NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Al Musella SNO Update

Hi. Just got back from SNO (Society of Neuro-oncology annual meeting). Excellent meeting - overwheling with the amount of information presented. I am going to mention a few of the highlights and welcome others who went to the meeting to post their thoughts.

DCVAX: No updated data was presented but we had a nice meeting with all of the advocacy groups and Northwest bio. They went over the unblinded data that they presented last time and said they will present the final results "soon". I pressed them on that and they said they know but can't tell me. I get the feeling it is going to be pretty good. The longer they wait the better the data will look and it has been a long time.

https://forum.virtualtrials.org/forum/main-forum/174-sno-update


Tocagen: The results from the trial were presented and it did not hit the main endpoint of overall survival in the intent to treat group. A few pre specified subgroups did show impressive results. There was a lot of discussion on reasons why. One possibility is that the trial stopped the oral 5FU part at the first sign of progression. 50% of the patients in the treatment group showed signs of progression at the first scan and were stopped. The average number of cycles of the drug was 2. Looking back, that was probably a terrible idea because with any immunotherapy, there is more swelling on patients who are responding to the therapy best - which appears as progression on scan.. so they stopped the trial early for those most likely to respond.
If you do not include the 1/2 of patients who had to stop at that first scan, the results were much better. However, most likely they have to do another trial to prove it works. They are planning another trial for newly diagnosed gbm, and in the control group they will allow patients to use Optune... so I support the new trial design. All get surgery, radiation and temodar, and are randomized to get tocagen or optune.
If anyone doesn't know what Tocagen is, ask and I will explain

Onc-201: (Diclaimer: The Musella Foundaiton gave a venture philanthropy grant to this company so we will benefit if the drug gets approved). There were a LOT of presentations on this drug and a lot of excitement among the pediatric neuro-oncologists. The data just keeps getting better with something like 80% of patients having a benefit and no serious side effects. There were a few patients who had complete responses, and a few with more than 50% reduction in tumor - which is unheard of for this group of patients (H3K27M mutant diffuse midline glioma and DIPG). Although not a miracle cure, it is a huge step in the right direction. It was noted that in the original trial for glioblastoma, that patients with the H3K27M mutation did much better than those without it, so further development was limited to those with this mutation. About 80% of DIPG patients have it, as do diffuse midline gliomas in mostly young adults). However, a new bit of information came out. Those glioblastomas that did not respond at all, had elevated levels of EGFR. Most diffuse midline gliomas do not overexpress EGFR. This is way too early but brings up the opportunity to test a combination of Onc201 with a EGFR inhibitor, which might work on GBMs with high levels of EGFR! I doubt if this is ever going to get tested until after Onc-201 gets FDA approval but we have to remember to try this at that point!

G47Delta oncolytic virus. This may be a home run. I wrote more about it on another thread. The trials were small but look good. I am working on finding out how to get it. If anyone has luck, let me know!

Neo-adjuvant checkpoint inhibitors: There were a few presentations on this. Since they are approved we can get easy (unless you consider cost
access anywhere. Basically it looks like if you start the checkpoint inhibitors when there is a lot of tumor, it will create a big immune response, but that immune response can't handle a large number of tumor cells. So the best stradegy seems to be start the checkpoint inhibitor when there is tumor, give it a little time to build up, then remove as much tumor as possible, either through surgery or radiation, then continue the checkpoint inhibitor. This is worth considering if you have time before a surgery.