An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors Including Sarcomas

This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).

开始日期2018-10-10

申办/合作机构

Inhibrx Biosciences, Inc.

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100 项与 Ozekibart 相关的转化医学

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100 项与 Ozekibart 相关的专利（医药）

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项与 Ozekibart 相关的文献（医药）

2025-04-01·CURRENT TREATMENT OPTIONS IN ONCOLOGY

Recent Advances in Succinate Dehydrogenase Deficient Gastrointestinal Stromal Tumor Systemic Therapies

Review

作者: Van Galen, Joseph ; Dedousis, Demitrios ; Gadra, Elyse ; von Mehren, Margaret

OPINION STATEMENT:

Gastrointestinal stromal tumors (GIST) are the most common gastrointestinal soft tissue sarcomas, with an incidence of about 15 cases per million person-years. Approximately 15% of GIST develop due to succinate dehydrogenase deficiency (SDH-Def), and such tumors do not respond well to the tyrosine kinase inhibitors (TKIs) used to treat other GIST. Due to its indolent nature SDH-Def GIST can often be surveilled if asymptomatic. In our current practice we typically treat advanced symptomatic SDH-Def GIST with the anti-angiogenic TKIs, sequentially treating with sunitinib, regorafenib and pazopanib. This practice is based on limited data. This systematic review provides an update on new data (12/21/2021 to 9/26/2024) for systemic treatment of SDH-Def GIST, both with agents generally used to treat other GIST subtypes and with agents approved in other malignancies. Olverembatinib and rogaratinib have shown promising activity in pre-clinical models and small SDH-Def GIST cohorts. Other agents whose benefits are explored here include the immune checkpoint inhibitors (ICI) ipilimumab and nivolumab and temozolomide, whether as monotherapy or in combination with INBRX-109 (a pro-apoptotic antibody) or olaparib. Additional research into TKI agents with anti-vascular endothelial growth factor receptor (VEGFR) and anti-fibroblast growth factor receptor (FGFR) activity in this clinical setting is needed. Patients with SDH-Def will benefit more broadly from ongoing explorations of treatments with alternative mechanisms of action, especially those that exploit cellular pathways involved in SDH-Def GIST tumorigenesis.

2025-03-01·Oncology and Therapy

Advancing Systemic Therapy in Chondrosarcoma: New Horizons

Article

作者: Duffaud, Florence ; Jones, Robin L ; Li, Ka Hou C ; Gulia, Ashish

The systemic treatment landscape for advanced and metastatic chondrosarcoma, a malignancy with limited responsiveness to conventional therapies, has always been notoriously challenging. While standard chemotherapy offers minimal benefits, certain subtypes, such as mesenchymal and dedifferentiated chondrosarcomas, have shown some response to systemic therapies initially developed for other sarcomas. Investigational strategies are focusing on molecular targets, including mutations in the isocitrate dehydrogenase gene (IDH), signaling pathways, such as hedgehog and death receptor 5 (DR5) and immune modulation. IDH mutations, notably found in conventional and dedifferentiated chondrosarcomas, have prompted the evaluation of IDH inhibitors, which have demonstrated promising efficacy in preclinical and early clinical trials, despite limited data in chondrosarcoma. Additionally, the hedgehog pathway, implicated in chondrosarcoma progression, has been targeted with inhibitors, although clinical translation has shown mixed results. Immunotherapy, including programmed cell death 1 (PD-1) checkpoint inhibitors and chimeric antigen receptor-T (CAR-T) cells, is also being investigated but faces challenges due to the immunosuppressive tumour microenvironment. Among new approaches, DR5 agonists such as INBRX-109 have shown single-agent efficacy, with minimal toxicity, opening possibilities for use in combination therapies to improve outcomes. Given the heterogenous and treatment-resistant nature of chondrosarcoma, we highlight the need for multi-omics and genetic profiling to guide personalized, combination therapies that target multiple carcinogenic pathways. The integration of multi-targeted approaches could enhance efficacy, address tumour heterogeneity, and overcome resistance, presenting a hopeful direction for systemic therapy in this challenging cancer. The investigation of combination regimens with IDH inhibitors, immunotherapy and DR5 agonists hold promise for transforming the management of advanced chondrosarcoma.

2023-08-15·Clinical cancer research : an official journal of the American Association for Cancer Research

Preclinical Characterization and Phase I Trial Results of INBRX-109, A Third-Generation, Recombinant, Humanized, Death Receptor 5 Agonist Antibody, in Chondrosarcoma.

Article

作者: Wilky, Breelyn A ; O'Neill, Brianne ; Lakhani, Nehal J ; Berz, David ; Hussain, Abrahim ; Chawla, Sant P ; Heidt, Analeah B ; Senne, Lane ; Crago, William ; Rowell, Emily ; Andrianov, Vasily ; Willis, Katelyn M ; Tolcher, Anthony ; Conley, Anthony P ; Eckelman, Brendan P ; Holcomb, Monica ; Subbiah, Vivek ; Veldstra, Carson ; Kalabus, James

PURPOSE:

Patients with unresectable/metastatic chondrosarcoma have poor prognoses; conventional chondrosarcoma is associated with a median progression-free survival (PFS) of <4 months after first-line chemotherapy. No standard targeted therapies are available. We present the preclinical characterization of INBRX-109, a third-generation death receptor 5 (DR5) agonist, and clinical findings from a phase I trial of INBRX-109 in unresectable/metastatic chondrosarcoma (NCT03715933).

PATIENTS AND METHODS:

INBRX-109 was first characterized preclinically as a DR5 agonist, with binding specificity and hepatotoxicity evaluated in vitro and antitumor activity evaluated both in vitro and in vivo. INBRX-109 (3 mg/kg every 3 weeks) was then evaluated in a phase I study of solid tumors, which included a cohort with any subtype of chondrosarcoma and a cohort with IDH1/IDH2-mutant conventional chondrosarcoma. The primary endpoint was safety. Efficacy was an exploratory endpoint, with measures including objective response, disease control rate, and PFS.

RESULTS:

In preclinical studies, INBRX-109 led to antitumor activity in vitro and in patient-derived xenograft models, with minimal hepatotoxicity. In the phase I study, INBRX-109 was well tolerated and demonstrated antitumor activity in unresectable/metastatic chondrosarcoma. INBRX-109 led to a disease control rate of 87.1% [27/31; durable clinical benefit, 40.7% (11/27)], including two partial responses, and median PFS of 7.6 months. Most treatment-related adverse events, including liver-related events, were low grade (grade ≥3 events in chondrosarcoma cohorts, 5.7%).

CONCLUSIONS:

INBRX-109 demonstrated encouraging antitumor activity with a favorable safety profile in patients with unresectable/metastatic chondrosarcoma. A randomized, placebo-controlled, phase II trial (ChonDRAgon, NCT04950075) will further evaluate INBRX-109 in conventional chondrosarcoma.

项与 Ozekibart 相关的新闻（医药）

2025-05-14

·PRNewswire

Inhibrx Reports First Quarter 2025 Financial Results

SAN DIEGO, May 14, 2025 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") today reported financial results for the first quarter of 2025. Following the completion of the sale of INBRX-101 by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. and the Former Parent's concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs in ongoing clinical trials, with data readouts for each expected within the current year. Because the spin-off was accounted for as a reverse spin-off, for periods prior to the spin-off, the Company's financial statements are the historical financial statements of the Former Parent. Upcoming Milestones INBRX-109 Data from the registration-enabling Phase 2 trial in unresectable or metastatic conventional chondrosarcoma are expected during the third quarter of 2025; and Initial data on the colorectal cancer expansion cohort are anticipated in the third quarter of 2025 with interim data from the Ewing sarcoma expansion cohort expected in the second half of 2025. INBRX-106 Initial Phase 2 data from the randomized Phase 2/3 trial in head and neck squamous cell carcinoma in combination with KEYTRUDA® (pembrolizumab) are expected during the fourth quarter of 2025; and Interim data from the Phase 1/2 checkpoint inhibitor refractory or relapsed non-small cell lung cancer are expected during the fourth quarter of 2025. Financial Results Cash and Cash Equivalents. As of March 31, 2025, Inhibrx had cash and cash equivalents of $216.5 million, compared to $152.6 million as of December 31, 2024. The Company's cash balance increased following the receipt of $100.0 million in gross principal in January 2025 under a loan and security agreement (the "2025 Loan Agreement") entered into with Oxford Finance LLC ("Oxford"). R&D Expense. Research and development expenses were $36.9 million during the first quarter of 2025, compared to $63.9 million during the first quarter of 2024. The decrease in research and development expenses was primarily due to a decrease in clinical trial expenses and contract manufacturing expenses following the spin-off of our INBRX-101 program in the second quarter of 2024. G&A Expense. General and administrative expenses were $6.0 million during the first quarter of 2025, compared to $10.0 million during the first quarter of 2024. The decrease in general and administrative expenses was primarily due to: a decrease in non-cash stock option expense as a result of fewer stock options outstanding in the current period under the Company's new 2024 Omnibus Incentive Plan following the termination of its prior plan in connection with the spin-off; a decrease in professional service expenses in the current period as a result of higher legal and accounting services in the prior period to support the spin-off transaction and the conclusion of legal proceedings. Other Income (Expense). Other expense was $0.4 million during the first quarter of 2025, compared to other expense of $4.9 million during the first quarter of 2024. Other expense consists of interest expense incurred on the Company's outstanding third-party debt during each period, offset in part by interest income earned on the Company's sweep and money market account balances. The Company incurred less interest expense during the first quarter of 2025 as compared to the first quarter of 2024 due to a lower principal balance under its 2025 Loan Agreement as compared to its prior borrowings with Oxford which were extinguished as a result of the spin-off transaction. Net Loss. Net loss was $43.3 million during the first quarter of 2025, or $2.80 per share, basic and diluted, compared to a net loss of $78.7 million during the first quarter of 2024, or $5.77 per share, basic and diluted. About Inhibrx Biosciences, Inc. Inhibrx is a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates. Inhibrx utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary protein engineering platforms. Inhibrx was incorporated in January 2024 as a direct, wholly-owned subsidiary of Inhibrx, Inc. Prior to the sale of Inhibrx, Inc. and the INBRX-101 program to Sanofi S.A., Inhibrx acquired certain corporate infrastructure and other assets and liabilities through a series of internal restructuring transactions effected by Inhibrx, Inc. Inhibrx, Inc. also completed a distribution to holders of its shares of common stock of 92% of the issued and outstanding shares of Inhibrx. Following such transactions, Inhibrx's current clinical pipeline of therapeutic candidates includes ozekibart (INBRX-109) and INBRX-106, both of which utilize multivalent formats where the precise valency can be optimized in a target-centric way to mediate what we believe to be the most appropriate agonist function. For more information, please visit . Forward Looking Statements Inhibrx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Inhibrx's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements regarding expected data readouts and the timing thereof and the Company's ability to develop therapeutic candidates. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Inhibrx's business, including, without limitation, risks and uncertainties regarding: the initiation, timing, progress and results of its preclinical studies and clinical trials, and its research and development programs; its ability to advance therapeutic candidates into, and successfully complete, clinical trials; the Company's ability to utilize the Company's technology platform to generate and advance additional therapeutic candidates; the implementation of the Company's business model and strategic plans for the Company's business and therapeutic candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering the Company's therapeutic candidates; the ability to raise funds needed to satisfy the Company's capital requirements, which may depend on financial, economic and market conditions and other factors, over which the Company may have no or limited control; the Company's financial performance; developments relating to the Company's competitors and the Company's industry; and other risks described from time to time in the "Risk Factors" section of its filings with the U.S. Securities and Exchange Commission, including those described in its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q, and supplemented from time to time by its Current Reports on Form 8-K as filed from time to time. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Inhibrx undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor and Media Contact: Kelly D. Deck Chief Financial Officer [email protected] 858-795-4260 SOURCE Inhibrx Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

财报并购临床1期临床2期

2025-03-17

·PRNewswire

Inhibrx Reports Fourth Quarter and Fiscal Year 2024 Financial Results

SAN DIEGO, March 17, 2025 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") today reported financial results for the fourth quarter and fiscal year 2024. Following the completion of the sale of INBRX-101 by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. (the "Acquirer") and the Former Parent's concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs in ongoing clinical trials, with data readouts for each expected within the next 12 months. Because the spin-off was accounted for as a reverse spin-off, for periods prior to the spin-off, the Company's financial statements are the historical financial statements of the Former Parent. Key Highlights On January 13, 2025, the Company entered into a loan and security agreement (the "Oxford Loan Agreement"), with Oxford Finance LLC ("Oxford"), and received $100.0 million in gross proceeds upon closing. The Oxford Loan Agreement provides for an additional $50.0 million to be funded upon the Company's request and at the lenders' sole discretion. The loan bears interest at (1) 5.61% plus (2) the greater of (i) the 1-Month Term Secured Overnight Financing Right (SOFR), as published by the CME Group or (ii) 4.34%. The Company will make payments of interest on the loan through February 1, 2028, with principal payments beginning on March 1, 2028 through the maturity date of January 1, 2030. Upon the maturity date, the Company will make a final payment of 9.0% of the total repaid principal amount. On January 21, 2025, the Company announced interim efficacy and safety data from the Phase 1 trial of ozekibart (INBRX-109) in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal adenocarcinoma (CRC). Efficacy was assessed in 10 of the 13 patients who received at least one dose of ozekibart, based on RECIST v1.1 criteria. Results demonstrated one complete response, three partial responses, and six cases of stable disease. Durable disease control lasting ≥180 days was observed in 46.2% of patients, with a median progression-free survival (PFS) of 7.85 months. All patients had received at least one prior line of systemic therapy (median: two; range: 1–6). Inhibrx has initiated a new expansion cohort to validate these findings in a more uniform patient population. The cohort is expected to enroll up to 50 patients, each with two to three prior lines of systemic therapy, and data are anticipated in the third quarter of 2025. Financial Results Cash and Cash Equivalents. As of December 31, 2024, Inhibrx had cash and cash equivalents of $152.6 million. Subsequent to year-end, the Company entered into the Oxford Loan Agreement and received gross proceeds of $100.0 million. As of February 28, 2025, Inhibrx had cash and cash equivalents of $230.5 million. R&D Expense. Research and development expenses were $33.4 million during the fourth quarter of 2024 as compared to $82.1 million during the fourth quarter of 2023. Research and development expenses decreased during the fourth quarter of 2024 primarily due to a decrease in contract manufacturing expenses, primarily due to the divestiture of INBRX-101, for which we incurred significant expenses during the fourth quarter of 2023 related to large scale drug substance manufacturing services performed by one of the Company's CDMO partners, including the utilization of raw materials; Research and development expenses were $203.7 million during the fiscal year 2024 as compared to $191.6 million during the fiscal year 2023, primarily due to the following factors: an increase in stock option expense following the recognition of $25.9 million upon the acceleration of outstanding options in connection with the closing of the spin-off transaction; an increase in clinical trial expenses primarily due to the ongoing registration-enabling Phase 2 trial for ozekibart (INBRX-109) for the treatment of unresectable or metastatic conventional chondrosarcoma and due to the expansion of the INBRX-106 Phase 1/2 trial and initiation of the Phase 2/3 trial for HNSCC, including expenses for in-house clinical trial support. These increases were offset in part by a decrease in clinical trial expenses as a result of the termination of the INBRX-105 program; and offset in part by a decrease in contract manufacturing expenses in the fourth quarter of 2024 as opposed to the fourth quarter of 2023 following the divestiture of INBRX-101, as discussed above. G&A Expense. General and administrative expenses were $16.7 million during the fourth quarter of 2024, compared to $7.8 million during the fourth quarter of 2023. General and administrative expenses increased during the fourth quarter of 2024 primarily due to legal services incurred in connection with the Company's legal proceedings, which have since concluded, finding the Company not liable for damages. General and administrative expenses were $127.9 million during the fiscal year 2024, compared to $29.4 million during the fiscal year 2023. General and administrative expenses increased during the fiscal year 2024, primarily due to the following factors: one-time expenses of $68.1 million incurred related to the spin-off transaction, which consisted of legal, advisory, and consulting services performed in connection to the transaction; an increase in stock option expense following the recognition of $15.2 million upon the acceleration of