To extend off Ben’s Post. I emailed Imugene during the week, inquiring on the current status of the Hervaxx trial Next Herzion. (see below)
I very much appreciate the company’s wiliness to answer our questions, and Nick’s no-nonsense response. I want to keep the faith and believe we will see a commercial outcome from Hervaxx. But I feel its looking more and more like a duster and will never progress out of phase 2 trials in sadly very sick people.
If the last patient is to be dosed by 2H 2024 (not March 2024 mind you). We won’t see an interim data read out until 6 months later. Its looking like December 2024 at the earliest.
To me the company's strategy to progress its B cell platforms are fundamentally flawed in that they are moving way too slow to keep pace with other innovation and technologies in the oncology space.
My Email
Hi Team,Hope you are well.I would like to inquire on the ongoing Next Herzion trial as it has been some time without a formal update to the market. I do not wish to seek any sensitive information about the trial outcomes, more seeking to understand the company's confidence in meeting the current advised time frames and what can be disclosed.On the 8th of September 2022 an announcement was made to say the first patient was dosed in the trial at the QEH in South Australia. Referencing the clinical trials government website at the time, primary completion was to be July 2023. I note on the 14th of June 2024 the record was updated to extend the primary completion date to March 2024 and the trial sites were significantly expanded. However no subsequent announcements have been made to the ASX regarding the trials progress despite being >12 months, a 7 month delay (63% relative extension to previous guidance), and regular progress updates on other inflight trials (Vaxinia MAST trial for example).Is there a particular reason for a communications blackout on the Next Herzion trial?Are you able to make any formal progress update to the ASX on how the trial is proceeding >12 months in? (For example we have dosed 20 of the 30 participants to date. We expect to dose the remaining participants by March 2024 through our expanded trial sites. And we will look to release the interim data read out by September 2024. - Or something to that effect)Are you able to reaffirm guidance for the trial? (The trial remains on track for completion by 2024)Wishing you all the best in your endeavours to find new treatments for people afflicted by cancer.Kind regards
ReplyDear,
Thank you for your query on HER-Vaxx and your ongoing support of Imugene.
The extension of timelines for the nextHERIZON study is mainly due to difficulties recruiting patients and the quality of those patients. This study aims to recruit patients who have already failed off all lines of standard of care therapy for their HER-2+ gastric cancer. By their very nature they are unfortunately very unwell and only have relatively harsh chemotherapy left where the statistics show their chances of survival are low. Positively this also sets the bar quite low for showing HER-Vaxx plus chemo benefit in the late-line setting.
The study opened in Australia 12 months ago and whilst we have recruited quite well, most of the patients were actually too far advanced and generally were sadly dying by the time they received HER-Vaxx plus pembrolizumab.
To mitigate this problem, we have opened more sites in Australia and importantly opened multiple sites in Taiwan, where HER-2+ gastric cancer is more prevalent and we have excellent experience from our HERIZON Phase 1b study. Whilst these original Taiwanese patients were far more healthy due to them being freshly diagnosed patients, our Taiwan oncologists are enthusiastic about participating in nextHERIZON and recruiting suitable patients. We are also about to open several US sites so we expect nextHERIZON to pick up recruitment and still complete by 2H2024.
We remain confident about prospects for HER-Vaxx. In two weeks we will present further mechanism of action (MoA) results for the Phase 2 HERIZON study at ESMO in Spain. The results will show strong correlations between tumour responses seen and the anti-HER2 antibodies generated with further data demonstrating these patient derived antibodies support the MoA of HER-Vaxx. These results are assisting in business development activities where interested parties can clearly visualise the benefits of HER-Vaxx.
We continue to be optimistic about HER-Vaxx as an excellent drug for HER-2+ patients and our prospects for its commercialisation.
Best regards,
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