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更新于：2025-08-02
ALLO-316
更新于：2025-08-02
概要
基本信息
非在研机构- |
最高研发阶段临床1期 |
首次获批日期- |
最高研发阶段(中国)临床1期 |
特殊审评快速通道 (美国)、再生医学先进疗法 (美国) |
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关联
1
项与 ALLO-316 相关的临床试验NCT04696731
A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 Following ALLO-647 Containing Conditioning Regimen in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
This is a Phase 1 dose escalation study following a 3+3 study design. The purpose of the TRAVERSE study is to assess the safety, efficacy, and cell kinetics of ALLO-316 in adults with advanced or metastatic clear cell renal cell carcinoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647 to define a Phase 2 dose.
开始日期2021-02-24 |
申办/合作机构 |
100 项与 ALLO-316 相关的临床结果
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100 项与 ALLO-316 相关的转化医学
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100 项与 ALLO-316 相关的专利（医药）
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1
项与 ALLO-316 相关的文献（医药）2022-07-18·Cancer research
Antitumor CAR T-cell Screening Platform: Many Are Called, but Few Are Chosen
Communications
作者: Adotévi, Olivier ; Galaine, Jeanne
Abstract:
Treatment with T cells expressing chimeric antigen receptors (CAR) is a promising anticancer therapy. However, this approach has several limitations and has not yet been effectively applied to treat solid tumors. The study by Panowski and colleagues represents the first comparative analysis of multiple single chain fragment variable (scFv)-based anti-CD70 CAR T-cell clones for the development of a clinical product to treat renal cell carcinoma (RCC). Despite the risk of T-cell fratricide due to CD70 expression on T cells, CD70 CAR T cells were produced successfully thanks to the protective CD70 masking phenomenon. Two distinct classes of CAR T cells were identified with different memory phenotypes, activation statuses, and cytotoxic activity. CD70 CAR T cells presented high cytotoxic activity against RCC both in vitro in RCC cell lines and in vivo in patient-derived xenograft mouse models. The off-target effects expected on the lymphoid compartment were confirmed by tissue cross-reactivity staining and in a cynomolgus monkey preclinical model with CD3-CD70 bispecific antibody treatment. The efficacy and the toxicity profile of the lead CD70 CAR T-cell candidate instigated the researchers to proceed with upscaled clinical production. This article emphasizes the influence of the scFv of the CARs on their efficacy:toxicity balance. Ultimately, they successfully managed to develop a highly effective CAR T-cell candidate to treat a solid tumor by an allogeneic approach, thereby overcoming two major hurdles to broaden application of CAR T-cell therapy.See related article by Panowski et al., p. 2610
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项与 ALLO-316 相关的新闻（医药）2025-08-01
Lymphodepletion Regimen Selection Made in Conjunction with the ALPHA3 Data and Safety Monitoring Board (DSMB) and Steering Committee, and in Consultation with the FDA Following an ALLO-647-Related Death in the FCA (FC plus ALLO-647) Lymphodepletion ArmUnplanned Review of Safety and Biomarker Data with Standard FC and Cema-cel Indicates Encouraging MRD Conversion Rate and Safety ProfileALPHA3 Study Now Proceeds as a Two-Arm Randomized Study Comparing Cema-cel After Standard FC Lymphodepletion to Observation; Scheduled Futility Analysis Remains 1H 2026, as PlannedConference Call and Webcast Scheduled for Today at 8:00 AM PT/11:00 AM ET SOUTH SAN FRANCISCO, Calif., Aug. 01, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that it has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen to be used in its ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line consolidation for large B-cell lymphoma (LBCL). This lymphodepletion regimen selection was made in conjunction with the ALPHA3 Data and Safety Monitoring Board (DSMB) and Steering Committee and following consultation with the U.S. Food and Drug Administration (FDA). The arm testing FC plus ALLO-647, an anti-CD52 mAb (FCA), is now closed to further enrollment. This decision, made ahead of the scheduled futility analysis, was prompted by a Grade 5 adverse event in the FC plus ALLO-647 arm that has been attributed to the use of ALLO-647. The event occurred on Day 54 post-infusion from hepatic failure, believed to have resulted from disseminated adenovirus infection in the setting of immune suppression. This event was deemed unrelated to cema-cel. Severe viral infections have been rare across Allogene’s clinical trials. However, when present, they have been attributed to immunosuppression due in part to ALLO-647. There have been no cases of adenoviral infection or hepatic failure in any participant treated with FC lymphodepletion across Allogene’s trials. “The loss of a patient is always deeply saddening, and we extend our heartfelt condolences to the patient’s family,” said David Chang, M.D., Ph.D., President, Chief Executive Officer, and Co-Founder of Allogene. “This event, which prompted an early review of the trial data, compelled us to make a decisive choice - one that may ultimately help bring this potentially life-saving therapy to patients more quickly. The ability to administer cema-cel following standard FC lymphodepletion in an outpatient setting will simplify study treatment and has the potential to accelerate trial enrollment and streamline regulatory review, ultimately transforming care for patients.” The adoption of standard FC in the ALPHA3 trial marks a key shift in Allogene’s clinical strategy. As a result, no trials open to enrollment or pipeline programs include ALLO-647. Instead, the Company is advancing its next-generation AlloCAR T product candidates using the proprietary Dagger® Platform Technology, which is designed to minimize or potentially eliminate the need for standard lymphodepletion. This approach is showcased in the ALLO-316 TRAVERSE trial for advanced renal cell carcinoma and the ALLO-329 RESOLUTION trial for autoimmune diseases, both of which leverage the Dagger® Technology to reduce reliance on traditional lymphodepletion strategies. The amended ALPHA3 trial now proceeds as a randomized study with two arms, comparing cema-cel after standard FC lymphodepletion to observation, the current