- Traditional methods for evaluating therapeutic efficacy and
cardiotoxicity often lead to high failure rates during clinical
trials, resulting in significant development costs
- Human-specific diseases cannot be accurately modeled by
animals, leading to limited medical options or advancements
- This new study leverages the capabilities of artificial
intelligence (AI) and machine learning (ML) to address the
challenge of achieving automated and comprehensive "smart" drug
screening using Medera's mini-Heart technology platform
- Innovative AI/ML-based model combines data from multiple human
mini-Heart screening assays and takes advantage of the
complementary strengths to achieve superior next-generation drug
classification capabilities
- The unique combination of AI/ML and human mini-Hearts can
accelerate drug discovery, clinical translation and precision
medicine by improving screening efficiency, reducing costs,
enhancing safety and creating new opportunities for patient
benefits
SUMMIT,
N.J. and BOSTON,
Mass., Oct. 31, 2024 /PRNewswire/ -- Medera
Inc. ("Medera"), a clinical-stage biotechnology company focused on
targeting difficult-to-treat cardiovascular diseases using a range
of next-generation gene- and cell-based approaches, announced today
the publication of a new study in the peer-reviewed journal
Pharmacological Research (volume 209). This study, entitled
"Enhanced Drug Classification Using Machine Learning with
Multiplexed Cardiac Contractility Assays," demonstrates how
Novoheart, Medera's wholly-owned preclinical subsidiary focused on
human cardiovascular disease modeling for drug discovery, is
leveraging AI and ML to improve next-generation drug screening
processes.
The present work aims to address a long-standing challenge in
the pharmaceutical industry: accurately screening and classifying
drug candidates for their effects on human heart function. By
applying AI-driven automation, the objective is to enhance the
success rates of future clinical trials and ultimately improve
patient benefits by modernizing the drug development process.
Traditional methods for evaluating therapeutic efficacy and
cardiotoxicity often lead to high failure rates (over 90%) during
clinical trials, resulting in development costs that can exceed
$2 billion per drug on average.
Furthermore, human-specific diseases cannot be accurately modeled
by animals, leading to limited medical options or advancements.
Novoheart's present study demonstrates a novel approach utilizing
AI/ML combined with comprehensive functional data from its various
human mini-Heart assays, engineered from human pluripotent stem
cell-derived cardiomyocytes, to create a more predictive and
automated preclinical model of human cardiac responses. This
innovative approach improves the accuracy of drug screening,
promising to increase efficiency, reduce costs, and enhance safety
of developing new drugs, thereby creating opportunities for drug
developers and improving outcomes for patients.
By testing three distinct proprietary engineered human
mini-Heart assays, including our flagship human-heart-in-a-jar,
specialized for measuring different cardiac characteristics, with a
library of known compounds spanning a range of drug classes, the
Novoheart research team generated a robust dataset encompassing
electrophysiology and contractility parameters. The resulting
ensemble AI-based algorithm achieved an impressive 86.2% predictive
accuracy in classifying the effects of unknown compounds,
surpassing prior ML methods for drug classification. This
study is an expansion of the Company's patent-pending, single-assay
ML technology as previously published.
"By harnessing the power of machine learning in our suite of
human-based mini-Heart assays, we are advancing the frontiers of
preclinical drug development," stated Kevin
Costa, Ph.D., Novoheart's Chief Scientific Officer and
co-founder. "This innovation simplifies and improves the cardiac
screening process for both our internal teams, partners and clients
utilizing Novoheart's technology."
"This innovative approach clearly outperforms traditional
single-assay models and aligns with the objectives advocated in the
FDA Modernization Act 2.0," stated Ronald
Li, Ph.D., Medera's CEO and Founder. "The unique combination
of AI/ML with human mini-Hearts can significantly accelerate drug
discovery and screening, reduce costs, and improve precision by
automating the analysis of very complex biological data. It can
minimize the need for animal testing and enhance predictive
toxicology, reducing the risk of late-stage failures, thereby
increasing successes for drug developers and maximizing benefits
for patients. Such a human-based AI approach also promotes
precision medicine (by taking into consideration different genetic
backgrounds or disease mutations) and optimization of formulations,
leading to more effective and marketable therapies and improving
patient safety throughout the drug development process."
This AI/ML-based automation will be made commercially available
via Novoheart's software and hardware platforms. Please direct any inquiries to
sales@novoheart.com.
On September 5, 2024, Medera
and Keen Vision Acquisition Corporation ("KVAC") (Nasdaq:
KVAC, KVACW), 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 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
Forward-Looking Statements
Certain statements included in this press release are not
historical facts but are forward-looking statements for purposes of
the safe harbor provisions under the United States Private
Securities Litigation Reform Act of 1995. All statements other than
statements of historical facts contained in this press release are
forward-looking statements. Any statements that refer to
projections, forecasts or other characterizations of future events
or circumstances, including any underlying assumptions, are also
forward-looking statements. In some cases, you can identify
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performance, future market conditions, or economic performance and
developments in the capital and credit markets and expected future
financial performance, including expected net proceeds, expected
additional funding, the percentage of redemptions of KVAC's public
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operations of certain of Medera's projects, as well as any
information concerning possible or assumed future results of
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statements regarding the expected benefits of the transactions
contemplated by the merger ("Transaction"). The forward-looking
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management teams of Medera and KVAC, as applicable, and are
inherently subject to uncertainties and changes in circumstance and
their potential effects. There can be no assurance that future
developments will be those that have been anticipated. These
forward-looking statements involve a number of risks, uncertainties
or other assumptions that may cause actual results or performance
to be materially different from those expressed or implied by these
forward-looking statements. These risks and uncertainties include,
but are not limited to, (i) the risk that the Transaction may not
be completed in a timely manner or at all, which may adversely
affect the price of KVAC's securities; (ii) the risk that the
Transaction may not be completed by KVAC's business combination
deadline and the potential failure to obtain an extension of the
business combination deadline if sought by KVAC; (iii) the failure
to satisfy the conditions to the consummation of the Transaction,
including the adoption of the Merger Agreement by the shareholders
of KVAC and the receipt of certain regulatory approvals; (iv)
market risks; (v) the occurrence of any event, change or other
circumstance that could give rise to the termination of the Merger
Agreement; (vi) the effect of the announcement or pendency of the
Transaction on Medera's business relationships, performance, and
business generally; (vii) the outcome of any legal proceedings that
may be instituted against Medera or KVAC related to the Merger
Agreement or the Transaction; (viii) failure to realize the
anticipated benefits of the Transaction; (ix) the inability to
maintain the listing of KVAC's securities or to meet listing
requirements and maintain the listing of Medera's securities on
Nasdaq; (x) the inability to implement business plans, forecasts,
and other expectations after the completion of the Transaction,
identify and realize additional opportunities, and manage its
growth and expanding operations; (xi) risks related to Medera's
ability to develop, license or acquire new therapeutics; (xii) the
risk that Medera will need to raise additional capital to execute
its business plan, which may not be available on acceptable terms
or at all; (xiii) the risk of product liability or regulatory
lawsuits or proceedings relating to Medera's business; (xiv)
uncertainties inherent in the execution, cost, and completion of
preclinical studies and clinical trials; (xv) risks related to
regulatory review, and approval and commercial development; (xvi)
risks associated with intellectual property protection; (xvii)
Medera's limited operating history and risk that it may never
successfully commercialise its products; (xviii) Medera expects to
continue to incur significant losses and may never achieve or
maintain profitability; and (xix) the risk that additional
financing in connection with the Transaction may not be raised on
favorable terms. The foregoing list is not exhaustive, and there
may be additional risks that neither KVAC nor Medera presently
knows or that KVAC and Medera currently believe are immaterial. You
should carefully consider the foregoing factors, any other factors
discussed in this press release and the other risks and
uncertainties described in the "Risk Factors" section of KVAC's
Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC
on March 29, 2024, the risks to be
described in the registration statement, which will include a
preliminary proxy statement/prospectus, and those discussed and
identified in filings made with the SEC by KVAC from time to time.
