Thanks for posting this. Its all a bit of a joke though is it not? Well over two years ago Imugene had impressive data on Her Vaxx, which at that stage was already presented to two reputable conferences.
Let's take a look at the announcement back in July 2021.
SYDNEY, Australia, 5 July 2021: Imugene Limited (ASX:IMU), a clinical stage immuno-oncology
company, today announced the company presented on the HER-Vaxx cancer immunotherapy program
at the ESMO World Congress on Gastrointestinal Cancer 2021 Annual Meeting.
The abstract presentation was entitled ‘HERIZON: A PHASE 1B/2 OPEN-LABEL STUDY OF IMU-131
HER2/NEU PEPTIDE VACCINE PLUS STANDARD OF CARE CHEMOTHERAPY WITH RANDOMIZATION IN
PHASE 2 IN PATIENTS WITH HER2/NEU OVEREXPRESSING METASTATIC OR ADVANCED
ADENOCARCINOMA OF THE STOMACH OR GASTROESOPHAGEAL JUNCTION’ Updated Interim Analysis
Results.
The presentation expanded on previously presented interim analysis data presented at AACR2021.
To recap previously released results:
• Interim analysis in the randomized Phase 2 study showed statistically significant overall survival
Hazard Ratio (HR) of 0.418 (80% 2-sided CI: 0.186, 0.942); HER-Vaxx showed a reduced risk of
death of 58.2% in the HER-Vaxx plus chemotherapy group as compared to chemotherapy alone.
• The median overall survival (OS) for patients receiving HER-Vaxx plus chemotherapy was 14.2
months, compared to 8.8 months in patients treated with chemotherapy alone.
• The Phase 2 data represent a clinical proof-of-concept signal for HER-Vaxx when added to
chemotherapy and indicate that B-cell activating immunotherapy vaccines can induce clinically
active antibody responses.
• Recruitment of the Phase 2 trial was completed in January 2021.
The ESMO presentation highlights and presents the following new data:
• HER-Vaxx treatment resulted in a 50% Overall Response Rate (ORR) compared to 29% in patients
treated with chemotherapy alone. The ORR measures the percentage of patients who responded
to treatment with a partial response (PR) or better.
2 IMUGENE LIMITED ACN 009 179 551
• Treatment with HER-Vaxx clearly demonstrates patients develop high levels of HER2-specific
antibodies early in the treatment protocol and are maintained during treatment and maintenance
phase with only a few booster injections.
• Tumour response is correlated with the amount of antibody levels. Patients with antibody levels
higher than 1050ng/ml received greater than 50% tumour reduction and may serve as a potential
biomarker.
• In contrast to patients on chemotherapy alone, the reduction of tumour size is substantially higher
in patients that received HER-Vaxx + chemotherapy.
Overall, this data demonstrates HER-Vaxx may provide treatment benefits consistent with traditional
monoclonal antibodies with a corresponding adaptive immune response without added toxicity.
Imugene’s HER-Vaxx is a B-cell activating cancer immunotherapy designed to treat tumours that overexpress the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers. The
immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER2/neu. It has been shown in pre-clinical studies and in Phase 1 and 2 studies to stimulate a potent
polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.
The content of the presentation can be found under Conference Presentations on the Imugene website.
For more information please contact:
Leslie Chong
Managing Director and Chief Executive Officer
So now well over two years later the best they can come up with is the promise to attempt to recruit a few more patients to a trial. That is having not delivered on the Merck/Her Vaxx supply trial initially promised, nor the Merck Germany/Pfizer Her Vaxx Trial gazetted at the time. These guys are really starting to have us on aren't they? I have been a loyal supporter but this is nonsensical, to say the least. Like I said at the time, they should have out licensed the B cell platform in its entirety to someone with the dollars and capability of fast tracking the drug to market via a large well funded trial. They should by this stage be conducting trials into multiple Her 2 expressing indications such as breast cancer, in conjunction with gastric cancer. It's all too long, too little to late. Flying solo was the worst possible option here, given the drugs potential at the time. Having inked a deal they could have had additional funds in the bank to support their OV and Oncarlytic endeavours, without the need for further CR's and excessive dilution. Sorry, but I'm beginning to seriously doubt their business acumen and ability to a deal. Make that any deal that is.
Nick's aforementioned letter says nothing, with all due respect to him. It's more like a recital of "All quiet on the western front" than action stations aplenty, as it should be. Irrespective of what comes of Vaxinia, or Oncarlytics, the company needs to make every post a winner. As I've noted on previous occasions, nothing happens unless you make it. They have really handled this product development poorly. They must be held accountable for their failure to commercialise a drug which at the time had the potential to take over from Roche's successful Herceptin drug, albeit without the side effects. Serious time wasting and disappointment on all fronts here. If their commercial and business department couldn't have raised a few hundred million upfront late in 2021 when the biotech market and M&A was going off, with milestone payments down the track, they ought to have been made to look for another job. If they can't pull something out of the bag in the coming weeks, maybe now they'll have too.
DYOR Seek investment advice as and when required Opinions only
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