If it’s not the weather it’s the bloody economy disrupting Spring Carnival Racing. Though there may be some light at the end of the race track this year, as COVID fears dissipate and stock markets continue to stabilise. Added to which I envisage a slowdown in future interest rate rises, as many economists suggest inflation may well be halved by the end of our financial year. Despite an anticipated rise of .75% in the cash rate by the US Federal Reserve in November, analysts are predicting this could slow in December to a moderate rise of .25 basis points. Either way companies are going to have to become accustomed to passing on higher costs to their customers, which shall no doubt lead to a reduction in earning forecasts in the months ahead. One silver lining in the macroeconomic world is the tight labour market which equates to more bums on seats and as such a floor in consumer spending.
On the investment front money is set to return to fixed interest in the near term, where strong corporate and government bond yields are in play, though value stocks are sure to have a following as deep recession fears subside.
The Cancer Stakes Cup
But realistically whether Netflix, Snap or for that matter the Bank of America beat or miss when it comes to earnings in the US, these announcements have little if anything to do with the future of Imugene (IMU - ASX). Imugene’s success at present begins and ends with clinical trial results and the company’s position in the race to fight, reduce and hopefully eliminate cancer is humans. The “Cancer Stakes” race to find a cure for cancer is hotting up, and not just at the Big Pharma level. October is bringing with it a flurry of activity in the US. On the NASDAQ exchange money is finding its way into race pools where the potential for winnings is high. In short Imugene is but one runner in a well contested field.
Back in 2600 BC the race began when cancer was treated with surgery, heat, or herbal (chemical) therapies. Wikipedia notes that back then Egyptian physician Imhotep recommended producing a localised infection to promote regression of tumours. According to the Ebers medical papyrus, this was done by placing a poultice near the tumour, followed by local incision.
More recently in an article entitled The Cancer Miracle Isn’t a Cure, It’s Prevention, at https://www.hsph.harvard.edu/magazine/magazine_article/the-cancer-miracle-isnt-a-cure-its-prevention/ the author Madeline Drexler makes the point there may never be a winner, as she notes we cannot treat our way out of the rising cancer caseload. She suggests the only solution is a full-scale defense, so that nobody suffers the disease in the first place.
But that hasn’t stopped Imugene and countless other participants enter the race to cure cancer. For in the US alone, 1 in 2 women and 1 in 3 men will develop cancer in their lifetime.
The race is on
Outside of Big Pharma there are many new contenders alongside Imugene in the Cancer Stakes race. This month as some may be aware Allogene Therapeutics have begun the first pivotal test of an “off-the-shelf” cell therapy for cancer. The biotech has been at the forefront of a push in recent years to develop treatments known as allogeneic therapies derived from donor cells. Last week they announced the start of two trials this month. These studies represent milestones for allogeneic cell therapies, which are meant to be more convenient alternatives to the personalised CAR-T treatments that have come to market to treat a handful of blood cancers. The issue with Car T treatment is that Car T cells are difficult to construct. It is not easy work when one considers medical practitioners must first draw out a patient’s white blood cells, before freezing and shipping them to a laboratory. Once in the lab scientists are then required to alter the T cells by adding a gene for a new receptor called a chimeric antigen receptor, or CAR that helps them grab proteins on the surface of cancerous cells. The T cells are then multiplied many times over and frozen before being reinfused back into the patient weeks later at the end of what is a time consuming and costly process.
Another contender in the Cancer Stakes race Nested Therapeutics launched last week with a view to continuing the work of their founders into the cancer gene known as KRAS. Decades of research have shown that mutated versions of KRAS were behind a variety of cancers. Amgen’s Lumakras, the first approved KRAS-targeting therapy, was formulated following the initial work of Nested’s founder Kevan Shokat. In 2013 his lab found a hidden groove on the proteins created by a certain, prevalent KRAS mutation, and developed compounds that used this groove to latch onto the proteins and keep them inactive.
