PR91863

BOSTON, Sept. 23, 2021 /PRNewswire=KYODO JBN/ --

BIORCHESTRA is a bio-tech company focused on the identification of novel

targets in neurodegenerative diseases using RNA-based therapeutics. To access

these novel targets, BIOCHESTRA has also developed a proprietary nanoparticle

formulation to deliver RNA-based drugs across the blood-brain barrier in

sufficient amounts to be therapeutically effective. In addition, their

proprietary exosome-based diagnostic that detects and quantifies markers of

neuroinflammation and neurodegeneration facilitates patient selection and

treatment monitoring.

Nonclinical models confirm the relevance of the neuroinflammation and

neurodegeneration pathways targeted by BIORCHESTRA and confirm deep brain

delivery of their proprietary drug, BMD-001, in rodents and primates and

disease models of ALS and Alzheimer's disease.

BIORCHESTRA has been recently recognized for its achievements by Johnson &

Johnson in their Innovation QuickFire Challenge in Neuroscience in June, 2021.

[i] [ii]

Reflecting the success of its research and development programs and

anticipating its international expansion and entry into clinical development,

the BIORCHESTRA has appointed Dr. Louis St.L. O'Dea as its first CMO (Chief

medical officer) in September, 2021. CEO Branden Ryu mentioned "Dr. O'Dea has

successfully has led 14 drugs including sNDA and ANDA, development program,

regulatory interactions and drug approvals at Moderna, Akcea, Serono and

Radius. He is a great fit for BIORCHESTRA having expertise and experience in

all phases of drug development, trial design and execution, regulatory affairs

and RNA. I am more than happy to be developing new drug with such a great

expert Dr. O'Dea. Dr. O'Dea will play key role in overall strategic direction,

planning, execution and interpretation of clinical research, clinical

operations and clinical pharmacology, data management, statistics and

safety/pharmacovigilance for neurodegenerative diseases and mRNA vaccines. This

will be a great opportunity for us to learn how great biotechs such as Moderna

and Ionis(Akcea) have grown, overcome difficulties and develop products. I will

be collaborating closely with Dr. O'Dea." In addition to the responsibilities

listed above, Dr. O'Dea has also joined the Board of Directors of BIORCHESTRA

as of September 2021 and will become President of the North American subsidiary

of BIORCHESTRA.

Dr. O'Dea said "my decision to join BIORCHESTRA was based on the innovative

foundational science, the high social value of the work of BIORCHESTRA in

addressing fatal neurodegenerative diseases, and the quality and commitment of

the people. Hence, the decision to travel over 7,000 miles to Daejeon, South

Korea, to join BIORCHESTRA. I am honored to steer this organization through its

next phase of growth, to deliver life-saving drugs to patients. We will have

the benefit of the best talent available in Boston and Daejeon to deliver on

the promise of BIORCHESTRA's scientific platforms.

Dr. Louis St.L. O'Dea (MB, BCh, BAO, FRCP has worked as CMO in global

pharmaceutical companies such as Serono, Moderna, Akcea (Ionis), Radius and

Oxford Immunotec for 28 years. He has successfully registered 14 NDAs including

NCEs, sNDAs and ANDAs, 5 Orphan drug designations, and 1 medical device

approval in USA, Europe, Canada, and Japan. He has expertise with

RNA(oligo-nucleotides), proteins, peptides, small molecules and route of

administration from numerous new drug development experiences. As CMO and head

of regulatory affairs of Moderna, Dr. O'Dea was a member of the executive team

that attracted research funds from DARPA (Defense Advanced Research Projects

Agency) to initiate the mRNA vaccine program and significant investments from

AstraZeneca and Alexion".

In Akcea Therapeutics (Ionis's subsidiary, developed treatment for rare

diseases using oligonucleotide platform) Dr.  O'Dea served as CMO and Executive

Vice president and registered "WAYLIVRA® (volanesorsen)" in Europe. The Akcea

executive team also successfully completed out-license deals with Novartis (>$1

billion) and Pfizer (>$1 billion) and listed Akcea Therapeutics on the NASDAQ

in 2017.

Dr. O'Dea graduated in Medicine from University College Dublin and did

postdoctoral research at McGill university hospitals, Massachusetts general

hospital/Harvard university, and was a member of the Faculty of Medicine at

McGill before coming to industry. He has published 36 papers, co-authored 11

book chapters, published more than 100 abstracts and filed 3 patent

applications. He also has extensive experience in clinical trials and

regulatory negotiations and meetings in EMA, Japan, Argentina, Australia,

Belgium, Canada, UK, France, Germany, Ireland, Netherlands, Sweden, as well as

the US FDA.

[i]

https://jlabs.jnjinnovation.com/news/biorchestra-named-awardee-in-nyc-innovation-quickfire-challenge-on-neuroscience

[ii]

https://jlabs.jnjinnovation.com/quickfire-challenges/nyc-innovation-quickfire-challenge-neuroscience

Source: BIORCHESTRA Co., Ltd.

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   Caption: Dr. Louis St. L. O'Dea