A business enterprise recently announced its participation in ASCO 2023 (American Society of Clinical Oncology 2023) and BIO 2023 (BIO International Convention 2023), throwing its gauntlet in the biopharmaceutical industry. Axceso Biopharma, a new drug developer, is the company.

Starting as a cosmetics company in 2010, Axceso took its current shape in 2018 by ushering in CEO Park Young-joon, who had worked at Yungjin Pharm and Celltrion. The company recently completed a Series A investment of 6 billion won ($4.5 million) and has attracted funding of 9 billion won.

As of April, it has a slim staff of just 16 employees, but Axceso is confident of its potential. The company is nearing the nonclinical phase for “AX-0085,” an AXL inhibitor. It aims to develop AX-0085 as a best-in-class drug, targeting Ipsen’s Cabometyx (cabozantinib), the first AXL inhibitor that has won approval.

Many license-out (L/O) discussions have been held with global and domestic pharmaceutical companies.

Korea Biomedical Review interviewed Vice President Han Dal-ho to learn about the company’s research achievements and future business plans.

Question: Could you explain AX-0085, your flagship pipeline?

Answer: AX-0085 is an AXL inhibitor developed by Axceso. It has a mechanism of action that simultaneously inhibits the expression of PD-L1 protein and IDO1 protein induced by IFN-γ (interferon gamma). Dual inhibition is expected to suppress tumors and activate immune cells in the malignant tumor microenvironment (TME). It is being developed to treat non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). It is in the final stages of the nonclinical process, with complete safety data, including toxicity studies, expected later this year. We are preparing to apply for a phase 1 investigative new drug clinical trial.

Q: We understand this is your first participation in BIO 2023. What made you decide to join it?

A: We decided we were ready to deal with global big pharma and biotech firms. In November, a paper on AX-0085 was published in the SCI(E)-class international journal, Cells, titled “Restoration of T cell activity and anticancer efficacy of AX-0085.” We believe concrete discussions will be held as we demonstrated the antitumor effect and immune response activation of AX-0085 through this study.

At BIO 2023, we will introduce AX-0085 to Korean and foreign companies and discuss joint R&D and technology transfer. A meeting with a global big pharma company starting with the initial M is also scheduled. Technology transfer discussions for AX-0085 are already active. We are considering the possibility of tech transfer to two large Korean pharmaceutical companies.

Q: Your company has stated its ambition to develop AX-0085 into a first-in-class drug. What are the competing drugs, and what is the market size?

A: The only AXL inhibitor approved by the U.S. Food and Drug Administration is the targeted anticancer drug Cabometyx. While AX-0085 is not the first drug in the class, we expect it to have the same or greater anticancer effect at lower concentrations. While the exact market size for this class is unknown, there is a significant unmet need, as breast cancer, NSCLC, acute myeloid leukemia, and melanoma show the highest new prevalence in the U.S. in 2022.

Q: You have successfully closed our Series A funding. What are your plans for Series B and initial public offering (IPO) beyond that?

A: We are looking to conduct a Series B in the first half of next year. We expect it to coincide with our domestic and international phase 1 IND applications. We also plan to attract a bridge investment. We expect to go public around 2025.

Q: We are curious about your mid- to long-term business plans.

A: In R&D, we are exploring the possibility of expanding indications for AX-0085 and developing its combined therapy with immune checkpoint inhibitors, including Keytruda (pembrolizumab). On the business front, we plan to participate in the JPMorgan Healthcare Conference next year. We will speed up company introductions and collaborations as we have all three points -- new targeted kinase small molecular compounds, mechanism of action (MOA) identification, and research data.