Aside from Allogene and Nested Therapeutics October has brought with it the proposed launch of another contender Carisma Therapeutics, via the reverse merger route onto the NASDAQ stock exchange, under the ticker of “CARM”. The new company plans on developing its portfolio of cancer cell therapies, which are led by a treatment in early clinical testing for solid tumors. Since June, at least three other privately held startups, Disc Medicine, Kinetaand ARS Therapeutics have listed via reverse merger as opposed to the IPO route. biopharmadive.com notes Carisma is developing therapies that harness myeloid cells, rather than the infection and tumor-fighting T cells used in approved CAR-T treatments from Novartis, Gilead Sciences and Bristol Myers Squibb. They state in an article entitled Cell therapy startup Carisma merges with troubled Sesen in bid for Wall Street that Carisma’s scientists believe this approach, which involves genetically modifying the macrophages that remove dead cells or attack bacteria, can help cell therapies work in more common tumor types. Similar to Imugene’s Her Vaxx, their lead program targets the protein HER2, which is implicated in a variety of cancers.
On another track cancer-focused contender Aum Biosciences is merging with blank check company Mountain Crest Acquisition to put its MNK and TRK inhibitors into phase 2 testing. fiercebiotech.com notes the Singapore-based biotech’s lead asset is AUM001, a selective and synergistic MNK inhibitor that is expected to enter phase 2 trials in metastatic colorectal cancer by the end of the year, both as monotherapy and in combination with Merck & Co.’s Keytruda. Similar to Imugene’s B cell platform the therapy also has another Big Pharma team-up in the works, thanks to a partnership with Roche to assess a combination with Tecentriq on solid tumor indications. The new company is to be a SPAC or special purpose acquisition company. SPAC’s being a termed used to describe well-funded shell companies who raise money from investors to go public and then snap up a company to list with.
Is the IMU stable well placed to win the race?
I believe the IMU stable has succeeded in bringing some worthy contenders in to the Cancer Stakes Cup, and I plan on discussing this further herein. Yet when one takes a closer look at Allogene, Nested, Carisma and Aum Biosciences they see the advantage of listing on the NASDAQ . The ability to raise funds quickly in that market, to obtain exposure and drive potential partnerships through mutually beneficial arrangements is of immeasurable benefit to NASDAQ biotechs. I believe the IMU stable could have beaten many of these newer players and closed in on Big Pharma much sooner had they planned for a NASDAQ listing earlier in 2021, when I first wrote about it on this thread. A biotech company with their extensive pipeline could have easily raised in excess of $500m USD for a NASDAQ listing if not a Billion USD in late 2021 in a hot biotech market.
The listing could have been supported through an extensive number of license agreements or memorandums of understanding (MOA’s) with Car T providers looking to benefit from the addition of a CF33 CD19 Oncarlytics lead platform to their Car T products. Imugene would have then had the exposure, funding and partnerships in place to focus on rapidly developing their own B cell protégés including Her Vaxx, PD1 Vaxx and B Vaxx combinations, which they knew at the time to have excellent safety profiles with little or no side effects and strong efficacy signals. Trials with huge participation could have commenced (i.e., 300 patients plus) which if successful could have moved quickly through to registrational trials and production. Instead 18 months later we are seeing a reliance on ongoing Phase 1 trial results with limited patient numbers in addition to Big Pharma combination trials with expensive drugs that we know have been found wanting from a safety perspective. Combinations with expensive drugs known to produce extensive side effects in patients upon delivery. As it stands only two of Professor Kaumaya’s large suite of B cell drugs are currently in post clinical trials at Imugene. Much of his Imugene licensed portfolio remains in the background yet to race.
Does anyone know IMU’s even in the race?
