"We were so excited to learn the successful dosing of the first patient for our BJ-001 program. It marked a significant milestone for BJ Bioscience and for the BJ-001 program. With its tumor targeting property, BJ -001 is expected to benefit many cancer patients with integrin overexpression. The successful dosing of the first patient is a small but key step of testing this promising investigational drug," said Joe Zhang, MD. Ph.D., DABT, the co-founder and CEO of BJ Bioscience. "With strong support from our investor, we will soon initiate trials in China to speed up the development of this drug candidate globally."
The ongoing first-in-human study is an open-label, Phase 1a trial in locally advanced/metastatic or relapsed/refractory solid tumors utilizes an accelerated dose escalation design followed by a traditional 3+3 dose escalation algorithm to assess the safety and tolerability of BJ-001, to identify the MTD, and/or and RP2D of BJ-001 as a single agent and in combination with an anti-PD-1 antibody.
"We achieved this milestone with approximately 3 months after we received the 'green light' from the FDA. More proudly, we achieved FPI milestone with 3 days after the site was activated. It is exceptional based on my past experience in multinational pharmaceutical companies," commented Grace Yu, MD., VP of Clinical Development at BJ Bioscience. "It is a great example of successful team work. The team had been working diligently for this milestone. Thanks go to our colleagues at Next Oncology as well as the patient. We cannot achieve this milestone without the hard work and collaboration of each of the members."
"As of 08 Dec 2019, the patient has been completed C1D5. No CRS and no other adverse events have been observed." said Dr. Raghad Abdul Karim, Medical Oncologist, Hematologist, Principle Investigator of BJ-001-01-001US study, NEXT Oncology.
BJ-001 is the first tumor targeting IL-15 fusion protein in the world. It is designed to target cancer cells that overexpress integrins such as αvβ3, αvβ5, and αvβ6 by its tumor targeting motif and to stimulate anti-cancer immunity by its IL-15 motif. Such design has a potent to increase anti-cancer effects and reduce systemic toxicity by localizing IL-15's effects in tumor microenvironment. Many cancer types such as NSCLC, stomach cancer, and pancreatic cancer have been shown to overexpress integrin.
About BJ Bioscience Inc.
BJ Bioscience Inc. is a biotechnology company dedicated to the research and development of innovative drugs. It was created by returnees with many years of experience in research and development of innovative drugs and complimentary expertise, including a review expert of National Key Innovative Drug R&D Projects, the National Health Commission of China. Based on its top notch trade secret protected antibody generation and screening technology, BJ Bioscience focuses its R&D in oncology, infectious and autoimmune diseases. Key members of the company's R&D team have many years of experience in research and development and management of antibody drugs from key national scientific research institutions, domestic and multinational pharmaceutical companies especially European and American multinational companies.
For additional information, please visit www.bjbioscience.com.
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