Below are my notes from the conference call. It includes timestamp reference & slides for those who want to refer back to the actual conference to hear/see what was actually said/shown.
7:10 Achieved all regulatory approvals of phase III trial enhancement …. So does that include Final approval by PEI?
Info Arm of 55 patients: improved median survival of this group from an expected 7–10 months to 18-19 months. A major benefit was thus seen for these patients.
8:50 HE – Insurance Reimbursement negotiations – not unusual to take a year – it involves negotiating 3 to 6 contracts with each individual hospital (which includes 2 contracts with the manufacturer regarding tumor tissue and blood draw). Each hospital and various departments within each hospital has their own hot buttons during these negotiations. Germany does not have a Single Payor heath insurance system like UK, and thus NWBO is currently in negotiations with four (4) Sickness Funds. NWBO is taking the rigorous approach and looking to negotiate their desired pricing with all parties prior to making any announcements. That said, NWBO is looking to make such announcement (hopefully) in the coming months. (Ironically though, “in the coming months” was also the terminology used in the March 2014 PR, I believe).
11:55 DCVax-Direct. NWBO was mobbed with patients who wanted to participate. Waiting list. These patients are late stage and basically on doorstep of hospice.
Slide 8: I believe that for the first time NWBO shows this breakdown of all cancer types of all 40 patients from phase I. Very diverse range of cancers.
DCVax technology … competitive strength = Both operable and inoperable cancers, so it applies to such a broad spectrum of patients.
No limitations on patient characteristics nor on tumor characteristics.
14:30 From a Regulatory Pathway Standpoint: After obtaining 1st approval for 1st cancer, then each additional cancer would just involve a Label Extension.
My question: so then why will NWBO be testing at least 2 cancer types in phase II … just to improve the odds that at least 1 of these cancers will respond greatly to DCVax-Direct, or to provide additional data/results for the FDA to see that it is indeed effective/very effective in different cancer types?
Expect an announcement regarding phase II trial “relatively soon”.
16:00 Immune Response. See slide 11. Looking for 3 things: local effects, systemic effects and (in the future) immune memory.
17:05 New info on Direct. See slide 12. Phase I trial is still ongoing. Completion of treatments estim end of 1Q2015 or early 2Q2015.
Full set of Date: 2Q2015.
Trial is not blinded, so they are seeing/witnessing the effects. NWBO would like to share lots more, but this might not be a good idea. Therefor mainly waiting until end of trial to provide most of the data.
In the meantime:
The trial is designed to be very “Info Rich”. It is providing lots of data.
19:00 Trial design allows NWBO to accelerate the development of the product.
7 types of cancers being tested: saves NWBO a lot of time.
3 dose levels tested.
“Secret sauce” of Direct involves the partial maturation. The trial tested 2 different levels of partial maturation/activation. This timing is very sensitive, even within the “teenager zone”.
All types of image guidance was incorporated. NWBO has FOUND that all types (ie Ultrasound, MRI, CT) work beautifully.
Imaging was performed as well as biopsies, and correlated.
Bulding tumors: can be Good Bulge or Bad Bulge.
Local & systemic effects were found to take place.
22:05 DCVax-L safety profile. In over 1000 treatment cycles and over 300 patients (guys … does this give any clues regarding where the current enrollment stands ???) there have only been 3 significant adverse effects (ie a seizure). Terrific safety profile therefor.
22:30: DCVax Direct: also has been showing beautiful safety profile over the past 15 months. Mainly just minor fevers.
23:15: Results seen. ( slide 14)
Striking result: responses seen in patients with diverse cancers
Encouraging SURVIVAL is being seen. Stay tuned until end of trial for more info hereover.
Quality of Life is found to be improved.
25:30 Immune therapy takes time to show results. Same with Checkpoint Inhibitors etc. My side note: therefor the early data reported was even that much more significant. From slide 15 it can be seen that oftentimes the tumor shrinkage might start at around 16 to 24 weeks.
25:55 Treatment early in the regime was close together, ie just a week apart between injections. Towards the end of treatment regime the injections are 2 months apart. NWBO finds this to be too far apart.
2 NEW PATIENT EXAMPLES (not reported about these patients previously).
1.) See slide 15. Another sarcoma patient (different type of sarcoma). Failed all other treatments. 5 measureable tumors. See the chart on the slide … at week 16-24 ALL FIVE TUMORS start to shrink (…. Systemic effect !). Only 1 of these 5 tumors was injected.
@27:50
2.) Lung cancer patient – 1 of the most difficult tyoes of cancer to treat. This is 1st time NWBO is mentioning anything about effectiveness of Direct on lung cancer.
