Morning all
There is a lot of entertaining speculation on this forum. Understandably, anyone holding IMU is keen to see the results of the Phase 1b study. We have been told that the "Top Line Results" will be released in December, so we simply have to be patient. We already know the study was a success in it's two primary outcome measures - 1. nil toxicity; nil adverse reactions; 2. dosage determined for the Phase 2 study - and that dosage will be at the highest level tested in Phase 1b.
We also know that it achieved either or both of the "Exploratory Outcomes" related to Immunogenicity. An immune response was found in all patients at all dose levels.
The speculation is around whether the Phase 1 B results will include positive data from the final "Exploratory Outcome" which is listed as: "Radiographic data measured by RECIST 1.1 criteria [ Time Frame: Day 0 to Day 56 and during Long-term maintenance ]. Radiographic data will be analyzed descriptively to explore the Response Rate (RR)". Note: RECIST is the acronym for "Response Evaluation Criteria In Solid Tumours." So this third exploratory outcome is all about whether scans/xrays etc show any impact on the cancer itself.
Right now, we just don't know. We also have to bear in mind that the Phase 1B is a small sample of patients, over a relatively short period - which is why a Phase 2 and maybe a Phase 3 trial will be needed.
On the other hand, Imugene is happy enough with the Phase 1B that they are moving straight to the Phase 2. So they appear to have a lot of confidence in what they are doing.
And this morning I discover that Professor Ursula Wiedermann - who invented Her-Vaxx and who remains on the IMU Scientific Board - is presenting on the Phase 1b/Phase 2 trial at a major conference in San Francisco on January 17th:
"BOARD N8
Abstract TPS176: A phase Ib/II open label study of IMU-131 HER2/Neu peptide vaccine plus cisplatin and either 5-fluorouracil or capecitabine chemotherapy in patients with HER2/Neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction.
First Author: Ursula Wiedermann, MD, PhD"
https://gicasym.org/program/poster-sessions/poster-session-a
It's possible to read too much into this, but presentation of the study at a Conference indicates (to me) a further level of confidence in the results.
Something else to read - I just found a very interesting article from a year ago which (so far as I can see) did not get any exposure here on HC.
https://finfeed.com/small-caps/biotech/immuno-oncology-new-horizon-fight-cancer/
I found particularly interesting this quote from Leslie Chong:
“Of importance is that we, and others (academics), have shown that our B cell epitopes enable the immune system to break tolerance against a self-protein, HER-2. The B cell route has worked already, for example the antigens in Merck’s HPV cancer vaccine Gardasill are B cell epitopes. Hence, we have entered the clinic with a high level of expectation. We have been at it for the last 10 years with a Phase 1a study in breast cancer providing the proof of concept.”
So yes - B cell Immunotherapy can certainly work. Gardasil has been a massive success for Merck - almost 100% effective and a huge seller worldwide ($2.3 billion USD in 2017). As an Australian reader, it's also nice to note that the Gardasil technology was invented at the University of Qld.
Anyway - December will be here soon, and presumably we will get the Phase 1B "Top Line" results - whatever they may be. Hopefully - a good Christmas present for us all....
Cheers
Dave
(20min delay)
