Shahin Gharakhanian MD Consulting LLC 2022 ANNUAL PROJECTS REPORT

January 3, 2023

[ACTICOR-BIOTECH, Paris, France] US Medical Executive @ Acticor-Biotech

ACTISAVE Study – ClinicalTrials.gov Identifier: NCT05070260. Adaptive Efficacy and Safety Study of Glenzocimab Used as an add-on Therapy on Top of Standard of Care un the 4.5 Hours Following an Acute Ischemic Stroke (ACTISAVE)

DECOY Therapeutics, Cambridge, MA, USA

Chairman, Scientific Advisory Board Chair

Prevention of Covid-19 Transmission Beyond the Needle: DCOY101, a novel antiviral fusion peptide-based prophylactic nasal spray.

Barbara Hibner, Peter Marschel, Frederick E. Pierce II, Shahin Gharakhanian*

*Research & Development Program Team, **Scientific Advisory Board,

DECOY Therapeutics, CAMBRIDGE MA, USA. [Contact: bhibner@decoytx.com].

ABSTRACT

Introduction: Covid-19 is a global health crisis with specific local features. This pandemic has revealed the complexities of global infection control involving age-driven infection patterns, levels of awareness, high viral variations, changes to vaccine immune response over time, social media, the heterogeneity of social responses and medical co-morbidities. A “one-size-fits-all” approach has proven insufficient. Vaccines are the backbone, but gap analysis points to the need for additional agents.

Methods/Results: We are developing a broad antiviral bioconjugate platform. Our lead candidate is a novel antiviral fusion peptide-based prophylactic nasal spray. DCOY101, a 41 amino acid heptad repeat C-based peptide, has been engineered to enhance half-life and target respiratory tissue. (1) DCOY101 lipopeptide inhibited S-mediated SARS-CoV-2 fusion (IC50=10nM/IC90~100nM) in 293T cells expressing ACE2 (mBio, 2020; 11:e01935). (2) DCOY101 inhibited live virus in monolayer Vero E6 cultures via a plaque neutralization assay (IC50=6nM). (3) DCOY101 enabled a 4-log reduction in viral load in a human airway epithelial ex vivo model. (4) DCOY101 is equipotent vs alpha, beta and gamma variants in a pseudotype assay. (5) Based on a close analogue, POC nasal drops QDx4 days demonstrated prophylaxis in a validated ferret transmission model, preventing infection in treated ferrets (0/6 infected) co-housed with a maximally infected ferret. All mock treated animals (6/6) became infected (de Vries RD et al., Science 2021, 371: 1379-1382).

Conclusion: Multiple prophylactic and population-friendly approaches are required to control Covid-19. DCOY101 can complement vaccines with advantages in manufacturing, self-administration, shelf life and no requirement for a cold supply chain.

[REFERENCE: Vaccine Summit 2021 Washington DC, USA, 20-21 Sept Vol. 1, #1, p57.]

PROLIANT Health & Biologicals, Aikeny, IA

Scientific Advisor.

● Evaluating the Impact of EnteraGam in People with COVID-19 (PICNIC Study)

PICNIC Study – ClinicalTrials.gov Identifier: NCT0468204

S Gharakhanian HIV MEDICINE PUBLICATIONS IN 2022

Gharakhanian S, De Wit S, [Editorial]

Hypogonadism in HIV Infection – Time to Fine-Tune Clinical Monitoring of Persons Living With HIV? AIDS 2022, 36:1197–1199.

Gharakhanian S, [Editorial]

Evolution of weight and BMI during the course of HIV infection: historical perspective and challenges. AIDS 2022, 36:2217–2219.