MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer

FOSTER CITY, Calif., Nov. 28, 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 a poster presentation of clinical results for vebreltinib in the treatment of NSCLC with MET exon 14 skipping mutation with or without concurrent MET amplification at the 2023 IASLC North America Conference on Lung Cancer (NACLC), being held on December 1 through 3, 2023 in Chicago, Illinois. A copy of the poster will be made available on the Apollomics website following the presentation at ir.apollomicsinc.com/news-events/presentations. Poster Presentation Details Title:Vebreltinib Efficacy In METex14 Mutant NSCLC With or Without Concurrent MET Amplification, MET GCN Status Distributions Compared With Public Databases Abstract No: PP01.104 Session: Poster Presentation Date/Time: December 2, 2023 from 5:40 p.m. - 6:55 p.m. CT 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 (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 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 Bozitinib or PLB1001 where it is being developed by Apollomics' partner Avistone Biotechnology Co. Ltd. Presented at the 2023 ESMO conference results from the KUNPENG Study, vebreltinib demonstrated efficacy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring c-MET exon 14 skipping mutation, with an overall response rate (ORR) of 75%. Among other notable findings, ORR and disease control rate (DCR) were 100% in patients with brain metastases (n=5) and ORR was 66.7% in patients with liver metastases (n=6). 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 recently received conditional approval from the National Medical Products Administration (NMPA) of China and is currently under clinical investigation and not approved for any use in any other regions 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 potential efficacy of the Company’s drug candidates 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 over financial reporting; (viii) unfavorable changes to the regulatory environment; and those risks and uncertainties discussed in the Form F-1 (as amended) and Form 20-F 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

BEIJING--(BUSINESS WIRE)-- Avistone Biotechnology Co. Ltd. (“Avistone” or “the Company”), an innovative biotechnology company focused on precision oncology therapeutics, announced that they received conditional approval from the National Medical Products Administration (NMPA) to commercialize Vebreltinib (also referred to as PLB1001, APL-101, Bozitinib, CBT-101) to treat patients with MET exon 14 skipping non-small cell lung cancer (NSCLC) in China. The conditional approval was based on results from a pivotal Phase II KUNPENG study with an objective response rate (ORR) of 75.0% and median progression-free survival (PFS) in patients with advanced METex14 mutations to 14.1 months with a good safety pro was recently presented at the 2023 European Society for Clinical Oncology (ESMO) Congress in Madrid, Spain (Poster# 1379P). MET signaling is implicated in cell proliferation, migration, invasion, and survival. Genomic alterations in MET can manifest in driving oncogenesis in the form of MET exon 14 skipping (METex14) or other activating mutations, MET gene amplification, gene fusion and MET protein overexpression. METex14 is an independent prognostic factor associated with poorer survival rates in patients with NSCLC. "The development of drugs for indications related to MET targets has always been a difficult one. With the NMPA approval of Vebreltinib, we look forward to providing this new treatment option to patients with MET exon 14 skipping NSCLC in China” said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone. Avistone holds the exclusive rights to Vebreltinib in China, Hong Kong and Macau. About Avistone Biotechnology Co. Ltd. Avistone is an oncology company focused on developing innovative therapies for patients with significant unmet medical needs globally. Avistone has an extensive pipeline of targeted therapies including two clinical-stage drug candidates and several ongoing programs in the pre-clinical development stage. The Company’s lead asset is PLB1001, a small-molecule inhibitor that targets MET tyrosine kinase activity, including aberrant activity observed with METexon14 skipping (genetic) alterations in NSCLC tumors and in other solid tumors. The company's second clinical asset is PLB1004, a potent inhibitor of EGFR tyrosine kinases (TKI), including aberrant activity observed with EGFR exon20 insertion (genetic) mutations in NSCLC tumors.

Apollomics’ partner, Avistone Biotechnology, received approval from Chinese National Medical Products Administration (NMPA) to commercialize vebreltinib (APL-101) in China Compelling clinical data serving as basis of this approval supports continued development of vebreltinib for the rest of world FOSTER CITY, Calif., Nov. 16, 2023 (GLOBE NEWSWIRE) --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 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 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 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