Categories
Archives Archives 2018

Appili Therapeutics Appoints Veteran Drug Development Executive, Dr. Armand Balboni, as Its Inaugural Chief Scientific Officer

HALIFAX, Nova Scotia, October 1, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, has named Dr. Armand Balboni as its first Chief Scientific Officer (CSO). In his new role with Appili, Dr. Balboni is responsible for the Company’s clinical and scientific strategy, with a particular emphasis on overseeing the scientific aspects of Appili’s government and industry collaborations and steering the Company’s clinical programs through regulatory and pre-commercialization processes.

“Armand’s medical science, business, and military experience, including his particular focus in infectious disease, is a powerful combination, and having an expert of his caliber on our team is a ‘win’ for this Company and our shareholders,” said Kevin Sullivan, MBA, Chief Executive Officer of Appili Therapeutics. “Our clinical program has grown substantially since our inception, and Armand’s experience with unique regulatory pathways and the role public/private partnerships can play in drug development will be critical to us as we advance our pipeline. We look forward to his continued guidance and support as we move into our next stage of growth.”

Dr. Balboni’s over 20-year healthcare career encompasses medical and drug development experience across a range of civilian and military organizations. He is a partner, senior advisor and member of the Board of Directors of the investment advisory firm Bloom Burton & Co. Dr. Balboni served as the senior advisor on scientific, regulatory, and medical affairs for the companies within Bloom Burton’s ‘incubation’ program, advising some of the most recent promising young Canadian biotech companies.

Earlier in his career, Dr. Balboni completed a period of active duty in the U.S. Army as the Deputy Director, Office of Regulated Activities (ORA) and senior reviewer on the clinical pharmacovigilance team. Dr. Balboni’s tenure in the ORA focused on regulatory filings (Emergency Use Authorizations (EUAs), meetings, pre-sub filings etc.) for military-relevant medical products across all therapeutic areas.

In addition, Dr. Balboni completed a U.S. Department of Defense fellowship at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) in the Division of Anti-infective Products, and in the Office of Counterterrorism and Emerging Threats (OCET). He also served as the Chief, Office of Research and Technology Application (ORTA) at the U.S. Army Research Institute of Infectious Disease (USAMRIID). His office was tasked with oversight of all strategic partnerships between USAMRIID and universities, U.S. and foreign government agencies, and biotechnology and pharmaceutical companies.

“Appili is doing very important work in the infectious disease space, from developing options for some of the most threatening drug-resistant bacteria emerging in our healthcare landscape, to tackling head-on significant bioterrorism threats,” said Dr. Balboni. “I have been impressed with their notable progress in the three years that the Company has been operating, and am eager to continue supporting their efforts as the first Chief Scientific Officer.”

Dr. Balboni has also held various academic teaching positions, including posts at Westfield State University, the University of Maryland University College, and currently as Assistant Professor in Chemistry and Life Sciences at the United States Military Academy at West Point. He completed his doctoral work in the MD/PhD program at the Icahn School of Medicine at Mount Sinai and earned his law degree at Brooklyn Law School.

 

About Appili Therapeutics

Appili Therapeutics, Inc., was founded to advance the global fight against infectious disease by matching clearly-defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors and society face in this challenging disease space. Balancing near-to-market product candidates with higher-risk but potentially transformative early-stage programs, Appili’s growing pipeline includes assets being developed by Appili as well as an active licensing program. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of pediatric and elderly patients with difficulty swallowing. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, a novel class of antibiotics with broad-spectrum activity against Gram-negative bacteria. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, removing risk from a weaponized bioterrorism pathogen. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, Ontario, Appili is pursuing worldwide opportunities in collaboration with science and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

###

Media Relations Contact:
Mike Beyer, Sam Brown Inc.
T: 312-961-2502
E: mikebeyer@sambrown.com

 

Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics
E: Info@AppiliTherapeutics.com

Categories
Archives Archives 2018

Appili Therapeutics Announces Results of 2018 Annual and Special Meeting

HALIFAX, Nova Scotia, August 16, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”) announced today the results of the Company’s annual and special meeting of shareholders (the “Meeting”), which was held on August 15, 2018.

