Imugene - market size, clinical trials and the opportunity ahead
The autologous CAR T market is forecast to grow to around $43 billion USD by 2033.
The percentage of patients relapsing after CAR T is close to 60% in the first year. This is the market Imugene’s Azer Cel therapy is chasing. Whilst the solid tumour market Vaxinia and Oncarlytics are targeting is estimated to be worth close to $900 Billion USD by 2033.
What does all this mean for Imugene and investors in this space? In short unlike biotech stocks focusing on rare diseases or specific cancer indications Imugene’s novel and unique therapies are centred upon the treatment of the majority if not all cancer patients. Unlike CAR T therapy, or immunotherapies aimed at treating blood cancers or haematological conditions, Imugene is working toward providing therapies for the majority of individuals diagnosed with cancer.
There is a lot at stake in Imugene’s current clinical trials. It’s not simply about ascertaining the optimal biological dose for each drug, or collecting data on the best mode of delivery, trial supervisors are monitoring any signs of efficacy in each patient. Despite the fact Imugene’s trial participants are suffering from advanced or late stage cancer, having failed on all previous treatment lines, there is an underlying expectation there could indeed be signs of efficacy present in these ongoing trials. Positive immune responses, signs of tumours turning from cold to hot combined with signs of necrosis have all heightened investors underlying expectations. This upbeat sentiment has been stimulated through comments made by the Imugene CEO and Managing Director, Leslie Chong, who has suggested these are some of the most promising signals she has seen when it comes to Phase 1 clinical trials. Traditionally designed for safety and toxicity purposes only, Phase 1 trials are not known for exhibiting signs of efficacy.
Recently I noted this was the chance of a lifetime for investors, to partake in what promises to be a medical platform capable of providing relief to the largest oncology markets. To alleviate suffering for those diagnosed with solid tumours, a group comprising close to 90 percent of all cancer diagnosis. A collective of individuals facing a huge unmet need. Given the pre clinical data amassed by Imugene in both the Vaxinia and Oncarlytics treatment arms at the City of Hope many are with me in recognising what is a huge opportunity. Azer Cel’s Phase 1 trial results have done little to dampen investor enthusiasm, with the overwhelming number of participants obtaining complete responses when administered with Imugene allogeneic therapy. In terms of dollars the rewards are immense for those capable of cracking but a fraction of these market. As an example were the Imugene licensed Vaxinia or for that matter Oncarlytics be in a position to achieve peak sales equating to 1% of the solid tumour market by 2033, at $9 billion USD in revenue each year that would bring either product in at a value of close to $40 billion USD, or dollars and dollars more than Imugene's closing price today.
The stakes are high
But the stakes are high. Oncolytic viruses such as Vaxinia have to date been unsuccessful in providing a meaningful benefit for the majority of cancer patients. In fact there are only a few oncolytic viruses approved by the FDA, the regulatory authority in the US. To make matters worse Imugene is seeking to administer their drugs intravenously, in addition to monotherapy doses, and it must be noted this form of administration has been less than successful in the past when it comes to cancer vaccines, due to secretion and other mitigating factors. Moreover the odds for success shorten even further somewhat as Imugene’s therapies are designed to stimulate one’s immune system in the fight against cancer, hardly an easy task given the majority if not all patients in their Vaxinia (MAST) Trial have severely compromised if not suppressed immunity following years of prior treatment, such as chemotherapy. I suppose if there were more negatives to be thrown out there into the land of dispertions one could note Imugene’s trials are only sampling a relatively small number of cancer sufferers, 3 to 6 at a time, with only 20 to 40 people scanned each year.
What’s going to have to take place to ensure success in these clinical trials? Is simply stabilising patients late stage cancer enough, given without treatment most would surely have a limited life span due to the advanced nature of their metastasised cancers?
Perhaps not, is the short answer. Either partial or complete responses may be required to see the FDA render either Vaxinia or Oncarlytics more effective than the existing standard of care (SOC). With this in mind Imugene had some good news late last year when the FDA granted Vaxinia a fast track designation following a complete response in the bile duct cancer indication. Whilst good news it was hardly enough to move the IMU share price long term due to the small market size attributable to this cancer indication, and probably due to the fact that it was only one complete response, as opposed to multiple partial or complete responses. That said the result and subsequent FDA recognition is one small step toward proof of concept for the oncolytic virus. With the trial now opening up to include a further 10 patients with biliary tract cancer the opportunity exists for Imugene’s Vaxinia to prove some further success in treating biliary tract patients with a view to forcing the FDA’s hand for a registrational trial for the drug in that indication later in 2024.
Markets hit higher highs - what about IMU?
With momentum building toward outcomes for Imugene’s clinical trials in what are potentially huge market places the disappointment surrounding the IMU share price clearly has investors on edge. Both large and smaller holders have become more and more frustrated when waking to hear of markets hitting new highs, whilst IMU plumbs new and new lows each day. Posts on these threads recently from investors such as @Glouva and @hargeo have called into question the performance, or lack thereof, when it comes to the company Chairman Paul Hopper and the existing Managing Director and CEO Leslie Chong. For whatever reason Imugene’s leaders have been unable to attract significant buying or commercial outcomes for the science they are fostering, and unfortunately have resided over substantial losses for both themselves and the majority of IMU holders, at a time when many biotech stocks have rebounded in price. Large IMU shareholders, while not wishing to sell, are starting to openly vent their anger amongst one another. Although it paves me to say having supported the overall management status quo clearly change would be for the best in November this year if Imugene is to take full advantage of the commercial opportunities on offer as their novel and unique science comes to fruition. Existing management has done little if anything to suggest they are capable of turning the IMU share price around or reach commercial partnerships, license agreements or product sales that can support a much deserved higher share price. Whilst having paid business and commercial personnel and directors large sums and bonuses to supposedly attract and cultivate investment and partnerships, the talking has come to nought. Someone obviously requires holding to account when it comes to the losses and inactivity in this arm of the business, and more often than not company heads are held responsible, as disgruntled shareholders join forces to reach more profitable outcomes. Clearly no one is immune from corporate upheaval in times of intense disquiet among shareholders.
Conclusion
Outside of market size the science licensed by Imugene holds potential due to the fact many leading oncology players are running out of patent life for their existing mAb’s and immunotherapy products. Existing blockbusters such as Keytruda and Opdivo only have a limited shelf life with their patents expiring prior to the end of this decade. There is room for not only new therapies and oncology players to fill the void, but for combination therapies to piggy back off the work these leading drugs have achieved in obtaining approvals through the FDA. By combining therapies with the likes of Merck’s Keytruda and Roche’s Tercentriq Imugene may not only produce a safer and more efficacious drug than the existing standard of care, in doing so they may jump through some of the hoops within the FDA bureaucracy to gain approval for a broad range of cancer indications, given the platform laid with the FDA by drugs such as Keytruda. If Imugene succeed in creating therapies that are in a position to face the huge unmet need existent within the solid tumour market, i.e., lung, breast and brain cancer, then now may be the best time in history to take centre stage, given the safety and low costs associated with their therapies. But as suggested earlier in this post we are a little away from reaching those conclusions, with ongoing results in their dose escalation trials yet to hit the ASX Announcement screens. Here’s hoping when they do Imugene’s shareholders can put some green ink in their pens and send IMU management out with a smile on their faces, as opposed to having their tail between their legs.
Irrespective of the outcome at this years AGM Imugene management can look back over the past decade and acknowledge the integral role thay have played in both acquiring and developing what promises to be groundbreaking medicine for cancer patients worldwide.
DYOR Seek investment advice as and when required Opinions only
