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Apollomics Announces Presentations of Vebreltinib Data at ESMO 2023

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Apollomics Inc. announces the availability of vebreltinib data at the ESMO 2023 Congress. The data includes safety and efficacy results from a Phase 2 trial in lung cancer patients with c-MET alterations, as well as preliminary data from a real-life cohort analysis in recurrent glioblastoma patients.
Positive
  • The Phase 2 trial of vebreltinib in lung cancer patients with c-MET alterations shows promising safety and efficacy results, reinforcing its potential as a treatment option for challenging-to-treat cancers.
  • The real-life cohort analysis of vebreltinib in recurrent glioblastoma patients provides preliminary data on the targeted therapy's effectiveness.
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  • None.

FOSTER CITY, Calif., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (the “Company”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced that two abstracts detailing vebreltinib data were made available as part of the European Society of Medical Oncology Congress (ESMO) 2023 being held in Madrid, Spain from October 20-24, 2023.

The preliminary safety and efficacy data from the Phase 2 KUNPENG clinical trial, evaluating vebreltinib in patients in China with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring c-MET alterations will be presented by Beijing Pearl, Apollomics’ partner in China in a poster presentation session. The poster will include data from patients with METex14 mutation (Cohort 1) from the Phase 2, open-label, multicenter and multi-cohort study.

"Vebreltinib continues to yield compelling data, reinforcing its potential as a vital treatment option for patients with challenging-to-treat cancers driven by c-MET alterations,” said Guo-Liang Yu, Ph.D., co-founder, Chairman and Chief Executive Officer of Apollomics. “We're excited to share these updates with the global oncology community at ESMO.”

In addition, as part of a real-life cohort analysis of targeted therapy for subjects with recurrent glioblastoma (GBM), preliminary data on vebreltinib from the APL-101-01 SPARTA study will be part of a mini-oral presentation.

Presentation materials will be available on the Apollomics website following the presentations at ESMO: https://ir.apollomicsinc.com/news-events/presentations.

Presentation Title: Preliminary Results of Phase II KUNPENG Study of Vebreltinib in Patients (Pts) with Advanced NSCLC Harboring c-MET Alterations
Speaker: Jin-Ji Yang from the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China.
Abstract Number: #1379P
Session: NSCLC, metastatic
Date: Monday, October 23 from 12:00-13:00 CEST

Presentation Title: Target therapy matched to genomic alterations in patients with recurrent IDH wildtype glioblastoma: A real-life cohort analysis from Veneto Institute of Oncology, Padua (Italy)
Speaker: Giulia Cerretti (Veneto Institute of Oncology, Padova, Italy)
Presentation Number: 502MO
Session: Mini Oral session
Date: Saturday, October 21 from 10:15 – 11:45 CEST

About vebreltinib (APL-101)

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 such as osimertinib. 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.

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 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 (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, 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.

Cautionary Statement Regarding Forward-Looking Statements

This 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 the Company’s future financial performance, as well as the Company’s strategy, future operations, revenue guidance, projected costs, prospects, plans and objectives of management are forward-looking statements. When used in this press release, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. Apollomics cautions you that these forward-looking statements are subject to numerous risks and uncertainties, most of which are difficult to predict and many of which are beyond the control of Apollomics. 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; (vi) risks related to the ongoing COVID-19 pandemic and response; (vii) the risk that Apollomics may not be able to develop and maintain effective internal controls; (viii) unfavorable changes to the regulatory environment; and those risks and uncertainties discussed in the Form F-4 (as amended) filed by Apollomics, Inc. with the U.S. Securities and Exchange Commission (“SEC”) under the heading “Risk Factors” and the other documents filed, or to be filed, by the Company with the SEC. Other unknown or unpredictable factors also could have material adverse effects on the Company’s future results and/or could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements. Should one or more of the risks or uncertainties described in this press release materialize or should underlying assumptions prove incorrect, actual results and plans could differ materially from those expressed in any forward-looking statements. New risk factors that may affect actual results or outcomes emerge from time to time and it is not possible to predict all such risk factors, nor can Apollomics assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. Additional information concerning these and other factors that may impact the operations and projections discussed herein can be found in the reports that Apollomics has filed and will file from time to time with the SEC. These SEC filings 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. If Apollomics updates one or more forward-looking statements, no inference should be drawn that Apollomics will make additional updates with respect to those or other forward-looking statements.

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 


FAQ

What data was made available at the ESMO 2023 Congress?

The data made available includes safety and efficacy results from a Phase 2 trial of vebreltinib in lung cancer patients with c-MET alterations, as well as preliminary data from a real-life cohort analysis in recurrent glioblastoma patients.

What does the Phase 2 trial of vebreltinib in lung cancer patients show?

The Phase 2 trial shows promising safety and efficacy results, reinforcing vebreltinib's potential as a treatment option for challenging-to-treat cancers.

What does the real-life cohort analysis of vebreltinib in recurrent glioblastoma patients provide?

The analysis provides preliminary data on the effectiveness of vebreltinib as a targeted therapy for recurrent glioblastoma patients.

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