[Translation] A randomized, double-blind phase III clinical study of socazolimab injection plus platinum-containing chemotherapy with or without bevacizumab versus placebo plus platinum-containing chemotherapy with or without bevacizumab for the first-line treatment of persistent, recurrent or metastatic cervical cancer

评价索卡佐利单抗注射液加含铂化疗联合/不联合贝伐珠单抗对比安慰剂加含铂化疗联合/不联合贝伐珠单抗用于一线治疗持续、复发或转移性宫颈癌患者的有效性和安全性

[Translation]

To evaluate the efficacy and safety of socazolimab injection plus platinum-containing chemotherapy with or without bevacizumab versus placebo plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for patients with persistent, recurrent or metastatic cervical cancer

Start Date20 Nov 2024

Sponsor / Collaborator

Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.

[+1]

NCT06459687

/ Not yet recruitingPhase 3

Efficacy and Safety of Socazolimab Combined With Chemotherapy With or Without Bevacizumab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer: A Randomized, Double-blind, Placebo-controlled Phase III Study

The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent, recurrent, or metastatic cervical cancer. The main question it aims to answer is:
Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent, recurrent, or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab.
Participants will be treated with Socazolimab/placebo + chemotherapy ± bevacizumab) for 6
8 cycles (Q3w), following maintenance treatment of Socazolimab/placebo (Q3w).

Start Date01 Sep 2024

Sponsor / Collaborator

Lee's Pharmaceutical Holdings Ltd.

ChiCTR2300078237

/ SuspendedEarly Phase 1IIT

A single-arm exploratory clinical study of nab-paclitaxel combined with subcutaneous PD-L1 monoclonal antibody in the treatment of advanced and posterior triple-negative breast cancer

Start Date01 Dec 2023

Sponsor / Collaborator-

100 Clinical Results associated with Socazolimab

100 Translational Medicine associated with Socazolimab

100 Patents (Medical) associated with Socazolimab

Literatures (Medical) associated with Socazolimab

29 Oct 2024·Proceedings of the National Academy of Sciences

O-GlcNAcylation of enolase 1 serves as a dual regulator of aerobic glycolysis and immune evasion in colorectal cancer

Article

Author: Lin, Bingyi ; Chai, Siyuan ; Zhu, Qiang ; Sun, Haofan ; Qin, Weijie ; Hu, Jiating ; Wu, Liming ; Yi, Wen ; Wang, Yong ; Fan, Zhiya ; Li, Jingchao ; Hsieh-Wilson, Linda C.

Aerobic glycolysis and immune evasion are two key hallmarks of cancer. However, how these two features are mechanistically linked to promote tumor growth is not well understood. Here, we show that the glycolytic enzyme enolase-1 (ENO1) is dynamically modified with an O -linked β- N -acetylglucosamine (O-GlcNAcylation), and simultaneously regulates aerobic glycolysis and immune evasion via differential glycosylation. Glycosylation of threonine 19 (T19) on ENO1 promotes its glycolytic activity via the formation of active dimers. On the other hand, glycosylation of serine 249 (S249) on ENO1 inhibits its interaction with PD-L1, decreases association of PD-L1 with the E3 ligase STUB1, resulting in stabilization of PD-L1. Consequently, blockade of T19 glycosylation on ENO1 inhibits glycolysis, and decreases cell proliferation and tumor growth. Blockade of S249 glycosylation on ENO1 reduces PD-L1 expression and enhances T cell–mediated immunity against tumor cells. Notably, elimination of glycosylation at both sites synergizes with PD-L1 monoclonal antibody therapy to promote antitumor immune response. Clinically, ENO1 glycosylation levels are up-regulated and show a positive correlation with PD-L1 levels in human colorectal cancers. Thus, our findings provide a mechanistic understanding of how O-GlcNAcylation bridges aerobic glycolysis and immune evasion to promote tumor growth, suggesting effective therapeutic opportunities.

