potentially providing an important new treatment option for patients with CDK4 or CDK6 amplified solid tumors.”

Under this agreement, Lilly will supply abemaciclib for Boundless Bio's ongoing Phase 1/2 clinical trial, POTENTIATE, which is investigating BBI-355 in combination with selected targeted therapies, including abemaciclib, for patients with specific oncogene-amplified solid tumors.

POTENTIATE is a Phase 1/2 clinical trial designed to assess the efficacy of BBI-355 in patients with locally advanced or metastatic solid tumors featuring oncogene amplifications, particularly those that have not responded to standard therapies or have no further available standard or clinically accepted treatments.

The trial comprises three parts: BBI-355 as a single-agent dose escalation and expansion in cancer patients with oncogene amplification, dose escalation of BBI-355 in combination with certain selected targeted therapies in cancer patients with specific oncogene amplifications, and dose expansion of BBI-355 in combination with selected targeted therapies in cancer patients with specific oncogene amplification on ecDNA. BBI-355 is administered orally every other day. In the third part of the trial, an ecDNA diagnostic clinical trial assay (CTA) called ECHO (ecDNA Harboring Oncogenes) will be employed to identify oncogenes amplified on ecDNA in patient tumor samples. ECHO is a proprietary bioinformatic diagnostic algorithm developed by Boundless Bio in collaboration with SOPHiA GENETICS to detect oncogenes amplified on ecDNA from tumor biopsy samples using standard clinical NGS assays.

BBI-355 is a novel, orally administered checkpoint kinase 1 (CHK1) inhibitor and is believed to be the first ecDNA-directed therapy (ecDTx) for patients with oncogene-amplified cancer. CHK1 plays a central role in regulating the cellular response to DNA replication stress (RS), which often occurs due to oncogene amplification on ecDNA. By disrupting CHK1 function in oncogene-amplified cancer cells, BBI-355 is thought to induce catastrophic RS and selectively eliminate cancer cells while sparing healthy cells. CHK1 was identified as an essential ecDNA target using Boundless Bio's proprietary Spyglass research platform.

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