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4/12

2022

Haihe Biopharma Presented Preliminary Clinical Data of MET Inhibitor Glumetinib (SCC244) in NSCLC at AACR Annual Meeting 2022

April 12, 2022, Shanghai, China---Shanghai Haihe Biopharma Co., Ltd (referred as "Haihe Biopharma" or the “Company”), a company focusing on the discovery, development and commercialization of innovative anti-tumor drugs, announced that the results of the pivotal Phase Ⅱ GLORY study of the highly selective MET inhibitor glumetinib (SCC244) was presented at AACR Annual Meeting 2022 by Professor Shun Lu, the global leading principal investigator of the GLORY study, from the Oncology Department of Shanghai Chest Hospital. The meeting is held in New Orleans, Louisiana during April 8-13, 2022.

Report contents

Title：Phase Ⅱ Study of SCC244 in NSCLC Patients Harboring MET exon 14 Skipping (METex14) Mutations (GLORY Study)

Report NO.: CT034

Report Time: Monday Apr 11, 2022 2:30 PM - 4:30 PM
Presenter: Prof. Shun Lu（Shanghai Chest Hospital）

Contents: SCC244 is an oral, potent and highly selective small molecule MET inhibitor. This is the first report of data from an ongoing single-arm phase Ⅱ study of SCC244 in NSCLC patients with METex14 skipping mutations (GLORY study). GLORY study is an open label, international, multi-center, single-arm phase Ⅱ study to evaluate the efficacy and safety of SCC244 in patients with locally advanced or metastatic NSCLC harboring METex14 mutations. The primary endpoint was objective response rate (ORR) assessed by blinded independent review committee (BIRC) per RECIST 1.1.

At data cut-off on May 6th, 2021, a total of 69 patients with METex14 mutation confirmed by central laboratory were treated at 300 mg QD dose and had ≥2 post-baseline tumor assessments or discontinued for any reason. Objective response rate (ORR) by BIRC was 60.9% overall, 66.7% and 51.9% in treatment naïve and previously treated patients respectively. Median duration of response (DoR) was 8.2 months and median progression free survival (PFS) was 7.6 months, tumor response from 30 of 42 responders was still ongoing. The response occurred fast with a median time to response (TTR) of 1.4 months. Partial response was observed in 8 of 10 patients with brain metastasis，5 patients who had brain metastasis selected as targeted lesion had intracranial response by investigator assessment. The patients were generally well tolerated.

The data shows compelling and robust efficacy of SCC244 in NSCLC patients with METex14 skipping mutations across treatment lines and encouraging intracranial anti-tumor activity. The safety profile was favorable with manageable toxicity.

Dr. Ruiping Dong, Chief Executive Officer of Haihe Biopharma, stated,

“Lung cancer has the highest morbidity and mortality among malignant tumors in China. The treatment of NSCLC with METex14 skipping mutations is still limited and unsatisfying. We are pleased to see the primary results of GLORY study presented at AACR annual meeting 2022. We would like to thank all the patients, physicians and operation staff in this trial for their great effort. We hope these clinical trials will benefit NSCLC patients as quickly as possible, bringing patients and their families hope for extended benefit.”

Prof. Shun Lu, the global leading principal investigator of the GLORY study, from the Oncology Department of Shanghai Chest Hospital, commented,

“The data results of the GLORY study will have a significant impact on the clinical practice of NSCLC patients in China, Japan and more regions. The GLORY study has confirmed that SCC244 has a rapid onset of anti-tumor activity, and it has compelling efficacy and good tolerance in the treatment naïve and previously treated NSCLC patients with METex14 skipping mutations, and patients with brain metastases also have clear benefits.” He expressed his great expectation for the approval of glumetinib (SCC244) as to benefit more NSCLC patients!

About AACR

The American Association for Cancer Research (AACR) was founded in 1907. The AACR is the first and largest cancer research organization dedicated to accelerating the conquest of cancer. The AACR has more than 50,000 members residing in 129 countries and territories. Membership includes 256 Fellows of the AACR Academy and 54 Nobel laureates. Through its programs and services, the AACR fosters research in cancer and related biomedical science; accelerates dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances understanding of cancer etiology, prevention, diagnosis, and treatment throughout the world.

About NSCLC and METex14 Skipping Mutations

Lung cancer is the malignant tumor with the highest morbidity and mortality in China. NSCLC accounts for approximately 85% of all lung cancers¹. The total incidence of METex14 skipping mutations in NSCLC is about 3%², and the incidence in Chinese NSCLC population is about 1.3%³. METex14 skipping mutation is a primary oncogenic driver gene, which usually does not coexist with other lung cancer mutations such as EGFR, KRAS and ALK⁴. Most patients are elderly, with a median age of 72 years⁵. METex14 skipping mutations predict poor prognosis, with progression-free survival (PFS) of only 2.9 months, overall survival (OS) of 7.9 - 8.3 months, and objective response rate (ORR) of 8.8% -- 9.1%⁶ in second-line chemotherapy. NSCLC patients with METex14 skipping mutations are insensitive to PD-1 therapy with ORR ranged from 16 to 17%, median PFS ranged from 1.9 to 3.4 months, and there is no increase in response rate among tumor patients with high PD-L1 receptor expression^7,8.

About Glumetinib (SCC244)

Glumetinib (SCC244) is an oral, potent and highly selective small molecule MET inhibitor. Glumetinib has excellent pharmacokinetic characteristics with long half-life and high steady-state trough concentration in human, which is conducive to continuous inhibition of the target. Glumetinib has shown robust efficacy and favorable safety profile in GLORY study in NSCLC patients with MET alterations. Haihe Biopharma owns the independent global intellectual property rights of glumetinib.

About Haihe Biopharma

Haihe Biopharma is an innovation-driven biotechnology company in China focusing on the discovery, development, production and commercialization of innovative anti-cancer therapies. Haihe brings life-saving drugs to cancer patients worldwide. It has a research and management team with global perspectives, who are proactively exploring and advancing development of innovative drugs globally. The Company currently has thirteen drug candidates under discovery and development. As of today, Haihe Biopharma has received 29 IND or clinical trial approvals in four countries and regions.

Reference

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[2].   Cao, W., et al., Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl), 2021. 134(7): p. 783-791.
[3].   Jemal, A., et al., Cancer Statistics, 2010. CA: A Cancer Journal for Clinicians, 2010. 60(5): p. 277-300.
[4].   Vuong, H.G., et al., Clinicopathological implications of MET exon 14 mutations in non-small cell lung cancer - A systematic review and meta-analysis. Lung Cancer, 2018. 123: p. 76-82.
[5].   Zheng, D., et al., MET exon 14 skipping defines a unique molecular class of non-small cell lung cancer. Oncotarget, 2016. 7(27): p. 41691-41702.
[6].   Ciuleanu T, Brodowicz T, Zielinski C, et al (2009) Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet, 374:1432-40.
[7].   Ettinger DS, Akerley W, Bepler G, et al (2010), Non-small cell lung cancer. J Natl Compr Canc Netw, 8:740–801.
[8].   Paz-Ares L, Luft A, Vicente D et al (2018), Pembrolizumab plus chemotherapy for squamous non-small cell lung cancer. N Engl J Med, 379:2040-51.