At the Meeting, the shareholders re-elected the following individuals to serve on the Board of Directors (the “Board”) until the next annual meeting of shareholders:

  • Brian M. Bloom, Chair, Chairman & Chief Executive Officer, Bloom Burton & Co.
  • John Holyoake, DPhil, Vice President, Investment Banking, Bloom Burton & Co.
  • Lidija Marusic, PhD, Investment Manager, Innovacorp
  • Stephen Nicolle, President, Cape Bear Advisors
  • Ian Mortimer, President and Chief Financial Officer, Xenon Pharmaceuticals Inc.
  • Kevin Sullivan, MBA, CEO, Appili Therapeutics

“Appili has, of late, experienced tremendous progress, and at this year’s AGM, we recognized the achievements our team has made over the past year, including advancing the clinical progress of our lead candidate, ATI-1501, and in-licensing a new asset with our ATI-1701 tularaemia vaccine candidate,” said Mr. Sullivan. “In addition, the shareholders and leadership are looking forward, strengthening the fundamental structural, leadership, and financing pillars of the company to prepare Appili for our next stage of progress.”

The shareholders also voted in favour of the following matters:

  1. The re-appointment of PricewaterhouseCoopers LLP, Chartered Accountants, as the Company’s independent auditors;

  2. The continuance of the company as a federal corporation under the provisions of the Canada Business Corporations Act (“CBCA”);

  3. The adoption of new CBCA compliant bylaws upon the effective date of the continuance; and

  4. Certain amendments to the authorized capital of the Company (to be effective upon the effective date of the continuance), including the redesignation of the existing common shares as Class A common shares, and the creation of Class B non-voting common shares and “blank cheque” preferred shares.

Despite receipt of shareholder approval for the continuance, new bylaws and amendments to the authorized capital, the Board may elect not to proceed with such matters if, in the opinion of the Board, such step would not be in the best interest of the Company.

 

About Appili Therapeutics

Appili Therapeutics, Inc., was founded to advance the global fight against infectious disease by matching clearly-defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors and society face in this challenging disease space. Balancing near-to-market product candidates with higher-risk but potentially transformative early-stage programs, Appili’s growing pipeline includes assets being developed by Appili as well as an active licensing program. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of pediatric and elderly patients with difficulty swallowing. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, a novel class of antibiotics with broad-spectrum activity against Gram-negative bacteria. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, removing risk from a weaponized bioterrorism pathogen. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, Ontario, Appili is pursuing worldwide opportunities in collaboration with science and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

Categories
Archives Archives 2018

Appili Therapeutics Completes Phase 1 Study for ATI-1501, Its Taste-Masked Oral Metronidazole Suspension

New Antibiotic Formulation Designed to Treat Parasitic and Anaerobic Bacterial Infections; Appili Will Use Study Data as Basis for NDA Filing

HALIFAX, Nova Scotia, July 30, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”) announced today positive top-line results of a pivotal relative bioavailability study evaluating pharmacokinetics, safety, and palatability of ATI-1501 in healthy, normal adults. Data from this study will be used to file a New Drug Application (NDA) with the US Food & Drug Administration (FDA) for ATI-1501 in early 2019. ATI-1501 is a proprietary, taste-masked oral suspension formulation of the antibiotic metronidazole, which is broadly prescribed to treat parasitic and anaerobic bacterial infections that heavily burden the elderly.

The clinical study results announced today showed that a single 500 mg dose of ATI-1501 achieved equivalent systemic drug levels to a 500 mg metronidazole tablet under fasted and fed conditions. ATI-1501 was well tolerated and safety observations for ATI-1501 were consistent with the known safety profile of metronidazole.

“Appili Therapeutics set out to address an unmet medical need – namely to provide an alternative antibiotic solution for patients with difficulty swallowing.  Our clinical data demonstrate that ATI-1501 has an acceptable safety profile while being more palatable than metronidazole tablets for a vulnerable patient population,” said Jamie Doran, MSc, DABT, ERT,Vice President of Drug Development for Appili. “As we move towards a submission to the FDA for market approval, we anticipate that ATI-1501 will soon be available to healthcare providers and caregivers as an excellent alternate treatment option for those with serious infections requiring treatment with metronidazole.”

In many countries, including the US and Canada, oral metronidazole is only available in solid forms. Patients with difficulty swallowing the oral tablet require pharmacists, the patients themselves or caregivers to crush the drug and add it to food prior to patients ingesting it. This process increases risk for dosing error and amplifies the pronounced bitter taste of metronidazole that can negatively impact patients’ ability to comply with their full treatment regimen. The bitter taste of metronidazole is so pronounced that it is listed as an adverse event on the drug label.  ATI-1501 has been designed to offer patients with difficulty swallowing the drug a more palatable, easy-to-take liquid suspension alternative.

