Distinguished Professor Nan-Shan Chang at the Institute of Molecular Medicine at NCKU, who discovered a small drug peptide named Zfra or dubbed “Zffi”, signed a cooperation agreement with an Indian Biopharmaceutical company Lazuline Biotech Pvt. Ltd (www.lazulinebio.com) based at Hyderabad early in September this year. Both research teams will work together on Zffi for drug and vaccine development. Hopefully, clinical trials for Zffi in treating cancer and Alzheimer’s disease (AD) will start in India sometime between 2022 and 2023. This marks a significant milestone in recent international collaborations.
Distinguished Professor Nan-Shan Chang
“Currently, there are no effective drugs in treating and preventing AD on the market”, Chang put it. As a technical innovation, Chang group has developed a single immunization shot of Zffi in individuals at childhood or middle ages. The treatment will activate a novel link in the immune system to fend off cancer and retard neurodegeneration as one grows older.
AD is an abnormal aging process of the brain that dramatically devastates the normal way of our thinking, memory, communication skill, and social behavior. The resulting estranged and erratic behavior in AD patients has been causing a lot of burden for families and societies. AD is the most common type of dementia among the elderly. Onset of AD may occur as asymptomatic in the middle age, and then the disease is gradually getting worse and worse over a period of 20 to 30 years and even longer. If Zffi works properly, it is expected to mitigate AD progression with age. Without doubt, a new drug for preventing AD is of particular importance in meeting the need of human families and societies.
Alzheimer's Disease International (ADI) projected that the total number of people with dementia around the world will reach 152 million by 2050. The Taiwan Alzheimer Disease Association also pointed out that the number of people with dementia around the world is growing every year; on average, a new patient is diagnosed with dementia every 3 seconds. For this reason, prevention and treatment are issues that are imperative to the survival of the human race.
NCKU Professor Chang and Lazuline Biotech Pvt. Ltd
Two decades ago, Chang’s team in the Guthrie Research Institute, PA, USA, was the first to discover the WWOX gene and linked its role in AD. The National Health Institutes (NIH) USA announced last year that WWOX gene is one of the newly identified risk factors for AD. Zffi is a binding partner with WWOX. During his tenure in NCKU since 2007, Chang has collaborated with neuroscientists Professors Chun-I Sze and Yu-Min Kuo to unravel the role of Zffi in mitigating the symptoms of AD in mice, and importantly restoring and preventing memory loss. To initiate the research work out of scratch, Chang has secured two medical research funds from the U.S. Department of Defense under high competitions.
Chang emphatically explained the underlying mechanism for Zffi action is mainly due to Zffi activation of the body’s immune system. Aside from the widely known T and B cells, Chang discovered a novel lineage of immune cells in the spleen called “Z cell”. Zffi activates the spleen Z cells in the body to fight against the progression of cancer and AD. Accordingly, Zffi is now being developed as a vaccine for Z cell activation. Activated Z cells can recognize the presence of cancer cells in the body and sense the progression of neurodegeneration in the brain. Z cells manage to block and prevent the disease progression.
For a new drug, the effort from bench work to clinical trials is tremendous and may take more than 30 years. In most cases, the rate of failure for a new drug in clinical trials is very high. The joined effort between NCKU and Lazuline Biotech will inevitably accelerate and streamline the drug development process. Both teams are confident in paving the way toward success and bring the research from bench to bedside for the enduring benefit of mankind.
Dr. Giri, an Indian alumnus of the Microbiology and Immunology Institute at NCKU, was aware of the international influence that medical research at NCKU has. After he returned to India, he kept seeking opportunities for transnational collaborations with advanced pharmaceutical companies, and he became the main contributor behind this transnational collaboration between NCKU and Lazuline Biotech. The pioneering academic achievements and new drug manufacturing processes of research teams at NCKU have a promising future.
NCKU Professor Chang and Lab member
Chang pointed out that international technology transfer and incubation projects are hard to come by. The exchanges in ideas, differences and common interests between the two parties had lasted more than a year, and each decision was made after careful deliberation. Lazuline Biotech owns a cGMP (current Good Manufacturing Practice) facility for the manufacturing of biosimilars and vaccines and also R&D facility in Hyderabad, which lies in the heart of India and is the fourth largest city in India with a population of around fifteen million people. It has a sound infrastructure and is a crucial hub for transportation to the Middle East and Southeast Asia. In its industrial park, there are over a hundred biotechnology companies, an industry the Indian government is continually investing in. A number of foreign companies also have headquarters or research centers here. Hyderabad has been the center of pharmaceuticals and biotechnology in India since the 1990s. At present, Lazuline Biotech is working on developing novel biotherapy products such as Recombinant Albumin, Industrial enzymes and Antigens for global markets.
To protect and support local pharmaceutical companies, the Indian government has introduced a number of policies and regulations in recent years that benefit their development. As a result, pharmaceuticals and its related industries have flourished, thereby resolving India’s past overreliance on imported drugs and elevating India to a pivotal position in the global pharmaceutical industry.