2024 ANNUAL PROJECTS’ & WORKFLOWS’ REPORT: SHAHIN GHARAKHANIAN MD CONSULTING LLC

November 7, 2024

Report issued: NOV.2024

ACTIVITIES & PROJECTS’ LISTED ALPHABETICALLY BELOW

EXECUTIVE SUMMARY OF 2024 PROJECTS & WORKFLOWS

  1. DECOY Therapeutics, Cambridge MA, USA (acting) Chief Medical Officer & Chair, Scientific Advisory Board comprised of Harvard University Medical School Faculty of Experts, Boston MA.
    • GATES Foundation collaboration pursued in 2024.
    • Corporate development strategy and operations.
  2. PROLANT Health & Biologicals, Aikeny, IA, USA. Medical Executive & Scientific Advisor for clinical trial in Barcelona, Spain. Results published.
  3. Expert keynote presentations, Program Committee chairperson, Publication of Clinical Development Studies.
    • 8th KAPAL: Korean American Professional Association in Life Sciences Annual Conference, Washingtonian Center MD, USA, 1-2 November 2024
    • 8th Boston Paris Biotechnology Summit™, 15 May and 5 June, 2024, Cambridge Innovation Center, Cambridge MA, and International BIO Convention, San Diego CA, USA.
    • Publication of clinical development studies in major peer-reviewed medical journals.

DECOY Therapeutics, Cambridge MA, USA

IMP3ACT:

a novel Alpha-helical Conjugate Technology Discovery Platform for Devolvement of Broad Spectrum Antivirals.

Linhai Jiang1, Chinh Duong1, Janna Sloand1, Barbara Hibner2, Jodi Cooper2, Michael Lipp2, Peter Marschel2, Frederic Pierce2, Shahin Gharakhanian2, Bradly Pentelute2.3

1,2 DECOY Therapeutics Inc., 1JLABS Life Science Incubator (New York City, NY), 2CIC: Cambridge Innovation Center (Cambridge, MA), 3Massachusetts Institute of Technology (Cambridge MA, USA).

A novel type of discovery platform called Immediate Peptide/PPMO/PNA Alpha-helical Conjugate Technology (IMP3ACT) leverages machine learning with physics based in silico computational tools and peptide “coiled-coils” chemistry to design therapeutic α-helical peptides which are cost effective and present structures with increased probability of in vivo results. Applications beyond coronaviruses and paramyxoviruses are now under investigation.

PROLIANT HEALTH & BIOLOGICALS, Ankeny, Iowa, USA

SUMMARY OF CLINICAL TRIALS’ RESULTS

Effective treatment to prevent hospitalization and death in people with COVID‐19 exists, but people still need interventions that alleviate symptoms without drug interactions. Oral serum‐derived bovine immunoglobulins (SBI) may reduce symptoms and time‐to‐improvement in people with mild‐to‐moderate COVID‐19. In this randomized, open‐label, single‐site study, participants with mild‐to‐moderate COVID‐19 received SBI 5.0 g bis in die (BID) + Standard of Care (SOC) or SOC alone (2:1) for 2 weeks. After 2 weeks, 78.8% of hospitalized participants on SBI + SOC improved by World Health Organization (WHO) scale of ≥3 compared to 61.1% on SOC alone (odds ratio: OR = 2.4; p = 0.0663), with older participants (>57 years) showing more significant differences between the arms (OR = 6.1; p = 0.0109). Further, more participants on SBI + SOC reported absence of COVID‐19 symptoms at Week 2 (74.2%) compared to SOC alone (43.6%; OR = 3.7; p = 0.0031), most notably the absence of dyspnea on exertion (OR = 4.4; p = 0.0047), with women exhibiting the most significant eradication of all symptoms (OR = 5.8; p = 0.0080). No difference in change of IL‐6 between arms was observed. Overall, participants with mild to‐moderate COVID‐19 on SBI + SOC had a shorter time‐to‐recovery than on SOC alone, with a significantly higher rate of complete resolution of symptoms. Dyspnea on exertion was the symptom most significantly impacted. For people with mild‐to‐moderate COVID‐19, oral SBI could be a safe and effective intervention, devoid of drug interactions.

PUBLICATIONS OF OUR INTERNATIONAL CLINICAL TRIAL RESULTS:

Utay NS, Güerri‐Fernández R, Gharakhanian S, et al. Serum‐derived bovine immunoglobulin treatment in COVID‐19 is associated with faster resolution of symptoms: a randomized pilot clinical trial. Journal of Medical Virology.

2024; 96:e70005. doi:10.1002/jmv.70005.

CLINICAL TRIAL CONCLUSIONS:

“Our findings of SBI and lessons learned from this study can be retained in designing and operationalizing future clinical trials involving patients with pandemic viral diseases. It has been stated that “final Chapters in treating acute COVID-19 are still unwritten.“ A significant clinical finding in this trial is the potential for hastening resolution of symptoms in people with COVID‐19 using a medical food, safely and without the risk of drug interactions”.

[Please also refer to abstract above]

Targeting GPVI with glenzocimab in COVID-19 patients: Results from a randomized clinical trial

Julien Pottecher1, Francois Raffi2, Martine Jandrot-Perrus3,4, Sophie Binay4, Andrea Comenducci4, Violaine Desort-Henin4, Deborah Francois4, Shahin Gharakhanian4,5, Marilyn Labart4, Adeline Meilhoc4, Elie Toledano4*, Yannick Pletan4, Gilles Avenard4‡, Victor H. Sato 6‡, the GARDEN Investigators¶

  1. Strasbourg University Hospital, UR3072, FHU OMICARE, FMTS, Strasbourg, France, 
  2. Nantes Universite CHU Nantes, INSERM, Department of Infectious Diseases, CIC 1413, Nantes, France,
  3. UMR_S1148 INSERM/Paris University, Paris, France,
  4. Acticor-Biotech, Paris, France,
  5. Shahin Gharakhanian MD Consulting LLC, Cambridge Innovation Center, Cambridge, MA, United States of America,
  6. International Research Center, Hospital Alemão Oswaldo Cruz, Sao Paulo, Brazil

PLOS ONE | https://doi.org/10.1371/journal.pone.0302897 June 17, 2024.

Shahin Gharakhanian MD, Summit International Program Committee Chair
8th BOSTON PARIS BIOTECHNOLOGY SUMMIT™

An exclusive, Trans-Atlantic bridge designed to foster innovative synergies between biotech and pharma companies, healthcare-focused cities, regional clusters and institutional, philanthropic and strategic investors. The Summit’s intent is to spark projects, their financing and strategic deals to solve unmet medical needs to improve patient lives globally.

The 8th Boston Paris Biotechnology Summit™ 2024 had three components:

  1. IN-PERSON I: 15 May 2024 at CIC CAMBRIDGE 02142 MA, USA
  2. LIVE STREAM 15 May 2024 from at CIC CAMBRIDGE 02142 MA, USA, Via a ZOOM PLATFORM.
  3. IN-PERSON II: Business France PANEL DISCUSSION, on 5 June 2025 at the Pavilion de France, International BIO Convention, Exhibition Area, San Diego 92101 CA.

2024 CORE PROGRAM THEME:

BUILDING MECANISMS FOR CUSTOMIZED SUCCESS PLANS.








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