Medera and Singapore’s Cardiovascular Disease National Collaborative Enterprise Launch Asia's First Cardiac Gene Therapy Trial for Heart Failure

• Medera and Cardiovascular Disease National Collaborative Enterprise (CADENCE) announce the initiation of Asia's first cardiac gene therapy clinical trial for heart failure, with Singapore being the first and only site outside of the United States (US).
• Heart failure is a global pandemic with an estimated 64.3 million cases worldwide. Asian patients tend to present with heart failure at a younger age (<15-20 years) compared to those in the Western population.
  
• Having received an Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA), Medera’s SRD-001, an adeno-associated virus (AAV)-based gene therapy candidate, is intended to treat patients with heart failure with reduced ejection fraction (HFrEF), which accounts for half of all heart failure cases worldwide.
  
• This site initiation of Singapore as the first outside of the U.S. for the multi-centre trial of SRD-001 also marks the first collaboration between Singapore’s two national heart centres, namely National Heart Centre, Singapore (NHCS) and National University Heart Centre, Singapore (NUHCS), and Tan Tock Seng Hospital, to jointly conduct a gene therapy trial for heart failure.

SINGAPORE and BOSTON, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Medera Inc. (“Medera”), a clinical-stage biotechnology company focused on targeting difficult-to-treat or incurable cardiovascular diseases using a range of next-generation gene- and cell-based approaches, and The Cardiovascular Disease National Collaborative Enterprise (CADENCE) of Singapore are pleased to announce the initiation of Asia’s first cardiac gene therapy clinical trial for heart failure in Singapore. Singapore is the first and only site selected outside of the United States (US) where the trials have been ongoing.

Heart failure is a global challenge with 64.3 million patients worldwide. Singapore, or Asia in general, is facing a particularly high burden. About 2.5% of Singaporeans aged 60 years old or above have heart failure¹. The condition is often the result of ischaemic heart disease, which contributes to around 20% of deaths in Singapore². Asian patients also tend to present with heart failure at a younger age (<15-20 years) than those in the Western population, and often with more severe conditions which require intensive care, longer length of hospital stay, and a higher hospital mortality rate³.

Having received an Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA), SRD-001, developed by Medera’s subsidiary Sardocor, is intended to treat patients with heart failure with reduced ejection fraction (HFrEF), a prevalent form of heart disease that accounts for half of all heart failure cases worldwide. A clinical update of the ongoing MUSIC-HFrEF (NCT0470384) Phase 1/2a trial of SRD-001 in the U.S. was featured in a late-breaking presentation at the American Society of Gene & Cell Therapy (ASGCT) in May 2024. The Phase 1/2a trial is expected to complete its enrollment, followed by an interim data readout and the randomized Phase 2b in 2025.

Medera’s Sardocor has also obtained IND clearances, as well as Fast Track Designation (SRD-002; NCT06061549)³ and Orphan Drug Designation (SRD-003; NCT0622466)⁴, for heart failure with preserved ejection fraction (HFpEF, which accounts for the remaining half of all HF cases) and Duchenne muscular dystrophy-associated cardiomyopathy, respectively.

SRD-001/2/3 employ an adeno-associated virus (AAV)-based vector system, delivered directly to cardiac ventricular muscle cells via Sardocor’s proprietary intracoronary infusion system. Furthermore, clinical dosages have been optimised by the human mini-Heart® technology developed by Novoheart, a pre-clinical subsidiary of Medera, in accordance with the FDA Modernisation Act 2.0. On November 21, 2023, the National Heart Centre Singapore (NHCS) announced a strategic partnership with Novoheart to develop Asia’s first bioengineered human heart-in-a-jar with heart failure for precision medicine⁵. An Agency for Science, Technology and Research (A*STAR) award of $5 million has been granted to foster this partnership.

The MUSIC-HFrEF trial in Singapore involves the country’s two national heart centres, namely NHCS and National University Heart Centre, Singapore (NUHCS), and Tan Tock Seng Hospital.

Roger Hajjar, MD, President and co-founder of Medera, expressed enthusiasm about the initiation of the Singapore clinical site, "Medera and Sardocor are very excited to initiate the Singapore clinical site as the first outside of the US, by deploying this cutting-edge technology for the first time ever to Asian heart failure patients. Sardocor’s unique regulated intracoronary delivery methodology is a minimally invasive procedure that targets the heart directly, designed to minimise drug dosage and therefore side-effects while preserving efficacy. While the Singapore trial’s initial focus is on congestive heart failure, this foundation will enable subsequent expansion to other cardiac indications."

Adding to the significance of this trial, Derek Hausenloy, MBBS/PhD, Executive Director of CADENCE, and Director of the National Heart Research Institute Singapore at NHCS, remarked, "The launch of the SRD-001 trial in Singapore is a landmark moment for cardiovascular cell and gene therapy research in Asia. It underscores our commitment to integrate cutting-edge research and technologies to combat cardiovascular diseases. By bringing together the best of our national research capabilities and expertise, we aim to pave the way for innovative treatments that can significantly improve patient outcomes. This trial not only highlights Singapore’s position as a leader in cardiovascular research but also showcases our potential to contribute to the global fight against heart failure."

