Apollomics Inc. (Nasdaq: JMAC), an innovative biopharmaceutical
company committed to the discovery and development of mono- and
combination-oncology therapies, today announced that the U.S. Food
and Drug Administration (FDA) has granted Orphan Drug
Designation to vebreltinib (APL-101) for the treatment of non-small
cell lung cancer (NSCLC) with MET genomic tumor aberrations. The
FDA granted the Orphan Drug Designation in August.
“While NSCLC is the most common type of lung cancer, a subset of
patients will have MET genomic dysregulations in their tumors which
make them more resistant to treatment, presenting an unmet medical
need,” said Guo-Liang Yu, PhD, co-founder, Chairman and Chief
Executive Officer of Apollomics. “We are pleased to have received
the Orphan Drug Designation for vebreltinib, as patients need new
and better treatment options. Through genomic testing, we can
identify patients who will benefit most from a targeted treatment
like vebreltinib. Orphan Drug Designation brings significant
developmental benefits to the vebreltinib program, most notably
seven-year market exclusivity upon its approval.”
Apollomics’ ongoing global Phase 2 SPARTA study is evaluating
vebreltinib in patients with NSCLC and other solid tumors with MET
genomic dysregulation.
Dysregulation of the c-MET tyrosine kinase receptor is
implicated in the development of tumor malignancy and can arise
through several mechanisms, including gene fusion and
amplification, overexpression of the receptor and/or its ligand
hepatocyte growth factor (HGF), and the acquisition of activating
mutations. One type of the activating mutations cause exon 14 to be
skipped due to aberrant splicing of MET mRNA. MET exon 14 skipping
occurs in approximately 3-4% of NSCLC and has been demonstrated to
be an oncogenic driver. MET amplification, another potential
oncogenic driver, occurs in ~3% of newly diagnosed NSCLC, as well
as in some NSCLC patients treated with targeted TKI therapy, such
as EGFR inhibitors, who become treatment resistant.
The FDA’s Office of Orphan Products Development grants
orphan designation status to drugs and biologics that are intended
for the treatment, diagnosis or prevention of rare diseases, or
conditions that affect fewer than 200,000 people in the United
States. Orphan Drug Designation provides certain benefits
including assistance in the drug development process, tax credits
for clinical costs, exemption from FDA Prescription Drug User Fee
Act (PDUFA) fees, and seven years of post-approval
exclusivity.
As previously announced on Sept. 14, 2022, Apollomics and Maxpro
Capital Acquisition Corp. (“Maxpro”) (Nasdaq: JMAC, JMACU, JMACW),
announced a definitive agreement for a business combination (the
“Transaction” or the “Business Combination”) that would result in
Apollomics becoming a publicly traded company on the Nasdaq Global
Market (“Nasdaq”). The Business Combination is expected to close in
the first quarter of 2023 and Apollomics is expected to be listed
on Nasdaq under the ticker symbol “APLM.”
About vebreltinib (APL-101)Vebreltinib is a
novel small molecule kinase inhibitor that targets c-MET. It is a
Type 1b class highly selective c-MET inhibitor. Vebreltinib has
demonstrated strong tumor inhibitory effect in a variety of
preclinical c-MET dysregulated human gastric, hepatic, pancreatic
and lung cancer xenograft animal models and patient-derived
xenograft models (PDX). In Phase 1 clinical trials, vebreltinib
(PLB1001) demonstrated a generally well-tolerated safety profile
with preliminary evidence of clinical activity in NSCLC subjects
harboring a mutation that leads to MET exon 14 skipping and in
secondary glioblastoma multiforme (sGBM) patients harboring MET
fusion and/or exon 14 skipping with evidence of brain penetration.
In China, vebreltinib is referred to as PLB1001 where it is being
developed by Apollomics' partner Beijing Pearl Biotechnology Co.
