By Rich Soll, Senior Advisor, Strategic Initiatives at WuXi AppTec (@richsollwx)
Viela Bio, a new spin-out from biotech trailblazer MedImmune, expects to bring new hope to patients who suffer from autoimmune and inflammatory diseases via its robust pipeline of unique molecules. Armed with a recent $250 million Series A, Viela Bio plans to develop medicines for severe autoimmune diseases by targeting critical pathways that are the root cause of disease. MedImmune will contribute three clinical and three pre-clinical potential new medicines to Viela Bio.
The new company is being funded from a consortium of investors led by Boyu Capital, 6 Dimensions Capital, and Hillhouse Capital, along with Temasek and Sirona Capital. MedImmune’s parent, AstraZeneca, will remain the largest minority shareholder of Viela Bio.
Viela Bio will use the proceeds from the initial financing to deliver the Phase II study of inebilizumab, efficiently develop the early-stage portfolio and continue exploring existing and novel pathways for next-generation inflammation and autoimmune therapy. Inebilizumab, which has received Orphan Drug Designation from the US Food and Drug Administration and the European Medicines Agency, is being evaluated for the treatment of neuromyelitis optica, a rare condition that affects the optic nerve and spinal cord in approximately five in 100,000 people.
Leading Viela Bio’s valiant effort is its CEO Bing Yao. Yao, who has spent more than two decades in the biopharmaceutical industry, has a track record of leading successful discovery and development of multiple biotherapeutics. Most recently, he was Senior Vice President, Head of Respiratory, Inflammation, Autoimmune iMED, MedImmune, AstraZeneca. During his tenure at MedImmune, he played key leadership roles in the development and approval of three novel biologics for autoimmune, respiratory, and immune-oncology indications respectively. Yao was also Senior Vice President, Head of Immuno-Oncology Franchise, AstraZeneca. In addition, he was the CEO for WuXi-MedImmune Joint Venture. Bing joined MedImmune in 2010 from Genentech, where he was the Head of PTL for Immunology, Infectious Diseases, Neuroscience, and Metabolic Disease.
I recently talked with Yao about Viela Bio’s unprecedented launch, the company’s strategy in developing its robust pipeline for high unmet medical needs, and why he believes we are in the ‘Golden Age’ for biotech drug development.
Rich Soll: What triggered the launch of Viela Bio and why now?
Bing Yao: I had been with AstraZeneca/MedImmune for more than seven years before the Viela Bio spin-out. We were able to build a strong pipeline for respiratory, inflammation, and autoimmunity diseases. Multiple molecules from our pipeline progressed into late stage, and two of them were approved and marketed. However we were constrained by resources and not able to fully develop all drug candidates. Having led the group to develop the inflammation and autoimmunity pipeline, I like the science behind these molecules and believe in their potential. We thought that if we could raise sufficient outside financing, we might be able to fully and optimally develop those assets and bring them to patients in an accelerated manner.
Rich Soll: What’s your vision for the company?
Bing Yao: The autoimmune therapeutic area has an extremely high unmet medical need. There are over 80 different types of autoimmune diseases, and for a vast majority of them, there are no approved therapies. The different types of autoimmune diseases, however, frequently share some common disease pathways. Our vision is to pioneer and advance treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease target shared pathways, and build a fully integrated biotechnology company based on those treatments, helping millions of patients worldwide
Rich Soll: Some of the disease indications that you’re targeting are rare diseases. What is your choice of disease indications based on?
Bing Yao: Some of the autoimmune diseases are rare, while others are common. We select indications based on sound science. Once we demonstrate a drug works for one indication, we can rapidly expand the treatment into multiple other indications that share the same disease pathway.
Rich Soll: When you look at your assets in terms of their competitive advantage or differentiation, how would you classify these?
Bing Yao: We have six well differentiated assets, and most of them are unique. Such as in the case of inebilizumab; we are the first one to take an anti-CD19 antibody into the neuromyelitis optica (NMO) indication.
Rich Soll: So that’s your lead molecule at this point?
Bing Yao: Yes. I also want to mention that we have tested inebilizuamb in a Phase 1b clinical study for two other inflammation and autoimmune indications. The results from those trials suggest additional potential development opportunities. And we are actively evaluating and identifying the next indication.
Rich Soll: Can you share with us the rest of your pipeline?
Bing Yao: VIB4920 targets a pathway that has had a lot of clinical validation previously. However, when people use the full antibody, it leads to thrombocytopenia because of the Fc portion. For our molecule, we use a novel technology to develop an antibody like molecule without Fc to address potential safety concern. We anticipate we will complete the Phase 1b this year and then make the decision for Phase 2.
Rich Soll: Then there’s VIB7734.
Bing Yao: VIB7734 is a monoclonal antibody against the target called ILT7. As far as we know, we are first in this class. We have been very creative in how we develop this molecule. Even in the current Phase 1 trial, we have enrolled patients with five different types of autoimmune diseases.
Rich Soll: What other molecules are you developing?
