Interview with StemCyte CEO Tong-Young Lee PhD

Tong-Young Lee, PhD, is a modest man who will repeatedly tell you that he “was lucky”, when it is clear that much of his success is the result of brilliance and hard work. Tong-Young Lee grew up in Taiwan and earned a PhD in pathology from Taiwan National University, the most prestigious university in Taiwan. He applied for post-docs at 100 schools in the US, and ended up going to Harvard to work with the late Dr. Judah Folkman. As a result of that experience, he participated in the development of the first three drugs that were approved to fight cancer as angiogenesis inhibitors. At that point, he was ready to leave academia and work for pharma in drug development. By then he was married and had a green card to stay in the United States. After weighing his offers from different organizations, Dr. Lee decided to return to Taiwan in 2010 to become deputy director of MicroBio, the largest biotech company in Taiwan. Since then, he has continued to rise in levels of leadership and responsibility. In 2016 he made his first foray into founding a start-up, the company Celtec that developed cellular immunotherapy for treating cancer, which was acquired in 2020. He later co-founded Protect, a company that brings immunotherapy to the field of animal healthcare, which is currently going public in Taiwan.

Dr. Tong-Young Lee was asked to serve as CEO of StemCyte in 2021. He had been familiar with StemCyte for over a decade, since MicroBio Group is their biggest shareholder. StemCyte is a multi-national biobank of cord blood and cord tissue that operates branches in the United States, Taiwan, and India. StemCyte has a hybrid cord blood bank that operates separate banks for family banking and public donations. In the past 27 years, StemCyte has provided more than 2300 cord blood units for transplants at over 350 treatment centers around the world. Under Dr. Lee, StemCyte has leveraged their public banking arm as a business advantage. One example is that clients of their family bank are offered “Public Bank Access”, a guarantee that if your child needs a cord blood unit from a donor, StemCyte will provide a matching unit from their public bank or pay for a matching unit from the global inventory. Another way of leveraging the StemCyte public inventory is their efforts to use donated cord blood as a resource for manufacturing CAR-T and NK cellular immunotherapies. StemCyte is also open to signing partnerships, such as the one they have with Cytoimmune Therapeutics, where StemCyte provides the raw material for the technology platforms of other companies.

StemCyte has applied for an IPO on the Taiwan stock exchange.

StemCyte has distinguished itself from most of the world’s cord blood banks by sponsoring multiple clinical trials. The currently active StemCyte trials are listed in the table below, and are also displayed in a diagram of their product development pipeline. These clinical trials are harnessing donated cord blood and cord tissue to treat a variety of neurologic disorders.

• The StemCyte trial for Post-COVID addresses a condition that covers large numbers of patients that have unmet needs. According to the WHO, about 1 in 5 patients experience at least one long term symptom following a COVID infection. In this trial, patients are receiving three infusions of RegeneCyte® from three cord blood donors, that are matched to the patient by blood type only. The efficacy endpoint evaluated is chronic fatigue, and preliminary results show that over 80% of patients recover to normal fatigue levels.
• The StemCyte phase 1 trial for acute stroke recently completed after running since 2014. It was very difficult to enroll patients for this trial because they had to be within a short time window after their stroke, but not have received other treatments. Stroke is the third leading cause of death and disability worldwide. The patients in the stroke trial gradually improved on the NIHSS scale of stroke severity and the Barthel Index of functional independence. Based on these outcomes, StemCyte has applied to both the USA FDA and the Taiwan FDA to run a phase 2 trial treating stroke with cord blood.
• The StemCyte phase 2 trial for Spinal Cord Injury (SCI) is a follow on to a previous trial conducted in China and it is currently enrolling. In this trial, the patients receive four small injections of cord blood mononuclear cells (the separated fraction of the blood that holds stem cells) directly into the spinal cord, accompanied by locomotor training.
• Cerebral Palsy is a pediatric disability caused by brain injury shortly before or after birth. In Taiwan, StemCyte has permission to treat patients diagnosed with cerebral palsy and related conditions under a Compassionate Use program. One patient that received UC-MSC responded with improvements in swallowing ability and muscle strength. Another patient that received cord blood responded with significantly reduced muscle tension and gained the ability to walk. Based on these case reports, StemCyte has received approval from the Taiwan FDA to run a clinical trial in which patients will receive three infusions of RegeneCyte® from three cord blood donors that are partially HLA matched. This will be the world’s first human clinical trial in which cerebral patients receive three infusions of donated cord blood.

The vision of Dr. Tong-Young Lee is for StemCyte to be a leading biotech company in the Asia-Pacific region and eventually globally. Dr. Tong-Young Lee believes that:

“The golden age of cell therapy will be the next decade.”