Imugene and the week that was
I guess the long and the short of it is that Imugene looks as if it is only planning on sharing data in the ongoing Vaxinia (MAST) Trial when it is impactful and not embargoed. I suppose we must take into consideration data takes time to generate and every scan does not result in meaningful change. That said the company has stated in the future they will focus on major updates at oncology conferencesin general, so perhaps the Cholangiocarcinoma Foundation’s (CCF) 11th Annual Cholangiocarcinoma Foundation Conference in Salt Lake City, UT, April 17-19, 2024 may be a location where further trial data could be announced. Let’s face it, it is a date close to 100 days from the dosing of patients in the latest Cohort on January 16 and 18 (i.e., at 10 parts to the 8), therefore some meaningful data that may make an impact could be released by then.
We must take into consideration that traditionally in Phase 1 dose escalation trials such as this no results are shared until RP2D (recommended phase 2 dose) is established. In retrospect Imugene probably only chose to release data in November 2023 as they were compelled to do so, given the fact 2 cholangio patients achieved positive responses with one attaining a complete response (at that time nearly 1 year in - now going on over 1.5 years) in addition to news of a few partial responses and stable diseases. Therefore with the fast track designation pathway being subsequently granted by the FDA no doubt the information could have been seen as falling under the companies continuous disclosure requirements imposed by the ASX.
Either way I am of the opinion that irrespective of the time taken to cut and peer review trial data it is of significant importance to shareholders, therefore the company should allocate the time and resources to providing results at least every 120 days, to keep them as the company’s owners abreast of ongoing developments with their flagship candidate.
In addition to the plethora of great posts on the topic of the Vaxinia (MAST) Trial if I could throw my hat in the ring with one or two summations. Firstly that its too early to gauge how well the virus is working given the data thus far. Vaxinia’s inventor, the esteemed Professor Yuman Fong has stated that when CF33 infects a tumor, it works. From what we can see, once it infects cancerous cells there appears to be a massive growth spurt in lesions where cancer is present. Clearly the cells become infected, turn from cold to hot and start swelling, as we are led to believe occurred within the initial cholangio complete responder whose lesions supposedly increased close to 50% in size following their initial treatment with Vaxinia. How well it works, is the million dollar question, at least for those who currently hold own 10 million IMU shares that is. Secondly I would note these patients have late stage tumours that have indeed metastasised, having spread to the nether regions of their bodies. We may find in years to come Vaxinia responds much better in earlier stage solid tumour patients whose immune systems are not as suppressed, as we have seen with many of the monoclonal antibody treatments currently being utilised for cancer therapy today. Once the drugs optimal biological dose is ascertained and the trial expansion into bile duct has been completed, the prospect of a registration trial in that indication may bring with it the opportunity to push the FDA for further trials with earlier stage participants. Let’s wait and see on that front.
But on another front the unfortunate outcome from an Imugene (IMU - ASX) perspective is that one may well conclude their CEO and Managing Director Leslie Chong has lost some creditability among the broader cross section of shareholders, notwithstanding the investment community in general. On the one hand she has hinted, insinuated and even suggested, if not alluded to the fact Imugene has important information to announce at large cancer conferences “very soon”. Only to have one of the worlds largest cancer conferencespass by, at which they were presenting, without so much as a whimper. A track record of at best hopes at worst false promises is beginning to emerge without significant follow through. This pattern of events is beginning to dampen her tenure at the helm of the Australian biotech. Once again without wishing to steal anyones thunder, the “boy who cried wolf” analogy springs to mind. It’s a long way until the 2024 AGM for Imugene (IMU ASX), but I do fear that if either a capital raise occurs between now and then, or alternatively no meaningful data arrives from the prioritised Vaxinia (MAST) Trial, her time at the top may be limited. Let’s not wish for any of these outcomes from an investment point of view.
I for one am looking forward to the remainder of this financial year and reviewing Imugene’s performance in the months to come. Azer Cel is fast approaching a data release, as is the company’s Oncarlytics trial. Both have shown brilliant results in earlier hit outs and the expectation of further strong results is beginning to mount. The PD1 Vaxx Imprinter Trial must be close to producing some data, and surely results from Vaxinia must arise to the table some time soon. The share price shall no doubt fail to respond until data is released, so I wouldn’t be holding my breath on that front. What must be remembered is that Imugene is backed by some experienced medical minds working across a number of products and platforms with many shots on goal. Let’s hope for Leslie’s sake one or two of them hit the back of the net between now and November 2024.
DYOR Seek investment advice as and when required Opinions only
(20min delay)