See original news release here
New data demonstrates durable protective response for Appili’s vaccine candidate against Francisella tularensis, a Category A pathogen and potential biological weapons threat
Presentation provides additional safety and efficacy data supporting use of ATI-1701 as a medical countermeasure, supports ongoing development under U.S. Food and Drug Administration’s medical countermeasure development guidelines
HALIFAX, Nova Scotia, November 18, 2019 – Appili Therapeutics Inc. (TSXV: APLI) (the Company or Appili), a biopharmaceutical company focused on anti-infective drug development, today announced that Dr. Carl Gelhaus, Senior Program Manager of the Medical Countermeasures Division at MRIGlobal, will present positive interim data on Appili’s ATI-1701 program at the Chemical and Biological Defense Science & Technology Conference (CBD S&T). The conference is being held from November 18-21 at the Duke Energy Convention Center in Cincinnati, Ohio.
The poster presentation at CBD S&T will summarize the latest findings from the ongoing preclinical study of ATI-1701, which showed complete (100%) protection 90 days after vaccination from a lethal exposure to the pathogen Francisca tularensis. This time period is the longest vaccine protection period tested to date in this model. Researchers will conduct an additional evaluation of vaccine efficacy up to 365 days in the same model in H1 2020. The U.S. Defense Threat Reduction Agency (DTRA), an arm of the U.S. Department of Defense (DOD), is funding this trial. MRI Global is managing the study under the DTRA contract HDTRA1-16-C-0028.
“Together with our partners at the DOD, MRIGlobal, and the National Research Council of Canada, we are greatly encouraged by results from the 90-day vaccine challenge study,” said Kevin Sullivan, CEO of Appili Therapeutics. “Although results are preliminary, they add to a growing body of evidence supporting advanced development of ATI-1701. We look forward to sharing the 365-day challenge results next year, and working with our biodefense partners to potentially produce the first FDA-approved vaccine for the prevention of tularemia.”
Presentation details are as follows:
Title: Development of Francisella Tularensis SCHU S4 DeltaclpB as a Vaccine for the Prevention of Pneumonic Tularemia in the Warfighter
Session: Medical Countermeasures in the Context of a Layered Medical Defense
Date: Wednesday, November 20, 2019
Time: 4:00 p.m. – 6:00 p.m. ET
Appili is developing ATI-1701 as a vaccine to combat Francisella tularensis, which the U.S. National Institutes of Health (NIH) defines as a Category A pathogen (an organism that poses the highest risk to national security and public health). As it is 1,000 times more infectious than anthrax, experts consider the aerosolized form to have a high potential use in a bioterrorist attack.[i] Several countries may already have operational weapons programs leveraging this pathogen, making the need for a vaccine to counter this biological weapons threat exceedingly important.[ii]
About the Chemical and Biological Defense Science & Technology Conference (CBD S&T)
DTRA will host the 2019 CBD S&T Conference at the Duke Energy Convention Center, in Cincinnati, Ohio, November 18-21, 2019. The conference provides the opportunity to collaborate with more than 1,500 scientists, program managers and leaders from across the globe who are committed to making the world safer by confronting chemical and biological defense challenges. Attendees will also network with DTRA science and technology managers as well as other members of DTRA’s Chemical and Biological Defense team.
Celebrating its 75th year of business, MRIGlobal addresses some of the world’s greatest threats and challenges. Founded in 1944 as an independent, non-profit organization, we perform contract research for government, industry, and academia. Our customized solutions in national security and defense and health include research and development capabilities in clinical research support, infectious disease and biological threat agent detection, global biological engagement, in vitro diagnostics, and laboratory management and operations. MRIGlobal is one of two partners in the Alliance for Sustainable Energy, LLC, which manages and operates the National Renewable Energy Laboratory (NREL) in Golden, Colo., for the U.S. Department of Energy. For more information, visit www.mriglobal.org
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. Appili has built pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, being developed to mitigate the risks of a very serious biological weapons threat. ATI-1503 is a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. 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.
This news release contains “forward-looking statements” which reflect the current expectations of the Company’s management future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding the Company’s proposed development plans with respect to its product. Wherever possible, words such as “may “, “would “, “could “, “should”, “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions including with respect to the ability of the Company to adequately fund and implement its development plans and business strategy. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements including, without limitation, those listed in the final prospectus of the Company dated June 12, 2019 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.
Investor Relations Contact:
Kimberly Stephens, CFO
E: [email protected]
Cablon Medical and Adaptiiv team up to expand the reach of 3D printed medical accessories for radiotherapy
HALIFAX, NS June 7, 2019 – Adaptiiv Medical Technologies Inc. (Adaptiiv) is pleased to announce that Cablon Medical, a leading developer and supplier of radiotherapy hardware and software, will become their latest Alliance Partner offering personalized 3D printed medical accessories in Belgium, The Netherlands, and Luxembourg. Cablon Medical and Adaptiiv will provide clinically viable solutions that focus on improving treatment and patient care.
As an Alliance Partner, Cablon Medical will be distributing Adaptiiv’s software solution to enable 3D printing of patient-specific bolus, for photon and electron radiotherapy treatment, as well as high dose rate (HDR) surface brachytherapy applicators. The Adaptiiv software solution integrates directly with existing treatment planning software, enabling practitioners to design and 3D print a patient-specific bolus or applicator. This innovative technique requires less fabrication time, replaces the need for complex bolus and expensive applicators, and provides an improved treatment and patient experience.
“Adaptiiv’s solution provides our clients with a method to improve the quality and efficiency of care as well as the patient experience,” said Peter Schoor, Vice President, Europe at Cablon Medical. Adaptiiv is the first company to offer a platform that seamlessly integrates into existing treatment workflows and their team has demonstrated the ability to rapidly validate new approaches to treatment that are being used in a clinical setting,” says Schoor.
In 2018, Adaptiiv became the first company in the world to receive US FDA 510(k) clearance and a CE Mark for a 3D printing software solution intended for use in radiation oncology. 3D printed accessories conform to the patient anatomy to improve radiation dose delivery, patients are more comfortable throughout the treatment period, and because the software fully integrates with treatment planning systems, setup and production times are drastically reduced.
“Cablon Medical and Adaptiiv are aligned in our vision of the importance of providing the highest standard of patient care. Our solution represents a step further to enabling patient-specific care by increasing the clinical acceptance and implementation of 3D printing at the point-of-care. To that end, we are excited to partner with Cablon Medical as our partnership provides reach into countries that will play a significant role in our efforts to provide patient-specific solutions to the global radiotherapy market,” says Peter Hickey, CEO of Adaptiiv.
Adaptiiv Medical Technologies Inc. is the definitive software platform to design 3D printed medical accessories for use in radiation oncology. Headquartered in Halifax, Nova Scotia, Canada, Adaptiiv is shaping the future of patient-specific healthcare through innovation and collaboration with industry leaders throughout the world. Adaptiiv has FDA 510(k) clearance, is ISO 13485 certified, has a CE Mark, and TGA (Australia) approval. The company’s solution is currently used in nine countries including Canada, United States, Mexico, Australia, New Zealand, Israel, Hong Kong, Ireland, and England.
About Cablon Medical
Cablon Medical is a supplier of high-quality medical devices, medicines and consumables. In addition, Cablon Medical, develops innovative software and hardware for radiotherapy treatment and software for ultrasound image quality control. The products are sold both in The Netherlands and increasingly abroad.
Adaptiiv Medical Technologies Inc.
+1 (902) 442-9091
Cablon Medical B.V.
Cindy van Loen
+31 33 494 39 64
Adaptiiv Medical Technologies Inc.
Cablon Medical B.V.
Read the full Entrevestor article here
Adaptiiv Medical Technologies Inc., the Halifax company that uses 3D printing to improve cancer treatment, has further extended its international reach by partnering with Italian peer Eckert & Ziegler BEBIG, or EZB.
EZB specializes in products used in brachytherapy, which applies radioactive sources directly to or into tumors while sparing the surrounding healthy tissue. For the patient, this means shorter treatment periods, fewer side effects and a faster recovery.
The two companies announced Sunday they will test and align their systems to provide an integrated workflow for cancer centers to create 3D-printed brachytherapy applicators customized to each patient. They believe the collaboration will demonstrate that 3D printing can provide clinically viable solutions that improve treatment and patient care.
