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Data from Phase 2 and 2/3 trials demonstrate continued efficacy and safety of vebreltinib for treating different tumor types carrying MET-driver alterationsFOSTER CITY, Calif., June 04, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, announced a poster presentation and an oral presentation by partner company, Avistone Biotechnology, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 31-June 4, 2024, in Chicago, Ill. and virtually. Copies of the poster and oral presentation are available on the Apollomics website at ir.apollomicsinc.com/news-events/presentations. “Vebreltinib continues to display impressive selectivity and efficacy against multiple tumor types, demonstrating its high potential to treat a range of MET-altered tumors,” said Guo-Liang Yu, PhD, Chairman and Chief Executive Officer of Apollomics. “We believe this data highlights vebreltinib as a potential agent to treat both non-small cell lung cancer (NSCLC) patients and previously treated glioblastoma (GBM) patients and we remain excited about its continued clinical development.” The poster presentation, titled “Efficacy and safety of vebreltinib in patients with advanced NSCLC harboring MET exon 14-skipping: Results of 2.5-year follow-up in KUNPENG”, demonstrated vebreltinib consistently showed promising efficacy and favorable safety in NSCLC patients with MET exon 14-skipping mutations. Patients in cohort 1 of the Phase 2, open-label, multi-cohort study, received 200 mg of vebreltinib twice daily. The primary endpoint was overall response rate (ORR) and was assessed by blinded independent review committee (BIRC). Per BIRC assessment, the ORR was at 75%, and subgroup analyses showed the ORR was 100.0%, 66.7%, 85.7% and 100.0% among patients with any baseline brain metastases (N=5), patients with any baseline liver metastases (N=6), patients aged 75 years and older (N=21) and patients with co-occurring of MET amplification (N=12), respectively. Other efficacy parameters included disease control rate (DCR) of 96.2%, the median duration of response (DoR) of 16.5 months, the median time to response (TTR) of 1.0 month and the median progression-free survival (PFS) of 14.3 months. Furthermore, the median overall survival (OS) was 20.3 months. The 3-year OS rate was 35.1%. No new safety signals were reported with long-term vebreltinib treatment. The oral presentation, titled “Efficacy and safety of the vebreltinib in patients with previously treated, secondary glioblastoma/IDH mutant glioblastoma with PTPRZ1-METFUsion GENe (FUGEN): A randomised, multicentre, open-label, phase 2/3 trial”, demonstrated vebreltinib data in the first completed Phase 2/3 trial of previously treated sGBM / IDH mutant glioblastoma patients with PTPRZ1-MET Fusion gene. The primary endpoint was overall survival (OS) and, after a median follow-up of 4.44 months, the median OS in the vebreltinib group and chemotherapy group were statistically significant at 6.31 months and 3.38 months, respectively. The secondary endpoints were progression-free survival (PFS) and objective response rate (ORR); the median PFS in the vebreltinib group and chemotherapy group were also statistically significant at 1.87 months and 1.05 months, respectively. No significant differences were observed in ORR (9.5% vs. 2.6%) for the vebreltinib group and chemotherapy group. Treatment-related adverse events of grade 3 or 4 were reported in 7% of the patients in the vebreltinib group, as compared with 12.2% of those in the chemotherapy group and no treatment-related deaths were observed. 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). 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 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, 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 and other hematologic cancers, which is currently in Phase 1 and Phase 3 clinical trials in China. 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, regarding the Company’s strategy, prospects, plans and objectives 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) 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”) 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 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. 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. CONTACTSInvestor RelationsPeter VozzoICR WestwickePeter.Vozzo@westwicke.com+1-443-213-0505 Media RelationsSean LeousICR WestwickeSean.Leous@westwicke.com+1-646-866-4012

BEIJING--(BUSINESS WIRE)-- Beijing Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone), an innovative biotechnology company focused on precision oncology therapeutics, announced results from the two presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. Details and highlights from the presentations are as follows: Oral Presentation: Title: Efficacy and safety of the Vebreltinib in previously treated, secondary glioblastoma / IDH mutant glioblastoma patients with PTPRZ1-METFUsion GENe (FUGEN): a randomised, multicentre, open-label, phase II/III trial Presenter: Zhaoshi Bao, MD, PhD Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, China Session Title: Central Nervous System Tumors Published Abstract Number: 2003 Isocitrate dehydrogenase (IDH)-mutant gliomas carry a high risk of malignant transformation from low-grade gliomas into high-grade gliomas within 10 years, resulting in poor prognosis. Effective targeted drugs for high-grade gliomas are still lacking. In this open-label, phase II/III trial, 84 patients with histologically confirmed secondary GBM or IDH-mutant GBM were assigned in a 1:1 ratio to receive twice-daily oral vebreltinib at a 300 mg dose or the investigator's choice of chemotherapy (temozolomide [100-150 mg/m2/day, 7 days on followed by 7 days off ]) or cis-platinum [80-100 mg/m2 for 3 days] combined with etoposide [100mg/m2/day for 3 days]) every 28 days. The primary endpoint was overall survival (OS), and the secondary endpoints were progression-free survival (PFS) and objective response rate (ORR). 