01 Jun 2024·Current Cancer Drug Targets

IR-780 Dye-based Targeting of Cancer-associated Fibroblasts Improves Cancer Immunotherapy by Increasing Intra-tumoral T Lymphocytes Infiltration

Article

Author: Chen, Zelin ; Shi, Chunmeng ; Tan, Xu ; Zheng, Jiancheng ; Chen, Hongdan ; Yang, Wei ; Zhang, Can ; Qu, Langfan ; Chen, Wanchao

Background::Immune-checkpoint inhibitors (ICIs) against programmed death (PD)-1/PD-L1 pathway immunotherapy have been demonstrated to be effective in only a subset of patients with cancer, while the rest may exhibit low response or may develop drug resistance after initially responding. Previous studies have indicated that extensive collagen-rich stroma secreted by cancer-associated fibroblasts (CAFs) within the tumor microenvironment is one of the key obstructions of the immunotherapy for some tumors by decreasing the infiltrating cytotoxic T cells. However, there is still a lack of effective therapeutic strategies to control the extracellular matrix by targeting CAFs.Methods::The enhanced uptake of IR-780 by CAFs was assessed by using in vivo or ex vivo nearinfrared fluorescence imaging, confocal NIR fluorescent imaging, and CAFs isolation testing. The fibrotic phenotype down-regulation effects and in vitro CAFs killing effect of IR-780 were tested by qPCR, western blot, and flow cytometry. The in vivo therapeutic enhancement of anti-PD-L1 by IR-780 was evaluated on EMT6 and MC38 subcutaneous xenograft mice models.Results::IR-780 has been demonstrated to be preferentially taken up by CAFs and accumulate in the mitochondria. Further results identified low-dose IR-780 to downregulate the fibrotic phenotype, while high-dose IR-780 could directly kill both CAFs and EMT6 cells in vitro. Moreover, IR-780 significantly inhibited extracellular matrix (ECM) protein deposition in the peri-tumoral stroma on subcutaneous EMT6 and MC38 xenografts, which increased the proportion of tumor-infiltrating lymphocytes (TILs) in the deep tumor and further promoted anti-PD-L1 therapeutic efficacy.Conclusion::This work provides a unique strategy for the inhibition of ECM protein deposition in the tumor microenvironment by targeted regulating of CAFs, which destroys the T cell barrier and further promotes tumor response to PD-L1 monoclonal antibody. IR-780 has been proposed as a potential therapeutic small-molecule adjuvant to promote the effect of immunotherapy.

01 Apr 2024·Annals of Pharmacotherapy

Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma

Review

Author: Elgawly, Mariam ; Orr, Roger ; Mancuso, David ; Seligson, Nathan D. ; Bergsma, Emilie J. ; Vuskovich, Theresa

Objective The objective was to review the pharmacology, efficacy, and safety of atezolizumab (Tecentriq) for the treatment of adult and pediatric patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma (ASPS). Data Sources A literature search was conducted using PubMed and MEDLINE databases, published abstracts, and ongoing studies from ClinicalTrials.gov between January 1, 1981, and May 31, 2023. Keywords included atezolizumab, Tecentriq, MPDL3280, immunotherapy, PD-L1, PD-1, pediatrics, sarcoma, and ASPS. Study selection and data extraction All English-language studies involving atezolizumab for ASPS were included and discussed. Data synthesis Atezolizumab is an anti-programmed death-ligand 1 (PD-L1) monoclonal antibody designed to block the interaction between PD-L1 and the programmed cell death protein 1 (PD-1) receptor. Atezolizumab was granted approval by the FDA specifically for ASPS based on a phase II clinical trial in adult and pediatric patients (n = 49), which reported an overall response rate of 24% and a durable response rate at 6 and 12 months of 67% and 42%, respectively. Common grade 3/4 adverse reactions include musculoskeletal pain (8%), followed by hypertension (6%), weight gain (6%), headache (4%), and dizziness (4%). Relevance to patient care and clinical practice in comparison with existing drugs Advanced ASPS is a high-risk disease with limited treatment options. Atezolizumab appears to be a viable treatment option in ASPS demonstrating clinical efficacy and a manageable toxicity profile. Conclusions With no other treatments that are FDA approved specifically for ASPS, and few demonstrating efficacy in the advanced setting, the approval of atezolizumab, including the first approval for pediatric patients, represents a landmark improvement to the therapeutic arsenal against this rare disease.