Not many people out there have heard of Imugene (IMU), let alone Yuman Fong and his CF33 runners. At a guess it would be fair to say 99.9 percent of people around the world have never even heard of Imugene (IMU), let alone anything from within their stable. That’s all about to change though, as eyeballs worldwide visualise first hand what many of us already know to be a good thing. For just this week the IMU stable’s Leslie Chong noted she is about to have a hitout early November on the Prime Time TV FOX channel in the US. Aside from a brief run on 7’s Nightly News a few years back this is the first time she is to be watched on TV in the massive US market, where sophisticated investors, health care analysts and everyday punters are on the sidelines loaded up with cash ready to enter the market. Given stocks live and die based on the relationship between supply and demand, the added rise in demand following this exposure is sure to increase the share price as selling volumes continue to dry up. The station carries a lot of financial clout now that Financial Journalist Maria Bartiroma is on prime time at Fox as the anchor of Mornings with Maria on FBN (6-9 AM/ET) as well as anchoring Sunday Morning Futures, one of the highest rated Sunday morning programs on cable (10 AM/ET) on FOX News Channel (FNC),
Anyway it’s never to late for Imugene (IMU) to pursue a NASDAQ listing. Hopefully the Fox Series gives the stock some much needed impetus and exposure in the States, not to mention Europe and potentially SE Asia. As I said at this time last year there is little joy to be gained in constantly implementing small capital raises through the likes of Bell Potter and banging your head against the wall in the Australian market. In the US even rare disease biotechs with no revenue command market caps in excess of 1 Billion USD. Meanwhile back in Australia unless you’re a bank, a miner or big on revenue you don’t get a look in, within a quintessentially baby boomer market that’s same old same old. Hey if Monil Shah and his new side kick need a hand making it happen over there I’m more than happy to take on a position marketing and selling the stable to US punters. From where I sit it’s high time they stepped up to the plate and made things happen from a commercial perspective in that market. If not they could just find themselves pipped to the post by the plethora of new and existing runners.
What’s the prize pool?
Well, the race is taking place in the field of oncology. In one recent M&A deal in this space Pfizer agreed to buy oncology specialist Array BioPharma for a total value of about $11.4 billion. Array’s two major marketed drugs at the time, MEK inhibitor Mektovi and BRAF inhibitor Braftovi, were approved as a combo treatment for melanoma. In addition to these results they turned up positive results in colon cancer. Back then the $48-per-share offer from Pfizer represented a premium of about 62% to Array stock’s closing price. As noted by fiercepharma.com in an article by Angus Liu on Jun 17, 2019, in a trial in BRAF-mutant metastatic colorectal cancer, the pair, used in tandem with Eli Lilly and Merck KGaA's Erbitux, produced a benefit in 26% of patients, versus the 2% that chemotherapy helped( i.e.),. The combo also showed it could reduce the risk of death by 48%. SVB Leerink analysts at the time called the data “extremely compelling.”
NB.Were IMU to be sold for $11.4 Billion USD the price per share paid to IMU holders would be close to $3.
Can IMU take the lead?
When it comes to big Pharma contenders recent wins by GSK’s Jemperli are set to give Merck’s Keytruda a run for its money as the leader in the Cancer Stakes field, outside of the existing standard of care (i.e., chemotherapy). However side effects are a significant setback for these more experienced runners. Side effects aside Imugene’s Her Vaxx is poised to become a potential contender as her Phase 2 combination trial with Merck’s Keytruda see’s Her Vaxx finally being dosed at the optimal dose rate of 100 mg, If successful this could definitely push Imugene toward the front of the pack. While it would be great to see Imugene’s Her Vaxx combine with their stables own PD1 Vaxx, the company's forthcoming PD1 Vaxx combination trial with Roche’s Tercentriq is definitely not one to be ruled out. Recent results highlight the fact that Imugene’s PD1 Vaxx continues to exhibit strong signals of efficacy in a Phase 1 trial into small non cell lung cancer patients in Melbourne, only miles away from the Cup.
But perhaps Imugene’s leading runner, CF33 and her stronger parental virus, Vaxinia, are sure to be favourites in the Imugene stable this November. There is pent up excitement in and around the bird cage this year as the public gather to mull over the form guide presented by Yuman Fong and other IMU celebrities. With three poster presentations to come from Imugene’s Oncarlytics runners, there is much to assess when it comes to form. Yet I’m thinking the eventual outcome of the race depends on the existing CF33 and Vaxinia trial printouts. CF33 looks to have performed well in the first few thousand metres, and given she can now be legally dosed up, her final 600 could be faster than most market pundits anticipated. The good thing is that the CF33 and Vaxinia trials comprise of a large number of patients (i.e., up to 100), so the form we glean from them can be considered strong. In other words the officials and race regulators may not need to see them race further before making a decision on their credentials. Given trainer Yuman Fong’s readouts from CF33’s initial hitout highlighted her unique ability to go to work early and practically wipe out all those in the field, one cannot rule her out as a favourite come the second week of November. We know she can perform on any surfaces, having succeeded in multiple barrier trials against practically all opponents. That said CF33 is sure to be carrying a heavy weight, as a number of runners are depending on her to run well. The likes of Celularity, Eureka and others from the CAR T stable are all endeavouring to piggy back off her success.
