Looking back over recent years I believe Imugene has made some fantastic decisions, particularly the acquisition of Vaxinia, then Oncarlytics, and more recently Azer Cel. These medical technologies stand to place Imugene at the forefront of cancer research and development, once their existing trials are complete. Imugene’s most recent acquisition Azer Cel, could prove even more valuable than initially forecast, given developments this month in the field of Car T therapy.
In a recent gengennews.com article the author notes “Unlike the all-but-unstoppable cyborgs of science fiction, CAR T cells are, well, stoppable. For example, they have struggled against solid tumors. Consequently, some therapeutic developers have been exploring alternatives to CAR T cells. One such developer, Frank Borriello, MD, PhD, the scientific founder and CEO of allogeneic therapy company Alloplex Biotherapeutics noted “The CAR T-cell approach has been phenomenal and has opened the door to a new therapeutic modality, however the first entrant into any field is rarely the optimal solution.” Borriello explains that the search for cell therapies has prompted some to reconsider the cyborgian approach. “Do we engineer or not engineer?” he asks. “The original CAR T cells were engineered to specifically recognise tumor cells.”
Whether or not cyborgian or more naturalistic cell therapies are deployed, another question looms. Should cells be obtained from patients or healthy donors? (The former approach results in autologous treatments; the latter, allogeneic treatments.) Whereas the original CAR T-cell approach used a patient’s own cells, various allogeneic treatments are being pioneered.
Allogeneic cells - the future of low cost cell therapy
Asmany of you may be aware Cell therapies (CTs) are revolutionising patient care and enabling treatment for serious or life-threatening diseases. However the FDA’s recent moves to place autologous Car T therapies under the microscope due to long term patients risks and potentialfatalities, has changed the game somewhat. While autologous CT will remain the go-to solution in the near term for development of personalised cancer therapeutics, access to treatment is restricted due to inefficient manufacturing and distribution processes, as well as high costs.
Imugene recently strode into the CT arena through their acquisition of an allogeneic therapy from Precision Biosciences known as Azer cel. Allogeneic CTs are emerging as a viable option to expand access to personalised medicine and treat a wider patient population with increased speed. Allogeneic CTs are engineered for specific therapeutic applications in any patient, and can be produced uniformly, at scale, in a quality-controlled environment. This “off-the-shelf” approach streamlines production processes and allows pharmaceutical companies to manufacture therapies in larger batches.
However, as lifescienceleader.com noted in a recent article on November 10, allogeneic CTs still face a number of obstacles that stand in the way of widespread adoption. Overcoming the possibility of adverse immune responses and achieving consistent quality results from one batch of cells to another is necessary to ensure patient safety and product efficacy. One way to mitigate the risks inherent in allogeneic cell production is to streamline an existing CT development pipeline, or to de-risk their entry into allogeneic CT, through acquiring a partner who specialises in cell therapy products. Keep in mind achieving consistent quality results from one batch of cells to another is a complicated process. Variability in manufacturing processes, environmental conditions, and donor characteristics can impact the final product.
Therefore sourcing an experienced manufacturer is key to driving your cell therapy forward in a regulated environment. Forming part of the Imugene azer cel deal is the ability to access a state-of-the art, 3047 square metre manufacturing facility in North Carolina. Last month Imugene received FDA support for the manufacturing of azer cel, which has the potential to be the first CD19-directed allogeneic cell therapy. At the time Imugene Managing Director and CEO Leslie Chong said, “Having FDA support on the manufacturing process which can be used for the pivotal Azer Cel trial is an extremely important milestone for us as it improves the overall robustness and scalability of the product.” Chong went on to say, “Azer-cel is a supercharged allogeneic T cell designed to identify and kill malignant cells expressing CD19.”
Vaxinia, Oncarlytics and Azer Cel
Both autologous and allogeneic cell therapy have combined in recent years with Imugene’s CF33 and cd19 Oncarlytics platforms to produce positive results, in particular “significant tumour killing” in one preclinical study. There is promise CF33’ potent and parental virus Vaxinia may prove effective when combined with Oncarlytics and eventually Azer Cel, in the treatment of solid tumours within cancer patients. As with Azer Cel Vaxinia has recently obtained support from the FDA, in receiving fast track designation and priority review status, in the indication known as bile duct cancer. If successful in treating bile duct patients and obtaining FDA registration, there is the prospect of utilising Vaxinia to treat a broader array of solid tumour indications. This opens the door for Imugene’s ancillary Oncarlytics and allogeneic therapies to treat solid tumour patients, when combined with Vaxinia. Why is this important? Because historically both autologous and allogeneic therapies have been successful in the treatment of blood cancers, or approximately 10%of cancer patients, as opposed the much larger solid tumour population of cancer diagnosis.
A while ago a friend of mine suggested I ask Yuman Fong whether he was going to develop his own Car T drug to compliment Vaxinia and Oncalytics. This would save Imugene the task of having to out license their pre eminent platforms to third party Car T therapy providers, he noted at the time. Then low and behold Imugene arrives with Azer Cel, courtesy of Chairman Paul Hoppers Chimeric (CHM). The way things are turning out this could well prove a masterstroke, equal to Hoppers courting and eventual acquisition of Vaxinia and then Oncarlytics. But have Imugene made the most so far of their acquisition from a marketing perspective? Perhaps not, if the truth be known. As discussed by me in previous posts, exposure to the US by more prominent Biotech figureheads there, such as Borelli, may have assisted in creating greater market awareness, as would have A Nasdaq listing in my opinion. But that’s just me beating a tired drum that is all well in hindsight. The fact is the acquisition of Azer cel has failed to move Imugene’s share price one way or another, which from where I sit is a huge missed opportunity.
Either way Imugene’s future is in good hands given the three acquisitions referred to in this post. Those who fail to recognise the value in these scientific advancements should perhaps stick to their own share price evaluations and trading analysis when it comes to Imugene. Perhaps they should continue to consider Imugene a joke stock with bad management. For if they don’t really understand the science, that’s really the best card for them to pull, right? The science can’t be any good because the share price isn’t going up, right? Yep, leave them to these opinions, and let’s stick to ours, based on the innovative scientific team Imugene has amassed to deliver their unique immunotherapies to patients. For the more you read the more you come to the conclusion Imugene is ahead of the curve when it comes to cancer treatment. Azer cel and its foray into the allogeneic therapy sphere is but one great example.
Enjoy your day
WMHB
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