News (Medical) associated with Socazolimab

12 Nov 2024

·www.globenewswire.com

Checkpoint Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Updates

Biologics License Application for cosibelimab under review by U.S. FDA PDUFA goal date of December 28, 2024 WALTHAM, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the third quarter ended September 30, 2024, and recent corporate updates. “With the Prescription Drug User Fee Act (“PDUFA”) goal date set for next month, we await the decision by the U.S. Food and Drug Administration (“FDA”) on our Biologics License Application (“BLA”) resubmission for cosibelimab, our anti-programmed death ligand-1 (“PD-L1”) antibody,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “The $9.2 million in cash proceeds received this month from the exercise of existing warrants has strengthened our balance sheet to extend beyond our PDUFA date and into 2025. We are now fully focused on preparing for the potential approval of cosibelimab and look forward to potentially offering oncologists a new, differentiated treatment option for patients with advanced cutaneous squamous cell carcinoma (“cSCC”).” Recent Corporate Updates: In July 2024, Checkpoint announced that the FDA accepted for review the resubmission of its BLA for cosibelimab as a complete response to the complete response letter (“CRL”) issued in December 2023 and set a PDUFA goal date of December 28, 2024.Also in July 2024, Checkpoint announced a collaboration to explore the combined therapeutic potential of cosibelimab, its anti-PD-L1 antibody with dual mechanism of action, with GC Cell’s Immuncell-LC, an innovative autologous Cytokine Induced Killer T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells.Also in July 2024, Checkpoint completed a registered direct offering priced At-the-Market under Nasdaq rules and a concurrent private placement of warrants to purchase Checkpoint common stock, for total gross proceeds of approximately $12.0 million.In September 2024, Checkpoint presented longer-term data from its pivotal trial of cosibelimab in locally advanced and metastatic cSCC during the European Society for Medical Oncology (“ESMO”) Congress 2024. Longer-term results for cosibelimab presented at the ESMO Congress demonstrate a deepening of response over time, with higher objective response and complete response rates than initially observed at the primary analyses. A copy of the ESMO poster can be found on the Publications page of Checkpoint’s website.In November 2024, Checkpoint received $9.2 million in cash proceeds through the exercise of existing warrants. Financial Results: Cash Position: As of September 30, 2024, Checkpoint’s cash and cash equivalents totaled $4.7 million, compared to $5.0 million at June 30, 2024 and $4.9 million at December 31, 2023, a decrease of $0.3 million for the quarter and a decrease of $0.2 million, year-to-date. Subsequent to the end of the quarter, in November 2024, Checkpoint received $9.2 million in cash proceeds through the exercise of existing warrants.R&D Expenses: Research and development expenses for the third quarter of 2024 were $6.4 million, compared to $5.5 million for the third quarter of 2023, an increase of $0.9 million. Research and development expenses for the third quarter of 2024 included $0.5 million of non-cash stock expenses, compared to $0.3 million for the third quarter of 2023.G&A Expenses: General and administrative expenses for the third quarter of 2024 were $3.4 million, compared to $2.2 million for the third quarter of 2023, an increase of $1.2 million. General and administrative expenses for the third quarter of 2024 included $1.4 million of non-cash stock expenses, compared to $0.6 million for the third quarter of 2023.Net Loss: Net loss attributable to common stockholders for the third quarter of 2024 was $9.7 million, or $0.23 per share, compared to a net loss of $5.7 million, or $0.29 per share, in the third quarter of 2023. Net loss for the third quarter of 2024 included $1.9 million of non-cash stock expenses, compared to $0.9 million for the third quarter of 2023. About Checkpoint Therapeutics Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential differentiated anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, as a potential new treatment for patients with selected recurrent or metastatic cancers, including metastatic and locally advanced cSCC. Checkpoint is also evaluating its lead small-molecule, targeted anti-cancer agent, olafertinib, a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.checkpointtx.com. Forward‐Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended, that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our resubmission of our BLA for cosibelimab and review thereof, our belief that the BLA resubmission potentially addresses all the issues in the CRL, our belief about the comprehensive nature of our BLA resubmission and reaching alignment with the FDA on our cosibelimab BLA resubmission strategy, our ability to work with our third-party contract manufacturing organization (“CMO”) and the FDA to adequately address the issues raised in the CRL and execute on a pathway forward for the potential marketing approval of cosibelimab, the adequacy of the responses to the inspection issues submitted to FDA by our third-party CMO, our projections of regulatory review timelines, the commercial potential of cosibelimab, if approved, and the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-programmed death receptor-1 therapies and the dual mechanism of action of cosibelimab translating into potential enhanced efficacy. Factors