This is a Phase 1b/2a, open-label, adaptive-design outpatient study to assess the safety, tolerability, and PK/PD of SON-1010 in combination with atezolizumab administered to patients with advanced solid tumors (Part 1) and patients with Platinum-resistant Ovarian Cancer (Part 2)

开始日期2023-09-15

申办/合作机构

Sonnet BioTherapeutics, Inc.

[+1]

NCT05408572 / Completed早期临床1期

A Phase 1, Randomized, Adaptive-Design, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SON-1010 (IL12-FHAB) in Healthy Adults

SB102 is a randomized, double-blind, single center, placebo-controlled study in healthy adults starting with sentinel participants at each dose level to carefully assess the safety, tolerability, PK, and PD of SON-1010.

开始日期2022-07-27

申办/合作机构

Sonnet BioTherapeutics, Inc.

NCT05352750 / Recruiting临床1期

A Phase 1, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SON-1010 (IL12-FHAB) in Adult Patients With Advanced Solid Tumors.

This is a Phase 1, first-in-human, open-label, adaptive-design outpatient study to assess the safety, tolerability, and PK/PD of SON-1010 administered to patients with advanced solid tumors.

开始日期2022-04-20

申办/合作机构

Sonnet BioTherapeutics, Inc.

100 项与 SON-1010 相关的临床结果

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100 项与 SON-1010 相关的转化医学

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100 项与 SON-1010 相关的专利（医药）

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项与 SON-1010 相关的文献（医药）

Frontiers in immunology

A phase I trial of SON-1010, a tumor-targeted, interleukin-12-linked, albumin-binding cytokine, shows favorable pharmacokinetics, pharmacodynamics, and safety in healthy volunteers

Article

作者: Cini, John K ; Kuan, Isabelle ; Lickliter, Jason ; Ryan, Philip J ; Polasek, Thomas M ; Chawla, Sant P ; Kenney, Richard T ; Dexter, Susan ; DaFonseca, Manuel ; Bingham, Justus

Background:

The benefits of recombinant interleukin-12 (rIL-12) as a multifunctional cytokine and potential immunotherapy for cancer have been sought for decades based on its efficacy in multiple mouse models. Unexpected toxicity in the first phase 2 study required careful attention to revised dosing strategies. Despite some signs of efficacy since then, most rIL-12 clinical trials have encountered hurdles such as short terminal elimination half-life (T½), limited tumor microenvironment targeting, and substantial systemic toxicity. We developed a strategy to extend the rIL-12 T½ that depends on binding albumin in vivo to target tumor tissue, using single-chain rIL-12 linked to a fully human albumin binding (FHAB) domain (SON-1010). After initiating a dose-escalation trial in patients with cancer (SB101), a randomized, double-blind, placebo-controlled, single-ascending dose (SAD) phase 1 trial in healthy volunteers (SB102) was conducted.

Methods:

SB102 (NCT05408572) focused on safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) endpoints. SON-1010 at 50-300 ng/kg or placebo administered subcutaneously on day 1 was studied at a ratio of 6:2, starting with two sentinels; participants were followed through day 29. Safety was reviewed after day 22, before enrolling the next cohort. A non-compartmental analysis of PK was performed and correlations with the PD results were explored, along with a comparison of the SON-1010 PK profile in SB101.

Results:

Participants receiving SON-1010 at 100 ng/kg or higher tolerated the injection but generally experienced more treatment-emergent adverse effects (TEAEs) than those receiving the lowest dose. All TEAEs were transient and no other dose relationship was noted. As expected with rIL-12, initial decreases in neutrophils and lymphocytes returned to baseline by days 9-11. PK analysis showed two-compartment elimination in SB102 with mean T½ of 104 h, compared with one-compartment elimination in SB101, which correlated with prolonged but controlled and dose-related increases in interferon-gamma (IFNγ). There was no evidence of cytokine release syndrome based on minimal participant symptoms and responses observed with other cytokines.

