JESINDA: Two-wheel drive mode to build a new anti-cancer drug pipeline

at the beginning of the
New Year, Jess Inda Biopharmaceutical Technology (Shanghai) Co., Ltd. (referred to as JesInda) welcomed the first good news: the company's own research and development of extracellular protein-regulating kinase 1/2 (ERK1/2) oral small molecule inhibitor JSI-1187 obtained the U.S. Food and Drug Administration (FDA) clinical trial license (IND). "2019 has been a bumper year for Jesinta, and we have submitted clinical approval applications for new drugs to the China Drug Administration (NMPA) and the FDA of the U.S. Drug Administration, respectively, and successfully introduced an original new anti-cancer clinical product," said Dr. Zhang Jintao, founder of Jesinta. Dr.founder of Jesinta, graduated from the Shanghai Institute of Organic Chemistry of the Chinese Academy of Sciences and went on to do postdoctoral research in the Department of Chemistry at the University of Chicago, USA, and worked at the Ben May Cancer Institute at the University of Chicago. Dr. Zhang Jintao was the first prize winner of China's National Natural Science Award in 2002 and, prior to starting his business, was the divisional director of MediChem Research and DeCode Genetics, a NASDAQ-listed company in the United States, and the co-founder and CEO of Shanghai Medici, a listed company on the Board. After leaving Shanghai Medici, he started a second venture and founded a new drug research and development company, Jess Inda.From starting a biopharmaceutical outsourcing service (CRO) to starting a new drug research and development company, dr. Zhang said in an interview that it was a challenging transition, with several successful examples of the industry's transition from CRO to new drug research and development, such as Array BioPharm, acquired by Pfizer for $11.6 billion in 2019, who started cro business in the U.S. Of course, CRO business and innovative drug research and development are two different business models - CRO business is characterized by "Hanxin dot soldiers more and better", the more customers the better, the more employees the better, and innovative drug research and development needs to have an experienced new drug development management team, can strive to quickly and efficiently establish their own product pipeline.Hard nuclear research and development management team: 25 years per capita research and development qualifications, research and development management and international business experiencethere is no doubt that, as a small molecule anti-tumor research and development enterprises, the key factor that determines the company's research and development pipeline height is the drug research and development team's research and development management capabilities. And JesInda's research and development executive team is a successful entrepreneurial experience and multinational large companies of new drug research and development and management experience, but also a wealth of project selection and research and development direction control ability, more outstanding international business development capabilities of the hard core team.Dr. Li Qun, Executive Vice President of Research and Development, has 29 years of experience in the research and development and management of small molecule original innovative drugs, leading and participating in the research and development of 10 clinical candidate drugs in the United States and China, one of which is a new drug product in the United States clinical phase III, new drug products involving targeted tumors, tumor immunity, metabolic diseases and other fields. Vice President of Liqun is a Ph.D. from Peking University, and he went on to work as a postdoctoral student in the Department of Chemistry at Boston College, Massachusetts, USA, where he has served as Senior Director of Pharmaceutical Products at Abbott Laboratories in the United States, and as Chief Scientific Officer (CSO) of Shanghai Baiyu Pharmaceuticals and Smart Trailblazer Chemistry.With 24 years of experience in biological research and new drug development, Dr. Wang Shaoxuan, Vice President of the Company, has led and participated in research and development projects for new drugs in oncology, neuroimmune and regenerative medicine, many of which have entered clinical trials and involved in the development of IDH1/2 inhibitors approved for market in the United States. Vice President Wang Graduated from Peking University and received his Ph.D. from Rochester University in the United States, completing postdoctoral studies at the University of Colorado and Notre Dame University in the United States. He has served as Deputy Director of GSK (China) Research and Development Center, Executive Director of Smart Chemical Biology, and Senior Scientist at Anyys Pharmaceuticals USA.Dr. CMO Myers is a hematologist and oncologist with 38 years of clinical development experience and has led and participated in more than 250 clinical trials, six of which have been approved by the U.S. Drug Administration. Dr. Myers has held senior positions as Vice President of Clinical Development for a number of large and medium-sized biopharmaceutical companies and pharmaceutical companies.

's Chief Development Officer for Clinical Development in the United States, Dr. Palatiso, has 32 years of clinical development experience and has successfully completed more than a dozen clinical approval applications to date, with 11 products in participating and managing clinical development projects approved for listing by the U.S. Drug Administration. Dr. Palatiso has held senior and middle positions in the clinical development departments of several large and medium-sized biopharmaceutical companies and pharmaceutical companies in the United States.Two-wheel drive business model: independent research and development-oriented, while the introduction of international new drug clinical productsJesInda adhere to the original anti-cancer new drug research and development-oriented road. Dr. Zhang Jintao said in an interview that in the face of increasing competition in new drug research and development, the company's continuous innovation and development capabilities are the company's vitality. Therefore, JesInda chose the "two-wheel drive" business model, that is, independent research and development-oriented, to maintain the sustainability of the company's innovative drug research and development, while the introduction of new foreign pharmaceutical clinical products, enrich the company's product pipeline, accelerate business development.In less than three years, the company successfully advanced its innovative ERK1/2 kinase inhibitor product JSI-1187 to the clinical stage. At present, the international leader in the development of ERK1/2 new drugs is still in the clinical 1b/2a stage, involving adaptations including RAS or RAF mutations of non-small cell lung cancer, melanoma, bowel cancer and other malignant solid tumors, Jesinta's JSI-1187 in the development of certain adaptations has a good chance to run to the international leading position. In addition, Jesinta has two innovative drug projects to nominate candidates, the company in the development of new drugs in terms of quality, speed and quantity of the research and development team to demonstrate a wealth of professional experience, strong executive and management capabilities.In addition to its own research and development business, the company noted that in recent years, with the spread of gene sequencing and the constant discovery of new targets for tumors, pharmaceutical companies and research institutions have invested significant resources in cancer translational medicine research and exploring new biomarker and drug-based treatment options. These latest research results have enabled the industry to select patients more precisely for clinical trials under a new perspective, giving new drug development unprecedented opportunities. As a result, Jesinta has set itself the goal of becoming one of the first companies to capture research and development opportunities and business opportunities for such new drugs. Guided by this idea, the company's business team and research and development team successfully introduced the international first-in-class clinical product - selective Aorora A kinase inhibitor JSI-1534 (overseas research and development code VIC-1911).
