Department of Defense Awards Ology Bioservices Contract to Manufacture and Test Novel Live Attenuated Tularemia Vaccine Candidate

ALACHUA, Fla.–(BUSINESS WIRE)–Ology Bioservices Inc. (Ology Bio), a biologics contract development and manufacturing organization (CDMO), announced today that the Department of Defense (DOD), through the Joint Science and Technology Office of the Defense Threat Reduction Agency (DTRA), has awarded the company with a contract to manufacture a novel live attenuated tularemia vaccine. The contract value is $6.3 million.

Ology Bio is pleased to be working with the DOD and Appili Therapeutics to advance this important new vaccine candidate. Tularemia remains an important biological threat but to date no licensed vaccine exists to protect against this disease.

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The vaccine candidate ATI-1701 (F. tularensis ΔclpB) is a novel attenuated version derived from the virulent SCHU S4 strain of tularemia. Appili Therapeutics (TSX: APL; OTCQX: APLIF), an infectious disease-focused biotechnology company, holds the world-wide license of the candidate and serves as the sponsor of the product-candidate. In this program, Ology Bio will manufacture the vaccine candidate under Current Good Manufacturing Practice guidelines and perform a safety assessment using a rabbit model.

“Ology Bio is pleased to be working with the DOD and our colleagues at Appili Therapeutics to advance this important new vaccine candidate,” said Dr. Peter Khoury, President and CEO at Ology Bio. “Tularemia remains an important biological threat but to date no licensed vaccine exists to protect against this disease.”

“ATI-1701 is an important part of our anti-infective pipeline program, and we are very grateful for the continued support from DTRA and our partners at Ology Bio to advance this program for the benefit of civilian and military populations,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics.

About Ology Bioservices Inc.

Ology Bio is a privately held, full-service Contract Development Manufacturing Organization (CDMO) serving both government and commercial clients, specializing in biologic drug substance manufacturing from early stage through commercial product. The company has 183,000 square feet of manufacturing, process development and QA/QC space in its state-of-the-art Advanced Development and Manufacturing Facility in Florida. The company’s infrastructure provides unique services to its clients, including full regulatory support from preclinical through licensure, clinical trial operational support and bioanalytical testing, as well as CGMP manufacturing up to Biosafety Level 3 (BSL3). Ology Bio has more than 20 years’ experience developing and manufacturing drugs and biologics for the U.S. government, with over $1.8 billion in government contracts awarded. The team at Ology Bio has decades of experience manufacturing, developing and licensing vaccines and protein/antibody therapeutics. For more information, visit the company’s website at www.ologybio.com.

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 critical disease space. Appili has built a 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, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, the Company is also testing FUJIFILM Toyama Chemical Inc.’s drug favipiravir for the prevention of COVID-19 as a potential prophylaxis treatment. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

About DTRA

The Defense Threat Reduction Agency enables the Department of Defense, the United States Government, and international partners to counter and deter weapons of mass destruction (WMD) and improvised threat networks.

Countering WMD and improvised threats is a global problem that requires DTRA’s unique global presence and execution capabilities. As a Combat Support Agency, DTRA provides various forms of support to the Combatant Commands (CCMDs) and the military services with both defensive and offensive capabilities. The agency is uniquely prepared to address some of the most immediate, consequential, and non-conventional weapon threats to national security through leveraging and expanding collaboration with interagency and international partners.

As the DoD’s research and development leader focused on WMD and improvised threats, DTRA facilitates innovation through combining traditional research with unconventional means to develop and quickly field solutions to the most complex, deadly and urgent threats facing the United States and the rest of the world.

DTRA has over 2,000 uniformed military personnel and DoD civilians working on every continent except Antarctica. The agency has thousands of global engagements in more than 100 countries and in addition to multiple locations stateside and overseas, the agency has liaisons in many embassies.

[The information contained in this press release does not necessarily reflect the position or the policy of the U.S. government and no official endorsement should be inferred.]

Contacts

Ology Bioservices Inc.
Robert V. House, Ph.D.
Senior VP, Government Contracts
301-276-7851
[email protected]

Surgence Communications Strategies
Wendy Crites Wacker, APR, CPRC
352-494-2129
[email protected]