Tularemia

Researchers Publish Manuscript on the Prevention and Emergency Response to Tularemia Outbreaks

Retrieved on: 
Tuesday, March 12, 2024
Infection, Risk, Pharming, United Nations, Manuscript, Weapon, Outline of health sciences, TSX, Therapy, Siege, Drug development, Literature, Safety, Frontiers, Tularemia, FDA, Physician, Vaccine

Appili’s Director of Non-Clinical Research, Dr. Carl Gelhaus, Ph.D., together with medical doctors from the United States Uniformed Services University of the Health Sciences and Ukrainian researchers published a perspective manuscript “ Considerations for prevention of and emergency response to tularemia outbreaks in Ukraine: vaccine involvement ”.

Key Points: 
  • Appili’s Director of Non-Clinical Research, Dr. Carl Gelhaus, Ph.D., together with medical doctors from the United States Uniformed Services University of the Health Sciences and Ukrainian researchers published a perspective manuscript “ Considerations for prevention of and emergency response to tularemia outbreaks in Ukraine: vaccine involvement ”.
  • “Appili has been developing ATI-1701 , a biodefense vaccine, to protect warfighters from tularemia.” said Carl Gelhaus, Ph.D., Director of Non-Clinical Research of Appili Therapeutics.
  • “With the help of our Ukrainian colleagues and U.S. Army physicians, we have assessed the potential risk for tularemia outbreaks in Ukraine, by reviewing the literature of previous wartime outbreaks in Eastern Europe.
  • Many of the conditions for tularemia outbreaks now exist in Ukraine, and their warfighters need protection.

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.

Appili Therapeutics Presents at the 10th International Tularemia Conference

Retrieved on: 
Wednesday, September 27, 2023
Infectious Diseases, Biotechnology, Pharmaceutical, Health, Infection, Partnership, Drug development, Defense Threat Reduction Agency, Tularemia, Government, TSX, United States Department of the Air Force, Conference, Pharmaceutical industry

Appili Therapeutics Inc. (TSX: APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced that Carl Gelhaus, Ph.D., Director of Non-Clinical Research, and key members of Appili’s scientific team, will participate at the 10th International Tularemia Conference, from September 24 to 26, 2023.

Key Points: 
  • Appili Therapeutics Inc. (TSX: APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced that Carl Gelhaus, Ph.D., Director of Non-Clinical Research, and key members of Appili’s scientific team, will participate at the 10th International Tularemia Conference, from September 24 to 26, 2023.
  • Dr. Gelhaus will present an update on Appili’s biodefense vaccine program ATI-1701 .
  • “The International Tularemia Conference is the premier tularemia conference in the world, and we look forward to sharing the progress we have made on ATI-1701 over the past several years and strengthen relationships with leading tularemia clinicians and researchers,” said Dr. Gelhaus.
  • Presentation details are as follows:
    Appili management will also be conducting in-person meetings throughout the conference.

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.

Appili Therapeutics Reports Financial and Operational Results for First Quarter of Fiscal Year 2024

Retrieved on: 
Friday, August 11, 2023
Biotechnology, General Health, Pharmaceutical, Health, Patent, Air force academy, Partnership, PRV, Drug development, Technology transfer, U.S. Department of Defense Strategy for Operating in Cyberspace, Pharming, Bank statement, United States Patent and Trademark Office, International Accounting Standards Board, New Drug Application, Defense Threat Reduction Agency, NDA, Infection, United States Air Force Academy, Research, Government, Metronidazole, DOD, Investigational New Drug, Non-governmental organization, Indian stock exchange, PDUFA, The Last of Us Part I, TSX, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Therapy, Food, Pharmaceutical industry, Security (finance), USAFA, Tularemia

Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced its financial and operational results for the first quarter of its fiscal year 2024, which ended on June 30, 2023.

Key Points: 
  • Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced its financial and operational results for the first quarter of its fiscal year 2024, which ended on June 30, 2023.
  • These achievements are expected to position us with the required resources to continue to make progress in advancing our infectious disease assets."
  • On May 5, 2023, Appili executed an initial cooperative agreement with USAFA the previously announced funding of the ATI-1701 program.
  • This initial funding, in the amount of US$7.3 million, will be used to kick-off ATI-1701 early-stage development and regulatory activities.

