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By M.E. Garza

Shares of Cleveland Biolabs (NASDAQ:CBLI) continue to rise in dramatic fashion, one day after the company announced the potential direct anticancer effect of CBLB502. Will the wonders of CBLB502 ever cease? Andrei Gudkov, Ph.D., D. Sci, the Chief Scientific Officer at Cleveland Biolabs appears to have stumbled upon a game-changing discovery involving his wonder drug.

Gudkov was doing experiments with radiation and chemotherapy on tumor bearing animals aimed at assessing the effect of CBLB502 on treatment side effects (supportive care/palliative). All the experiments had a control arm, in which animals received CBLB502 alone with no radiation or other drug. It was in this group that the scientific team at Cleveland first took notice of the anti-tumor effect of CBLB502 applied as a single agent.

“If the tumor expresses TLR5, it is induced by CBLB502 to attract the immune system,” explains Gudkov. “The organism interprets this situation as salmonella attack going through the tumor.”

As he reminds us, CBLB502 is re-engineered flagellin of salmonella, so the concept is elegantly simple: Once the cancer cells ingest 502, the immune system recognizes the growth as something that must be attacked. The once relatively invisible cells are seen as a threat by the body’s own defense mechanisms.

The implications here are also far reaching when one considers that the company and FDA already know so much about the safety and mechanism profiles of 502. In short, the company already knows so much about how the drug works in humans, that re-designing and adjusting their protocols to simultaneously test the anti-tumor effects as well as the palliative care effects may not only be possible, but also help bring the drug to market more quickly than anyone ever imagined.

“One can test both if the subject is not immunosuppressed,” explains Gudkov. “Otherwise the direct anti-tumor effect would not be visible. Tumors irradiated locally without immunosuppressive chemotherapy, such as those seen in head and neck cancer treatment, offer such an opportunity.”

At the very least, scientists believe that even if tumors are not eliminated, they could be delayed in growth. In fact, 502 shows innate immune attacks within hours by immune cell infiltration. The follow on effect of the drug may require activation of adaptive immune response, which Gudov thinks could take up to two weeks.

One assumption that will need to be confirmed experimentally is whether once the body has recognized the tumor that it will continue to fight the regrowth of those cells. Gudov and his team have some publications under review by peers and/or in the advanced stage of preparation for other discoveries. Investors can also rest assured that the company has filed extensive patents; otherwise they would not be openly discussing the discoveries.

“It is noteworthy that there were previously published observations about TLR5 agonist flagellin- a precursor of CBLB502, having anti-tumor effect in animal models,” says Godov. “Our studies provide the pharmacological agent usable in humans and the rationale for choosing tumors for such treatment. “

Make no mistake, if the drug can be proven to do what has been observed in animal models, it has the potential to change the immunotherapy landscape that so many biotech investors are excited about.

After all, what Cleveland is proposing here is an off-the-shelf drug that does not have to be tailored. It does not involve the timely and expensive re-programming of the body’s dendritic cells and perhaps because of those factors, the potential cost of treatment would not be as prohibitive as some of the existing immunotherapy drugs which are on the way to market now.

This is the same drug candidate that the company has fast tracked through the FDA as a countermeasure against acute radiation injury. The company doesn’t have to get validation for manufacturing. They don’t have to file a new IND and they don’t have to do a Phase I safety study. Instead, if they so choose, they get to move directly into Phase II with 502 as an anti-cancer play.

Remember also that this is the same drug candidate that the government has spent millions developing as a nuclear attack counter-measure thus far. We continue to hear chatter about additional grants, increasing in value, which may be announced in the very near term. And, we fully anticipate that the drug will be approved by the FDA for its current indication, thereby setting the stage for substantial profitability as requests for purchase begin to roll in from not only the U.S. but foreign governments as well.

What’s not to like here? As I've been telling our readers for months, this is a winner through and through.

Disclosure: Long CBLI