NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170628836
Thank you hoffmann!

12-5-2022 Webinar: Dr. Linda Liau on DcVax for Glioblastoma

Presentation

- DCVax-L is feasible in wide variety of clinical settings
- DCVax-L is safe with minimal toxicity
- DCVax-L is statistically significant in mOS for both rGBM and nGBM
- Independent statistics firm developed SAP using MAIC
- 25 nGBM patients alive at 5 years while 0 of 1366 ECA patients alive at 5 years
- 228% OS improvement in DCVax-L v. ECA in nGBM at 60 months
- 217% OS improvement in DCVax-L v. ECA in rGBM at 30 months
- Subgroup analysis showed (1) significant survival advantage in patients over 65,
(2) significant survival advantage in patients with significant residual disease, and
(3) significant survival advantage in patients with MGMT methylation
- Interim survival analysis of rGBM patients with Adj ATL-DC + PD-1 mAB is 800 days
for 55-60% of the patients (trial ongoing) which is about 27 months.
Keep in mind the ECA for rGBM showed about 2% alive at 24 months in the DCVax-L trial.

Q&A

- ATL-DC is DCVax-L
- Unsure of mechanism of action regarding Optune
- Thinks new batch with each recurrence is probably best
- Comparing DCVax-L in nGBM versus the non-crossover placebo this is 29 patients and many passed away early
- 2012-2015 was primary time frame for comparators and when most of DCVax-L patients were enrolled
- SAP was finalized before unblinding
- Need tumor saved correctly to be able to use DCVax-L (proper way on Dr. Musella’s website)
- Ongoing trials with DCVax-L using Poly ICLC, a TLR agonist.
- TLR 3 seems to be one the works best with DCVax-L combo
- Ideal order is vaccine with Poly ICLC followed by the PD-1 inhibitor
- DCVax-L might not work well in Grade 2/3 Gliomas or DIPG as 2/3 isn't mutated enough and DIPG is hard to resect
- DCVax-L can be used for other types of cancers
- Poly ICLC – hiltonol, approved can get off label
- There are approximately 62 patients that took DCVax-L that are still alive today (25 + 25 + 12 = ~ 62)
- Can only make 1 vaccine at a time at UCLA
- Regarding ECAs, why put another 1k+ patients at risk when we already have consistent data.
- FDA is more open to considering ECAs.
- In the ITT group they were able to make vaccine for 94% of the patients
- DCVax-L is injected in arm near lymph node
- DCVax-Direct injects directly into tumor (inoperable tumors)