Sunday Edition
An Underdog Penny Stock with Big Possibilities in the Fight Against Cancer — Pela (ONCY)
Earlier Jones Reports have explored some intriguing "what if" possibilities surrounding Oncolytics Biotech (ONCY) and its experimental cancer treatment, Pelareorep — or Pela.
Before going any further into the "what ifs," let's remind ourselves this is speculation, based on "some" encouraging scientific evidence from relatively small clinical trials. But let's also remember that many of these trials have involved patients with advanced cancers, often with few treatment options remaining.
Perhaps an urgent unmet need to help courageous cancer fighters is one reason the FDA seems to be engaging more closely with Oncolytics lately. At the same time, let's not forget that putting real money into even "some" shares of an underdog penny stock carries risk. So let's keep our expectations humble.
Pela is a naturally occurring reovirus, first studied during the polio research era of the 1950s, including work by famed polio vaccine pioneer Dr. Albert Sabin. Today, that virus is cultivated and amplified into an experimental IV treatment designed to stimulate the body's immune response against cancer.
Now, with initial results from the REO-033 colorectal cancer trial anticipated around year's end, another important "what if" is approaching.
Recall that the earlier, small REO-022 trial produced an impressive 33% objective response rate (ORR) compared with historical standard-of-care benchmarks of approximately 6–11%. The trial also reported encouraging evidence of longer survival.
Unlike the earlier trial, REO-033 is designed to compare Pela's results against an actual control group receiving standard treatment, rather than relying on historical comparisons.
Importantly, Pela has already received FDA Fast Track designation, and Oncolytics and the FDA have made significant progress toward establishing a potential pivotal expansion of REO-033, with ORR serving as a possible basis for accelerated approval.
Consider the possibilities.
What if the initial REO-033 results begin to confirm the earlier findings? Or better yet, what if they exceed them substantially?
Could such results prompt the FDA to consider an extraordinary acceleration of Pela's development and potential approval?
And here is another intriguing possibility.
Could Pela become a candidate for FDA Breakthrough Therapy designation?
There is an interesting historical precedent.
Merck's blockbuster cancer immunotherapy Keytruda received Breakthrough Therapy designation in January 2013, followed by its initial FDA approval in September 2014.
But consider something else about Keytruda.
Despite its remarkable success in treating several cancers, evidence has demonstrated that Keytruda alone is often ineffective against immunologically "cold" tumors, particularly microsatellite-stable colorectal cancers.
In fact, one early clinical study reported no objective responses among 18 patients with mismatch-repair-proficient colorectal cancer treated with Keytruda.
And that brings us back to Pela...
Earlier clinical studies have demonstrated Pela's ability to stimulate immune activity within tumors, potentially providing the very immune activation that treatments such as Keytruda need to become more effective against otherwise resistant cancers.
Pancreatic cancer tumor biopsy — immune-cell activity
Figure 8: Distinct Distribution of Tumor Infiltrating Leukocyte (TIL) populations and Metabolic Alteration
Study: https://oncolyticsbiotech.com/wp-content/uploads/2022/12/ASCO-2021_final.pdf
These studies have also demonstrated a generally favorable safety profile, with encouraging evidence of longer survival in certain cancer treatment combinations.
Although REO-033 is not testing Pela with Keytruda, compelling results could strengthen interest in Pela's broader potential as an adjunct to existing cancer treatments.
And what about Big Pharma?
Could extraordinary REO-033 results, potentially followed by Breakthrough Therapy designation, suddenly change the level of interest among major pharmaceutical companies?
Might licensing agreements, development partnerships, or even acquisition possibilities begin taking on an entirely different dimension?
After all, Pela's potential application across multiple cancer types could represent a much larger opportunity than colorectal cancer alone.
And consider another possibility.
Because Pela is administered separately from existing cancer treatments, one can envision a future where patients might visit convenient outpatient infusion clinics to receive Pela as an adjunct therapy, under the direction of their oncologists.
Such a development could open an entirely new dimension in the delivery of cancer treatment.
Now, consider the bigger picture.
For years, the vision has been that a naturally occurring virus could become the missing piece that helps existing cancer treatments save more lives.
Earlier Jones Reports coined the term "The Trinity Approach" — envisioning the potential combination of Pela with checkpoint inhibitors and antibody-drug conjugates.
But perhaps there's another intriguing dimension to that name.
Consider a virus provided by nature, studied decades ago by Dr. Sabin, and now cultivated and amplified by Oncolytics into a potential weapon against cancer.
Could there even be a touch of divine Providence in this long journey? Who knows?
Again, let's stay humble in our expectations and keep it to the science. After all, ONCY trades well under a buck, and its following seems largely confined to a group of us retail scientists, believers, and hopefuls.
And as earlier Jones Reports have suggested, I now proclaim that a wake-up call may be coming for institutional money managers. If the initial REO-033 ORR readout points convincingly upward, perhaps Wall Street will finally begin taking a closer look at this underdog penny stock.
What might that mean for Oncolytics itself?
Could today's underdog penny stock eventually emerge as a key player in the fight against cancer?
Perhaps the approaching REO-033 results will begin to tell us whether some of these extraordinary possibilities could become reality.
For a little penny stock with such enormous potential, that would be quite a story.
This report has presented some intriguing "what if" scenarios.
For those of us willing to take a chance on something with the potential to make a real difference, perhaps owning just "some" shares is a way to be part of it.
But perhaps - not too many to limit the risk.
Let it be known that I still personally hold 1000 ONCY retail shares, now under a buck. Although they are seemingly embattled shares during the wait for the initial readout - I want to see what is actually about to develop with Pela advancement.
- Jones Report
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