"Based on our in vivo data for our lead CEACAM1/5 antibody YB-200, we have obtained orphan drug status from FDA for the treatment of liver cancer."

Katrin Rupalla

CEO, YMMUNOBIO

May 31, 2023

Could you present Ymmunobio and key milestones since the firm's creation?

We founded the company in 2021. Based on our extensive experience in drug development in oncology, our team is focusing on finding solutions to one of the highest unmet medical need areas in oncology through innovation. We have identified gastrointestinal (GI) cancers as the top priority, as one in three cancer deaths are related to gastrointestinal cancer. Reasons for the high mortality include late diagnosis, current treatments not being very effective and there has been little innovation over the last decade in treating GI cancers. In response, we bought the patent family for two novel classes of antibodies CEACAM1/5 agonist and NPTXR antibodies, which have a strong scientific rationale for potentially treating GI cancers. We have conducted in vitro and in vivo preclinical studies and have established the proof of principle for both compounds. Based on our in vivo data for our lead CEACAM1/5 antibody YB-200, we have obtained orphan drug status from FDA for the treatment of liver cancer.

How are the YB-200 and YB-800 candidates shaping up, and what will the Orphan Drug Designation by the FDA mean for the development of YB-200?

On of our main study focus has been how to attack cancer cells through the different, but complimentary mechanism of action – one being through stimulating the immune response and the other being direct cytotoxicity of cancer cells. We, therefore, explored the development of two monoclonal antibodies, one for immune-oncology (YB-200) and one for direct cytotoxicity (YB-800), and how they can be used to fight cancer. The YB-200 antibody stimulates the immune system to fight cancer cells, while the YB-800 antibody targets directly tumor cells and inhibits their growth. We obtained the orphan drug designation from the FDA for YB-200 in liver cancer and are moving towards IND-enabling studies. We continue to see the potential to extend the pipeline by building on these two meachanism of action. Obtaining an orphan drug designation can provide significant benefits for a company developing a rare disease treatment, both in terms of regulatory support and financial incentives.

How can monoclonal antibodies help fight gastrointestinal cancer?

The immune-oncology mechanism of action of the CEACAM1/5 antibodies has the potential to treat a wide range of cancers by harnessing the power of the immune system to fight tumors. The direct cytotoxicity of the anti-NPTXR antibodies on the tumor cells could provide a potential new targeted treatment for patients whose tumors neo-express NPTXR. The focus is currently on gastrointestinal cancers due to a strong scientific rationale of both antibody classes, but the mechanisms are applicable across different cancer types.

What is your analysis of the funding environment for biotech in 2023?

As a board member of two biotech companies that recently went public, I believe it is still difficult and expensive to raise money for small biotechs. Companies must rigorously prioritize to advance projects that have a high probability of success and represent a true commercial opportunity and then put “all hands on board” to advance these projects. There is currently less appetite to invest in new targets and more validation is required before investors are willing to commit larger sums. Companies should ensure they have raised money when they have good data and try to build a sufficient cash reserve to be able to advance their key project to the next company value inflection point.

Why do you think Ymmunobio is going to be a great story in the future?

Our focus is identifying and addressing the unmet medical needs of patients with gastrointestinal cancers by seeking strong scientific solutions. Our priority is to ensure that patient needs are at the forefront of our mission. We are confident that our efforts will lead to positive outcomes for these patients.

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