By Peter Moreira
Halifax-based PhotoDynamic Inc. will put its plaque-killing oral health product through clinical trials in the next month, the outcome of which will shape its strategy for the next few years.
The company will test its product with 20 patients at the Forsyth Institute in Boston, one of the world’s most prestigious research facilities in the field of oral health. If it gets good results from these tests, the company plans to work closely with a Fortune 100 consumer products company to bring the product to market.
That product — called PD Foam and PD Tray — is a system that kills plaque buildup on teeth through a combination of light and an extract from a plant that grows wild in Nova Scotia. Because the plant is known to be safe for human consumption, the product has a relatively simple regulatory path. Its initial target market is the one-fifth of the population who suffer from excessive plaque buildup on their teeth regardless of how much they brush.
“We’ll start in a few weeks and have the results by January,” said CEO Martin Greenwood in an interview. “If the results are good, it will be easy to raise our next round (of financing) and then we’ll be moving on to a larger trial.”
In the spring of 2016, PhotoDynamic raised $250,000 in equity funding through the First Angel Network, and supplemented that capital with money from government programs. The company, which grew out of research by Acadia University professor Sherri McFarland, has remained lean with four employees and used the FAN money to build a working prototype.
PhotoDynamic has developed foam made from the plant extract, which the user places in the top and bottom trays of a special mouthpiece, like a mouthguard a hockey player would wear and which contains LED lights. Users turn on the lights, place the device in their mouth for one minute, and the plaque is gone.
So far the system has killed plaque successfully in a petri dish and in animal tests, but surprises can crop up in human trials, Greenwood said. For example, 10 subjects will be given the PhotoDynamic device and the other 10 a placebo, to establish a clear gap between plaque buildup in the two groups. If a few of the 10 placebo-takers obsessively brush their teeth all day, it could skew the results.
Greenwood feels confident in the PD Foam and Tray and believes the company has positioned itself to proceed promptly with its commercialization. It has built up a strong working relationship with its multinational partner (whom Greenwood declines to name publicly), and that could help bring the product to market.
PhotoDynamic has also strengthened its board, recently adding former Johnson & Johnson consumer products CTO Neal Matheson and Barry Turner, a former vice-president of global complimentary medicines with Warner-Lambert.
Assuming the trials are successful, Greenwood plans to raise about $1.5 million to take the company through the next two years. In that period he hopes to fine-tune the engineering of the product and carry out more thorough clinical trials, involving about 75-125 people over six months.
Then Greenwood plans to sell the oral health product to a large company that can develop it, and PhotoDynamic will use the proceeds to work on other applications for the plant extract.
“The way to really grow this company is to say, ‘We’re the people that can really take this technology to its potential,’” he said. “Let us be the R&D hub. . . . What we want to do is hit a home run and take the funds and reinvest them into the next one.”
By Peter Moreira
With its indoor farm in Guelph, Ont., nearing completion, TruLeaf Sustainable Agriculture is plotting its next phase of growth with more farms, a licensing model for its technology and a new round of funding.
Gregg Curwin, founder and CEO of the Halifax vertical farming company, also says the company is focused ever more on machine learning and data analytics to help it produce the most nutritious local food possible.
Halifax-based TruLeaf aims to be a leader in sustainable agriculture through the use of vertical farming — which combines proven hydroponic technology with advancements in LED lighting and reclaimed rainwater to allow year-round production of plants indoors.
Vertical farming is nearly 30 times more efficient than traditional agriculture, uses as much as 95 per cent less water, and takes up less land.
Curwin told a panel discussion at the Big Data Congress last week that the company is now focusing on applying advanced technology to the process of growing plants indoors.
The Guelph plant — which is due to be completed in June, will be fully automated and TruLeaf is looking into using data to improve the process of growing nutritious food.
“The light bulb that’s going off for us is all about machine learning and data,” said Curwin.
Curwin said that in the controlled environment of its growing facilities, the company can monitor data produced over time from the creation of the seed to shipping grown food to the supermarket. Outdoors, a farmer can get 40 points of data in his or her career; TruLeaf can get 10,000 data points in 10 days at its indoor farms.
One example of TruLeaf’s experimentation is the work it has been doing with LED lighting.
The company is experimenting with how different plants grow under different light spectrums, and what lighting is best at specific phases of the growing process. It is even examining whether special lighting in a supermarket shelf can prolong the freshness of produce.
Curwin added that the company is investigating whether there is a direct link between adding certain greens to your diet and improving cognitive health.
It is interested in producing in Nova Scotia a vegetable prominent in West Africa, where dementia rates are really low.
“Can we make a defensible claim about the prevention of cognitive diseases?” he asked. “Making accurate claims is a significant goal of ours.”
The last 18 months have been busy ones for TruLeaf. It closed an $8.5-million financing round last December and has been working with Loblaw Companies, the parent company of Atlantic Superstores, on the development of its farms.