outstanding options in connection with the closing of the spin-off transaction; an increase in legal services incurred in connection with the Company's legal proceedings as discussed above; and an increase in pre-commercialization expenses, primarily related to increases in consulting services and scientific publications to support the Company's commercial operations business intelligence strategies related to ozekibart (INBRX-109) and prior to the spin-off transaction, related to INBRX-101, in addition to a focus on patient advocacy and recruitment efforts, offset in part by a decrease in market research efforts following the disposition of INBRX-101. Other Income (Expense). Other income was $2.1 million during the fourth quarter of 2024, compared to other expense of $3.7 million during the fourth quarter of 2023. Following the Company's spin-off transaction in the second quarter of 2024, the Company no longer had any outstanding third-party debt, and therefore did not incur any interest expense during the period. During the fourth quarter of 2024, other income consisted of interest earned on the Company's sweep and money market account balances. Other income was $2.0 billion during the fiscal year 2024 as compared to other expense of $20.5 million during the fiscal year 2023. During the fiscal year 2024, other income consisted of interest earned on the Company's sweep and money market account balances, as noted above, in addition to the gain recorded in connection with the completion of the spin-off transaction. This gain consisted of (i) the consideration paid by the Acquirer for all outstanding common stock, warrants, and stock options, (ii) the extinguishment of the Company's outstanding debt which was assumed by the Acquirer, (iii) assets and liabilities related to the 101 Business, which were assumed by the Acquirer, and (iv) transaction costs paid for by the Acquirer. Other expense in the prior year consisted of interest expense related to the Company's third-party debt outstanding in the period. Net Income (Loss). Net loss was $47.9 million during the fourth quarter of 2024, or $3.09 per share, basic and diluted, compared to $93.6 million during the fourth quarter of 2023, or $6.93 per share, basic and diluted. Net income was $1.7 billion during the fiscal year 2024, or earnings per share of $114.01, basic, and $112.62, diluted, compared to a net loss of $241.4 million during the fiscal year 2023, or $20.48 per share, basic and diluted. About Inhibrx Biosciences, Inc. Inhibrx is a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates. Inhibrx utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary protein engineering platforms. Inhibrx was incorporated in January 2024 as a direct, wholly-owned subsidiary of Inhibrx, Inc. Prior to the sale of Inhibrx, Inc. and the INBRX-101 program to Sanofi S.A., Inhibrx acquired certain corporate infrastructure and other assets and liabilities through a series of internal restructuring transactions effected by Inhibrx, Inc. Inhibrx, Inc. also completed a distribution to holders of its shares of common stock of 92% of the issued and outstanding shares of Inhibrx. Following such transactions, Inhibrx's current clinical pipeline of therapeutic candidates includes ozekibart (INBRX-109) and INBRX-106, both of which utilize multivalent formats where the precise valency can be optimized in a target-centric way to mediate what we believe to be the most appropriate agonist function. For more information, please visit . Forward Looking Statements Inhibrx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Inhibrx's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements regarding expected data readouts and the timing thereof and the Company's ability to develop therapeutic candidates. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Inhibrx's business, including, without limitation, risks and uncertainties regarding: the initiation, timing, progress and results of its preclinical studies and clinical trials, and its research and development programs; its ability to advance therapeutic candidates into, and successfully complete, clinical trials; the Company's ability to utilize the Company's technology platform to generate and advance additional therapeutic candidates; the implementation of the Company's business model and strategic plans for the Company's business and therapeutic candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering the Company's therapeutic candidates; the ability to raise funds needed to satisfy the Company's capital requirements, which may depend on financial, economic and market conditions and other factors, over which the Company may have no or limited control; the Company's financial performance; developments relating to the Company's competitors and the Company's industry; and other risks described from time to time in the "Risk Factors" section of its filings with the U.S. Securities and Exchange Commission, including those described in its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q, and supplemented from time to time by its Current Reports on Form 8-K as filed from time to time. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Inhibrx undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor and Media Contact: Kelly D. Deck Chief Financial Officer [email protected] 858-795-4260 SOURCE Inhibrx Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期财报临床结果并购引进/卖出