Conclusion:

SON-1010, a novel presentation for rIL-12, was safe and well-tolerated in healthy volunteers up to 300 ng/kg. Its extended half-life leads to a prolonged but controlled IFNγ response, which may be important for tumor control in patients.

Clinical trial registration:

https://clinicaltrials.gov/study/NCT05408572, identifier NCT05408572.

项与 SON-1010 相关的新闻（医药）

2024-09-21

·GlobeNewswire-Health Care

Sonnet BioTherapeutics Completes Enrollment in Phase 1 Study of SON-1010 (IL12-FHAB) as a Monotherapy (SB101) for the Treatment of Solid Tumors

SON-1010 is a targeted immune activation cancer therapy designed to turn ‘cold’ tumors ‘hot’ Topline safety data of SB101 Phase 1 study expected by Q4 2024 Sept. 18, 2024 -- Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, today announced the completion of enrollment and initiation of dosing in its Phase 1 SB101 clinical trial of SON-1010 (IL12-FHAB) in adult patients with advanced solid tumors. The Company expects to report topline data from this study in Q4 2024. Pankaj Mohan, Founder and Chief Executive Officer of Sonnet commented, “This milestone is an important step forward in our development program for SON-1010 as a monotherapy. We are encouraged by the data seen to date demonstrating safety and tolerability being well within expected levels. We are hopeful that we will continue to see extended PK/PD, tumor targeting and clinical activity during treatment. We remain committed to bringing this trial to completion and we expect to report topline safety data in Q4 2024.” SB101 is the Company’s open-label, adaptive-design dose-escalation study to assess the safety, tolerability, and PK/PD of SON-1010 administered to patients with advanced solid tumors. The study enrolled 24 subjects. Primary outcome measures for the study are to evaluate the safety and tolerability of SON-1010 and establish the maximum tolerated dose (MTD) of SON-1010. SON-1010 is the Company’s proprietary version of recombinant human interleukin-12 (rhIL-12), configured using Sonnet’s Fully Human Albumin Binding (FHAB®) platform, which extends the half-life and activity of the IL-12 component due to binding native albumin in the serum and targets the tumor microenvironment (TME) by strongly binding gp60 and Secreted Protein Acidic and Rich in Cysteine (SPARC). As previously announced, the safety of SON-1010 was reviewed by the Safety Review Committee at each step during dose escalation. The trial uses a ‘desensitizing’ first dose to take advantage of the known tachyphylaxis with rhIL-12, which minimizes toxicity and allows higher maintenance doses. No dose-limiting toxicities have occurred to date. The safety and toxicity profile that has developed is typical for a Phase 1 oncology trial, with the majority of adverse events (AEs) being reported as mild. All have been transient, with no evidence of cytokine release syndrome. As previously announced, one patient with progressive endometrial sarcoma receiving SON-1010 monotherapy in SB101 had stable disease (SD) for almost 2 years before progressing - her ascites had resolved and tumors had shrunk at one point but she never reached a partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) rules. Cytokine analysis following each dose in that study revealed controlled and prolonged induction of interferon gamma (IFNγ) that peaked at 24 to 48 hours and returned to baseline within 2 to 4 weeks. A small increase in IL-10 was observed with each dose as expected in response to IFNγ. There was either a minimal or no signal for IL-1β, IL-6, IL-8, and TNFα, and there was no indication of any potential for cytokine release syndrome (CRS) at these doses. For more information about the SB101 Phase 1 trial in adult patients with advanced solid tumors visit www.clinicaltrials.com and reference identifier NCT05352750. SON-1010 is a candidate