In 1893, William Coley, a New York orthopedic surgeon, accidentally discovered that postoperative streptococcus pyogenes infection caused tumor regression in patients with sarcoma, which opened the prelude to immunotherapy. After countless explorations, although immunotherapy has added milestones one after another to the history of human anti-cancer, this marathon is far from reaching the end. In 2018, under the era of great changes in the China medical system and investment environment, Dr. Xin Dong believes that immunotherapy will set off a new revolution and bring infinite possibilities to life. Dr. Dong founded Neologics Bioscience (Neologics) and committed to the development of "global new" R&D pipelines for the immune regulation mechanism of anti-tumor and inflammation based on innovation. In May of this year, the IND application for NB002, the first new drug of Neologics, was approved by the FDA for clinical approval, successfully taking a key step towards internationalization.
Neologics Bioscience
As an innovative pharmaceutical company established less than 5 years, what is the strength of Neologics Bioscience in the field of tumor immunotherapy? How Neologics Bioscience establishes and consolidates the competitive advantage? What are the current challenges facing in the field of tumor immunotherapy? What transformative treatments will the future usher in? To this end, Shanghai Medicilon Inc. (Medicilon) interviewed Dr. Xin Dong to get a glimpse of his profound insights in the field of immunotherapy, and "learn from the experience" to grow in the era of new drugs.
Dr. Xin Dong
Founder, Chairman & CEO of Neologics Bioscience
A leading entrepreneurial talent in Suzhou Park, graduated from Sichuan University, and received the master degree and a doctorate in biochemistry from the University of Science and Technology of China and the Ludwig Maximilian University of Munich, Germany, respectively. After that, Dr. Dong worked as a postdoctoral researcher in dendritic cell antigen presentation, tumor immunity and autoimmunity at the University of Pittsburgh Cancer Center and UCSD Howard Hughes Medical Institute. He worked as an assistant professor in the Rheumatology Department of UCLA School of Medicine and LIAI. After entering the industry, he worked in PaxVax, Biogen-Idec's BI³ Innovation Incubation Center, Crown Biotech, and Galaxy Biomedical. Dr. Dong has also participated in entrepreneurship in China and the United States, including PersImmune, IASO Biotherapeutics, etc.
A corner of Neologics Bioscience Office
Dr. Dong: NB002 is a monoclonal therapeutic antibody targeting a unique epitope of TIM-3, which has a significant single-drug anti-tumor effect. It can significantly activate the activity of T and NK cells and enhance their ability to fight tumors. According to the crystal structure, NB002 can interact with specific epitopes of TIM3, such as tyrosine 82, and its functional mutation phenotype leads to excessive immune function in some familial hereditary leukemia patients, especially the activation of inflammasomes. In particular, NB002 can also restore the antigen granuloblast response ability of DC, effectively enhance the killing effect of the immune system on tumors, and turn "cold" tumors into "hot" tumors.
I special thank to Medicilon for their support. In preclinical animal experiments, since mice and monkeys do not have the TIM-3 epitope to which NB002 specifically binds, Medicilon established a transgenic mouse toxicity test model, which helped Neologics Bioscience's NB002 successfully obtain FDA clinical approval.
R&D Laboratory of Neologics Bioscience
Dr. Dong: The positioning that Neologics Bioscience has always insisted on is the pursuit of differentiation, hoping to maintain a leading position in the world. We hope that the phase I clinical trial of NB002 will demonstrate the efficacy and new mechanism of action consistent with preclinical studies. In the future, Neologics Bioscience plans to obtain IND approval for 2-3 projects and conduct clinical trials.
In terms of layout, for relatively mature targets, we pursue new mechanisms of action in old targets to achieve effective monotherapy. For example, the NB002 pipeline is the relatively popular TIM-3. Our team based on the understanding of target biology and disease biology to perform verification through target discovery and functional verification platform Tier-A, to actively explore some new targets that have not yet been drugged or lack clinical data and to pursue First-in-Class medicines on the brand new target.
Recently, BioWorld Science specifically reported the preclinical data of our NB003 project, which shows that the international pharmaceutical community has recognized our research direction. We hope that Neologics Bioscience can explore a development path suitable for China's biotech, endow old targets with new mechanisms, explore new targets, continue to maintain high standards of R&D and rigorous clinical practice, and could occupy a leading position in the world.
Neologics Bioscience Research and Development Laboratory
Dr. Dong: In terms of talent, our team has extensive experience in the fields of tumor biology and immunobiology. For example, Dr. Zhang, the Vice President of R&D, is an expert in the field of tumor biology. His first job was the research on the mechanism of IL-33/ST-2 pathway for liver cancer metastasis. Later, he did translational research at MD Anderson, and his discoveries in the fields of tumor immunity and tumor microorganisms reached the international leading level. Dr. Bishnu from the San Diego branch in CA, USA, has worked in Novartis and Pharmacyclics for many years in immune drugs, and successfully led the preclinical development of Pharmacyclics' BTK. Florencia McAllister of MD Anderson, our scientific advisory board, has 20 years of experience in clinical translation. Jon Braun, the former head of the Department of Pathology at UCLA, has decades of experience in tumor and tumor immunology research. In addition, as a member of the R&D team, I have been focusing on tumor immunity and autoimmunity research for 20 years. The entire R&D team has rich and diverse experience in target biology and disease biology transformation, which is one of the core competitiveness of Neologics Bioscience.
