Award Abstract # 2029723
SBIR Phase I: Immunity Transfer by Magnetic Separation (COVID-19)

NSF Org: TI
Translational Impacts
Recipient: 42BIO, INC
Initial Amendment Date: August 13, 2020
Latest Amendment Date: October 14, 2020
Award Number: 2029723
Award Instrument: Standard Grant
Program Manager: Kaitlin Bratlie
TI
 Translational Impacts
TIP
 Dir for Tech, Innovation, & Partnerships
Start Date: August 1, 2020
End Date: September 30, 2021 (Estimated)
Total Intended Award Amount: $255,993.00
Total Awarded Amount to Date: $255,993.00
Funds Obligated to Date: FY 2020 = $255,993.00
History of Investigator:
  • Isaac Finger-Baker (Principal Investigator)
    ifinger-baker@42bio.com
Recipient Sponsored Research Office: 42BIO, LLC
10203 SW 49TH LN
GAINESVILLE
FL  US  32608-7159
(239)464-6713
Sponsor Congressional District: 03
Primary Place of Performance: 42Bio
747 SW 2nd Ave, IMB 52, Suite 38
Gainesville
FL  US  32601-7164
Primary Place of Performance
Congressional District:
03
Unique Entity Identifier (UEI): J3MJMP8VCF75
Parent UEI:
NSF Program(s): SBIR Phase I
Primary Program Source: 01002021DB NSF RESEARCH & RELATED ACTIVIT
Program Reference Code(s): 053E, 096Z, 6883, 8032, 8038
Program Element Code(s): 537100
Award Agency Code: 4900
Fund Agency Code: 4900
Assistance Listing Number(s): 47.041

ABSTRACT

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project addresses the COVID-19 global pandemic. Recently, transfusions of plasma from recovered COVID-19 patients has shown some efficacy in treatment. This is due to antibodies in the donor plasma that recognize the SARS-CoV-2 virus, boosting the recipient?s immune system to better fight COVID-19. By mixing donor plasma with magnetic particles coated with molecules that can capture these therapeutic antibodies, we will magnetically extract, purify and concentrate these antibodies for use in COVID-19 treatment. This technology can potentially be extended to other diseases as well.

This Small Business Innovation Research Phase I project proposes to develop chemical conjugation strategies and novel magnet arrays capable of isolating large amounts of therapeutic antibody from each unit of plasma. This strategy introduces the potential to harvest large amounts of therapeutic SARS-CoV-2 antibodies from a single recovered COVID-19 patient, enabling treatment of multiple patients from the plasma of one convalescent patient. The antibody-depleted plasma can be returned to the donor, enabling multiple plasma donations without the requirement of permanently removing plasma from the donor. In addition, access to purified antibodies should enable scaling of the therapeutic dose, potentially conferring longer immunity or inducing a more robust immune response in the patient.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

PROJECT OUTCOMES REPORT

Disclaimer

This Project Outcomes Report for the General Public is displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed in this Report are those of the PI and do not necessarily reflect the views of the National Science Foundation; NSF has not approved or endorsed its content.

As of October, 2021, the COVID-19 global pandemic has claimed nearly 5 million lives world-wide. One treatment that has seen widespread use is the transfusion of plasma from COVID-recovered patients to those with the most serious symptoms. While this therapy has no doubt saved many lives, it is not possible to determine the level of antibodies needed to elicit a response as the variability in antibody titer between recovered patients is significant. In addition, there are limitations to the amount of plasma that can be donated by a single recovered patient.

The goal of this project was to develop and test a therapeutic antibody harvesting technology based on conjugating antibodies present in COVID-recovered plasma to magnetic microparticles and magnetically concentrating them for therapy and study. The technology has the potential to enable both scaling of separation to the large volumes required for responding to a global pandemic such as COVID, while also enabling dose-response studies to refine antibody therapies. In addition, by extracting the antibodies, it should be possible to concentrate these therapeutic agents while returning the plasma to the donor, enabling the harvesting of antibodies from multiple plasma draws per patient.

Though there were issues with implementation, this work conducted during this project demonstrated the feasibility of extracting SARS-CoV-2 antibodies using magnetic separation and eluting them from the concentrate for use as a therapeutic agent. The significant advantage of the 42Bio systems is the ability to scale separations for high throughput. This is especially important for responding to a global pandemic such as COVID and these proof-of-concept studies indicate that systems designed to run in parallel can fulfill that need.

While feasibility was demonstrated, several issues were encountered, primarily with particle design and surface chemistry, and the solutions to these issues will require further optimization before commercial launch of the product. Future work at 42Bio will focus on the development of particle surface chemistries that allow for antibody capture in undiluted plasma without fouling of the particles by plasma proteins. In addition, we plan to modify particle strategies to enable rapid response to emerging pathogens in the for of a general particles linker strategy that can be easily modified for capture and concentration of antibodies targeting these pathogens. Further, we will optimize the flow chamber design and develop a modular system so that the principles demonstrated here can be scaled easily and rapidly to specific applications as they arise.

 


Last Modified: 10/29/2021
Modified by: Isaac Finger-Baker

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