Our History

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Our History

1996

Observed that only viable embryos secrete PIF

1997

Awarded first PIF patent

2001

Established BioIncept, LLC to develop PIF potential

2002-2006

Identified native PIF amino acid sequence; Generated synthetic PIF; Developed anti-PIF monoclonal antibodies

2007

Documented PIF effects: regulate immunity, inflammation and transplant acceptance; Initiated studies in clinically-relevant preclinical models

2008

Developed basic assays to detect PIF in viable embryo culture media and maternal blood; Confirmed PIF’s promoting effect on embryo, endometrium and trophoblast

2009

Gained insight into PIF’s targeted mode of action

2010

Published first-of-series of PIF studies supporting pro-pregnancy effects

2011

Completed FDA-mandated comprehensive toxicology studies: PIF has high safety profile – no toxicity, no side effects observed

2012

Published that PIF is effective in autoimmune and transplant models; Produced (cGMP) PIF human-grade, ready-to-inject for patients in a clinical setting

2013

Awarded FDA Fast-Track Designation for PIF in Orphan Drug Disease therapy; Initiated diagnostic clinical trials for PIF in IVF and maternal blood (NCT01805102, NCT01803893, NCT02222831 and NCT02129998)

2014

Obtained FDA and University IRB approval for FIH (first-in-human) PIF-based therapy; Initiated University-sponsored PIF clinical trial for an ongoing immune disorder

2015

Launched FDA Fast-Track First-in-Human Phase 1 clinical trial to establish sPIF safety (NCT02239562)

2016

Completed Phase 1 clinical trial establishing that sPIF has high safety profile and no toxicity.

2017

Launched parallel Phase 2 trials to assess sPIF efficacy and dosing in humans.