eFFECTOR Therapeutics, Inc., a leader in the development of
selective translation regulation inhibitors (STRIs) for the
treatment of cancer, today announced that the first patient has
been dosed in a Phase 1b trial evaluating zotatifin (eFT226) as an
antiviral agent in an outpatient setting for those with mild to
moderate COVID-19 disease. This study is sponsored by a $5.0
million cooperative agreement from the Defense Advanced Research
Projects Agency (DARPA) and Defense Health Agency (DHA) and is
being conducted in collaboration with the Quantitative Biosciences
Institute (QBI) at University of California, San Francisco (UCSF).
“Rising cases of COVID-19 due to emerging variants and lack of
vaccination in far too many people highlight the need for more
effective therapies,” said Steve Worland, Ph.D., president and CEO
of eFFECTOR. “We believe that positive clinical data from this
trial would support continued development of zotatifin as an
antiviral treatment for SARS-CoV-2 and its emerging variants, such
as the Delta variant, as well as potential future coronavirus
strains that may emerge for which vaccines will be unavailable.
Furthermore, by targeting a human protein required for viral
replication, known as a host protein, zotatifin is expected to be
less susceptible to resistance arising from viral mutations than
approaches directed against virus-encoded proteins, such as
nucleosides or protease inhibitors.”
The Phase 1b trial is a double-blind, randomized dose escalation
trial in non-hospitalized patients ages 18-65 with mild to moderate
COVID-19. Primary endpoints of the study include safety and
tolerability of zotatifin in patients with COVID-19. Secondary
endpoints include antiviral activity as assessed by mean change in
viral load over time and time to viral load undetectability, as
well as time to clinical resolution. Zotatifin will initially be
administered in two intravenous (IV) infusions one week apart.
eFFECTOR recently concluded toxicology and pharmacokinetic studies
demonstrating comparable exposure and safety between IV and
subcutaneous administration of zotatifin and anticipates
transitioning to subcutaneous administration, which is more
conducive to treatment in an outpatient setting.
An independent international study published in Nature and led
by Nevan Krogan, Ph.D., professor, Department of Cellular and
Molecular Pharmacology and director of the Quantitative Bioscience
Institute at UCSF, identified zotatifin’s antiviral activity
against SARS-CoV-2 in in vitro studies. Subsequent in vitro studies
confirmed that zotatifin had selective antiviral activity with
approximately 10-fold greater potency than Remdesivir, the current
standard of care for treating patients with COVID-19 with an
antiviral agent, and more than 100-fold greater potency than
AT-511, the free base form of AT-527, an agent currently in Phase 3
development as a direct-acting SARS-CoV-2 antiviral treatment.
Further, in vitro studies have shown that zotatifin has potent
antiviral activity across all unique coronavirus subtypes tested,
including SARS-CoV-2, SARS-CoV-1, MERS-CoV and CoV-229E.
About Zotatifin (eFT226)Zotatifin is a potent
and sequence-selective inhibitor of eukaryotic translation
initiation factor 4A (eIF4A) mediated translation. eIF4A is
responsible for unwinding complex structures in the non-coding 5’
untranslated region of messenger RNA. Zotatifin is designed to
inhibit the translation of mRNAs encoding several important
oncogenes and survival factors, including receptor tyrosine kinases
(RTKs), KRAS, Cyclin D, CDK4/6 and MYC. In vivo studies have shown
potent tumor regression in multiple tumor models dependent on these
factors, including non-small cell lung cancer (NSCLC) and breast
cancer. Since zotatifin inhibits the translation of mRNA in the
non-coding region of mRNAs, it is not limited to specific KRAS
activating mutation subtypes such as KRAS G12C or KRAS G12D.
Zotatifin is currently being evaluated as an IV infusion in a Phase
1/2 clinical trial in patients with solid tumors and in a Phase 1b
clinical trial in patients with mild to moderate COVID-19
infections pursuant to grant sponsorship by DARPA.
Please visit www.propelcovidclinicaltrial.com or
www.clinicaltrials.gov for further information on ongoing clinical
studies of zotatifin.
