- Oncology pipeline features significant safety/efficacy advantages
- Lead candidate poised for FDA acceleration due to significant unmet need in AML
- Broad-spectrum applicability of WP1066 & WP1122 portfolios of molecules
For preclinical oncology biopharma Moleculin Biotech, Inc. (NASDAQ: MBRX), the quest to deliver potentially revolutionary anti-cancer drugs to the market is enkindled by a close association with The University of Texas MD Anderson Cancer Center. This institution’s stated mission is nothing less than to make “cancer history,” and eliminate cancer on a global scale. Truly an American success story to be proud of, MD Anderson is one of the largest cancer centers in the world, employs some 20,000 people in Houston and Central Texas, and is ranked number one by U.S. News & World Report’s “Best Hospitals” when it comes to quality cancer treatment. The superbly integrated programs of patient care, research and prevention – for which MD Anderson is widely known – have massively helped to foster innovative thinking when it comes to wrangling some of the most ornery cancer types.
More Powerful, Novel, Safer, More Versatile Pipeline of OncoTech
Moleculin’s rapidly developing pipeline (some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center) consists of the company’s lead drug candidate Annamycin, which targets relapsed or refractory acute myeloid leukemia (AML), as well as its extremely promising WP1066 and WP1122 portfolios of molecules. WP1066 is designed to defeat cancer by modulating cancer progression transcription factors (WP1066), while WP1122 has been shown to actively manipulating cancer’s metabolic envelope via a novel glucose decoy technology invented by the company’s scientific founder, Dr. Waldemar Priebe.
The broad-spectrum potential of the WP1122 portfolio was heavily underscored by the announcement in late June that MBRX had identified new properties of a modified WP1122 compound (known as WP1234) that could help stamp out pancreatic cancer. The global treatment market for this cancer was recently forecast to hit somewhere around $4.2 billion by 2025, rising sharply from just $1.7 billion in 2015 (there were nearly 412,000 deaths from pancreatic cancers that year) due to factors such as a growing geriatric population and increasing rates of obesity, smoking, and excessive alcohol consumption. Shares of MBRX rose to $3.28 on June 28 given the strength of the news, as well as the announcement of an agreement with a physician at the prestigious Mayo Clinic in Rochester, Minnesota, to enable additional research into WP1066 for a rare form of pediatric brain tumor.
WP1234 showed both improved drug characteristics over WP1122 and a 20-fold to 50-fold more powerful cancer cell line-killing ability than traditional glycolysis inhibitors in preclinical testing. Because tumors are so reliant on glycolysis for energy, WP1234 could become a breakaway indication for what is still largely considered an untreatable disease. Notably, this disease has an 80 percent or greater mortality rate and will see nearly 54,000 diagnoses this year alone in the U.S., according to ACA projections.
WP1234’s apparent efficacy in pancreatic cancers owes a great deal to the ongoing collaboration with MD Anderson Cancer Center, and the enhanced cellular uptake/retention characteristics associated with the blood brain barrier-crossing WP1122 platform technology. The platform technology was designed to enable 2-DG (the molecule uptaken by cellular glucose transporters) accumulation in the brain at significantly higher levels than normal and tackle a wide variety of solid tumors; even difficult-to-treat and often progressively resistant to treatment brain tumors, like glioblastomas. The Glioblastoma multiforme treatment market is on track to run around 10.9 percent CAGR through 2025 when it will reach over $1 billion in revenues for the first time in history, according to a recent report from Brisk Insights. With notable players like Merck’s (NYSE: MRK) Temodar® or Roche’s (OTCQX: RHHBY) Avastin® currently the standard of care, humble MBRX might appear to some investors as David taking on Goliath.