standard of care. Statistical design of the trial and the prespecified study conduct remain the same. The next milestone will be the futility analysis comparing MRD conversion and is expected to occur 1H 2026. To date, over 50 clinical sites are activated across the United States and Canada, including community cancer centers and major academic institutions. Conference Call and Webcast DetailsAllogene will host a live conference call and webcast today at 8:00 a.m. PT / 11:00 a.m. ET to discuss this recent update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company's website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company's website for approximately 30 days. About Cemacabtagene Ansegedleucel (cema-cel)Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T™ investigational product for the treatment of large B cell lymphoma (LBCL). The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan. About the ALPHA3 TrialOver 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% who initially respond will relapse and require subsequent treatment. The current standard of care after 1L treatment has been simply to “watch and wait” to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, “off-the-shelf” treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard “7th cycle” of frontline treatment available to all eligible patients with MRD. About Allogene TherapeuticsAllogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow Allogene Therapeutics on X and LinkedIn. Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as “indicates,” “deem,” “expected,” “next,” “potential,” “transform,” “believe,” “will,” “to see,” “scheduled,” “reduce,” “advancing,” “may,” “could,” “designed to,” “comparing,” “can,” “accelerate,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: ALPHA3 being a pivotal trial and the extent to which it will support regulatory approval of cema-cel; the potential for preliminary encouraging MRD conversion rate and safety profile being consistent with future trial results; the potential cause of the Grade 5 adverse event; the possibility that the selection of the FC arm will bring life-saving therapy to patients more quickly, simplify study treatment, accelerate trial enrollment, streamline regulatory review, or transform care for patients; the Company’s clinical strategy; the design and potential benefits of our Dagger® platform technology, including it becoming the next-generation allogeneic platform, or reducing reliance on traditional lymphodepletion strategies; the potential for cema-cel to be a one-time off-the-shelf treatment or become the standard “7th cycle” of frontline treatment; that cema-cel can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy; the timing for completion of ALPHA3 milestones, including the futility analysis; the potential for our product candidates to be approved; the potential benefits of the ALPHA3 trial and of AlloCAR T™ products; cema-cel’s safety profile; our ability to deliver cell therapy on-demand, more reliably, and at greater scale to more patients; the expected annual patient population for LBCL in the US and EU; and other statements related to future events or conditions. Various factors may cause material differences between Allogene’s expectations and actual results, including, risks and uncertainties related to: our product candidates are based on novel technologies, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; the limited nature of our pre-clinical, and Phase 1 and Phase 2 data and the extent to which such data may or may not be validated in any future clinical trial; our product candidates in the past have and may in the future cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval or limit their commercial potential; the extent to which the Food and Drug Administration disagrees with our clinical or regulatory plans or the import of our clinical results, which could cause future delays to our clinical trials, including initiation of clinical trials, or require additional clinical trials; we may encounter difficulties enrolling patients in our clinical trials; we may not be able to demonstrate the safety and efficacy of our product candidates in our clinical trials, which could prevent or delay regulatory approval and commercialization; and the challenges with manufacturing or optimizing manufacturing of our product candidates. Additional factors that could cause actual results to differ materially from those stated or implied by the Company’s forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission (SEC), including in the section captioned “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 13, 2025. These forward-looking statements represent the Company’s judgment as of the time of this press release. The Company disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law. AlloCAR T™ and Dagger® are trademarks of Allogene Therapeutics, Inc. Allogene’s investigational AlloCAR T™ oncology products utilize Cellectis technologies. The anti-CD19 oncology products are developed based on an exclusive license granted by Cellectis to Servier. Servier, which has an exclusive license to the anti-CD19 AlloCAR T investigational products from Cellectis, has granted Allogene exclusive rights to these products in the U.S., all EU Member States and the United Kingdom. Allogene Media/Investor Contact:Christine CassianoEVP, Chief Corporate Affairs & Brand Strategy OfficerChristine.Cassiano@allogene.com
免疫疗法临床2期引进/卖出
2025-07-23
USA News Group News Commentary
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, BC, July 23, 2025 /PRNewswire/ -- USA News Group News Commentary – Cancer diagnoses are climbing fastest among younger women, sparking alarm that looming cuts to U.S. research budgets could stall progress in prevention and treatment. Adding to the strain, federal and state regulators are re‑examining mRNA vaccines, creating a cloud of uncertainty over future cancer‑funding priorities. Yet even amid this policy turbulence, a new wave of oncology innovators is lining up near‑term milestones that could reshape the landscape—led by
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC),
Cue Biopharma, Inc. (NASDAQ: CUE),
Verastem, Inc. (NASDAQ: VSTM),
Allogene Therapeutics, Inc. (NASDAQ: ALLO), and
Perspective Therapeutics, Inc. (NYSE-American: CATX).
