Free safety testing of exploratory COVID-19 medications and SARS-COV-2 vaccine formulations | InSphero

In the race to find therapeutic agents to treat COVID-19

Repurposing approved drugs and identifying novel treatment modalities for COVID-19

Worldwide, numerous urgent initiatives have been started with the aim to repurposing approved drugs for the treatment of COVID-19. Hopefully, this fast-track approach will serve to cure affected patients in the near future, as clinical safety of this approved drugs has already been demonstrated. In addition, research teams in industry and academia are unleashing many antiviral drug development programs to identify new treatment modalities (e.g., RNA-based vaccines) or develop novel therapeutic viral targets.

The InSphero COVID-19 Safety Testing Initiative

To join the fight against the COVID-19 pandemic, InSphero has decided to support these efforts by providing free access to our 3D in vitro liver toxicology platform for the assessment of drug induced liver injury (DILI) as part of the preclinical risk assessment. New therapeutic modalities, such as RNA based vaccines are not always suitable for classical safety testing, which typically includes translational testing using animal models. InSphero’s 3D in vitro human liver models can mimic liver function for up to four weeks in the lab. These co-culture models, comprised of primary human hepatocytes and NPCs (which are important for capturing the immune response), represent the smallest functional unit of a human liver and are highly predictive for identifying safety hazards. Our testing technology is fast (typically, a three week turnaround) to ensure drug development programs move forward swiftly and offer a new, efficient way to test novel modalities as well as classical compounds.

Key benefits of InSphero long-term DILI safety testing

The InSphero 3D InSight™ Liver Toxicology Platform is well suited for hepatotoxic risk assessment of most therapeutic agents relevant to the treatment of COVID-19. Here's why:

 

  • Human cell-based models
  • Biological relevant. 3D InSight™ Human Liver models mimic human liver function for up to four weeks in the lab
  • Highly predictive in identifying safety hazards
  • Fast turnaround times (typically within three weeks) to ensure drug development programs proceed swiftly
  • Suitable for testing viral disease-combating modalities as well as classical small molecule compounds, such as recombinant, polysaccharide, or nucleic-acid-based antigen vaccines (based on results of our internal R&D pilots)

Who is eligible?

This offer is directed globally to any pharmaceutical or biotech industry as well as academic, governmental or NGO research entity engaging in drug/vaccine development programs targeted to treat and foster immunity against COVID-19

What are we offering?

Long term toxicity testing on 3D InSight™ Liver Microtissues with most therapeutic agents. A full concentration response is assessed using human liver microtissues, composed of primary human hepatocytes and NPCs (primarily Kupffer cells), conferring innate immunity. Three repeated treatments are provided over a period of 14 days to mimic chronic exposure. For more information, click on the links below:

 

Per program, each project order is limited to max. 3 test items of the above indicated therapeutic classes. Timing is at InSphero’s discretion, with fastest turn around possible (approx. 3-4 weeks). Due to the current situation, we cannot offer a processing guarantee of your samples at this time.

What do you get?

  • Measurement of ATP levels after 14 days of exposure
  • Measurement of LDH release (marker for membrane damage) at three timepoints
  • Concentration response curve for 7 concentrations, positive control (chlorpromazine)
  • Written report summarizing results

What you need to provide

Maximum of 3 (three) test items per program, dissolved at 200x max. dosing concentration, provided in screw cap tubes.

  • Small molecules should be delivered in 100% DMSO solutions, other solvents possible upon requests (e.g., for antibodies or ASOs)
  • Volume 50-100 μl
  • Please note that neither volatile substances nor powders will be accepted.

Terms and Conditions of this COVID-19 Safety Testing Offer

    1. InSphero covers full cost of testing, including handling, data analysis and reporting
    2. Requests are served on a first come first served basis
    3. This offer is subject to availability and can be terminated at any time
    4. InSphero cannot guarantee execution of testing as circumstances due to Corona outbreak may prohibit to maintain lab services due to governmental lockdown decree or supply shortage
    5. InSphero has no interest in participating on potential future revenues related to tested drug candidates (no IPR, license fees or other payments)
    6. All information regarding customer relationship, compound specifications and experimental data will be handled strictly confidential. Experimental data are owned by the project partner
    7. Partner allows InSphero to list its organization name as member of the Covid-19 DILI initiative
    8. InSphero shall under no circumstances be liable for direct or indirect damage or loss of any kind, including any contract penalties which the Partner may have to pay to a third party, nor for the Partner's operating loss, time loss, lost supplies or similar losses.
    9. The Partner shall indemnify and hold harmless InSphero from and against any and all third party losses, claims, damages, or liabilities, to the extend caused by, arising from or in connection with (i) any use, including but not limited to clinical trials, or sale or transfer by the Partner to any third party or any product or information provided by InSphero to the Partner under these Terms & Conditions, or (ii) any use or storage by InSphero of any materials supplied by the Partner to InSphero under these Terms & Conditions.
    10. Force majeure: InSphero shall not be liable for failing or delayed fulfilment of supplies if the cause is force majeure, such as fire, government intervention or intervention by other public authorities, strike, lockout, export and/or import bans, vandalism, currency restrictions, delayed and/or defective supplies from subcontractors or any other cause beyond the control of InSphero.

Start testing your COVID-19 therapeutics with InSphero

Please download and complete this application form to sign up for our COVID-19 Drug Testing initiative.

March 24, 2020