Alligator Bioscience AB

▎药明康德内容团队编辑 本期看点 1. 抗体偶联药物（ADC）rinatabart sesutecan（Rina-S）用于治疗表达叶酸受体α（FRα）的晚期卵巢癌患者，在一项早期临床试验中的疾病控制率（DCR）近90%。 2. 第二代抗雄激素药物masofaniten联用恩杂鲁胺（enzalutamide）治疗转移性去势抵抗性前列腺癌（mCRPC）患者的1/2期临床试验结果积极，88%患者的前列腺特异性抗原（PSA）减少≥90%（PSA90）。 3. 抗CD39抗体TTX-030的联合疗法一线治疗转移性胰腺癌，在一项早期临床试验中使3名患者获得完全缓解（CR）。 药明康德内容团队整理 Rinatabart Sesutecan（Rina-S）：公布1/2期临床试验数据 Genmab公司公布了其靶向FRα的抗体偶联药物Rina-S的1/2期临床试验数据。Rina-S旨在治疗比第一代FRα靶向ADC更广泛的患者群体。2024年1月，美国FDA授予Rina-S快速通道资格，用于治疗表达FRα的高级别浆液性或子宫内膜样铂耐药卵巢癌患者。 该研究的B部分将42名既往接受过治疗的经组织学或细胞学确诊的晚期卵巢癌（上皮性卵巢癌、原发性腹膜癌或输卵管癌）的患者随机分配接受100 mg/m2 Rina-S（n=22）或120 mg/m2 Rina-S（n=20）治疗。接受100 mg/m2 Rina-S治疗患者的确认的客观缓解率（ORR）为18.2%，4名患者获得了部分缓解（PR），15例患者实现疾病稳定（SD），DCR为86.4%。120 mg/m2组患者的ORR为50.0%，1名患者获得CR，4名患者获得了PR，8名患者为SD，DCR为88.9%。基于这些结果，Rina-S 120 mg/m2剂量已被选定在2024年开始的针对晚期卵巢癌患者的3期临床试验中进行进一步评估。 安全性方面，该研究中常见的治疗伴发不良事件（TEAE）包括贫血、中性粒细胞减少、恶心、血小板减少、白细胞减少、疲劳、呕吐、脱发和腹泻。剂量减少和治疗中止的情况较少，未观察到眼部毒性、神经病变或间质性肺病（ILD）的信号。 Masofaniten（EPI-7386）：公布1/2期联合治疗临床试验的新数据 ESSA Pharma公司公布了其第二代抗雄激素药物masofaniten与恩杂鲁胺联合治疗转移性去势抵抗性前列腺癌患者的1/2期临床试验的新数据。Masofaniten是一种高选择性的雄激素受体N-末端结构域的口服小分子抑制剂。 此次公布的研究结果显示，该组合疗法32个给药周期测试的剂量水平下耐受性良好。无论患者先前的化疗状态如何，包括接受低于全剂量（120 mg）恩杂鲁胺的患者在内，mCRPC患者的PSA都有快速、深度且持久的降低。在所有队列中，88%（14/16）的患者达到了PSA90，69%（11/16）的患者在90天内达到PSA90，63%（10/16）患者达到PSA<0.2 mg/mL的水平。中位随访时间为15.2个月时，PSA进展的中位时间以及影像学无进展生存期尚未达到。 TTX-030：公布1期临床试验数据 Trishula Therapeutics公司公布了其与艾伯维（AbbVie）合作开发的抗CD39抗体TTX-030一线治疗转移性胰腺癌患者的1期临床试验结果。CD39是一种将三磷酸腺苷（ATP）转化为单磷酸腺苷（AMP）的酶，是在肿瘤微环境中生成腺苷的初始步骤。TTX-030能够阻止免疫抑制性胞外腺苷的生成，并维持高水平的免疫激活性胞外ATP，进而刺激树突状细胞和骨髓衍生细胞，促进先天性和适应性抗肿瘤免疫反应。 该1期临床试验评估了TTX-030＋吉西他滨/白蛋白结合型紫杉醇联合使用±budigalimab（一种在研PD-1抗体）作为胰腺癌一线治疗的效果。在可评估疗效的人群（n=57）中，92%为一线转移性胰腺癌患者，8%为局部晚期不可切除患者，ORR为30%，其中3名患者获得了CR。中位无进展生存期（PFS）为7.5个月，中位总生存期（OS）为19.1个月。在28名高表达免疫相关生物标志物HLA-DQ的患者中，ORR为46%，中位PFS为9.6个月，中位OS为21.9个月。 安全性方面，两种治疗方案的耐受性良好，只有5名患者（8%）因不良事件（AE）中止治疗。最常见的不良事件为标准化疗方案中预期出现的不良反应，未见发生频率或严重程度的增加。 CFT1946：公布1期临床试验数据 C4 Therapeutics公司公布了其小分子降解剂CFT1946治疗携带BRAF V600突变的实体瘤患者的1期临床试验数据。CFT1946可以直接降解突变BRAF蛋白，消除其蛋白支架的功能，从而彻底规避RAF信号的异常激活。在临床前研究中，CFT1946导致BRAF-V600E突变体的降解，显著抑制MAPK信号传导，并且在降低BRAF-V600E细胞生存能力的同时并未影响野生型BRAF细胞。在BRAF V600E小鼠肿瘤模型中，CFT1946也导致肿瘤显著缩小。 截至2024年7月19日的数据，27名可评估患者中有16名的靶转移灶缩小，2名患者获得了CR。此外，CFT1946在迄今为止探索的5个剂量水平中表现出剂量依赖性的生物利用度。在迄今为止收集的所有可用的治疗后活检样本中，均观察到BRAF V600E蛋白的降解。安全性方面，CFT1946具有良好的耐受性和安全性，支持其作为单一疗法以及与MEK和EGFR抑制剂联用进行进一步的临床开发。 Brenetafusp（IMC-F106C）：公布1期临床试验数据 Immunocore公司公布了brenetafusp在铂耐药卵巢癌患者中的1期数据。IMC-F106C是一种通过ImmTAX平台开发，靶向PRAME抗原的双特异性蛋白。该研究中，37例既往接受过大量治疗（中位线数为5线）的浆液性卵巢癌患者接受了 brenetafusp单药治疗，大多数患者既往接受过贝伐珠单抗（81%）和PARP抑制剂（59%）。31例可评估患者的DCR为58%，2例患者获得确认的PR。在所有37例患者中，中位PFS为3.3个月，6个月时的总生存率为73%。在可评估循环肿瘤DNA（ctDNA）的29例患者中，31%获得了分子学缓解。 16例既往接受过大量治疗（中位线数为4线）的铂类耐药卵巢癌患者接受了brenetafusp联用化疗的治疗，大多数患者既往接受过贝伐珠单抗（75%）和PARP抑制剂（75%）。Brenetafusp联合化疗的安全性与每种单独药物的预期特征一致。13例可评估患者的DCR为69%，3例患者获得PR。在可评估ctDNA的11例患者中，82%获得了分子学缓解。 IMA401：公布1期临床试验数据 Immatics公司公布了其下一代半衰期延长的T细胞受体（TCR）双特异性抗体平台的首个候选药物IMA401的概念验证临床数据。IMA401靶向HLA-A*02呈递的肽，该肽来源于两种不同的癌症相关蛋白，即黑色素瘤相关抗原4和/或8（MAGEA4/8）。 来自首次人体1期剂量递增试验的数据表明，IMA401单药治疗具有初始抗肿瘤活性和可控的耐受性。患者群体包括35名既往接受过大量治疗的患者，共涉及16种不同的实体瘤类型。在MAGEA4/8水平高且接受相关IMA401剂量的患者人群中，ORR为29%，DCR为53%。