In terms of technology platforms, we have established Tier-A, an immunomodulatory target discovery and functional verification platform, for target verification and discovery of new targets. In view of the fact that the tissues and cells required for tumor immunity are different from previous target discovery, our early drug screening work was carried out on single cells. However, the relationship between tumor cells and the immune system we are currently involved in is more complex, and may involve mixed cells, 3D structures, and organoids. Therefore, we have higher requirements for controlling the dynamic and three-dimensional relationship between various systems. The selection of the reporter gene and the challenges encountered in the co-culture of different immune cells and tumor cells make the entire platform optimized for high-throughput screening of functional antibodies. What we value very much in the early screening process is the biological function, not just a tool for screening antibodies, which is crucial for our subsequent research.
Dr. Dong: First of all, in the early stage of project approval, we will conduct in-depth research, and we will establish projects based on the research background of team members, market application prospects, and especially the real clinical needs. Secondly, we must have the ability to make quick decisions at each important node encountered in the advancement of the project, and we must promptly stop the loss of projects that are not sufficiently different, behind schedule, and have no advantages. Finally, we will make timely choices for projects according to market demand and clinical demand, as well as from the perspective of industrial development, so as to reduce homogeneity as much as possible and ensure leading competitiveness.
Neologics Bioscience Research and Development Laboratory
Dr. Dong: Since the approval of revolutionary immune checkpoint inhibitor drugs such as CTLA-4 and PD-1, tumor immunology R&D has developed rapidly, but there have been relatively few new advances in this field in recent years, which is the ups and downs that any field and technology development may experience. I think that although the current market is in a low period, it provides us with an opportunity to calm down and summarize the early successful experience and existing problems.
Currently, tumor immunotherapy faces two key challenges. One is that most of the new targets of tumor immunity and the effectiveness of monotherapy of new products have some defects, which may be caused by insufficient screening of early projects or products. Second, unmet clinical needs are dynamically changing. The indications of PD-1 and PD-L1 have been transferred to the first-line treatment, and it is impossible to make a significant difference by simply restoring T cells. It may be that the patient's immune system is ineffective in repairing or lacking acquired immunity, which leads to increasing difficulties and challenges in the development of new drugs. Therefore, one of the problems we solve is to improve the effectiveness of monotherapy, and the other is to explore new mechanisms of action. At the same time, we need to accurately identify patient populations with suitable indications, predict tumor changes, and stay ahead of them.
Neologics Bioscience Office
Dr. Dong: Collaboration is necessary and always present in any industry, and it is even more important for small biotech companies like ours to collaborate and complement each other. Each company has its own advantages and expertise, and the advantage of Neologics Bioscience is its deep understanding and experience in the biology of early targets and disease biology. However, it may be relatively incomplete in terms of toxicology testing, CMC and clinical development. For these aspects, we will choose to collaborate with CRO companies like Medicilon. In addition, in terms of product or clinical development strategies, we will also collaborate with large pharmaceutical companies to improve commercialization, drug indications and market information. Through collaboration, we can achieve the optimal allocation of industrial chain resources, improve the efficiency, quality and success rate of new drug research and development, and achieve a win-win situation.
Neologics Bioscience Research and Development Laboratory
Dr. Dong: In more than ten years since I returned to China, the biopharmaceutical industry has developed vigorously, but the problem of talent shortage still exists. In the fast-growing biopharmaceutical industry, many young people quickly accumulate some technical or management experience and grow rapidly, but we also keep in mind that "haste makes waste". Experience can only become experience through deep reflection and the precipitation of time. At present, the industry is entering an important moment of reflection and adjustment from the noise and radicality of previous years. Young people can pay more attention to the relationship between their own growth and the needs of start-up companies.
The cycle of the biopharmaceutical industry chain is long, and the demand for technical background continues to increase. Young people not only need to be familiar with all links of the industrial chain, but also need to have more accumulation in the fields they are familiar with or good at. Therefore, in the current development cycle, I suggest that young people should calm down, accumulate more experience, and improve their own deficiencies.
In the end, Dr. Dong mentioned that engaging in the biopharmaceutical industry is of great significance to every colleague, and I hope everyone can find the most meaningful and valuable things, and can unswervingly work towards this goal.
Founded in 2018, Neologics Bioscience is an innovative biopharmaceutical company, focusing on the preclinical stage of immunomodulatory biologics, and the disease areas include cancer, autoimmunity and inflammation. The company has established Tier-A platform for discovery and functional verification of immune regulatory targets, which can screen and verify multiple new cancer immune targets. At present, one project has obtained FDA clinical approval, and 5 candidate drugs are in the early discovery stage. The company has the strong support of well-known professional VCs such as Oriza Holdings, Co-Win Ventures, Yonghua Capital, and Elikon Venture. It has obtained a pre-A round of financing of more than RMB 100 million, and has established a research and development center in San Diego, USA.
Since the founding of our company in 2004, Medicilon (Stock Code: 688202.SH) has grown into one of the professional drug discovery contract research organizations (CRO) in China. Over the years, Medicilon keeps improving their services in biotechnology and pharmaceutical research. Their services now span across medicinal chemistry, process chemistry, in vitro and in vivo DMPK, preclinical development and bioanalytical support. By the end of 2022, Medicilon has provided new drug R&D services to more than 1,840 clients around the world, and participated in the R&D of 330 new drug projects that have been approved for clinical trials. Medicilon is proud to contribute to human health in the globe.
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