- Heart failure is a global pandemic with an estimated 64.3
million cases worldwide, costing over US$100B per year
- Heart failure with preserved ejection fraction (HFpEF)
accounts for nearly half of all heart failure cases, but has
limited disease-modifying therapeutics
- Promising efficacy results in cardiovascular performance
observed in Cohort A (low-dose SRD-002) at six months with
additional data being collected
- Initiated dosing patients in Cohort B (high-dose SRD-002)
following recommendation of the DSMB
SUMMIT,
N.J. and BOSTON,
Oct. 24,
2024 /PRNewswire/ -- Medera Inc. today announced that
its clinical-stage gene therapy subsidiary, Sardocor Corp., has
successfully completed its Cohort A (low-dose). Following the
recommendation of the Data Safety Monitoring Board (DSMB), dosing
has begun for patients in Cohort B (high-dose). This Phase 1/2a
clinical trial evaluates the first-in-human cardiac gene therapy
candidate SRD-002 for the treatment of Heart Failure with Preserved
Ejection Fraction (HFpEF).
"New treatment approaches, like Medera's gene therapy product,
are critical for patients and caregivers faced with this
devastating disease," stated Marat Fudim, MD, MHS, Advanced Heart
Failure Specialist and Associate Professor at Duke University Medical Centre and site principal
investigator. "We look forward to continuing this critical research
in the second cohort."
"The progression of MUSIC-HFpEF, with dosing underway in the
second cohort, is a key milestone in the clinical development of
our gene therapy candidate SRD-002 as a potential effective
treatment for HFpEF patients, who still have significant unmet
needs," said Roger Hajjar, MD,
President and co-founder of Medera. "SRD-002 has been well
tolerated with no unexpected events or toxicities observed and
promising efficacy results observed in some patients in Cohort A at
the six-month mark, with additional data being collected and
analysed. We expect to complete enrolment in the second cohort in
the first quarter 2025, with an interim data readout anticipated in
the first half of 2025."
MUSIC-HFpEF is an open-label, dose-escalation, 52-week clinical
trial designed to evaluate the safety and tolerability, as well as
preliminary efficacy, of SRD-002 in patients diagnosed with HFpEF.
SRD-002, a gene therapy candidate utilizing an adeno-associated
virus (AAV) vector carrying the cardiac isoform of the sarcoplasmic
reticulum calcium ATPase pump (SERCA2a), is administered via
Sardocor's proprietary one-time intracoronary infusion methodology.
The role of SERCA2a, in relaxation has been demonstrated by
Novoheart (a subsidiary of Medera which develops cardiac tissue
engineering technology for disease modelling and drug discovery) in
their first-of-a-kind bioengineered human mini-Heart HFpEF models,
co-developed with AstraZeneca as previously
announced. Delivery of SRD-002 in the human mini-Heart HFpEF
models leads to improved relaxation defects as published.
Human mini-Heart models have also been used to optimise dosages.
These data were used to support our Fast Track Designation (FTD)
for MUSIC-HFpEF obtained from the FDA, in accordance to the
Modernization Act 2.0.
In Cohort A, five patients were infused with SRD-002 at the low
dose of 3x10^13 vg per patient. Following the DSMB's recommendation
to proceed, investigators are currently enrolling the next five
patients in Cohort B, evaluating SRD-002 at the high dose of
4.5x10^13 vg per patient.
For additional information about the MUSIC-HEpEF trial, visit
ClinicalTrials.gov using the study identifier NCT06061549.
On September 5, 2024, Medera and
Keen Vision Acquisition Corporation ("KVAC") (Nasdaq: KVAC, KVACW)
announced they had entered into a definitive merger
agreement.
About HFpEF
Heart failure (HF) is a global pandemic with an estimated 64.3
million cases worldwide and a rising prevalence trend. Accounting
for 50% or more of the overall HF population, HFpEF is an
age-related condition that has become increasingly prevalent in
recent years. This surge is partly due to better awareness and
identification of the condition and partly due to lifestyle changes
affecting cardiac myocytes. Individuals affected by HFpEF
experience similar morbidity and mortality to patients with HF with
reduced ejection fraction (HFrEF). Despite the growing epidemic of
this emerging syndrome, HFpEF-focused interventional trials have
had little success, except for the use of sacubitril-valsartan
(Entresto™) and the sodium glucose transporter-2 (SGLT-2) inhibitor
empagliflozin (Jardiance™) for reducing cardiovascular mortality
and heart failure hospitalization. However, these agents are not
disease-modifying, highlighting the critical need for therapeutic
interventions targeting the physiological mechanisms involved in
HFpEF.
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.
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
forward-looking statements by words such as "estimate," "plan,"
"project," "forecast," "intend," "expect," "anticipate," "believe,"
"seek," "strategy," "future," "opportunity," "may," "target,"
"should," "will," "would," "will be," "will continue," "will likely
result," "preliminary," or similar expressions that predict or
indicate future events or trends or that are not statements of
historical matters, but the absence of these words does not mean
that a statement is not forward-looking. Forward-looking statements
include, without limitation, KVAC's, Medera's, or their respective
management teams' expectations concerning the outlook for their or
Medera's business, productivity, plans, and goals for future
operational improvements and capital investments, operational
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
shareholders, growth prospects and outlook of Medera' operations,
individually or in the aggregate, including the achievement of
project milestones, commencement and completion of commercial
operations of certain of Medera's projects, as well as any
information concerning possible or assumed future results of
operations of Medera. Forward-looking statements also include
statements regarding the expected benefits of the transactions
contemplated by the merger ("Transaction"). The forward-looking
statements are based on the current expectations of the respective
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
a request to info@kv-ac.com. The information contained on, or that
may be accessed through, the websites referenced in this press
release is not incorporated by reference into, and is not a part
of, this press release.
Participants in the Solicitation
KVAC, Medera and their respective directors, executive officers
and other members of management and employees may, under the rules
of the SEC, be deemed to be participants in the solicitations of
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
direct and indirect interests, which may, in some cases, be
different than those of KVAC's shareholders generally, will be
included in the registration statement and the Proxy Statement and
other relevant materials when they are filed with the SEC when they
become available. Shareholders, potential investors and other
interested persons should read the registration statement and the
Proxy Statement and other such documents carefully, when they
become available, before making any voting or investment decisions.
You may obtain free copies of these documents from the sources
indicated above.
No Offer or Solicitation
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.
View original
content:https://www.prnewswire.com/news-releases/medera-announces-completion-of-cohort-a-and-initiation-of-dosing-in-cohort-b-of-music-hfpef-a-phase-12a-clinical-trial-evaluating-first-in-human-gene-therapy-srd-002-for-heart-failure-with-preserved-ejection-fraction-302285414.html
SOURCE Keen Vision Acquisition Corporation; Medera Inc.
