Imugene - the Penthouse awaits
Reading the posts on HC pertaining to Imugene today I note there is much supposition surrounding the forthcoming AACR Presentation on CF33, including those contributing to the presentation, and the number of them. On another thread I note posters aligned with competing biotechs are questioning the veracity of CF33 and its effectiveness in curing cancer. Then as always the media thread discusses Leslie Chong’s comments if not performance in Proactive Investor and similar interviews.
My take is not to read too much into the number of those involved in the AACR Presentation awaiting us on April 9. The majority are charged with the responsibility of collating data from trial supervisors and transcribing results into a palatable form for presentation and thereafter publication in medical journals. The large number of those involved speaks to the number of locations assisting in the ongoing Vaxinia (MAST) Trial.
Just as I would suggest pay little attention to those questioning the prospective efficacy of CF33, be that in IT or IV format. Those who choose to ignore the results presented by Imugene in early November should in my opinion do so at their own peril. Jov88, tb, Hamish, Outlander, DavyBabyK, Hamish, Harry and many more worthwhile contributors to these threads have said as much of late. In my opinion Vaxinia’s success to date in stemming the spread of cancer in late stage advanced solid tumour patients within gastrointestinal cancers, is nothing short of outstanding. However as alluded to by CF33 Vaxinia’s founder Yuman Fong, to think a virus can be administered to cure cancer, could seem somewhat far fetched to many. I guess it is all a bit much to comprehend life beyond targeted therapy or precision oncology. That is all many of us have become accustomed to. Just as I am sure it is difficult for those unfamiliar and not involved with medical minds such as Professor Yuman Fong and Saul Priceman M.D, to fathom why Imugene (IMU - ASX) is worth multiples of other small Australian biotechs such as Race Technology (RAC), Prescient Therapeutics (PTX) or even the detection and diagnostic strategist Rhythm Biosciences (RHY).
As an investor I would pay attention to Imugene CEO and Managing Director Leslie Chongs recent discussions surrounding triangulation, bile duct cancer as an indication and the company’s desire to cross pollinate results between platforms. Chong appears keen to coach if not direct the FDA toward registrational trials for a variety of her products and platforms. As an example Leslie was more than excited to announce the dosing of a bile duct patient in the Oncarlytics trial, given the recent FDA Fast Track Designation granted to Vaxinia. Were Oncarlytics to prove successful in combatting bile duct cancer, it could be argued both Vaxinia and Oncarlytics are capable of meeting the huge unmet need within that indication, a feat worthy of dual Registrational Trial approvals, were such an outcome were to eventuate. Perhaps of even greater relevance is Leslie’s candid admission of positive signals across multiple cancer indications, in the ongoing MAST Trial. Aside from bile duct cancer she mentions other indications where the drug is exhibiting positive signals, including head and neck cancer and melanoma.
Imugene is now specifying their goal of delivering meaningful data to create a registrational trial pathway for a number of their products in multiple cancer indications.
Cancer is an insidious disease spreading throughout healthy cells, penetrating deep into difficult to locate parts of the human body such as those existing behind the abdominal cavity wall, invading at times the serous membrane lining the peritoneal cavity with malignant cells. Endometrial and other cancers associated with the uterus and abdomen cause the cells lining the uterus to grow in an abnormal and uncontrolled way. However just as these cancers populate the healthy cells within ones body, oncolytic viruses engage in a similar manner, though in reverse. They are designed to target the malignant cells in the body, leaving the healthy cells alone. Once a virus gets into a patients's body, it travels along the surfaces of cells until its proteins begin to bind with receptors on the cells. The virus and the cells then fuse, allowing the DNA or RNA inside the virus to enter the cells, where it begins to reproduce or replicate. Vaxinia is not only eliciting positive immune responses in those suffering with gastrointestinal tumours, including those surrounding the pancreas and liver, there are signs the virus is in fact replicating. If indeed the virus is not seen to be replicating enough in current data cuts, Dr Paul Woodard of Imugene said recently he is prepared for the data to drive trial direction, not ruling out the prospect of dialling up Vaxinia doses to 10 parts too the 9 if required.
Cancer patients today are often subjected to targeted and precision therapy that although proving effective, nonetheless produces adverse effects on their healthy cells, leading often to side effects such as nausea, diarrhea, stomach cramps, hair loss, allergic reactions, vomiting, muscle aches and pain. Vaxinia has been shown to result in fatigue and flu like symptoms in trial participants, without the serious side effects found in monoclonal antibody (MAB) or chemotherapy patients. This factor is yet another silver lining when it comes to Professor Yuman Fongs virus, which can be produced at a fraction of the cost of MAB’s and targeted or precision therapies.
Keep in mind the number of contributors to the AACR CF33 presentation does exemplify one thing. That is the length and breadth of Imugene’s Vaxinia (MAST) Trial, in which “any type of cancer” is acceptable when it comes to participation. The number of locations hosting participants, combined with the experience of those monitoring patient behaviour, highlights the extremes management are prepared to go to in prioritising this clinical trial. The fact Imugene has funds available to ramp up patient numbers to over 100 is even more impressive, given the need to focus on specific cancer indications where results have been highly effective, I.e., bile duct cancer.
Who know what the results in the ongoing Vaxinia Trial are to bring on April 9, we certainly do not. They could be either a miserable failure, or an overwhelming success. Either way I’m going out on a limb here to suggest the average punter has no idea what we are dealing with here. Let alone the sums involved were Imugene to achieve Registrational Trial status for several solid tumour indications, be they bile duct, head and neck, melanoma or gastrointestinal cancers. Put simply its telephone number stuff IMO. Thus far Imugene’s oncolytic viral therapy arm is displaying positive signals and immune responses within solid tumours, those contributing to up to 90 percent of all cancer diagnosis. I realise all that glitters isn’t gold, but phrases such as all roads lead to Rome, and Hop on the train do spring to mind. We now know Rome wasn’t built in a day, but from where I sit the foundations laid by Team Imugene are looking both broad and sturdy. Most of those on board need not wait too much longer for admission to the first floor. The penthouse awaits.
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