Replies to post #122999 on NorthWest Biotherapeutics Inc (NWBO)

[abeta]

Remember that this trial has the rapid progressors removed, not the pseudoprogressors

NW Bio To Present At The 2nd Immunotherapy Of Cancer Conference, ITOC-2

During his presentation, Dr. Bosch will discuss data relating to 51 patients with Glioblastoma multiforme (GBM) brain cancer who were treated with DCVax-L on a compassionate basis in an “Information Arm” outside of the Company’s Phase III clinical trial.

These patients were not eligible for the clinical trial because they were already showing some actual or apparent re-growth of their brain tumor in imaging at a Baseline Visit when they finished 6 weeks of daily radiotherapy and chemotherapy following the surgical removal of their original tumor as part of the standard of care.

Such patients are considered either

“rapid progressors”
or
“pseudo-progressors,”

based upon whether the appearance of early tumor re-growth can be subsequently confirmed. Dr. Bosch will discuss survival data relating to such patients.

The ITOC conference will focus on topics such as immunomodulatory agents, anti-cancer vaccines, adoptive and engineered T cell Therapy and monoclonal antibodies.

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6/17

Northwest Bio (NWBO) has a real chance of hitting its Primary Endpoint

I re-ran my DCVax-L Progression Free Survival (PFS) model with updated assumptions from last week's ASCO presentation.

My model now gives DCVax-L a 13 month mPFS vs 7 months for its placebo thereby providing a 6 month treatment advantage (measured from time of treatment). This trial requires a 4 to 5 month treatment advantage to demonstrate statistical significance.

Previously my model gave DCVax-L a 16 month mPFS vs 6 months for placebo. The main reason for my now lower estimated PFS number is that I increased the efficacy curve of the placebo arm. I made this change based on Dr Bosch’s statement at ASCO that ~90% of all trial patients have received DCVax-L treatment either upfront or at cross-over.

Previously, around December 2016, Principle Investigator, Dr. Linda Liau stated 86% of patients have received DCVax-L treatment. So it can be inferred that during the past 6 months ~12 additional placebo patients may have experienced PFS events. It is possible Dr. Bosch's ~90% figure is the same as Dr. Liau's 86%, in this case the trial's chance of success improves significantly.

Changes to my modal -
* updated enrollment ramp numbers (extrapolated from ASCO slide)
* broke-down my K-M curve points into 6 month increments
* added 6 patients as Lost to Follow-up (LTFU)
* made Dec’16 the date 248 PFS events hit
* assumed 16 placebo had not evented at Dec’16

Highlights from ASCO presentation:

DCVax-L Program -
* Efficacy determination is made by a central review process
* 90% of pts received L (LL said 86%?)
* trial is powered both for PFS and OS independently
* ~3 month period btw screening and treatment
* pseudo progressors not mentioned in exclusion criteria
* 80-80% cell purity required to produce vaccine
* a few patients were lost to follow-up
* enrollment midpoint hit in May2014
* fully enrolled in November2015
* 231 pts have evented
* OS 233 event expected to be hit around mid July
* preliminary analysis publication of results is in the works
* 7 SAEs related to L or placebo
* 132 SAEs related to GBM or SOC
* SOC expected OS 15 -17 mths from diagnosis

DCVax-L Information Arm:
* Dr B said most indeterminate patients are probably rapids with a few pseudos (LL said the opposite)
* mOS of this group was 21.5 mths
* 24% > 48 mths OS
* 40% > 35 mths OS

DCVax-Direct Highlights:
* Sarcoma Phase2 trial to open in several months
* plan to expand this trial for pediatric patients
* Phase 2 trials to include CI in indications where they are approved already
* 7 of 8 PH1 sarcoma pts exceeded their expected survival times
* PH1 survival times 18% > 30 mths, 23% > 24 mths
* 59% exceeded their expected survival time by an average of 11 mths
* 4 SAEs * Direct is manufactured in an automated system

NWBO is in a very distressed financial state. The company has ~$6.5M debts due in late June. Investors may suffer substantial dilution when this debt is settled.

Branko