Appearing under the company’s GoodLeaf Farms brand, products grown in the company’s farm in Bible Hill are now available in a dozen Superstores spanning the three Maritime provinces.
According to the TruLeaf website, the products include broccoli shoots, kale shoots, daikon radish shoots, pea shoots, baby arugula and baby kale.
The company now has 38 employees in Nova Scotia.
“We’re eliminating low-level jobs and most of the jobs we are creating now are . . . in computer science, engineering and plant science,” said Curwin.
For Immediate Release
November 7, 2017 – HALIFAX, Nova Scotia –– Appili Therapeutics Inc. (the “Company” or “Appili”), an anti-infective drug development company, announced today it has been awarded a $1.2 million USD grant by the Department of Defense, Congressionally Directed Medical Research Programs, Peer Reviewed Medical Research Program .
The Peer Reviewed Medical Research Program (PRMP) supports military health-related research that has the potential to make a strong impact on patient care. Appili will use the funds to develop a lead compound as a preclinical candidate for its ATI-1503 antibiotic program targeting drug-resistant, Gram-negative bacteria.
“Drug-resistant bacteria threaten a doctor’s ability to care for battlefield wounds among military service men and women,” said Kevin Sullivan, CEO of Appili Therapeutics. “We are honoured to have been selected for this PRMRP award, which helps us advance our most promising antibiotic candidate through the critical early stages of development.”
Drug-resistant bacteria constitute some of the highest threats to human health, with over 2 million infections and at least 23,000 deaths each year in the U.S. alone. These superbugs can present serious challenges in both battlefield situations, as well as in veterans’ hospitals, making it a priority research area for the Department of Defense (DOD).
ATI-1503 is a synthetic version of the naturally-occurring antibiotic called Negamycin. Its broad spectrum activity allows it to tackle the most deadly Gram-negative bacteria, including Klebsiella pneumoniae, Acinetobactor baumannii, and Pseudomonas aeruginosa. These are high priority pathogens for the Centers for Disease Control and Prevention and the World Health Organization because of the lack of effective antibiotic treatment options for the most resistant strains.
Appili’s expert drug development team will use the PRMRP funding to optimize the potency of ATI-1503 to effectively target Gram-negative bacteria. Because Gram-negative bacteria have two protective cellular walls, it is hard for existing antibiotics to penetrate. ATI-1503 holds promise for treating these superbugs because it penetrates the double exterior membranes and attacks the protein generating machinery of the Gram-negative bacteria.
About the PRMRP Grant
This work is supported by the DOD Congressionally Directed Medical Research Programs through the Peer Reviewed Medical Research Program under Award No. W81XWH-17-1-0180. In conducting this research, the investigators will adhere to the laws of the United States and regulations of the Department of Agriculture, as well as the CDC-NIH Guide for Biosafety in Microbiological and Biomedical Laboratories. For more information, visit http://cdmrp.army.mil.
About Appili Therapeutics
Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501 is a taste-masked treatment for anaerobic infections, including C. difficile. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat drug-resistant Gram-negative infections. For more information visit www.AppiliTherapeutics.com.
Media Relations Contact:
Investor Relations Contact:
Kevin Sullivan, CEO, Appili Therapeutics
For Immediate Release
HALIFAX, Nova Scotia – October 30, 2017 – Appili Therapeutics Inc. (the “Company” or “Appili”), an anti-infective drug development company, announced today that both the US Food and Drug Administration (FDA) and Health Canada have cleared its IND and CTA clinical investigation applications, respectively, to conduct a clinical trial of ATI-1501, a taste-masked antibiotic targeting anaerobic bacteria like Clostridium difficile. ATI-1501 has been optimized in an oral liquid suspension to provide patients who have difficulty swallowing with a more convenient alternative to the currently marketed metronidazole tablet.
Appili plans to conduct the ATI-1501 clinical study in Toronto, Ontario and will begin recruiting subjects in November 2017. The company expects to enroll approximately 40 healthy volunteers in this bioavailability study.
“Having both Health Canada and FDA authorization affirms our confidence in our regulatory and development strategy,” said Kevin Sullivan CEO of Appili Therapeutics. “We’re excited to take ATI-1501 into clinical trials because it brings us a step closer to offering physicians a new weapon to fight serious infections and improve patient compliance.”
ATI-1501 fulfills an unmet market need for millions of people with swallowing difficulties who have been prescribed metronidazole. These individuals, primarily children and the elderly, are not completing their full course of metronidazole tablets because of the extreme bitter taste and difficulty swallowing tablets. Poor patient compliance is leading to the spread of infection, recurrent infections, and antibiotic resistance, which makes treatment more complicated and expensive. As the mainstay for treating anaerobic bacterial infections, IMS Health reports that over 9.5 million prescriptions of metronidazole tablets are issued in the US each year.
Appili’s ATI-1501 oral liquid antibiotic candidate has been taste-masked to improve palatability and reduce issues with non-compliance. Once ingested, the well-studied and established antibiotic is designed to kill anaerobic bacteria by interfering with their DNA, which clears up the infection.
“We expect the completion of this clinical trial will set us up to file our new drug application in 2018 and advance our commercialization activities,” said Jamie Doran, Vice President of Drug Development of Appili Therapeutics.
Appili’s regulatory strategy involves registration using a 505(b)(2) pathway in the US, which is an abbreviated FDA pathway that allows the Company to reference safety and efficacy data of the original oral metronidazole tablet.
About Appili Therapeutics
Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The Company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501 is a taste-masked treatment for anaerobic infections that has been granted orphan drug status by the FDA. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat deadly Gram-negative infections. These drug-resistant infections have been identified by the US Centers for Disease Control (CDC) and the World Health Organization as posing the highest threat to human health. For more information visit www.AppiliTherapeutics.com.
Media Relations Contact:
Investor Relations Contact:
Kevin Sullivan, CEO, Appili Therapeutics
The 2017 Game Changers awards were presented at the annual gala Monday night at the Westin Nova Scotia with an audience of more than 300 people.
The Halifax Partnership, which runs the Game Changers Youth Retention program, recognizes Halifax employers and connectors who demonstrate leadership in the industry through youth hires and meaningful learning opportunities. With the goal of keeping more youth workers in the province, the private-sector initiative aims to reduce the net annual average youth outmigration to zero by 2019.
Since Game Changers began, the net interprovincial outmigration of youth aged between 20 and 29 years old has improved from 1,500 to 222 between 2014 and 2015. Last year’s outmigration is estimated to be 231, showing the start of a positive trend for more youth staying and working in Nova Scotia.
“We at the Halifax Partnership are so proud of our province’s progress to date, and it is thanks to our business community,” said Ron Hanlon, president and CEO of the Halifax Partnership. “We’re making great strides, we need to keep the momentum going.”
After receiving more than 100 nominations, the annual awards are presented by TD Canada Trust, who named nine businesses in four categories as this year’s winners.
Best Youth Employer Awards
• Agada Biosciences Inc. (Small Business Category)
• Spring Loaded Technology (Medium Business Category)
• Citco (Canada) Inc. (Large Business Category)
Experiential Learning Awards
• Halifax Refugee Clinic (Small Business Category)
• Kinduct Technologies (Medium Business Category)
• Stantec Consulting Ltd. (Large Business Category)
• Chris O’Shea, Business Development Bank of Canada
• Shelagh McCorry, HSBC Bank Canada
• National Public Relations
By Peter Moreira
For the past few years Kami Harris has received 1,000 ticks annually at her office at Mount Allison University in Sackville, N.B. She hopes it continues. Her business model depends on it.
Some come from scientists, some from New Brunswick’s Natural Resources Department, others from members of the public who have heard about her work in ticks and Lyme disease.
Harris is the founder and CEO of Zecken Laboratories, which is dedicated to enhancing the diagnosis of Lyme disease. She has been studying ticks and Lyme disease for her PhD at Mount A, and now she is transforming her research into a company. Her faith in the endeavour is based in part on the growing public awareness and fear of Lyme disease.
“We’ve gone in five years from people thinking, ‘This could happen in the Maritimes’ to ‘This is a big problem,’” Harris told the BioPort Atlantic conference in Halifax last week. “Half my day already goes to answering emails from people who know I’m the ‘tick girl.’”
Lyme disease is a bacterial infection spread to humans by blood-feeding insects, particularly deer ticks. And as the climate warms, ticks are spreading north and their bites are becoming more common in the Maritimes. Concern about Lyme disease is growing.
Harris said there are actually 21 types of Lyme disease but current diagnostic tests only identify one type. That means about 90 per cent of the instances of Lyme disease go undetected, which can lead to long-term health problems. What Zecken is doing is devising products that can identify markers in the other types of Lyme disease to improve diagnosis and therefore generate more treatment.
The company has already identified peptides that show the presence of the affliction, and continues to research the disease to identify new strains as they come along.
“We’re not only going to give you the right information; we’ll give you more information,” Harris said. “We’ll be able to tell you the type of Lyme disease you have.”
At BioPort, Zecken was a finalist in the BioInnovation Challenge, the region’s main pitching competition for life sciences competitions. Earlier this year, it was a semifinalist in Breakthru, the main startup competition in New Brunswick. Soon it will be ready to start bringing in revenue.
The company is planning a basic swab test for consumers in 2018. For $50, consumers can swab their mouths at home, send the sample to the company and learn if they have Lyme disease and if so what type. Harris said this service will not require regulatory approval.
