Why Imugene is a multi bagger - by WatmighthavbenImugene is...

Why Imugene is a multi bagger - by Watmighthavben

Imugene is transitioning from small clinical trials at low dosage rates on late stage cancer patients, toward clinical trials with an increased number of participants, earlier stage patients and higher dosage rates. This bodes well for the company’s future, particularly when one considers they have the cash to fund these clinical trials. The lack of efficacy data during this transitional phase has weighed heavily on the company’s share price, which is understandable. Institutions, pharmaceutical companies and investors require in human results prior to pulling the trigger. But with clinical trials now taking place at close to their optimal biological dosage rate in most of if not all Imugene’s current trials, the stage is set for a plethora of results. Increased dosage rates have been shown to stimulate antibody production and enhanced immunity among Imugene patients. If this pattern continues at now higher dosage rates, there should be an increased number of both complete and partial responses to Imugene’s immunotherapies. As witnessed with Friday’s Her Vaxx announcement significant immune responses within cancer patients can and does lead to healthy outcomes for these patients, including tumour regression.

Another development during this transitional phase has been the addition of new products, with the Oncarlytics platform joining the Imugene pipeline in mid 2021. Whilst Oncarlytics has subsequently produced strong pre-clinical results one could argue it has made Imugene’s science rather difficult to comprehend for the average lay person, if not investor. Has this weighed on the share price as well? Quite possibly. It’s kind of like watching Martin Scorcese’s “The Departed”. Viewers are just assessing Jack Nicholson and Matt Damons characters and then along comes Leonardo De Caprio, Martin Sheen, Mark Wahlberg, Alec Baldwin and a whole host of other big name actors and we’re just getting started. Likewise Imugene investors were just coming to grips with the notion B cell vaccines could stimulate the immune system through increased antibody production in order to fight off cancer, then CF33 came along. They then had to grasp the concept of a virus that infects only cancer cells, before exploding and ultimately eradicating them, in the fight against solid tumours. Then all of a sudden they had to come to terms with a whole new scientific concept known as Oncarlytics, wherein a target was painted on solid tumours, enabling CAR T cells to assist CF33 in the war on cancer. It was all becoming just a little too scientifically complicated. And why was Imugene chasing down further rabbit burrows when they were already on a good thing? Some well may have asked. And could Imugene pull it all off? And what would it all cost? And would the advent of Oncarlytics mean the company would be running too skinny and drop the ball on their initial goal, that of seeing Her Vaxx and their B cell therapies through from bench to bedside, as it were.

In retrospect clearly the acquisition of Oncarlytics has broadened and in doing so strengthened Imugene’s portfolio. The ability to combine with a multitude of CAR T cell and allogenic therapy companies and products adds a string to the company’s commercial bow. With significant tumour killing evident in initial Oncarlytics combination trials and an FDA Approval in place for an human trial, the City of Hope licensed treatment arm could well take the world by storm once this trial is underway, given the enormity of the solid tumour market in which it is operating. However despite the huge growth potential Oncarlytics holds for Imugene, and although the company’s initial B cell candidates Her Vaxx and PD1 Vaxx have proven extremely successful in their recent hitout’s, Imugene has rightfully stated they are prioritising their Vaxinia (MAST) Trial, as documented in their most recent newsletter. Whilst we all want to be all things to all people, sometimes it’s prudent to maintain a focus and complete one task successfully, before we start onto the next. With this in mind Imugene has expanded the number of centres and hospitals open for solid tumour cancer patients in the Vaxinia Trial, at the same time broadening the number of solid tumour indications able to enrol and participate in the trial. This move strengthens not only the creditability of the Vaxinia trial, but affords trial supervisors the opportunity of going back to the FDA toward the years end with a large amount of data in their kit bag. Data with which to fast track the health regulators approval for commercial administration into much needed patients.

Therefore Imugene’s attention turns to the assessment of data in the oncolytic virus trials, those being a CF33 Trial into late stage Triple Negative Breast Cancer patients, alongside the aforementioned Vaxinia (MAST) Trial. Where are we up to with both trials? Well in short we are nearing if not close to the optimal biological dose in both, with up until now “positive signs” of efficacy and ongoing safety prevalent. Now it’s simply a matter of analysing data from cohorts 3,4 and then 5 within the concurrent trials, before having the data assessed in the lab, peer reviewed and published. Having done so the FDA is the next “cab off the rank” for Imugene’s flagship product(s). Are they going to be successful in achieving tumour regression if not tumour elimination in solid tumour patients? Are they about to set the world stage on fire in announcing a prospective cure for cancer? Is it possible CF33 and Vaxinia could eliminate all cancer types, as they were so successful in doing pre-clinically? Well as we wake every morning from now through the month of July 2023 that is the million dollar question, for both cancer patients and Imugene investors alike. For unlike other clinical trials there is no shortage of patients lining up to participate in the OV trials. Oncologists are clearly liking what they are seeing from the initial cohort of trial patients, albeit at low dosage rates. From all accounts CF33 and Vaxinia are working, as stated by Imugene CEO and Managing Director Leslie Chong as recently as last Wednesday, during an online presentation to investors. This month CF33 and Vaxinia founder Professor Yuman Fong from the City of Hope cancer research facility in California is revisiting Australia, Imugene’s headquarters, to meet face to face to face with investors, having done so only recently in March of this year. In March Professor Fong stated “everything we saw in animals, we are now seeing in humans”, when speaking of the current OV trials. Further to which he noted “we are seeing unequivocal signs of cancer killing within humans”. Since then images of necrosis (I.e., cell death), have been presented to medical conference attendees in April of this year. City of Hope’s Dr Jamie Rand, who is Assistant Professor in the division of Breast Surgery within the Department of Surgery, presented the data at the American Association for Cancer Research Annual Meeting 2023 in Florida. Notwithstanding the exceptionally low doses of CF33 administered to these extremely sick patients, 75% of the injected breast cancer lesions that received CHECKvacc via IT injection showed enhancement. Imaging of these patients revealed improved enhancement in subcutaneous nodules, intramuscular nodules and lymph nodes compared to matted dermal metastasis. A phenomenal result considering all the elements involved.