42 patients of the vebreltinib group and 39 patients of the chemotherapy group were included in the full analysis set. After a median follow-up of 4.44 months, the median OS in the vebreltinib group and chemotherapy group was 6.31 months (95% CI, 4.44-8.77) and 3.38 months (95% CI, 2.37-4.27), respectively. The HR for OS was 0.52 (90% CI, 0.32-0.85; P = 0.009). The median PFS in the vebreltinib group and chemotherapy group was 1.87 months (95% CI, 1.41-2.76) and 1.05 months (95% CI, 0.95-1.77), respectively. The HR for PFS was 0.54 (95% CI, 0.33-0.88; P = 0.014). No significant differences were observed in ORR (9.5% vs. 2.6%) for the vebreltinib group and chemotherapy group. Treatment-related adverse events of grade 3 or 4 were reported in 7% of the patients in the vebreltinib group, as compared with 12.2% of those in the chemotherapy group. No treatment-related deaths were observed. These results of the FUGEN trial support the use of vebreltinib as the first target therapy in patients with previously treated, PTPRZ1-MET fusion gene positive, secondary glioblastoma / IDH-mutant glioblastoma, and shed light on a novel therapeutic pathway in the landscape of IDH-mutant high-grade gliomas. "The development of drugs for indications related to MET targets has always been a difficult one. This is not only a victory for translational medicine, but also marks the advent of the era of targeted therapy in the field of brain glioma,” said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone. Clinical Trials Information: NCT06105619 and ChiCTR2300077783 Poster Presentation: Title: Efficacy and Safety of Vebreltinib in Patients with Advanced NSCLC Harboring MET Exon 14-Skipping: Results of 2.5-year follow-up in KUNPENG Presenter: Jin-Ji Yang, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China Session Title: Lung Cancer - Non-Small Cell Metastatic Abstract Number: 8557 MET exon 14 skipping mutation is present approximately 3% to 4% of non-small cell lung cancers (NSCLCs) and is associated with poorer survival rates. Vebreltinib (PLB1001), a potent and highly selective c-MET inhibitor, demonstrated superior objective response rate (ORR) benefits in locally advanced or metastatic non-small-cell lung cancer (NSCLC) patients (pts) with MET exon 14 (METex14) skipping mutations in the previous analysis of the phase II KUNPENG study. In this Phase II, open-label, multicenter, and multi-cohort study, tumor tissue was assessed for METex14 skipping mutation using next-generation sequencing (NGS) from CAP or CLIA certificated local or central laboratories. Patients in Cohort 1 received 200 mg of vebreltinib twice daily (28 days per cycle) until discontinuation criteria were met. The primary endpoint was ORR assessed by blinded independent review committee (BIRC). Between Jan 17, 2020 and Feb 09, 2021, 52 patients were enrolled in Cohort 1. As of the data cutoff date (Aug 09, 2023), the median duration of follow-up was 19.1 months (range, 1.0-42.7) and the median duration of treatment was 9.9 months (range, 0.6-42.7). Per BIRC assessment, the ORR was 75% (95% CI: 61.1-86.0), the disease control rate (DCR) was 96.2% (95% CI 86.8-99.5), the median duration of response (DoR) was 16.5 months (95% CI 9.2-19.4), the median time to response (TTR) was 1.0 month (95% CI 1.0-2.8), the median progression-free survival (PFS) was 14.3 months (95% CI 6.4-18.2), and the median overall survival (OS) was 20.3 months (95% CI 16.2-29.7). The 3-year OS rate was 35.1%. Subgroup analyses showed the ORR was 100.0%, 66.7%, 85.7% and 100.0% among pts with any baseline brain metastases (N=5), pts with any baseline liver metastases (N=6), pts aged 75 years and older (N=21) and pts with co-occurring of MET amplification (N=12), respectively. The most common (≥20%) treatment-related adverse events (TRAEs) in all of the 135 patients enrolled in this study were peripheral edema (56.3%), hypoalbuminemia (27.4%), hypoproteinemia (25.9%) and anemia (20.7%). "With this study, we continue to see best-in-class potential of Vebreltinib in patients with MET exon 14 skipping mutation NSCLC,” said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone. Clinical trial information: NCT04258033 About Avistone Biotechnology Beijing Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone) is an innovative biotechnology company focused on developing innovative therapies for patients with significant unmet medical needs globally. Avistone has an extensive portfolio and pipeline of targeted therapies in Non-Small Cell Lung Cancer (NSCLC) and in other solid tumors.

