Imugene - Not much to report at this stage
Lots of chatter on the IMU threads from TA and FA posters trying to divine which way the share price is heading. 2024 now tells us IMU stock is trading in a tight band with Moving Day Averages touching the upper side of Bollinger bands, but failing to break through, or break out, if you want to look at it that way. The US markets have been strong, with future interest rate falls in sight, yet the Nasdaq Biotech Index has stalled somewhat, which is not assisting IMU’s plight. The overall market move may well be sideways, as lagging inflation and stubbornly high interest rates start to weigh on company earnings in the near term.
B cell development - or non development, as the case may be
What is holding Imugene back is not simply a delay in the release of critical clinical trial data, but a failure of company management to release important “patient dosed” data in a number of trials. Having promised so much at the outset of clinical trials such as NEXT HERIZON (a combo between Imugene’s HER VAXX and PEMBROLUZIMAB) and their IMPRINTER TRIAL (a combo between Imugene’s PD1 VAXX and TERCENTRIQ), investors have been left somewhat in the dark when it comes to the number of patients dosed and overall trial data. Unlike the company’s VAXINIA TRIAL, where investors have been kept abreast of ongoing patient dosed numbers, and ongoing trial data, Imugene has failed to follow through with thorough reporting on the B cell side of their pipeline. We know the IMPRINTER TRIAL covers many sites around the world. Setting the trial up in each of these domiciles, let alone domains, would have been costly from a man management and time management perspective. So what has become of these B cell trials? How many patients have been dosed? The same could even be said of their current OASIS TRIAL in play for the company’s Oncarlytics treatment arm. Investors would surely like to know the number of patients dosed in that clinical trial.
So when Imugene CEO and Managing Director comes out with exuberance at the commencement of a clinical trial, as she did at the commencement of the NEXT HERIZON Trial, one has to admit the broader market views such emotion with a note of caution now, as opposed to the cautious optimism held previously. It comes across as the “boy who cried wolf,” for want of a better analogy. Until company management comes clean with precise data on their ongoing B cell trials many may well hold off pushing IMU through the upper Bollinger bands, when it comes to trading, and start throwing stones at the decision to employ highly paid executives such as Monil Shah, who from all accounts was charged with the responsibility of delivering a commercial result for the said suite of products.
Azer Cel, Vaxinia and Oncarlytics hold the key
Market machinations and B cell development aside, the autologous vs allogeneic debate has played into Imugene’s hands, with the decision to purchase an allogeneic therapy, in Azer cel, proving a masterstroke in hindsight. It would appear the drug is on a collision path with a registrational trial, leading to revenue streams for investors much sooner than they anticipated this time last year. Whilst management’s decision to prioritise the VAXINIA (MAST) TRIAL has been vindicated, with the recent FDA FAST TRACK DESIGNATION for the drug in the bile duct cancer indication highlighting TEAM IMUGENE’S prowess when it comes to not only discovering game changing therapies, but delivering on them.
From a personal perspective despite some discrepancies when it comes to the release of B cell trial data, not to forget the ongoing CF33 CHECK VACC TRIAL at The City of Hope Cancer Research Facility in LOS ANGELES, I can see nothing but blue sky ahead for Imugene followers and IMU holders alike. The company is reaching the pointy end in their Azer Cel and Vaxinia Trials, with all roads pointing toward registrational trial status sooner rather than later. It would appear the FDA is onside when it comes to both trials, with the company’s ONCARLYTICS platform set to be the beneficiary of any approvals to either Azer cel, Vaxinia, or both. If the Vaxinia results released last November are replicated in April this year, IMU stock is set to have a rocket put under it, with many folk sitting on the sidelines awaiting the release of such crucial data. If they are less than impressive I for one cannot see too much downside in the IMU share price. The company already has the runs on the board when it comes to trial data pertaining to gastrointestinal indications, as exemplified by the aforementioned FDA PRIORITY REVIEW STATUS awarded the drug. Therefore that should be enough to underpin the stock at current prices, given the quantum of that market in size, irrespective of any unpleasant outcomes from the pending 10 to the 8 patient data in the ongoing MAST Trial. Obviously negative results would not be advantageous to the IMU share price, however one must take into consideration what has already been achieved in the trial to date.
I think the combination of CF33 ONCARLYTICS holds the answer to the question of How much blue sky is on the horizon, when it comes to the IMU share price? This targeted approach of “mark and kill” when it comes to solid tumours in cancer patients, is one that has not been done before, as noted by me in previous posts.
Imugene - tackling solid tumours head on
In normal tissues, CD19 is only expressed in mature B cells, precursor B cells, and plasma cells, but hematopoietic stem cells and non-hematopoietic stem cells do not express CD19. Most B cell malignant tumor cells express CD19, and CD19 antigen is expressed in more than 95% of B-cell lymphoma cases. Therefore the success of CAR T cell therapy has been confined in the main to blood cancers, such as Non Hodgkins Lymphoma, and lymphomas in general, or leukemia. The Imugene website notes that in a recent study by City of Hope (COH) scientists led by Dr. Saul Priceman demonstrated proof-of-principle for their Oncarlytics strategy [Park etal. 2020], designed to tackle solid tumours in cancer patients head on. In this study, the COH team used CF33 OV to selectively deliver CD19 to tumor cells in murine cancer models, and used CAR-T cells directed against CD19. The combination of CD-19-directed CAR T with CD19-encoding OV resulted in greatly improved survival of mice compared to antigen-mismatched combinations. If indeed these results are replicated in the current Oncarlytics OASIS TRIAL the outcome could be potentially groundbreaking, as the door then opens for CAR T therapy to be utilised in the treatment of solid tumours in cancer patients, as opposed to the much smaller blood cancer market.
Personally speaking I would not read much into macroeconomic or trading activity when it comes to the IMU share price. From here on in the fate of Imugene’s share price rests squarely on the shoulders of their oncolytic virus, Oncarlytics and allogeneic therapy results. If successful, blue sky abounds for investors. If not, it may well be back to the drawing board for company management as they seek to deliver on their own mission, that being to provide meaningful outcomes for cancer patients worldwide.
DYOR Seek investment advice Opinions only
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