Imugene - joining the dots as we speak….
With the exception of Azer-cel, prior to late 2021 Imugene had already laid the foundations for future success. Then in 2022 upon visualising outstanding results in preclinical studies with CF33, Oncarlytics and a number of CAR T and allogeneic therapies, it was simply a matter of time before the IMU Board decided to bite the bullet and acquire their own allogeneic therapy. As luck would have it their chosen therapy became all the more valuable in late 2023, given its potential to treat patients who have relapsed following CAR T therapy.
So 2024 brings with it a year of data, the prospect of Fast Track FDA Approval designations and Priority Review status for cancer indications we had not forecast to appear in their arsenal, as little as two years ago.
A quick scan of their highlights reel can be found herein:
Her Vaxx
Analysis showed a 42% survival benefit for patients treated with HER-Vaxx plus chemotherapy compared to chemotherapy alone. This translated into an OS HR of 0.580 (80% 2-sided CI: 0.362, 0.927) with a statistically significant p-value of 0.066
PD1 Vaxx
PD1-Vaxx what illustrated effectiveness in inhibiting tumor growth. Studies highlight it is even more effective when used in combination with a second therapeutic peptide vaccine, one that targets two sites on the HER-2 receptor on colon cancer cells. The combination treatment produced complete responses in nine of 10 animals. That vaccine, called B-Vaxx, was developed earlier by the same research team.“Our study is important for two key reasons,” says first author and vaccine developer Pravin T.P. Kaumaya, PhD, a member of the OSUCCC – James Translational Therapeutics Research Program and a professor in Ohio State’s College of Medicine. “First, PD1-Vaxx activates both B- and T-cell functions to promote tumor clearance. Second, the treatment is targeted to block signalling pathways that are crucial for tumor growth and maintenance.
“By giving this vaccine in combination with an immunotherapy drug,” he explains, “we are supercharging and directing the immune system to target and kill cancer cells.”
CF33
Preclinical results demonstrate a significant therapeutic potential for CF33-oncolytic viruses in treating gastric cancer peritoneal metastases (GCPM), for which there are currently no durable therapies.
Taken together, data suggests that CF33-hNIS has the potential to be used as a therapeutic and also as an agent for noninvasive imaging, in the treatment of liver cancer.
SPECT imaging after treatment with CF33-hNIS-antiPD-L1 administered by IT injection in patients with mTNBC showed enhancement in 75% of injected lesions, suggesting local viral replication and hNIS express
Azer Cel
Azer-cel has demonstrated clinically meaningful activity with an acceptable safety profile for patients with non-Hodgkin’s lymphoma (NHL) and acute lymphocytic leukemia (ALL). Azer-cel achieved an 83% overall response rate, a 61% complete response rate with 55% durable response greater than or equal to six months in this difficult to treat auto CAR T relapse setting. Notably, the Azer-cel data has been found to be especially strong in patients with diffuse large B cell lymphoma (DLBCL) who had relapsed following auto CAR T therapy. Patients with DLBCL who have relapsed after autologous CAR T therapy have limited therapeutic options and are an unmet medical need. New and effective therapies are needed for these patients.
Vaxinia
Management says 34 patients have been dosed with Vaxinia during the dose-escalation phase, with 16 patients treated intratumorally and 18 patients intravenously as either monotherapy treatment or in combination with pembrolizumab. Of the 34 patients, 25 of them have entered the evaluation stage, with the remaining seven due to receive their first scan.
Encouragingly, one patient with bile duct cancer treated intravenously with a mid-dose has achieved a complete response with no recurrence in more than 200 days. Another patient has had a partial response and a further 16 patients have remained stable.
Early results from six patients with gastrointestinal cancers who received Vaxinia alone – including two with colorectal cancer, two bile duct, one pancreatic and one liver – showed positive treatment effects with a disease control rate of 75 per cent.
Oncarlytics
"The data supports the potential benefit of the 'Mark-and-Kill' approach in addressing the lack of tumour specific targets in treating solid tumours with T-cell therapies,” said Dr. Cheng Liu, President of Estrella Biopharma.
Imugene has been busy joining the dots. In spite of limited, at times slow clinical trial recruitment, they are now amassing enough data to support registrational trials for at least two of their treatment arms.
There is still no commercial deal(s) afoot. But the optimist in me is of the opinion that if Imugene continue to join the dots, dollars may not be too far away. Can the whole shebang fall over? Maybe, if CF33 throws us a medical curve ball, that wouldn’t be too flash. But I hardly envisage such an event occurring. The virus worked more effectively at higher doses pre clinically, particularly when it came to the IV Cohorts, therefore I see no reason not to continue counting my chickens in the existing MAST Trial.
Are you planning on buying more IMU? Is your decision based upon the uptick within the bio sector, the prospect of interest rates flat lining, or the pending data awaiting IMU followers? Personally I think the recent steady rise in shorts could be a good sign. It would appear there are one or two players or institutions going long on Imugene, and whilst they may choose to take out some insurance in the name of shorts, from where I si the overall sentiment remains bullish.
Existing Vaxinia results are enough to support the current IMU share price on its own, if valuations on overseas markets in similar stocks are anything to go by. Keep in mind Imugene may well be closer to reaching revenue status than many think, making the prospect of high price to earning ratios in the early years in market all the more feasible.
For those believing in the Professor Yuman Fong Vaxinia story, I guess now is the time to buy, before the results from higher cohorts are to be revealed. To date “everything the scientists witnessed pre clinically, has been now evident in the existing in human clinical trials.” Therefore IMO you would be a brave person to bet against even more promising results at higher dose rates in the current Vaxinia (MAST) Trial. For those awaiting the so called “proof of concept” for Vaxinia, who are yet to buy into the oncolytic virus story, I suppose you face two scenario’s. Firstly, Vaxinia patients take a U Turn and rather than stabilise, regress, or experience high levels of toxicity at higher dose rates. Or secondly, the future cohorts bring with them significant reductions in their tumour burden at higher dose rates, hence vindicating those close to the trial at Team Imugene. I suppose it all comes back to the glass half empty of full scenario. Where do you sit? Either way sitting on the fence may not be the best recipe for success in 2024.
DYOR Seek investment advice as and when required Opinions Only
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