Venatorx Pharmaceuticals has been awarded an NIH R01 Grant for novel approaches to address biodefense-related infections. The company may receive up to $6M of funding under the grant.
Founder, Chief Executive Officer and Director
Dr. Truong is a founder of Aridis and was elected CEO in 2014 after having served as the company’s Chief Scientific Officer since 2005. He has more than 20 years of experience in biopharmaceutical drug development, having held positions of increasing responsibilities in companies which were eventually acquired by larger entities, including Gene Medicine (sold to Megabios), Aviron (sold to MedImmune) and MedImmune (sold to Astra Zeneca). Having maintained a life-long interest in infectious diseases, he has focused on researching and developing innovative human monoclonal antibodies and vaccines designed to address life-threatening infections. His product development experience includes FluMist™, Synagis™ mAb and a number of other monoclonal antibody-based therapeutics. Dr. Truong is the principal architect of Aridis’ technologies, which includes a range of anti-infective products and pharmaceutical processing technologies. He received his Ph.D. in Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine.
Chief Executive Officer
John McDonough has served as President and Chief Executive Officer and a member of T2’s Board of Directors since November 2007. From 2003 to 2007, John held various positions at Cytyc Corporation, a company engaged in the design, development, manufacturing and marketing of clinical products that focus on women’s health, and ultimately served as President at Cytyc Development Corporation. John had the responsibility of designing and executing Cytyc Corporation’s growth strategy for expanding the company from a single product company with revenue of approximately $300 million to a diverse women’s health company with revenue of approximately $750 million. He led the efforts that resulted in Cytyc’s acquisition by Hologic, Inc. in October, 2007, for over $6 billion. John has served in senior executive management and CEO roles in several private and public companies. He is currently a member of the Board of Directors at Solace Therapeutics and Cytrellis Biosystems. John earned his B.S.B.A. from Stonehill College.
Senior Vice President and Global Head, Acute Care Business
Frank Pasqualone joined Theravance Biopharma as Senior Vice President, Operations in June 2014 in connection with the spin-off from Theravance, Inc. Prior to the Spin-Off, Mr. Pasqualone held the position of Senior Vice President, Operations at Theravance, Inc. since January 2014. From 2010 to 2012, he served as President of Intercontinental Region: Latin America, Middle East and Africa and also as President of Southern Europe from 2009 to 2010, at Bristol-Myers Squibb (“BMS”). Over a 25-year period with BMS, Mr. Pasqualone held senior management positions in the U.S. and globally. In the U.S., he was responsible for the Oncology/Virology business and led the marketing group in the Diabetes business. Since leaving BMS and prior to joining Theravance, Mr. Pasqualone was self-employed as a part-time consultant. Mr. Pasqualone holds an M.B.A. from University of Dayton and a B.S. in Marketing from Bowling Green State University in Ohio.
Vice President, Biology
Edward Garvey, Ph.D, has spent his entire academic and professional career within the field of infectious disease drug discovery and development. He is the Vice President of Biology at Viamet Pharmaceticals and has led Viamet’s antifungal drug discovery and development program since 2010, playing leading roles in the development of VT-1161 (now in Phase 3) and VT-1598 (now in Phase 1). He has been the PI on numerous grant and contract research programs funded by the NIH and DOD while at Viamet, and is author or co-author on 19 peer-reviewed articles since 2014. Beginning in 1989, he had previously focused on antiviral drug discovery his entire career at Burroughs Welcome/Glaxo Welcome/GlaxoSmithKline. The highlight of that work was the discovery program he initiated and led that resulted in the approval of the best-in-class HIV integrase inhibitor Dolutegravir and also the late-stage clinical asset Cabotegravir. His Ph.D. research in the department of Pharmaceutical Chemistry at UCSF described various mechanisms of drug resistance in the protozoal parasite Leishmania.
