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Lynn Fosse, Senior Editor
Steve Alexander, Associate Editor
Bud Wayne, Marketing
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Christy Rivers -
Zhiyong Yang PhD
Elizabeth Smith, CBO Fzata
Interview conducted by:
Lynn Fosse, Senior Editor
Published – July 18, 2022
CEOCFO: Dr. Yang, what is the idea behind Fzata, Inc?
Dr. Yang: We are developing a therapeutic biologics platform with the vision of reducing health inequities by expanding patient access to biologics. Conventional biologics are very large and complex protein drugs. These are expensive and are administered mainly through IV injection or infusion. To address these problems, we developed a first-
BioPYM is patient friendly, safe, easy to manufacture, and unlike conventional biologics, there is no need for cold-
CEOCFO: What are the challenges? How did you go about creating this?
Dr. Yang: For BioPYM we had to break the barrier of engrained thinking to create this completely novel, first-
CEOCFO: Where are you in the development process?
Dr. Yang: We have spent years developing and optimizing the BioPYM this platform. We have now developed about a dozen therapeutic drug candidates that have been proven out in their respective animal models. The front runner of our products is FZ002 for C diff infection, which is an urgent threat to US health. FZ002 is in GMP manufacturing right now. It is projected to enter first-
CEOCFO: Would you tell us a little bit about the importance of the gut?
Dr. Yang: Yes. Previously people just thought of the gut as an organ for food digestion and passage. However, more and more data are telling us that the gut is connected to many different systems, like the brain, the heart, the liver, the skin, and even oral health. Therefore, we call it gut-
CEOCFO: Fzata is working on something for diabetes as well. Tell us about that if you would?
Dr. Yang: Yes, one of the products in our pipeline, FZ010, is targeting diabetes. We used our BioPYM platform to genetically modify yeast to secrete a cytokine that has been proven to alleviate diabetes. Then we tested the yeast drug in a couple of animal diabetes models. In one model, we fed the mice with a high fat diet, and then the blood glucose level in the mice quickly rose up. However, if we fed the mice a high fat diet plus our candidate FZ010, we could significantly bring the blood glucose level down. We also tested FZ010 in some transgenic mouse diabetes models, and we saw similar blood glucose level reducing effects. We are super excited about bringing an oral solution to diabetes to the market and the potential impact FZ010 may have for patients.
CEOCFO: Would you tell us about the Nova Innovation Award?
Dr. Yang: Yes, we are very honored to have received that award! That is the Mid-
CEOCFO: What is the interest from the medical industry? Do they recognize what you are doing?
Dr. Yang: Yes. Currently the medical industry is keenly interested in oral delivery of biologics. We received consistently positive feedback at the BIO 2022 convention in June. We are now engaged in conversations with multiple pharmaceutical companies and we are pursuing collaboration opportunities for Fzata.
As I mentioned, our BioPYM is very patient friendly, and it also has a lot of other competitive advantages compared to the currently available therapeutics. For example, with Inflammatory Bowel Disease (IBD), Humira® or other biologic treatments are administered with a needle. They can be very effective at the beginning of treatment, but they gradually lose their effect when the body mounts an immune response, attacking the drug after repeated use. This causes safety issues and patients have to switch drugs. Oral BioPYM is superior. It directly targets the gut, avoiding side effects. Patients are expected to be able to use an oral BioPYM drug long-
With all of these clear advantages, the medical industry is highly interested; however, they are awaiting our clinical results. After all, it is a first-
CEOCFO: Are you seeking investment, funding, or partnerships?
Dr. Yang: Yes. We are proud to have already raised $17M non-
CEOCFO: What is the interest from the investment community?
Dr. Yang: Their response is similar to that of the pharmaceutical companies. They are very excited and show great interest. Although we have very beautiful animal data, they want to see how it will work in humans, which we will see in 2023 clinical trials.
CEOCFO: What are your next steps? What does the next year or so look like for Fzata?
Dr. Yang: Right now, our leading compound is under good manufacturing practices (GMP) manufacturing to be used for human phase 1 clinical trial. We really want to wrap up the GMP run, talk to the FDA in a pre-
CEOCFO: There are so many ideas and so many companies to look at in health. Why pay attention to Fzata, Inc? Why is the company important?
Dr. Yang: We are bringing a novel modality of biologics to the medical field. With removal of needles, our oral innovation is expected to be really patient friendly, efficacious and safe and also cost-
Fzata, Inc. | Zhiyong Yang PhD | Biologic Therapeutics | Oral Biologics | GI Biologics | Fzata developing breakthrough Biologic Therapeutics Modality in a Pill | CEO Interviews 2022 | Medical Companies | Biologic therapy, Biologics in a pill, Crohn’s Disease, C. diff infection, Gastrointestinal, Gut health, Humira, Gut-
“We are bringing a novel modality of biologics to the medical field. With removal of needles, our oral innovation is expected to be really patient friendly, efficacious and safe and also cost-
Zhiyong Yang PhD