Company Profile: Matinas BioPharma Holdings, Inc.
Matinas BioPharma Holdings, Inc., is a clinical-stage publicly-traded biopharmaceutical company based in New Jersey. The company is developing lipid-based prescription therapies, with a focus on the treatment of fungal and bacterial infections, addressing the acute threat of multi-drug-resistant infections, and metabolic/cardiovascular conditions. The management team and Board of Directors have solid track records in developing and commercializing blockbuster pharamaceutical products.
MATINAS’ FOCUS IS ADDRESSING THE SIGNIFICANT PROBLEM OF DURG-RESISTANT BACTERIA
Matinas BioPharma’s (MTNB) core capabilities combine the use of lipids as active pharmaceutical ingredients (API) and the use of lipids in “cochleate-shaped” lipid-crystal nano-particle drug delivery vehicles. Matinas’ revolutionary and proprietary lipid delivery technology is focused on the delivery of several potent and highly efficacious anti-fungal and anti-bacterial agents which, unfortunately, are currently still associated with serious side effects, including irreversible toxic effects on kidney and hearing function. MTNB’s technology allows for the safe and targeted delivery of these agents, which position the Company to be at the forefront of dealing with these very serious problems. In fact, the need for effective treatments is drastically increasing with the rise of drug-resistant fungal and bacterial strains which are becoming more prevalent throughout the world. According to the CDC, approximately 2 million multi-drug resistant infections occur in the US each year, leading to approximately 23,000 deaths annually. The development of new anti-infective treatments has become a critical mandate governments all over the world. This has led to the dedication of important resources as well as incentives to pharmaceutical companies who are able to effectively develop therapies in these areas. Importantly, Congress has initiated new legislation that increases market exclusivity for new anti-infective treatments, appropriately rewarding those companies that invest in this space. Notably, the United States government recently demonstrated its commitment in this area by allocating approximately $1.2 billion to the development of new anti-infectives, of which $650 million to the National Institutes of Health (NIH). The ability to partner with the government in the development of these therapies provides a competitive advantage to those companies seeking to provide effective medicines for the benefit of patients everywhere.
The disruptive MTNB lipid-based delivery technology locks these potent but dangerous anti-infective drugs up in tiny lipid-crystals which are selectively picked up by certain immune-cells and transported to the site of infection [see Figure 1]. These tiny lipid crystals are referred to as “cochleates.” Cochleates have a multilayer crystalline, spiral structure with no internal aqueous space. The structure is formed when a series of solid lipid sheets roll up and engulf drug molecules in between the sheet, a proprietary process referred to as “encochleation”. The result is a lipid-crystal encochleated drug formulation made up of nano-sized particles. Because the medications are locked in the particles, the sensitive-organ exposure to these medications is drastically reduced, as are the toxic side-effects. In addition, the technology adds the ability to delivery is delivering injection-only medications by oral administration, thus significantly reducing the cost of administration and increasing patient convenience. In summary, this unique technology offers (1) targeted delivery, (2) sensitive organ protection, and (3) oral administration (even for IV-only medications).
The cochleate lipid-crystal nano-particle drug delivery technology was brought into MTNB through its recent acquisition of Aquarius Biotechnologies, a spin-out of Rutgers University in New Jersey. The inventor of the cochleate technology, Raphael Mannino, PhD, is an associate professor at Rutgers’ Medical School and is a core member of MTNB’s Scientific Advisory Board (SAB). He and his team patented this technology across 12 issued patent families and 3 more recently filed patent families, claiming several inventions that significantly improve the cochleate drug delivery technology platform. Former Aquarius CEO and CMO Carl Craft, MD (formerly “Venture Head” of Abbott’s anti-infective R&D group), has stayed with MTNB as the chair of the anti-infective section of the SAB.
The benefits of the cochleate delivery technology have been recognized and embraced by the NIH through a range of development collaborations between MTNB and NIH. Given its profile, this exciting technology allows for a much broader use of these potent, but toxic, anti-infective therapies and provides an opportunity for MTNB to develop a broad and deep product pipeline in collaboration with the NIH and other governmental organizations.
MAT2203 – A GAME CHANGING ANTI-FUNGAL FORMULATION
The lead anti-infective product in the MTNB pipeline is the lipid-crystal nano-particle formulation of Amphotericin B (MAT2203), a potent broad-spectrum fungicidal agent for which no clinical cases of resistance have been reported to date. The latter is vitally important because emerging resistance to the agents in the fungistatic azole and echinocandin anti-fungal classes is limiting the clinical utility of these agents. These limitations and the spread of resistance, combined with MTNB’s breakthrough technology will potentially increase the use of Amphotericin B (currently ~$700 million/year). Importantly, Amphotericin B is also the only fungicidal anti-fungal agent approved for non-topical use and can actually kill a fungus or yeast inside the human body, as opposed to fungistatic agents which will stop growth, but require an active immune system to kill the infectious agent, something that is unfortunately lacking in many patients. This is important because this elevates Amphotericin B to the most preferred antifungal treatment in immunocompromised patients, such as those with chronic viral infections (HIV), patients undergoing organ or bone-marrow transplants, or patients with weak immune systems due to chemotherapy. The ability to protect sensitive organs from the toxic side-effects of Amphotericin B positions MAT2203 well to gain a major market share within the Amphotericin B class, while growing this class at the same time.
