IPA's UpdateSARS-CoV-2 multi-antibody cocktail therapy 2021-11-30 08:01 ET - News Release
Polytope™ Reaches Multiple Milestones and IPA Has Commenced Omicron Variant Analysis
Company Website: https://www.immunoprecise.com
VICTORIA, British Columbia -- (Business Wire)
IMMUNOPRECISE ANTIBODIES LTD. (the “Company” or “IPA”) (NASDAQ: IPA) (TSX VENTURE: IPA) is providing an update on its Polytope™ Development Program. The Company continues to rapidly progress it SARS-CoV-2 multi-antibody cocktail therapy, PolytopeTM, and has met the following milestones:
U.S. Food and Drug Administration assessed IPA’s pre-investigational new drug application; preclinical safety studies have now commenced as previously scheduled.
IPA drafted a pre-investigational new drug (PIND) application and received feedback from the U.S. Food and Drug Administration (FDA). IND-enabling studies have now commenced on schedule with initial IND-enabling data from the studies still expected by the end of 2021. The feedback from the FDA on the PIND file is crucial in preparation for the potential submission to the FDA of a full IND-application, which must be approved by the FDA prior to commencing first-in-human clinical studies.
SARS-CoV-2 PolyTope™ antibody cocktail retains binding efficacy against viral variants-of-concern tested in pre-clinical studies
As stated in prior announcements by IPA, the PolyTope™ strategy is to sustainably combat SARS-CoV-2 and emerging variants, which have the potential to escape protective antibodies via mutations in their antibody-targeted spike protein. IPA’s therapeutic multi-antibody cocktail continues to demonstrate binding to spike proteins of all novel viral variants tested by IPA to date. Recent studies confirm that the PolyTope™ antibody mixture is also resilient to WHO-designated variants-of-concern Lambda (C.37) and Mu (B.1.621). The Company continues to track efficacy of its proprietary antibodies against a number of novel amino acid mutations from emerging variants-of-concern (VoC) designated by WHO.
As with previous variants, IPA has already begun analysing the recent Omicron variant (B.1.1.529) to assess retention of binding to cell associated Omicron spike protein variant.
Protein homogeneity in PolyTope™ antibody cocktail for production purposes has improved
The quality of future clinical production batches was significantly advanced by successful single amino acid substitutions in the variable region of two constituents in the PolyTope™ antibody mixture. Expression of the modified protein backbones yields antibodies resistant to non-functional post-translational modifications. This adaptation will prevent so-called microheterogeneity and is expected to increase the quality and yield of future clinical production batches. The unaltered efficacy of the adjusted antibodies was demonstrated in in vitro virus neutralization experiments and in in vivo experiments involving virus-challenged hamsters.
“Our Polytope program continues to exceed internal expectations and we are cautiously optimistic that it will continue to prove effective against all emerging variants, in particular as our Polytope was conceived with this specific purpose in mind,” stated Dr. Jennifer Bath, IPA CEO and President. “IPA is fully aware of the global importance of the continued advancement of its proprietary cocktail therapy, and we are happy to share the program remains on track.” Dr. Bath added, “FDA feedback on our pre-IND application was very helpful as we entered our pharmacokinetic and toxicological studies and as we continue on our quest to provide a best-in-class COVID therapy.”
In conclusion, IPA has engineered a blend of what the Company believes to be highly active anti-SARS-CoV-2 antibodies comprising a potential COVID-19 therapeutic which have demonstrated in vitro and in vivo efficacy in pre-clinical studies conducted to date against a number of variants of concern. In those studies, the PolyTope therapeutic has not only shown synergistic activity, but also resilience towards viral mutants. Following discussions with the FDA on IPA’s PIND, the PolyTope™ cocktail has entered PIND studies beginning with the determination of acute toxicity in dose-escalation experiments. The PIND studies are expected to end with final toxicology evaluations in January 2022 when the pharmacokinetic analyses, which are planned to commence by mid-December this year, are anticipated to have been completed.