Evidence of necrosis via SPECT imaging was on patients with this TNBC that had received CHECKvacc via intratumoral (IT) injection - photo courtesy of Imugene

In Imugene’s most recent Vaxinia announcement MD & CEO Leslie Chong said: “As we continue to move through the cohorts at pace, we’re aiming to have this high-quality science peer reviewed and recognised within publications or conferences befitting of its results and potential benefit to patients in need.” With this in mind if patient biopsies return positive proof of tumour regression and ultimately elimination as discussed in my previous posts, the door opens for Vaxinia to be accepted as a “significant breakthrough therapy” by the FDA, worthy of prospective fast track approval for treatment in solid tumour patients. A registrational trial could commence as early as 2024, should all things run to plan. For the Biden “Moonshot Project” is currently centred upon accelerating the drug approval process to ensure breakthrough medication reaches patient arms as quickly as is humanly possible, given the veracity of the disease. To Vaxinia’s credit it has proven itself safe to date, and can be administered not simply intratumorally (i.e., into one’s sold tumour), but intravenously as well (i.e, into the bloodstream). This makes the drug extremely attractive to regulators in the US, in search of cost effective drugs to limit the burden currently placed on the healthcare system. There is a definite and imminent need to reduce the extensive “in hospital" hours and treatment expenditure associated with existing cancer treatment in the US. A problem exacerbated by the fact that due to the high cost of treatment, cancer care is simply out of reach for many in the US healthcare system.

The current Vaxinia (Mast Trial) progression - Courtesy of Imugene

Could the trial all blow up, fail and be revealed as a flop, with patients being harmed if not killed by the virus? Well anything’s a possibility, but news this week from Imugene MD and CEO dosing is set to commence within the next cohort of patients intratumorally in the trial, would suggest all is well (see above - trial progression). IMO the Vaxinia Trial at this level of cohorts has advanced well and truly far enough to be placed firmly in the de-risked basket. Are the results Vaxinia results going to come as early as mid July, before, during or after Professor Yuman Fong’s forthcoming Australian visit? During his last visit Yuman spoke said biopsies from existing OV patients had at that time been forwarded to the clinical lab for analysis. Results from these biopsies would already have been assessed by the trial supervisors. Whilst I note pre-clinically Professor Fong stated he visualised Vaxinia results within 30 days of treatment. Therefore he would by now be well aware of the effect Vaxinia is having on the cohort of patients dosed with Vaxinia in combination with pembroluzimab (I.e., Keytruda), in early April of this year. Yes in a few weeks time he shall be in position to further discuss with the public the progress CF33 and indeed Vaxinia are making, as they head toward what shall be their optimal biological dose rates.

So where does this leave IMU investors? Well sitting on the edge of their seats to put it mildly. Everyone I have spoken with is salivating over the prospect of Vaxinia proving what could be a potential cure for the treatment of solid tumour in cancer patients. They are somewhat stunned at how many cancer indications are being accepted into the trial, and buoyed by the fact the trial is including up to 100 patients. This is a significant sample size of patients across a broad number of cancer indications, that if successful could change the way we treat cancer from here into the future. Professor Fong noted as much in late 2022 on US late night KPLC TV when he stated he was convinced Vaxinia would one day become “human therapy”, in combination with other immunotherapies. Now patients and in turn investors need to see if the proof’s in the pudding. If so is the IMU share price worth a dollar, or ten times that? Either way I think we’ll know sooner rather than later.

In the interim I’m off to Martin Scorcese’s house to ask if he can direct the film version of IMU story. It appears far too big and complicated for anyone else to manage. I’m wondering whom he’ll cast…

DYOR Seek investment advice as and when required Opinions only

Disclaimer : Biotech stocks can be hugely speculative and as a rule should only be considered a s a part of a diversified portfolio having appropriately assessed one’s risk profile and financial position

Of Vaxinia - The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models. Overall, the study aims to recruit up to 100 patients across approximately 10 trial sites in the United States and Australia.