此外，在头颈部鳞状细胞癌、神经内分泌肿瘤、皮肤和粘膜黑色素瘤患者中观察到客观缓解，包括长达超过13个月的持久PR和深度缓解（肿瘤缩小≥50%）。药代动力学数据表明，IMA401的中位半衰期为16.9天，支持当前的每两周一次的给药方案和未来延长至四周一次的给药方案。 ▲IMA401的概念验证研究数据（图片来源：参考资料[6]） CY-101（CyPep-1）：公布1/2a期临床试验数据 Cytovation公司公布了其双功能免疫疗法CY-101联用抗PD-1疗法帕博利珠单抗治疗晚期实体瘤的1/2a期临床试验结果。CyPep-1是一种独特的、高度差异化的合成肽疗法，它具有独特的双重作用机制，既能通过激活Axin2抑制Wnt/β-catenin致癌通路，还能通过释放新抗原激活全身性肿瘤特异性免疫反应。 此次公布的结果显示，在推荐的2期剂量（RP2D）下，CY-101具有良好的耐受性。配对肿瘤活检分析表明，患有不同癌种的患者接受RP2D治疗，癌细胞的死亡率>70%，并转化为临床获益。值得注意的是，在接受CY-101单药治疗的6例肾上腺皮质癌患者中，观察到DCR为50%，2例患者缓解超过6个月。这两名患者均表达β-catenin，且Wnt/β-catenin通路中发生了体细胞突变。 Luveltamab tazevibulin（luvelta）：公布1b期联合治疗临床试验的新数据 Sutro Biopharma公司公布了正在进行的luveltamab tazevibulin（luvelta）联合贝伐珠单抗治疗上皮性卵巢癌患者的1b期研究的最新数据。Luvelta是一种FRα靶向ADC，每个抗体含有4个hemiasterlin细胞毒素，能够精确定位并有效递送至肿瘤，同时确保给药后的全身稳定性。 在这项研究中，luvelta联合贝伐珠单抗在晚期卵巢癌患者中显示出令人鼓舞的抗肿瘤活性，无论FRα表达如何（包括没有FRα表达的患者），以及既往接受过贝伐珠单抗治疗的患者，总缓解率为35%，中位缓解持续时间为9.3个月。RP2D组患者的ORR为56%。这些早期数据提示luvelta有望作为一种非生物标志物驱动的方法来治疗上皮性卵巢癌患者。 APV-527：公布1期临床试验数据 Alligator Bioscience公司和Aptevo Therapeutics公司公布了APV-527用于治疗可能表达肿瘤抗原5T4的实体瘤患者的1期临床试验数据。APV-527是一种靶向4-1BB和肿瘤抗原5T4的双特异性抗体，仅在与4-1BB和5T4同时结合时才有活性。 此次公布的结果显示，15名疗效可评估的患者中有9名（60%）实现了SD，1名乳腺癌患者已保持SD超过11个月，1名结肠癌患已保持SD超过4个月。安全性方面，APV-527在所有队列中均表现出积极的安全性和耐受性，尚未确定最大耐受剂量。 GV20-0251：公布1期临床试验数据 GV20 Therapeutics公司公布了其靶向新型免疫检查点IGSF8的抗体疗法GV20-0251治疗实体瘤患者的1/2期研究结果。结果显示，29例疗效可评估的患者中有14例获得了SD，包括4例肿瘤缩小。在12例疗效可评估的转移性皮肤黑色素瘤患者中观察到2例确认的PR。安全性方面，GV20-0251在所有剂量水平下均具有良好的耐受性，未观察到剂量限制性毒性。大多数治疗相关不良事件为1/2级，仅报道1例3级肺炎。 ▲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] Investigational Rinatabart Sesutecan (Rina-S) Shows Promising Anti-Tumor Activity as Single Agent in Heavily Pretreated Patients with Ovarian and Endometrial Cancers in Phase 1/2 Clinical Trial. Retrieved September 20, 2024, from https://ir.genmab.com/news-releases/news-release-details/investigational-rinatabart-sesutecan-rina-s-shows-promising-anti [2] ESSA Pharma Presents Updated Phase 1/2 Masofaniten (EPI-7386) Clinical Data at the 2024 ESMO Congress. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/essa-pharma-presents-updated-phase-12-masofaniten-epi-7386-clinical-data-at-the-2024-esmo-congress-302248122.html [3] Trishula Therapeutics Presents Positive Results from Phase 1 Trial of TTX-030 in First-Line Metastatic Pancreatic Cancer Patients. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/trishula-therapeutics-presents-positive-results-from-phase-1-trial-of-ttx-030-in-first-line-metastatic-pancreatic-cancer-patients-302247474.html [4] C4 Therapeutics Presents Monotherapy Data Demonstrating Proof of Mechanism and Early Evidence of Proof of Concept From Ongoing CFT1946 Phase 1 Trial in BRAF V600 Mutant Solid Tumors at the European Society for Medical Oncology (ESMO) Congress 2024. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/13/2946010/0/en/C4-Therapeutics-Presents-Monotherapy-Data-Demonstrating-Proof-of-Mechanism-and-Early-Evidence-of-Proof-of-Concept-From-Ongoing-CFT1946-Phase-1-Trial-in-BRAF-V600-Mutant-Solid-Tumor.html [5] Immunocore presents Phase 1 data of brenetafusp, an ImmTAC bispecific targeting PRAME, in patients with ovarian cancer. