Ann: Phase 1 CF33-hNIS Study Update - Positive Early Signals, page-108

Vaxinia - the plot thickens

1 million or 10 million viral particles have been administered to the majority of patients analysed today in Imugene's announcement pertaining to their Vaxinia (MAST) Trial. 100,000,000 viral particles are now being administered to patients in the trial, with results to be forthcoming toward the end of this quarter if not into Q2. There is room to even progress ten times more to 1000,000,000 particles or 10 to the power of 9, should the Vaxinia Founder Professor Yuman Fong deem necessary, taking into account safety considerations. Pre-clinically his studies progressed to that dose before realising any toxicity in the tiny rodents he was injecting with the virus at the time. Last time I checked human participants in the current Vaxinia (MAST) are much larger than those mice were, hence they may be capable of stomaching a bit more of the drug.

So I guess given the state of play, as it is only the embryonic stages of what is to be a now expanded clinical trial to ascertain the optimal biological dose for the drug, one must come to the conclusion that the results thus far are simply astonishing. For those who have not followed the trial closely, the patients are presenting to the trial with metastasised tumours, or late stage cancer. In other words advanced cancer patients at stage 4 or above in their illnesses progression. Their cancer has spread throughout their body, from the location of the initial tumour. Unfortunately having attempted to stem the progression of their disease they have been dealt blow after blow on prior treatment lines, succumbing to a worsening of their condition. medscape.com refers to the severity of the condition referred to as metastic cancer when stating : The 5-year overall survival rate is about 11%. In those with multiple organ involvement and poor performance status, the median survival is only 3-4 months; the 1-year survival rate is less than 15%, with a 5-year survival of 5-10%. Keep in mind a patient with widespread metastasis or with metastasis to the lymph nodes has a life expectancy of less than six weeks. So in short the patients presenting to the Vaxinia (MAST) Trial are very ill. Yet in spite of the mid level doses reported today, close to half the patients reviewed experienced stabilisation of their disease. In other words there was neither an increase in size of more than 20% nor a decrease in size of more than 30% since the initial baseline measurement. To my way of thinking that’s nothing short of amazing, given the condition they presented to the trial in.

But that’s not the end of the good news released today by Imugene. Notably, as Imugene announced to the ASX, 1 patient with biliary tract cancer, treated IT with mid-dose level displayed pseudo progression with a 49% increase in tumour burden after 2 cycles of therapy. However, by the 4th cycle they achieved a Complete Response (iCR) with no known recurrence in over 430 days. A second patient with bile duct cancer, who previously progressed on prior drug therapies, achieved Stable Disease (SD) for > 4 months upon receiving IV-administered CF33-hNIS. So as the virus goes to work and replicates there is the potential for more patients to realise improvement in their condition in months to come, as they move through the cycles. As you are aware many cancer patients receive up to 8 cycles of chemotherapy before their treatment is complete.

I’ve given up on the ASX and local pundits to be honest, it goes without saying Imugene should probably have never been listed there in the first place, suffice to say I’m confident when those present at the recent JP Morgan Conference and the soon to be convened Asco Conference, (where Imugene are presenting this week), have time to digest these results, there shall be significant interest in the company. For withIn the gastrointestinal cancer indications the Imugene licensed Vaxinia reported today an 86% positive treatment effect, with a disease control rate (all CR, PR and SD) of 86%. Importantly in these patients, changes in tumour burden correlated with systemic immunological changes known to promote anti-tumour immunity, medical speak for its working.

Rising demand for new and advanced gastrointestinal cancer drugs and incline in demand for research and development activities of specifically targeted drugs and biological therapies are factors contributing to more opportunities for market players such as Imugene, to such an extent the drug may not last until Phase 2 before offers are made to acquire it. Whilst Array BioPharma, Arog Pharmaceuticals, Inc., ASLAN Pharmaceuticals, Galena Biopharma, Ipsen Biopharmaceuticals, Inc., Taiho Oncology, AstraZeneca PLC, Merck & Co. Inc., Amgen Limited, Bristol-Myers Squibb, Hoffmann-La Roche & Co., Eli Lilly and Company, GlaxoSmithKline Plc., Pfizer Inc., Sanofi S.A and Novartis AG are all conducting R&D in this growing market, I’d be confident in assuming few if any have exhibited an 86% positive outcome for participants in the commencement of a Phase 1 trial for their drugs. Perhaps the millions if not billions they are spending in search of a recipe to attain a share in this growing market segment may be better spent on aligning with Imugene’s Vaxinia now, before the results at higher doses come to fruition. This novel oncolytic virus is not dissimilar to a few CAR T drugs developed tears ago now, which were acquired pre revenue and FDA Approval. At the time their purchasers were well aware they’d have to multiples down the track when all their chickens came home to roost. Or more recently one or two of ADC's who have earn their developers large sums, off the back of promising early results.

Soon our attention shall turn to the genius of Professor Kauyama, as results of his PD1 Vaxx’s combination trial with Tercentriq come to hand. But spare a thought for his former colleague Professor Yuman Fong tonight, it’s been a good day.

DYOR Seek investment advice as and when required Opinions only