Avistone Biotechnology Co., Ltd.

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 an oral presentation at the IASLC 2024 World Conference on Lung Cancer (#WCLC24) in San Diego, CA. “The development of drugs for indications related to both c-MET and EGFR targets has always been a difficult one. We are now entering an era where the clinical combination of these targets has shown meaningful potential benefit to patients with NSCLC. We are excited to share these preliminary clinical results from the combination of our two novel (cMET and EGFR) inhibitors in NSCLC patients with EGFR mutation-positive, MET amplified or MET overexpression,” said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone. Details and highlights from the oral presentation are as follows: Title: Vebreltinib plus PLB1004 in EGFR-mutated, NSCLC with MET amplification or MET overexpression following EGFR-TKI Results: Forty-four patients received Vebreltinib 100mg plus PLB1004 160mg (n=15), Vebreltinib 150mg plus PLB1004 160mg (n=13), Vebreltinib 200mg plus PLB1004 80mg (n=3), or Vebreltinib 150mg plus PLB1004 80mg (n=13) and were included in the overall safety analysis. Among the 44 patients evaluated, 36.4% of patients had brain metastases and 86.4% of patients had previously received a third-generation EGFR-TKI, respectively. Objective responses occurred across all Vebreltinib and PLB1004 dose levels tested, with partial responses (PRs) observed in 19/32 (59.4%) response-evaluable patients. Among patients with brain metastases, the ORR was 75.0% (9/12). The ORR was 58.6% (17/29) in patients who received prior third-generation EGFR-TKI. The most common TRAEs were rash and paronychia. No patients discontinued treatment due to TRAEs. Clinical Trial Identifier: NCT06343064 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. Contacts David Chung Chief Business Officer david.chung@avistonebio.com

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.

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 pro 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 75%. Among other notable findings, ORR and 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 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 . 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 or to be 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 time to time with the SEC. These SEC filings are available publicly on the SEC’s website at 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. CONTACTS Investor Relations Peter Vozzo ICR Westwicke Peter.Vozzo@westwicke.com 443-213-0505 Media Relations Sean Leous ICR Westwicke Sean.Leous@westwicke.com 646-866-4012