“Medera is extremely delighted to partner with Singapore’s cardiac experts in its first precision medicine efforts in Asia to comprehensively cover important areas from mini-Heart®-based drug discovery all the way to clinical gene therapy starting with SRD-001 for the benefit of the large number of Asian heart patients,” said Ronald Li, PhD, CEO and co-founder of Medera.

“We are pleased that Medera is setting yet another milestone in further expanding its international footprints. I am confident that the potential merger between KVAC and Medera will provide a platform for efficiently assessing capital from global markets thereby accelerating the various exciting clinical programs for heart patients worldwide,” said Kenneth KC Wong, Chairman and CEO of KVAC.

On September 5, 2024, Medera and Keen Vision Acquisition Corporation ("KVAC"), announced they had entered into a definitive merger agreement.

About Medera
Medera (www.medera.bio) is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat or currently incurable diseases with significant unmet needs, utilizing next-generation gene and cell-based approaches in combination with bioengineered human-based technology (including the mini-Heart platform). Medera operates via the two preclinical and clinical business units, Novoheart and Sardocor, respectively.

Novoheart capitalizes on the world’s first and award-winning “mini-Heart” Technology for revolutionary disease modelling and drug discovery, uniquely enabling the modelling of human-specific diseases and discovery of therapeutic candidates free from species-specific differences in accordance to the FDA Modernization Act 2.0. Novoheart's versatile technology platform provides a range of state-of-the-art automation hardware and software as well as screening services, for human-specific disease modelling, therapeutic target discovery and validation, drug toxicity and efficacy screening, and dosage optimization carried out in the context of healthy and/or diseased human heart chambers and tissues. Global pharmaceutical and academic leaders are using Novoheart's technology platform their drug discovery and development purposes. The Novoheart platform has facilitated and accelerated the development of Sardocor's lead therapeutic candidates that are currently in clinical trials.

Sardocor is dedicated to the clinical development of novel next-generation therapies for Medera. Leveraging Novoheart’s human-based drug discovery and validation platforms, Sardocor aims to expedite drug development and regulatory timelines for its gene and cell therapy pipeline. Sardocor has received Investigational New Drug (IND) clearances from the FDA for three ongoing AAV-based cardiac gene therapy clinical trials targeting Heart Failure with Reduced Ejection Fraction (HFrEF), Heart Failure with Preserved Ejection Fraction (HFpEF) with the Fast Track Designation, and Duchenne Muscular Dystrophy-induced Cardiomyopathy (DMD-CM) with the Orphan Drug Designation. Additionally, Sardocor's pipeline includes four preclinical gene therapy and three preclinical small molecule candidates targeting various cardiac, pulmonary, and vascular diseases.

About CADENCE
Established in February 2023, the Cardiovascular Disease National Collaborative Enterprise (CADENCE) is a national clinical translational programme aimed at synergising cardiovascular research and technology capabilities across Singapore.

Its goal is to integrate existing research capabilities, and bring together the strongest basic, clinical, and translational talent and expertise across Singapore and institutions, to establish a focused and impactful national cardiovascular disease research and translational programme with world-class peaks of excellence.

To achieve this, CADENCE has established four national joint platforms focused on data science, clinical trials, and artificial intelligence/digital health, together with a business intelligence and development unit to attract industry collaborations/external investments.

CADENCE is a programme of the Consortium for Clinical Research and Innovation, Singapore (CRIS). CADENCE is supported by the Singapore Ministry of Health through the National Medical Research Council (NMRC) Office, MOH Holdings Pte Ltd under the NMRC RIE2025 National Clinical Translational Programme Funding Initiative (MOH-001277).

For more information, please visit https://cadence-cvd.sg

Forward-Looking Statements
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Contacts:

Investor Relations
Stephanie Carrington
ICR Healthcare
Stephanie.Carrington@icrhealthcare.com
(646) 277-1282 

Media Relations
Sean Leous
ICR Healthcare
Sean.Leous@icrhealthcare.com
(646) 866-4012

¹ SingCLOUD Data 2012-2021.
² https://www.moh.gov.sg/resources-statistics/singapore-health-facts/principal-causes-of-death
³ https://www.ktalnews.com/business/press-releases/ein-presswire/688652471/mederas-sardocor-announces-fast-track-designation-and-dosing-of-3-patients-in-first-in-human-hfpef-gene-therapy-trial/
⁴ https://www.kxan.com/business/press-releases/ein-presswire/691834036/mederas-sardocor-granted-fda-orphan-drug-designation-for-cardiomyopathy-secondary-to-dmd-associated-cardiomyopathy/
⁵ https://www.singhealthdukenus.com.sg/news/research/national-heart-centre-singapore-partners-mederas-novoheart-to-develop-asias-first-bioengineered-human-heart-in-a-jar-with-heart-failure-for-precision-medicine

11/19/2024 08:34 -0500

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