Chief Scientific Advisor
Dr. John Talley, the Chief Scientific Advisor for Forward, is one of the world's most successful medicinal chemists, bringing over 30 years of industry experience to the R&D team. He is the inventor of Celebrax (celecoxib), Pfizer's blockbuster product-COX-2 inhibitor, which has generated cumulative sales of over $50 billion for Pfizer. Other drugs including Dynastat (parecoxib) and Bextra were also subsequently invented by him. In addition, Dr. Talley has led the development of the HIV protease inhibitors Agenerase, Lexiva and Prezista. During his career, Dr. John Talley has invented 8 new drugs that have been marketed worldwide, and has several subsequent drugs still in development. Dr. Talley served as the Senior Vice President (SVP) of Ironwood Pharmaceuticals and held key positions at G. D. Searle and Pharmacia. He holds over 215 U.S. granted patents, has published over 50 influential academic dissertations, and was awarded the Excellence in Invention Award by the American Society for Drug Development and Manufacturing in 2002.
Chief Executive Officer
Dr. Xu Liangliang received his undergraduate and doctoral degrees from the Department of Biological Sciences and Technology and the School of Medicine of Tsinghua University (2000-2012), and worked at the Institute of Biomedicine and Health of the Chinese Academy of Sciences from 2012-2013. He returned to China in 2014 to start his own business. Founded in 2015, Forward Pharmaceuticals Co., Ltd has independently developed several new drug products including "the fourth generation of non-small cell lung cancer targeted drug", and has completed three rounds of marketize equity financing, raising nearly RMB 100 million. Dr. Xu Liangliang has applied for 12 patents for drug inventions (3 of them have been granted). He has been awarded with personal honors and government projects such as Pearl River Talents(Entrepreneurial leader) of Guangdong Province, Shenzhen Overseas High-Level Talents (Class B), Nanshan District Navigator Talents, Second Prize of Shenzhen Entrepreneurship Support Program for Overseas Students, and "Navigator Plan" High-Level Talents Entrepreneurship Support Program. He is also the Executive Director of the Anti-tumor Innovative Drug Development Center of Tsinghua University Research Institute in Shenzhen, the Director of Guangdong Small Molecule New Drug Innovation Center and the Director of Shenzhen Life Science and Biotechnology Association. Dr. Xu Liangliang is a self-employed entrepreneur with a scientific background, who has achieved results in two distinct fields: basic research and industrial transformation.
Chief Scientific Officer
Dr. Zhu Chenggang received his undergraduate degree from Tsinghua University and his PhD from the University of California, Irvine School of Pharmacy. He has more than 10 years of industrial experience in the biopharmaceutical R&D industry. He has held key innovative drug discovery positions at Novartis and AstraZeneca, where he led several preclinical small molecule and biomolecule drug discovery projects and successfully advanced to clinical trials. He also holds more than 20 invention patents and has published more than 10 academic dissertations. He is a member of the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO); he is a member of the Chinese Society of Clinical Oncology (CSCO).
On January 7, 2021, the U.S. FDA Approved Forward IND application for clinical development of FWD1509, which is an innovative drug targeting for non-small cell lung canser(NSCLC) with EGFR exon20 insertion mutation. This clinical development will provide a novel approach to the treatment of NSCLC patients with EGFR exon 20 insertion mutations.
EGFR gene mutation is one of the main driving gene for NSCLC. Currently, the 1st, 2nd and 3rd generations of EGFR-targeting drugs have been approved clinically. However for NSCLC patients with EGFR exon20 insertion mutation, the clinical efficacy of existing drugs is still limited. There is no EGFR exon20 insertion mutation targeting drug up to now and effective treatment plan is desideratum for patients who suffering from such condition.
FWD1509 is a small molecule inrreversible oral inhibitor of EGFR. This candidate is highly suppressive for all kinds of EGFR exon20 insertion mutations, and has strong inhibitory activity to common mutations (L858R, exon19del) and drug-resistant mutation (T790M) of EGFR. At the same time, it's low inhibitory activity on wild-type EGFR had been proved, indicating a good safe therapeutic window. In addition, FWD1509 can effectively cross the blood-brain barrier (BBB) and thus be used to treat brain metastases in EGFR mutated NSCLC. In several preclinical studies, FWD1509 inhibited the proliferation of a variety of EGFR exon20 insertion mutations in lung cancer cells, demonstrating good safety and antitumor efficacy.
