Leading Health and Life Sciences in Nova Scotia

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: [email protected]

Investor Relations Contact:

Kimberly Stephens, CFO Appili Therapeutics

E: [email protected]

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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: [email protected] Investor Relations Contact: Kimberly Stephens, CFO, Appili Therapeutics T: 902-442-4655 E: [email protected]
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Appili Therapeutics Channeling Funds into Drug Discovery

entrevestor.com, written by Peter Moreira Kevin Sullivan had the pride of a guy showing off his new Cadillac. But it wasn’t a car he was displaying, it was the new laboratory that his company had recently moved into. The company is Halifax-based drug discovery outfit Appili Therapeutics Inc., which in May announced $3.3 million in funding, comprising equity, debt and grants. On the same day, Sullivan unveiled the company’s new lab in the Innovacorp Enterprise Centre in Halifax and introduced the team of PhDs working for the company. A month earlier, Appli had announced it received a special fast-track approval designation from the Food and Drug Administration. Not bad for a company that began last year. “Appili is a company that hasn’t been around long, and coming from where they started to where they are today is truly impressive,” said Scott Moffitt, the Managing Director of BioNova, the life sciences industry association in Nova Scotia. Appili is a notable company because of its leadership, its strategy and the story of how the company came together. Sullivan is a businessman operating in a segment that is often known for the high concentration of academics. He’s raised more than $40 million for various companies, and he brings a deep expertise in developing new drugs. Sullivan came to Nova Scotia in 2013 to take the helm at DeNovaMed, a Halifax company working on a cure for antibiotic-resistant viruses. He had previously spent 10 years (including four as COO) with London-based Viron Therapeutics Inc., which was developing a cardiovascular drug. Viron raised more than $35 million in equity and non-dilutive capital and took its lead product through Phase 2 trials. During his work in the biotech field, Sullivan met up with Brian Bloom and Jolyon Burton, the principals of the Toronto-based healthcare-focused investment boutique Bloom Burton & Co. Together, they decided to form a company in Halifax headed by Sullivan that would develop drug candidates. The first is ATI-1501, which aims to remove the nasty taste from an existing drug that treats Clostridium difficile infection, or CDI, an urgent antibiotic-resistant bacterial threat that causes 29,000 deaths annually. A drug called Metronidazole has been used to treat the condition since the 1970s, but kids with CDI don’t want to take it because of its dreadful taste. ATI-1501 removes the bitter taste. The Food and Drug Administration recently granted orphan drug designation to ATI-1501, meaning Appili could have an accelerated regulatory path and protection against competition for seven years. The company expects to begin clinical trials next year and have a product on the market in three or four years. The second drug candidate is ATI-1503, a drug that could fight deadly infections such as Klebsiella pneumoniae. The media is full of warnings about viruses that are resistant to antibiotics and Sullivan said this drug could help combat them, but it’s a longer, riskier project than the first drug. “We’re now entering a post antibiotic era, where a common cut could be deadly,” said Sullivan. “That’s what keeps us up at night.” Sullivan described Appili’s strategy as one based on “hitting home runs and singles.” The idea is that the drug for CDI can get to market quickly, but address a limited market. By selling the product, it could produce a steady income stream. That would help to finance the drug for antibiotic-resistant viruses, which could become a blockbuster drug. The strategy helped Sullivan attract $2.3 million in equity financing in the latest round  — $1.8 million from individuals brought together by Bloom Burton, and $500,000 from Innovacorp. Appili supplemented the raise with funding from theAtlantic Canada Opportunities Agency and NRC Irap. “This is a seed round,” said Sullivan. “We’ll be looking to go back to the capital markets in the summer and close another round of financing in the fall.”]]>