that could cause our actual results to differ materially include the following: the risks and uncertainties associated with the regulatory review process; uncertainties regarding the timeline of FDA review of the resubmitted BLA; any inability to successfully work with the FDA to find a satisfactory solution to address any concerns in a timely manner or at all during the review process for the BLA, including any inability to provide the FDA with data, analysis or other information sufficient to support an approval of the BLA; our, and our third party CMO’s, ability to adequately address the issues raised in the CRL; issues associated with any facility inspection or re-inspection of our third party CMO or otherwise during the review process for the BLA; the risk that our third-party CMO will not meet deadlines, and/or comply with applicable regulations; whether the FDA accepts the data and results as included in the BLA resubmission at levels consistent with the published results, or at all; our ability to execute a partnering or other relationship to enable the commercialization of cosibelimab, if approved, on acceptable terms, if at all; the risk that topline and interim data remains subject to audit and verification procedures that may result in the final data being materially different from the topline or interim data we previously published; the risk that safety issues or trends will be observed in the clinical trial when the full safety dataset is available and analyzed; the risk that a positive primary endpoint does not translate to all, or any, secondary endpoints being met; risks that regulatory authorities will not accept an application for approval of cosibelimab based on data from the Phase 1 clinical trial; the risk that the clinical results from the Phase 1 clinical trial will not support regulatory approval of cosibelimab to treat cSCC or, if approved, that cosibelimab will not be commercially successful; risks related to our chemistry, manufacturing and controls and contract manufacturing relationships; risks related to our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks related to our need for substantial additional funds; other uncertainties inherent in research and development; our dependence on third-party suppliers; government regulation; patent and intellectual property matters; competition; unfavorable market or other economic conditions; and our ability to achieve the milestones we project, including the risk that the evolving and unpredictable Russia/Ukraine conflict and COVID-19 pandemic delay achievement of those milestones. Further discussion about these and other risks and uncertainties can be found in our Quarterly Report on Form 10-Q for the period ended June 30, 2024, and in our subsequent other filings with the U.S. Securities and Exchange Commission. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. This press release and prior releases are available at www.checkpointtx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. Company Contact: Jaclyn Jaffe Checkpoint Therapeutics, Inc. (781) 652-4500 ir@checkpointtx.com Investor Relations Contact: Ashley R. Robinson Managing Director, LifeSci Advisors, LLC (617) 430-7577 arr@lifesciadvisors.com Media Relations Contact: Katie Kennedy Gregory FCA 610-731-1045 checkpoint@gregoryfca.com CHECKPOINT THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands, except share and per share amounts) (Unaudited) September 30, 2024 December 31, 2023 ASSETS Current Assets: Cash and cash equivalents$4,703 $4,928 Prepaid expenses and other current assets 476 450 Total current assets 5,179 5,378 Total Assets$5,179 $5,378 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities: Accounts payable and accrued expenses$15,635 $15,485 Accounts payable and accrued expenses - related party 2,009 2,815 Common stock warrant liabilities 125 125 Total current liabilities 17,769 18,425 Total Liabilities 17,769 18,425 Commitments and Contingencies Stockholders’ Equity (Deficit) Common Stock ($0.0001 par value), 175,000,000 and 80,000,000 shares authorized as of September 30, 2024 and December 31, 2023, respectively Class A common shares, 700,000 shares issued and outstanding as of September 30, 2024 and December 31, 2023 - - Common shares, 45,095,500 and 27,042,035 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 5 3 Common stock issuable, 0 and 1,492,915 shares as of September 30, 2024 and December 31, 2023, respectively - 3,419 Additional paid-in capital 329,078 297,864 Accumulated deficit (341,673) (314,333)Total Stockholders’ Equity (Deficit) (12,590) (13,047)Total Liabilities and Stockholders’ Equity (Deficit)$5,179 $5,378 CHECKPOINT THERAPEUTICS, INC. CONDENSED STATEMENTS OF OPERATIONS (in thousands, except share and per share amounts) (Unaudited) For the three months ended September 30, For the nine months ended September 30, 2024 2023 2024 2023Revenue - related party$- $31 $41 $97 Operating expenses: Research and development 6,366 5,496 19,343 35,267 General and administrative 3,358 2,236 8,043 6,809 Total operating expenses 9,724 7,732 27,386 42,076 Loss from operations (9,724) (7,701) (27,345) (41,979) Other income (expense) Interest income 2 7 9 81 Gain on common stock warrant liabilities - 1,970 - 9,179 Foreign currency exchange loss (3) - (4) - Total other income (expense) (1) 1,977 5 9,260 Net Loss$(9,725) $(5,724) $(27,340) $(32,719) Loss per Share: Basic and diluted net loss per common share outstanding$(0.23) $(0.29) $(0.73) $(2.07) Basic and diluted weighted average number of common shares outstanding 43,151,861 19,988,079 37,556,863 15,842,693

ImmunotherapyFinancial StatementPhase 1Accelerated ApprovalCell Therapy

01 Nov 2024

·www.prnewswire.com

The Phase III clinical trial application for first-line treatment of extensive disease small cell lung cancer with Chiauranib has been approved

SHENZHEN, China, Nov. 1, 2024 /PRNewswire/ -- On November 1, Shenzhen Chipscreen Biosciences Co., Ltd. (hereinafter referred to as "Chipscreen Biosciences") and its wholly-owned subsidiary Chengdu Chipscreen Pharmaceutical Ltd., received the "Drug Clinical Trial Approval Notice" approved by the National Medical Products Administration. The company's self-developed original new drug, Chiauranib, combined with PD - (L) 1 monoclonal antibody and standard chemotherapy for the first-line treatment of extensive stage small cell lung cancer, has been approved for phase III clinical trials. Extensive disease small cell lung cancer (ES-SCLC), as a highly aggressive subtype of lung cancer, has long been a huge challenge in the field of treatment. In recent years, chemo-immunotherapy has greatly improved the survival outcomes of patients with small cell lung cancer. However, compared to other types of tumors, there is still great room for improvement in the long-term survival of patients with small cell lung cancer. Chiauranib has a multi pathway pharmacological mechanism and has unique anti-tumor activity against neuroendocrine tumors such as small cell lung cancer. At the same time, it can produce synergistic effects with immunotherapy and chemotherapy through its dual effects of anti-angiogenesis and immune regulatory activity. On the basis of first-line chemo-immunotherapy, the introduction of the new regimen of Chiauranib is expected to further improve the long-term survival of patients with extensive stage small cell lung cancer, demonstrating enormous clinical treatment potential. In addition to the approved Phase III clinical trial, the phase III clinical trial of Chiauranib monotherapy for the later-line treatment of small cell lung cancer has been completed and the Pre NDA is currently under communication. The phase III clinical trial of Chiauranib combined with chemotherapy for ovarian cancer, and the phase II clinical trial of single or combined treatment for triple negative breast cancer, soft tissue sarcoma and pancreatic cancer are also being progressed. In terms of overseas clinical trials, the phase Ib/II clinical trial of Chiauranib monotherapy for small cell lung cancer / solid tumor is in progress in the United States. About Chiauranib Chiauranib is a novel molecular entity independently designed and developed by the Chipscreen Biosciences, with global patent protection. It is a selective inhibitor of Aurora B, a key mitotic regulator. Additionally, Chiauranib targets VEGFR to inhibit tumor angiogenesis, and blocks CSF1R and DDR1 pathways to reduce the infiltration and activity of immunosuppressive cells, thereby enhancing tumor immune microenvironment. Its unique Aurora B inhibitory activity specifically targets neuroendocrine tumors, such as SCLC, making it a novel small molecule anti-tumor drug candidate. Chiauranib exerts a comprehensive anti-tumor effect by a triple-pathway mechanism that simultaneously inhibits tumor angiogenesis, prevents tumor cell mitosis, and modulates the tumor microenvironment. Chiauranib has outperformed drugs with a similar mechanism in overall efficacy and safety profile. About Chipscreen Chipscreen Biosciences is an innovative drug company driven by core technologies with globally competitive pipelines. As a pioneer in drug innovation & development in China, adhering to the concept of "Constant Innovation for Life", we focus on developing revolutionary innovative drugs with new mechanisms of action, to address patients' pressing clinical needs. Our complete industry chain that covers early exploratory discovery through commercialization allows us to provide innovative Chinese drugs for patients worldwide. With a global development strategy based on early-stage research in China, Chipscreen Biosciences has leveraged the top scientists and teams with extensive experience in related fields from the Shenzhen Small Molecule Early R&D Center and Chengdu Small Molecule Early R&D Center to create an integrated technology platform based on AI-driven design and chemical genomics, which spanned the whole process from basic science to clinical translation. We have successfully developed first-in-class and best-in-class innovative drugs. Currently, 2 drugs with 6 indications have been marketed worldwide. In addition, we have launched a number of R&D projects with differentiated advantages and global competitiveness in the five major areas, including malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antivirals. Chipscreen Biosciences has formed a global industrial layout consisting of Shenzhen Head Office/R&D Center/GMP production base, Chengdu Regional Head Office/R&D Center/GMP production base, Beijing Branch, Shanghai Branch, and Chipscreen Biosciences (USA) Co., Ltd. Meanwhile, as one of the first batches of national "innovative drug incubation bases" and national high-tech enterprises, Chipscreen Biosciences has independently undertaken many national "863" plans and national major science and technology projects, such as "10th five-year plan", "11th five-year plan", "12th five-year plan" and "13th five-year plan", and National Science and Technology primary Project for Innovative Drug Development. We have filed over 680 invention patents in China and worldwide, with over 200 granted. SOURCE Shenzhen Chipscreen Biosciences Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 3Phase 2Drug Approval

01 Nov 2024

·www.prnewswire.com

Akeso Announces First Patient Enrollment in Phase 3 Trial of Ivonescimab Combination as First-Line Therapy for Biliary Tract Tumors, Compared to Durvalumab

