Humanetics Corporation
Humanetics Corporation is a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of proprietary drugs for markets with urgent and unmet needs. The company specializes in radiation modulators for oncology and medical countermeasure uses, with a mission to develop medical countermeasures for warfighters, first responders, and civilians exposed to radiation, as well as therapies for cancer and inflammatory diseases. Humanetics has received significant federal funding and collaborates with public and private research institutions to advance its drug candidates, notably BIO 300, which has applications in radiation protection, cancer treatment, and COVID-19 related lung injury.
Industries
Nr. of Employees
small (1-50)
Humanetics Corporation
Products
Lead clinical-stage small-molecule radiation modulator (oral nanoparticle formulation)
A clinical-stage small-molecule therapeutic formulated as a nanoparticle oral formulation to improve bioavailability. Being developed for multiple indications including mitigation of radiation-induced injury (acute and delayed), adjunctive protection of normal tissues during radiotherapy for solid tumors, and mitigation of inflammatory pulmonary injury.
Lead clinical-stage small-molecule radiation modulator (oral nanoparticle formulation)
A clinical-stage small-molecule therapeutic formulated as a nanoparticle oral formulation to improve bioavailability. Being developed for multiple indications including mitigation of radiation-induced injury (acute and delayed), adjunctive protection of normal tissues during radiotherapy for solid tumors, and mitigation of inflammatory pulmonary injury.
Services
Sponsor-led development including IND filings, protocol design, clinical trial execution (Phase I–II), safety and PK assessments, and regulatory engagement for therapies targeting radiation injury, oncology adjunctive use and inflammatory lung disease.
Formulation engineering, nanoparticle oral formulation development, process development for manufacturing and development of delivery forms compatible with autoinjectors and other systems.
Sponsor-led development including IND filings, protocol design, clinical trial execution (Phase I–II), safety and PK assessments, and regulatory engagement for therapies targeting radiation injury, oncology adjunctive use and inflammatory lung disease.
Formulation engineering, nanoparticle oral formulation development, process development for manufacturing and development of delivery forms compatible with autoinjectors and other systems.
Expertise Areas
- Clinical trial management
- Regulatory affairs (IND submissions, FDA interactions, Fast Track designation)
- Medical countermeasure development for CBRN threats
- Formulation and CMC development
Key Technologies
- Nanoparticle-based oral formulation for poorly soluble small molecules
- Small-molecule radiation modulators
- Autoinjector-compatible drug formulation
- Preclinical animal models for radiation-induced injury (pulmonary and systemic)
News & Updates
Supporting the development of BIO 300 for the prevention of Acute Radiation Syndrome.
Supporting the development of BIO 300 for COVID-19 related lung injury.
Funding to support further development of BIO 300 as a radiation countermeasure.
Study showing BIO 300's efficacy in protecting lung tissue during radiation therapy.
Research comparing BIO 300 to Neulasta® showing its protective effects.
BIO 300 Receives Fast Track Designation from FDA
Expedited review process granted by FDA for BIO 300 as a radiation countermeasure.
Supporting the development of BIO 300 for the prevention of Acute Radiation Syndrome.
Supporting the development of BIO 300 for COVID-19 related lung injury.
Funding to support further development of BIO 300 as a radiation countermeasure.
Study showing BIO 300's efficacy in protecting lung tissue during radiation therapy.
Research comparing BIO 300 to Neulasta® showing its protective effects.
BIO 300 Receives Fast Track Designation from FDA
Expedited review process granted by FDA for BIO 300 as a radiation countermeasure.