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/14/2946230/0/en/Immunocore-presents-Phase-1-data-of-brenetafusp-an-ImmTAC-bispecific-targeting-PRAME-in-patients-with-ovarian-cancer.html [6] Immatics Presents Clinical Proof-of-Concept Data from Ongoing Phase 1 Dose Escalation Trial with TCR Bispecific Molecule TCER® IMA401 Targeting MAGEA4/8 at ESMO 2024 and Provides Development Update. Retrieved September 20, 2024, from https://investors.immatics.com/news-releases/news-release-details/immatics-presents-clinical-proof-concept-data-ongoing-phase-1-0/ [7] Cytovation to present full safety and efficacy data from the CICILIA Phase I/IIa trial evaluating CY-101 in solid tumors at ESMO 2024. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/13/2945717/0/en/Cytovation-to-present-full-safety-and-efficacy-data-from-the-CICILIA-Phase-I-IIa-trial-evaluating-CY-101-in-solid-tumors-at-ESMO-2024.html#:~:text=Cytovation%20to%20present%20full%20safety%20and%20efficacy%20data,activity%2C%20especially%20in%20tumors%20with%20dysregulated%20Wnt%2F%CE%B2-catenin%20signalling [8] Alligator Bioscience and Aptevo Therapeutics Announce Data from Phase 1 ALG.APV-527 Monotherapy Trial Showing 60% of Evaluable Patients Achieved Stable Disease in Solid Tumor Study. Retrieved September 20, 2024, from https://alligatorbioscience.se/en/mfn_news/alligator-bioscience-and-aptevo-therapeutics-announce-data-from-phase-1-alg-apv-527-monotherapy-trial-showing-60-of-evaluable-patients-achieved-stable-disease-in-solid-tumor-study/ [9] Sutro Biopharma Announces Updated Data from Phase 1b Study of Luvelta in Combination with Bevacizumab at ESMO 2024. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/14/2946228/0/en/Sutro-Biopharma-Announces-Updated-Data-from-Phase-1b-Study-of-Luvelta-in-Combination-with-Bevacizumab-at-ESMO-2024.html [10] GV20 Therapeutics Presents Promising Phase 1 Monotherapy Data on Novel Checkpoint Inhibitor GV20-0251 at ESMO Congress 2024. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/gv20-therapeutics-presents-promising-phase-1-monotherapy-data-on-novel-checkpoint-inhibitor-gv20-0251-at-esmo-congress-2024-302247149.html [11] AAVantgarde announces first patient dosed in First-In-Human Phase 1/2 LUCE-1 study, evaluating AAVB-081 (Dual-AAV) in retinitis pigmentosa related to Usher Syndrome type 1B. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/16/2946331/0/en/AAVantgarde-announces-first-patient-dosed-in-First-In-Human-Phase-1-2-LUCE-1-study-evaluating-AAVB-081-Dual-AAV-in-retinitis-pigmentosa-related-to-Usher-Syndrome-type-1B.html [12] Biosyngen's first-in-class CAR-T asset targeting solid tumors has entered pivotal phase II trial, Phase I trial data debut at ESMO 2024 Annual Congress. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/biosyngens-first-in-class-car-t-asset-targeting-solid-tumors-has-entered-pivotal-phase-ii-trial-phase-i-trial-data-debut-at-esmo-2024-annual-congress-302251709.html [13] Vico Therapeutics Announces Positive Interim Phase 1/2a Clinical Data of VO659 in Treatment of Huntington's Disease. