Good morning all
The scientific journal "Nature" has just published a paper which is highly relevant to the "nextHERIZON" trial of Her-vaxx.
The lead author of the paper is Dr Yelena Janjigian, a senior researcher at the Memorial Sloan Kettering Cancer Center and also a member of Imugene's Scientific Advisory Board.
Unless you have a subscription to Nature then you can (like me) only access the Abstract/summary - but that's enough to get the key message. The paper reports on a Phase III trial of permbrolizumab (Keytruda) in combination with trastuzumab (Herceptin) and chemotherapy - for the treatment of advanced gastric cancer.
The extract explains that Herceptin + Chemo has been the "standard first line treatment" for advanced Her-2 positive gastric cancer for more than 10 years. (Note: only in countries where Herceptin is available). The Phase III trial, however, has shown that adding Keytruda "markedly reduces tumour size, induces complete responses in some participants, and significantly improves objective response rate." So that makes it likely that the "standard first line treatment" will become Herceptin PLUS Keytruda.
Why is this relevant to Her-vaxx? Well - Her-vaxx essentially does the same job as Herceptin. It addresses the exact same target as Herceptin, but where Herceptin is an artificially manufactured antibody treatment, with significant side effects and a tendency to lose effectiveness over time, Her-vaxx induces the immune system to produce its own natural antibodies to attack the same target on the cancer.
Results of the current Her-vaxx Phase 2 trial so far indicate that Her-vaxx is at least as effective as Herceptin, and possibly more effective, and it has no significant side effects or toxicity at all. It is also far cheaper and easier to administer - a huge plus in many countries in Asia, where gastric cancer is very common and Herceptin is either not available or too expensive.
The study reported in Nature proves that Keytruda improves on the effectiveness of Herceptin. Given that Her-vaxx addresses the same target as Herceptin, but in a gentler and non-toxic way, it is very reasonable to assume that Keytruda will also work well in combination with Her-vaxx.
The nextHERIZON trial will put that to the test, with Her-vaxx trialled in combination with Chemotherapy (as in the current Phase 2 trial) and also in combination with Keytruda (without chemo). Success in the Chemo + Her-vaxx trial arm could make Her-vaxx plus Chemo the "standard first line treatment" in countries where Herceptin and/or Keytruda are just too expensive or unavailable. Success in the Keytruda + Her-vaxx trial arm could make Keytruda plus Her-vaxx the new "standard first line treatment" everywhere else.
You can read the abstract of the article in Nature here:
https://www.nature.com/articles/s41586-021-04161-3@hersuit - I have only just seen your question in the previous post. The answer is - I don't know. The nextHERIZON trial will take at least a couple of years. The Phase III trial reported in Nature ran for around 3 years. If you read back through the reports and discussion so far with regard to the current Her-vaxx Ph 2 trial, now close to completion, it has taken longer than expected because the patients, or some of them at least, are surviving much longer than expected - which is wonderful news for them, and also for Her-vaxx.
However that does not necessarily mean that a commercial deal for Her-vaxx is two years away. The current Phase 2 trial is now close to ending and if the results are as good as many here hope, then there is a very real possibility that "offers will be made." Typically a deal involves an up front payment plus royalties on future sales. A decent up front payment would be a huge boost to the IMU share price immediately, because it would increase the material $ value oil the company, and also because it would also be a strong signal that big Pharma sees value in the entire B-cell platform. Future success in any or all of the additional Her-vaxx trials would then expand the range of applications for Her-vaxx and therefore the likely sales and royalty value.
Dr Yelena Janjigian was central to the Phase III trial reported in Nature. As a member of Imugene's Scientific Advisory Board she will be well aware of the nextHERIZON trial. Possibly she has been involved in negotiations between Imugene and Merck & Co, who make Keytruda.
Cheers
Dave
(20min delay)