While regulatory red tape tightens, surging diagnoses of colorectal and other GI cancers in young people demand quicker innovation in oncology. Forecasts suggest worldwide cancer‑drug revenues could blow past US$900 billion by 2034. Within that, next‑gen therapies built on precision techniques are slated to reach US$175.2 billion, advancing at a brisk 7.35% annual clip.
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) recently held a well‑attended key opinion leader (KOL) webinar where pancreatic and gastrointestinal cancer specialists dissected pelareorep's clinical history, its biomarker data package, and where the oncolytic virus could slot into evolving chemotherapy and immunotherapy regimens.
"I want to thank our esteemed panel of oncologists for their meaningful contributions to our KOL event," said Jared Kelly, CEO of
Oncolytics. "Their insights underscore a critical and timely message: pelareorep is a compelling immunotherapy platform that is well situated for combination strategies and a highly differentiated asset for pharma partners looking to expand or establish leadership in GI oncology. We are committed to moving forward aggressively toward registrational development while engaging with partners who share our vision of transforming outcomes in these difficult-to-treat cancers."
The panel revisited survival gains in metastatic pancreatic ductal adenocarcinoma (mPDAC), reviewed translational evidence of "cold‑to‑hot" tumor conversion, and outlined next steps for a registration-enabling study. Management said feedback from the discussion would inform both upcoming trial designs and partnering talks now underway.
The event came on the heels of
Oncolytics having rolled out an expanded translational‑data review that tightened the scientific case for pelareorep, an intravenously delivered oncolytic reovirus. Renewed analyses from the GOBLET gastrointestinal cancer study and the AWARE‑1 breast cancer study confirmed that the virus replicates inside tumors, switches on interferon signaling in the immune system, and draws tumor‑infiltrating lymphocytes into the tumor microenvironment.
"This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of
Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep."
Investigators also recorded higher PD‑L1 expression and tracked newly expanded cytotoxic T‑cell clones in blood samples that matched those inside shrinking lesions—molecular fingerprints that point to stronger responses when pelareorep is combined with standard-of-care treatments and checkpoint inhibitors.
"The collection of data here show that pelareorep works how a cancer immunotherapy should work," said Jared Kelly, CEO of
Oncolytics. "Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs."
Clinical outcomes already hint at real‑world benefit. In more than 100 first‑line mPDAC patients, pelareorep‑based regimens achieved a 21.9% two‑year overall‑survival rate versus a 9.2% historical benchmark. A separate single‑arm study that paired pelareorep with chemotherapy and a checkpoint blocker produced a 62% objective‑response rate—especially notable given that no checkpoint therapy is approved in this cancer today.
In hormone‑receptor‑positive, HER2‑negative metastatic breast cancer (HR+/HER2‑ mBC), two randomized trials added more than ten months of median overall survival, while BRACELET‑1 nearly doubled median progression‑free survival to 12.1 months compared with 6.4 months for control patients.
To steer these data toward value‑creating deals and late‑stage trials, the company strengthened its leadership earlier this year by appointing industry veteran Jared Kelly as CEO and naming Andrew Aromando Chief Business Officer. The duo previously helped guide
Ambrx Biopharma into a US$2 billion sale to
Johnson & Johnson, experience the board believes will support capital‑efficient development and strategic partnering for pelareorep.
"Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications," said Kelly. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy."
As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile.
"I'm thrilled to join
Oncolytics at such a pivotal moment in its evolution," said Aromando. "With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term."
Pelareorep currently holds FDA Fast Track designations in mPDAC (pancreatic cancer) and HR+/HER2‑ mBC (breast cancer), along with Orphan‑Drug status for pancreatic cancer in the United States and Europe.
With mechanistic proof, survival data that outperform historical controls, and fresh validation from the recent KOL event,
Oncolytics Biotech is aligning its clinical, regulatory, and business strategies to move pelareorep into registration‑enabling trials and position it as a backbone immunotherapy across solid tumors.
CONTINUED… Read this and more news for Oncolytics Biotech at:
In other recent industry developments and happenings in the market include:
Cue Biopharma, Inc. (NASDAQ: CUE) recently reported that adding CUE‑101 to pembrolizumab produced a 50% overall response rate in patients with recurrent/metastatic HPV‑positive head and neck cancer who had a combined positive score (CPS) ≥ 1, including the same 50% response in those with low CPS 1–19. The regimen has now generated two complete responses, an 88% 12‑month overall survival rate, and a median overall survival of 32 months, handily outperforming historical pembrolizumab data.