The phase I clinical trial of FWD1509 will be conducted simultaneously in China and the U.S. by the Chest Hospital affiliated to Shanghai Jiao Tong University and MD Anderson Cancer Center in the U.S.
"Compared with current chemotherapy methods, FWD1509 has great potential for NSCLC carrying EGFR exon20 insertion mutation. The rapid approval and promotion of the clinical development of FWD1509 not only enriched the clinical pipeline of Forward, but also strenghened our faith and confidence of rooting in China, accelerate the development of innovative drugs for Chinese and global patients. We will, as always, activately promote clinical research and atrive to bring more innovative drugs to the market as soon as possible to benefit more patients!" said Dr Chenggang Zhu, The founder and CSO of Forward.
"The realization of the approved clinical IND milestone of FWD1509 marks that Forward has entered a new stage of development after 5 years of entrepreneurial process. We appreciate all team members of the FWD1509 project for their tireless efforts, as well as WuXi Apptec and other partners for their support. Forward will always remain true to our original aspiration, and be committed to solving the clinical needs of cancer patients worldwide with innovative pharmaceutical products." said Dr Liangliang Xu, The founder and CEO of Forward.
April 16, 2019 — ROCKVILLE, Md.– (BUSINESS WIRE)–NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Hyleukin-7TM, a T cell amplifier, in development for the treatment of Idiopathic CD4+ Lymphocytopenia (ICL). Hyleukin-7 also received ODD from the European Medicines Agency in 2017, and it is the first and only agent that has obtained ODD for ICL.
ICL was first defined in 1992 by the Centers for Disease Control and Prevention, and is a rare disease in which patients present persistently low CD4+ T lymphocyte counts without human immunodeficiency virus (HIV) infection or any other cause of immunodeficiency.
"Patients with ICL frequently suffer from severe and recurrent opportunistic infections and are at high risk for developing certain types of cancer. Currently, no specific treatment for ICL exists. As such, there is high medical need for therapies that can increase CD4+ T cells in ICL patients," said NgocDiep (Diep) Le, M.D., Ph.D., NIT's Executive Vice President and Chief Medical Officer. "We are delighted that the FDA recognized the potential of Hyleukin-7 as an innovative and transformative treatment for ICL and look forward to conducting a clinical trial in this patient population."
In the phase 1 trial in healthy subjects and multiple ongoing dose-escalation trials in cancer patients, Hyleukin-7 showed a well-tolerated safety profile and dose-dependent increases of CD4+ and CD8+ T lymphocyte counts. NIT has been also actively conducting and planning multiple proof-of-concept clinical trials to develop Hyleukin-7 as an immune-oncology (IO)-enabling drug in combination with other IO therapeutics.
The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Receiving ODD may help to expedite and reduce the cost of development, approval and commercialization of a therapeutic agent.
Hyleukin-7TM (rhIL-7-hyFc, NT-I7), an immuno-oncology agent, is a T cell growth factor composed of a covalently linked homodimer of engineered Interleukin-7 (IL-7) molecule, biologically fused with the proprietary long-acting platform - hyFc™. IL-7 is known to be a critical factor for T cells homeostasis, acting to increase both the number and functionality of T cells. Hyleukin-7 amplifies and reinvigorates persistent T cell immunity in the treatment of patients with cancer and lymphopenia, thus providing unique opportunities for immuno-oncology (IO) combination strategies. Hyleukin-7 is being developed as an "IO enabling" therapy to harness T cell immunity in combination with current cancer treatments such as anti-PD-(L)1 agents or chemo/radiotherapy as well as next generation IO therapeutics. 
1. FDA Grants Orphan Drug Designation Status to NeoImmuneTech’s Hyleukin-7 for Idiopathic CD4+ Lymphocytopenia Treatment. http://neoimmunetech.com/board/list.html?Ncode=b1. Accessed April 22th, 2019.
https://news.bioon.com/article/6737146.html. Accessed April 22, 2019.
Shenzhen Address: Room 406, Block B, 19 Gaoxin South 7th Road, Nanshan District, Shenzhen
Shanghai Address: 1706, 555 Haiyang W. Road, New Bund Center, Pudong