Ltd. Details on the Phase 1/2 SPARTA clinical trial can be found on
clinicaltrials.gov: NCT03175224. Apollomics is actively assessing
the potential of investigating vebreltinib in combination with
novel therapies and in a variety of tumor types in addition to
developing vebreltinib as single-agent cancer therapy. Vebreltinib
is currently under clinical investigation and not approved for any
use anywhere in the world.
About the Phase 2 SPARTA StudySPARTA is the
Phase 2 portion of an ongoing Phase 1/2 international multicenter,
open-label study evaluating the safety, pharmacokinetics, and
preliminary efficacy of vebreltinib. SPARTA is assessing activity
in NSCLC with a mutation that leads to MET exon 14 skipping, and
across tumor types (pan-cancer) with MET amplification or fusions.
SPARTA is enrolling patients into multiple cohorts. In NSCLC, the
trial will evaluate both c-MET inhibitor naïve and experienced
patients with mutations that lead to MET exon 14 skipping. Two
cohorts will enroll patients with solid tumors with MET
amplifications and fusions, including glioblastoma multiforme, the
most aggressive form of brain cancer. The primary objective of
SPARTA is to assess efficacy by overall response rate (ORR) and
duration of response (DOR) per Response Evaluation Criteria in
Solid Tumors (RECIST) or relevant evaluation criteria per tumor
type. Secondary objectives include the incidence and severity of
adverse events and additional efficacy measurements including time
to progression, progression free survival, and overall
survival.
About Non-Small Cell Lung Cancer (NSCLC)Lung
cancer is a disease in which malignant cancer cells form in the
tissues of the lung. In 2017, there were an estimated 558,000
people living with lung and bronchus cancer in the United States,
with new cases estimated to be over 228,000 in 2020. Lung cancer is
also one of the more deadly cancers with a relative 5-year survival
rate of around 20%. NSCLC is the most common type of lung cancer
with about 80% to 85% of lung cancers falling into this
category.
About Apollomics
Inc.Apollomics Inc. is an innovative clinical-stage
biopharmaceutical company focused on the discovery and development
of oncology therapies with the potential to be combined with other
treatment options to harness the immune system and target specific
molecular pathways to inhibit cancer. Apollomics currently has a
pipeline of nine drug candidates across multiple programs, six of
which are currently in the clinical stage of development.
Apollomics’ lead programs include investigating its core product,
vebreltinib, a potent, selective c-Met inhibitor for the treatment
of non-small cell lung cancer and other advanced tumors with c-Met
alterations, which is currently in a Phase 2 multicohort clinical
trial in the United States, and developing an anti-cancer enhancer
drug candidate, uproleselan (APL-106), a specific E-Selectin
antagonist that has the potential to be used adjunctively with
standard chemotherapy to treat acute myeloid leukemia and other
hematologic cancers, which is currently in Phase 1 and Phase 3
clinical trials in China.
About Maxpro Capital Acquisition
Corp.Maxpro is a blank check company formed for the
purposes of effecting a merger, capital share exchange, asset
acquisition, share purchase, reorganization, or similar business
combination with one or more businesses in the healthcare and
technology industries. In October 2021, Maxpro consummated a $103.5
million initial public offering of 10.35 million units (including
the underwriters’ full exercise of their over-allotment option),
each unit consists of one share of Class A common stock and one
redeemable warrant, each warrant entitles the holder to purchase
one share of Class A common stock at a price of $11.50 per share.
EF Hutton, division of Benchmark Investments LLC, served as the
sole book-running manager of Maxpro’s initial public offering.
Important Information About the Proposed Business
Combination and Where to Find It
For additional information on the proposed Transaction, see
Maxpro’s Current Report on Form 8-K, filed with the U.S. Securities
and Exchange Commission (the “SEC”) on September 14, 2022. In
connection with the Business Combination, Maxpro and Apollomics
intend to file relevant materials with the SEC, including a
registration statement on Form F-4 with the SEC, which will include
a proxy statement/prospectus, and will file other documents
regarding the proposed Transaction with the SEC. Maxpro’s
stockholders and other interested persons are advised to read, when
available, the preliminary proxy statement/prospectus and the
amendments thereto and the definitive proxy statement and documents
incorporated by reference therein filed in connection with the
proposed Business Combination, as these materials will contain
important information about Apollomics and Maxpro and the proposed
Business Combination. Promptly after the Form F-4 is declared
effective by the SEC, Maxpro will mail the definitive proxy
statement/prospectus and a proxy card to each shareholder entitled
to vote at the meeting relating to the approval of the business
combination and other proposals set forth in the proxy
statement/prospectus. Before making any voting or investment
decision, investors and stockholders of Maxpro are urged to
carefully read the entire registration statement and proxy
statement/prospectus, when they become available, and any other
relevant documents filed with the SEC, as well as any amendments or
supplements to these documents, because they will contain important
information about the Business Combination. The documents filed by
Maxpro with the SEC may be obtained free of charge at the SEC’s
website at www.sec.gov, or by directing a request to Maxpro Capital
Acquisition Corp., 5F-4, No.89, Songren Rd., Xinyi Dist., Taipei
City, Taiwan 11073, Attention: Secretary; telephone: +886 2 7713
7952.
Participants in the Solicitation
Maxpro and certain of its directors, executive officers and
other members of management and employees may, under SEC rules, be
deemed to be participants in the solicitation of proxies from
Maxpro’s stockholders in connection with the proposed Transaction.
A list of the names of those directors and executive officers and a
description of their interests in Maxpro will be included in the
proxy statement/prospectus for the proposed Business Combination
when available at www.sec.gov. Information about Maxpro’s directors
and executive officers and their ownership of Maxpro securities is
set forth in Maxpro’s Annual Report on Form 10-K, filed with the
SEC on March 31, 2022, as modified or supplemented by any Form 3 or
Form 4 filed with the SEC since the date of such filing. Other
information regarding the interests of the participants in the
proxy solicitation will be included in the proxy
statement/prospectus pertaining to the proposed business
combination when it becomes available. These documents can be
obtained free of charge from the source indicated above.
Apollomics and its directors and executive officers may also be
deemed to be participants in the solicitation of proxies from the
stockholders of Maxpro in connection with the proposed Business
Combination. A list of the names of such directors and executive
officers and information regarding their interests in the proposed
Business Combination will be included in the proxy
statement/prospectus for the proposed Business Combination.
Additional information regarding the participants in the proxy
solicitation and a description of their direct and indirect
interests will be included in the proxy statement/prospectus filed
with the SEC on Form F-4. Stockholders, potential investors and
other interested persons should read the proxy statement/prospectus
carefully when it becomes available before making any voting or
investment decisions. You may obtain free copies of these documents
from the sources indicated above.
Cautionary Statement Regarding Forward-Looking
Statements
Certain statements in this press release may be considered
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements include,
but are not limited to, statements about future financial and
operating results, plans, objectives, expectations and intentions
with respect to future operations, products and services; and other
statements identified by words such as “will likely result,” “are
expected to,” “will continue,” “is anticipated,” “estimated,”
“believe,” “intend,” “plan,” “projection,” “outlook” or words of
similar meaning. These forward-looking statements include, but are
not limited to, statements regarding Apollomics’ industry and
market sizes, expected clinical trial results, future opportunities
for Apollomics and Maxpro, Apollomics’ estimated future results and
the potential transaction between Maxpro and Apollomics, including
the implied enterprise value, the expected transaction and
ownership structure and the likelihood, timing and ability of the
parties to successfully consummate the proposed Transaction.
