Shahin Gharakhanian MD Consulting LLC, Year 2021 Selected Activities’ Summary Report.

January 6, 2022

[ACTICOR-BIOTECH, Paris, France] US Operations’ Collaboration

[Press Release] November 4, 2021 at 06:30 pm CET – ACTICOR BIOTECH (ISIN: FR0014005OJ5 – ALACT), a clinical stage biotechnology company involved in the acute phase of thrombotic diseases, today announces that the U.S Food and Drug Administration (FDA) has provided clearance for the initiation of a clinical trial in US with glenzocimab, a novel humanized monoclonal antibody fragment, for use in patients with acute ischemic stroke. This active IND represents a significant milestone and marks the launch in the US of the Phase 2/3 clinical trial with glenzocimab in acute ischemic stroke as an add-on therapy to standard of care for this indication.

“The development of new therapeutic options for the treatment of the acute phase of ischemic stroke without increasing the bleeding risk, is a major medical need of the coming years. The FDA acceptance of an IND application for glenzocimab and the clinical program that will be conducted by Acticor Biotech in the US constitute important steps to offer new safe treatments to stroke patients” says Pr. James Grotta, M.D., Memorial Hermann Hospital, Texas Medical Center, and Global Coordinating Investigator for ACTISAVE.

“We are very pleased with the achievement of this milestone which materializes our clinical objective stated at the time of our IPO which took place a few days ago, to enroll a first US patient in Q1 2022, following the enrollment of a first patient in Europe at at the end of September 2021” concluded Gilles Avenard, Chief Executive Officer of Acticor Biotech.

PRIX GALIEN MEDSTARTUP 2021 FOR COLLABORATION WITH A US MEDICAL INSTITUTION

November 8, 2021

Shahin Gharakhanian had the honor to accept on behalf of ACTICOR-BIOTECH – the PRIX GALIEN MEDSTARTUP 2021 – Award in the «collaboration» category recognizing joint work with the Memorial Hermann Hospital in Houston, Tx. Ceremony held at the Alexandria Life Sciences Center in New York 28 Oct. 2021. We are developing Glenzocimab, a humanized monoclonal antibody fragment, in Stroke and other thromboembolic conditions within internal medicine and infectious diseases indications.

[PROLIANT Health & Biologicals, Aikeny, IA] Scientific Advisor.

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

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.

[DECOY Therapeutics, Cambridge, MA] Scientific Advisory Board Chair

Utay, N. S., Asmuth, D. M., Gharakhanian, S., Contreras, M., Warner, C. D., & Detzel, C. J. (2021).

Potential use of serum-derived bovine immunoglobulin/protein isolate for the management of COVID-19. Drug Development Research, 1–7.

https://doi.org/10.1002/ddr.21841

ABSTRACT

COVID-19 manifests as a mild disease in most people but can progress to severe disease in nearly 20% of individuals. Disease progression is likely driven by a cytokine storm, either directly stimulated by SARS-CoV-2 or by increased systemic inflammation in which the gut might play an integral role. SARS-CoV-2 replication in the gut may cause increased intestinal permeability, alterations to the fecal microbiome, and increased inflammatory cytokines. Each effect may lead to increased systemic inflammation and the transport of cytokines and inflammatory antigens from the gut to the lung. Few interventions are being studied to treat people with mild disease and prevent the cytokine storm. Serum derived bovine immunoglobulin/protein isolate (SBI) may prevent progression by (1) binding and neutralizing inflammatory antigens, (2) decreasing gut permeability, (3) interfering with ACE2 binding by viral proteins, and (4) improving the fecal microbiome. SBI is therefore a promising intervention to prevent disease progression in COVID-19 patients.