NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Thanks for your feedback hyperopia. I do have a few comments and questions related to your feedback.

You stated the following quote below, which suggests that each DCVax-L production batch would be limited to only 3 years of doses, which as you correctly stated would be about 10 doses:

studies have confirmed product stability for 3 years, or ~10 doses per batch.

I do agree that in the Phase III trial, NWBio wanted at least enough tumor tissue to produce 3 years of doses. But in a few cases less than 10 doses were produced, and in some cases more than 10 doses were produced.

What I have seen from my research is that the total number of DCVax-L doses produced in a batch for each patient, is dependent on how much of the tumor can be safely resected, and then how much DCVax-L vaccine can be produced from the resected tumor tissue.

If you take a look at this Compassionate Use case that was presented by Dr. Bosch at ASCO on 6/3/2023, you can see that the first batch of DCVax-L doses were produced for this patient (Sarah), and administered to this patient in 2013. There were enough DCVax-L doses produced in this first batch to give to this patient from 2013 to 2019. That is almost 6 years:



This patient was scanned and monitored every 6 months. There was no tumor recurrence or disease progression since 2013.

Also, apparently, some of her original resected tumor tissue was cryopreserved / frozen, and was saved and not used to make the first batch of doses. Apparently, there was enough tumor tissue leftover to make a second batch of DCVax-L doses, so that this patient has been able to receive more doses through 2022. That was about 9 years of doses total, without a second tumor resection surgery.

She is alive 11 years after her original tumor resection surgery in 2012, with no tumor recurrence or disease progression. You can listen to Dr. Bosch’s remarks about Sarah’s case beginning at about the 44:10 minute mark: