A Global Multicenter, Double-blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination With Azacitidine (AZA) in Patients With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4).

A global multicenter, randomized, double-blind, placebo-controlled, pivotal phase III study. To evaluate overall survival (OS) of Lisaftoclax (APG-2575) combined with azacitidine (AZA) vs. placebo combined with azacitidine in newly diagnosed patients with HR-MDS.

Start Date22 Jan 2025

Sponsor / Collaborator

Ascentage Pharma Group, Inc.

CTR20243841

/ RecruitingPhase 3

APG-2575 (Lisaftoclax）联合阿扎胞苷(AZA)治疗新诊断的中高危骨髓增生异常综合征患者的一项国际多中心、随机、双盲、安慰剂对照的关键性注册临床3期研究(GLORA–4)

[Translation] An international, multicenter, randomized, double-blind, placebo-controlled, pivotal Phase 3 registration study of APG-2575 (lisaftoclax) in combination with azacitidine (AZA) in patients with newly diagnosed intermediate- and high-risk myelodysplastic syndrome (GLORA-4)

评估APG-2575 (Lisaftoclax)联合阿扎胞苷(AZA)对比安慰剂联合阿扎胞苷治疗新诊断的中高危骨髓增生异常综合征(Higher-risk MDS)受试者的有效性及安全性。

[Translation]

To evaluate the efficacy and safety of APG-2575 (lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in the treatment of subjects with newly diagnosed intermediate- or high-risk myelodysplastic syndrome (Higher-risk MDS).

Start Date22 Jan 2025

Sponsor / Collaborator

Suzhou Yasheng Pharmaceutical Co., Ltd.

CTR20233944

/ RecruitingPhase 1/2

评估APG-2575在轻中度系统性红斑狼疮患者中的安全性、药代动力学和药效动力学的随机，双盲，安慰剂对照Ⅰb/Ⅱ期临床研究

[Translation] A randomized, double-blind, placebo-controlled Phase Ib/II clinical study to evaluate the safety, pharmacokinetics and pharmacodynamics of APG-2575 in patients with mild to moderate systemic lupus erythematosus

评估APG-2575在系统性红斑狼疮患者中的安全性、耐受性、药代动力学特征、药效动力学特征及初步疗效。

[Translation]

To evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic characteristics and preliminary efficacy of APG-2575 in patients with systemic lupus erythematosus.

Start Date09 Aug 2024

Sponsor / Collaborator

Suzhou Yasheng Pharmaceutical Co., Ltd.

100 Clinical Results associated with Lisaftoclax

100 Translational Medicine associated with Lisaftoclax

100 Patents (Medical) associated with Lisaftoclax

Literatures (Medical) associated with Lisaftoclax

05 Jul 2023·Clinical cancer research : an official journal of the American Association for Cancer Research

Novel BCL-2 Inhibitor Lisaftoclax in Relapsed or Refractory Chronic Lymphocytic Leukemia and Other Hematologic Malignancies: First-in-Human Open-Label Trial.

Article

Author: Ailawadhi, Sikander ; Ahmad, Mohammad ; Davids, Matthew S ; Glass, Laura ; Yang, Dajun ; Chen, Zi ; Huang, Bo ; Liang, Eric ; Wang, Hengbang ; Men, Lichuang ; Li, Mingyu ; He, Zhicong ; Mekala, Divya J ; Collins, Mary C ; Parrondo, Ricardo ; Zhai, Yifan ; Yannakou, Costas K ; Fu, Lei Tommy ; Lasica, Masa ; Chanan-Khan, Asher ; Paulus, Aneel

PURPOSE:

This global phase I trial investigated the safety, efficacy, pharmacokinetics, and pharmacodynamics of lisaftoclax (APG-2575), a novel, orally active, potent selective B-cell lymphoma 2 (BCL-2) inhibitor, in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (R/R CLL/SLL) and other hematologic malignancies (HMs).

PATIENTS AND METHODS:

Maximum tolerated dose (MTD) and recommended phase II dose were evaluated. Outcome measures were safety and tolerability (primary) and pharmacokinetic variables and antitumor effects (secondary). Pharmacodynamics in patient tumor cells were explored.

RESULTS:

Among 52 patients receiving lisaftoclax, MTD was not reached. Treatment-emergent adverse events (TEAEs) included diarrhea (48.1%), fatigue (34.6%), nausea (30.8%), anemia and thrombocytopenia (28.8% each), neutropenia (26.9%), constipation (25.0%), vomiting (23.1%), headache (21.2%), peripheral edema and hypokalemia (17.3% each), and arthralgia (15.4%). Grade ≥ 3 hematologic TEAEs included neutropenia (21.2%), thrombocytopenia (13.5%), and anemia (9.6%), none resulting in treatment discontinuation. Clinical pharmacokinetic and pharmacodynamic results demonstrated that lisaftoclax had a limited plasma residence and systemic exposure and elicited rapid clearance of malignant cells. With a median treatment of 15 (range, 6-43) cycles, 14 of 22 efficacy-evaluable patients with R/R CLL/SLL experienced partial responses, for an objective response rate of 63.6% and median time to response of 2 (range, 2-8) cycles.

CONCLUSIONS:

Lisaftoclax was well tolerated, with no evidence of tumor lysis syndrome. Dose-limiting toxicity was not reached at the highest dose level. Lisaftoclax has a unique pharmacokinetic profile compatible with a potentially more convenient daily (vs. weekly) dose ramp-up schedule and induced rapid clinical responses in patients with CLL/SLL, warranting continued clinical investigation.

01 Feb 2023·Acta pharmacologica Sinica

Discovery and identification of a novel small molecule BCL-2 inhibitor that binds to the BH4 domain

Article

Author: Jiang, Hua-Liang ; Zheng, Ming-Yue ; Song, Jia ; Lu, Cheng-Hao ; Zhang, Ying-Hui ; Yang, Rui-Rui ; Fan, Zi-Sheng ; Zhang, Su-Lin ; Chang, Jie ; Zhou, Jing-Yi

The B-cell lymphoma 2 (BCL-2) protein family plays a pivotal role in regulating the apoptosis process. BCL-2, as an antiapoptotic protein in this family, mediates apoptosis resistance and is an ideal target for cell death strategies in cancer therapy. Traditional treatment modalities target BCL-2 by occupying the hydrophobic pocket formed by BCL-2 homology (BH) domains 1-3, while in recent years, the BH4 domain of BCL-2 has also been considered an attractive novel target. Herein, we describe the discovery and identification of DC-B01, a novel BCL-2 inhibitor targeting the BH4 domain, through virtual screening combined with biophysical and biochemical methods. Our results from surface plasmon resonance and cellular thermal shift assay confirmed that the BH4 domain is responsible for the interaction between BCL-2 and DC-B01. As evidenced by further cell-based experiments, DC-B01 induced cell killing in a BCL-2-dependent manner and triggered apoptosis via the mitochondria-mediated pathway. DC-B01 disrupted the BCL-2/c-Myc interaction and consequently suppressed the transcriptional activity of c-Myc. Moreover, DC-B01 inhibited tumor growth in vivo in a BCL‑2‑dependent manner. Collectively, these results indicate that DC-B01 is a promising BCL-2 BH4 domain inhibitor with the potential for further development.

04 Jan 2023·Clinical cancer research : an official journal of the American Association for Cancer Research

Lisaftoclax in Combination with Alrizomadlin Overcomes Venetoclax Resistance in Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia: Preclinical Studies

Article

Author: Zhang, Kaixiang ; Yang, Dajun ; Tang, Qiuqiong ; Xue, Sheng-Li ; Deng, Jing ; Fang, Douglas D. ; Yin, Yan ; Fu, Chengcheng ; Li, Na ; Wang, Qixin ; Zhai, Yifan ; Zhou, Feng

Abstract:

Purpose::

Despite approval of B-cell lymphoma (BCL)-2 inhibitor venetoclax for certain hematologic malignancies, its broader clinical benefit is curtailed by resistance. Our study aimed to determine if treatment with novel anticancer agents targeting BCL-2 and mouse double minute 2 (MDM2) could overcome venetoclax resistance in preclinical models.

Experimental Design::

Venetoclax-sensitive and venetoclax-resistant acute myeloid leukemia (AML) and acute lymphoblastic leukemia cells and xenograft models were used to evaluate antitumor effects and underlying mechanisms associated with combined BCL-2 inhibitor lisaftoclax (APG-2575) and MDM2 inhibitor alrizomadlin (APG-115).

Results::

The combination exhibited synergistic antiproliferative and apoptogenic activities in TP53 wild-type AML cell lines in vitro. This synergy was further exemplified by deep antitumor responses and prolonged survival in AML cell line–derived and patient-derived xenograft models. Interestingly, the combination treatment resensitized (to apoptosis) venetoclax-resistant cellular and mouse models established via chronic drug exposure or genetically engineered with clinically relevant BCL-2 gene mutations. Synergistic effects in reducing cellular viability and proliferation were also demonstrated in primary samples of patients with venetoclax-resistant AML treated with lisaftoclax and alrizomadlin ex vivo. Mechanistically, alrizomadlin likely primes cancer cells to BCL-2 inhibition-induced cellular apoptosis by downregulating expression of antiapoptotic proteins myeloid cell leukemia-1 and BCL–extra-large and upregulating pro-death BCL-2–associated X protein.

Conclusions::

Lisaftoclax in combination with alrizomadlin overcomes venetoclax resistance mediated by various mechanisms, including BCL-2 mutations. In addition, we posit further, putative molecular mechanisms. Our data rationalize clinical development of this treatment combination in patients with diseases that are insensitive or resistant to venetoclax.

News (Medical) associated with Lisaftoclax

08 Apr 2025

·www.prnewswire.com

TIBSOVO's Continued Success Solidifies Its Position as a Leader in IDH1 Mutant Space | DelveInsight

With its ability to specifically inhibit the mutant IDH1 enzyme, TIBSOVO addresses an unmet need in personalized cancer treatment, offering new hope for patients with limited options. As clinical evidence continues to support its efficacy and safety, TIBSOVO is positioned for strong growth in the oncology market, especially with expanding indications and global market penetration. LAS VEGAS, April 8, 2025 /PRNewswire/ -- DelveInsight's " TIBSOVO Market Size, Forecast, and Market Insight Report" highlights the details around TIBSOVO, the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TIBSOVO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Servier's TIBSOVO (ivosidenib) Overview TIBSOVO (ivosidenib) is a small molecule developed by Servier, acts as an isocitrate dehydrogenase-1 (IDH1) inhibitor. It is indicated for patients with a susceptible IDH1 mutation, which is identified through an FDA-approved test. Currently, TIBSOVO is approved for the treatment of newly diagnosed acute myeloid leukemia (AML), relapsed or refractory AML, relapsed or refractory myelodysplastic syndromes (MDS), and locally advanced or metastatic cholangiocarcinoma. According to Servier's pipeline, TIBSOVO is also being actively investigated for a range of additional indications, with key areas of exploration including solid tumors and hematological malignancies. Learn more about TIBSOVO projected market size for AML, cholangiocarcinoma, and MDS @ TIBSOVO Market Potential The oncology market has experienced significant growth in recent years, driven by advances in cancer research, the development of targeted therapies, and the increasing global prevalence of cancer. As the second-leading cause of death worldwide, cancer continues to pose a major public health challenge, creating a substantial demand for innovative treatments. The market is marked by a shift toward personalized medicine, where therapies are tailored to an individual's genetic profile, allowing for more effective and less toxic treatments. Immunotherapies, such as checkpoint inhibitors, CAR-T cell therapies, and oncolytic virus therapies, are at the forefront of these advancements, offering new hope to patients with previously untreatable cancers. Moreover, the oncology market is expanding due to the growing adoption of precision oncology and molecular diagnostics, which enable earlier and more accurate detection of cancer. This has led to increased investments in research and development, especially in areas like liquid biopsies, companion diagnostics, and next-generation sequencing. The demand for more effective and accessible cancer treatments is fueling innovation in both the pharmaceutical and biotechnology sectors, with numerous new drugs and therapies entering clinical trials and moving toward commercialization. As a result, the oncology market is poised to continue growing, with significant opportunities for breakthrough therapies in immuno-oncology, targeted treatments, and gene therapies. DelveInsight has expertise in the oncology market with an experienced team handling the oncology domain proficiently. DelveInsight has released a series of epidemiology-based market reports on Acute Myeloid Leukemia, Cholangiocarcinoma, and Myelodysplastic Syndrome. These reports include a comprehensive understanding of current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Gain deeper insights into these diseases with a customized report tailored to your needs. Connect with us today—our experts are ready to assist you! Emerging Competitors of TIBSOVO TIBSOVO faces significant competition in the newly diagnosed AML market from several alternative treatments. Oral therapies like VENCLEXTA (venetoclax), which inhibits BCL-2, and DAURISMO (glasdegib), which targets the hedgehog pathway, present strong contenders. Additionally, emerging therapies such as Lisaftoclax (Ascentage Pharma), another BCL-2 inhibitor, and gilteritinib (Astellas), a kinase inhibitor, are expected to further challenge TIBSOVO in the newly diagnosed AML space. In the R/R AML market, TIBSOVO competes with several therapies, including XOSPATA (gilteritinib), IDHIFA (enasidenib), and others. Emerging therapies such as Ziftomenib (Kura Oncology) and RVU-120 (Ryvu Therapeutics) are also expected to compete with TIBSOVO upon their approval. Ziftomenib, a small molecule developed by Kura Oncology, is currently in Phase I/II trials. In the relapsed/refractory (R/R) MDS market, TIBSOVO faces competition from therapies such as RYTELO (Imetelstat), an IV injection that inhibits oligonucleotide telomerase, and REBLOZYL (Luspatercept), a subcutaneous injection, among other treatment options. In the metastatic cholangiocarcinoma market, TIBSOVO faces relatively less competition, as there are few approved therapies. One such competitor is PEMAZYRE (pemigatinib), a kinase inhibitor that was approved in the US in 2020 and in Europe in 2021. Whereas, Tyra Biosciences' TYRA-200, an FGFR1/2/3 inhibitor, is in phase I stage of development that might be a threat to TIBSOVO one approved. To know more about the number of competing drugs in development, visit @ TIBSOVO Market Positioning Compared to Other Drugs Key Developmental Activities of TIBSOVO In October 2023, Servier announced that the FDA has approved TIBSOVO (ivosidenib tablets) for the treatment of IDH1-mutated R/R MDS. In May 2023, Servier announced that the European Commission has approved TIBSOVO as a targeted therapy in two indications: in combination with azacitidine for the treatment of adult patients with newly diagnosed AML with an isocitrate dehydrogenase-1 R132 mutation who are not eligible to receive standard induction chemotherapy; as well as in monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy. In May 2022, Servier announced FDA approval of TIBSOVO (ivosidenib tablets) in combination with azacitidine for patients with newly diagnosed IDH1-mutated acute myeloid leukemia. In August 2021, Servier announced FDA approval for TIBSOVO (ivosidenib tablets) for the treatment of adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved test. TIBSOVO is the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma. In May 2019, Agios announced FDA approval of TIBSOVO (ivosidenib tablets) as monotherapy for newly diagnosed adult patients with IDH1 mutant acute myeloid leukemia not eligible for intensive chemotherapy. In July 2018, the FDA approved TIBSOVO (ivosidenib) for relapsed or refractory acute myeloid leukemia with an idh1 mutation. In February 2018, the FDA accepted a new drug application and granted priority review for ivosidenib in relapsed or refractory AML with an IDH1 mutation. In December 2017, Agios submitted an NDA to the FDA for ivosidenib for the treatment of patients with relapsed/refractory aml and an IDH1 mutation. TIBSOVO Patent Details TIBSOVO is a drug owned by Servier Pharmaceuticals. Currently, it is protected by 10 Orange book-listed patents filed from 2018 to 2023, out of which none have expired yet. It is also protected by ODE exclusivity for various indications. Discover how TIBSOVO is shaping the blood cancer treatment landscape @ TIBSOVO Side Effects TIBSOVO Market Dynamics In recent years, the therapeutic landscape has undergone significant changes, with promising approaches including immunotherapy, chemotherapy combined with targeted treatments, and the regulation of immune checkpoint-mediated signaling pathways. One such treatment, Ivosidenib, works by inducing the bone marrow to develop normal blood cells, helping to reduce the frequency of blood transfusions. Investment in the research and development of drugs has surged, contributing to a rich pipeline and forecasting promising opportunities in the treatment markets for AML and cholangiocarcinomas. Therapies like TIBSOVO have the potential to capture market attention due to their efficacy and innovation. As healthcare spending continues to rise globally, the pharmaceutical market is expected to expand, providing greater opportunities for market penetration by manufacturers and facilitating the development and distribution of new treatments. Despite progress in cancer treatment, significant gaps remain in understanding the full process that governs carcinogenesis and resistance to treatments, particularly in cancers like acute myeloid leukemia (AML). This highlights the need for more advanced research to address these challenges. Additionally, the limited biomarker testing for patients with the IDH1 mutation restricts the targeted patient pool, posing a challenge for therapies like TIBSOVO to achieve their expected market share. The increasing competition from emerging therapies, such as KEYTRUDA (pembrolizumab), IMFINZI (durvalumab), and the combination of Azacitidine + Venetoclax, further intensifies the pressure on TIBSOVO. Moreover, the difficulty in obtaining sufficient patient pools and diagnostic samples during disease recurrence presents significant hurdles to the effective development of translational research, potentially slowing progress in optimizing treatments. Dive deeper to get more insight into TIBSOVO's strengths & weaknesses relative to competitors @ TIBSOVO Market Drug Report Table of Contents Related Reports Acute Myeloid Leukemia Market Acute Myeloid Leukemia Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key AML companies including Agios Pharmaceuticals, Abbvie, Jazz Pharmaceuticals, Astellas Pharma, Pfizer, Novartis Oncology, Daiichi Sankyo, AstraZeneca, Astex Pharmaceuticals, Inc., Chimerix, Takeda, Rafael Pharmaceuticals Inc., Delta-Fly Pharma, GlycoMimetics Incorporated, BerGenBio ASA, MacroGenics, Syndax Pharmaceuticals, Arog Pharmaceuticals, Forma Therapeutics, Sellas Life Sciences Group, Actinium Pharmaceuticals, Clear Creek Bio Inc., CellCentric Ltd., Biosight Ltd., Astex Pharmaceuticals, Inc., Curis, Inc., NexImmune Inc., Immunomedics, Inc., Sumitomo Dainippon Pharma Co., Ltd., Incyte Corporation, Aprea Therapeutics, Immunicum, DCPrime BV, GT Biopharma, Inc., Hanmi Pharmaceutical Company Limited, Cardiff Oncology, Bio-Path Holdings, Actinium Pharmaceuticals, Aptevo Therapeutics, Synimmune GmbH, GEMoaB Monoclonals, ImmunoGen, Inc., AGC Biologics S.p.A., Precigen, Inc., Novartis Pharmaceuticals, Xencor, Inc., Novartis, Celgene, Bristol Myers Squibb, among others. Relapsed/Refractory Acute Myeloid Leukemia Market Relapsed/Refractory Acute Myeloid Leukemia Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key R/R AML companies including Agios Pharmaceuticals, Abbvie, Jazz Pharmaceuticals, Astellas Pharma, Pfizer, Novartis Oncology, Daiichi Sankyo, AstraZeneca, Astex Pharmaceuticals, Inc., Chimerix, Takeda, Rafael Pharmaceuticals Inc., Delta-Fly Pharma, GlycoMimetics Incorporated, BerGenBio ASA, MacroGenics, Syndax Pharmaceuticals, Arog Pharmaceuticals, Forma Therapeutics, Sellas Life Sciences Group, Actinium Pharmaceuticals, Clear Creek Bio Inc., CellCentric Ltd., Biosight Ltd., Astex Pharmaceuticals, Inc., Curis, Inc., NexImmune Inc., Immunomedics, Inc., Sumitomo Dainippon Pharma Co., Ltd., Incyte Corporation, Aprea Therapeutics, Immunicum, DCPrime BV, GT Biopharma, Inc., Hanmi Pharmaceutical Company Limited, Cardiff Oncology, Bio-Path Holdings, Actinium Pharmaceuticals, Aptevo Therapeutics, Synimmune GmbH, GEMoaB Monoclonals, ImmunoGen, Inc., AGC Biologics S.p.A., Precigen, Inc., Novartis Pharmaceuticals, Xencor, Inc., Novartis, Celgene, Bristol Myers Squibb, among others. Myelodysplastic Syndrome Market Myelodysplastic Syndrome Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key MDS companies such as Bristol-Myers Squibb, Astex Pharmaceutical, Taiho Oncology, Fibrogen, AbbVie, Gilead Sciences, Novartis, Syros Pharmaceuticals, Takeda, Pfizer, Geron Corporation, Karyopharm Therapeutics, Antengene Corporation, BerGenBio ASA, Jazz Pharmaceuticals, Aprea Therapeutics, Sanofi, Medac, among others. Cholangiocarcinoma Market Cholangiocarcinoma Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key cholangiocarcinoma companies such as AstraZeneca, Decalth Systems, Basilea Pharmaceutica, Taiho Oncology, Eisai Pharmaceuticals, TransThera Sciences, Incyte Corporation, Roche, Agios Pharmaceuticals, Servier Pharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalImmunotherapyPhase 1Priority Review

27 Mar 2025

·www.prnewswire.com

Innovent to Present Preclinical Data of Multiple Novel Molecules at the 2025 AACR Annual Meeting

SAN FRANCISCO and SUZHOU, China, March 26, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that preclinical data on multiple novel bispecific antibodies as well as antibody-drug-conjugates (ADCs) from its oncology pipeline will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. The AACR Annual Meeting will take place from April 25 to April 30, 2025, in Chicago, Illinois. Late-Breaking Research: Immunology 2 Topic: Preclinical Data of IAR037, A Novel CD40/PD-L1 Bispecific Antibody for the Treatment of Advanced Solid Tumors Resistant to Immune Checkpoint Inhibitors Abstract Number: LB139 Presentation Time ：Monday Apr 28, 2025 9:00 AM - 12:00 PM Location: Poster Section 52 Late-Breaking Research: Clinical Research 1 Topic: Preclinical characterization of IBI3010, a FRα targeting biparatopic antibody-drug conjugate (ADC), for the treatment of FRα expressing tumors Abstract Number: LB222 Presentation Time ：Monday Apr 28, 2025 2:00 PM - 5:00 PM Location: Poster Section 53 Poster Session: Experimental and Molecular Therapeutics - New and Emerging Cancer Drug Targets Topic: IBI3019, a first-in-class EGFR/CDH17/CD16A tri-specific antibody, demonstrated potent efficacy against CRC and an excellent safety profile in preclinical studies Abstract Number: 4249 Presentation Time: Tuesday Apr 29, 2025 9:00 AM - 12:00 PM Location: Poster Section 17 Poster Board Number: 6 Poster Session: Experimental and Molecular Therapeutics - Therapeutic Approaches to Attack the Tumor Microenvironment Topic: IBI3026, a first-in-class anti-PD-1/IL-12 fusion protein, demonstrates the potential to be a new immuno-oncology therapy by releasing the break in immune response and strongly activating T and NK cells in the tumor microenvironment Abstract Number: 3118 Presentation Time: Monday Apr 28, 2025 2:00 PM - 5:00 PM Location: Poster Section 24 Poster Board Number: 2 Poster Session: Experimental and Molecular Therapeutics - Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies Topic: IBI3014, a TROP2xPD-L1 bi-specific ADC integrating ADC killing with checkpoint blockade within one molecule, exhibits promising efficacy and safety in preclinical models Abstract Number: 344 Presentation Time: Sunday Apr 27, 2025 2:00 PM - 5:00 PM Location: Poster Section 16 Poster Board Number: 11 Poster Session: Experimental and Molecular Therapeutics - Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies Topic: Trop2 and B7H4 bi-specific ADC with improved efficacy and safety for gynecologic cancers Abstract Number: 345 Presentation Time: Sunday Apr 27, 2025 2:00 PM - 5:00 PM Location: Poster Section 16 Poster Board Number: 12 Poster Session: Immunology - T Cell Engagers Topic: A 2+1 format MUC16 targeting T cell engager induces MUC16-dependent T cell activity and superior anti-tumor efficacy Abstract Number: 3510 Presentation Time: Monday Apr 28, 2025 2:00 PM - 5:00 PM Location: Poster Section 38 Poster Board Number: 18 Poster Session: Immunology - Modulation of Tumor Microenvironment: Modulation of Lymphocyte Influx Topic: A PD1-IFNα fusion protein, composed of an attenuated IFNα fused to a clinically validated PD1 mAb, induced PD1-dependent IFNα signaling and demonstrated superior anti-tumor efficacy Abstract Number: 4881 Presentation Time: Tuesday Apr 29, 2025 9:00 AM - 12:00 PM Location: Poster Section 40 Poster Board Number: 9 Poster Session: Experimental and Molecular Therapeutics - Novel Antitumor Agents 3 Topic: Olverembatinib* (HQP1351) in combination with lisaftoclax (APG-2575) overcomes venetoclax resistance in preclinical models of acute myeloid leukemia (AML) Abstract Number: 5652 Presentation Time: Tuesday Apr 29, 2025 2:00 PM – 5:00 PM Poster Session: Experimental and Molecular Therapeutics - Novel Antitumor Agents 3 Topic: Effects of olverembatinib* (HQP1351) in combination with BCL-2 inhibitor lisaftoclax (APG-2575) in T-cell acute lymphoblastic leukemia (T ALL) Abstract Number: 5648 Presentation Time: Tuesday Apr 29, 2025 2:00 PM – 5:00 PM * In July 2021, Innovent and Ascentage Pharma (6855.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China. Dr. Kaijie He, Vice President of Innovent, stated: "With the expansion and enhancement of Innovent Academy's technology platforms, our global R&D efforts are taking shape and accelerating global competitiveness, enabling the efficient generation of novel molecules with global potential. We are proud to showcase a batch of preclinical research findings at this year's AACR Annual Meeting, including multiple globally first-in-class bispecific antibodies, multi-specific antibodies, and antibody-drug conjugates (ADCs). These breakthroughs not only demonstrate our growing scientific capabilities but also reaffirm our commitment to delivering transformative therapeutic options for patients worldwide. Moving forward, we remain focused on innovation—optimizing precision targets and exploring novel mechanisms—to provide revolutionary solutions for some of the world's most challenging diseases and enable more patients to benefit from the rapid advancements in cutting-edge science." About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 16 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company. Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AACRADCImmunotherapy

24 Jan 2025

·www.pharmaceutical-technology.com

Ascentage Pharma raises $126m in first biotech IPO of 2025

Ascentage sold 7,325,000 American Depositary shares at $17.25 each. Credit: Andrey Zhuravlev via Getty Images. China-based biotech Ascentage Pharma has raised $126m in a US initial public offering (IPO), marking the first biotech IPO of 2025. Free Report What’s missing from your IPO industry assessment? IPO activity all but stopped in 2020, as the investment community grew wary of the effects of COVID-19 on economies. No matter how deserving a business was of flotation, momentum was halted by concerns of when a ‘new normal’ of working patterns and trade would set in. Recently, sentiment has changed. Flotations picked up again during the second half of 2021, and now in 2022 the mood is decidedly optimistic. Business leaders have their eyes on fast rebounding economies, buoyant market indices and the opportunity once again to take their businesses public. As a result, global IPOs are expected to hit back this year. With GlobalData’s new whitepaper, ‘IPOs in Consumer and Retail: 5 must-include elements for your prospectus industry report’, you can explore exactly what is needed in the essential literature. GlobalData’s focus lies in the critical areas to get right: Macroeconomic and demographic environment Consumer context Industry environment Competitive environment Route to market Interested to learn more about what to include in your IPO Industry Assessment report? Download our free whitepaper. Thank you. You will receive an email shortly. Please check your inbox to download the Report. Go deeper with GlobalData Reports LOA and PTSR Model - Bemcentinib in Acute Myelocytic Leukemia (AML,... Reports LOA and PTSR Model - Bemcentinib in Lung Adenocarcinoma Data Insights The gold standard of business intelligence. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. The company sold 7,325,000 American Depositary shares at $17.25 each. Shares for the company began trading today (24 January) on the Nasdaq under the ticker symbol “AAPG”, and are up by as much as 4% since markets opened, as per Bloomberg . The funds will primarily support the development of Ascentage’s cancer drug pipeline, including its lead candidate olverembatinib for the treatment of chronic myeloid leukaemia (CML). Olverembatinib, a tyrosine kinase inhibitor (TKI), is approved and marketed as Nelic in China for the treatment of adult patients with TKI-resistant chronic-phase CML (CP-CML) or accelerated-phase CML (AP-CML) with the T315I mutation, and for those with CP-CML resistant disease or intolerant to first and second generation TKIs. The IPO comes after the company signed a significant licencing agreement with Takeda in 2024. Takeda paid $100m upfront for the option to licence olverembatinib outside China, Hong Kong, Macau, Taiwan, and Russia, and committed to potential milestone payments totalling $1.2bn. The broader IPO market has seen fluctuations in recent years. Following a surge in 2020 and 2021, activity slowed, only to pick up slightly in late 2024. In September 2024, three biotech firms – Bicara Therapeutics, Zenas BioPharma, and MBX Biosciences – raised over $700m collectively in a single day on Nasdaq, reflecting renewed investor interest. Industry sentiment remains optimistic for 2025 , with many expecting IPO activity to increase. A Jefferies survey reported that 64% of respondents anticipate a stronger IPO market this year, with equity raising expected to play a significant role. Ascentage’s listing aligns with this outlook and suggests a favourable environment for biotech funding as the year begins. Ascentage’s olverembatinib is being investigated in the Phase III POLARIS-2 registrational study (NCT06423911) which plans to enrol 285 patients with CML. Beyond olverembatinib, Ascentage has other candidates in its pipeline including lisaftoclax, a treatment for blood cancers. The candidate is in late-stage trials and under regulatory review in China. Free Report What’s missing from your IPO industry assessment? IPO activity all but stopped in 2020, as the investment community grew wary of the effects of COVID-19 on economies. No matter how deserving a business was of flotation, momentum was halted by concerns of when a ‘new normal’ of working patterns and trade would set in. Recently, sentiment has changed. Flotations picked up again during the second half of 2021, and now in 2022 the mood is decidedly optimistic. Business leaders have their eyes on fast rebounding economies, buoyant market indices and the opportunity once again to take their businesses public. 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Phase 3IPODrug Approval

100 Deals associated with Lisaftoclax

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Lymphocytic Leukemia	NDA/BLA	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	16 Nov 2024
Small Lymphocytic Lymphoma	NDA/BLA	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	16 Nov 2024
High Risk Myelodysplastic Syndrome	Phase 3	United States	Ascentage Pharma Group, Inc.	22 Jan 2025
High Risk Myelodysplastic Syndrome	Phase 3	China	Ascentage Pharma Group, Inc.	22 Jan 2025
Myelodysplastic Syndromes	Phase 3	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	22 Jan 2025
Acute Myeloid Leukemia	Phase 3	China	Ascentage Pharma Group, Inc.	11 Jun 2024
Acute Myeloid Leukemia	Phase 3	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	11 Jun 2024
Systemic Lupus Erythematosus	Phase 2	China	Ascentage Pharma Group, Inc.	09 Aug 2024
Systemic Lupus Erythematosus	Phase 2	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	09 Aug 2024
Recurrent Chronic Lymphoid Leukemia	Phase 2	China	Ascentage Pharma Group, Inc.	28 Dec 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2025	Not Applicable	pre-TCR/Src signaling \| BCL-2 family proteins	-	Olverembatinib	agncgxzoot(lpatdgcmul) = the combination significantly increased the percentage of apoptotic cells compared to either agent alone (p < 0.0001) agnarbirpl (pudpaphlic )	Positive	29 Apr 2025
				Lisaftoclax
NCT04942067 (APG2575MU101, ASH2024) Manual	Phase 1/2	Multiple Myeloma \| Immunoglobulin Light-Chain Amyloidosis	49	Lisaftoclax + pomalidomide + dexamethasone (Arm A)	vjprjypsdr(yettkuhzmw) = tdagjjkvsh rjdockvduk (ajlbxfhugd ) View more	Positive	09 Dec 2024
				lisaftoclax and daratumumab, lenalidomide, and dexamethasone (R/R MM + Arm B)	vjprjypsdr(yettkuhzmw) = duoiitdtwa rjdockvduk (ajlbxfhugd ) View more
NCT04215809 (ASH2024) Manual	Phase 1	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	176	APG-2575	jgxflnzsnj(qixbfznask) = Incidence and severity of TEAEs were similar across cohorts. Common (>10%) any-grade TEAEs in all cohorts combined were neutropenia (59 [33.5%]), diarrhea (38 [21.6%]), anemia (27 [15.3%]), and thrombocytopenia (26 [14.8%]). cphjkzxmeh (vgjmfeeudk ) View more	Positive	09 Dec 2024
				APG-2575+Acalabrutinib
NCT04501120 (APG2575AC101, ASH2024) Manual	Phase 1/2	Myelodysplastic Syndromes	49	Lisaftoclax Azacitidineazacitidine (R/R MDS)	cefiyyjwdm(iaavmxrarn) = mgjsdnciev thytlvbnja (lxiuzzgsrw ) View more	Positive	08 Dec 2024
				Lisaftoclax Azacitidineazacitidine (TN MDS)	dgepuuewnf \| cefiyyjwdm(egvxazstpf) = xfeeoukvra vukuhqrohc (avixtisrqr, 61.5 - 89.2) View more
PRNewswire Manual	Not Applicable	Multiple Myeloma \| Immunoglobulin Light-Chain Amyloidosis	44	APG-2575+泊马度胺+地塞米松 (MM)	zusgdimdlw(prbqpyjrce) = tvxydmypzc rnnearebog (teosnwsist ) View more	Positive	18 Jun 2024
				APG-2575+达雷妥尤单抗+来那度胺+地塞米松 (MM)	bbzmejxrbm(aetlxwyyma) = baeglbmica ptdsohcczl (sqkhuxgiqm )
NCT04501120 (ASCO2024) Manual	Phase 1/2	Relapsing acute myeloid leukemia \| Refractory acute myeloid leukemia	72	Lisaftoclax 400 mgAZA mg	jjzxcfugkb(eigfinsftz) = ihihmrejkn cmkvpalpze (cjsdzuiixu, 28.1 - 63.6) View more	Positive	24 May 2024
				Lisaftoclax 600 mgAZA mg	jjzxcfugkb(eigfinsftz) = potthmnyex cmkvpalpze (cjsdzuiixu, 34.8 - 67.6) View more
NCT04260217 (APG2575WU101, ASCO2024) Manual	Phase 1/2	Waldenstrom Macroglobulinemia MYD88 Gene Mutation Negative \| MYD88 \| CXCR4	46	Lisaftoclax	zqmbnoefto(emehcbaydg) = jpooaxdnym wanvlaxrfc (axntxisxjg, 1 - 28) View more	Positive	24 May 2024
				Lisaftoclax + Ibrutinib	zqmbnoefto(emehcbaydg) = fxasyogmtc wanvlaxrfc (axntxisxjg, 1 - 34) View more
NCT04501120 (APG2575AC101, ASH2023) Manual	Phase 1/2	Myeloid Tumor \| Acute Myeloid Leukemia \| Myelodysplastic Syndromes	115	Lisaftoclax monotherapy	fpuaqfngow(jgofliaffk) = nioaviuxpc udeoxqmmqu (afwavjmkaa ) View more	Positive	10 Dec 2023
				Lisaftoclax+LD-HHT (R/R AML)	fpuaqfngow(jgofliaffk) = vwsxgtgvgp udeoxqmmqu (afwavjmkaa ) View more
NCT04942067 (APG-2575-MU101, ASH2023) Manual	Phase 1/2	Multiple Myeloma \| Immunoglobulin Light-Chain Amyloidosis	30	Lisaftoclax + Pomalidomide + Dexamethasone (R/R MM)	sqepzdtrty(xbuwhjqsco) = eaycirqwnl nesthufbxx (axxegnghgk ) View more	Positive	09 Dec 2023
				Lisaftoclax + Daratumumab + Lenalidomide + Dexamethasone (R/R MM)	sqepzdtrty(xbuwhjqsco) = cmtjpkfotw nesthufbxx (axxegnghgk ) View more
NCT04494503 \| NCT03913949 (APG-2575-CC101, ASH2023) Manual	Phase 1/2	Chronic Lymphocytic Leukemia	47	Lisaftoclax	pqlybtrozt(twzslkdyly) = nfjilxuenw hrbphuhcbo (zqwbmhbnbv ) View more	Positive	09 Dec 2023

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