Apollomics Presents Vebreltinib Data at the 2024 American Association for Cancer Research (AACR) Annual Meeting
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Insights
The data presented on vebreltinib's efficacy in MET-altered tumors is indicative of a promising therapeutic avenue, particularly for non-small cell lung cancer (NSCLC) patients with MET-amplification dependent resistance to EGFR therapies. The focus on patient-derived tumor models adds a layer of clinical relevance to the preclinical findings, suggesting a closer approximation to human response than traditional cell line models. Furthermore, the mention of brain-penetrating capabilities is significant as central nervous system (CNS) metastases are a common complication in NSCLC, often necessitating treatments that can cross the blood-brain barrier.
From an investment perspective, the positive preclinical results could signal a competitive edge for Apollomics in the targeted therapy space, especially considering the unmet need for effective treatments against MET-driven and EGFR-resistant cancers. The potential for vebreltinib to be used both as a single agent and in combination with other therapies expands its market applicability. However, it is important to note that preclinical success does not guarantee clinical efficacy and the transition from preclinical to clinical stages often presents significant challenges.
Apollomics' presentation at the AACR Annual Meeting may have a positive impact on the company's valuation due to the innovative nature of vebreltinib and its potential market in NSCLC treatments. The specificity of vebreltinib in addressing MET-amplification resistance could fill a niche in the existing market, which is currently dominated by broad-spectrum EGFR inhibitors. The ability to overcome resistance mechanisms can lead to extended treatment durations and improved patient outcomes, which in turn can result in increased market share and revenue.
However, investors should consider the lengthy and uncertain path from preclinical studies to market approval. Regulatory hurdles, the need for extensive clinical trials and the possibility of unforeseen adverse effects can all impact the timeline and success of vebreltinib's development. Additionally, the competitive landscape, including the emergence of similar drugs and the patent environment, will influence the potential return on investment.
The pharmacological profile of vebreltinib as a selective MET kinase inhibitor that is capable of crossing the blood-brain barrier could represent a substantial advancement in targeted cancer therapy. MET alterations are implicated in various tumor types and are associated with poor prognosis and resistance to existing therapies. The ability of vebreltinib to act on clinically relevant drug levels and its demonstrated action in diverse MET-dysregulated tumor models suggest a broad therapeutic potential and a scientific basis for further clinical investigation.
Understanding the pharmacodynamics and pharmacokinetics of such a drug is essential for predicting its safety and efficacy in human populations. The brain-penetrating nature of the drug also raises questions about its potential central nervous system side effects, which will need to be closely monitored in clinical trials. Investors should be aware of the complexity and costs associated with developing brain-penetrating drugs, which could affect the drug's pricing and accessibility if approved.
Preclinical studies demonstrate vebreltinib is effective for a variety of tumor types carrying MET-driver alterations, and effective for overcoming MET-amplification dependent resistance to EGFR therapies in EGFR-positive non-small cell lung cancer
FOSTER CITY, Calif., April 10, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (“Apollomics” or the “Company”), a clinical-stage biopharmaceutical company developing medicines to address difficult-to-treat cancers, presented two posters at the 2024 American Association for Cancer Research (AACR) Annual Meeting, held April 5-10, 2024 in San Diego, Calif. Copies of the posters are available on the Apollomics website at ir.apollomicsinc.com/news-events/presentations.
“Vebreltinib’s selectivity and high in vivo potency against multiple tumor types in a variety of patient-derived tumor models demonstrate its potential to treat a variety of MET-altered tumors, as a single agent or in combination,” said Guo-Liang Yu, PhD, Chairman and Chief Executive Officer of Apollomics. “Based on preclinical models established from patients, we believe vebreltinib may also provide meaningful clinical benefit towards overcoming or preventing MET-amplification dependent resistance in EGFR-positive non-small cell lung cancer (NSCLC) patients.”
The first poster presented, titled, “Vebreltinib: A novel brain-penetrating MET kinase inhibitor demonstrates the mechanism of action and pharmacological anti-tumor activity in diverse patient-derived MET-dysregulated tumor models at clinically relevant drug levels,” demonstrated that vebreltinib is a novel potent and selective MET kinase inhibitor showing promising preclinical activity against patient-derived tumors from diverse organ sites and genomic alterations such as MET exon 14 skipping, MET fusion, MET amplification, or MET and hepatocyte growth factor over-expression at clinically relevant drug levels, providing proof-of-concepts for continued clinical development.
The second poster presented, titled, “Dependence of EGFR-mutant NSCLC on MET as demonstrated by vebreltinib, a novel and selective brain-penetrating MET kinase inhibitor,” demonstrated that adding vebreltinib to EGFR therapies overcomes MET-amplification dependent resistance with durable effect or prevents MET-dependent resistance to maximize therapeutic benefits.
About vebreltinib (APL-101)
Vebreltinib is a potent, small molecule, orally bioavailable, brain penetrating and highly selective c-MET inhibitor. It works by inhibiting the aberrant activation of the HGF/MET axis, a key pathway involved in tumor growth, proliferation, and the development of resistance to certain targeted therapies such as osimertinib. By targeting MET dysregulation, vebreltinib offers a potential breakthrough for many cancers driven by 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 (bozitinib or PLB1001) demonstrated a generally well-tolerated safety profile with preliminary evidence of clinical activity in NSCLC subjects harboring a mutation that leads to MET Exon14 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 bozitinib, or PLB1001, where it is being developed by Apollomics' partner Avistone Biotechnology Co. Ltd. KUNPENG study results were presented at the 2023 European Society of Medical Oncology Congress on October 23, 2023. The presentation showed that vebreltinib-treated patients with locally advanced or metastatic NSCLC harboring c-MET exon-14 skipping mutation achieved an overall response rate (ORR) of
Details on the Phase 1/2 SPARTA global clinical trial can be found on clinicaltrials.gov: NCT03175224. Apollomics is actively assessing the potential of vebreltinib in combination with novel therapies and in a variety of tumor types in addition to developing vebreltinib as single-agent cancer therapy. Vebreltinib received conditional approval from the National Medical Products Administration (NMPA) of China.
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. For more information, please visit www.apollomicsinc.com.
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, are forward-looking statements. When used in this press release, the words “potential,” “could,” “should,” “will,” “may,” “believe,” “estimate,” “expect,” “look,” “forward,” 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. Apollomics cautions you that its forward-looking statements are subject to unknown risks and uncertainties that could cause actual results to differ materially from those indicated in the Company’s forward-looking statements, 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 intellectual property, and the risk of litigious claims, proceedings, litigation or other types of disputes related to Apollomics’ business, licenses or intellectual property; (v) breaches in data security; (vi) the risk that Apollomics may not be able to develop and maintain effective internal controls; (vii) unfavorable changes to the regulatory environment; and those risks and uncertainties discussed in the Annual Report on Form 20-F for the year ended December 31, 2023, filed by Apollomics Inc. with the U.S. Securities and Exchange Commission (“SEC”) on March 28, 2024, under the heading “Risk Factors” and the other documents filed, or to be filed, by the Company with the SEC. Additional information concerning these and other factors that may impact the Company 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. Forward-looking statements speak only as of the date made by the Company. Apollomics undertakes no obligation to update publicly any of its 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 law.
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