About QBIThe Quantitative Biosciences Institute
(QBI) fosters collaborations across the biomedical and the physical
sciences, seeking quantitative methods to address pressing problems
in biology and biomedicine. Motivated by problems of human disease,
QBI is committed to investigating fundamental biological
mechanisms, because ultimately solutions to many diseases have been
revealed by unexpected discoveries in the basic sciences. Learn
more at qbi.ucsf.edu.
About UCSFThe University of California, San
Francisco (UCSF) is exclusively focused on the health sciences and
is dedicated to promoting health worldwide through advanced
biomedical research, graduate-level education in the life sciences
and health professions, and excellence in patient care. It includes
UCSF Health, which comprises three top-ranked hospitals, as well as
affiliations throughout the Bay Area. Learn more at
https://www.ucsf.edu.
UC DisclaimerThe information stated above was
prepared by eFFECTOR and reflects solely the opinion of the
corporation. Nothing in this statement shall be construed to imply
any support or endorsement of eFFECTOR, or any of its products, by
The Regents of the University of California, its officers, agents
and employees.
About eFFECTOR TherapeuticseFFECTOR is a
clinical-stage biopharmaceutical company focused on pioneering the
development of a new class of oncology drugs referred to as
selective translation regulator inhibitors. eFFECTOR’s STRI product
candidates target the eIF4F complex and its activating kinase,
mitogen-activated protein kinase 1/2 (MNK 1/2). The eIF4F complex
is a central node where two of the most frequently mutated
signaling pathways in cancer, the PI3K-AKT and RAS-MEK pathways,
converge to activate the translation of select mRNA into proteins
that are frequent culprits in key disease-driving processes. Each
of eFFECTOR’s product candidates is designed to act on a single
protein that drives the expression of multiple functionally related
proteins, including oncoproteins and immunosuppressive proteins in
T cells, that together control tumor growth, survival and immune
evasion. eFFECTOR’s lead product candidate, tomivosertib, is a MNK
1/2 inhibitor currently being evaluated in KICKSTART, a randomized,
double-blind, placebo-controlled Phase 2b trial of tomivosertib in
combination with pembrolizumab in patients with metastatic NSCLC.
Zotatifin, eFFECTOR’s inhibitor of eIF4A, has recently completed
the dose-escalation portion of a Phase 1/2 trial, and is now
progressing into Phase 2a indication-specific expansion cohorts.
eFFECTOR has a global collaboration with Pfizer to develop
inhibitors of a third target, eIF4E. In addition to the company’s
oncology focus, zotatifin is being evaluated a potential
host-directed antiviral therapy in patients with mild to moderate
COVID in collaboration with the University of California, San
Francisco, under a $5 million grant sponsored by the Defense
Advanced Research Projects Agency.
Additional Information and Where to Find ItOn
May 26, 2021, eFFECTOR entered into a definitive Agreement and Plan
of Merger (the “Merger Agreement”) with Locust Walk Acquisition
Corp. (NASDAQ: LWAC), a special purpose acquisition company, and
Locust Walk Merger Sub, Inc., a wholly owned subsidiary of
LWAC.
In connection with the Merger Agreement, LWAC has filed a
registration statement on Form S-4 with the SEC, which includes a
document that will serve as a prospectus and proxy statement of
LWAC, referred to as a proxy statement/prospectus. A proxy
statement/prospectus will be sent to all LWAC stockholders. LWAC
also will file other documents regarding the Merger Agreement and
the transactions contemplated thereby (the “Transactions”) with the
Securities and Exchange Commission (“SEC”). Before making any
voting decision, investors and security holders of LWAC are urged
to read the registration statement, the proxy statement/prospectus
and all other relevant documents filed or that will be filed with
the SEC in connection with the Transactions as they become
available because they will contain important information about the
Transactions, including the terms of the Transactions, the parties
involved and the risks associated with the Transactions.
