Introduction
It can be difficult and time-consuming to manage chronic and degenerative conditions. One example is wet age-related macular degeneration (AMD), a condition that causes abnormal blood vessel growth in the eye. These vessels leak fluid and scar the eye, affecting a person’s vision. The treatment for this condition is generally a monthly injection of eye medication.
AiViva has developed a treatment for this and other eye, skin, urinary tract, and cancer conditions that would provide more long-term relief. We spoke with AiViva founder and CEO Dr. Diane Tang-Liu about this new treatment and its potential applications.
Note: This interview was conducted over phone and email. It has been lightly edited for clarity and length.
In your own words, how would you describe your company?
AiViva is a clinical stage biotech company. We are a group of seasoned drug developers. The AiViva Team is committed to developing effective treatments to address diseases which currently have no cure or could be managed with better treatment options. Within a few years of the inception of AiViva, we have already opened several Investigational New Drug Applications (INDs) with the US Food and Drug Administration (FDA) and are conducting clinical trials in patients. With our extensive experience and passion, we believe we can do it.
What inspired you to take the leap and start AiViva?
I’ve always been a trailblazer. I am inspired by the profound impact pharmaceutical sciences has made and continues to make in developing medicinal treatments to improve and save lives. After decades of a successful career developing products to market entry, I decided to start AiViva to develop transformational medical treatments for diseases that currently have no cure or effective treatment options. Many of these diseases are manifested by abnormal growth of blood vessels and tissue, resulting in scarring of the tissues. For example, wet AMD robs older people of their sight. At AiViva, we have the potential to not only provide easier treatments but also potentially treat the root cause of this devastating disease. I am energized whenever I reflect upon AiViva’s incredible opportunity to make a positive impact in the world of medicine.
Who is on your team, and how did you come together?
Three professional colleagues and I decided to combine our extensive experience in the pharmaceutical industry and focus on making a difference. These four co-founders together have a stellar track record across the full spectrum of drug development, registration approvals, and commercialization, as well as fundraises, reverse mergers, and IPOs on the NYSE and Nasdaq.
How is AiViva transforming the biopharma industry?
Many diseases do not have a cure yet or do not have effective treatment because of the complex nature of their dysfunctions. AiViva’s drugs are selected for their ability to target multiple disorders at the same time. In other words, we aim to address the disease completely and effectively. We also understand the importance of patient convenience. AiViva’s JEL technology was developed to provide an efficient way to treat diseases.
Our phase-changing JEL is in liquid form at room temperature, making it easy for physicians to administer. Once JEL is placed at the diseased site under body temperature, it quickly hardens into a drug reservoir to provide a continuous presence of the drug for therapeutic effects. The advantages of this precision medicine are to achieve long local drug action and no systemic toxicity. We believe that delivering our drugs in JEL will transform the medical practices in the treatment of many significant diseases.
What does the competitive landscape look like, and how do you differentiate AiViva from other market participants?
Most of our competition for wet AMD is publicly traded and currently running their clinical trials. AiViva differentiates from our competition in two aspects. First, our competitors and current therapies only focus on the abnormal blood vessel growth of the disease. Many patients do not respond well to these monthly or bimonthly injections in the eye, develop drug tolerance and may become recalcitrant to these therapies. Their vision would continue to decline over time. AiViva’s drug AIV007 addresses not only the abnormal blood vessel growth, but also the underlying scarring process which is known to lead to irreversible long-term vision loss. Our drug has demonstrated positive proof-of-concept of vision improvement by reducing swelling and scarring. AIV007 clearly would become a real, effective option for wet AMD, a disease currently without a cure. Second, AiViva’s innovative JEL delivery technology would form a local drug reservoir to steadily release AIV007 in the eye for effective disease control over time. We believe we would provide the patient with a superior treatment option: a single treatment which could last over a roughly six-month duration. This would be a game changer in the industry. Current treatments are injections in the eye every four to 12 weeks with frequent doctor’s visits.
How do you intend to use the money you raise over the course of this round to scale the business?
We will use this money to start our clinical trial in patients of macular edema, i.e., patients of wet AMD and diabetic macular edema. The money will also be used for manufacturing clinical investigational products and for supporting ongoing operations. AiViva has already raised $10 million this year through venture capitalists and angel investors.
What’s the current product road map, FDA process, and timeline?
The FDA has three phases a new drug must complete and as well as demonstrate safety and efficacy prior to it being approved. The time frame can be up to 10 years in order to bring a drug from preclinical to phase 3 clinical trials. Currently AiViva has two phase 2 clinical trials, one focused on basal cell carcinoma and one on scarring. The results for these trials are expected in 2023. Our phase 1 wet AMD clinical trial, one that is based around the use of AIV007 in combination with our JEL technology, will be starting in early 2023. It will take approximately one to two years to complete.
Given the time-consuming nature of the approval process, how would you encourage investors to back AiViva?
AiViva’s corporate development maintains flexibility in our partnering, commercialization, and exit options. Our diverse pipeline is protected by our strong intellectual property positions, which will afford us market exclusivity beyond 2040 for any product coming out of development. We have filed more than 63 patent applications worldwide. We demonstrate the novelty of our assets, and so far 23 patents have been granted in major markets such as the US, Japan, China, Korea, Canada, and Australia.
AiViva has a track record of fiscal discipline, and this approach allows us to focus our current resources on ongoing clinical trials, extend our cash runway, and maximize value for shareholders.
AiViva’s management team has had a stellar record in strategic alliance, in and out license, merger and acquisition, and/or IPO.
What else do you want potential investors to know about you and/or your company?
I am intellectually curious by nature and have a strong sense of commitment to purpose. Innovation is a clear differentiator and drives growth. We invented cutting-edge delivery technology that can put a drug precisely where the disease is located and allow the drug to be released gradually over months so that patients would not have to take pills on a daily basis or suffer from injections in the eye every two months.
I believe in winning together by embracing diversity. Drug development requires strong teamwork, know-how, and discipline. The AiViva team collectively has very deep experience, covering more than 300 years of hands-on expertise in drug development, and has brought many successful billion-dollar products on the market. We aim to develop transformative treatment options. We believe that our hard work today will translate to improved quality of life for millions of patients tomorrow.
As you think about the business five to 10 years down the road, what do you see exit opportunities looking like? Have you set any future goals for the company?
We are result-oriented and currently focus on generating data of positive treatment outcomes in ongoing and upcoming clinical trials.
AiViva believes that collaboration is a highly effective way to advance the development of our innovative and novel treatments. We would embrace partners who share our vision and commitment to bringing transformative therapies to the millions of patients living with diseases that negatively impact their lives. AiViva could receive payments, such as upfront, milestone-based, and royalties.
As both an underrepresented minority and a woman, what challenges have you encountered in founding your company? What advice would you give to minority and women founders?
I came to the United States when I was 22 years old. Exploring American culture was an adventure and opened up a whole new world for me. Ever since then, I have embraced two wonderful cultures, Chinese and American. This broadens my perspective and gives me insight that I think many people with multicultural experiences will also appreciate. I strongly believe in the value of education and opportunity. I also believe in winning together by embracing diversity. I have had the privilege to work with many, many brilliant scientists and professionals.
Innovation is a clear differentiator and drives growth. It brings in changes and affects every aspect of our lives. Regardless of whether you are providing a service or product, always keep your customers in mind. You will be making a positive difference in their lives and their communities. Always keep a long-term view of your business initiatives and personal growth. Be resilient and disciplined.
We look forward to seeing where Dr. Tang-Liu and her team take the company. AiViva is currently raising on StartEngine.
