Francisella tularensis

Aditxt Signs a Definitive Agreement to Acquire Appili Therapeutics Inc., Developer of a Biodefense Vaccine Funded by the U.S. Department of Defense (DoD)

Retrieved on: 
Tuesday, April 2, 2024
Health, Defense, Infectious Diseases, Pharmaceutical, Contracts, Biotechnology, Ulcer, Paromomycin, Patient, NTD, IND, Metronidazole, Francisella tularensis, Infection, OTCQX, Therapy, Priority review, USD, Risk, Systemic, NIH, Anthrax, Arrangement, World Health Organization, Investigational New Drug, Calendar, Scar, Neglected tropical diseases, Tablet, Public, Research, News, PRV, Acquisition, TSX, Drug development, Population health, Cutaneous leishmaniasis, Canada Business Corporations Act, FDA, Transaction, Government, Growth, Entrepreneurship, Skin infection, Share, Procurement, WHO, Pharmaceutical industry

The U.S. FDA's approval of LIKMEZ highlighted Appili’s capacity to identify and develop significant opportunities within the infectious disease domain.

Key Points: 
  • The U.S. FDA's approval of LIKMEZ highlighted Appili’s capacity to identify and develop significant opportunities within the infectious disease domain.
  • Appili licensed the manufacturing and commercialization rights in the U.S. and other selected territories to Saptalis Pharmaceuticals, LLC (“Saptalis”).
  • Appili, in collaboration with Saptalis, continued the product's development, ultimately achieving FDA approval in the United States.
  • With FDA approval, future revenue is expected to be derived from milestone payments and royalties from Saptalis under the license agreement.

Appili Therapeutics Announces Issuance of Patent for ATI-1701 Biodefense Vaccine Candidate to Protect Against Tularemia and Provides Update on Bridge Loan

Retrieved on: 
Friday, December 15, 2023
Infectious Diseases, Biotechnology, Pharmaceutical, Health, Bridge loan, Safety, GMP, Engineering, Therapy, Technology transfer, Toxicology, Acceleration, Tularemia, National Research Council, FDA, Francisella tularensis, Infection, NRC, CMC, Biologics license application, Patent, TSX, Pharming, State, Drug development, Pharmaceutical industry

16/982,322 filed on September 18, 2020 and titled “A Method for Lyophilizing Live Vaccine Strains of Francisella Tularensis”.

Key Points: 
  • 16/982,322 filed on September 18, 2020 and titled “A Method for Lyophilizing Live Vaccine Strains of Francisella Tularensis”.
  • The patent covers the composition and preparation methods for the vaccine through 2039.
  • Appili licensed the biodefense vaccine candidate ATI-1701 from NRC in December 2017.
  • Under the amended terms, the Bridge Loan will now mature on March 31, 2024, subject to acceleration in connection with certain corporate events.

Appili Therapeutics’ Biodefense Vaccine Candidate ATI-1701 is Awarded Additional Funding from the U.S. Air Force Academy

Retrieved on: 
Wednesday, October 25, 2023
Health, Infectious Diseases, Research, Pharmaceutical, Science, Biotechnology, IND, Bioterrorism, Investigational New Drug, Infection, Francisella tularensis, Drug development, Pharming, DTRA, Defense Threat Reduction Agency, Partnership, TSX, Tularemia, Pharmaceutical industry, USAFA

ATI-1701 is the Company’s potential first-in-class vaccine candidate for the prevention of infection with Francisella tularensis, the causative agent of tularemia and a top-priority biothreat.

Key Points: 
  • ATI-1701 is the Company’s potential first-in-class vaccine candidate for the prevention of infection with Francisella tularensis, the causative agent of tularemia and a top-priority biothreat.
  • With this additional 6.6 million award, Appili’s ATI-1701 program has been awarded the total US$14 million in USAFA funding commitments announced on May 8, 2023.
  • In May 2023, Appili was awarded the first stage of funding commitment from USAFA of US$7.3 million.
  • Appili has also entered into an agreement with its lender whereby if needed, Appili has obtained temporary waivers of a minimum cash balance requirement.

T2 Biosystems Receives FDA 510(k) Clearance for the T2Biothreat Panel

Retrieved on: 
Tuesday, September 19, 2023
Ochsner Medical Center, ASPR, Burkholderia pseudomallei, Plague, Emergency, Biomedical Advanced Research and Development Authority, CBRN, Office of Inspector General, U.S. Department of Health and Human Services, HHS, Administration for Strategic Preparedness and Response, Public, Infection, Tularemia, Public Health Service Act, Unitary state, Typhus, Biosafety, Glanders, Yersinia pestis, Government, Melioidosis, Bacillus anthracis, Burkholderia mallei, Development, Administration, Disaster, MRIGlobal, Francisella tularensis, Biological warfare, Public health, Patient, Rickettsia prowazekii, Bacillus, Mortality, FDA, Anthrax, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BARDA, Food, Pharmaceutical industry, Vaccine, Medical device

LEXINGTON, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the T2Biothreat™ Panel.