"The culmination of maturing data further support our conviction that CUE-101, representative of our approach with the CUE-100 series, demonstrates a potential breakthrough therapeutic approach for establishing a new standard of care," said Dan Passeri, CEO of
Cue Biopharma. "With this maturing data, we are further emboldened in our conviction that our Immuno-STAT® platform represents transformative potential for selectively modulating the patient's immune system."
Verastem, Inc. (NASDAQ: VSTM) recently published Phase 2 RAMP 201 results in the Journal of Clinical Oncology, showing avutometinib + defactinib delivered a 31% confirmed overall response rate in recurrent low‑grade serous ovarian cancer, rising to 44% in KRAS‑mutant tumors.
"The publication of the primary analysis of the RAMP 201 study in recurrent low-grade serous ovarian cancer in the Journal of Clinical Oncology reflects the meaningful clinical advancement demonstrated by the combination of avutometinib plus defactinib for patients with recurrent low-grade serous ovarian cancer," said John Hayslip, M.D., Chief Medical Officer at
Verastem Oncology. "The findings supported the recent
FDA approval of the combination in KRAS-mutated recurrent low-grade serous ovarian cancer and our ongoing global Phase 3 RAMP 301 trial of the combination in recurrent low-grade serous ovarian cancer with and without a KRAS mutation."
Median progression‑free survival reached 12.9 months overall and 31.0 months in the KRAS‑mutant subgroup, with 82% of patients experiencing some tumor shrinkage regardless of mutation status.
Back in June,
Allogene Therapeutics, Inc. (NASDAQ: ALLO) presented updated Phase 1 TRAVERSE data showing a single dose of ALLO‑316 achieved a 31% confirmed response rate in heavily pre‑treated renal cell carcinoma patients whose tumors expressed CD70 in ≥ 50 % of cells.
"ALLO-316 is showing clear evidence of targeted antitumor activity in patients who had failed most or all approved therapies for advanced or metastatic renal cell carcinoma," said Zachary Roberts, M.D., Ph.D., EVP, Research and Development and Chief Medical Officer at
Allogene. "Our proprietary Dagger technology allows the use of a standard cyclophosphamide and fludarabine-based lymphodepletion regimen with a single dose of ALLO-316. Strong CAR T-cell kinetics and extensive infiltration of tumor tissue by CAR T cells are combining to generate deep and durable remissions. These are results that were previously considered out of reach for patients with advanced solid tumors."
Four of five responders remain in remission—including one lasting more than 12 months—while safety remained manageable with no graft‑versus‑host disease observed. Investigators say the results highlight allogeneic CAR T's potential in solid tumors and justify continued expansion of the study.
Perspective Therapeutics, Inc. (NYSE-American: CATX) recently began recruiting the third dose‑escalation cohort of its Phase 1/2a trial testing [²¹²Pb]VMT‑α‑NET in unresectable or metastatic somatostatin receptor 2 (SSTR2)‑positive neuroendocrine tumors, raising the fixed dose by 20% to 6 mCi. Earlier cohorts showed anti‑tumor activity with mostly low‑grade adverse events, prompting
FDA alignment to explore whether the higher dose can further enhance efficacy.
"We are excited to start exploring a higher dose level of VMT-α-NET after successfully completing an interaction with the FDA that was agreed prior to commencement of this trial," commented Markus Puhlmann, Chief Medical Officer of Perspective. "We are encouraged by the overall clinical profile observed at the second dose level of VMT-α-NET—including evidence of anti-tumor activity and primarily low-grade adverse events—and we believe it is important to assess whether a higher dose could further improve the therapeutic profile."
The company plans additional safety and efficacy readouts, including dosimetry analyses, at scientific meetings in 2H 2025.