immunotherapeutic recombinant drug that links unmodified single-chain human IL-12 with the albumin-binding domain of the single-chain antibody fragment A10m3. This was selected to bind albumin both at normal pH, as well as at the acidic pH typically found in the TME. The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an opportunity to improve the safety and efficacy profile of not only IL-12, but a variety of potent immunomodulators that can be linked using the platform. Interleukin-12 can orchestrate a robust immune response to many cancers and pathogens. Given the types of proteins induced in the TME, such as the Secreted Protein and Rich in Cysteine (SPARC) and glycoprotein 60 (GP60), several types of cancer such as non-small cell lung cancer, melanoma, head and neck cancer, sarcoma, and some gynecological cancers are particularly relevant for this approach. SON-1010 is designed to deliver IL-12 to local tumor tissue, turning ‘cold' tumors ‘hot' by stimulating IFNγ, which activates innate and adaptive immune cell responses and increases the production of Programed Death Ligand 1 (PD-L1) on tumor cells. This first-in-human study is primarily designed to evaluate the safety of multiple ascending doses of SON-1010 in cancer patients and is being conducted at several sites across the United States. While the optimal dose is unknown at this stage, the potential to target tumors, the extended PK mechanism, and our preclinical data suggest the therapeutic dose may be lower compared to native human IL-12. The study, utilizing a standard 3+3 oncology design in at least five cohorts, should establish the MTD using subcutaneous injections of SON-1010 every 3 to 4 weeks. The primary endpoint explores the safety and tolerability of SON-1010, with key secondary endpoints intended to measure pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and anti-tumor activity. This study will form the basis for potential combinations with other types of immunotherapies and the future development of bispecific candidates using the FHAB platform. Sonnet is an oncology-focused biotechnology company with a proprietary platform for developing targeted biologic drugs with single or bifunctional action. Known as FHAB (Fully Human Albumin Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and "hitch-hikes" on human serum albumin (HSA) for transport to target tissues. Sonnet's FHAB was designed to specifically target tumor and lymphatic tissue, with an improved therapeutic window for optimizing the safety and efficacy of immune modulating biologic drugs. FHAB platform is the foundation of a modular, plug-and-play construct for potentiating a range of large molecule therapeutic classes, including cytokines, peptides, antibodies and vaccines. Sonnet’s lead program, SON-1010, or IL-12-FHAB, is in development for the treatment of solid tumors and ovarian cancer. SON-1010 is being evaluated in an ongoing Phase 1/2a study through a Master Clinical Trial and Supply Agreement, along with ancillary Quality and Safety Agreements, with Roche in combination with atezolizumab (Tecentriq®) for the treatment of Platinum-Resistant Ovarian Cancer (PROC). The Company is also evaluating its second program, SON-1210, an IL12-FHAB-IL15 for solid tumors, in collaboration with the Sarcoma Oncology Center to commence an investigator-initiated and funded Phase 1/2a study for the treatment of pancreatic cancer. The Company’s SON-080 program is a low dose of rhIL-6 in development for Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Diabetic Peripheral Neuropathy (DPN). SON-080 demonstrated encouraging results in a Phase 1b/2a clinical trial, being well tolerated with no evidence of a pro-inflammatory cytokine response. Sonnet is currently seeking partnership opportunities to support a Phase 2 trial. 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临床结果免疫疗法

