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Abbisko and Allist Pharmaceuticals Jointly Announce the Initiation of a Phase 2 Clinical Study Evaluating oral PD-L1 small molecule ABSK043 in Combination with Furmonertinib Mesylate Tablets for the Treatment of Advanced Non-Small Cell Lung Cancer

May 09,2024
By Abbisko

9 May 2024, Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) and Shanghai Allist Pharmaceuticals Co., Ltd. ("Allist" hereafter, SSE code: 688578), today jointly announce that its investigational oral small molecule PD-L1 inhibitor (ABSK043), developed by Abbisko, will be evaluated in a clinical study in combination with Furmonertinib Mesilate Tablets(IVESA®, “Furmonertinib ” hereafter), independently developed by Allist, for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Details of the research collaboration includes an IND/CTA filing pertaining to the exploration of ABSK043 in combination with Furmonertinib in a multicenter, open-label phase 2 dose-escalation/dose-expansion clinical trial.

Abbisko Therapeutics previously disclosed first-in-human clinical trial results for ABSK043 in patients with advanced solid tumors at the 2023 European Society for Medical Oncology (ESMO) Congress. Among 11 evaluable patients (BID dosing), ABSK043 demonstrated an Objective Response Rate (ORR) of 27.3%. No dose-limiting toxicities or peripheral neuropathy were observed across all dose levels. ABSK043 is the first oral small molecule PD-L1 inhibitor in China and the second globally to have disclosed efficacy and safety data, and exhibits best-in-class potential.

In comparison to antibodies, small molecule inhibitors typically possess a lower risk of immunogenicity, flexible dosing regimens as monotherapy/combination therapy, and a convenient oral administration profile that can avoid adverse reactions caused by intravenous infusions.

The clinical study of ABSK043 in combination with Furmonertinib is expected to bring potential better treatment regimen for advanced non-small cell lung cancer patients.

About ABSK043

ABSK043 is a novel, orally administered small molecule PD-L1 inhibitor, displaying exceptional activity and high selectivity. Tumor cells can exploit immune checkpoints such as PD-1 and its ligand PD-L1 to evade immune detection and clearance, thereby suppressing or restricting T-cell responses. While several PD-1/PD-L1 monoclonal antibodies have been approved worldwide, there are currently no approved PD-1/PD-L1 small molecule drugs. ABSK043 selectively binds to the PD-L1 receptor and induces its internalization from the cell surface, effectively inhibiting the interaction of PD-1/PD-L1 and alleviating PD-L1-mediated suppression of T-cell activation. In several preclinical models, ABSK043 has demonstrated anti-tumor efficacy comparable to approved PD-L1 antibody drugs. At present, ABSK043 is undergoing Phase I clinical trial targeting advanced solid tumors in Australia and China.

About Furmonertinib

Furmonertinib is a self-developed 3rd generation of EGFR-TKI with independent IP from China. It is approved by CDE for the second-line and first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR mutations in March 2021 and June 2022, respectively, both of which are included in the National Reimbursement Drug List. Allist has entered into a licensing agreement with ArriVent Biopharma, Inc. in June 2021 for the exclusive global rights (ex-China) of Furmonertinib. Thus far, the global multi-center (including China, the United States, the United Kingdom, France, Japan, South Korea, etc.), registrational Phase III clinical study of Furmonertinib is well advanced, which is used for the first-line treatment of NSCLC patients harboring EGFR Exon 20 insertion mutations. In addition, Furmonertinib has been granted as Breakthrough Therapy Designation in China and the United States for the treatment of NSCLC with EGFR Exon 20 insertion mutations. The phase III clinical studies for adjuvant treatment of NSCLC with EGFR-sensitive mutations and for the first-line treatment of NSCLC with uncommon EGFR mutations are also progressing smoothly.

About Allist

Shanghai Allist Pharmaceuticals Co., Ltd, founded in March, 2004, is an innovative pharmaceutical company with a fully integrated system for research and development, manufacturing, and commercialization of novel oncology drugs with a purpose to meet with medical needs across the globe. In accordance with its development concept “Advancing Long Life with Innovation of Science and Technology”, Allist is dedicated to self-develop First-in-class and Best-in-class drug candidates. After 20 years of endeavor, Allist has successfully developed and received approvals of two innovative drugs by its own. On December 2nd, 2020, Shanghai Allist Pharmaceuticals Co., Ltd. was officially listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange (stock number: 688578). Based on the Best-in-class potential of Furmonertinib and professional commercial capability, Allist has achieved a leap-forward growth. In 2023, Allist achieved a total operating revenue of 2.018 billion yuan and a net profit attributable to shareholders of 644 million yuan. In the first quarter of 2024, Allist achieved a total operating revenue of 743 million yuan and a net profit attributable to shareholders of 306 million yuan.

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