Source:
CONTACT:
USA NEWS GROUP
[email protected]
(604) 265-2873
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临床结果免疫疗法快速通道ASCO会议临床1期
2025-06-07
·药明康德
本期看点1. 靶向Clever-1的单克隆抗体bexmarilimab与标准治疗（SoC）联用治疗初治高危骨髓增生异常综合征（HR-MDS）患者的早期临床试验结果亮眼，客观缓解率（ORR）达100%。2. 口服靶向抗癌化合物ibrilatazar联合化疗治疗III/IV期鳞状非小细胞肺癌（SQ-NSCLC）患者的1/2a期临床试验结果积极，与历史对照相比，联合治疗组的中位总生存期（OS）接近翻倍（22.5个月对比11.3个月）。3. Kymera Therapeutics公司的口服STAT6降解剂KT-621在一项1期研究的所有≥50 mg的多剂量递增（MAD）组中表现积极，患者血液与皮肤中的目标蛋白均达成完全降解。Bexmarilimab：公布1期联合治疗试验数据Faron Pharmaceuticals公司宣布，其靶向Clever-1的单克隆抗体bexmarilimab的一项1期研究结果已发表在《柳叶刀-血液学》（Lancet Haematology）杂志上。该研究旨在评估bexmarilimab联合SoC治疗高危骨髓增生异常综合征和复发/难治性（r/r）急性髓系白血病（AML）患者的安全性和有效性。Bexmarilimab是Faron公司全资拥有的研究性免疫疗法，旨在通过靶向髓系细胞功能和激活免疫系统，克服对现有疗法的耐药性并优化临床疗效。Bexmarilimab能与巨噬细胞上的免疫抑制受体Clever-1结合，该受体有助于肿瘤生长和转移（即帮助癌症躲避免疫系统）。通过靶向巨噬细胞上的Clever-1受体，bexmarilimab可改变肿瘤微环境，将巨噬细胞从免疫抑制（M2）状态重编程为免疫刺激（M1）状态，上调干扰素的产生，启动免疫系统攻击肿瘤，使癌细胞对标准治疗敏感。此次公布的结果显示，bexmarilimab联合阿扎胞苷在初治和低甲基化药物（HMA）治疗失败的HR-MDS患者中的ORR分别为100%和89%。HMA治疗失败的MDS患者的估计中位OS为13.4个月，r/r AML患者为8.1个月。两名HMA治疗失败的MDS患者在治疗后接受了造血干细胞移植（HSCT）。此外，治疗后患者的骨髓免疫生物标志物较基线水平提升了近3倍。在67%的HMA治疗失败的MDS患者中观察到HLA-DR分子增加，进一步支持bexmarilimab的作用机制。安全性方面，bexmarilimab联合治疗的耐受性良好，未观察到剂量限制性毒性。大多数治疗伴发不良事件（TEAE）为轻度至中度，仅6%与bexmarilimab相关。Ibrilatazar（ABTL0812）：公布1/2a期联合治疗试验数据AbilityPharma公司宣布，其评估ibrilatazar（ABTL0812）联合化疗（紫杉醇/卡铂）治疗III/IV期鳞状非小细胞肺癌患者的1/2a期临床试验ENDOLUNG的数据已发表在Lung Cancer杂志上。Ibrilatazar是一种潜在“first-in-class”、差异化的口服靶向抗癌化合物，通过诱导内质网应激和抑制PI3K/Akt/mTOR通路来引发自噬。在临床试验中，ibrilatazar对子宫内膜癌和肺癌患者显示出临床益处。此外，它在包括肺癌、子宫内膜癌、胰腺癌、神经母细胞瘤和胶质母细胞瘤等癌症类型的动物模型中展示了强有力的临床前概念验证。此次公布的结果显示，与历史对照相比，ibrilatazar联合化疗在所有疗效终点均显示出改善，包括：ibrilatazar联合治疗组的总缓解率为52%，历史对照为31.7%；ibrilatazar联合治疗组的中位无进展生存期（PFS）为6.2个月，历史对照为4.2个月；ibrilatazar联合治疗组的中位OS为22.5个月，历史对照为11.3个月。安全性方面，ibrilatazar联合化疗表现出良好的安全性。在紫杉醇/卡铂基础上加入ibrilatazar的安全性与历史对照中紫杉醇/卡铂单独使用时的安全性一致，并未带来除紫杉醇/卡铂本身已知不良事件之外的显著新增安全性风险。KT-621：公布1期临床试验数据Kymera Therapeutics公司公布其潜在“first-in-class”口服STAT6降解剂KT-621在1期健康受试者研究中的积极结果。数据显示，KT-621在每日一次口服给药下，于所有高于1.5 mg剂量水平中实现了超过90%的平均血液STAT6降解；在所有≥50 mg的MAD组中，更在血液与皮肤中均达成完全降解。此外，KT-621对Th2炎症相关生物标志物TARC和Eotaxin-3的中位降低幅度分别高达37%与63%，表现优于或相当于现有获批药物。KT-621在本项试验中展现出优异的安全性，未观察到严重不良事件或与治疗相关的不良事件，整体耐受性与安慰剂无明显差异。Kymera公司指出，KT-621的临床表现已显著优于其预设的产品特征目标，进一步验证了其“生物制品口服化”开发策略的可行性。当前，KT-621正在中重度特应性皮炎（AD）患者中开展1b期BroADen试验，预计将在2025年第四季度公布数据，并计划分别于2025年第四季度与2026年第一季度启动针对AD与哮喘的两项2b期临床研究。ISB 2001：公布1期临床试验的新数据Ichnos Glenmark Innovation公司公布了其三特异性抗体ISB 2001用于治疗复发/难治性多发性骨髓瘤（RRMM）的1期研究的新数据。ISB 2001同时靶向多发性骨髓瘤（MM）细胞上的BCMA和CD38，以及T细胞上的CD3，旨在增加对MM细胞的特异性结合，同时最大限度地减少脱靶效应。此次公布的结果显示，在经过大量治疗的患者群体中，7个活性剂量（≥50 μg/kg）组患者的持续总缓解率为79%，完全缓解/严格完全缓解（CR/sCR）率为30%。所有接受治疗的患者的总缓解率为74%，包括2例接受较低剂量治疗的患者。安全性方面，ISB 2001具有良好的安全性，大多数患者在数据截止时仍在接受治疗。EBC-129：公布1期临床试验的新数据新加坡实验药物研发中心（EDDC）公布了其在研抗体偶联药物（ADC）EBC-129的一项1期临床试验的新数据。EBC-129靶向CEACAM5和CEACAM6上保守的肿瘤特异性N256糖基化位点，这两种蛋白在肿瘤发生和转移中起关键作用。该ADC的毒性有效载荷是微管蛋白抑制剂MMAE，该药物已在其他上市的ADC中被广泛测试并获批用于临床，且已显示出与PD-1抑制剂之间的协同作用。此次公布的结果显示，EBC-129在21名此前接受过大量治疗的胰腺导管腺癌（PDAC）患者中显示出积极的总缓解率和延长的无进展生存期，包括那些之前接受过SoC（通常含有紫杉烷类药物）的患者。在接受1.8 mg/kg和2.2 mg/kg剂量治疗的患者中，总缓解率分别为25%和20%，疾病控制率（DCR）达87.5%和63.6%，中位PFS分别为19周和12周。EBC-129在迄今为止接受治疗的58例患者中显示出可控的安全性，观察到的主要治疗相关不良事件（TRAE）为无并发症的中性粒细胞减少和输液相关反应。IMC-002：公布1期联合治疗试验的中期数据ImmuneOncia Therapeutics公司公布了其下一代CD47靶向抗体IMC-002与lenvatinib联用治疗晚期肝细胞癌（HCC）患者的1b期临床试验的中期结果。IMC-002是一款全人源化IgG4单克隆抗体，通过阻断CD47-SIRPα相互作用，促进巨噬细胞对肿瘤细胞的吞噬作用。该抗体疗法可以在保证高疗效的同时最大限度地减少与红细胞的结合并避免血液学毒性。此次公布的结果显示，IMC-002表现出良好的安全性特征，未报告中性粒细胞减少或血小板减少，96%的不良事件为1/2级。在疗效可评估的10名患者中，有3名达到部分缓解（PR），DCR达80%，中位PFS为8.3个月。两名患者的治疗时间已超过一年，提示该疗法可能带来持久的临床获益。参考资料（可上下滑动查看）[1] ImmuneOncia Announces Interim Results from Phase 1b Clinical Trial of Next-Generation CD47 Antibody 'IMC-002' at ASCO 2025. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/immuneoncia-announces-interim-results-from-phase-1b-clinical-trial-of-next-generation-cd47-antibody-imc-002-at-asco-2025-302470514.html[2] Pasithea Therapeutics Presents Updated Interim Data from Ongoing Phase 1 Study of PAS-004 at the ASCO Annual Meeting 2025. Retrieved June 5, 2025, from https://ir.pasithea.com/news-events/press-releases/detail/122/pasithea-therapeutics-presents-updated-interim-data-from[3] Allogene Therapeutics Provides Updated Phase 1 Data Highlighting Durable Responses with ALLO-316 in Heavily Pretreated Advanced Renal Cell Carcinoma at ASCO. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/01/3091475/0/en/Allogene-Therapeutics-Provides-Updated-Phase-1-Data-Highlighting-Durable-Responses-with-ALLO-316-in-Heavily-Pretreated-Advanced-Renal-Cell-Carcinoma-at-ASCO.html[4] MYTX-011, a cMET-targeting antibody-drug conjugate (ADC), in patients with previously treated, advanced NSCLC: Updated dose escalation results in the phase 1 KisMET-01 study. Retrieved June 5, 2025, from https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8613[5] NervGen Pharma Reports Positive Topline Data from the Chronic Cohort of its Phase 1b/2a Clinical Trial Evaluating NVG-291 in Spinal Cord Injury. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091725/0/en/NervGen-Pharma-Reports-Positive-Topline-Data-from-the-Chronic-Cohort-of-its-Phase-1b-2a-Clinical-Trial-Evaluating-NVG-291-in-Spinal-Cord-Injury.html[6] Kymera Therapeutics Announces Positive First-in-Human Results from Phase 1 Healthy Volunteer Clinical Trial of KT-621, a First-in-Class, Oral STAT6 Degrader. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091701/0/en/Kymera-Therapeutics-Announces-Positive-First-in-Human-Results-from-Phase-1-Healthy-Volunteer-Clinical-Trial-of-KT-621-a-First-in-Class-Oral-STAT6-Degrader.html[7] Erasca Announces IND Clearance for Potential First-in-Class and Best-in-Class Pan-KRAS Inhibitor ERAS-4001. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091800/0/en/Erasca-Announces-IND-Clearance-for-Potential-First-in-Class-and-Best-in-Class-Pan-KRAS-Inhibitor-ERAS-4001.html[8] Diakonos Oncology Presents Promising Phase I Results of Dubodencel (DOC1021) for the Treatment of Glioblastoma at the ASCO 2025 Annual Meeting. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/diakonos-oncology-presents-promising-phase-i-results-of-dubodencel-doc1021-for-the-treatment-of-glioblastoma-at-the-asco-2025-annual-meeting-302469896.html[9] GV20 Therapeutics Presents Updated Phase 1 Monotherapy Data on GV20-0251 at the ASCO Annual Meeting 2025. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/gv20-therapeutics-presents-updated-phase-1-monotherapy-data-on-gv20-0251-at-the-asco-annual-meeting-2025-302463359.html[10] Mersana Therapeutics Reports Additional Positive Interim Phase 1 Clinical Data for Emi-Le in Oral Presentation at 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091831/0/en/Mersana-Therapeutics-Reports-Additional-Positive-Interim-Phase-1-Clinical-Data-for-Emi-Le-in-Oral-Presentation-at-2025-ASCO-Annual-Meeting.html[11] Merck Announces MK-1084, an Investigational KRAS G12C Inhibitor, Shows Antitumor Activity in Phase 1 Trial of Patients With Advanced Colorectal Cancer and Non-Small Cell Lung Cancer Whose Tumors Harbor KRAS G12C Mutations. Retrieved May 30, 2025 from https://www.merck.com/news/merck-announces-mk-1084-an-investigational-kras-g12c-inhibitor-shows-antitumor-activity-in-phase-1-trial-of-patients-with-advanced-colorectal-cancer-and-non-small-cell-lung-cancer-whose-tumors-harbo/[12] IN8bio Presents Positive Phase 1 Data of INB-200 in Newly Diagnosed GBM Demonstrating Prolonged Progression-Free Survival. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091745/0/en/IN8bio-Presents-Positive-Phase-1-Data-of-INB-200-in-Newly-Diagnosed-GBM-Demonstrating-Prolonged-Progression-Free-Survival.html[13] OnCusp Therapeutics Announces Encouraging Initial Phase 1a Results from Ongoing First-in-Human Study Evaluating its CDH6-Directed Antibody-Drug Conjugate, CUSP06, in Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors at the 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/oncusp-therapeutics-announces-encouraging-initial-phase-1a-results-from-ongoing-first-in-human-study-evaluating-its-cdh6-directed-antibody-drug-conjugate-cusp06-in-platinum-refractoryresistant-ovarian-cancer-and-other-advanced--302470621.html[14] Perspective Therapeutics Highlights Updated Interim Data from its Ongoing Phase 1/2a Clinical Trial of [212Pb]VMT-α-NET at the 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/05/30/3091346/0/en/Perspective-Therapeutics-Highlights-Updated-Interim-Data-from-its-Ongoing-Phase-1-2a-Clinical-Trial-of-212Pb-VMT-%CE%B1-NET-at-the-2025-ASCO-Annual-Meeting.html[15] AbCellera Receives Authorization from Health Canada to Initiate a Phase 1 Clinical Trial of ABCL575. Retrieved June 5, 2025, from https://investors.abcellera.com/news/news-releases/2025/AbCellera-Receives-Authorization-from-Health-Canada-to-Initiate-a-Phase-1-Clinical-Trial-of-ABCL575/default.aspx[16] Faron announces publication of full Phase I BEXMAB study data in Lancet Haematology. Retrieved June 5, 2025, from https://faron.com/releases-and-publications/faron-announces-publication-of-full-phase-i-bexmab-study-data-in-lancet-haematology/[17] Enterome presents positive Phase 1/2 MSS/pMMR metastatic colorectal cancer data in patients treated with EO4010 OncoMimics™ immunotherapy plus nivolumab at ASCO 2025. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/05/30/3090836/0/en/Enterome-presents-positive-Phase-1-2-MSS-pMMR-metastatic-colorectal-cancer-data-in-patients-treated-with-EO4010-OncoMimics-immunotherapy-plus-nivolumab-at-ASCO-2025.html[18] Experimental Drug Development Centre Announces the Presentation of Updated Data from the Phase 1 Study of Antibody-Drug Conjugate EBC-129 at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO). Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/experimental-drug-development-centre-announces-the-presentation-of-updated-data-from-the-phase-1-study-of-antibody-drug-conjugate-ebc-129-at-the-2025-annual-meeting-of-the-american-society-of-clinical-oncology-asco-302467763.html[19] Full Dose-Escalation Data Show Continued High Response Rates and Favorable Safety Profile of ISB 2001, a First-in-Class BCMA × CD38 × CD3 Trispecific Antibody, for the Treatment of Relapsed/Refractory Multiple Myeloma. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091923/0/en/Full-Dose-Escalation-Data-Show-Continued-High-Response-Rates-and-Favorable-Safety-Profile-of-ISB-2001-a-First-in-Class-BCMA-CD38-CD3-Trispecific-Antibody-for-the-Treatment-of-Relap.html[20] Cardiff Oncology Announces Positive Data from Investigator-Initiated Trial of Onvansertib in Combination with Paclitaxel in Metastatic Triple-Negative Breast Cancer Presented at ASCO 2025. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3092323/0/en/Cardiff-Oncology-Announces-Positive-Data-from-Investigator-Initiated-Trial-of-Onvansertib-in-Combination-with-Paclitaxel-in-Metastatic-Triple-Negative-Breast-Cancer-Presented-at-AS.html[21] Lilly presents first clinical data for its investigational, next-generation FRα targeting ADC in platinum-resistant ovarian cancer at the 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/lilly-presents-first-clinical-data-for-its-investigational-next-generation-fr-targeting-adc-in-platinum-resistant-ovarian-cancer-at-the-2025-asco-annual-meeting-302470018.html[22] Arrowhead