My bet
Whether you take Her Vaxx, PD1 and CF33 as a trifecta, or simply have CF33 and Vaxinia as a quinella it’s up to you. Given Fong’s ability to produce the goods in CF33’s barrier trial my money is on CF33 on the nose. But a mate of mine is picking her along with Vaxinia and the three IMU oncarlytics runners in the Quaddie, as early indications from Novembers SIT Conference highlight an uptick in recent form. Apparently she wiped out the field in the Cancer Liver Stakes over there.
Actually on second thoughts I’m picking all the IMU stable up top in a first four. Given the size of the prize pool there’s sure to be a big payout in the “Cancer Stakes Cup”. Oh and now I’ve had a chance to take a closer look, forget all the US runners, they have plenty of money behind them but perhaps not the Midas touch of Fong and Kaumaya. Either way despite not being a value stock, I think the IMU rug is certain to have many more followers into November than it did at Cup time last year. You may even be able to get in at better odds than back then, in October that is.
Hey, wait just a minute… Is this the winner?
npr.org reported earlier this year “In a very small trial done by doctors at New York's Memorial Sloan Kettering Cancer Center, patients took a drug called dostarlimab for six months. The trial resulted in every single one of their tumors disappearing. The trial group included just 18 people, and there's still more to be learned about how the treatment worked. But some scientists say these kinds of results have never been seen in the history of cancer research.”
See : https://www.npr.org/2022/06/07/1103545361/cancer-drug-experimental-rectal-chemotherapy-surgery-treatment-immunotherapy for more details
Conclusion
Unfortunately there are no real winners when it comes to the fight to cure cancer. Existing medications tend to make the disease more manageable through their ability to alleviate chronic pain within patients. Some even prolong life, at often great expense to patients with considerable side effects. In some instances, as we have found with Professor Kaumaya’s PD1 Vaxx, a few patients are lucky enough to have been disease free having been initially faced with imminent death. Many companies are endeavouring to cure cancer through various trials utilising allogenic therapies, oncolytic viruses, Car T cells, KRAS targeted therapies and cell therapy designed to target solid tumours. The most successful treatments thus far have been those focusing on blood cancers.
Hence the appeal of Professor Yuman Fong’s 33rd runner CF33, for cancer is a myriad of diseases intertwined and expressed more often than not through solid tumours, as opposed to blood cancers. The potential for a vaccine to target, hunt, kill and eradicate these solid tumours is, if successful, a major breakthrough in the fight to eliminate cancerous cells within humans. At this point in time CF33 has been overwhelmingly successful at a pre clinical level. Since October 2021 we can glean from its Phase 1 trial int TNBC patients at the City Of Hope Facility in California that it is indeed safe when dosed into humans. Are there any strong efficacy signals? Is CF33’s potent parental virus showing early signs of efficacy in its Phase 1 trial? Until we monitor the printouts on this form we are still in the dark. Internally the signs coming out of the IMU stable apppear positive. This week Imugene announced it had appointed drug manufacturer ABL to produce CF33 for use in future clinical and even registrational trials. Would they have taken such a step were the drug to be failing at the clinical level? I think not? Would they be presenting three poster presentations at the SIT Conference in November 8-12 of this year with CF33 at the core of their Oncarlytics platform had the drug failed at the clinical level? I think not.
Imugene investors hope and pray the pending announcements pertaining to CF33 are everything they had dreamed of. More importantly cancer patients worldwide hope and pray Professor Fongs oncolytic virus repeats the run it had earlier in its lifetime when tested on smaller opponents. But whether the winner is a combinations of B cell immunotherapies, allogenic therapies, CD19 - Car T cell treatment in combination with oncolytic viruses, or a drug such as dostarlimab, one thing is for sure. Existing monoclonal antibody treatments are akin to the the gasoline fed cars of industry, they have a lifespan. Just as the treatments used to treat cancer back in 2600 BC were found wanting, so is the primary standard of care today. Therefore irrespective of who wins the race, mankind is sure to be the ultimate winner.
DYOR - Seek investment as and where necessary - Opinions only
(20min delay)