President and Chief Executive Officer
Vijay B. Samant joined Vical as President and Chief Executive Officer in November 2000. Mr. Samant has 23 years of diverse U.S. and international sales, marketing, operations, and business development experience with Merck. From 1998 to mid-2000, he was Chief Operating Officer of the Merck Vaccine Division. From 1990 to 1998, he served in the Merck Manufacturing Division as Vice President of Vaccine Operations, Vice President of Business Affairs, and Executive Director of Materials Management. Mr. Samant earned a master's degree in management studies from the Sloan School of Management at the Massachusetts Institute of Technology in 1983. He received a master's degree in chemical engineering from Columbia University in 1977 and a bachelor's degree in chemical engineering from the University of Bombay, University Department of Chemical Technology, in 1975. Mr. Samant presently serves as a member of the board of directors of AmpliPhi Biosciences Corporation. Mr. Samant was a member of the Board of Directors for Raptor Pharmaceutical from 2011 to 2014, and was a member of the Board of Directors for BioMarin Pharmaceutical from 2002 to 2004. Mr. Samant was a Director of the Aeras Global TB Vaccine Foundation (Rockville, MD) from 2001 to 2010; a member of the Board of Trustees for the National Foundation for Infectious Diseases (NFID, Bethesda, MD) from 2003 to 2012; and a member of the Board of Trustees for the International Vaccine Institute (IVI, Seoul, Korea) from 2008 to 2012.
About Vical Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented vaccine technologies and other therapeutic approaches. Vical has three active clinical development programs:
1. ASP0113 vaccine for prevention of cytomegalovirus (CMV) reactivation in hematopoietic cell transplant recipients. Partnered with Astellas. Data from a pivotal Phase 3 trial expected in 1Q 2018. 2. VCL-HB01 vaccine for reduction of genital lesion recurrences caused by herpes simplex virus type 2 (HSV-2) infection. Data from a Phase 2 trial expected in 2Q 2018. 3. VL-2397 antifungal drug with novel mechanism of action for the treatment of invasive fungal infections. Phase 2 trial in invasive aspergillosis (IA) expected to initiate in 1Q 2018. Eligible for limited use indication approval by FDA. Target Indications CMV HSV-2 IA and other invasive fungal infections Hepatitis B virus (HBV) - treatment of chronic infections Leadership Vijay B. Samant - President and Chief Executive Officer Mammen P. "Anza" Mammen, Jr., M.D. - SVP, Clinical Development Larry R. Smith, Ph.D. - SVP, Research Anthony A. Ramos - Chief Financial Officer Keith D. Hall - VP, Operations
Discovering and Developing Breakthrough Therapies Based on Leadership and expertise in Metalloenzyme Chemistry & Biology About Viamet Viamet discovers and develops breakthrough therapies based on their leadership in metalloenzyme chemistry and biology. Viamet's promising clinical and preclinical candidates include potential therapies to treat invasive and hospital-based fungal infections, cancer, cardiovascular and orphan diseases. Viamet utilizes its MIDAS technology to design novel drugs that we expect to have improved potency, greater selectivity and superior therapeutic index. Our initial drug discovery and development efforts have been focused on a clinically validated metalloenzyme target, fungal CYP51, with broad applications in the treatment of human fungal infections. This approach includes VT-1598, an orally available inhibitor of fungal CYP51 that has shown high potency and selectivity in in vitro studies. An IND has been approved for VT-1598 and the molecule is ready to enter clinical testing for a range of invasive fungal infections, including cryptococcal meningitis. The Company’s pipeline also includes promising preclinical product candidates which target other validated metalloenzymes in the areas of cardiovascular disease and oncology. Viamet believes that their MIDAS technology is applicable to a broad range of metalloenzyme targets across many therapeutic indications. Target Indications Invasive fungal infections Leadership Robert Schotzinger, M.D., Ph.D. – President & Chief Executive Officer and Director Ed Garvey, Ph.D. – VP Biology
Medicines That Make a Difference