2024-08-03

·药渡

美股龙虎报：自体CAR-T涨4倍，WEE1被叫停，PAH跌93%

1514字6图，阅读大约需要4分钟。数据新进展：处于1/2期阶段CD20自体CAR-T细胞疗法MB-106用于治疗WM（华氏巨球蛋白血症），披露最新数据，ORR为90%；处于2b期阶段IBAT抑制剂Volixibat用于治疗胆汁酸淤积，包括PBC（原发性胆汁性胆管炎）和PSC（原发性硬化性胆管炎），公布两项2b期VANTAGE研究和VISTAS研究积极中期结果数据新挫折：处于1/2期阶段WEE1抑制剂Azenosertib用于治疗实体瘤，FDA暂停3项临床研究，ZN-c3-001研究（1期剂量递增）、DENALI研究（2期铂耐药性卵巢癌）和TETON研究（子宫浆液性癌），由于在DENALI研究出现2例疑似因败血症而死亡的案例，第二天反弹26%；处于1b/2期PPAR⍺拮抗剂TPST-1120用于一线治疗HCC（肝细胞癌），更新OS数据，基线不平，OS的HR较之前有所降低且95%CI超1，PFS的HR较大；处于3期阶段CH24H抑制剂soticlestat用于治疗DS（Dravet综合征）和LGS（Lennox-Gastaut综合征），SKYLINE研究（DS)勉强达到主要终点，p=0.06，SKYWAY研究（LGS）未达主要终点；处于2b/3期阶段干粉吸入伊马替尼制剂AV-101用于治疗PAH（肺动脉高压），公布2b期顶线结果，未达PVR（肺血管阻力）主要终点 20240617-20240621 美股龙虎榜 20240617-20240621 美股蛇猫榜 1 Mustang Bio/MBIO 2024年6月17日，Mustang公司宣布处于1/2期阶段CD20自体CAR-T细胞疗法MB-106用于治疗WM（华氏巨球蛋白血症）的最新数据。 ●该队列的ORR为90%，且观察到持久缓解；一名患者在31个月时仍处于CR状态 ●所有患者均接受过大量BTK抑制剂治疗或对其有耐药性，只有一名患者在接受MB-106治疗后开始接受新的抗WM治疗 ●允许门诊治疗，且被认为是可行的 ●目前尚无FDA批准的针对WM的CAR-T疗法 6月20日，折价配股筹集250万美元，下跌34%。 2 GeoVax Labs/GOVX 2024年6月18日，GeoVax宣布处于2b期阶段MVA病毒载体COVID-19疫苗GEO-CM04S1用于预防COVID-19，获BARDA资助2430万美元，可能增至4500万美元，最高达3.43亿美元，6月21日继续涨23%。 3 Sarepta Therapeutics/SRPT 2024年6月20日，Sarepta公司宣布处于商业化阶段AAV基因疗法ELEVIDYS用于治疗DMD（杜氏肌营养不良症），获FDA完全批准门诊患者及加速批准无法行走的患者。 4 Mirum Pharmaceuticals/MIRM 2024年6月17日，Mirum公司宣布处于2b期阶段IBAT抑制剂Volixibat用于治疗胆汁酸淤积，包括PBC（原发性胆汁性胆管炎）和PSC（原发性硬化性胆管炎）的两项2b期VANTAGE研究和VISTAS研究积极中期结果。 ●VANTAGE PBC中期分析显示，瘙痒的主要终点较基线下降3.8个百分点，经安慰剂调整后下降2.3个百分点（p=0.0026） ●VISTAS PSC中期分析结果超出继续研究的疗效阈值 5 Zentalis Pharmaceuticals/ZNTL 2024年6月18日，Zentalis公司宣布处于1/2期阶段WEE1抑制剂Azenosertib用于治疗实体瘤，FDA暂停3项临床研究，ZN-c3-001研究（1期剂量递增）、DENALI研究（2期铂耐药性卵巢癌）和TETON研究（子宫浆液性癌），由于在DENALI研究出现2例疑似因败血症而死亡的案例，第二天反弹26%。该公司表示，迄今为止，已有500多名患者接受了azenosertib单药治疗，我们认为我们的数据表明治疗指数良好，可能为面临PROC（铂耐药性卵巢癌）和US（子宫浆液性癌）的女性带来有意义的益处。我们已经完成了DENALI研究第1b组的招募，招募了一百多名患者，进一步证明了我们对azenosertib等新型口服疗法的支持。 6 Longeveron/LGVN 2024年6月17日，Longeveron公司宣布折价配股筹集440万美元，该司核心品种为处于2期阶段同种异体MSCs细胞疗法Lomecel-B用于治疗HLHS（左心发育不全综合征）。 7 Tempest Therapeutics/TPST 2024年6月20日，Tempest公司宣布处于1b/2期PPAR⍺拮抗剂TPST-1120用于一线治疗HCC（肝细胞癌）的OS数据。 ●TPST-1120组的mOS为21个月，对照组为15个月 ●HR为0.65，与10个月之前观察到的0.59相比保持不变 ●生存曲线在早期分离并保持持续分离 ●OS是一线HCC治疗的主要监管终点基线不平，OS的HR较之前有所降低且95%CI超1，PFS的HR较大。 8 Sonnet BioTherapeutics/SONN 2024年6月20日，Sonnet公司宣布折价配股筹集340万美元，该司核心品种为处于1期阶段IL-12白蛋白结合区融合蛋白SON-1010用于治疗实体瘤。 9 Ovid Therapeutics/OVID 2024年6月17日，Ovid公司宣布处于3期阶段CH24H抑制剂soticlestat用于治疗DS（Dravet综合征）和LGS（Lennox-Gastaut综合征），SKYLINE研究（DS)勉强达到主要终点，p=0.06，SKYWAY研究（LGS）未达主要终点。 10 Aerovate Therapeutics/AVTE 2024年6月17日，Aerovate公司宣布处于2b/3期阶段干粉吸入伊马替尼制剂AV-101用于治疗PAH（肺动脉高压） 2b期顶线结果，未达PVR（肺血管阻力）主要终点。药渡媒体商务合作媒体公关 | 新闻&会议发稿张经理：18600036371（微信同号）点击下方“药渡“，关注更多精彩内容免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！👇👇👇