Pharmaceuticals Initiates Phase 1/2a Study of ARO-ALK7 for the Treatment of Obesity. Retrieved June 5, 2025, from https://ir.arrowheadpharma.com/news-releases/news-release-details/arrowhead-pharmaceuticals-initiates-phase-12a-study-aro-alk7[23] Obsidian Therapeutics Announces Positive Clinical Data from OBX-115 in Patients with Advanced Melanoma in Ongoing Multicenter Study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 5, 2025, from https://obsidiantx.com/news-releases/obsidian-therapeutics-announces-positive-clinical-data-from-obx-115-in-patients-with-advanced-melanoma-in-ongoing-multicenter-study-at-the-2025-american-society-of-clinical-oncology-asco-annual-meet/[24] Johnson & Johnson unveils first-in-human results for pasritamig, showing early anti-tumor activity in prostate cancer. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/johnson--johnson-unveils-first-in-human-results-for-pasritamig-showing-early-anti-tumor-activity-in-prostate-cancer-302470142.html[25] Initial Data from the ARC-20 Study of Casdatifan Plus Cabozantinib Showed Nearly Half of Patients with Metastatic Kidney Cancer Had a Confirmed Response. Retrieved June 5, 2025, from https://www.businesswire.com/news/home/20250601016939/en/Initial-Data-from-the-ARC-20-Study-of-Casdatifan-Plus-Cabozantinib-Showed-Nearly-Half-of-Patients-with-Metastatic-Kidney-Cancer-Had-a-Confirmed-Response[26] 에이비엘, 'B7-H4x4-1BB' 삼중 1b/2상 "국내 IND 승인". Retrieved June 5, 2025, from https://www.biospectator.com/news/view/25313[27] Sionna Therapeutics Announces Positive Phase 1 Data for NBD1 Stabilizers SION-719 and SION-451 and Advances Both Programs in Clinical Development for Cystic Fibrosis. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/04/3093440/0/en/Sionna-Therapeutics-Announces-Positive-Phase-1-Data-for-NBD1-Stabilizers-SION-719-and-SION-451-and-Advances-Both-Programs-in-Clinical-Development-for-Cystic-Fibrosis.html[28] Moleculin Reports Positive Topline Efficacy Results from U.S. Phase 1B/2 Clinical Trial Evaluating Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases (MB-107). Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/04/3093575/0/en/Moleculin-Reports-Positive-Topline-Efficacy-Results-from-U-S-Phase-1B-2-Clinical-Trial-Evaluating-Annamycin-for-the-Treatment-of-Soft-Tissue-Sarcoma-Lung-Metastases-MB-107.html[29] REGENXBIO REPORTS NEW POSITIVE FUNCTIONAL DATA FROM PHASE I/II AFFINITY DUCHENNE® TRIAL OF RGX-202. Retrieved June 5, 2025 from https://ir.regenxbio.com/news-releases/news-release-details/regenxbio-reports-new-positive-functional-data-phase-iii[30] AbilityPharma’s IBRILATAZAR (ABTL0812) doubles overall survival in patients with squamous non-small cell lung cancer. Retrieved June 5, 2025 from https://abilitypharma.com/en/main-menu/media-center-2/press-release/abilitypharma%E2%80%99s-ibrilatazar-(abtl0812)-doubles-overall-survival-in-patients-with-squamous-non-small-cell-lung-cancer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：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2
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肾细胞癌 | 临床1期 | 美国 | 2021-02-24 | |
| CD70阳性肿瘤 | 临床前 | 美国 | 2024-12-01 | |
| 急性髓性白血病 | 临床前 | 美国 | 2020-11-26 |
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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 |
|---|
临床1期 | 肾细胞癌 CD70 positive | 44 | 觸範醖廠鹹鹽壓醖獵觸(鹽糧齋選鹽窪糧鬱鑰憲) = 獵襯範蓋鏇獵衊選製範 製獵膚遞選獵蓋艱構餘 (鑰鏇鬱憲窪觸鏇選襯齋 ) 更多 | 积极 | 2025-05-30 | ||
临床1期 | 29 | 選齋網繭積艱淵艱餘壓(觸衊糧衊構鏇鑰窪餘蓋) = 繭願膚糧鬱選糧憲鑰網 齋淵齋淵夢觸選壓窪遞 (糧獵鹽憲襯鹽製顧顧壓 ) 更多 | 积极 | 2024-11-05 | |||
临床1期 | 17 | 積顧製繭鹽窪願窪襯觸(艱觸壓顧選網築廠鬱艱) = 餘構淵艱夢衊簾壓窪選 窪鑰襯壓築觸顧夢醖鹹 (範鏇糧糧衊憲範製顧觸 ) 更多 | 积极 | 2023-04-14 |
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