Medera and KVAC caution you against placing undue reliance on
forward-looking statements, which reflect current beliefs and are
based on information currently available as of the date a
forward-looking statement is made. Forward-looking statements set
forth in this press release speak only as of the date of this press
release. Neither Medera nor KVAC undertakes any obligation to
revise forward-looking statements to reflect future events, changes
in circumstances, or changes in beliefs. In the event that any
forward-looking statement is updated, no inference should be made
that Medera or KVAC will make additional updates with respect to
that statement, related matters, or any other forward-looking
statements. Any corrections or revisions and other important
assumptions and factors that could cause actual results to differ
materially from forward-looking statements, including discussions
of significant risk factors, may appear, up to the consummation of
the Transaction, in KVAC's public filings with the SEC, and which
you are advised to review carefully.
Important Information for Investors and Shareholders
In connection with the Transaction, KVAC and Medera filed a
registration statement with the SEC, which includes a
prospectus with respect to the securities to be issued in
connection with the Transaction and a proxy statement to be
distributed to holders of KVAC's common shares in connection with
KVAC's solicitation of proxies for the vote by KVAC's shareholders
with respect to the Transaction and other matters to be described
in the Registration Statement (the "Proxy Statement"). After the
SEC declares the registration statement effective, KVAC plans to
mail copies to shareholders of KVAC as of a record date to be
established for voting on the Transaction. This press release does
not contain all the information that should be considered
concerning the Transaction and is not a substitute for the
registration statement, Proxy Statement or for any other document
that KVAC may file with the SEC. Before making any investment or
voting decision, investors and security holders of KVAC are urged
to read the registration statement and the Proxy Statement, and any
amendments or supplements thereto, as well as all other relevant
materials filed or that will be filed with the SEC in connection
with the Transaction as they become available because they will
contain important information about, Medera, KVAC and the
Transaction.
Investors and security holders will be able to obtain free
copies of the registration statement, the Proxy Statement and all
other relevant documents filed or that will be filed with the SEC
by KVAC through the website maintained by the SEC at www.sec.gov.
In addition, the documents filed by KVAC may be obtained free of
charge from KVAC's website at https://www.kv-ac.com or by directing
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may be accessed through, the websites referenced in this press
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Participants in the Solicitation
KVAC, Medera and their respective directors, executive officers
and other members of management and employees may, under the rules
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proxies in connection with the Transaction. For more information
about the names, affiliations and interests of KVAC's directors and
executive officers, please refer to KVAC's annual report on Form
10-K filed with the SEC on March 29,
2024, which can be found at
https://www.sec.gov/ix?doc=/Archives/edgar/data/1889983/000121390024027973/ea0201104-10k_keenvision.htm
and registration statement, Proxy Statement and other relevant
materials filed with the SEC in connection with the Transaction
when they become available. Additional information regarding the
participants in the proxy solicitation and a description of their
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other relevant materials when they are filed with the SEC when they
become available. Shareholders, potential investors and other
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become available, before making any voting or investment decisions.
You may obtain free copies of these documents from the sources
indicated above.
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This communication shall not constitute an offer to sell or the
solicitation of an offer to buy any securities, nor shall there be
any sale of securities in any jurisdiction in which such offer,
solicitation, or sale would be unlawful prior to registration or
qualification under the securities laws of any such jurisdiction.
No offering of securities in the Transaction shall be made except
by means of a prospectus meeting the requirements of Section 10 of
the Securities Act of 1933, as amended.
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content:https://www.prnewswire.com/news-releases/medera-announces-publication-of-study-utilizing-machine-learning-to-enhance-next-generation-drug-screening-with-human-mini-heart-technology-302292441.html
SOURCE Keen Vision Acquisition Corporation; Medera Inc.
