Apollomics Announces the First Approval of Vebreltinib for MET Exon 14 Skip Non-Small Cell Lung Cancer
16 Noviembre 2023 - 7:30AM
Apollomics Inc. (Nasdaq: APLM), a late-stage clinical
biopharmaceutical company developing multiple oncology drug
candidates to address difficult-to-treat and treatment-resistant
cancers, today announced that its partner in China, Avistone
Biotechnology Co. Ltd., received conditional approval from the
National Medical Products Administration (NMPA) of China for the
commercialization of vebreltinib to treat patients with MET exon 14
skipping non-small cell lung cancer (NSCLC).
"The NMPA approval of vebreltinib is an important milestone
toward providing a new treatment option for patients with MET exon
14 skipping NSCLC in China. Apollomics extends its full support and
congratulations to Avistone on this significant achievement," said
Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of
Apollomics. "Our collaboration with Avistone and our ongoing global
SPARTA trial with vebreltinib underscores our dedication to
developing novel therapies for difficult to treat cancers and drug
resistant patients worldwide."
Vebreltinib is a potent, small molecule, orally bioavailable and
highly selective c-Met inhibitor. It works by inhibiting the
aberrant activation of the HGF/c-Met axis, a key pathway involved
in tumor growth, proliferation, and the development of resistance
to certain targeted therapies. By targeting c-Met dysregulation,
vebreltinib offers a potential breakthrough for patients with MET
exon 14 skipping NSCLC and other cancers driven by c-Met
alterations, i.e. exon 14 skipping, MET amplification, MET
fusions.
In pursuit of the MET exon 14 skipping NSCLC indication,
Apollomics is in active discussion with the U.S. Food and Drug
Administration (FDA) regarding a New Drug Application (NDA) for
vebreltinib based on totality of clinical data from the global
SPARTA trial and Avistone’s KUNPENG trial in China.
NSCLC accounts for approximately 85% of all lung cancer cases
and remains a leading cause of cancer-related deaths worldwide.
Patients with MET exon 14 skipping mutations, comprise
approximately 3% to 4% of all NSCLC cases, face significant
challenges due to limited treatment options.
Under the partnership agreement, Avistone holds the exclusive
rights to vebreltinib in China, Hong Kong and Macau, while
Apollomics retains the exclusive rights in the rest of the world,
including the U.S, and partners have access to each other’s data.
This collaboration enables both companies to leverage their
strengths and maximize the benefit of vebreltinib worldwide.
About SPARTA
Apollomics is conducting a multi-cohort Phase 2 study of
vebreltinib, SPARTA, at over 90 centers in 13 countries
investigating the efficacy and safety of vebreltinib in MET exon 14
skipping non-small cell lung cancer (NSCLC). Cohorts A-1 is
recruiting in first line Met exon 14 skipping NSCLC subjects and
Cohort A-2 is recruiting in pretreated (> 2L) MET exon 14
skipping NSCLC subjects. In addition, Cohort C includes histology
agnostic cMet amplified cancers (excluding primary CNS tumors) and
Cohort C-1 includes NSCLC harboring MET amplification and wild-type
epidermal growth factor receptor (EGFR).
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 vebreltinib (APL-101), a potent,
selective c-Met inhibitor for the treatment of non-small cell lung
cancer and other advanced tumors with c-Met alterations, and
uproleselan (APL-106), a specific E-Selectin antagonist that has
the potential to be used adjunctively with standard chemotherapy to
treat acute myeloid leukemia.
Cautionary Statement Regarding Forward-Looking
StatementsThis press release includes statements that
constitute “forward-looking statements” within the meaning of
the federal securities laws, including Section 27A of the
Securities Act of 1933, as amended (the “Securities Act”), and
Section 21E of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”). All statements, other than statements of
present or historical fact included in this press release,
regarding clinical trials and results, as well as the Company’s
strategy, business plans and objectives of management are
forward-looking statements. In addition, Apollomics cautions you
that the forward-looking statements contained in this press
release are subject to unknown risks, uncertainties and other
factors, including: (i) 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; (ii) the 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; (iii) the
failure to commercialize product candidates and achieve market
acceptance of such product candidates; (iv) the failure to
protect Apollomics’ intellectual property; (v) breaches in data
security; and other risks included in the Annual Report on
Form 20-F filed with the SEC and other SEC filings that are
available publicly on the SEC’s website at www.sec.gov. Apollomics
undertakes no obligation to update publicly any of these
forward-looking statements to reflect actual results, new
information or future events, changes in assumptions or
changes in other factors affecting forward-looking statements,
except to the extent required by applicable laws.
CONTACTS Investor
Relations Peter Vozzo ICR
Westwicke Peter.Vozzo@westwicke.com +1-443-213-0505
Media Relations Sean Leous ICR
Westwicke Sean.Leous@westwicke.com +1-646-866-4012
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