The company announced on July 25 that it would support acceleration of a physician-sponsored Investigational New Drug application to clinically study WP1066 in glioblastomas. Modeled after a natural compound with tumor-fighting properties, WP1066 appears to not only supercharge a patient’s natural ability to stave off tumor development through stimulation of the immune system, it also attacks tumors directly by inhibiting the master regulator of a wide range of tumors known as STAT3 (transcription factor). And it does so in a way which bypasses the multifactorial activation of STAT3, directly and independently from upstream effectors. This means it is possible that WP1066 could hit a variety of targets, irrespective of their upstream method of activation, delivering a powerful one-two punch of direct and indirect action against tumors.
Potential AML Blockbuster
This is pretty exciting stuff already, without even really talking about the company’s lead drug for AML. On that note, Annamycin is being geared up for clinical trials, with Moleculin recently signing a brand new license agreement with MD Anderson to clear the way for key patent applications and ensure that the collaboration has a bright future. According to the American Cancer Society’s 2017 estimates, AML will make up roughly 34.4 percent of all the 62,130 projected new leukemia cases, and will lead to around 10,590 deaths this year.
A roughly $1.85 billion market last year in just North America, leukemia treatments are expected to hit upwards of $2.83 billion by 2021, clocking in at around 8.9 percent CAGR. Globally, this will most likely become a $12 billion market by 2022. More specifically, the global AML segment of this market was recently forecast to hit $1.2 billion by the end of 2023, growing at a 5.3 percent CAGR, according to one study.
And Annamycin has several significant advantages that set MBRX up for either breakout success, or a buyout by a sector major. First of all we have the elephant in the room: cardiotoxicity (which damages heart muscle) associated with antiquated anthracycline induction therapies. These therapies have been yielding about the same success rate (20 percent) as they did when first developed back in the 70s, according to MBRX. Induction therapy always includes an anthracycline like doxorubicin, which, while an important discovery in its day and still useful, is also cardiotoxic. Not only is this factor the leading cause of having to limit the dose, tumor cells also have a tendency (via the phenomena known as multidrug resistance) to develop resistivity to first-line anthracyclines, which invalidates the therapy altogether.
A unique liposome formulated anthracycline, Annamycin is engineered to avoid triggering multidrug resistance mechanisms and has been shown to be non-cardiotixic in animal models when compared directly with doxorubicin. The global doxorubicin market was worth almost $810 million in 2015, according to a report out late last year from Grand View Research, and appears on-track to do 6.4 percent CAGR through 2024. Annamycin posted solid efficacy numbers in its Phase 1 and 1/2 patient studies, with around half the patients clearing their leukemic blasts to the point where they qualify for a bone marrow transplant, and it was shown to be more potent than the leading approved drug in lab studies on AML cell lines.
Annamycin is very exciting for AML patients who must first go through induction therapy in order to qualify for a life-saving bone marrow transplant. And because the drug may serve a serious unmet medical need, the FDA may approve accelerated status. If the conversations thus far with FDA are any indication, MBRX could be sitting on a winner. If Annamycin qualifies for Orphan Drug Status, MBRX could be looking at up to a decade of market exclusivity in the two biggest AML therapy markets on earth, the U.S. and EU. By deliberately targeting approval for Annamycin as a second-line therapy, in a market where there is currently no approved second-line therapy and where around 80 percent of AML patients fail first-line therapies, MBRX has set itself up for serious momentum.
Management Has “Eye of the Tiger”
And management is clearly aware of how much potential kinetic energy exists in the company’s anti-cancer drug pipeline. This was recently demonstrated once again by doubling down on their apparently strong oncology hand with the recent tapping of product commercialization and business development veteran John M. Climaco for the Board of Directors. Climaco brings years of frontline experience on the boards of noteworthy industry players like nuclear imaging device manufacturer Digirad (NASDAQ: DRAD), oncology infusion services provider InfuSystem (NASDAQ: INFU), and biopharma sector specialized commercial services provider PDI (NASDAQ: PDII).
With so many white-hot irons in the fire, targeting underserved/unserved markets where regulatory clearance can be accelerated, this company is looking more and more like a serious contender in the space.
For more information on this company, visit www.moleculin.com
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