HONG KONG, Oct. 31, 2024 /PRNewswire/ -- Akeso Biopharma (9926.HK) is pleased to announce the successful enrollment of the first patient in the AK112-309 trial, a randomized, controlled, multicenter Phase III registration study for biliary track tumor. This trial is designed to compare the ivonescimab combined regimen, a PD-1/VEGF bispecific antibody internally developed by Akeso, with the durvalumab (PD-L1) combined regimen for the first-line treatment of advanced biliary tract cancers (BTC). The primary endpoint of the AK112-309 study is overall survival (OS). This study represents the sixth registrational Phase III clinical trial featuring ivonescimab, with a PD-1/L1 monoclonal antibody as the comparator. It underscores Akeso's commitment to advancing the field of cancer immunotherapy and establishing a global standard of care for cancer treatment. Furthermore, it highlights Akeso's capability to maximize the number of cancer patients globally that can benefit from its product portfolio through a strategic approach to clinical development. Previously, the positive results from a Phase II clinical study of ivonescimab in combination with chemotherapy for the first-line treatment of BTC were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The findings demonstrated that the ivonescimab regimen exhibits significant antitumor activity and a good safety profile in BTC. The objective response rate (ORR), as assessed by investigators, was 63.6%, with an ORR of 77.8% specifically for patients with gallbladder cancer. The disease control rate (DCR) reached 100%. The median progression-free survival (PFS) was 8.5 months, with a 6-month PFS rate of 84.4%. Furthermore, the median overall survival (OS) was 16.8 months, with a 9-month OS rate of 81.8%. Notably, patients with gallbladder cancer exhibited a median OS of 16.8 months. At the time of the analysis, the median follow-up time was 13.8 months. The study included patients with a median age of 65.3 years, of whom 81.8% had an ECOG performance status of 1. All enrolled patients are presented with unresectable tumors, and 40.9% were diagnosed with gallbladder cancer. Biliary tract malignancies, originating from the bile ducts and gallbladder, represent a group of highly heterogeneous cancers associated with a poor prognosis. At the time of diagnosis, approximately 50% of biliary tract cancer patients are already in advanced stages, often with a survival period of less than one year. Although PD-1/L1 inhibitors in combination with chemotherapy have been approved as a first-line treatment for advanced biliary tract cancer, the overall survival benefit has been limited, particularly for patients with gallbladder cancer. The initial positive clinical data from the ivonescimab regimen indicates a possible advancement in the therapeutic landscape for these challenging malignancies. About Ivonescimab (AK112/SMT112) Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics's license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab's first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultImmunotherapyDrug ApprovalASCO

100 Deals associated with Socazolimab

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Metastatic Cervical Carcinoma	CN	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	19 Dec 2023
Recurrent Cervical Cancer	CN	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	19 Dec 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Extensive stage Small Cell Lung Cancer	NDA/BLA	CN	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	13 Jul 2024
Uterine Cervical Cancer	Phase 3	-	Lee's Pharmaceutical Holdings Ltd.	01 Sep 2024
Esophageal Squamous Cell Carcinoma	Phase 2	CN	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	19 Nov 2020
Metastatic melanoma	Phase 1	CN	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	27 Sep 2021
Biliary Tract Neoplasms	Phase 1	CN	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	24 Mar 2021
Advanced Urothelial Carcinoma	Phase 1	CN	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	14 Sep 2020
Osteosarcoma	Phase 1	-	Lee's Pharmaceutical Holdings Ltd.	01 Jun 2020
Metastatic urothelial carcinoma	Phase 1	CN	Lee's Pharmaceutical Holdings Ltd.	10 Oct 2018
Transitional Cell Carcinoma	Phase 1	CN	Lee's Pharmaceutical Holdings Ltd.	10 Oct 2018
Metastatic Carcinoma to the Uterine Cervix	Phase 1	CN	Lee's Pharmaceutical Holdings Ltd.	16 Aug 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04878016 (Pubmed) Manual	Phase 3	Extensive stage Small Cell Lung Cancer First line	498	Socazolimab + Carboplatin and Etoposide	(ztciwoizaf) = qonsdobdeo jfeyvxpbiw (kkevkypeut ) View more	Positive	13 Jan 2025
NCT04878016 (Pubmed) Manual	Phase 3	Extensive stage Small Cell Lung Cancer First line	498	Placebo + Carboplatin and Etoposide	(ztciwoizaf) = oieszfuych jfeyvxpbiw (kkevkypeut ) View more	Positive	13 Jan 2025
NCT04603846 (Pubmed \| Oncologist) Manual	Phase 1	Advanced Urothelial Carcinoma First line	20	Socazolimab+Albumin-bound Paclitaxel	(udufkvdnxb) = All patients had TRAEs, most of which were grade 1 or 2. The common TRAEs (≥20%) were peripheral neurotoxicity, alopecia, rash, increased ALT, weight loss, weakness, pruritus, increased AST, increased γGT, increased ALP, neutropenia, emesis, and anorexia. ogudwmlkln (taoovpgypy ) View more	Positive	17 Oct 2024