2025-01-26

·药明康德

疾病控制率超95%的CLDN 18.2靶向疗法；可穿越血脑屏障的变构小分子痴呆症疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 靶向CLDN18.2的抗体偶联药物（ADC）ATN-022用于治疗晚期或转移性胃癌，在一项1/2期临床试验中表现亮眼，CLDN 18.2高表达患者的疾病控制率（DCR）达95.2%。 2. 在研环肽疗法certepetide联合标准治疗（SoC）化疗及免疫治疗一线治疗局部晚期不可切除的胰腺导管腺癌（PDAC），16例接受4个周期治疗的患者中有9例达到部分缓解（PR），1例达到完全缓解（CR）。 3. 小分子TREM2激动剂VG-3927在1期临床试验中获得积极数据，在阿尔茨海默病（AD）患者脑脊液（CSF）中实现了高达约50%的游离TREM2（sTREM2）显著剂量依赖性降低。药明康德内容团队整理 ATN-022：公布在中国和澳大利亚开展的1/2期临床试验的新数据 Antennova公司在美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI 2025）上公布了其正在中国和澳大利亚进行的1/2期研究CLINCH的最新数据，该研究评估了其靶向CLDN18.2的抗体偶联药物ATN-022在晚期或转移性胃癌患者中的治疗效果。Claudin是正常组织紧密连接中重要的一种蛋白质，具有4个跨膜结构域，它参与细胞旁通透性和电导等过程的调节。CLDN18.2在包含胃癌在内的消化道癌症中高度表达。因此，CLDN18.2为治疗胃癌、胰腺癌等实体肿瘤的有效靶标。截至2024年11月22日的数据，在剂量扩展研究中，CLDN 18.2表达为免疫组化（IHC）染色2+≥20%，且至少有1次肿瘤评估的21例胃癌患者中，总缓解率（ORR）达42.9%，DCR达95.2%，包括9例PR和11例疾病稳定（SD）的患者。在10例以1.8–2.4 mg/kg的有效剂量治疗，CLDN 18.2表达为IHC染色2+<20%的胃癌患者中，ORR为30.0%，包括1例CR和2例PR患者（均确认为CLDN 18.2表达为IHC染色2+<5%），DCR为50.0%。截至截止日期，CR患者已持久缓解超过14个月。总体来说，ATN-022在晚期胃癌患者中表现出可控的安全性和初步的抗肿瘤活性，且在不同CLDN18.2表达水平的患者中均显示出潜力，支持进一步在胃癌患者中进行临床研究。 Certepetide（LSTA1）：公布1b/2a期临床试验的初步数据 Lisata Therapeutics公司与非营利性临床研究组织WARPNINE Incorporated公布了1b/2a期临床试验iLSTA的初步结果。该试验评估了Lisata公司的在研环肽疗法certepetide联合标准治疗化疗及免疫治疗作为一线治疗，用于治疗局部晚期不可切除的胰腺导管腺癌患者的效果。Certepetide旨在激活一种肿瘤特异性的转运系统，使与之联合使用的全身性抗癌药物能够更有效地穿透肿瘤并在肿瘤内蓄积。此外，certepetide还被证明可以调节肿瘤微环境，使肿瘤对免疫疗法更加敏感。此次公布的结果显示，根据RECIST标准可评估的16例患者中，有5例在2个治疗周期后达到PR，其余11例患者达到SD。经过4个治疗周期后，16例患者中有9例患者达到PR，1例患者达到CR，其余6例患者保持SD。在完成4个治疗周期的17例患者中，有14例患者的CA19-9水平下降，其中6名患者的CA19-9水平降低>90%，8名患者降低>50%。5例接受重复活检的患者的结果显示，所有患者的肿瘤浸润淋巴细胞显著增加，基质浸润率为15%至50%。 VG-3927：公布1期临床试验的中期数据 Vigil Neuroscience公司宣布，其用以治疗阿尔茨海默病的在研小分子疗法VG-3927在1期临床试验中获得积极数据。VG-3927是一种口服生物利用度强的小分子TREM2激动剂。其作为激动剂和正变构调节剂（PAM）的新型作用模式可能会放大其在病灶部位的作用，从而强烈调节小胶质细胞并可能增强神经保护。VG-3927旨在增强小胶质细胞对聚集淀粉样蛋白和tau的保护性反应，同时不增加炎症反应。由于VG-3927不与sTREM2结合，与抗体TREM2激动剂相比，该疗法可最大限度地提高受体活化和小胶质细胞功能，这可能会增加其进入AD病灶的机会。此外，VG-3927没有Fc结构域，该结构域与免疫系统中与淀粉样蛋白相关成像异常（ARIA）风险增加相关的元素有关。此次公布的分析显示，VG-3927的脑部渗透性高，并展现出支持每日一次给药的良好且可预测的药代动力学（PK）特征。值得注意的是，该疗法在CSF中实现了高达约50%的sTREM2显著剂量依赖性降低，且显示出强劲的PK/药效学（PD）关系、持久的靶点结合能力以及TREM2激动剂活性。根据此积极结果，该公司预计于2025年第三季度启动VG-3927的2期试验。根据新闻稿，VG-3927是首个准备进入2期临床的每日一次口服TREM2小分子激动剂。 Ozekibart（INBRX-109）：公布1期临床试验的初步数据 Inhibrx Biosciences公司公布了ozekibart（INBRX-109）联合FOLFIRI治疗晚期或转移性不可切除的结直肠癌（CRC）的1期临床试验的初步疗效和安全性数据。Ozekibart是一种经过精密设计的四价死亡受体5（DR5）激动剂抗体，旨在利用DR5激活诱导的肿瘤偏向性细胞死亡。2021年1月，美国FDA授予ozekibart快速通道资格，用于治疗转移性或不可切除的传统软骨肉瘤患者。2021年11月，FDA授予ozekibart用于治疗软骨肉瘤的孤儿药资格。此次公布的结果显示，在10名疗效可评估的患者中，观察到1例CR、3例PR和6例SD，46.2%的患者实现了持续≥180天的疾病控制，中位无进展生存期（PFS）为7.85个月。值得注意的是，达到CR的患者既往接受过3线治疗，其中2例PR发生在既往接受基于FOLFIRI治疗后失败的患者中。安全性方面，大多数治疗伴发不良事件（TEAE）为低级别，≥3级TEAE的发生率为30.8%。 Ivaltinostat：公布1b/2期联合治疗试验数据 CG Pharmaceuticals公司公布了ivaltinostat用于治疗转移性PDAC的1b/2期临床试验结果。在这项1b期研究中，28名接受过至少一线治疗的局部晚期或转移性PDAC患者接受了3种不同剂量的ivaltinostat联用卡培他滨。Ivaltinostat是一种表观遗传靶向的HDAC抑制剂，与其他同类在研药物相比，ivaltinostat显示出优异的安全性和药代动力学特性。截至2024年12月28日的数据，28名患者中有7名仍然存活，18名死亡（全部由于停止研究后疾病进展，没有与研究治疗直接相关的死亡），1名失访，2名退出研究。存活时间最长的患者已存活27个月，最长治疗持续时间为20个月。在总共28名患者中，65%显示SD或没有疾病证据，14%出现疾病进展，22%未接受评估。 ATTO-1310：1期临床试验完成首例患者给药 Attovia Therapeutics公司宣布，其用于治疗不明原因慢性瘙痒症（CPUO）等瘙痒症的全身治疗药物ATTO-1310的首次人体1期研究已完成首例受试者给药。