细胞疗法临床2期免疫疗法疫苗ASH会议

2024-05-26

·药明康德

不用吃药，自身免疫疾病患者实现长期缓解；总生存率100%的细胞疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点1. Dyne Therapeutics公司治疗杜氏肌营养不良（DMD）等肌肉疾病的潜在“first-in-class”抗体偶联反义寡核苷酸（ASO）疗法的早期临床试验数据积极，可改善患者的肌肉功能。2. 在Orca Bio公司的在研同种异体T细胞免疫疗法Orca-T治疗急性髓系白血病（AML）的1期研究中，患者的一年总生存率达100%。3. iCell Gene Therapeutics公司的BCMA与CD19靶向复合嵌合抗原受体-T（BCMA-CD19 cCAR-T）细胞免疫疗法在早期临床试验中使系统性红斑狼疮（SLE）患者实现了长期无药物缓解。药明康德内容团队整理DYNE-101、DYNE-251：公布1/2期临床试验数据Dyne Therapeutics公司公布了分别用于治疗强直性肌营养不良1型（DM1）和DMD的抗体偶联ASO疗法DYNE-101和DYNE-251的积极1/2期临床试验结果。DYNE-101由与片段抗体（Fab）偶联的反义寡核苷酸组成，Fab与肌肉上高表达的转铁蛋白受体1（TfR1）结合。它旨在实现靶向肌肉组织递送，目的是减少细胞核中的有毒DMPK RNA、释放剪接蛋白、允许正常mRNA处理和正常蛋白翻译，并有可能阻止或逆转疾病进展。在1/2期临床试验ACHIEVE中，DYNE-101（5.4 mg/kg）在第3个月时表现出剂量依赖性剪接校正，剪接校正比例达到27%。此外，DYNE-101改善了患者的肌肉强直、肌肉力量以及多种患者报告的功能性和疲惫指标。DYNE-251由Fab偶联的磷酸二酰胺吗啉寡聚物（PMO）组成。它旨在实现靶向肌肉组织递送，促进外显子51跳跃，使肌肉细胞产生截短、功能性的抗肌萎缩蛋白（dystrophin），目标是停止或逆转疾病进展。在1/2期临床试验DELIVER中，DYNE-251（10 mg/kg）在6个月时将抗肌萎缩蛋白的表达水平提高到接受标准治疗患者的10倍。多种功能性检测也显示出接受DYNE-251治疗患者的功能改善。Orca-T：公布1b期临床试验数据 Orca Bio公司公布了其在研同种异体T细胞免疫疗法Orca-T用于治疗AML患者的1b期临床试验的积极结果。这款细胞疗法由富集的CD34+干细胞，以及通过高精度平台纯化、取材自单倍体匹配供体的特定T细胞亚群组合而成。Orca-Q有潜力改善患者的预后和降低移植物抗宿主疾病（GvHD）风险，并且无需对无法找到人类白细胞抗原（HLA）匹配的患者进行移植后环磷酰胺（PTCy）治疗。此次公布的结果显示，接受Orca-T治疗的37例AML患者中，12个月的无复发生存率和总生存率分别为82.5%和100%，12个月的非复发死亡率为0%。Orca-T在该亚组中的安全性与更大范围的1b期人群一致，没有发现新的安全性信号。Orca-T目前正在美国各大治疗中心进行关键性的3期临床试验评估。BCMA-CD19 cCAR-T：公布1期临床试验数据 iCell Gene Therapeutics宣布其BCMA-CD19 cCAR-T细胞免疫疗法的研究者发起临床试验（IIT）的积极结果。这款由iCell所设计的cCAR-T细胞免疫疗法，在单一结构中表达两种不同且功能齐全的CAR分子，一种靶向B细胞上的CD19分子，另一种靶向浆细胞上的BCMA。鉴于B细胞和长寿浆细胞具有独立的记忆，因此需要同时靶向B细胞和长寿浆细胞以消除所有升高的自身抗体。分析显示，所有接受足量初始剂量cCAR-T治疗的SLE/狼疮性肾炎（LN）患者，在治疗3个月后体内自身抗体呈现阴性，并在随访46个月时，均达到无症状和无药物缓解。ARO-RAGE：公布1/2期临床试验数据Arrowhead Pharmaceuticals公司公布了其用于治疗哮喘等肺部炎症性疾病的RNA干扰（RNAi）疗法ARO-RAGE的最新中期临床数据。