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/vico-therapeutics-announces-positive-interim-phase-12a-clinical-data-of-vo659-in-treatment-of-huntingtons-disease-302247239.html [14] Cybrexa Therapeutics Announces Positive Final Data at ESMO 2024 from Phase 1 Study of Peptide Drug Conjugate CBX-12 in Advanced Solid Tumors. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/16/2946456/0/en/Cybrexa-Therapeutics-Announces-Positive-Final-Data-at-ESMO-2024-from-Phase-1-Study-of-Peptide-Drug-Conjugate-CBX-12-in-Advanced-Solid-Tumors.html [15] Cullinan Therapeutics Announces Submission of Investigational New Drug Application to U.S. Food and Drug Administration for CLN-978 to Treat Systemic Lupus Erythematosus. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/16/2946504/0/en/Cullinan-Therapeutics-Announces-Submission-of-Investigational-New-Drug-Application-to-U-S-Food-and-Drug-Administration-for-CLN-978-to-Treat-Systemic-Lupus-Erythematosus.html [16] TORL BioTherapeutics Presents Updated Phase 1 Results of Novel Claudin 6 Targeted Antibody-Drug Conjugate TORL-1-23 at the 2024 European Society of Medical Oncology Congress. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/torl-biotherapeutics-presents-updated-phase-1-results-of-novel-claudin-6-targeted-antibody-drug-conjugate-torl-1-23-at-the-2024-european-society-of-medical-oncology-congress-302248489.html [17] NextCure Presented Results of the Phase 1b Study of NC410 in Combination with Pembrolizumab at ESMO 2024. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/16/2946611/0/en/NextCure-Presented-Results-of-the-Phase-1b-Study-of-NC410-in-Combination-with-Pembrolizumab-at-ESMO-2024.html [18] Sonnet BioTherapeutics Completes Enrollment in Phase 1 Study of SON-1010 (IL12-FHAB) as a Monotherapy (SB101) for the Treatment of Solid Tumors. Retrieved September 20, 2024, from https://www.sonnetbio.com/news-media/press-releases/detail/97/sonnet-biotherapeutics-completes-enrollment-in-phase-1 [19] Engrail Therapeutics Initiates ENX-104 Clinical Program for the Treatment of Major Depressive Disorder Characterized by Anhedonia. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/18/2948077/0/en/Engrail-Therapeutics-Initiates-ENX-104-Clinical-Program-for-the-Treatment-of-Major-Depressive-Disorder-Characterized-by-Anhedonia.html [20] Antennova Releases Latest Data of CD73 Inhibitor ATN-037, including a DCR of 89.5%, in a Mini Oral at ESMO Congress 2024. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/antennova-releases-latest-data-of-cd73-inhibitor-atn-037--including-a-dcr-of-89-5-in-a-mini-oral-at-esmo-congress-2024--302247371.html [21] Incyte’s CDK2 Inhibitor INCB123667 Shows Promising Evidence of Clinical Activity in Patients with Advanced Solid Tumors, Notably Ovarian Cancer. Retrieved September 20, 2024, from https://investor.incyte.com/news-releases/news-release-details/incytes-cdk2-inhibitor-incb123667-shows-promising-evidence [22] Eisbach Bio Announces First Patient Dosed in Phase 1/2 Trial for EIS-12656, a First-In-Class Allosteric Inhibitor of ALC1 in Refractory Advanced Solid Tumors. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/16/2946482/0/en/Eisbach-Bio-Announces-First-Patient-Dosed-in-Phase-1-2-Trial-for-EIS-12656-a-First-In-Class-Allosteric-Inhibitor-of-ALC1-in-Refractory-Advanced-Solid-Tumors.html [23] Nxera’s Partner Cancer Research UK to Present on Phase 1/2a Clinical Trial with Cancer Immunotherapy Drug HTL0039732 at ESMO. 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Retrieved September 20, 2024, from https://www.curevac.com/en/curevacs-cvgbm-cancer-vaccine-induces-promising-immune-responses-in-phase-1-study-in-glioblastoma-presented-at-the-esmo-2024-congress/ 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

DUBLIN--( BUSINESS WIRE )--The "CD137 Antibodies Clinical Trials & Market Opportunity Insight 2027" report has been added to ResearchAndMarkets.com's offering. CD137, also known as 4-1BB, has emerged as a promising target for cancer immunotherapy in recent years. The potential of CD137-targeted therapies lies in their ability to stimulate and expand cytotoxic T cells leading to improved tumor cell killing and long-lasting immune memory. As a result, the field has gained attention from researchers and pharmaceutical companies alike, with several research publications hinting at a promising future for this cancer therapeutic approach. Moreover, data emerging from early clinical trials have already begun demonstrating therapeutic benefits, providing real-time validation of CD137-targeted drug development. With no licensed medications currently on the market, CD137-targeted therapies are still in their infancy. Nonetheless, there is an abundance of candidates in the pipeline in different phases of clinical development, with phase 2 being the highest. Several major pharmaceutical companies and biotech firms, including BioNTech, Genmab, Adagene, and Shanghai Henlius Biotech, are actively pursuing drug development programs after recognizing the potential of this target. This presents a significant opportunity for both established players and newcomers in the field of immuno-oncology. The ability of CD137-targeted treatments to get past some of the drawbacks of existing immunotherapies, like immune checkpoint inhibitors, is one of their main advantages. Although checkpoint inhibitors have fundamentally altered the way that cancer is treated, only a small percentage of patients and cancer types respond well to them. The range of individuals who can benefit from immunotherapy may be increased by CD137 agonists, which may enhance or supplement the effectiveness of these currently available treatments. The most advanced CD137-targeted therapies in clinical development are agonistic antibodies. The intended effect of these compounds is to stimulate T cell survival, proliferation, and effector activities via activating CD137 signaling. Regarding anti-tumor effectiveness and safety characteristics, early clinical trials have produced encouraging results. YH004, ADG106, ADG206, and ATOR-1017 are a few CD137 agonistic antibodies that are now undergoing clinical trials. There have been challenges, nevertheless, such as dose-limiting hepatotoxicity seen in certain candidates. Due to this, other strategies are being investigated that might provide better safety and efficacy profiles, such as bispecific antibodies and tailored ligands. Combining CD137-targeted therapies with other immunomodulatory drugs is one highly intriguing area of investigation. CD137 agonists have been shown to have synergistic benefits when paired with checkpoint inhibitors, chemotherapy, targeted therapy, or even radiation therapy, according to preclinical research and early phase clinical evidence. These combination approaches may result in more potent and more persistent anti-tumor responses, which would fulfill the unmet demand for efficient treatments for malignancies that are challenging to treat. The market potential for effective CD137 antibodies is significant, considering the wide range of applications of CD137-targeted treatments in cancer. New and efficient treatment modalities are highly sought after, as the global market for cancer immunotherapy is expected to grow to many billions of dollars in the next several years. A sizeable portion of this market may be taken up by CD137-targeted treatments, especially if they show greater efficacy and can treat conditions where immunotherapies have not been very successful. Furthermore, the versatility of CD137 as a target extends beyond oncology. Recent studies point to possible uses in transplantation, autoimmune diseases, inflammatory disorders, and infectious diseases. This wide-ranging therapeutic potential could open up additional market opportunities for drug developers, willing to explore these indications. Despite the promising outlook, several challenges need to be addressed in the development of CD137-targeted therapies. These include optimizing dosing regimens to balance efficacy and safety, identifying predictive biomarkers for patient section, and developing strategies to overcome potential resistance mechanisms. Overcoming these hurdles will be crucial for the successful translation of CD137-targeted therapies from bench to bedside. In conclusion, CD137-targeted therapies represent a significant opportunity to transform treatment of cancer and various other diseases involving the immune system. The increasing comprehension of CD137 biology, in conjunction with developments in antibody engineering and combination strategies, offers a robust basis for novelty in this domain. CD137-targeted therapies have the potential to fill a significant gap in the medical community and gain a significant portion of the cancer immunotherapies market, which presents a strong case for development and innovation. CD137 Antibodies Clinical Trials & Market Opportunity Insight 2027 Report Highlights: Currently No Drug Commercially Available In Market More Than 80 Drugs In Clinical Trials Highest Clinical Trials Phase: Phase II (7 Drugs) CD137 Drugs Market Opportunity In Initial 24 Months Of Launch: > US$ 400 Million Global & Regional Trends (Clinical & Commercial) CD137 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase CD137 Therapeutic Approaches By Antibodies Classification