Defender Pharmaceuticals Announces Exclusive License Agreement with the U.S. Army for the Development of Products to Treat Tropical Diseases

Retrieved on: 
Monday, July 31, 2023
Q fever, Regulated Activation Networks, United States Army Medical Materiel Agency, Tularemia, Licensure, United States Army Medical Research and Development Command, Chikungunya, Investigational New Drug, Venezuelan equine encephalitis virus, United States Department of the Army, Government, Rift Valley fever, Disease, Pharmaceutical industry, Defender

Medical Research and Development Command (USAMRDC), to develop and commercialize a total of eight products for use against the following tropical diseases: tularemia (rabbit virus); Venezuelan Equine Encephalitis (two formulations); Eastern Equine Encephalitis; Western Equine Encephalitis; Rift Valley Fever; chikungunya and Q Fever.

Key Points: 
  • Medical Research and Development Command (USAMRDC), to develop and commercialize a total of eight products for use against the following tropical diseases: tularemia (rabbit virus); Venezuelan Equine Encephalitis (two formulations); Eastern Equine Encephalitis; Western Equine Encephalitis; Rift Valley Fever; chikungunya and Q Fever.
  • The agreement was entered into on July 25th, 2023 and covers eight investigational vaccines that have been part of the Army’s Special Immunization Program.
  • Under the agreement, USAMMDA will transfer the Investigational New Drug applications for each of the eight products, related data, and biological materials to Defender.
  • Development work on these products will commence once this transfer is complete.

Appili Therapeutics Reports Fiscal Year 2023 Financial and Operational Results

Retrieved on: 
Friday, June 23, 2023
Infectious Diseases, Biotechnology, Pharmaceutical, Health, Taste, Pharming, Social stigma, Defense Threat Reduction Agency, Patent, Patient, Government, R, Ulcer, International Accounting Standards Board, U.S. Department of Defense Strategy for Operating in Cyberspace, Infection, Research, Net, SEDAR, TSX, FDA, Skin, Delays, Cutaneous leishmaniasis, United States Patent and Trademark Office, Scar, Parasitism, Metronidazole, DOD, Non-governmental organization, Fast track (FDA), The Last of Us Part I, Therapy, Accounting, Partnership, PRV, Drug development, Bank statement, USAFA, NDA, United States Air Force Academy, Sale, State, Indian stock exchange, Anthrax, Pharmaceutical industry, Cryptocurrency, Tularemia, IND

Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced its financial and operational results for the fiscal year ended March 31, 2023, and provided an update on the Company’s strategy for fiscal 2024.

Key Points: 
  • Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced its financial and operational results for the fiscal year ended March 31, 2023, and provided an update on the Company’s strategy for fiscal 2024.
  • In May 2023, Appili executed the initial contract with USAFA (the “USAFA Cooperative Agreement”) for the previously announced funding of the ATI-1701 program.
  • Appili has submitted its first invoice for such costs and anticipates receiving payment by the end of June 2023.
  • The Company has included a going concern note in its financial statements for the fiscal year ended March 31, 2023.

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.

Tick-Borne Illness on the Rise Across the U.S.

Retrieved on: 
Monday, May 8, 2023
Environment, Pets, General Health, Health, Children, Family, Consumer, Other Consumer, Disease, Notifiable disease, Public affairs, Lyme disease, Senior, Babesiosis, Lyme, Deer, Tick, Clothing, Tularemia, National Pest Management Association, Anaplasmosis, Multimedia, The Harris Poll, CDC, DEET, Pet, RMSF, NPMA, Vaccine, Rocky Mountains

Notably, there are two tick-borne illnesses on the rise across the nation:

Key Points: 
  • Notably, there are two tick-borne illnesses on the rise across the nation:
    Lyme Disease: is the most common vector-borne disease in the U.S.
  • According to the CDC , nearly half a million Americans are diagnosed and treated for Lyme disease annually.
  • This concerning disease is transmitted by blacklegged (deer) ticks and is often recognized by a red “bull’s eye” rash near the bite site.
  • For complete survey methodology, including weighting variables and subgroup sample sizes, please contact [email protected] .