54 year old woman. Her only prior treatment was radiation.
10 cm (approx 5 inch) tumor in her lung … about the size of a grapefruit. She could barely breathe.
Now: tumor is shrinking measurably.
To the point where she is now back to swimming.
LP said she plans to frame the email from her doctor, which indicated “She seems to have recovered”.
NWBO inquired with the doctor what he meant …. She is back to her full life.
AND … she has not even completed her full treatment regimen yet.
29:45 Caution. P1 trial has not completed yet, and the results could still get better or worse. BUT … these 2 new case studies are very encouraging, especially op top of the 4 previously reported (incl. sarcoma, pancreatic and ovarian).
30:00 So NWBO is measuring, learning and seeing the various results immediately in this unblinded P1 trial.
FDA approved the P1/II trial design to allow P2 to commence now, which saves approx 6 to 9 months (as opposed to waiting for end of P1 & top of line data etc).
Slide 16.
30:35 Phase II. Will be (“probably”) injecting multiple tumors (not just 1 tumor)
Treatments will be closer together! At most a couple weeks apart, not months apart !
Will continue to do extensive imaging plus biopsies plus correlations.
Quality of Life will be even more intensely evaluated.
At least 2 trials in 2 cancers in the coming year. And that while P3 is ongoing in 2015 and heading towards its fruition.
Significant expansion of the trial sites for P2.
Slide 17.
31:30 DCVax-L
Expect to finish enrollment approx September 2015. Depends somewhat on how fast some german sites come online.
Top line results: approx 3 – 5 months after Fully Enrolled. Therefor approx end-2015 or early-2016.
Slide 18: Info Arm of 55 patients: 13 of 51 (approx 25%) of patients are still alive at 23 – 34.5 months.
Slide 22.
Manufacturing. We want this DCVax technology to become the New Standard of Care. Not a last resort. For diverse cancers.
Very practical. Batch manufacturing … 8 days.
NWBO has built manufacturing in US and in Europe in past 5 years, and these sites are fully operational.
NWBO has over 180 patents (issued & pending)
Monthly burn: approx $4 Million.
34:00 Questions from the audience.
55 Patient Info Arm: Will NWBO release any more info/data regarding breakdown between Rapid Progressors and Pseudo Progressors? Maybe/undecided. If they decide to do so, then likely in the form of an Abstract at a Scientific Conference.
NWBO intends to continue to provide occassional new info or any interim results on Phase 2, despite any critisism of them doing so.
35:00 “Investigations” (8) … they are bogus/outlandish. Nobody has joined in the investigations, so no current lawsuits. NWBO would defend vigorously.
36:00 EAMS = 2-stage process. Will NWBO be filing a Step 2 application, or have they already done so?
LP: We have not made any announcements about this publicly. Stay tuned.
Step 2 actually has 3 components:
a. Pre-submission
b. Company needs to be invited to make application for Step 2.
c. Make Step 2 application.
LP made said Step 2 could be a multi-month process … but it focusses on the company Manufacturing. Thus LP feels very good about this (manufacturing is a massive sweet spot for NWBO). Afterall, Germany grilled NWBO regarding the manufacturing as it was being considered for HE.
38:00 Personalized treatments. How can NWBO scale up for this?
See other comments on iHub already made re Hundreds & Hundreds of thousands of patients for which DCVax could be a fit (most solid cancers).
Today L is a manual process and Direct is already partially automated.
Business-wise: NWBO wants to get its products to the patients and to the market asap.
39:30 Busily working on End to End Automation. This would allow “any number of patients” to be treated.
Scale issue. Capacity issue.
Further revolutionize product economics.
Currently sterile clean rooms. (since some of the manufacturing steps currently expose the product to the open air.
Massively capital intensive. Most of this can disappear after fully automated (E to E).
Couple year process.
Working with the biggest & the best, from all over the world.
40:40 DCVax-L …. Definitely do not want to sell to Big Pharma. They have nothing to offer regarding getting L to market, other than their checkbook. We would rather not be bought. DCVax-L sale target involves just a few hundred brain surgeons in the US (for example), which could be handled by a small 20-person sales team.
42:45. Dry shipping of the product. Shipping container looks like R2D2 … and can keep product good for 12 -14 days at stable temperature. So a few days shipping delay will not harm the product.
43:20 LP said she believes Allan Butler has already disclosed on message boards that he has received surgery.
Immune Memory (as seen in pre-clinical animal trial) … similar to tetanus shot, which you only need to get say every 10 years.