Key Points: 
  • LEXINGTON, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the T2Biothreat™ Panel.
  • The FDA 510(k) clearance allows the company to immediately begin marketing and selling the T2Biothreat Panel in the U.S. market.
  • The U.S. clinical evaluation to support the FDA 510(k) submission included testing of the T2Biothreat Panel at MRIGlobal, a Biosafety Level 3 laboratory specializing in biothreat pathogens, and Ochsner Medical Center.
  • The T2Biothreat Panel is able to detect the six aforementioned biothreat pathogens within four hours providing clinicians with the needed information to appropriately treat infected patients.

T2 Biosystems Announces FDA 510(k) Submission for the T2Biothreat Panel

Retrieved on: 
Tuesday, May 23, 2023
Burkholderia pseudomallei, Plague, Biomedical Advanced Research and Development Authority, U.S. Department of Defense Strategy for Operating in Cyberspace, Public, Infection, Office of Inspector General, U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Tularemia, Typhus, Glanders, Yersinia pestis, Melioidosis, Bacillus anthracis, Burkholderia mallei, Administration, Development, Francisella tularensis, Biological warfare, Public health, Patient, Rickettsia prowazekii, Bacillus, Mortality, Health, FDA, Anthrax, Regulation of tobacco by the U.S. Food and Drug Administration, BARDA, Food, Vaccine, Pharmaceutical industry

LEXINGTON, Mass., May 23, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the Company’s T2Biothreat™ Panel.

Key Points: 
  • LEXINGTON, Mass., May 23, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the Company’s T2Biothreat™ Panel.
  • The FDA submission follows the recently completed U.S. clinical evaluation that demonstrated very high sensitivity and specificity, and included 350 contrived positive samples and over 470 negative blood samples from both healthy and febrile subjects.
  • "This FDA submission marks an important milestone in our commitment to protect Americans from the threat of deliberate or naturally occurring outbreaks of biothreat pathogens,” stated John Sperzel, Chairman and CEO of T2 Biosystems.
  • The T2Biothreat Panel is able to detect the aforementioned biothreat pathogens within 4 hours and provide clinicians with the needed information to appropriately treat infected patients.

T2 Biosystems Announces Positive Results upon Completion of U.S. Clinical Evaluation for the T2Biothreat Panel

Retrieved on: 
Monday, February 13, 2023
Administration, Francisella tularensis, Anthrax, Office of Inspector General, U.S. Department of Health and Human Services, Tularemia, Burkholderia mallei, Food and Drug Administration, Development, Plague, Patient, Biosafety, BARDA, Clinical trial, Yersinia pestis, Glanders, Food, Health, Melioidosis, Bacillus anthracis, Burkholderia pseudomallei, Mortality, U.S. Department of Defense Strategy for Operating in Cyberspace, MRIGlobal, Typhus, Biological warfare, Biomedical Advanced Research and Development Authority, FDA, Public health, Bacillus, Public, Infection, Administration for Strategic Preparedness and Response, Vaccine, Pharmaceutical industry, Rickettsia

LEXINGTON, Mass., Feb. 13, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced positive results upon completion of the U.S. clinical evaluation for the T2Biothreat™ Panel.

Key Points: 
  • LEXINGTON, Mass., Feb. 13, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced positive results upon completion of the U.S. clinical evaluation for the T2Biothreat™ Panel.
  • “We are extremely pleased with the results of the clinical evaluation.
  • Rapid detection of these pathogens is essential to getting infected patients on the appropriate antimicrobial therapy and improving clinical outcomes.
  • The results of the clinical trial demonstrated very high sensitivity and specificity across all six targets.

Appili Therapeutics Appoints Dr. Carl Gelhaus and Arthur Baran to support the ATI-1701 Biodefense Vaccine Program

Retrieved on: 
Tuesday, January 17, 2023
Biotechnology, Infectious Diseases, Other Health, Health, Pharmaceutical, Infection, Therapy, New product development, TSX, DTRA, Drug development, Conference, Growth, PMP, Research, Francisella tularensis, Pharming, Tularemia, MBA, Pharmaceutical industry, Management

Dr. Gelhaus brings over 20 years of infectious disease and animal model research experience to the role, with an emphasis on tularemia research.