NCT04603846 (ZKAB001, CSCO2022)	Phase 1	Advanced Urothelial Carcinoma	20	ZKAB001 (5mg/kg) + 白蛋白紫杉醇 (260mg/m2)	ufvndmhvzp(rgfxftkreh) = 4/20,20% anbzhcyett (ugergegvyv ) View more	-	21 Sep 2022
NCT04460066 (ESMO2022) Manual	Phase 2	Locally Advanced Esophageal Squamous Cell Carcinoma Neoadjuvant	64	Socazolimab+nab-paclitaxel+cisplatin	(cxqzydxdpg) = pptqfqdzba pxsyecuixt (lnnumcsuhi ) View more	Positive	10 Sep 2022
NCT04460066 (ESMO2022) Manual	Phase 2		64	placebo+nab-paclitaxel+cisplatin	(cxqzydxdpg) = wpgoejeyzk pxsyecuixt (lnnumcsuhi ) View more	Positive	10 Sep 2022
NCT04603846 (ASCO2022) Manual	Phase 1	Advanced Urothelial Carcinoma First line	20	nab-paclitaxel+socazolimab	(bexsvkpipv) = qvsjlfxsbz rjvxbwrlke (ekgyueeptv ) View more	Positive	02 Jun 2022
NCT03676959 (ASCO2022) Manual	Phase 1	Metastatic Carcinoma to the Uterine Cervix	104	socazolimab ( dose-expansion phase)	(zvpeotlkxg) = lvreixfqgi frrmsvmjiz (yfwutqjgip ) View more	Positive	02 Jun 2022
NCT03676959 (ASCO2022) Manual	Phase 1	Metastatic Carcinoma to the Uterine Cervix	104	socazolimab (CPS < 1)	(zvpeotlkxg) = irwlvrbbsq frrmsvmjiz (yfwutqjgip ) View more	Positive	02 Jun 2022
NCT04346914 (ESMO_ELCC2022 \| ESMO_ELCC2022) Manual	Phase 1	Extensive stage Small Cell Lung Cancer First line	20	Socazolimab+carboplatin+etoposide	(bkyywighmr) = akmnycfyvv tuafcrolfx (ktswlfplug ) View more	Positive	03 Apr 2022
NCT03676959 (phase I plus expansion study, IGCS2021)	Phase 1	Metastatic Carcinoma to the Uterine Cervix PD-L1-positive	-	Socazolimab 5mg/kg	(klosnzqjat) = qgcxcazqel utuajufbcm (jzjuivhauu, 10.9 - 27.4) View more	Positive	01 Nov 2021
NCT04603846 (ZKAB001, CSCO2021)	Phase 1	Extensive stage Small Cell Lung Cancer	20	ZKAB001+卡铂+依托泊苷	kokqtkqvcl(suielpimby) = 最常见治疗相关不良事件包括血小板计数降低(30.0%)、贫血(25%)、中性粒细胞计数降低(20%)、高血糖症(20%)和白细胞计数降低(20%) deudsagedo (tnhuhffbsh )	-	25 Sep 2021
NCT04603846 (ZKAB001, CSCO2021)	Phase 1	Advanced Urothelial Carcinoma	11	ZKAB001 5mg/kg + 白蛋白结合型紫杉醇 260mg/kg	(sjacwbiogj) = oflfwgwtyq lnalkojwnv (tsgvpasdef ) View more	-	25 Sep 2021

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