Friday, October 24, 2025 4:07:55 PM
Manufacturing in the US for In-licensed Technologies. The Company continued its progress on developing manufacturing capacity in the US for technologies that the Company has in-licensed. (The Sawston facility is handling the manufacturing of the Company’s DCVax-L and DCVax-Direct products for global use.) After extensive discussions in prior quarters with GMP facilities in several states, the Company selected two locations as the finalist candidates for development the US manufacturing capacity. The Company progressed with contract negotiations in both locations, and anticipates reaching an agreement in the near term. The Company also undertook personnel screening and selection processes for the specialized expertise required, and has secured certain initial key anchor personnel. The Company is in the process of negotiations with key equipment suppliers.
??Potential Compassionate Use Programs in the US. The Company has had a compassionate use program in the UK for a number of years, and believes that those compassionate use cases have been helpful for the patients involved and have generated real world data that is quite useful. As previously reported, the Company is expanding its existing compassionate use program with additional clinics and doctors. The Company is also interested in undertaking a compassionate use program in the US when feasible. The Company has noted that well over a dozen US states have enacted expanded compassionate use legislation, including during this year to date, and that expanded access programs are also possible at the federal level. The Company is actively exploring the potential for expanded access/ compassionate use in the US. ?
Yes, this is specifically about in-licensed products (think Roswell acquisition) and compassionate use program. But as we've seen at Sawston: today's compassionate care facility becomes tomorrow's commercial facility.
I don't have any idea how far away US commercialization of DCVax is, but this is a huge first step.
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