ENTREVESTOR: Appili Names Balboni as CSO

Read the original article here.  Appili Therapeutics, a Halifax-based drug development company, has appointed its first ever Chief Scientific Officer. Armand Balboni, the new CSO, will be responsible for the company’s clinical and scientific strategy as well as steering its 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 Appili CEO Kevin Sullivan in a statement. Balboni has over 20 years of medical and drug development experience across an extensive range of civilian and military organizations. Early in his career, Balboni completed a period of active duty with the U.S. Army as the Deputy Director of its Office of Regulated Activities and was a senior reviewer on the clinical pharmacovigilance team. He is also a partner, senior advisor and member of the Board of Directors of the investment advisory firm Bloom Burton & Co. “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,” Balboni said in a statement. In January, Appili struck a deal with the National Research Council of Canada to work on a vaccine that could protect people against a potential bioterror threat. The vaccine, called ATI-1701, will protect against bacteria called Francisella tularensis. The company, which is considering a listing on the Toronto Stock Exchange, has raised a total of $11.8 million in less than two years. The company is now on a fast-track to get its portfolio of anti-infectious drug candidates to market within the next couple of years. Already, Appili has had positive results from its first clinical trial in Canada and the US for its ATI-1501 drug compound. Said 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.”]]>

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

See the original post here. 

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.

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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

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Appili Therapeutics Completes Phase 1 Study for ATI-1501, Its Taste-Masked Oral Metronidazole Suspension, Demonstrating Significant Improvements in Taste and Palatability

See original article here 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.
Media Relations Contact: Christy Curran, Sam Brown Inc. T: 615-414-8668 E: christycurran@sambrown.com Investor Relations Contact: Kimberly Stephens, CFO, Appili Therapeutics T: 902-442-4655 E: Info@AppiliTherapeutics.com
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Business Wire: Appili Therapeutics to Present at 2018 Bloom Burton & Co. Healthcare Investor Conference

See original story here 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.]]>

ENTREVESTOR: Appili Raises $4.3M in Equity Funding

See original story here Halifax drug discovery company Appili Therapeutics Inc., has raised $4.3 million in equity financing to further its operations and add to its number of drug candidates. The company said in a press release it raised the money through a private placement, which was over-subscribed. It received money from new and existing investors, including Innovacorp, Nova Scotia’s innovation and venture capital organization. Appili, which previously has raised money with the help of the Toronto investment boutique Bloom Burton & Co., said it has now raised a total of $11.8 million in less than two years. Appili also said it would borrow a further $500,000 through the Atlantic Canada Opportunities Agency‘s 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 CEO Kevin Sullivan in a statement Wednesday. Appili has been working to develop a portfolio of anti-infectious drug candidates. In the statement Wednesday, the company said it plans to “expand its pipeline of anti-infectives with additional in-licensed assets.” In October, Appili’s first drug candidate ATI-1501 received approval to begin clinical trials in both Canada and the U.S. It treats clostridium difficile infection, or CDI, in children. ATI-1501 removes the bitter taste from Metronidazole, a drug that has been used to treat the condition since the 1970s. Metronidazole is effective, but it tastes awful, so children often won’t take it, thereby limiting its effectiveness. By removing the bitter taste, ATI-1501 improves the results of the drug. Last month, the company struck an agreement to work on a vaccine that could protect people against a potential bioterror threat. It signed a licence agreement with the National Research Council of Canada to help develop ATI-1701, to vaccinate against tularemia. The vaccine will protect against bacteria called Francisella tularensis, which can cause tularemia, a highly infectious disease also known as rabbit fever. The company is also working on a compound called ATI-1503, an antibiotic that could fight deadly infections such as Klebsiella pneumonia. Sullivan has said the drug could combat viruses that are resistant to antibiotics, but it’s a longer-term, riskier project than the other candidates. “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,” said CFO Kimberly Stephens in the statement. Disclosure: Innovacorp and ACOA are clients of Entrevestor. ]]>

ENTREVESTOR: Appili To Work on Anti-Bioterror Vaccine

See original Entrevestor post here Appili Therapeutics has struck an agreement to work on a vaccine that could protect people against a potential bioterror threat. The Halifax drug discovery company said Monday it signed a licence agreement with the National Research Council of Canada to help develop ATI-1701, to vaccinate against tularemia. The vaccine will protect against bacteria called Francisella tularensis, which can cause tularemia, a highly infectious disease also known as rabbit fever. People can become infected with tularemia through tick and deer fly bites, drinking infected water or by simply inhaling the disease if it becomes airborne. This is why the U.S. Centers for Disease Control and Prevention lists F. Tularensis (the bacteria that causes the disease) as a Category A pathogen, a bacteria that poses the highest threat to national security and public health. “Francisella tularensis is a very infectious bacteria,” Sean McBride, Appili vice-president of business development, said in the announcement. “A small number (of bacteria) can cause tularemia disease. If used as a weapon, the bacteria would likely be made airborne for exposure by inhalation.” He added: “People who inhale an infectious aerosol would generally experience severe respiratory illness, including life-threatening pneumonia and systemic infection, if they are not treated,” Aerosolized F. tularensis was studied by the Soviet Union during the Second World War and the Cold War for military purposes. The Soviets also developed a vaccine, but with limited effectiveness. The NRC’s ATI-1701 compound was developed through genetic engineering and has shown a strong immune response to the F. tularensis strain. “The NRC has developed an elegant attenuated vaccine that is showing dramatic results, better than the current vaccination,” Appili CEO Kevin Sullivan said in an interview. Wayne Conlan led the team that developed NRC’s ATI-1701 compound. In the statement, he said: “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.” Part of the funding to develop the vaccine is from the Defense Threat Reduction Agency, a part of the U.S. Department of Defense, which has invested $6.2 million into a five-year program to develop the tularemia vaccine. The licence agreement with the NRC grants Appili — which has raised money from Innovacorp and through the investment boutique Bloom Burton  & Co. — exclusive worldwide rights to develop and commercialize the tularemia vaccine. Under the agreement, Appili is responsible for the preclinical and clinical testing to evaluate the safety of the ATI-1701 vaccine in humans as per the guidelines from the Food and Drug Administration and Health Canada. The vaccine won’t be commercially available for another 3-5 years but Sullivan says this is the right step to hinder the development of a tularemia bioweapon. “It’s one of the goals of the West to develop the tularemia vaccine in case there is a bioterror attack,” said Sullivan. “We want to minimize the threat of a bioterror weapon to a point where the adversary doesn’t even bother making one.”]]>