Thanks @Shaunbra, in answer to your question we are expecting further clinical trial results in the ongoing Vaxinia (MAST) Trial in the next week to ten days. I would envisage they shall come to hand prior to Imugene’s presentation at 9:30am AEDT, Wednesday, on January 10. The remaining 9 patients of the 34 initially administered with Vaxinia in the current dose escalation trialwere set to receive their first scan in early November, hence they would have by now I’m assuming have entered the evaluation phase, from which biopsy results and subsequent peer reviewed analysis can be released to the market.
As Imugene CEO and Managing Director Leslie Chong has stipulated at every interval this is merely a dose escalation trial, designed to determine the optimal biological dose rate for Vaxinia, as opposed to establish efficacy. Yet the initial positive signals have left many in Team Imugene more than impressed with Vaxinia’s effectiveness, even at relatively low doses. Particularly when one considers 18 of the initial 34 patients evaluated were administered the drug intravenously. Intravenous, as opposed to intratumoral administration is often not as effective at low doses of a specific drug, due to the bodies want to secrete a portion of the drug through either urine, bile, sweat, saliva, tears, milk, and stool. This fact makes the disease stabilisation resultant in 16 of 25 patients evaluated thus far even more outstanding.
On a micro level Vaxinia now has an FDA fast track designation and priority review status pathway open to it within the indication of bile duct cancer. One patient with bile duct cancer achieved a complete response having been administered with Vaxinia, and to the best of our knowledge is still cancer free. As a consequence a further 10 late stage bile duct cancer patients are gazetted to participate in the ongoing Vaxinia Trial. Bile duct cancers are notoriously difficult to treat and typically respond poorly to immunotherapy drugs. Early in the treatment process, tumours can exhibit signs of pseudo progression – a phenomenon in which the cancer initially appears to be growing, largely due to the cancer cells being infected by the virus followed by infiltration of cancer-fighting immune cells. The phenomenon often leads to premature discontinuation of treatment owing to the false impression that the cancer is growing. Given time and continued treatment, the tumour can decrease in size as the therapy takes effect. These facts make the results released next week of even greater interest to patients, investors and the market alike. Is Vaxinia continuing to replicate? Or has the patients cancer won out over Vaxinia, given the metastasised nature of their existing tumours? Have patients continued to experience stabilisation of their disease, and if so has their tumour burden regressed?
On a macro level the stars are continuing to align for Imugene from a share trading perspective. As @Footmax noted earlier today in the US, The DOW rose 111 points (.3%), the NBI rose 65 points (1.51%), the NASDAQ Composite rose 24 points (.16%) and the Russell small cap index rose 7 points (.34%) last night. The NBI’s strength signifies a return to all things biotech as inflation continues to dissipate, easing fears of continued rate rises in 2024. Importantly pharmaceutical M&A in 2023 hit record highs as larger companies turned again and again to young biotechs for innovation. As noted by biopharmadive.com, these deals focused on cancer, rare diseases and immune system disorders — areas of drug research that were seeing major victories in clinical trials and huge profits for treatments that made it to market.
Chart courtesy of biopharmadive.com
This time last year I was anticipating a strong vote of investor confidence in Imugene following the JP Morgan Conference, given the strength exhibited by Oncarlytics in late 2022, when combined with Celularity, Eureka and Blincyto. Though in retrospect the market may still have been awaiting further data from CF33, which is such an in important cog in the Oncarlytics wheel. Now we have the CF33 Vaxinia results, and with more Vaxinia results to come the light is set to shine upon the small Aussie biotech, with so much to offer cancer patients maligned with solid tumours. Approximately 90 percent of all cancer diagnosis are attributable to solid tumours. This is not a rare disease with a limited revenue stream. This is a monolith encompassing a huge unmet need that is crippling medical institutions, governments and regulators the world over. Imugene has a shot at the title, when it comes to treating these afflicted individuals.
Ongoing Vaxinia results perhaps hold the key to the delivery of silver bullets, when it comes to suppressing this insidious disease. Time shall tell, yet if initial positive signs are anything to go by, future results at higher dose rates of Vaxinia could be even more promising than those announced in early November. If indeed Vaxinia is continuing to turn tumours from cold to hot, to replicate, and in so doing infiltrate these dastardly cancerous cell hubs, we may be on track for a bright start to the New Year. JP Morgan may well be the stage from which Imugene has the opportunity to tell the world all about Yuman Fongs inspirational technology.
DYOR Seek investment advice as and when required Opinions only
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