These forward-looking statements are based upon estimates and
assumptions that, while considered reasonable by Maxpro and its
management and/or Apollomics and its management, as the case may
be, are inherently uncertain and are subject to significant
business, economic and competitive uncertainties and contingencies,
many of which are difficult to predict and generally beyond the
control of Maxpro and Apollomics. Actual results and the timing of
events may differ materially from the results anticipated in these
forward-looking statements. Factors that may cause actual results
to differ materially from current expectations include, but are not
limited to: the inability to meet the closing conditions to the
Business Combination, including the occurrence of any event, change
or other circumstances that could give rise to the termination of
the Business Combination Agreement; the inability to complete the
Transaction due to the failure to obtain approval of Maxpro’s
stockholders, the failure to achieve the minimum cash condition
following any redemptions by Maxpro stockholders, or the failure to
meet Nasdaq’s initial listing standards in connection with the
consummation of the contemplated transactions; costs related to the
Transaction; a delay or failure to realize the expected benefits
from the Business Combination; risks related to disruption of
management’s time from ongoing business operations due to the
Business Combination; the impact of any current or new government
regulations in the United States and China affecting Apollomics’
operations and the continued listing of Apollomics’ securities;
inability to achieve successful clinical results or to obtain
licensing of third-party intellectual property rights for future
discovery and development of Apollomics’ oncology projects; failure
to commercialize product candidates and achieve market acceptance
of such product candidates; failure to protect Apollomics’
intellectual property; breaches in data security; risks related to
the ongoing COVID-19 pandemic and response; risk that Apollomics
may not be able to develop and maintain effective internal
controls; unfavorable changes to the regulatory environment; and
other risks and uncertainties indicated in Maxpro’s final
prospectus dated October 7, 2021 and filed with the SEC on October
8, 2021 for its initial public offering, the Annual Report on Form
10-K, filed with the SEC on March 31, 2022, and the proxy
statement/prospectus relating to the Business Combination,
including those under “Risk Factors” therein, and in Maxpro’s other
filings with the SEC. Maxpro and Apollomics caution that the
foregoing list of factors is not exclusive.
Actual results, performance or achievements may differ
materially, and potentially adversely, from any projections and
forward-looking statements and the assumptions on which those
forward-looking statements are based. There can be no assurance
that the data contained herein is reflective of future performance
to any degree. You are cautioned not to place undue reliance on
forward-looking statements as a predictor of future performance as
projected financial information and other information are based on
estimates and assumptions that are inherently subject to various
significant risks, uncertainties and other factors, many of which
are beyond the control of Maxpro and Apollomics. All information
set forth herein speaks only as of the date hereof in the case of
information about Maxpro and Apollomics or the date of such
information in the case of information from persons other than
Maxpro or Apollomics, and Maxpro and Apollomics disclaim any
intention or obligation to update any forward looking statements as
a result of developments occurring after the date of this
communication. Forecasts and estimates regarding Apollomics’
industry and end markets are based on sources Maxpro and Apollomics
believe to be reliable, however there can be no assurance these
forecasts and estimates will prove accurate in whole or in part.
Annualized, pro forma, projected and estimated numbers are used for
illustrative purpose only, are not forecasts and do not reflect
actual results.
No Offer or Solicitation
This press release is for informational purposes only and shall
not constitute a solicitation of a proxy, consent or authorization
with respect to any securities or in respect of the Business
Combination. This press release also shall not constitute an offer
to sell or the solicitation of an offer to buy any securities
pursuant to the Business Combination or otherwise, nor shall there
be any sale of securities in any jurisdiction in which the offer,
solicitation or sale would be unlawful prior to the registration or
qualification under the securities laws of any such jurisdiction.
No offer of securities shall be made except by means of a
prospectus meeting the requirements of Section 10 of the Securities
Act of 1933, as amended, or an exemption therefrom.
CONTACTS
Investor RelationsPeter VozzoICR
WestwickePeter.Vozzo@westwicke.com443-213-0505
Media RelationsSean LeousICR
WestwickeSean.Leous@westwicke.com646-866-4012
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