Her Vaxx definitely isn't a fail, it produced a 42% overall survival benefit for gastric cancer patient's over and above the SOC (i.e., chemotherapy,) in a Phase 2 Trial. Keep in mind the longest HER-Vaxx treated patients remain alive 2.5 years (with one patient approaching 3 years) after starting therapy. It is noteworthy that these patients generated the strongest anti- HER-2 antibody levels from their dosing schedule on HER-Vaxx, thereby proving the concept the drug is able to stimulate ones own immune system in the fight against cancer, when adequately dosed. As Imugenes own website notes, unlike HER-2 targeting mAbs that are synthetically manufactured, Imugene’s approach involves activating the patients’ own immune system to produce a continuous supply of anti-HER-2 antibodies.
So in answer to your question, whilst many critics may see Her Vaxx as a fail, it definitely is not. The difficulty is in marrying it with a Big Pharma pipeline in combination with their existing suite of products. Some may be coming off patent, others not suited to a combination with Her 2 targeting therapies. Therefore reaching a sound commercial outcome has proven difficult for Imugene, a factor that has no doubt had a detrimental effect on the overall IMU share price. Meanwhile Imugene's desire to set such a high bar in the drugs combination Trial with Pembroluzimab, hasn't helped. The company has obviously found it difficult to recruit patients in their Next Herizon Trial, due to the fact prospective participants are required to jump through difficult hoops to simply qualify for the trial.
It must be remembered however that both Her Vaxx and PD1 Vaxx have established "Proof of Concept" when it comes to Imugene's B cell platform. Both vaccines have been shown to produce potent immune responses and effective anti tumour activity in human trials. Therefore it could be argued Imugene's B cell platform adds as much if not more to the IMU share price than later additions to their pipeline, given these B cell vaccines have already established proof of concept. It goes without saying many protagonists want a quick fix, or a rapid commercial outcome when it comes to biotech stocks. The situation with Her Vaxx is no different. Though just because the vaccine has not been out licensed, or indeed sold, does not mean it's a fail. It simply means Imugene have not yet found an appropriate home for it yet.
For those interested in the IMU share price watch closely for the forthcoming results of patients dosed at 10 parts to the 8 in the current Vaxinia MAST Trial. At the same time shareholders should receive an update on patients dosed earlier. This announcement has the potential to move the dial significantly in a northerly direction. If further positive signs become evident at the higher dose, as anticipated by trial supervisors, results from the ongoing Oncarlytics OASIS Trial may just put the icing on Imugene's cake. Both outcomes have the potential to have a much more meaningful impact on the IMU share price than Her Vaxx, due to the huge unmet need they can satisfy. The FDA is much more likely to approve drugs in indications within which there is little or no existing therapy (i.e, bile duct, liver or pancreatic cancer) as opposed to those in which alternative treatment arms exist (i.e., breast or gastric cancer).
The reality is though, as touched on by you, these questions are at times too complex to answer, for investor sentiment is subjective. Share price analysis is not an exact science. We are all driven by different investment needs and wants, as a consequence of our risk profile, availability of funds and investment time frames. With no revenue to speak of speculative stocks such as Imugene, whilst de risked to a large extent, are seen as opportunities, as opposed to realities. They exhibit potential, rather than a definitive price to earnings ratio one can rely on. They offer prospective forecasts years down the track, as opposed to earnings figures in the current financial year. It is difficult for investors to hang their hat on such variables, or expectations as it were. That said the resultant boom that can occur when drugs such as Vaxinia, or perhaps Oncarlytics hit their mark, is far greater than that to be found when a blue chip stock meets expectations. For there is little if any value attributed to these drugs until results in human clinical trials are released.
If I were you I would simply assess your own financial position, continue to diversify, and maintain a healthy interest in Imugene. Imugene in my opinion is on the cusp of greatness, not simply as a result of their innovative researchers and therapy arms, but due to the fact they are in the right place at the right time. Existing medication is riddled with side effects, a high cost structure and negative social impacts. Imugene offers health regulators, patients and governments the chance to engage with treatments that stimulate ones own immune system in a healthy, non invasive, low cost environment requiring minimal treatment time and hospital hours. With the population continuing too live longer and cancer numbers continuing to steadily grow in years to come, the need for natural solutions to the problems facing health authorities, as opposed to averse reactions following expensive at times unaffordable treatment, is paramount.
It is an extremely competitive marketplace when it comes to the world of immunotherapy, yet Imugene's "mark and kill' approach when it comes to the effective elimination of solid tumours within cancer patients has an element of novelty present unlike none other in the field of oncology. IF this unique therapy platform can establish "proof of concept', as Imugene's B cell platform already has, the value attributed to IMU's share price in months to come shall be significant, to say the least. I say IF, because the future is as of today, unknown. For every clinical trial success there are multiple failures. Nothing is guaranteed, nothing is a given.
Thank you again @WellsEicke for liking my post and asking such a relevant, though difficult to answer question. Best of health you you..WMHB
Hey but these are simply my opinions.....DYOR