Bing Yao: We have two other molecules in pre-clinical and one in research stages. We already finished the pre-clinical study for one, and plan to bring it into Phase 1 clinical trial this year. It’s a novel molecule targeting a receptor in an innate cell type. It has potential to target a number of different immune complex-driven diseases.
It’s wonderful to have this portfolio to jumpstart Viela Bio. We have a very rich and balanced portfolio from research all the way to the potential for registration in the next two-to-three years. That’s one of the reasons why personally I’m so excited about this opportunity.
Rich Soll: You have put together an outstanding team. What role will this team play in the success of the company?
Bing Yao: I think that’s the number one ingredient for the success of a biotech company. We do have a very experienced management team as well as team members who have deep expertise in autoimmune research and development. This team has proven track record to bring molecules from R&D to regulatory approval. Our CMO, the head of R&D, Dr. Jorn Drappa, who was trained as a physician scientist is an expert in the autoimmune diseases area. He started his career with Amgen and worked with Genentech and at MedImmune as vice president of clinical development. We also have Soraya Madani. She has been the team leader of inebilizumab for many years, and has extensive Regulatory affairs experience, since she started her career with the FDA as a reviewer. She will be leading our portfolio as well as regulatory group. In addition, Aaron Ren, who has drug development and business experience, will run operations and business development. In addition to the management team, we have a team of experienced clinicians, talented in clinical operation, research, and translational sciences.
Rich Soll: You have your company, your assets, your team, and you have capital. What was your strategy in seeking out key investors?
Bing Yao: We raised sizable capital to fully develop the molecules in our pipeline. We are very happy with the consortium of investors. When we went out to raise capital, we had quite a few criteria. First, they have to have a good track record and experience in biotech investing. Secondly, they have to be committed to longer term – as you can see we have a pipeline and we want to be able to build a fully integrated biotech company and a commitment to the long-term success of the company is critical. Thirdly, because of the amount we intended to raise, it needs to be well capitalized. We feel fortunate that there’s a lot of enthusiasm from the investor community.
Rich Soll: So with the capital in hand, what do you hope to accomplish over the next couple of years?
Bing Yao: The funding will be used to progress our pipeline. The highest priority is inebilizumab and the ongoing Phase 2 study. We anticipate the data readout by the end of the fourth quarter of 2019 or first quarter of 2020. That’s an important milestone for us. We will also complete the phase 1b clinical study for VIB4920 and make the decision on Phase 2. For VIB7734, we plan to complete the Phase 1a, and enter Phase 1b. In addition, we also plan to bring the fourth molecule into a first-in-human clinical study.
Rich Soll: Will you be ramping the research as well or will you take a more conservative approach until you get these later stage milestones completed?
Bing Yao: That’s a good question. We believe that scientific research is the foundation of biotech companies. We do have a research group with talented scientists. Near term, for a company of our size with six molecules, and potential for multiple indications for each molecule, there is a lot to be done with indication selection and translational sciences. One differentiation for Viela Bio is our deep expertise in the autoimmune and inflammatory disease areas. We are not going to have a big research organization, but we will have sufficient research capability and talents in research and translational sciences to continue to look for the next big breakthrough in the autoimmune and inflammatory disease areas.
Rich Soll: Five years from now, what do you hope to achieve?
Bing Yao: Our goal is pretty simple: It’s to bring these medicines to patients and do great science. We hope that some of our molecules will be either available to patients or close to being available to patients. If we are able to bring even one drug to the patients, and market it, I would think we are successful.
Rich Soll: Do you have any closing thoughts on the company or about what you want to accomplish?
Bing Yao: I’m personally really excited about this new opportunity. We believe that we have the key ingredients to be successful – rich pipeline assets, an experienced and motivated team, strong financial backing, and support from AstraZeneca/MedImmune.
Rich Soll: You have had such an illustrious career and got this company off the ground with such great assets. It must be a real milestone for you. When you look back on your career, what has been your proudest achievement to date?
Bing Yao: I am passionate about science and about developing therapies for patients. MedImmune provided a great environment for people to do both. With a strong support, I was very lucky to play important roles that led to the approval of three novel biologics during my time at MedImmune. These medicines are helping patients suffering from psoriasis, severe asthma, and lung cancer.
Rich Soll: What lessons have you learned along the way?
Bing Yao: It’s about science and resilience. Along the way there are a lot of surprises too. For example, the drugs targeting IL17/IL17 receptor were first tried for rheumatoid arthritis, Crohn’s disease among others. There were not successful. However, the drug was incredible effective for psoriasis in clinical studies, and later on approved and marketed. We need to be persistent if we believe in the science of the molecule and we should not give up easily.
Rich Soll: What kind of message would you give to young people entering this industry?
Bing Yao: Biotech and drug development are extremely exciting and highly rewarding. Every time you think about how you can help patients, it’s an unbelievable experience; nothing is comparable to that feeling. On the other hand, drug development is a long process. You have to love what you do and not be afraid of failure.