高级糖化终产物受体（RAGE）是2型和非2型炎症级联的上游介质，与哮喘和多种炎症疾病的发病机制有关。ARO-RAGE通过RNAi抑制RAGE表达，旨在减少肺上皮细胞中RAGE蛋白的表达，从而有望减少RAGE依赖性炎症通路，以达到降低哮喘患者病情恶化的频率并改善其通气的目的。此次公布的中期结果表明，使用ARO-RAGE治疗后，正常健康受试者（NHV）和轻中度哮喘患者支气管肺泡灌洗液（BALF）和血清中的可溶性RAGE浓度呈剂量依赖性降低。轻度至中度哮喘患者使用两剂ARO-RAGE后，血清中的可溶性RAGE降低了88%，平均最大降幅达77%。此外，该候选疗法的安全性良好，药效学效应持续时间长，有望支持每两个月一次的给药频率。FG-3246：公布1期临床试验的新数据 FibroGen公布了其与Fortis Therapeutics联合开发的潜在“first-in-class”抗体偶联药物（ADC）FG-3246的1期临床试验的新数据。FG-3246旨在治疗转移性去势抵抗性前列腺癌和其他肿瘤类型，其靶向的CD46是一种细胞受体靶点，在前列腺癌和其他肿瘤类型中高度表达，并在大多数正常组织中表达非常有限。FG-3246由抗CD46抗体与抗有丝分裂剂MMAE连接而成，MMAE是一种已经过临床验证的ADC有效载荷。此次公布的结果显示，FG-3246联用恩杂鲁胺使未经生物标志物筛选的患者的中位放射学无进展生存期（PFS）达到10.2个月。此外，FG-3246具有可接受的安全性，不良事件与其他包含细胞毒性药物MMAE作为载荷的ADC一致。TTX-080：公布1b期临床试验数据 Tizona Therapeutics公司公布了其HLA-G靶向抗体TTX-080在转移性结直肠癌（mCRC）和局部晚期/转移性头颈部鳞状细胞癌（mHNSCC）患者中的1b期临床试验数据。TTX-080联用西妥昔单抗对野生型RAS、BRAF、HER2阴性mCRC患者具有抗肿瘤活性，这些患者之前接受过的中位治疗线数为2线（范围为1-5）。患者的中位PFS为24.4周，36周时的无进展生存率为47%。在14例可评估的患者中，4例患者（29%）获得部分缓解（PR），6例患者（43%）保持疾病稳定（SD），这10例（71%）患者的疾病控制了超过90天。TTX-080联用西妥昔单抗可在人乳头瘤病毒（HPV）阴性mHNSCC患者中产生抗肿瘤活性。这些患者之前接受过的中位治疗线数为1线（范围为1-2），所有患者之前都接受过免疫疗法。患者的中位PFS为23.9周，24周时的无进展生存率为43%。在7例可评估的患者中，1例（14%）患者达到了完全缓解（CR），3例（43%）患者达到了PR，1例（14%）患者达到了SD，这5例（71%）患者的疾病控制了超过90天。SON-1010：公布两项1期临床试验的新数据 Sonnet BioTherapeutics公司公布了其在研免疫调节重组蛋白SON-1010的两项1期临床试验的新数据。SON-1010为一重组蛋白，由单链人类IL-12蛋白与和白蛋白结合的抗体单链片段组合而成，具潜力通过刺激产生干扰素γ将像是非小细胞肺癌、黑色素瘤等肿瘤微环境由“冷”转“热”，活化先天免疫与适应性免疫细胞。这些肿瘤的肿瘤微环境中表达SPARC与GP60蛋白。目前，SON-1010研究共招募了61名受试者，患者已接受了25个周期的SON-1010单药治疗或10个周期的SON-1010联用Tecentriq治疗，在任何剂量水平上都未出现剂量限制性毒性。细胞因子数据显示，与重组人IL-12相比，SON-1010的半衰期延长了约10倍，可诱导长时间和可控的干扰素γ反应，且任何剂量下均未发现细胞因子释放综合征的证据。可评估的晚期实体瘤患者中有35%（8/23）在开始给药后的第四个月出现临床获益。Azenosertib：公布1期临床试验数据Zentalis Pharmaceuticals公司公布了新型、选择性口服生物可利用的WEE1抑制剂azenosertib联用吉西他滨治疗复发性或难治性骨肉瘤1期试验的最终结果。