BEIJING--(BUSINESS WIRE)-- Beijing Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone), an innovative biotechnology company focused on precision oncology therapeutics, announced the approval to expand the use of vebreltinib (also referred to as PLB1001, APL-101, bozitinib, CBT-101) from the Chinese National Medical Products Administration (NMPA) for the treatment of adult patients with isocitrate dehydrogenase (IDH) mutant Astrocytoma (World Health Organization grade 4) with the PTPRZ1-MET fusion gene or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion (ZM fusion) gene and have failed previous treatments. This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration. In November 2023, vebreltinib received conditional approval for the treatment of metastatic patients with MET Exon14 Skipping non-small cell lung cancer (NSCLC) from the NMPA. Glioma is a refractory primary malignant intracranial tumor, accounting for approximately 46% of intracranial tumors [1]. Surgery, radiotherapy and chemotherapy are current standard treatment strategies for gliomas, and the prognosis is poor. The 5-year overall survival (OS) rate of patients with malignant glioma is less than 10% [2]. In previous studies in Chinese patients, about 12% of brain gliomas were found to have MET fusion [3]. Among the representative type PTPRZ1-MET fusion gene (hereinafter referred to as ZM fusion) occurs in about 14% of glioblastomas with a history of lower-grade disease, often co-occurring with MET Exon 14 skipping mutations and is associated with poor prognosis [3-4]. The approval of vebreltinib for the ZM fusion-positive glioma indications is based on the positive results of the FUGEN study (NCT06105619). The FUGEN study is a randomized controlled, open label, multicenter clinical registration phase II/III study. This 84-patient study compared the efficacy and safety of vebreltinib with the dose-dense regimen of temozolomide or the combination of etoposide and cisplatin, with OS as the primary endpoint. The median OS for the vebreltinib monotherapy regimen was 6.31 months, compared to 3.38 months for the control group, reducing the risk of death by 48% and significantly improving the survival of patients with recurrent relapsing ZM fusion glioma, with an acceptable safety profile. "The development of drugs for indications related to MET targets has always been a difficult one. This is not only a victory for translational medicine, but also marks the advent of the era of targeted therapy in the field of brain glioma,” said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone. About Avistone Biotechnology Beijing Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone) is an innovative biotechnology company focused on developing innovative therapies for patients with significant unmet medical needs globally. Avistone has an extensive portfolio and pipeline of targeted therapies in Non-Small Cell Lung Cancer (NSCLC) and in other solid tumors. References: [1] Louis D N. Annu Rev Pathol, 2006, 1: 97-117. [2] Qi Y, et al. Front Immunol. 2020 Nov 27;11:578877. [3] Guo R, et al. Nat Rev Clin Oncol. 2020 Sep;17(9):569-587. [4] Hu H, et al. Cell. 2018 Nov 29;175(6):1665-1678.e18. View source version on businesswire.com: Contacts David Chung Chief Business Officer david.chung@avistonebio.com Source: Avistone Biotechnology Co., Ltd. View this news release online at: