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8 BioPharm International eBook October 2020 www.biopharminternational.com optimizing the production process and manufacturing AT-100 at CGMP levels for clinical study (21). Biotech firm ILC Therapeutics is developing two separate novel t herapies t hat may potent ia lly treat COVID-19 patients prior to them needing ventilators (22,23). The company has a patented new Interferon-Alpha subtype, desig- nated as Interferon Alpha 14, that can potentially prevent COVID- 19-induced ARDS. ILC formed a collaboration with the University of St. Andrews to progress devel- o p m e nt o f t h i s t h e r a p e u t i c , wh ic h it ha s na med A l fac y te. The second therapeutic is being developed (in collaboration with Professor Shoumo Bhattacharya at the University of Oxford) from Ev a si n s - mole c u le s, wh ic h a r e derived from ticks. These Evasins- molecules have the potential to end an immune overreaction that is damaging to the lungs. Meanwhile, GigaGen, a biotech- nology company, has highlighted in a recent study a novel technol- ogy for producing a new class of drugs, named recombinant hyper- immunes, which it is developing for a potential COVID-19 therapeu- tic candidate (24). Recombinant hyperimmunes are polyclonal anti- bodies that are derived from donor B cells from convalescent serum. GigaGen's potential drug candidate, GIGA-2050, is a mixture of 12,500 anti-coronavirus antibodies and it has a similar result to recombinant convalescent serum. The results of the company's study showed that GIGA-2050 demonstrated a greater IgG purity compared to other refer- ence plasma-derived drugs and had 100x more protective attributes that high-titer COVID-19 convalescent plasma. The study also showed a potential for the drug candidate to have broad efficacy because it binds to a variety of natural SARS CoV-2 variants as well as the predecessor, SARS CoV (24). REFERENCES 1. S.M. Hahn, "The Path Forward: Coronavirus Treatment Acceleration Program," www.fda.gov, April 20, 2020. 2. FDA, "FDA Covid-19 Response at a Glance Summary as of September 25, 2020," www.fda.gov, Sept. 25, 2020. 3. FDA, Guidance for Industry, Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment (CDER, CBER, September 2020). 4. Humanigen, "Humanigen Announces Lenzilumab in COVID-19 Program Updates," Press Release, Oct. 2, 2020. 5. Humanigen, "Humanigen Announces Thermo Fisher Partnership to Expand Manufacturing for COVID-19 Therapeutic Candidate Lenzilumab," Press Release, Sept. 23, 2020. 6. Humanigen, "Humanigen and Lonza Announce Collaboration to Expand Manufacturing of Humanigen's COVID- 19 Therapeutic Candidate Lenzilumab," Press Release, Sept. 15, 2020. 7. Humanigen, "Humanigen Expands Partnership with Catalent Biologics to Manufacture Investigational COVID-19 Therapeutic Candidate Lenzilumab," Press Release, July 16, 2020. 8. Ajinomoto Bio-Pharma Services, "Ajinomoto Bio-Pharma Services Signs Manufacturing Agreement with Humanigen for Lenzilumab, Currently in FDA-Approved Phase III Study for COVID-19," Press Release, May 27, 2020. 9. Eusa Pharma, "EUSA Pharma and the Papa Giovanni XXIII Hospital, Bergamo, Italy Announce Initiation of an Observational Case-Control Study of Siltuximab in Patients with COVID- 19 Who Have Developed Serious Respiratory Complications," Press Release, March 18, 2020. 10. Eusa Pharma, "EUSA Pharma and Papa Giovanni XXIII Hospital, Italy, Provide Interim Analysis Data for Siltuximab- treated COVID-19 Patients from the SISCO Study," Press Release, April 1, 2020. 11. Eusa Pharma, "EUSA Pharma Announces FDA Approval of Phase 3 Clinical Trial for Siltuximab in Hospitalized Patients with COVID-19 Associated Acute Respiratory Distress Syndrome," Press Release, July 2, 2020. 12. Eli Lilly and Company, "Lilly Begins World's First Study of a Potential COVID-19 Antibody Treatment in Humans," Press Release, June 1, 2020. 13. Eli Lilly and Company, "Lilly and Amgen Announce Manufacturing Collaboration for COVID-19 Antibody Therapies," Press Release, Sept. 17, 2020. 14. Amgen, "Amgen and Adaptive Biotechnologies Announce Strategic Partnership to Develop a Therapeutic to Prevent or Treat COVID-19," Press Release, April 2, 2020. 15. Regeneron Pharmaceuticals, "Regeneron Announces Manufacturing and Supply Agreement for BARDA and US Department of Defense for REGN- COV2 Anti-Viral Antibody Cocktail," Press Release, July 2020. 16. Roche, "Roche and Regeneron Collaborate to Significantly Increase Global Supply of REGN-COV2 Investigational Antibody Combination for COVID-19," Press Release, Aug. 19, 2020. 17. Regeneron, "Regeneron's REGN-COV2 Antibody Cocktail Reduced Viral Levels and Improved Symptoms in Non- Hospitalized Covid-19 Patients," Press Release, Sept. 29, 2020. 18. AstraZeneca, "Phase I Clinical Trial Initiated for Monoclonal Antibody Combination for the Prevention and Treatment of COVID-19," Press Release, Aug. 25, 2020. 19. S.J. Zost, et. al., Nature 584, 443–449 (2020). 20. HHS, "Trump Administration Expands Collaboration with AstraZeneca to Develop and Manufacture an Investigational Monoclonal Antibody to Prevent COVID-19," Press Release, Oct. 9, 2020. 21. Airway Therapeutics, "Airway Therapeutics and Celonic Group Collaborate to Produce AT-100aAs Promising New Candidate for Coronavirus," Press Release, May 20, 2020. 22. BioPharm International, "UK Biotech Discovers Two Novel Treatments for COVID-19 Patients," biopharminternational.com, April 30, 2020. 23. BioPharm International, "ILC Therapeutics Enters Research Agreement with University of St. Andrews," biopharminternational.com, June 25, 2020. 24. GigaGen, "GigaGen Announces Publication of Research Describing a New Class of Drugs, Recombinant Hyperimmunes, Including its Novel COVID-19 Therapy, GIGA-2050," Press Release, Aug. 10, 2020. BP Regulatory Sourcebook Pandemic Response Sponsors should establish their list of key indentifying symptons from a list of common COVID- 19-related symptoms provided by the CDC.