Immunotherapeutic PolyTope® from ImmunoPrecise (IPA) Potently Neutralizes the SARS-CoV-2 Omicron Variant – Moves Towards FDA/IND-Submission
- During in vitro pseudovirus assays, IPA’s PolyTope® advanced immunotherapeutic TATX-03 prevents infection of cells by SARS-CoV-2 variant-of-concern, Omicron, and all variants of concern tested to date.
- On January 27, 2022, Talem Therapeutic LLC, a wholly owned subsidiary of IPA, filed a non-provisional US patent application and concurrent PCT (Patent Cooperation Treaty) international and other national patent applications, relating to the discovery of PolyTope TATX-03, its in vitro and in vivo effects, and therapeutic use.
Figure 1. Demonstration of Potent Neutralization Efficacy for IPA’s PolyTope TATX-03 Against Pseudoviruses of Prominent Variants of Concern, Including Omicron. (Graphic: Business Wire)
January 31, 2022 07:02 AM Eastern Standard Time
VICTORIA, British Columbia–(BUSINESS WIRE)–IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the “Company”) (NASDAQ: IPA) (TSXV: IPA) is pleased to announce the release of data demonstrating strong neutralizing potency of its PolyTope® TATX-03 antibody cocktail towards the SARS-CoV-2 Omicron variant (B.1.1.529) in in vitro pseudovirus assays. This first generation four antibody cocktail against SARS-CoV-2 was rationally designed to sustain efficacy against all SARS-CoV-2 strains and variants with the goal of protecting and treating all individuals. The Company believes that it possesses the only first-generation cocktail therapy against SARS-CoV-2 (first publicly announced 2020) that has been demonstrated to retain efficacy against every variant of concern to date through in vitro pseudovirus assays conducted with respect to such variants of concern. PolyTope TATX-03 is unique in its ability to engage multiple modes of action, facilitated through simultaneously targeting various non-overlapping epitopes on the spike trimer.
“Our enduring position is clearly supported today as the Omicron variant, with its unusually large number of mutations, cannot escape the efficacy of our well-conceived cocktail”
The Company expects that, upon completion of its ongoing studies, the aforementioned data will enable the Company to file an Investigational New Drug (“IND”) application in accordance with its internal schedule previously announced on November 30, 2021. The approval of the U.S. Food and Drug Administration (FDA) with respect to the IND application will be required prior to commencing any first-in-human clinical studies.
With the ongoing threat of COVID-19 and rising concerns from the frontlines about the effectiveness of existing vaccines and antibody therapies, IPA’s Polytope® antibody cocktail continues to demonstrate promising efficacy during studies conducted by the Company, even when tested against newly emerged variants. New data from IPA reveals remarkable consistency in the ability of PolyTope TATX-03 antibody cocktail to retain its potent and complete in vitro neutralization against all variants, as demonstrated with Omicron pseudovirus reinforced with neutralization data against the wild-type parental virus (Wuhan) and all predominant variants of concern (see Figure 1 above).
The Company’s PolyTope TATX-03 antibody cocktail was developed to target multiple, non-overlapping epitopes on the spike trimer, reducing the risk of mutagenic escape, and facilitating engagement of mechanisms of action that are collectively distinctive from other SARS therapies obtainable to date.
The previously observed high viral clearance efficacy of TATX-03 in SARS-CoV-2-D614G-challenged hamsters implied a concerted action of the respective antibodies. Apart from anti-viral effects resulting from blocking host cell infection via synergistic effects, the demonstrated ability of TATX-03 to simultaneously bind to four different regions of the spike trimer is anticipated to promote viral clearance by the host’s immune system. Recently obtained in vitro studies support this role of antibody-mediated clearance via activation of the Fcγ-receptors, cell surface receptors involved in antibody-dependent cellular cytotoxicity (ADCC) and phagocytosis (ADCP). As Fc receptor engagement of the fully human antibodies of PolyTope TATX-03 is expected to be even more efficient in humans compared to hamsters, the previously demonstrated potent in vivo efficacy in the hamster SARS-CoV-2 challenge model may even be an underestimation.
On January 27th, 2022, Talem Therapeutics LLC, a wholly owned subsidiary of IPA, filed for patent protection of its PolyTope® TATX-03 antibody cocktail via the PCT (Patent Cooperation Treaty) system (which has 154 member states) as well as national filings in the US, Taiwan, Argentina, and Paraguay, enabling IPA to pursue patent protection of the PolyTope TATX-03 cocktail in all sizeable potential markets. In the meantime, the PolyTope TATX-03 final IND-enabling studies are expected to conclude as scheduled.
At the request of the FDA, IPA has prepared a comprehensive status update demonstrating the performance of PolyTope TATX-03 toward Omicron, and other variants of concern listed in Figure 1, for FDA review. Meanwhile, the Company is also compiling a data package to seek rapid scientific advice from the EMA (European Medicines Agency). Finally, the latest data on Omicron and alternative mechanisms of action of PolyTope TATX-03 has been processed for inclusion in IPA’s updated scientific paper “Cornering an Ever-Evolving Coronavirus: TATX-03, a Fully Human, Synergistic, Multi-Antibody Cocktail Targeting the SARS-CoV-2 Spike Protein with in vivo Efficacy” (https://doi.org/10.1101/2021.07.20.452858) and the Company expects to publish an extended version on bioRxiv in the coming weeks.
“Today’s news is yet another exciting milestone as we continue to validate the significance of generating sustainable and meaningful therapies based on well comprehended scientific principles. It is amazing to consider how far we have come from two years ago, when we clarified why IPA was (and why others should be) concerned about the potential for viral variants to emerge, to today, owning what we believe is the only remaining first generation therapy to have retained strong efficacy against all tested variants of concern”, stated Dr. Jennifer Bath, IPA CEO and President.
“In stark contrast to most companies, large and small, we could replace today’s quote with any PolyTope quote from the past 24 months and it would remain just as relevant. From day one, our scientific team chose a path of rigorous investigation to arrive at a diverse set of functional therapeutic antibodies and we did not sacrifice quality”, continued Dr. Bath, concluding “Our enduring position is clearly supported today as the Omicron variant, with its unusually large number of mutations, cannot escape the efficacy of our well-conceived cocktail”.