WEE1是G1-S和G2-M细胞周期检查点的主调控因子，通过对CDK1和CDK2的负调控来阻止DNA受损细胞的复制。通过抑制WEE1，azenosertib可使细胞周期在存在高水平DNA损伤的情况下继续进行，从而使癌细胞积累DNA损伤并最终死亡。此次公布的结果显示，azenosertib联用吉西他滨的耐受性良好，与过去类似患者人群的队列相比，接受该组合疗法的患者的无事件生存率（EFS）的提高具有临床意义。前者16周的EFS大约为12%，后者18周时的EFS为39%（11/28）。NDI-101150：公布1/2期临床试验数据 Nimbus Therapeutics公司公布了其小分子HPK1抑制剂NDI-101150的早期临床试验的新数据。临床前研究发现，NDI-101150对HPK1的选择性是MAP4K家族相关蛋白的300多倍，这有望减少脱靶效应。此次公布的结果显示，NDI-101150的单药治疗为30例可评估患者中的5例（16.7%）带来了临床获益，包括1例CR（肾细胞癌）、1例PR（肾细胞癌）和3例SD。3名患有胰腺癌、肾细胞癌或子宫内膜癌的患者表现出了长时间（>6个月）的SD，肾细胞癌患者已保持疾病稳定21个月。此外，NDI-101150的耐受性良好，整体安全性可接受。KN-002：公布1b期临床试验数据 Kinaset Therapeutic公司公布了其口腔吸入式泛JAK抑制剂KN-002的1b期研究的积极结果。KN-002是一种对所有JAK亚型（即JAK1、JAK2、JAK3和TYK2）均有效的均衡抑制剂，目前正作为一种非侵入性抗炎治疗药物进行开发，适用于所有接受中高剂量吸入型糖皮质激素（ICS）或长效β2受体激动剂（LABA）维持治疗但病情控制不佳的嗜酸性粒细胞性和非嗜酸性粒细胞性哮喘患者以及慢性阻塞性肺病患者。KN-002配制成干粉，具有出色的递送效率和化学/物理稳定性。通过吸入进行局部给药，KN-002能够在肺部炎症部位达到治疗浓度，同时最大限度地降低全身暴露水平。这项随机、双盲、安慰剂对照研究报告称，在为未接受过吸入皮质类固醇治疗的轻度哮喘患者进行为期10天、每天剂量≤16 mg的治疗后，未发现安全性或耐受性问题。此外，每天使用一次和两次KN-002可在临床上显著降低部分呼出一氧化氮（FeNO）水平。▲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] GC Biopharma/Novel Pharma's Sanfilippo Syndrome Treatment Obtains FDA IND Approval. 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Retrieved May 24, 2024, from https://www.globenewswire.com/news-release/2024/05/23/2887728/33333/en/Coherus-Presents-Preliminary-Results-from-Phase-I-Dose-Escalation-Study-of-its-Anti-chemokine-receptor-8-CCR8-Antibody-CHS-114-at-the-2024-American-Society-of-Clinical-Oncology-ASC.html[26] AffyImmune Announces Confirmed Complete Response in Patient with Anaplastic Thyroid Cancer. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240523653892/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

