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Heat Biologics Completes Manufacture of HS-410

Will begin Phase 1/2 bladder cancer trial

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Heat Biologics, Inc. has successfully completed the manufacture of the first GMP batch of its HS-410 investigational drug for its Phase 1/2 bladder cancer trial. HS-410 is a fully-allogeneic, live-cell cancer immunotherapy, which consists of a bladder cancer cell line that has been genetically modified using Heat’s ImPACT technology platform to secrete a wide range of bladder cancer antigens designed to activate a T-cell immune response against the cancer.
 
Heat Biologics’ allogeneic approach allows its live cell-based vaccines to be mass-produced and stockpiled for use on all patients, before they are identified and enrolled. Additionally, the drug is capable of being produced and administered at a reduced cost of autologous or “personalized” therapies, with fewer logistical hurdles in its production and delivery.
 
“The successful manufacture and delivery of our first clinical trial-grade drug for use in our upcoming Phase 1/2 bladder cancer study represents an important milestone for Heat and we believe clearly demonstrates the efficiency and effectiveness of our manufacturing efforts,” said Jeff Wolf, chief executive officer of Heat Biologics. “This is especially exciting as it showcases a true differentiation of Heat’s proprietary technology and manufacturing platform.”

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