The first bispecific antibody to win regulatory approval, Removab (catumaxomab) was voluntarily withdrawn due to commercial reasons. Now Chinese biotech Lintonpharm Co. Ltd., of Guangzhou, said it plans to move catumaxomab to a global phase III trial following an IND approval from China’s NMPA, investigating the trifunctional bispecific antibody in patients with peritoneal carcinomatosis, a form of advanced gastric cancer.
NEW DELHI – Bangalore-based Biocon Ltd. has received the Indian drug regulator's approval for restricted emergency use of its psoriasis biologic, itolizumab, to treat patients with severe cases of COVID-19 in need of ventilator support.
HONG KONG – Incheon, South Korea-based Celltrion Inc. will start manufacturing its COVID-19 treatment for clinical trials and commercial distribution, even though it’s only reached phase I.
LONDON – From the start of the pandemic antibodies have been the main focus of attempts to understand the immune response to SARS-CoV-2 and ascertain what it will take for vaccines to be protective.
HONG KONG – Shanghai-based I-Mab Biopharma Co. Ltd. expects to begin clinical trials for the world’s first and only claudin18.2 and 4-1BB bispecific program in a year. "We expect the trial to start in U.S. in the [middle of] next year. We will then expand the trial to China afterwards as planned," Joan Shen, CEO of I-Mab, told BioWorld.
Zymeworks Inc.’s business update – which included a new, potential $891 million deal for multispecific antibody drugs with longtime partner Merck & Co. Inc. – drew mixed reviews from Wall Street, especially with regard to phase I prospect ZW-49.
With some positive early data for an antibody to block the COVID-19 virus, Sorrento Therapeutics Inc. is now looking to test a product in a few dozen intensive care patients by the end of July or early August and move into a much broader pool of patients by October.
VANCOUVER, British Columbia – With some positive early data for an antibody to block the COVID-19 virus, San Diego-based Sorrento Therapeutics Inc. is now looking to test a product in a few dozen intensive care patients by the end of July or early August and move into a much broader pool of patients by October.
Blincyto (blinatumomab, Amgen Inc.), the first FDA-approved bispecific antibody, gained regulatory approval in 2014, but the intervening years have been fairly bleak for bispecific antibodies as companies worked through technical challenges.
By analyzing the antibody response of a survivor of Marburg virus infection, researchers at the University of Texas Medical Branch and Vanderbilt University Medical Center have gained new insights into the function of non-neutralizing antibodies in fighting infections.
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