 

About the Bioavailability Study

The primary objective of the randomized, open-label, single-dose, two-sequence, cross-over clinical study was to assess the relative bioavailability of ATI-1501 compared to the reference product Flagyl® (solid metronidazole tablets) under fasted and fed conditions. Clinicians performed the study under an Investigational New Drug application (IND) and a Clinical Trial Application (CTA) approved, respectively, by the US Food and Drug Administration and Health Canada in 2017. A total of 44 healthy adults aged 18 to 63 years completed the study.

A planned subset of participants was also asked to evaluate the taste properties and relative preference for ATI-1501 compared to metronidazole crushed in applesauce, which is the current standard of care for elderly and pediatric patients with difficulty swallowing. Palatability measures were assessed using the 9-point hedonic scale, the most widely recognized and used scale to measure taste preference and selection in the food industry. A total of 25 participants participated in this palatability and preference component, ranging from 18 to 63 years of age. ATI-1501 exhibited meaningful and statistically significant improvements across all palatability measures (taste, bitterness, smell, texture) compared to crushed tablets with a corresponding reduction in bitterness scores and a strong preference for ATI-1501 over the current standard of care.

Based on these findings, Appili expects to submit complete study results for publication in a peer-reviewed medical journal.

“We are currently pursuing commercial manufacturing activities to support an NDA filing in the first quarter of 2019,” said Appili CEO Kevin Sullivan, MBA. “In addition, we are actively engaged in commercialization and licensing activities to maximize patient access to ATI-1501 in US and global markets.”

 

About Appili Therapeutics

Appili Therapeutics, Inc., was founded to advance the global fight against infectious disease by matching clearly-defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors and society face in this challenging disease space. Balancing near-to-market product candidates with higher-risk but potentially transformative early-stage programs, Appili’s growing pipeline includes assets being developed by Appili as well as an active licensing program. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of pediatric and elderly patients with difficulty swallowing. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, a novel class of antibiotics with broad-spectrum activity against Gram-negative bacteria. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, removing risk from a weaponized bioterrorism pathogen. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, Ontario, Appili is pursuing worldwide opportunities in collaboration with science and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

Categories
Archives Archives 2018

Appili Therapeutics to Present at 2018 Atlantic Venture Forum Technology Showcase

HALIFAX, Nova Scotia, June 21, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, announced today that it will present at the 2018 Atlantic Venture Forum Technology Showcase. The event takes place June 28-29, 2018 in Halifax, Canada.

Appili’s Chief Executive Officer Kevin Sullivan will present a corporate overview and update on the Company’s active pipeline and business development programs.

 

Presentation details are as follows:

Date: Thursday, June 28, 2018

Time: 2 p.m. Atlantic time

Session: Growth Stage Presenting Companies

Location: Halifax Marriott Harbourfront Hotel

Learn more about the Technology Showcase.

 

About Appili Therapeutics

Appili Therapeutics, Inc., was founded to advance the global fight against infectious disease by matching clearly-defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors and society face in this challenging disease space. Balancing near-to-market product candidates with higher-risk but potentially transformative early-stage programs, Appili’s growing pipeline includes assets being developed by Appili as well as an active licensing program. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of pediatric and elderly patients with difficulty swallowing. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, a novel class of antibiotics with broad-spectrum activity against Gram-negative bacteria. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, removing risk from a weaponized bioterrorism pathogen. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, Ontario, Appili is pursuing worldwide opportunities in collaboration with science and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

Categories
Archives Archives 2018

Appili Therapeutics to Present at 2018 Bloom Burton & Co. Healthcare Investor Conference

HALIFAX, Nova Scotia, April 18, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, announced today that it will participate in this year’s annual Bloom Burton & Co. Healthcare Investor Conference. The conference takes place May 2-3, 2018 in Toronto, Canada.

Appili’s Chief Executive Officer Kevin Sullivan will present a corporate overview and update on the Company’s active pipeline and business development programs.

 

Presentation details are as follows:

  • Date: Wednesday, May 2, 2018
  • Time: 2:00 p.m. ET
  • Location: Sheraton Centre Hotel Toronto, 123 Queen Street, Toronto, Ontario, M5H 2M9

Investors interested in arranging a meeting with Mr. Sullivan during this conference should contact Bloom Burton & Co.’s conference coordinator.

 

About the Conference

The Bloom Burton & Co. Healthcare Investor Conference brings together U.S., Canadian and international investors who are interested in the latest developments in the Canadian healthcare sector. Attendees will have an opportunity to obtain corporate updates from the premier Canadian publicly traded and private companies through presentations and private meetings.