The swab service will bring in revenues as the company seeks regulatory clearance for more sophisticated products, such as a blood test to detect Lyme disease for health-care providers. It also wants a business-to-business product to offer to such industries as forestry, where tick bites are a growing concern.
So far, the company’s research has been financed through Harris’ research funding, but she and her three teammates know they will need a more structured financing model.
They will probably aim for a $250,000 funding round in their first year.
For Immediate Release
October 23, 2017 – HALIFAX, Nova Scotia –– Appili Therapeutics Inc. (the “Company” or “Appili”), an anti-infective drug development company, announced today it raised $3,062,000 in a private placement financing, bringing the total equity raised since its seed round in March 2016 to $7,477,000.
This 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 advance its pipeline of anti-infectives and move its lead antibiotic, a taste-masked treatment for anaerobic infections, into the clinic.
“Appili has assembled a team with the proven ability to bring new antibiotics to market, and has made remarkable progress in building a pipeline that addresses major unmet needs in bacterial infections,” said Dr. Lidija Marušić, life sciences investment manager at Innovacorp and member of Appili’s Board of Directors. Innovacorp has participated in all of Appili’s financing rounds.
“There is a robust market opportunity for antibiotics that really bring value and the successful closing of this financing round reflects that,” said Kimberly Stephens, CFO of Appili Therapeutics.
“We appreciate the confidence investors have in our strategy to build a balanced-risk pipeline of products designed to treat the most serious and drug-resistant infections affecting patients today,” said Kevin Sullivan, CEO of Appili Therapeutics.
Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The Company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501 is a taste-masked treatment for anaerobic infections that has been granted orphan drug status by the FDA. Appili plans to take ATI-1501 into clinical trials in 2017. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat deadly Gram-negative infections. These drug-resistant infections have been identified by the U.S. Centers for Disease Control (CDC) and the World Health Organization as posing the highest threat to human health.
For more information visit www.AppiliTherapeutics.com.
For more information, please contact:
Kimberly Stephens, CFO
By: Peter Moreira
Delegates to BioPort 2017 on Wednesday were told of the impact of recent life sciences innovation in Atlantic Canada and encouraged to embrace further change.
The impact so far is found in the fact that $1 billion has flowed into Atlantic Canada in the last six years from exits by companies in the life sciences and digital health space, and follow-on investment by the companies that bought them.
BioPort is the annual get-together for life sciences entrepreneurs and innovators in the region, and the gathering this year celebrated the growth of biotech in the region, especially in New Brunswick. Pfera Inc., the winner of the BioInnovation Challenge, the conference’s $45,000 pitching competition, is from New Brunswick, as are Zecken Laboratories and Tieös Pharmaceuticals Inc., the two other finalists in the event. (Read our full report on the BioInnovation Challenge.)
The delegates were told to embrace further innovations, especially in overall healthcare.
Peter Vaughan, Chair of Canada Health Infoway and Nova Scotia’s former Deputy Health Minister, urged the delegates to embrace current innovations in healthcare – not just futuristic technologies on the horizon but products that are on the market now.
For example, he cited such companies as Babylon Healthcare in the U.K. and the Mercy Virtual in St. Louis as organizations that are cutting costs and meeting patient requirements through online and video consultations, often including drug delivery.
Patient surveys show that citizens want modern medical processes like e-prescriptions, online access to their medical records and timely medical consultations – goals met by groups like Babylon and Mercy. These organizations also meet the needs of government, as provinces spend upwards of 40 percent of their budgets on healthcare, only to find that 30 percent of healthcare spending has no value, said Vaughan.
“You’re starting to get a picture of what’s available in the present,” said Vaughan. “So how do we take these things and change the one thing that’s on everyone’s mind – access to healthcare?”
Vaughan said the future of healthcare is found in data because the analysis of vast reams of healthcare data reveals patterns that can predict severe health problems. This data can signal a problem is imminent so measures can be taken to prevent a crisis. Multinationals like Google, Apple and Amazon are now analyzing such data in the cloud, he said, but there is an opportunity for public, open data projects that could benefit everyone. He called on the Atlantic Provinces to come together to pioneer such a project with the data from its 2.2 million residents.
“We in this country have the opportunity to produce a publicly funded ecosystem,” he told the assembled innovators. “This is the opportunity we face in Atlantic Canada. We can be that industry and then you can have access to more information than you ever imagined.”
Scott Moffitt, Executive Director of BioNova, said in an interview there is evidence the life sciences segment in the region is evolving as exits in the space have created about $1 billion in investment.
The exits of the past few years in the life sciences and digital health segments have included the sale of Ocean Nutrition Canada of Dartmouth for $540 million, BioVectra of Charlottetown for $100 million, and STI Technologies of Halifax, reportedly for more than $200 million. Moffitt said his tally also included other exits and investments that the purchasing companies made after the purchases closed.