Sano Chemicals pipeline is comprised of first-in-class antibacterials, antifungals, and anticancer therapeutics.
A novel first-in-class therapeutic is desperately needed for effective treatment of fungal infections. It is estimated that more than 300 Million people globally are suffering from serious fungal infections resulting in more than 1.6 Million deaths annually. Fungal pathogens infect more than 7,000,000 adults in the US each year alone and are a significant source of economic health cost (CDC). These infections can occur on skin and nails, respiratory tract, and internal organs. These infections can be especially dangerous for individuals with compromised immune systems, such as the elderly or critically ill, cancer patients, and HIV patients.
Sano’s lead, OCF001, will serve as the underlying basis for a platform chemotherapeutic that will be developed into broad scale applications with the intent to treat conditions ranging from systemic fungal infections (such as candidiasis and aspergillosis) to vulvovaginal candidiasis (VVC). These applications would be tremendously impactful considering the complications and diminished quality of life associated with all types of fungal infections.
In the United States alone it is estimated that seventy percent of the female population will suffer from VVC (vaginal yeast infections). A subset of this population, nearly 5,000,000 women annually, suffer from recurrent VVC (RVVC). RVVC’s estimated health care costs in the USA is $4-5 billion per year. This estimate is based on increased medical costs to treat vulvovaginal candidiasis and the economic impact from lost productivity. The global cost of VVC and RVVC is expected to be over 10 billion per year. VVC and RVVC also place a significant cost on quality of life for any infected individual, their family, and employers. Although there are several preventative measures in development, there is no current therapeutic available on the market that is considered to be an effective treatment for RVVC. An effective therapeutic that could treat VVC in a relatively non-invasive manner could significantly reduce the cost to patients, while at the same time increase their quality of life. OCF001 has demonstrated potent fungicidal activity against antifungal resistant Candida species in preclinical studies. The fungicidal activity of OCF001 at the site of infection has the potential to be more effective than the fungistatic azoles in reducing recurrence of Candida infections in women with RVVC. A new RVVC therapeutic being developed by Sano Chemicals will reduce the impact of these infections on the people inflicted.
Additionally, there is a growing concern over the increase in drug resistant strains of Candida and the lack of new treatment of options available. These resistant strains are expected to increase the global costs associated with systemic fungal infections. OCF001 shows potent inhibitory activity against zygomycetes and drug resistant yeasts. Fluconazole resistant Candida albicans and C. glabrata are sensitive to OCF001. Furthermore, strains of Rhizopus sp. and Cryptococcus neoformans are more sensitive to OCF001 than fluconazole. C. neoformans is insensitive to echinocandin class of antifungals but is sensitive to OCF001 at sub-micromolar concentrations (0.5 µg/mL).
OCF001 has demonstrated pharmacological properties to be an effective preventative or treatment for serious fungal infections. Sano Chemicals is focused on developing a highly effective, antifungal treatment for fungal infections that is effective at treating both C. albicans and non-albicans yeast infections. Three OCF001 products for treating VVC, cutaneous, and systemic yeast infections will make a significant impact on health in the US and globally.
Sano has acquired technology from Texas A&M University for a novel first-in-class therapeutic for the treatment of serious Gram-positive infections. Mutacin 1140 (mu1140) analogs hold significant promise for the treatment of Gram-positive pathogens. A significant amount of work has gone into identifying effective structural analogs of mu1140 for clinical development. A careful understanding of the structural elements that do not interfere with the antibiotic’s bioactivity or interfere with the antibiotic’s post-translational modifications was necessary. Therapeutic leads with potent activity against MRSA and S. pneumoniae that have improved pharmacokinetic properties and a demonstrated efficacy are being developed into a novel MRSA therapeutic and a novel treatment for a systemic bacterial infection.
S. aureus, as well as other staphylococci, infections are often life-threatening diseases. These infections continue to impose a financial burden on hospitals whether the infection is hospital or community acquired. In particular, S. aureus has become increasingly resistant to many antibiotics, such as β-lactams, aminoglycosides, and vancomycin. Infections are now, in many cases, untreatable and MRSA alone leads to more than 70,000 serious infections in the United States each year (CDC). MRSA is also the leading cause of diabetic foot infections and the growing demand for potential prophylactic treatment options.
There are at least 400,000 hospitalizations from pneumococcal pneumonia each year in the United States (CDC). Approximately thirty percent of S. pneumoniae infections are resistant to one or more antibiotics. These infections lead to excessive hospital stays and far too often death. Patients with pneumococcal pneumonia have a high incidence of bacteremia (~30%) leading to death in about 6% of the cases. Treatment of pneumococcal pneumonia with MUT001 hold tremendous promise for reducing patient suffering and death.
There is no doubt, there is still a need for developing alternative approaches to lessen the burden associated with these infectious diseases. The increasing tolerance of these infections to beta-lactams, aminoglycosides and vancomycin is alarming. Sano Chemicals realizes that it is critically important to develop new antibiotics that can be added to the dwindling arsenal of treatment options available in the hospitals and clinics. MUT001 has demonstrated activity against several Gram-positive pathogens, including oxacillin- and vancomycin-resistant Staphylococcus aureus and vancomycin resistant Enterococcus faecalis, as well as preclinical data supporting that it will be effective in treating MRSA and systemic infections. There is an absolute need for alternative treatment option for Gram-positive bacterial infections in the clinic and MUT001 has the attributes that can fill this need.
Sano Chemicals has in vitro toxicity studies demonstrating that OCF001 has potent activity against brain, ovarian, and lymphoma cell lines. With the use of Sano chemicals platform technology to synthesize and identify new analogs of OCF001 with enhances pharmacological properties, Sano is well positioned for the development of novel first-in-class anticancer therapeutics. Identification of first-in-class anticancer therapeutics will provide patients a new opportunity to fight and defeat cancer.