 

About Appili Therapeutics

Appili Therapeutics, Inc., was founded to advance the global fight against infectious disease by matching clearly-defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors and society face in this challenging disease space. Balancing near-to-market product candidates with higher-risk but potentially transformative early-stage programs, Appili’s growing pipeline includes assets being developed by Appili as well as an active licensing program. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of pediatric and elderly patients with difficulty swallowing. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, a novel class of antibiotics with broad-spectrum activity against Gram-negative bacteria. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, removing risk from a weaponized bioterrorism pathogen. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, Ontario, Appili is pursuing worldwide opportunities in collaboration with science and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

Categories
Archives Archives 2018

Appili Therapeutics Raises an Additional $4.3 Million in Oversubscribed Financing to Advance its Anti-infective Pipeline

HALIFAX, Nova Scotia, February 7, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”), a biopharmaceutical company developing and commercializing anti-infective drugs, announced today it raised an additional $4,339,000 in an oversubscribed private placement financing, bringing the total equity raised since its seed round in March 2016 to $11,816,000.  In addition, Appili is also pleased to be receiving a $500,000 repayable contribution from the Government of Canada, through the Atlantic Canada Opportunities Agency’s (ACOA) Business Development Program.

“The second wave of financing in the last quarter of 2017 and into early 2018 confirms the confidence of our investors in the company’s strategy to bring to market new anti-infective drugs for resistant or neglected infections,” said Kevin Sullivan, CEO of Appili Therapeutics.

The private placement includes investments from new and current investors, including Innovacorp, Nova Scotia’s early-stage venture capital organization. Proceeds from the financing will be used to fund operations and the continued growth of the company. Specifically, the additional funding will enable Appili to expand its pipeline of anti-infectives with additional in-licensed assets.

“The Government of Canada is pleased to continue its support of Appili Therapeutics as it expands its portfolio and business, creating more opportunities for export and foreign investment. Appili is contributing to the global community’s search for solutions to combat antibiotic resistance and is a valued member of Canada’s life sciences industry,” said Andy Fillmore, Parliamentary Secretary to the Minister of Democratic Institutions and Member of Parliament for Halifax, on behalf of the Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and Minister responsible for ACOA.

“Appili Therapeutics was formed with the intent to create a portfolio of research and development assets, and this funding will allow us to be opportunistic in our in-licensing activities,” added Kimberly Stephens, Appili Therapeutics CFO.

 

About Appili Therapeutics

Appili Therapeutics, Inc., was founded to advance the global fight against infectious disease by matching clearly-defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors and society face in this challenging disease space. Balancing near-to-market product candidates with higher-risk but potentially transformative early-stage programs, Appili’s growing pipeline includes assets being developed by Appili as well as an active licensing program. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of pediatric and elderly patients with difficulty swallowing. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, a novel class of antibiotics with broad-spectrum activity against Gram-negative bacteria. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, removing risk from a weaponized bioterrorism pathogen. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, Ontario, Appili is pursuing worldwide opportunities in collaboration with science and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

Categories
Archives Archives 2018

Appili Recognized as ‘New Business of the Year’ by the Halifax Chamber of Commerce

HALIFAX, Nova Scotia, January26, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development and commercialization, today announced that Halifax Chamber of Commerce presented Appili with its 2018 ‘New Business of the Year’ award. The announcement was made during a ceremony at the Halifax Business Awards gala event on Thursday, January 25, 2018, held at the Halifax Convention Centre. Kevin Sullivan, Appili’s Chief Executive Officer, accepted the award on behalf of the Company.

“In the first few years since Appili started, our team has generated a balanced-risk pipeline with three thriving programs, two of which are approaching near-to-market, and could start providing much-needed options for addressing significant unmet medical needs. In our third program, we’ve laid the groundwork to address one of the biggest health crises of our time: antibiotic resistance,” said Kevin Sullivan, MBA, Chief Executive Officer of Appili Therapeutics. “The Chamber of Commerce awards ceremony provided an occasion to recognize not only our successes within Appili, but also the critical component that the Halifax community, and other Canadian resources, have played in our accomplishments. From funding and human capital, to access to cutting-edge academic research and technology, this community has been an integral part of our story.”

The ‘New Business of the Year’ award honours an active business located in Halifax that has been operating for less than two years. Appili was founded by a team of drug development, infectious disease, and commercialization experts to advance the global fight against infectious disease and the mounting threat of drug-resistant pathogens.