ATTO-1310基于该公司专有的生物制品平台ATTOBODY开发，是一种新型皮下（SQ）给药、半衰期延长（HLE）的抗IL-31疗法。该公司的ATTOBODY平台通过专有的连接技术能够将两个与同一靶点蛋白两个不同表位结合的抗体片段连接起来，构成双互补位生物制品（biparatopic biologics）。ATTOBODY具有多种优势，包括可与靶点以皮摩尔的亲和力结合，并且亲和力可以调节，从而获得优化的药代动力学特征。此外，它具有模块化结构，可以将不同ATTOBODY模块结合在一起构建多特异性生物制品。此外，ATTOBODY可以和各种不同延长半衰期的片段融合，根据需要延长生物制品的半衰期，甚至具有每三个月给药一次的潜力。 CG001419：启动1期临床试验给药 Cullgen公司宣布启动CG001419的人体试验。该公司的泛素介导的小分子诱导靶标消除技术（uSMITE）平台能够让药物设计范式超越功能位点抑制，让“难以靶向”的酶和蛋白质调控成为可能。其开发的CG001419是一种潜在“first-in-class”的口服泛TRK蛋白降解剂，旨在选择性降解突变型和野生型TRK蛋白。该疗法正在被开发为一种非阿片类、非非甾体抗炎药的新镇痛疗法，并有望降低与其他药物治疗疼痛相关的成瘾风险。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Antennova Presents Latest Phase I/II Data on ATN-022 in Advanced/Metastatic Gastric Cancer, Including an ORR of 42.9%, at ASCO GI 2025. Retrieved January 24, 2025, from https://www.prnewswire.com/news-releases/antennova-presents-latest-phase-iii-data-on-atn-022-in-advancedmetastatic-gastric-cancer-including-an-orr-of-42-9-at-asco-gi-2025--302356818.html [2] Inhibrx Biosciences Announces Preliminary Data from the Phase 1 Trial of ozekibart (INBRX-109) for the Treatment of Colorectal Cancer. Retrieved January 24, 2025, from https://www.prnewswire.com/news-releases/inhibrx-biosciences-announces-preliminary-data-from-the-phase-1-trial-of-ozekibart-inbrx-109-for-the-treatment-of-colorectal-cancer-302356540.html [3] Lisata Therapeutics and WARPNINE Announce Encouraging Preliminary Results from the Phase 1b/2a iLSTA Trial Evaluating Certepetide in Locally Advanced Non-Resectable Pancreatic Ductal Adenocarcinoma. Retrieved January 24, 2025, from https://www.globenewswire.com/news-release/2025/01/23/3014226/18623/en/Lisata-Therapeutics-and-WARPNINE-Announce-Encouraging-Preliminary-Results-from-the-Phase-1b-2a-iLSTA-Trial-Evaluating-Certepetide-in-Locally-Advanced-Non-Resectable-Pancreatic-Duct.html [4] Vigil Neuroscience Reports Positive Data from its Phase 1 Clinical Trial Evaluating VG-3927 for the Potential Treatment of Alzheimer’s Disease. Retrieved January 23, 2025 from https://investors.vigilneuro.com/news-releases/news-release-details/vigil-neuroscience-reports-positive-data-its-phase-1-clinical [5] CG Pharmaceuticals: Progress of U.S. Phase 1b/2 Metastatic Pancreatic Cancer Clinical Trial at the ASCO Gastrointestinal Symposium. Retrieved January 23, 2025 from https://www.prnewswire.com/news-releases/cg-pharmaceuticals-progress-of-us-phase-1b2-metastatic-pancreatic-cancer-clinical-trial-at-the-asco-gastrointestinal-symposium-302358895.html [6] NiKang Therapeutics® Announces First Patient Dosed in a Phase 1b/2 Study of NKT2152 in Combination with Standard-of-Care in First-Line Regimen for Hepatocellular Carcinoma. Retrieved January 23, 2025 from https://www.prnewswire.com/news-releases/cg-pharmaceuticals-progress-of-us-phase-1b2-metastatic-pancreatic-cancer-clinical-trial-at-the-asco-gastrointestinal-symposium-302358895.html [7] Cullgen Begins Phase 1 Dosing of its Potential First-in-Class, Oral Pan-TRK Protein Degrader for Acute and Chronic Pain. Retrieved January 23, 2025 from