This past month I’ve had three conversations with friends that included the following sentences.
- “It’s been two years but something doesn’t feel right, I’m going in next week.”
- “I’m cancer-free.. at least for now.”
- “Dad’s decided not to fight it this time, it’s just not worth it to him.”
Three friends that are either right in cancer’s line of fire, and not for the first time, or have beaten it once but fear it’s coming back.
Clearly medical science has achieved wonders in finding ways to slow or stop various cancers from ravaging the human body. We have drugs, we have chemo, we blast it with radiation and hack at it with scalpels, and patients deal with the pain and suffering of those processes because months of nausea and pain sure as hell (usually, anyway) beat the alternative.
But sometimes that fight results in only a temporary stay.
And even if it doesn’t, even if it’s wildly successful, the patient doesn’t know for sure that it worked permanently until they have the benefit of long term hindsight.
Getting cancer sucks.
Treating cancer sucks.
But seeing it return might be the worst option of the lot.
I heard a pitch last week from a group called Onco Innovations (ONCO.C) that stopped me in my tracks because there are few companies I want more to see succeed on the public markets. If the tech they espouse is real, I’ll go to the fucking wall for them to be a success.
So far, it’s looking good.
THE PROBLEM
Their tech, licensed from the University of Alberta, involves PNKP inhibitors, which block the repair of DNA. This matters because radiation hits helalthy systems as hard as it does tumors and cancer cells, and some subgroups of cancer cells become resistant to radiation treatment. Some slip past chemo treatment, and survive in areas of low oxygen.
And those bastards are the ones that take root elsewhere, repair their DNA, and become new cancer locations.
About 40% of people with colorectal cancer (CRC)—a common type of cancer that starts in the colon or rectum—die because the cancer spreads to other parts of the body (called metastasis). Once the cancer spreads beyond the colon, it becomes much harder to treat, so while it would be great to be better at killing cancer, slowing its regrowth and reemergence can be a life saver in and of itself.
THE SOLUTION
You want to stop those cancer cells from repairing, growing, and getting stronger. To do that, one might try to limit DNA repair, and Polynucleotide Kinase 3′-Phosphatase (PNKP) inhibitors have been shown in animal studies to do just that.
Onco has licensed a new class of PNKP inhibitors known as A83B4C63, designed and developed by Professor Dennis Hall, which they believe could turn cancer treatment on its head.
And that news has sent its stock running hard.
A 150% jump in one month is nothing to sneeze at, but there’s nothing I like better than making money while doing good in the world: like curing cancer.
HOW IT WORKS
From Onco’s materials:
Researchers worked with mice carrying colorectal cancer tumors. These tumors were introduced to the mice 12 days before the start of the experiment. The mice received six injections over 22 days. There were two types of injections: A placebo injection (5% dextrose) and the patented nanoparticle drug formulation (NP/A83B4C63). During the entire process, the researchers performed imaging on the mice four times to monitor the tumors and the effects of the treatments.
At top, the placebo mice showed significant growth in their tumours.
At bottom, the mice getting a full dose of NP/A83B4C63 nanoparticle (NP) formulation.
Now, let’s be clear, these mice are implanted with the colorectal tumour at an advanced stage, with the intent being to see rapid tumour growth and to see if the treatment can make a dent in its progress. It appears these animal tests show marked success.
The blue lines/dots are the nanoparticle delivered A83B4C63.
Effectiveness of A83B4C63 as CE & NP Formulations in Combination with Ionizing Radiation (IR)
Now, nothing here is telling me ONCO is going to ‘cure cancer’ per se, but if you can limit cancer’s regrowth, you’re definitely saving lives.
So Onco needs to take this through the US FDA approval process, which is a bit of a black box to many investors, so here’s how it rolls, from a layman’s perspective.
1. Preclinical Research
- Goal: Assess the safety and biological activity of the drug in laboratory and animal studies.
- What Happens:
- Scientists test the drug in cell cultures and animal models to evaluate toxicity, dosing, and pharmacological effects.
- Results help determine whether the drug is safe enough to proceed to human testing.
- Outcome: A promising preclinical profile leads to the submission of an Investigational New Drug (IND) application to the FDA.
2. Investigational New Drug (IND) Application
- Goal: Get FDA approval to start human clinical trials.
- What Happens:
- The IND includes preclinical data, proposed protocols for clinical trials, and manufacturing details.
- The FDA reviews the IND within 30 days to ensure participant safety before trials can begin.
3. Clinical Trials (Phases 1-3)
- Clinical trials are conducted in three phases, each with specific goals:
Phase 1: Safety and Dosage
- Goal: Test the drug’s safety, side effects, and appropriate dosage.
- Success Rate: ~70% of drugs move to Phase 2.
Phase 2: Efficacy and Side Effects
- Goal: Determine if the drug works for its intended purpose and evaluate short-term side effects.
- Success Rate: ~33% of drugs move to Phase 3.
Phase 3: Large-Scale Testing
- Goal: Confirm the drug’s effectiveness, monitor side effects, and compare it to existing treatments (or a placebo).
- Success Rate: ~25-30% of drugs move forward.
4. New Drug Application (NDA) or Biologics License Application (BLA)
5. FDA Review and Advisory Committee
6. Phase 4: Post-Marketing Surveillance
When a drug gets through stage 1 clinical trials, there’s usually a fat jump in its stock price, which happens again at stage 2 and 3, Beyond that, the big dogs will usually come in and take things over, because bringing a new drug to the mainstream pharma market can ultimately cost anywhere up to and beyond a billion dollars.
Right now, Onco is at the pre-stage 1 clinical trials stage, which means this process has some time before it gets near the market, but this was a $20 million market cap company when it hit the street six weeks ago, and it’s a $70 million company today, now that people are hearing the story, and that tells you folks see this as a potential gamechanger, if the tech fleshes out.
Yes, it’s had a big run so far, but the trading volume on ONCO in the last 24 hours has been the highest daily volume it’s seen since it went to market, so things dont appear to be slowing down as yet. I noted the ticker on social media last week at $1.20 and anyone who jumped aboard at that time has had some nice green days since.
BE DARING, BUT BE SMART
Ultimately, you should keep your head about you in any pharma stock like this because of three points that any investor should understand.
- Early stage pharma stocks can hit days of quiet as the drug trial approval processes can take a long time, and they can sometimes be limited in what they can say publicly for a bit.
- When they do have news, it can come out of nowhere and take folks by surprise, so day trading can be tricky
- When stocks like this rocket up fast, the big algorithm shorter shops can come in and screw things up, even if the story is good.
I’ve been interested to this point because the tech makes sense, the market is massive, and I feel like the stock is still cheap, though that scenario is evolving with every passing day. I’ve had some great successes in the biotech and pharma spaces before by being in when news is heavy, out when news is slow and profits are there to be had, and returning in time for that random Tuesday when you suddenly get news that the company has cleared another regulatory hurdle and has added a digit to its value.
I’ve also been there when the company does everything right, and can’t fight its way through the big shorter funds that just hit anyone on a run without a shareholder base thick enough to fight them off.
Onco appears to be having no trouble finding new lovers right now, but set your stop loss triggers if you do climb aboard, to protect your downside if things swing.
Worth noting: I was saying the same thing at $1.20. I’d say the same at $0.90.
So what do you say? Let’s kick arse cancer in the arse.
— CHRIS PARRY
FULL DISCLOSURE: I have purchased stock in this company and am in negotiations to work with the company on market awareness. As of the time of writing, there is no commercial arrangement between us, but that could change. If/when it does, I will update the information here. Consider me conflicted either way.