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New Alert: Moleculin Biotech, Inc. (NASDAQ: MBRX)
Last Close: $8.37
Moleculin Biotech, Inc.(MBRX) is our new biotech Nasdaq alert that has the potential to be a game changer. Moleculin(MBRX) recently completed their IPO and became a publicly traded company on the Nasdaq last Thursday(June 2nd, 2016).
MBRX is an early stage biotech company focused on the development of game changing anti-cancer drug candidates, many of which are based on discoveries made at M.D. Anderson Cancer Center, the world’s largest cancer research facility headquartered within the world’s largest medical center.
Moleculin's(MBRX) lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of acute myeloid leukemia(AML). AML(Acute Myeloid Leukemia) is a lethal form of cancer that starts in the tissues that form blood and currently has only one first-line treatment option. Since there are no approved second-line therapies, if the patient fails first-line therapy, the chances of survival diminish greatly. Annamycin is a new hope for AML Patients.
Before we get deeper into MBRX's lead drug candidate, it is important to mention another company who offers a comparative product and was bought out by Jazz Pharmaceuticals for $1.5 billion last Tuesday. This company is Celator Pharmaceuticals(CPXX). After the acquisition, CPXX jumped 71% from $17.53 to $30.01 overnight. This is important because the main reason Jazz Pharmaceuticals acquired Celator was so it could get its hands on a drug called VYXEOS, which like Annamycin, is a treatment for acute myeloid leukemia (or AML). Back in March, CPXX gained over 400% after announcing positive results from the Phase 3 trial of VYXEOS. The median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving 7+3, representing a 3.61 month improvement in favor of VYXEOS.
In a person who has developed AML, cancerous white blood cells are produced instead and cause the body’s circulatory system to fail. The first-line treatment for eradication of these cancerous cells is called “7+3 induction therapy”, which is a 50+ year old treatment that is estimated to only be effective for about 20% of the AML population. With VYXEOS, instead of the "other" 80% of the AML population dying in 6 months, the drug extends the survival time to 9.5 months. That's more than significant enough to likely make VYXEOS the standard of care over current induction therapies, and why Jazz wanted it. But, based on clinical trials so far, Annamycin already looks like it outperforms VYXEOS.
First, Annamycin has the advantage of being engineered to be non-cardiotoxic. Cardiotoxic refers to drugs that cause severe, permanent, and sometimes fatal damage to the heart. Already, in multiple clinical trials involving a total of 114 patients with different cancers, no patient expressed any signs of cardiotoxicity.
It’s important to note that cardiotoxicity is the number one dose limiting toxicity of currently approved Anthracyclines used in the treatment of AML patients. Because of Annamycin’s lack of cardiotoxicity, patients will be able to be treated without the fear of life-threatening heart damage. We believe Annamycin's lack of cardiotoxicity alone makes it a game changing new drug.
The second major advantage with Annamycin is that it is “invisible” to the body’s natural defense mechanisms. This allows it to not be recognized by the multidrug resistance pumps that plague current therapies.
One of the leading Anthracyclines is Doxorubicin, which is both cardiotoxic and vulnerable to multidrug resistance. You can watch an animation of how an Anthracylcline therapy actually works by clicking here.
What’s most impressive about Annamycin is that in the two most recent trials, Annamycin was able to generate significant activity with acute leukemia patients who would be considered part of the unlucky 80% or labeled as “untreatable".
Specifically, in the most recent trial, 30% of patients who had failed an average of five previous induction therapies of 7+3, responded to Annamycin well enough to qualify for a curative bone marrow transplant(which is the goal and can provide remission and save lives). Putting this in the context of the recent VYXEOS data, that would be the equivalent of getting an additional 24% of patients to qualify for a bone marrow transplant. And, at the same time, putting none of those patients at risk for heart damage.
The importance of this cannot be overstated, as we believe it makes Annamycin a potential game changer in the treatment of AML patients.
Annamycin was given to a population of AML patients that didn’t respond to first-line therapy. On average, they received 5 induction therapies which ALL failed. Induction therapies like 7+3 are extremely aggressive treatments and take a significant toll on patients while trying to kill the cancer. At this point in the patient’s life, after 5 treatments, their bodies are beginning to fail them and death is near.
Annamycin was able to take 30% of that near-death population and achieve a strong enough response to qualify for them for a curative bone marrow transplant. This is why the company believes there is truly new hope when it comes to the treatment of relapsed or refractory AML patients.
Moleculin(MBRX) is strategically seeking approval as a "second line" therapy for important reasons.
This begins with recognizing that the FDA has the ability to grant accelerated approval on the basis of fewer and smaller clinical trials where a drug has the potential to fill a “significant unmet need".
Since there is NO approved second-line therapy for the treatment of relapsed and refractory AML patients and since an average of 80% of AML patients fail the first-line therapies, MBRX believes the unmet need for a second-line therapy is truly significant and that Annamycin could potentially fill that void.
At the same time, since such a large majority of patients fail the first-line therapies, MBRX believes becoming the ONLY second-line therapy has potentially greater value than a first-line drug that is only successful in a minority of patients.
Finally, if MBRX is able to get approved as a second-line therapy, they can then focus on generating the expanded data required to ultimately seek approval as a first-line therapy.
MBRX also has two other drug development technologies. One involves a portfolio of small molecules focused on the treatment of melanoma, bladder cancer, pancreatic cancer, and stomach cancer. The other technology targets the treatment of Glioblastoma, which is the most common form of brain cancer.
We believe Moleculin(MBRX) is a promising early stage biotech company that is creating a solid portfolio of drug candidates. Read more about their lead drug candidate, Annamycin, by clicking here and get started on your research now.
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