Key Milestones

2023

  • Major General (Ret.) Barbara R. Holcomb Joins Board at Humanetics
  • Dr. Colin Chinn, retired Rear Admiral, joins Humanetics as Chief Medical Officer
  • Humanetics awarded NIH grant to study the use of BIO 300 for the treatment of Idiopathic Pulmonary Fibrosis (IPF)
  • Humanetics awarded contract from the Department of Defense to develop first FDA-approved oral prophylactic drug to prevent ARS
  • Independent Data Safety Monitoring Board recommends continuation of BIO 300 Oral Suspension phase 2 study in COVID long-haul patients

2022

  • Phase 2b protocol clears FDA review for study in non-small cell lung cancer patients undergoing chemoradiotherapy
  • Second oncology indication approved for clinical study by FDA (mitigation of erectile dysfunction in prostate radiotherapy patients)
  • Humanetics adds Jake R. Nunn and Thomas F. Jasper to its Board of Directors
  • Humanetics Awarded $5.1 by U.S. Department of Defense to Develop BIO 300 for use in Autoinjectors
  • Humanetics appoints Douglas W. Bryce to its  Board of Advisors

2021

  • Humanetics adds Karen L. Smith, M.D., Ph.D. and Timothy E. Morris to its Board of Directors
  • BIO 300 awarded Fast Track designation from FDA for use to prevent Acute Radiation Syndrome.
  • Humanetics completes successful Phase 1 trial of BIO 300 Oral Powder in healthy volunteers.
  • Humanetics receives funding from Regenerative Medicine Minnesota to study BIO 300 in triple negative breast cancer.
  • Enrollment begins in Phase 2 study of BIO 300 in COVID-19 patients.

2020

  • Dr. Matthew Nathan, Vice Admiral (ret.) and former Surgeon General of the United States Navy joins the Board of Directors.
  • Humanetics is awarded a grant from the Department of Defense to study BIO 300 in COVID-19 as a post-infection prophylaxis.
  • Humanetics receives funding from NIAID to test BIO 300 in COVID-19 patients.
  • Humanetics acquires the manufacturing assets of DSM related to the active pharmaceutical ingredient in BIO 300.  The purchase encompasses all intellectual property, including patents issued in 14 countries.
  • Dr. Colin Chinn, Rear Admiral (ret.) and former Staff Surgeon and chief medical advisor to the Chairman of the Joint Chiefs of Staff joins Humanetics' Medical Advisory Board.
  • Humanetics is awarded funding from NIAID for Phase 2 study in COVID-19 patients.
  • Humanetics is awarded 5 new patents for BIO 300.

2019

  • Humanetics is awarded a $6.0 million cooperative agreement from the Department of Defense under its Joint Warfighter Medical Research .Program.  This will fund advanced development of BIO 300 for use by warfighters and first responders.
  • Enrollment is completed in the Phase 1b/2a clinical study of BIO 300 in non-small cell lung cancer.
  • Humanetics is awarded 2 new U.S. patents for BIO 300 and received notice of allowance of patents in Israel and Europe.

2018

  • Humanetics is awarded a $5.4 million multi-year grant from the National Institute of Allergy and Infectious Disease to continue development of BIO 300 as a medical countermeasure to mitigate radiation toxicity to the lungs.
  • Vice Admiral Matthew L. Nathan, M.D., former Surgeon General of the U.S. Navy, joins Humanetics' Medical Advisory Board

2017

  • Humanetics is awarded a $125,000 grant from the National Aeronautics and Space Administration to evaluate BIO 300 as a radioprotectant for use in deep space
  • Humanetics is awarded a $3.8 million grant through the Congressionally Directed Medical Research Program of the Department of Defense to develop new forms of BIO 300 that can be used by military personal and first responders
  • Humanetics is invited to present data about BIO 300 as a oral prophylactic drug to prevent acute radiation syndrome in Warfighters at the Military Health System Research Symposium
  • Humanetics is awarded a patent that protects the use of BIO 300 in cancer patients

2016

  • Humanetics is awarded a $150,000 grant from the National Space Biology Research Institute to study BIO 300 for space-like radiation protection
  • Humanetics is awarded a $600,000 SBIR grant from the National Institute of Allergy and Infection Disease to study BIO 300 for mitigation of lung injury as a delayed effect of acute radiation exposure
  • Researchers at the Armed Forces Radiobiology Research Institute receive a three-year $900,000 grant from the Department of Defense to further develop BIO 300 as a medical radiation countermeasure for use by Warfighters 

2015

  • Humanetics begins enrollment in Phase I/II clinical trial in non-small cell lung cancer
  • FDA clears IND 119322 for adjunctive treatment of non-small cell lung cancer with BIO 300

2014

  • Humanetics is awarded a new $225,000 STTR grant from the National Cancer Institute (NCI) to study the protective effects of BIO 300 in a preclinical model of prostate cancer
  • Humanetics receives approval from NCI to enter Phase II of its Fast Track Contract to test the protective effects of BIO 300 on non-small cell lung cancer patient

2013

  • Humanetics is awarded U.S. patent 8,551,530 for a nanoparticle formulation of BIO 300 allowing oral administration

2012

  • Humanetics is awarded a $1.7 million Fast Track Contract from the National Cancer Institute to study BIO 300 as a treatment for patients undergoing chemoradiation treatment for non-small cell lung cancer

2011

  • Humanetics receives a $3.5 million dollar contract from the Biomedical Advances Research and Development Authority to pursue development of BIO 300 as a post-irradiation treatment to prevent pneumonitis and fibrosis of the lung
  • Humanetics receives $333,779 from the Internal Revenue Service under the Qualified Therapeutics Discovery Project for funding of Research & Development

2010

  • Humanetics obtains exclusive rights to develop BIO 700 and BIO 800 for the treatment of Acute Radiation Syndrome and Delayed Effects of Radiation Injury

2009

  • Humanetics receives fourth $2.5 million appropriation from the Department of Defense to fund medical radiation countermeasure programs
  • Humanetics receives $600,000 NIAID Grant to study BIO 600 for Acute Radiation Syndrome

2008

  • Humanetics receives third $2.5 million appropriation from the Department of Defense to fund medical radiation countermeasure programs
  • Humanetics successfully completes Phase I Safety and Pharmacokinetic trial for BIO 300 Oral Capsules in healthy volunteers

2007

  • Humanetics begins Phase I trial for BIO 300 Oral Capsules in health volunteers
  • Humanetics receives first-ever Orphan Drug designation for a medical radiation countermeasure
  • Humanetics receives second $2.5 million appropriation from the Department of Defense to fund medical radiation countermeasure programs

2006

  • Humanetics receives first $2.5 million appropriation from the Department of Defense to fund medical radiation programs
  • Humanetics obtains clearance from FDA to begin clinical studies for BIO 300 under an Investigational New Drug (IND) application

2005

  • Humanetics signs unique Master Research and Development Cooperative Agreement (CRADA) with AFRRI
  • Humanetics obtains Exclusive Worldwide License for BIO 300 Compound for ARS Countermeasure

2003

  • Humanetics begins Collaboration with Armed Forces Radiobiology Research Institute (AFRRI) to discover and develop medical radiation countermeasures