Investors and security holders will be able to obtain free
copies of the registration statement, the proxy
statement/prospectus and all other relevant documents filed or that
will be filed with the SEC by LWAC through the website maintained
by the SEC at www.sec.gov. Alternatively, these documents, when
available, can be obtained free of charge from LWAC upon written
request to Locust Walk Acquisition Corp., c/o eFFECTOR, 11120
Roselle Street, Suite A, San Diego, CA 92121, Attn: Secretary, or
by calling (858) 925-8215.
Participants in the SolicitationLWAC and
eFFECTOR and their respective directors and executive officers may
be deemed to be participants in the solicitation of proxies from
LWAC’s stockholders in connection with the Transactions. A list of
the names of the directors and executive officers of LWAC and
information regarding their interests in the Transactions will be
contained in the proxy statement/prospectus when available. You may
obtain free copies of these documents as described in the preceding
paragraph.
No Offer or SolicitationThis communication does
not constitute an offer to sell or the solicitation of an offer to
buy any securities or a solicitation of any vote or approval, nor
shall there be any sale of any securities in any state or
jurisdiction in which such offer, solicitation, or sale would be
unlawful prior to registration or qualification under the
securities laws of such other jurisdiction.
Forward-Looking StatementsThis press release
contains certain forward-looking statements within the meaning of
the federal securities laws. All statements other than statements
of historical facts contained in this press release, including
statements regarding the potential that inhibition of eIF4E could
broaden the treatment landscape for cancer patients, the potential
for zotatifin’s use as an anti-viral treatment for SARS-CoV-2 and
its emerging variants, and the proposed business combination of
eFFECTOR and LWAC, are forward-looking statements. These
forward-looking statements are subject to a number of risks,
uncertainties and assumptions, including, but not limited to:
potential delays in the commencement, enrollment and completion of
clinical trials; disruption to eFFECTOR’s operations from the
COVID-19 pandemic, including delaying or otherwise disrupting its
clinical trials, manufacturing and supply chain; eFFECTOR’s
dependence on third parties in connection with product
manufacturing and clinical testing; the results of preclinical
studies and early clinical trials are not necessarily predictive of
future results; the success of eFFECTOR’s clinical trials and
preclinical studies for its product candidates; unexpected adverse
side effects or inadequate efficacy of eFFECTOR’s product
candidates that may limit their development, regulatory approval
and/or commercialization, or may result in recalls or product
liability claims; risks relating to the proposed business
combination, including the risk that the transaction may not be
completed in a timely manner or at all; and the risks associated
with eFFECTOR’s business and the business combination set forth in
the Appendix to the investor presentation filed as Exhibit 99.3 to
the Current Report on Form 8-K filed by LWAC on May 27, 2021 .
Because forward-looking statements are inherently subject to risks
and uncertainties, some of which cannot be predicted or quantified
and some of which are beyond LWAC’s and eFFECTOR’s control, you
should not rely on these forward-looking statements as predictions
of future events. The foregoing list of factors is not exclusive,
and you should carefully consider the foregoing factors and the
other risks and uncertainties described in the “Risk Factors”
section of LWAC’s Annual Report on Form 10-K for the year ended
December 31, 2020 filed with SEC on March 29, 2021, the
registration statement on Form S-4 discussed above and other
documents filed by LWAC from time to time with the SEC. These
filings identify and address other important risks and
uncertainties that could cause actual events and results to differ
materially from those contained in the forward-looking statements,
including the risk that the conditions under the Merger Agreement
are not satisfied. Forward-looking statements speak only as of the
date they are made. Readers are cautioned not to put undue reliance
on forward-looking statements, and except as required by law. LWAC
and eFFECTOR assume no obligation and do not intend to update or
revise these forward-looking statements, whether as a result of new
information, future events, or otherwise. Neither LWAC nor eFFECTOR
gives any assurance that either LWAC or eFFECTOR or the combined
company will achieve its expectations.
Contacts:
Investors:Stephanie CarringtonWestwicke, an ICR
Company646-277-1282Stephanie.Carrington@westwicke.com
Media:Heidi Chokeir, Ph.D.Canale
Communications619-203-5391heidi.chokeir@canalecomm.com
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