Role Of CD137 & Clinical Progress By Indication Key Topics Covered: 1. Brief Introduction To CD137 1.1 Clinical Overview 1.2 Biological History Of CD137 1.3 CD137 Hosting An Era Of Agonists Over Antagonists 1.4 Bi-Directional Signaling In CD137 2. Global CD137 Antibody Market Outlook 2.1 Current Research & Market Scenario 2.2 Future Commercialization Opportunities 3. CD137 Antibody Clinical Developments by Regions 3.1 China 3.2 US 3.3 South Korea 3.4 Europe 3.5 Australia 4. Role Of CD137 & Clinical Progress By Indication 4.1 Cancer 4.1.1 Leukemia 4.1.2 Lymphoma 4.1.3 Lung Cancer 4.1.4 Melanoma 4.1.5 Breast Cancer 4.1.6 Colorectal Cancer 4.2 Autoimmune & Inflammatory Diseases 4.3 Microbial Infections 4.3.1 Viral Infections 4.3.2 Bacterial infections 5. Global CD137 Antibodies Clinical Trials Overview 5.1 By Company 5.2 By Country 5.3 By Indication 5.4 By Phase 5.5 By Patient Segment 6. CD137 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase 6.1 Research 6.2 Preclinical 6.3 Phase I 6.4 Phase I/II 6.5 Phase II 7. CD137 Targeting Proprietary Technology Platforms By Companies 8. CD137 Therapeutic Approaches By Antibodies Classification 8.1 Monoclonal Antibody Based Strategies 8.2 Bispecific Antibody Centered Approaches 8.3 Trispecific Antibody Established Strategies 8.4 Tetraspecific Antibody Strategies 9. Combination Therapies With CD137 Antibodies 10. Competitive Landscape ABL Bio Adagene Alligator Bioscience BeiGene Bicycle Therapeutics BioNTech Biotheus Crescendo Biologics Eutilex F-star Therapeutics Genmab I-MAB Biopharma Lyvgen Biopharma OriCell Therapeutics Pieris Pharmaceuticals Shanghai Henlius Biotech Sichuan Baili Pharmaceutical SystImmune For more information about this report visit https://www.researchandmarkets.com/r/uh1uil About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

LUND, Sweden I September 16, 2024 I Alligator Bioscience AB (“Alligator”) (Nasdaq Stockholm:ATORX) and Aptevo Therapeutics (“Aptevo”) (Nasdaq: APVO) today announced positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors likely to express the tumor antigen 5T4. The results, which include clinical activity, safety, tolerability outcomes, pharmacokinetics and pharmacodynamics were presented in a poster session on Saturday, September 14, 2024, at the European Society for Medical Oncology (ESMO) Annual Congress in Barcelona, Spain. ALG.APV-527 is a first-in-class bispecific antibody that targets 4-1BB and the tumor antigen 5T4. The compound is being evaluated in a multi-center, dose escalation trial that has 18 patients included in the safety analysis. These patients received multiple prior rounds of therapy for the treatment of solid tumor types. The trial is approaching full enrollment and interim results include: Clinical Activity/Efficacy Safety and Tolerability Evidence of favorable pharmacokinetics and biological activity of ALG.APV-527 “4-1BB has been a target of interest-though with excess toxicity-for decades, and novel bispecific approaches like this will enable us to maximize anti-tumor immunity while limiting the systemic toxicity