@HamishM your post does highlight the sentiments of many leading shareholders who feel the communication and marketing of Imugene has been below par. It goes without saying correspondence pertaining to ongoing clinical trials appears to be the major gripe. Given the shares recent landslide the BOD clearly has their work cut out for them if they expect to keep their positions and/or remuneration packages in the year to come. Leading shareholders have lost hundreds of thousands if not millions of dollars investing in IMU in recent years. As such clearly heads shall roll in one way or another, that's the way business works, fortunately or unfortunately depending on which side of the fence you happen to sit on.
Oncarlytics |
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solid tumours “seen” by CD19 targeting therapies OnCARlytics infects tumour cells Virus replication and production of CF33-CD19 on the cell surface enabling CD19 cell targeting Tumour cell lysis leads to viral particle release and the combination promotes endogenous immune cell recruitment to tumours
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The news Imugene has dosed the first patient in their Oncarlytics trial is a fantastic outcome for all involved. Congratulations to Saul Priceman MD and Professor Yuman Fong. The platforms ability to combine with CF33 and Vaxinia to deliver outstanding results pre clinically auger's well for the forthcoming trial, in addition to prospective combinations with azer cel, CAR T and allogenic therapy providers. Clearly the opportunity to effectively target solid tumours represents a viable alternative to the current euphoria surrounding ADC's, as a delivery mode in the oncology space.
Her VaxxStill no word on an out licensing deal for Her Vaxx. I really wish the BOD had out sourced all their M&A activities to professionals in the US. But either way I guess we are all still holding out hope for an outcome here in the near term. Her Vaxx has been shown to be an excellent drug in the treatment of HER 2 expressing cancers, both exhibiting safety and extending life for sick patients well above the existing standard of care. Good news is long overdue in this arena. The tardiness shown in enrolling patients to the current Her Vaxx Keytruda combination may be overlooked in the event of good news. That said if none is forthcoming the positions of the existing business and financial team at Imugene shall be called into question at the AGM later next month.
PD1 Vaxx TercentriqClearly a shining light in the Imugene pipeline, Professor Kauyama's PD1 Vaxx shall, if successful in its current hit-out with Roche's Tercentriq, surely turn some heads in the Big Pharma space. Unfortunately for all involved lung cancer isn't going anywhere and the possibility of extending the life of those suffering from the disease is hugely exciting for all those participating in the vaccines development.
VaxiniaWhat can one say that hasn't already been said about this potent Oncolytic virus with the potential to eradicate solid tumours in cancer patients. The preclinical results have been outstanding. The news coming out of the existing Vaxinia (MAST) Trial is good, according to the drugs founder, the esteemed Professor Yuman Fong, of the leading City of Hope cancer research facility in Los Angeles America. This week a "trial in progress" presentation highlighting the safety and tolerability of the drug is to take place at the renowned SITC Convention in Las Vegas America. Whilst it is the wish of many for information pertaining to the Oncolytic viruses efficacy in treating solid tumour patients to be discussed, It should be noted Big Pharma, the FDA and associated medical associations are less than enthused with biotechs who display their hand during, as opposed to after, primary endpoints have been reached. Not that Big Pharma are in any position to pass judgement, for their record when it comes to communicating effectively during clinical trials is a topic for discussion in and of itself (see
time.com for more).
Following on from the shareholder conferences of earlier this year it would appear the existing Vaxinia (MAST) trial may require expanding, or indeed a well defined Phase 2 study, if a pattern of results in specific cancer indications is to be established. Surely the FDA is going to look for synergies in particular cancer indications, as opposed to results across a smattering of solid tumour types, if fast track approval under the "significant breakthrough category' is to be granted. In the event of such an expansion, or trial extension, perhaps the company management may see fit to recognise and relay ongoing Vaxinia trial results at a "snapshot in time", with a view to explaining the rationale behind such a strategic move. "The trial has proved successful in the following cancer indications, hence the existing results warrant further investigation into these.......and so forth and so on and words to that effect"...Significant changes to a clinical trial program can have a considerable impact on market value and should be announced to the market as soon as possible.
According to Wilkie.com in their article Inside information disclosure by Biotech companies : the FMSA has published good practice guidelines:
In order to determine which information must be disclosed by biotech companies, a first step is to consider whether the information related to a product candidate may likely have a significant effect on the price of the company shares (should the information be made public). This depends on the “value” or the “materiality” of the product candidate, which in principle depends on the expectation of significant revenues for the company, assuming the granting of a marketing authorization.
With respect to a product candidate fulfilling this materiality test, any information modifying materially the evaluation of the expected revenues, the likelihood and timing of the marketing authorization and any decision of the company to start a new phase of the clinical development of the product candidate is in general considered Inside Information.
Alternatively were the existing trial to continue in its current format the company may decide having had the existing clinical trial result biopsies returned and peer reviewed, they may have grounds to release the ongoing results as "material facts" that must be disclosed to the market.
As an aside were the existing results to be less than promising and the results of the existing biopsies and peer reviews be to the negative, the same level of disclosure would be necessary.
Taking all things into consideration IMO the correspondence communicated during the company's Phase 1 PD1 Vaxx trial, highlighting both complete and partial responses, in addition to disease stabilisation events among patients, was excellent, as a guide to what shareholders are indeed looking for.
Azer celAs noted by Imugene Diffuse large B-cell lymphoma (DLBCL) is an aggressive type of non-Hodgkin lymphoma (NHL) that develops from the B-cells in the lymphatic system, which are responsible for producing antibodies typically to fight infectious disease. Azer-cel has the potential to improve outcomes in this large and growing population with high unmet need. Imugene's quest to treat such blood borne cancer utilising their recently acquired allogenic therapy, azer cel, is one that could bring sound revenue in the near term, should ongoing clinical trials for the drug go as planned, There is the potential to combine the therapy with both CF33/Vaxinia and Oncarlytics, in the treatment of not only blood cancers, but solid tumour indications as well.
Tenacity and patience are required when assessing the aforementioned data, and analysing the path ahead. Though it must be said even the most resilient investor is not in a position to wait too much longer for a clear direction from which to move forward.
Best of luck to all long term holders of IMU, and to all those monitoring and participating in the company's much needed cancer trials.
DYOR Seek investment advice as and when required Opinions only
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