https://www.globenewswire.com/news-release/2025/01/22/3013421/0/en/Cullgen-Begins-Phase-1-Dosing-of-its-Potential-First-in-Class-Oral-Pan-TRK-Protein-Degrader-for-Acute-and-Chronic-Pain.html [8] ENA Respiratory Successfully Completes Phase Ib Dosing of Antiviral Host Defense Immune Enhancer INNA-051 Dry Powder Formulation in Older Adults and Advances Study in Young Adults. Retrieved January 23, 2025 from https://enarespiratory.com/ena-respiratory-successfully-completes-phase-ib-dosing-of-antiviral-host-defense-immune-enhancer-inna-051-dry-powder-formulation-in-older-adults-and-advances-study-in-young-adults/ [9] LAPIX Therapeutics Doses First Patient-In Phase 1b Clinical Trial of LPX-TI641 for Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA). Retrieved January 23, 2025 from https://www.globenewswire.com/news-release/2025/01/23/3014360/0/en/LAPIX-Therapeutics-Doses-First-Patient-In-Phase-1b-Clinical-Trial-of-LPX-TI641-for-Rheumatoid-Arthritis-RA-and-Psoriatic-Arthritis-PsA.html [10] Kiromic BioPharma Reports Tumor Volume Decrease in Two Patients Enrolled in Deltacel-01. Retrieved January 24, 2025, from https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-reports-tumor-volume-decrease-two-patients [11] EXUMA Biotech Announces Phase 1 Results for its Autologous HER2 Directed, Tumor Metabolism Regulated (TMR) CAR-T Product at ASCO GI 2025. Retrieved January 24, 2025, from https://www.prnewswire.com/news-releases/exuma-biotech-announces-phase-1-results-for-its-autologous-her2-directed-tumor-metabolism-regulated-tmr-car-t-product-at-asco-gi-2025-302358845.html [12] Century Therapeutics Announces Investigator-Initiated Phase 1/2 Trial of its iPSC-derived iNK Cell Therapy CNTY-101 in B-cell Mediated Autoimmune Diseases Sponsored by Internationally Renowned Key Opinion Leaders. Retrieved January 24, 2025, from https://investors.centurytx.com/news-releases/news-release-details/century-therapeutics-announces-investigator-initiated-phase-12 [13] ORYZON announces first patient dosed in an Investigator-initiated Phase I study of iadademstat in myelodysplastic syndrome. Retrieved January 24, 2025, from https://www.oryzon.com/en/news-events/news/oryzon-announces-first-patient-dosed-investigator-initiated-phase-i-study [14] Attovia Therapeutics Announces First Participant Dosed in First-in-Human Phase 1 Study of ATTO-1310, its Novel Half-life Extended Anti-IL-31 ATTOBODY for the Treatment of Chronic Pruritus. Retrieved January 24, 2025, from https://www.globenewswire.com/news-release/2025/01/23/3014175/0/en/Attovia-Therapeutics-Announces-First-Participant-Dosed-in-First-in-Human-Phase-1-Study-of-ATTO-1310-its-Novel-Half-life-Extended-Anti-IL-31-ATTOBODY-for-the-Treatment-of-Chronic-Pr.html [15] BlossomHill Therapeutics Doses Patients in the First Cohort of the Phase 1/2 SOLARA Clinical Trial of BH-30643 for EGFR- and HER2-Mutated Non-Small Cell Lung Cancer. Retrieved January 24, 2025, from https://www.businesswire.com/news/home/20250122706462/en 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果ASCO会议抗体药物偶联物免疫疗法临床2期