细胞疗法免疫疗法临床结果临床1期信使RNA

100 项与 SON-1010 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
晚期恶性实体瘤	临床2期	美国	Sonnet BioTherapeutics, Inc.	2023-09-15
晚期恶性实体瘤	临床2期	美国	Hoffmann-La Roche Ltd.	2023-09-15
晚期恶性实体瘤	临床2期	澳大利亚	Sonnet BioTherapeutics, Inc.	2023-09-15
晚期恶性实体瘤	临床2期	澳大利亚	Hoffmann-La Roche Ltd.	2023-09-15
铂耐药性卵巢癌	临床2期	美国	Hoffmann-La Roche Ltd.	2023-09-15
铂耐药性卵巢癌	临床2期	美国	Sonnet BioTherapeutics, Inc.	2023-09-15
铂耐药性卵巢癌	临床2期	澳大利亚	Sonnet BioTherapeutics, Inc.	2023-09-15
铂耐药性卵巢癌	临床2期	澳大利亚	Hoffmann-La Roche Ltd.	2023-09-15

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临床结果

适应症

分期

评价

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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


NCT05408572 (SB102, Literature) 人工标引	临床1期	-	-	SON-1010	糧願願憲蓋願膚窪築糧(鬱積襯構簾網窪製鬱積) = two-compartment elimination in SB102 with mean T½ of 104 h, compared with one-compartment elimination in SB101 鏇願願願憲獵淵憲獵鑰 (網顧膚壓壓鏇積廠鬱鬱 )	积极	2024-02-29
AACR2023 人工标引	N/A	HR阳性/HER2低表达实体瘤	11	SON-1010	廠襯簾蓋餘鬱鹽鹽獵夢(憲蓋齋築鑰窪願襯選窪) = 齋獵淵顧衊簾築獵繭築繭鹽鹹夢遞簾製艱齋憲 (鏇遞積艱範鏇鬱繭蓋壓 ) 更多	积极	2023-04-14
AACR2023 人工标引	N/A	HR阳性/HER2低表达实体瘤	11	SON-1010 (the first 3 dose cohorts)	廠鏇顧獵範蓋獵餘觸糧(醖壓餘製簾鏇廠顧願糧) = 淵築築廠膚醖繭獵鏇獵壓鹽廠壓醖顧繭範淵鏇 (願齋網淵遞製構鏇膚願 )	积极	2023-04-14
NCT05352750 (SB101, Corporate Publications) 人工标引	临床1期	癌症	12	SON-1010	齋鬱齋鹹製繭廠構膚憲(壓製鹹範鹽積鑰獵膚鏇) = mild/moderate, transient in nature, and have all been tolerable 選鹹醖遞鹽鹹網壓遞襯 (顧醖壓蓋餘積壓鬱鹹膚 )	积极	2022-11-02