Rightly or wrongly, many retail investors had it hardwired in their brain that Vaxinia alone was going to be a miracle cure for cancer. A guaranteed cure for any type of cancer at any stage, no matter how sick the patient. It's dawning on some that this assumption is likely incorrect. IMO this type of thinking was/is unproductive, unnecessary. The FDA was never going to approve Vaxina for all cancer indications--all at once. There's no such thing as "blanket" FDA approvals. There's no magic wand. Going forward IMU will have to run trials and make FDA applications for each cancer indication that Vaxinia addresses.
With IMU's limited financial resources it was always going to be a case of "which cancer indication(s) to submit for FDA approval". No matter how many cancers Vaxinia was capable of curing! IMU has clearly set their sights on gaining FDA approval for cancer indications with a high unmet need. Cancer indications with a very low bar in terms of gaining quick FDA approval. IMO, a small company like IMU would be unlikely to manage more than 3 or 4 FDA registrational trials at any given time.
Onto the question of Vaxinia's overall cancer-killing power. While Vaxinia kickstarts the cancer killing process, it's largely the patient's immune system that does the lion's share of the work of clearing the cancer. Vaxinia modifies the tumor's micro-environment, unmasking it, allowing the patient's immune system to recognize and attack the cancer body head-on. Hence the practical notion of using the patient's T-cell diversity as a biomarker of a patient's relative immune health--as a predictor of Vaxinia's likely clinical benefit. They already have a raft of exclusion criteria for patient enrollment in the MAST study; for example: active autoimmune disease, recent radiotherapy, systemic treatment with corticosteroids, and any condition resulting in a systemic immunosuppressed state.
Clearly they're already aiming to exclude patients likely to be in an immuno-compromised state. Adding a presumptive blood test for overall immune health just makes common sense. And once this test is added we're likely to see a doubling or more of Vaxinia's overall response rate (ORR). They will effectively be cherry-picking the best cancer patients for Vaxinia treatment. Hopefully IMU will add this blood test for the MAST expansion studies planned for this year.
While I may be wrong, I believe we're only going to see marginal gains in the current MAST study as they dose escalate. IMO, this will largely be due to the large number immuno-compromised patients in the MAST study. We'll certainly pickup additional CRs, PRs and SDs, here and there, at higher doses. These will be mainly from relatively healthy patients. I believe the next trial update(s) will likely fall short in terms of the wow factor many retail investors are looking for. It's going to take something substantial to turn around the current dark investor mood.
To brighten investor sentiment I'm placing my bet on the Azer Cel phase 1b trial update which should drop sometime May-June. For the phase 1b trial all they've done is cherry pick from a particular cohort from the previous Azer Cel trial. A cohort with well-known, exceptional ORR statistics. I'm also looking forward to the first update for the OnCARlytics (Oasis) study, from the combo arm with Amgen's Blyincyto CD19 drug. Of course it wouldn't hurt if the FDA granted Fast Track for more Vaxinia cancer indications. However, because key milestones won't likely happen until June/July we can expect more downward pressure on the SP.
The Oasis Trial - A Key Inflection Point:
A month ago IMU announced the opening of the combo arm of the OnCARlytics Oasis trial. I can only hope that the first patient has been dosed and they have strong enrollment numbers. This is a critical period as a lot is riding on the early success of OnCARlytics. Up until now we've been pretty confident about the safety profile of IMU's "drugs". Now they're combining OnCARlytics with Blincyto. While a very potent cancer killer, make no mistake, this drug is toxic.
While less toxic than frst generation CAR T-cell drugs, in rare cases (< 1% of patients) taking Blincyto can lead to death. So why do people risk these potentially severe side effects? The simple answer: because of the drug's impressive cure rates. Because of its cancer killing efficacy. The preclinical animal study likewise showed very impressive results when OnCARlytics was combined with Blincyto. So I'm expecting good results from the Oasis trial. Much better than the Vaxinia results. Maybe as much as 2X better. Maybe more. Importantly, this combination should work better than Vaxinia does for immuno-compromised patients.
So where am I'm willing to place my bet and spin the roulette wheel on the IMU story? For me it's when IMU can combine OnCARlytics with Azer Cel. Don't get me wrong, we're likely to see very impressive results if OnCARlytics is combined with any "classic" CAR T-cell drug. But most CAR T-cell drugs will bring potentially severe side-effects. What makes Azer Cel such a standout "drug" is its safety profile. Like other CAR T-cell drugs, Azer Cel should be very effective with immuno-compromised patients. Azer Cel is effectively a complete patient immune system in an IV bag. It provides patients with a guaranteed number of T-cells (cancer-fighting soldiers) that should be sufficient to overcome even aggressive cancers.
And we can't forget that Azer Cel is allogenic. That means patients can receive their CAR T-cell treatment on-demand, the very first day they walk into the clinic; as opposed to having to wait a month or two before receiving therapy. And because the supply chain and manufacturing advantages patients can receive CAR T-cell treatment at a fraction of the cost.
IMU will even be able to treat very hard to reach cancers through their partnership with RenovoRx. They will be able to use RenovoRx's Trans-Arterial Micro-Perfusion (TAMP) device to deliver "drugs" to organs walled off in the intraperitoneal cavity (e.g., the liver, stomach, colon, pancreas, etc). It is very difficult to deliver any type of drug into the intraperitoneal cavity due to the limited blood supply found there. Plus the immuno-suppressive conditions in the cavity makes it doubly hard for any type of immunotherapy to be effective. Hence the dismal outcomes for those cancers not treatable via surgery. TAMP will provide OnCARlytics with a powerful unique selling point for these types of cancers.
Unfortunately we're going to have to wait until sometime next year before this novel combination therapy--OnCARlytics and Azer Cel--gets into the clinic. But it will be more than worth the wait. IMO, this combination--at least on paper--has all the necessary ingredients to revolutionize cancer treatment. Leslie may actually have found her holy grail for the treatment of cancer. For all cancers. A treatment that may bring incredible relief for millions of cancer sufferers the world over.
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While none of us are happy with IMU's current SP these are the enormous stakes that IMU is playing for. The suffering millions. Some of them people that we know. I understand to each his own. That we must each weigh the pros and cons of investing in a high-risk company like IMU. That it will take longer than many of us expected to reach key clinical milestones. But for me it's well worth the wait. So I plan to be around when the IMU train pulls into the station. I owe it to the loved one's I've lost to cancer to support this cause.
These are all just my opinions. Every shareholder should do their own research, assess the risks and draw their own conclusions.
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