Aulos Bioscience Shares Positive Interim Phase 1/2 AU-007 Data at 2024 ASCO Meeting

Aulos Bioscience, a trailblazer in immuno-oncology, has disclosed promising interim results from its Phase 1/2 clinical trial of AU-007, marking a significant advancement in cancer therapeutics. AU-007 is a human IgG1 monoclonal antibody designed through artificial intelligence, aimed at leveraging interleukin-2 (IL-2) to combat solid tumors. These findings, slated for presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, underscore the potential of AU-007 in treating various solid tumors, especially among patients with extensive prior treatments.

Key Findings from the AU-007 Trial

Tumor Reduction and Patient Responses

The clinical trial data, as of April 9, 2024, involving 59 patients, have shown substantial and durable tumor shrinkage across multiple types of solid tumors. Highlights include:

- A patient with extensive metastatic melanoma, previously unresponsive to anti-PD-1 and anti-CTLA-4 inhibitors, showed a 76% reduction in tumor size after an AU-007 treatment combined with a low dose of IL-2.
- Another melanoma patient, whose disease also progressed despite checkpoint inhibitors, exhibited a 48% tumor shrinkage under a different AU-007 and IL-2 regimen.
- A head and neck cancer patient experienced a 32% tumor shrinkage in cervical bone metastasis and reported significant pain reduction and improved motor functions.
- A bladder cancer patient achieved a metabolic complete response after treatment with AU-007 and IL-2, despite prior progression through anti-PD-L1 therapy.
- Additional tumor shrinkages were noted in patients with renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and colorectal cancer.

Safety and Tolerability

AU-007 has demonstrated a well-tolerated safety profile with no cases of vascular leak syndrome or pulmonary edema. Most drug-related adverse events were mild (Grade 1 or 2), with exceptions including:

- One patient experienced a Grade 4 cytokine release syndrome (CRS), which was quickly resolved with steroid treatment.
- Five patients had transient Grade 3 or 4 lymphopenias, a known effect of IL-2 therapy, which did not lead to adverse outcomes.
- One patient with pre-existing anemia experienced a temporary escalation to Grade 3 anemia.

Pharmacodynamics and Pharmacokinetics

AU-007's unique pharmacodynamic and pharmacokinetic profiles have reinforced its therapeutic potential. The antibody has shown the ability to redirect IL-2 to bolster immune responses against tumors while minimizing immunosuppressive mechanisms. Specific outcomes include:

- Decreases in peripheral regulatory T cells and increases in CD8/Treg ratios, indicating effective IL-2 redirection.
- Elevated levels of peripheral natural killer (NK) cells.
- Dose-proportional pharmacokinetics with no neutralizing anti-drug antibodies and a half-life exceeding 15 days.

Future Directions

Aulos Bioscience is progressing with Phase 2 expansion cohorts, focusing on melanoma and renal cell carcinoma, and plans to present updated clinical data in late 2024. Additional cohorts will explore the combination of AU-007 and aldesleukin in second-line PD-L1+ NSCLC, with and without the PD-L1 antibody avelumab.

About AU-007 and Aulos Bioscience

AU-007 represents a pioneering approach in IL-2-based cancer therapy. By selectively binding to the CD25 portion of IL-2, AU-007 enhances anti-tumor immunity while reducing potential side effects like vascular leak syndrome and pulmonary edema. This novel strategy stems from the collaboration between Biolojic Design's machine learning expertise and Aulos Bioscience's deep immune system knowledge.

Aulos Bioscience is committed to revolutionizing cancer care by developing advanced IL-2 therapeutics. Their mission is to harness the immune system's power to target and eliminate cancer cells effectively, with ongoing research and development promising new treatment avenues for patients with advanced solid tumors.

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