“This is a significant milestone for us,” said Adaptiiv CTO Alex Dunphy in the press release.“Collaborating with the team at EZB has allowed us to continue to make significant strides towards improving the standard of care using a patient-specific approach in brachytherapy. The successful alignment of our systems will demonstrate that 3D printing can be used to provide a clinically viable solution in brachytherapy treatment.”
Read the original article here.
Halifax-based Adaptiiv has announced major new clients in Hong Kong and the U.S. as the young medical technology company expands its customer base to seven countries.
The company – which uses 3D printing technology to improve radiation therapy in cancer treatment – said Monday it had signed a deal to sell its product to University of Hong Kong and work with the institution as a research partner.
That announcement came days after Adaptiiv announced its 3D Bolus technology would be used by the U.S. Military at the Walter Reed National Military Medical Center. Dubbed “The Nation’s Medical Center,” the Reed is the United States’ largest and most renowned joint military medical facility, providing services in over 100 clinics and specialties.
“We have accomplished a lot in a short period of time and I am very proud of the team but I feel we are just getting started,” said CEO Peter Hickey in an email Sunday night.
Just two years old, Adaptiiv has quickly found customers for its 3D Bolus product, which revolutionizes the use of a bolus in radiation therapy. A bolus is a piece of plastic placed over the cancerous area, assuming the tumours are close to or in the skin. The radiation hits the bolus, builds up and then is transferred into the tumour.
There can be no air pockets between the bolus and the skin, which complicates matters given that every body is unique. Hospitals using the Adaptiiv product buy a system that includes 3D printers with special filaments, so boluses customized to each patient can be printed within seconds. They can be reused as the patient receives repeated radiation dosages. Or, if the patient’s body shape changes over the course of multiple treatments, the medical staff can print off another bolus quickly.
In June, the company announced it had received 510(k) clearance from the U.S. Food and Drug Administration, allowing the product to be sold in the U.S.
That opened the flood gates to more sales, and to announcements of new partnerships and projects. The company’s software is now used in the U.S., Canada, Australia, Israel, Ireland, England and now Hong Kong.
The university in Hong Kong will use 3D Bolus in radiation therapy and its Department of Clinical Oncology will work with Adaptiiv to develop new applications.
Meanwhile, Adaptiiv last week also released a new product called AccuCALC, which helps cancer centers to assess the business case for offering the 3D Bolus product. AccuCALC was developed by Churchill Consulting, which provides consulting and integrated system solutions to radiation therapy departments.
Rules for billing insurers vary from state to state in the U.S., and facilities that offer radiation therapy can use AccuCALC to assess how and when they can charge for using the 3D Bolus product.
“We have seen significant demand from our clients for information pertaining to 3D Bolus,” said Jordan Johnson, Churchill’s Director of Compliance. “Yet. as is common with many leading-edge technologies, our clients are unsure of whether they can bill for a new technology or its potential return on investment. AccuCALC addresses that problem.”]]>
Read full issue of LINK magazine here.
Halifax-based company Adaptiiv, formerly known as 3D Bolus, is using advanced software to create personalized 3D-printing medical devices to help cancer patients receive more precise radiation treatments and improve their quality of care. Adaptiiv’s customized medical devices have been well received by clinicians, with sales in six countries worldwide.
One of Adaptiiv’s most revolutionary medical devices is their 3D-printed bolus. To improve the accuracy of radiation treatment, a tissue-like material called a bolus is applied to the patient’s body. Unlike traditional boluses, Adaptiiv’s advanced software allows clinicians to design 3D-printed boluses using data from the patient’s CT scans to create a personalized design, improving the patient experience. The boluses are cost effective and fit the contours of the patient, which allows for more accurate dosages in the areas that need it most and sparing healthy tissue during radiation therapy.
Aside from improving the lives of cancer patients, Adaptiiv also provides high-quality jobs to Atlantic Canadians, stimulating the economy. With recent funding from Atlantic Canada Opportunities Agency (ACOA) and recently receiving FDA (510K) approval, Adaptiiv has big plans to upgrade their marketing strategy and bring their patient-specific solution to the global radiotherapy market.]]>
See original release here
, July 18, 2018
/CNW/ – Adaptiiv, an innovative medical technology company announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market 3D Bolus Software, an advanced software solution that enables the creation of customized personal medical devices using 3D printing, used primarily in the treatment of cancer.