concerns that have plagued this key immune costimulatory receptor. With this backdrop, these Phase 1 interim results are very encouraging, with ALG.APV-527 showing a positive safety profile with 60% of evaluable patients achieving stable disease, meaning not progressing for variable time frames including one breast cancer patient being treated with monotherapy on study with SD for more than 11 months. We are excited to see signs of clinical activity, underscoring the potential of the drug to benefit patients with solid tumors in the clinical setting, supported by a positive safety and tolerability profile,” stated Thomas Marron, MD, PhD, Professor in Immunology & Immunotherapy and in Medicine, Hematology and Medical Oncology at Icahn School of Medicine at Mount Sinai , participating Investigator of the trial. Trial Overview The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label dose-escalation trial that includes administration of ALG.APV-527 in up to six escalating dose levels in a 3+3 design*. The trial is enrolling adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG.APV-527 will be given intravenously once every two weeks. The trial is assessing the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of ALG.APV-527. *The 3+3 design proceeds in cohorts of three patients treated at increasing dose levels. Dose escalation stops when at least two out of three or six patients experience dose limiting toxicities (DLTs) at that dose level. About ALG.APV-527 ALG.APV-527 is a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4. This has the potential to be clinically important because 4-1BB can stimulate the immune cells (antitumor-specific T cells and NK cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer. Preclinical studies, highlighting the differentiated design of the molecule that minimizes systemic immune activation, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in preclinical models, has been published in the peer-reviewed publication, Molecular Cancer Therapeutics , a journal of the American Association for Cancer Research (AACR). About Alligator Bioscience Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator’s portfolio includes several promising drug candidates, with the CD40 agonist mitazalimab as its key asset. Furthermore, Alligator is co-developing ALG.APV-527 with Aptevo Therapeutics Inc., several undisclosed molecules based on its proprietary technology platform, Neo-X-Prime™, and novel drug candidates based on the RUBY™ bispecific platform with Orion Corporation. Out-licensed programs include AC101/HLX22, in Phase 2 development, by Shanghai Henlius Biotech Inc. and an undisclosed target to Biotheus Inc. Alligator Bioscience’s shares are listed on Nasdaq Stockholm (ATORX) and is headquartered in Lund, Sweden. For more information, please visit alligatorbioscience.com . About Aptevo Therapeutics Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel bispecific immunotherapies for the treatment of cancer. Aptevo is seeking to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com . SOURCE: Aptevo Therapeutics