About Theravance Theravance’s pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV® (telavancin), the Company’s first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S., Europe and certain other countries for certain difficult-to-treat infections. Revefenacin (TD-4208) is a long-acting muscarinic antagonist (LAMA) being developed as a potential once-daily, nebulized treatment for chronic obstructive pulmonary disease (COPD). Theravance’s neprilysin (NEP) inhibitor program is designed to develop selective NEP inhibitors for the treatment of a range of major cardiovascular and renal diseases, including acute and chronic heart failure, hypertension and chronic kidney diseases such as diabetic nephropathy. Theravance’s research efforts are focused in the areas of inflammation and immunology, with the goal of designing medicines that provide targeted drug delivery to tissues in the lung and gastrointestinal tract in order to maximize patient benefit and minimize risk. The first program to emerge from this research is designed to develop intestinally restricted pan-Janus kinase (JAK) inhibitors for the treatment of a range of inflammatory intestinal diseases. Target Indications cSSSI, HABP/VABP, Concurrent Bacteremia - Approved Primary Bacteremia Gram+ MRSA HCV COPD OIC Opioid FDC: Pain Gastroparesis ICU IV Prokinetic Ulcerative Colitis Heart Failure, Chronic Kidney Disease nOH Leadership Rick E Winningham - Chairman and Chief Executive Officer Renée D. Galá - Senior VP and Chief Financial Officer Brett K. Haumann, M.D., M.B.A. - Senior VP, Clinical Development and Chief Medical Officer Frank Pasqualone - Senior VP and Global Head, Acute Care Business
Enabling patients to receive the best treatment faster than ever before, by transforming diagnostics – radically improving patient care and hospital economics.
About T2 Biosystems: T2 Biosystems is dedicated to developing innovative diagnostic products to improve patient health. With the FDA-cleared T2Dx Instrument and T2Candida Panel targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2 Magnetic Resonance technology, or T2MR, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of patient sample types, including whole blood. Antimicrobial Resistance The rapid and accurate T2 results are critical weapons in the hospital’s fight against antimicrobial resistance. T2 results reduce the overuse of antimicrobial therapies by getting doctors and hospitals specific pathogen information faster than ever before. Positive results enable targeted treatment, and negative results may allow physicians to limit or eliminate the use of unnecessary drugs. Technology & Solutions T2MR Technology - The technology platform for next-generation diagnostics T2Sepsis Solution T2Bacteria Panel T2Candida Panel T2Dx Instrument Leadership John McDonough - Chief Executive Officer Tom Lowery, Ph.D. - Chief Scientific Officer Rahul Dhanda - Senior Vice President, Corporate Development & Marketing
Developing MDR Bacterial Infection Treatments
Spero Therapeutics is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections. Spero is advancing SPR994, which is designed to be the first broad-spectrum oral antibiotic for use in adults to treat MDR Gram-negative infections. Spero is also advancing its Potentiator Platform, which it believes will enable it to develop drugs that will expand the spectrum and potency of existing antibiotics, including formerly inactive antibiotics, against Gram-negative bacteria. The product candidates are two IV-administered agents, SPR741 and SPR206, designed to treat MDR Gram-negative infections in the hospital setting. Spero is also developing SPR720, its novel oral therapy product candidate designed for the treatment of pulmonary non-tuberculous mycobacterial (NTM) infections.
Complicated urinary tract infections MDR gram-negative infections Pulmonary non-tuberculous mycobacterial (NTM) infections
Ankit Mahadevia, MD - President and CEO
Thomas Parr, PhD - Chief Scientific Officer
Joel Sendek - Chief Financial Officer
Cristina Larkin - Chief Operating Officer
David Melnick, MD - Chief Medical Officer
Developing novel anti-infectives to address significant unmet therapeutic needs
SCYNEXIS, Inc. is a biotechnology company committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections by delivering innovative anti-infective therapies. The SCYNEXIS team has extensive experience in the life sciences industry discovering and developing more than 30 innovative medicines over of therapeutic areas.