 

About Appili Therapeutics

Appili Therapeutics, Inc., was founded to advance the global fight against infectious disease by matching clearly-defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors and society face in this challenging disease space. Balancing near-to-market product candidates with higher-risk but potentially transformative early-stage programs, Appili’s growing pipeline includes assets being developed by Appili as well as an active licensing program. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of pediatric and elderly patients with difficulty swallowing. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, a novel class of antibiotics with broad-spectrum activity against Gram-negative bacteria. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, removing risk from a weaponized bioterrorism pathogen. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, Ontario, Appili is pursuing worldwide opportunities in collaboration with science and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

Categories
Archives Archives 2018

Appili Therapeutics Licenses BioTerrorism Vaccine Rights

HALIFAX, Nova Scotia, January 9, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”), an anti-infective drug development company, announced today it has signed a licence agreement with the National Research Council of Canada (NRC) to develop ATI-1701, a vaccine to protect against Francisella tularensis, a potential bioterrorism agent that causes tularemia.

The U.S. Centers for Disease Control and Prevention (CDC) ranks F. tularensis, the bacteria that causes tularemia, as a Category A pathogen (i.e., an organism that poses the highest risk to national security and public health). Aerosolized F. tularensis is on this list because it is considered to have high potential as a biological weapon and has been studied prior to and during World War II, and it was also examined for military purposes by the Soviet Union during the Cold War.

Francisella tularensis is a very infectious bacteria. A small number (approximately 10 to 50 organisms) can cause tularemia disease. If used as a weapon, the bacteria would likely be made airborne for exposure by inhalation. People who inhale an infectious aerosol would generally experience severe respiratory illness, including life-threatening pneumonia and systemic infection, if they are not treated,” said Sean McBride, Vice President, Business Development at Appili Therapeutics.

Although a vaccine was developed in the former Soviet Union that partially protects against respiratory challenges, it may have limited effectiveness when used in a mass casualty, bioterrorism attack and is currently not approved for use by the U.S. Food and Drug Administration (FDA). Various antibiotic regimens are effective as post-exposure prophylaxis and treatment for tularemia and would likely comprise the first line of public health intervention in response to a deliberate release of F. tularensis; however a highly effective vaccine has long been sought after to protect vulnerable populations.

“If an adversary finds a way to make Francisella tularensis resistant to antibiotics and uses it as an aerosolized bioweapon, the results could be devastating,” continued Mr. McBride. “We are proud to be a part of the team working to advance a vaccine to protect civilians and military personnel in the event of an attack.”

ATI-1701 is based on research led by Dr. Wayne Conlan at the NRC. Dr. Conlan’s team used genetic engineering to disable a previously virulent strain of F. tularensis and develop a live attenuated vaccine.  Their research showed the genetically modified bacterium induced a strong immune response that triggers a protective immune response to F. tularensis.

“It is very rewarding to see our team’s research on this vaccine progress from our labs to the next stage of development. We are delighted to partner with Appili on this important program designed to protect the health of Canadians exposed to bioterror threats,” said Dr. Conlan.

Some of the development work for the vaccine is being funded by the Defense Threat Reduction Agency (DTRA), part of the U.S. Department of Defense, which recently announced a $6.2 million, 5-year program to develop a tularemia vaccine. Appili will conduct the preclinical and clinical testing required by the FDA to evaluate the safety of the ATI-1701 vaccine and to ensure it offers the desired protection against the bacteria for humans. These pivotal studies could support the regulatory approval of the vaccine under the FDA Animal Rule.

Today’s license agreement with the NRC grants Appili exclusive worldwide rights to develop and commercialize this tularemia vaccine. “This continues to build out our portfolio of products that have dual civilian and military defensive applications,” said Kevin Sullivan, CEO of Appili Therapeutics. “We will continue to identify partnering opportunities to work with defense departments around the world to develop infectious disease solutions for unmet needs in the military and civilian populations alike.”

 

About Tularemia

Tularemia is a disease of animals and humans. Rabbits, hares, and rodents are especially susceptible to tularemia and often die during outbreaks. Humans can become infected in several ways including tick and deer fly bites; skin contact with infected animals; ingestion of contaminated water; inhalation of contaminated dust or aerosols; and acts of bioterrorism.

 

About Appili Therapeutics

Appili is a biopharmaceutical company dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. Its pipeline includes three anti-infective programs: ATI-1501, a novel taste-masking technology applied in an oral suspension for the treatment for anaerobic infections, ATI-1503, a novel antibiotic targeting drug-resistant Gram-negative infections, and ATI-1701, a vaccine reducing the threat of tularemia bioterrorism. For more information visit www.AppiliTherapeutics.com.