Keen Vision Acquisition Corporation (Nasdaq: KVAC, KVACW) and Medera Inc., a clinical-stage biotechnology company, announced today that they have entered into a definitive merger agreement. Upon closing of the merger, which is expected to occur in the fourth quarter of 2024, the combined company is to be named Medera Inc.
Company Overview
Medera Inc. is a clinical-stage biopharmaceutical company, focused on targeting difficult-to-treat and currently incurable diseases by developing next-generation gene- and cell-based approaches in combination with bioengineered human-based (including the exclusively available mini-Heart®) screening technology platform for disease modeling and drug discovery. Medera operates through its two business units, Sardocor and Novoheart.
Sardocor executes clinical development of novel next-generation therapies for Medera. Leveraging the Novoheart human-based drug discovery and validation platforms, as described below, Sardocor aims to expedite the drug development and regulatory timelines for its gene therapy and cell therapy pipeline. Sardocor has been granted Investigational New Drug (IND) clearances from the US Food and Drug Administration (FDA) for three ongoing adeno-associated virus (AAV)-based cardiac gene therapy clinical trials for Heart Failure with Reduced Ejection Fraction (HFrEF), Heart Failure with Preserved Ejection Fraction (HFpEF) and Duchenne Muscular Dystrophy-induced Cardiomyopathy (DMD-CM). In addition, Sardocor’s pipeline also includes four preclinical gene therapy and three preclinical small molecule candidates for a range of cardiac, pulmonary and vascular diseases.
Sardocor is currently focused on its three most advanced clinical programs, which are AAV-based gene therapy candidates:
- SRD-001 is intended to treat patients with HFrEF, a prevalent form of heart disease that accounts for half of an estimated 64.3 million heart failure cases worldwide. With an open IND clearance from the FDA, SRD-001 is being evaluated in an ongoing Phase 1/2a clinical trial (called MUSIC-HFrEF; NCT0470384). To date, six patients have been infused with SRD-001 in Cohort A (low-dose 3×1013 vg per patient) and one patient has been infused in Cohort B (high-dose 4.5×1013 vg per patient). A clinical update of this trial was featured in a late-breaking oral presentation at the American Society of Gene & Cell Therapy (ASGCT) in May 2024. Clinically meaningful improvements in multiple metrics of heart function and patient health were observed following delivery of SRD-001 (e.g., NYHA class, 6MW, LVEF and pro-BNP). Sardocor expects to complete the Phase 1/2a portion of the ongoing trial in the fourth quarter and commence an international randomized Phase 2b portion shortly after.
- SRD-002 is intended to treat patients with HFpEF, another prevalent form of heart failure accounting for the remaining half of all heart failure cases that currently still lack disease-modifying therapeutics. With an open IND and Fast Track Designation from the FDA, SRD-002 is being evaluated in an ongoing First-In-Human Phase 1/2a clinical trial (called MUSIC-HFpEF; NCT06061549). To date, five patients have been infused with SRD-002 in Cohort A (low-dose 3×1013 vg per patient) and Sardocor has been cleared to dose patients in Cohort B (high-dose 4.5×1013 vg per patient). Improvements in cardiovascular performance were observed in the first three patients at six months with additional data being collected. Sardocor expects to complete patient enrolment in both cohorts of the Phase 1/2a clinical trial by the end of 2024 and to provide an interim data readout in the first half of 2025.
- SRD-003 is intended to treat patients (aged 18 or above) with DMD-CM, for which there is still no cure. Almost all DMD patients eventually die from DMD-CM. With the FDA’s IND clearance and Orphan Drug Designation, SRD-003 is currently being evaluated in an ongoing First-In-Human Phase 1/2a clinical trial (called MUSIC-DMD; NCT06224660). Sardocor expects to dose the first patient in the fourth quarter of 2024.
Using its proprietary intracoronary infusion methodology, Sardocor delivers its gene therapy candidates directly via blood vessels to the cardiac ventricular muscle cells as an out-patient procedure. This minimally invasive technique allows the delivery of optimal and least amount of drug products to achieve efficient transduction and improved efficacy while avoiding side effects (such as those typically seen with systemic delivery of very large AAV doses).
With its proprietary, award-winning human mini-Heart® screening technology platform, Novoheart conducts preclinical disease modelling and drug discovery for Medera, aiming to create, expand, validate, and optimize Medera’s therapeutic pipeline (under Sardocor). 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. These are free from species-specific differences and in 3D configurations that accurately reflect the native human heart’s physiology or pathophysiology. These properties substantially improve success rates and reduce development cost and time in accordance with the FDA Modernization Act 2.0. 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 and regulatory approvals of Sardocor’s lead therapeutic candidates that are currently in clinical trials.
Management Comments
“Medera is uniquely positioned for sustainable growth with its one-of-a-kind technology platform and a broad portfolio of clinical and preclinical candidates, three of which are leading gene therapy candidates with ongoing FDA clinical trials. In line with FDA’s Modernization Act 2.0, Medera’s use of its bioengineered human-based technology in drug discovery and development processes promotes more accurate drug testing and fewer animal killings, which are environmentally and socially responsible. Medera’s collaboration and licensing arrangements now in place with global pharmaceutical leaders provide validation for its achievements,” remarked Kenneth KC Wong, Chairman and Chief Executive Officer of KVAC.
“Achieving a Nasdaq listing will allow Medera to be better positioned for advancing our various clinical and preclinical programs, enabling more efficient development aimed at bringing novel therapeutic solutions to patients with unmet needs,” stated Ronald Li, PhD, Chief Executive Officer and Founder of Medera.
“With this business combination, Sardocor will be well positioned to potentially expediate its three clinical trials for our lead gene therapy candidates in HFrEF, HFpEF and DMD-CM. By utilizing our intra-coronary methodology to directly deliver our gene therapy candidates into the heart, our approach has the potential to significantly lower the dosage compared other therapies that typically utilize systemic delivery. We also plan to accelerate our timetable to apply for an Investigational New Drug (IND) and the start of the Phase 1 trial for our next gene therapy candidate,” said Roger Hajjar, MD, President, Chief Medical Officer and co-Founder of Medera.
Transaction Overview
This merger values Medera at a pre-money valuation of $622.6 million. Cash proceeds from the transactions contemplated by the merger agreement may consist of up to approximately $149.50 million of cash currently held in KVAC’s trust account (before any redemptions by KVAC’s stockholders).
The transaction includes a management incentive plan that the parties intend to tie to the successful commercialization of the three clinical stage assets, reflecting an alignment of interest with shareholders
The transaction, which has been unanimously approved by the each of the boards of directors of KVAC and Medera, is subject to, among other customary closing conditions, approval by the shareholders of KVAC and of Medera, with the holders of a majority of the votes of both companies required to approve the transaction having provided commitments to approve the transaction. The transaction is expected to close in the fourth quarter of 2024.
A more detailed description of the transaction terms and a copy of the merger agreement will be included in a current report on Form 8-K to be filed by KVAC with the United States Securities and Exchange Commission (the “SEC”). A registration statement (which will contain a proxy statement/ prospectus) will be filed with the SEC in connection with the transaction.
About Keen Vision Acquisition Corporation
Keen Vision Acquisition Corp (“KVAC”), listed on Nasdaq, is a blank check company incorporated for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. KVAC is focused on biotechnology, consumer goods or agriculture opportunities, which are also evaluated on their sustainability, environmental, social, and corporate governance (“ESG”) imperatives. EF Hutton LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, are serving as Capital Markets Advisors for KVAC.
www.kv-ac.com
About Medera Inc.
Medera is a clinical-stage biopharmaceutical company focused on eradicating difficult-to-treat cardiovascular diseases with significant unmet needs, using a range of next-generation gene- and cell-based approaches in combination with bioengineered human-based technology (including mini-Heart®) platform. Medera operates via two business units Sardocor and Novoheart.
www.medera.bio