The company's lead product candidate, SCY-078, is the first representative of a novel intravenous and oral triterpenoid antifungal family. SCY-078 is in Phase 2 clinical development for the treatment of several fungal infections, including serious and life-threatening invasive fungal infections caused by Candida and Aspergillus species. The FDA granted Fast Track, Qualified Infectious Disease Product and Orphan Drug Designations for the formulations of SCY-078 for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis.
Invasive candidiasis (including candidemia)
Vulvovaginal candidiasis (VVC)
Marco Taglietti, M.D. - President and Chief Executive Officer
David Angulo, M.D. - Chief Medical Officer
Positive Outcomes. Positive patient stories
Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, is a new, once-daily oral and intravenous broad-spectrum antibiotic being developed for the treatment of serious community-acquired bacterial infections, including community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI), and urinary tract infections.. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration (FDA) for the target indications of ABSSSI, CABP, uUTI and cUTI. Paratek has completed Phase 3 development activities for omadacycline in CABP and ABSSSI and has completed its New Drug Applications to the U.S. FDA and is preparing a marketing authorization in the European Union. Paratek has licensed rights for omadacycline to Zai Lab for the greater China region and retains all remaining global rights. Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.
Paratek's second Phase 3 product candidate, Seysara™ (sarecycline), is being developed by Allergan in the U.S. as a new once-daily oral therapy for the treatment of acne. Allergan has completed Phase 3 development activities for Seysara and its new drug application was accepted for review by the U.S. FDA in December 2017. Paratek retains all ex-U.S. rights to sarecycline. Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.
Acute bacterial skin and skin structure infections (ABSSSI)
Community-acquired bacterial pneumonia (CABP)
Urinary tract infections (UTI)
Moderate to severe acne vulgaris
Michael F. Bigham - Chief Executive Officer and Chairman of the Board
Evan Loh, M.D., - President, Chief Operating Officer & Chief Medical Officer
Driven to Deliver Innovative Treatments for Patients with Infectious Diseases
Nabriva is a clinical-stage biopharmaceutical company engaged in the research and development of new medicines to treat serious bacterial infections, with a focus on the pleuromutilin class of antibiotics. Nabriva's medicinal chemistry expertise has enabled targeted discovery of novel pleuromutilins, including both intravenous and oral formulations of its lead product candidate. Nabriva's lead product candidate, lefamulin, is a novel semi-synthetic pleuromutilin antibiotic with the potential to be the first-in-class available for systemic administration in humans. The comany believes that lefamulin is the first antibiotic with a novel mechanism of action to have reached late-stage clinical development in more than a decade. Nabriva has announced positive topline data for lefamulin from the first of its two global, registrational Phase 3 clinical trials evaluating lefamulin in patients with moderate to severe community-acquired bacterial pneumonia (CABP).. Nabriva believes that lefamulin is well positioned for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, oral and IV formulations and a favorable tolerability profile, with the results of the LEAP 1 trial showing a rate of treatment-emergent adverse events comparable to moxifloxacin with or without linezolid. Nabriva Therapeutics intends to further pursue development of lefamulin for additional indications and is developing a formulation of lefamulin appropriate for pediatric use.
Through research and development efforts, Nabriva has also identified a topical pleuromutilin product candidate, BC-7013, for which the Company completed a Phase 1 clinical trial. Nabriva believes that this pleuromutilin compound is well suited for the topical treatment of a variety of Gram-positive infections, including uncomplicated skin and skin structure infections.
CABP - Community Acquired Bacterial Pneumonia
ABSSSI - Acute Bacterial Skin and Skin Structure Infections
STI - Sexually Transmitted Infections
HABP- Hospital Acquired Bacterial Pneumonia
VABP -Ventilator Acquired Bacterial Pneumonia
uSSI - uncomplicated skin and skin structure infections
Prosthetic joint infections
Colin Broom - Chief Executive Officer
Francesco Maria Lavino - Chief Commercial Officer
Steven Gelone - Chief Scientific Officer and Head of Business Development
Gary Sender - Chief Financial Officer