Key Points: 
  • Dr. Gelhaus brings over 20 years of infectious disease and animal model research experience to the role, with an emphasis on tularemia research.
  • Carl has a long history as a research partner with Appili on ATI-1701, including having designed and conducted key animal model efficacy studies for ATI-1701.
  • Arthur Baran brings to Appili more than 22 years of experience in global product manufacturing operations, drug product development team leadership, program management, business development, manufacturing site leadership and quality assurance.
  • “We are fortunate to have both Carl and Arthur join our team at a pivotal time in Appili’s development and growth.

Appili Therapeutics ATI-1701 Biodefense Vaccine Secures ~US$14 Million of Funding from the U.S. Department of Defense in Partnership with the U.S. Air Force Academy

Retrieved on: 
Thursday, November 24, 2022
Biotechnology, Pharmaceutical, Health, Other Health, Negotiation, Public health, Nature, PRV, Infection, Investigational New Drug, Chairperson, IND, Lead, Research, Animal, Failure, Partnership, Death, U.S. Department of Defense Strategy for Operating in Cyberspace, News, Principal investigator, Francisella tularensis, Degenerative disease, Therapy, Anthrax, Priority review, United States Department of Defense, Risk, OTCQX, TSX, Bioterrorism, Government, Documentation, Survival, NIH, Tularemia, DTRA, Drug development, Defense Threat Reduction Agency, FDA, MRIGlobal, Pharming, Pharmaceutical industry, Vaccine, Management, Risk management, USAFA

ATI-1701 is a potential first-in-class vaccine candidate for the prevention of infection with aerosolized Francisella tularensis, a top-priority biothreat.

Key Points: 
  • ATI-1701 is a potential first-in-class vaccine candidate for the prevention of infection with aerosolized Francisella tularensis, a top-priority biothreat.
  • This revised funding represents a 40% increase over the originally anticipated DTRA funding for this program, as announced in February 2022.
  • This funding is expected to strengthen Appilis foundation in infectious disease and biodefense, said Dr. Don Cilla, Pharm.D., M.B.A., Appilis President and CEO.
  • The expected total program funding amount is ~US$14 million, with a portion of the funding subject to future U.S. federal budget approval.

Appili Therapeutics Reports Financial and Operational Results for Second Quarter of Fiscal Year 2023

Retrieved on: 
Thursday, November 10, 2022
Infectious Diseases, Biotechnology, Pharmaceutical, Health, DTRA, International Accounting Standards Board, Infection, Atlas Shrugged: Part I, Pharming, Research, Department, Intention, Therapy, Francisella tularensis, Mission statement, Gram-negative bacteria, Priority review, Net, News, Indian stock exchange, OTCQX, Company, Drug development, Government, Program, Tularemia, Conference, Public health, Bacteria, Patient, Growth, TSX, Death, FDA, Pharmaceutical industry

Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) (the Company or Appili), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced its financial and operational results for the second quarter of its fiscal year 2023, which ended on September 30, 2022.

Key Points: 
  • Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) (the Company or Appili), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced its financial and operational results for the second quarter of its fiscal year 2023, which ended on September 30, 2022.
  • Appili expects this program may be eligible for a Priority Review Voucher (PRV) if approved by the United States Food and Drug Administration (FDA).
  • Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections.
  • Led by a proven management team, Appili is at the epicenter of the global fight against infection.

T2 Biosystems Announces BARDA Exercise of Contract Option 3 Valued at $3.7 Million

Retrieved on: 
Thursday, September 29, 2022
Adoption, Francisella tularensis, Development, Biomedical Advanced Research and Development Authority, Department, Burkholderia mallei, Burkholderia pseudomallei, Assistant, FDA, Food, Office of Inspector General, U.S. Department of Health and Human Services, North Carolina Department of Health and Human Services, BARDA, U.S. Securities and Exchange Commission, Bacillus anthracis, Contract, Health, Private Securities Litigation Reform Act, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Patient, Regulation of tobacco by the U.S. Food and Drug Administration, CEO, Office of the Assistant Secretary for Preparedness and Response, Yersinia pestis, Diagnosis, NASDAQ, GLOBE, SEC, Rickettsia prowazekii, Bloodstream infections, Failure, Pharmaceutical industry, Vaccine

The total potential BARDA funding if all contract options are exercised is $62.0 million, reflecting a reduction in the scope of work under contract option 3.

Key Points: 
  • The total potential BARDA funding if all contract options are exercised is $62.0 million, reflecting a reduction in the scope of work under contract option 3.
  • T2 Biosystems products include the T2Dx Instrument, T2Bacteria Panel, T2Candida Panel, T2Resistance Panel, and T2SARS-CoV-2 Panel and are powered by the Companys proprietary T2 Magnetic Resonance (T2MR) technology.
  • Thus, no one should assume that the Companys silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements.
  • These forward-looking statements should not be relied upon as representing the companys views as of any date subsequent to the date of this press release.