Over the past decade, most major pharmaceutical companies have developed Aorora kinase inhibitors, and more than 20 products have entered clinical trials, but the vast majority have failed. Recent studies have shown that the main reason for the failure of these clinical trials is that product selectivity is not good enough to produce toxic side effects of bone marrow inhibition. At present, there are only two clinical products of Aurora A inhibitors that are highly selective internationally, with no obvious side effects of bone marrow inhibitors: one of the clinical phase I products was acquired by Lilly Pharmaceuticals for more than $500 million in 2018, mainly for the development of new drugs for RB1 missing small cell lung cancer and CDK4/6 inhibitors after treatment with ER-breast cancer;
JSI-1534 has completed clinical Phase 1a trials in the United States, clinically proven to have no obvious bone marrow inhibitory side effects, and the progress of research and development is in a "unique" position internationally. Even more surprising is the fact that research reports published in internationally renowned journals in the last year show that JSI-1534 has broader clinical application prospects:(1) Preclinical data published in the journal Nature Medicine by the research team at the University of California, San Francisco (UCSF) in January 2019 suggest that Aur A inhibitors can delay or inhibit EGFR inhibitors. The production of hetinib tolerance, i.e. the use of EGFR inhibitors such as JSI-1534 and Oghithini, is expected to improve the first-line therapeutic effect ofnon-small cell lung cancer with EGFR mutations; A inhibitor is superior to the already marketed JAK2 inhibitor in the treatment of bone marrow fibrosis, promising to truly reverse bone marrow fibrosis and potentially improve patient anemia symptoms, a clinical study rated by industry experts as: Aurora A inhibitor has the opportunity to be the next heavy bomb drug to treat bone marrow fibrosis (Bea next Mega-hit"therapeutic alone or in the syndrome with ruxolitinib to treat myelobrosis).
(3) In January 2020, a team at the Memorial Sloan-Kettering Cancer Center (MSKCC) published a research paper in the journal Nature, pointing out that the new cystic redness anti-cancer drug, KRAS G12C inhibitors, which are currently in clinical development, have limited efficacy in patients, mainly because cancer cells are resistant. An important means of resolving KRAS G12C inhibitor tolerance is the joint use of Aurora A kinase inhibitors and KRAS G12C inhibitors; the mutation of thecancer protein KRAS occurs in about 25% of cancer cases and is associated with very poor disease prognostication. The development of new drugs for KRAS targets has always been a difficult point in international research and development of new drugs. In 2019, the industry rekindled hope for KRAS inhibitors with exciting Phase 1 clinical data from companies such as AMS, and in January 2020 Mercadon announced a $2.5 billion strategic partnership for KRAS inhibitors, further demonstrating the pharmaceutical company's expectations for KRAS as a target drug. Through the in-depth study of the mechanism of drug action, Jesinta carried out all-round research and development of new drugs for KRAS mutant malignant solid tumors with different drug action mechanisms, single drug or drug combination strategies. With its own research and development and the introduction of a two-wheel drive business model, jesinta's research and development pipeline quickly demonstrated the synergy > 1 to 2.Dr. Zhang said 2020 will be a fast-growing year for Jesinta, with JSI-1534 conducting 1b/2a clinical trials for multiple adaptive disorders in the United States and JSI-1187 conducting clinical Phase 1 trials in the United States. JSI-1534 and JSI-1187 have also initiated clinical trial applications in China.Fortunately, Jess Inda has invited leading clinical experts from the United States in areas such as lung cancer, melanoma, and myeloma to conduct and direct clinical trials from leading research institutions such as Harvard General Hospital, Harvard University's Dana-Farber Cancer Institute, the University of California, San Francisco, and the University of Texas Anderson Cancer Center. This gives the company's research and development team the opportunity to learn from relevant experts in the international frontiers of new drug research and development, and to communicate and share with them to ensure that clinical trials are conducted in a high quality and smooth manner. This also reflects from one side the industry's recognition and support of JesInda's new drug development concept and new drug projects.In terms of capital, the company has the honor of being supported by well-known investment institutions such as Boyuan Capital. At the end of the interview, Dr. Zhang Jintao expressed his vision: New drug research is a race against time, looking forward to the new year, more partners and JesInda with the same, high-quality, efficient new drug research and development projects to continue to move forward.
(arterial network)