Hervaxx Trials

Hi Everyone,

I am curious to see what others people’s thoughts are on the new Hervaxx trials, and if any further details were mentioned regarding them from the IMU leadership team this week? (Sadly, I am not able to attend the investor meetings).

There is a lot of IMU’s agenda currently with all the different trials and studies in flight. I find its easy to lose track of specifics to assess where we are at. I’m specifically interested in Hervaxx as it seems the most progressed and therefore most likely to reach a commercialisation outcome first.

The original phase 2 study for Hervaxx (Herizon) ran 30/08/2017 – 31/01/2022 with results now published.

On the 01/09/2021 Leslie released an announcement stating IMU was looking to start three new trials off the back of encouraging results from the Herizon trial.

· NextHERIZON

· NeoHERIZON

· NeuHERIZON

Exact quote below

Imugene’s MD & CEO Ms Leslie Chong said “We are encouraged by the PFS and anticipated

primary OS clinical data to commence three new HER-Vaxx trials, to be called NextHERIZON,

NeoHERIZON and NeuHERIZON, in early and late stage gastric cancer including combination

with PD-1 and PD-L1 checkpoint inhibitors”.

We then had a Supply agreement announced 16/11/2021 Merck – (neoHerizon study). (Merck Germany)

And a further Supply agreement announced 15/03/2022 Merck – (NextHerizon study). (Merck and Co USA). And subsequently termination of supply agreement 02/05/2022 (NextHerizon study). (Merck and Co USA - Only)

At the time the termination agreement was not great news but it clearly was a storm in a tea cup, as Imugene has pushed on with the NextHerizon trial regardless. That trial commenced 17/08/2022, will have 30 participants, is expected to go for 1 year and concluded 31/07/2023, though final data not to be published until late 2025. In the study 15 participants to get Merck – pembrolizumab (Keytruda) in combination with Hervaxx. And the other 15 participants to get Pfizer – camptosar (irinotecan) in combination with Hervaxx.

Full details of the study available on this link: https://clinicaltrials.gov/ct2/show/NCT05311176

My question I hope someone can answer; neoHerizon is still listed on IMU’s presentation posters. It was flagged on 01/09/2021. Given a supply agreement 16/11/2021. But since then no further announcements. Did the leadership team at all mentioned neoHerizon? Is there a delay or an issue? Was any guidance given when could we expect to see the trial kick off? (I also note it is not listed in their up-and-coming announcements poster). Or have I missed something?

Circling back to NextHerizon, participants have had to progress off trastuzumab (Herceptin - Roche) before being eligible for enrollment. From I can find online gastric cancer treated with trastuzumab has a median survival of approximately 11 months. If the trial is to take 12 months to recruit 30 participants. Will it therefore take a further 12 months to show benefit from Hervaxx combinations?

(Unless participants receive a complete response and go into full remission from Hervaxx combinations. And let’s hope for these poor people that is the case)

So, unless NextHerizon really smashes the ball out the park and cures people of their cancer outright. We won’t be able to know the fate of Hervaxx and if a commercial deal is possible until approximate 2 years’ time (2024)?