Heat Biologics, Inc. has unveiled enhanced allogeneic cell therapy manufacturing capabilities through its Scorpion Biological Services subsidiary.
Jeff Wolf, Chief Executive Officer of Heat, commented, “We are excited to rollout our new 3-D allogeneic cell manufacturing capabilities to replace our current 2-D HS-110 manufacturing. This new process is designed to increase yield, improve operating efficiency, as well as provide both a rapid and scalable solution to support Phase 3 trials and commercialization. We plan to implement these processes for the manufacturing of our own therapies, including HS-110, as well as provide these services to other biopharma companies on a fee-for-service basis through our Scorpion subsidiary. One of the greatest challenges to broad adoption of cell therapies has been the time and cost of production. We believe these capabilities will help position Scorpion as a leading contract development and manufacturing organization (CDMO), as we advance our mission to become a fully-integrated biopharmaceutical company.”
Wolf continued, “We are incorporating these manufacturing changes into our clinical and commercial plans for HS-110 and plan to discuss these changes with the FDA during our Type C meeting scheduled for next quarter. We have received positive industry feedback on our new 3-D process, as well as the clinical results of our Phase 2 trial of HS-110, and plan to accelerate discussions with potential partners following our FDA interaction. We then plan to resubmit a Type B meeting request, including clinical setting and selection of the checkpoint inhibitor to be used in combination with HS-110, in collaboration with a potential partner.”
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