Company Profile

NovaDigm Therapeutics Inc is a clinical-stage biotechnology company developing vaccines for fungal and bacterial infections. The firm's lead product candidates target the fungal pathogen Candida and the bacterial pathogen Staphylococcus aureus (S. aureus), including methicillin-resistant S. aureus (MRSA). These pathogens are increasingly drug-resistant and can lead to recurrent skin and mucosal infections, as well as life-threatening systemic infections. NovaDigm’s lead development candidate, NDV-3, is the first vaccine to demonstrate preclinical efficacy in reducing the severity of disease caused by both fungal and bacterial pathogens. Additionally, results published from a Phase 1 clinical trial demonstrated that the NDV-3 vaccine was safe, well-tolerated and induced strong antibody and T-cell immune responses in healthy adults. NovaDigm is conducting a Phase 1b/2a clinical trial to evaluate NDV-3 in patients diagnosed with recurrent vulvovaginal candidiasis (RVVC), a fungal infection that affects approximately five million women in the United States. NovaDigm is also advancing NDV-3 for use in reducing skin and soft tissue infections (SSTI) caused by S. aureus, as well as life-threatening nosocomial (hospital-acquired) systemic infections due to Candida or S. aureus —indications for which there is great medical need and large, growing markets. Finally, NovaDigm is assessing additional bacterial and fungal vaccine antigens to expand its development programs. Evolution has equipped bacteria, viruses and other infectious diseases with the ability to rearrange their genetics—mutating and becoming resistant to the therapies that have discovered to eliminate them. Antiviral and antifungal antibiotics put evolutionary pressure on microbes to become resistant, selectively killing those organisms not resistant and leaving those resistant alone to multiply. Eventually, these drugs will lose their effectiveness as more and more of the surviving resistant microbes reproduce, further increasing the number of resistant strains. By teaching the immune system how to fight these microbes with novel vaccines and developing new strategies for antibiotic and antifungal therapies that are not as susceptible to resistance, the ability to potentially combat the large and growing problem of drug-resistant infections will be more available. NovaDigm is developing innovative immunotherapeutic and preventative vaccines to protect patients from fungal and bacterial diseases, which can be recurrent, drug-resistant and in some cases, life-threatening. NovaDigm’s lead development candidate, NDV-3A, is the first vaccine to demonstrate preclinical efficacy in reducing the severity of disease caused by both fungal and bacterial pathogens. NDV-3A is in Phase 2 clinical development for recurrent vulvovaginal candidiasis (RVVC) with follow-on indications planned for diseases associated with Candida and Staphylococcus aureus infections.