From a development perspective, several animal model studies were conducted for serious fungal infections such as aspergillosis, cryptococcal meningitis and candida, all in collaboration with the NIH. A Phase 1 study in humans has been completed and demonstrated a positive safety and tolerability profile with no adverse events reported. MTNB is currently preparing for a Phase 2a clinical in patients with refractory mucocutaneous candidiasis to be conducted at the NIH, under a clinical trial agreement where the company is only responsible for delivering drug product to the NIH.
MAT2501 – A POTENTIAL LEADER IN THE TREATMENT OF GRAM-NEGATIVE BACTERIAL INFECTIONS
The second anti-infective product under development is the cochleate formulation of the aminoglycoside antibiotic Amikacin (MAT2501) for the treatment of gram-negative bacterial infections. Multi-drug-resistant (MDR) infections are rapidly rising and, while the gram-positive segment of this emerging threat to population health is being addressed by a blockbuster category comprising Zyvox (Pfizer), Cubicin (Cubist), and Vancomycin, the gram-negative MDR segment is significantly under-served. Typical infections in this category are lung infections in Cystic Fibrosis patients and patients on respiratory ventilators in hospitals or nursing homes, patients with complex hospital acquired urinary tract infections, tuberculosis and atypical mycobacterium infections. Similar to Amphotericin B, Amikacin is a very potent anti-infective agent with significant and irreversible side effects such as toxicity for the kidneys and hearing organs. The cochleate formulation of Amikacin (MAT2501) provides a similar targeted delivery to infected sites while significantly reducing the toxicity profile.
MAT2501 is currently undergoing formal animal toxicity studies at the NIH in preparation for filing an IND with the FDA later in 2015 and initiation of human studies shortly thereafter. Given the prevalence of drug-resistant gram-negative bacterial infections (approximately 500,000/year) and the lack of effective therapies, MTNB’s MAT2501 should be carefully monitored.
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OPPORTUNITIES BEYOND ANTI-INFECTIVES
In the category of lipids as active pharmaceutical compounds, MTNB has two ongoing programs - MAT9001 and MAT8800.
MAT9001 is under development for dyslipidemia with severe hypertriglyceridemia as primary indication (TG≥500 mg/dL). The market and clinical need in the cardiovascular/metabolic disease space remains significant and growing due to the increasing obesity epidemic and human life-span. In fact, in the US alone, approximately 65 million adults have above normal triglycerides, with 4 million adults diagnosed with severe hypertriglyceridemia (VHTG: TG≥500 mg/dL).
MAT9001 is a complex omega-3 fatty acid composition with DocosaPentaenoic Acid (DPA) as the key differentiating component. MTNB has developed a unique capability to manufacture and isolate rare omega-3 fatty acids, such as DPA, and obtain them in a highly pure form. These rare omega-3 fatty acids are very hard to isolate from natural sources at any meaningful commercial scale there is no known abundant source material with high levels of DPA. DPA has shown to have highly differentiating features and demonstrated to be a very potent reducer of triglycerides (see the “Our Science” page on the Company’s website). Late 2014, MTNB filed an IND for MAT9001 and started its first human study with MAT9001, with results expected during the second quarter of 2015.
The MAT8800 discovery program seeks to identify promising product candidates for the treatment of fatty liver disease. Approximately 30 million US adults suffer from a form of fatty liver disease such as Non-Alcoholic Fatty Liver disease (NAFLD) or Non-Alcoholic Steato-Hepatitis (NASH), conditions that may lead to cirrhosis and liver failure and for which no pharmaceutical treatment has been approved to date. Several treatments under development for fatty liver disease are focusing on a particular nuclear receptor called Farnesoid X Receptor (FXR), including Intercept and Gilead programs. Through its own research, Matinas has demonstrated that these unique omega-3 fatty acids are also known to interact with these receptors, potentially positioning MTNB well to play a prominent role in the treatment of these high-need conditions.
A HISTORY OF SUCCESS
The founding management team of MTNB has a significant track record of success in many pharmaceutical and biotech companies, highlighted by numerous product approvals and the launch and commercialization of several products that went on to achieve ‘blockbuster’ status. The core team worked together at Reliant Pharmaceuticals where they gained broad experience in the dyslipidemia field and received FDA approval for five product candidates. After they successfully developed and launched and Lovaza (the first FDA-approved prescription omega-3 medication) in 2005, Lovaza saw significant prescription growth (a blockbuster with peak sales over$1 billion annually) and in 2007 GlaxoSmithKline acquired Reliant for $1.65 billion. Matinas’ CEO and co-founder Roelof Rongen previously led the global team for Humira at BASF Pharma (now Abbvie).
In addition to Mr. Rongen and the rest of the Matinas management team, the Company’s Board of Directors brings decades of drug development and commercialization success to the Company. In fact, a Board of this repute is not typically associated with a microcap stock. Notably, Chairman Herbert Conrad was the President of Roche’s North American Pharmaceutical Division, has been a Director of Celldex since its inception, and most recently was the Chairman of Pharmasset at the time it was sold to Gilead for $11 billion in 2011.
Clearly, MTNB’s pipeline (Figure 2) and experienced team bring the credibility and wherewithal necessary to build a new company focused on developing novel prescription medications for high-need clinical areas.
For more information about Matinas BioPharma, go to: www.MatinasBioPharma.com
The company paid consideration to SNN or its affiliates for this article.
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