100 项与 Ozekibart 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
软骨肉瘤	临床2期	美国	Inhibrx Biosciences, Inc.	2021-09-23
软骨肉瘤	临床2期	澳大利亚	Inhibrx Biosciences, Inc.	2021-09-23
软骨肉瘤	临床2期	法国	Inhibrx Biosciences, Inc.	2021-09-23
软骨肉瘤	临床2期	德国	Inhibrx Biosciences, Inc.	2021-09-23
软骨肉瘤	临床2期	爱尔兰	Inhibrx Biosciences, Inc.	2021-09-23
软骨肉瘤	临床2期	意大利	Inhibrx Biosciences, Inc.	2021-09-23
软骨肉瘤	临床2期	荷兰	Inhibrx Biosciences, Inc.	2021-09-23
软骨肉瘤	临床2期	西班牙	Inhibrx Biosciences, Inc.	2021-09-23
软骨肉瘤	临床2期	英国	Inhibrx Biosciences, Inc.	2021-09-23
大肠腺癌	临床1期	美国	Inhibrx Biosciences, Inc.	2018-10-10

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03715933 (ASCO_GI2025)	临床1期	大肠腺癌二线	13	Ozekibart 1 mg/kg + FOLFIRI	鑰鹹網鹹膚餘積廠餘遞(膚壓網製醖選餘鏇範鏇) = Ozekibart-related adverse events (AEs) were reported in 85% of pts (grade ≥3, 31%) and led to ozekibart interruption in 3 pts and discontinuation in 1 pt 遞網膚襯繭鑰淵範衊觸 (顧顧選齋膚鹽鏇範積憲 ) 更多	积极	2025-01-23
NCT03715933 (PRNewswire) 人工标引	临床1期	尤文肉瘤	13	INBRX-109+Irinotecan+Temozolomide	築膚簾膚範餘衊鬱願積(鏇顧構遞憲膚窪蓋製選) = 築製襯壓齋網蓋鹹鑰範淵窪糧夢積廠糧淵壓願 (製壓鏇廠築夢鬱夢醖簾 ) 更多	积极	2023-11-02
NCT03715933 (Pubmed \| Clin Cancer Res)	临床1期	软骨肉瘤 IDH1/IDH2-mutant	-	INBRX-109 3 mg/kg	醖願憲鏇膚簾鏇齋網憲(簾糧糧顧顧糧餘築糧顧) = <4 months 範獵簾襯選窪繭醖鹽觸 (選壓醖憲艱構願積製鏇 ) 更多	-	2023-08-15
NCT03715933 (Corporate Publications) 人工标引	临床1期	软骨肉瘤	33	INBRX-109	網蓋網壓淵築糧簾淵築(觸遞積襯簾構獵網夢壓) = increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), and increased blood bilirubin and fatigue. 積襯鏇膚遞構積襯憲築 (製製衊鹹壓壓願鹹壓鏇 )	积极	2022-11-16
NCT04950075 (ASCO2022)	临床2期	软骨肉瘤	201	INBRX-109	壓積製構獵選範鏇壓襯(蓋蓋獵範襯膚製鬱製鬱) = 憲夢鹽廠獵憲醖鬱範繭簾網觸壓齋鑰範壓願襯 (蓋獵憲廠餘範膚選衊簾 )	-	2022-06-02
NCT04950075 (ASCO2022)	临床2期	软骨肉瘤	201	Placebo	壓積製構獵選範鏇壓襯(蓋蓋獵範襯膚製鬱製鬱) = 繭製鹽鹹構襯窪範網鑰簾網觸壓齋鑰範壓願襯 (蓋獵憲廠餘範膚選衊簾 )	-	2022-06-02