更新于：2024-11-01
Masofaniten
更新于：2024-11-01
概要
基本信息
非在研机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评快速通道 (美国) |
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结构
分子式C24H24Cl2N4O4S |
InChIKeyGVCZSODXLFBYSS-UHFFFAOYSA-N |
CAS号2416716-62-4 |
关联
5
项与 Masofaniten 相关的临床试验Phase 2 Trial Combining EPI-7386 with Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer
The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer. The main goals of this study are to evaluate the antitumor activity of EPI-7386 in combination with enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC), and to evaluate the pharmacokinetics (PK) of EPI-7386 when dosed in combination with enzalutamide. Participants will will take the study drug, EPI-7360, twice a day by mouth and enzalutamide once a day by mouth, alongside clinic visits every two weeks.
开始日期2024-05-16 |
申办/合作机构 |
A Randomized, Open-Label, Phase 2 Study of Darolutamide as Single Agent or in Combination with EPI-7386 as a Neoadjuvant Treatment for Patients Undergoing Prostatectomy for Localized Prostate Cancer (DaSCENT)
开始日期2023-02-20 |
申办/合作机构- |
A Phase 1b Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone or Apalutamide in mCRPC (ARES: Androgen Receptor Eradication Study)
The purpose of this study is to determine safety, including dose limiting toxicities, and the recommended phase 2 dose (RP2D) of EPI-7386 in separate combinations with (a) abiraterone acetate plus prednisone or prednisolone (AAP) and (b) apalutamide (dose-finding) and to determine the antitumor activity of EPI-7386 in separate combinations with (a) AAP and (b) apalutamide (dose-expansion).
开始日期2022-03-23 |
100 项与 Masofaniten 相关的临床结果
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100 项与 Masofaniten 相关的转化医学
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100 项与 Masofaniten 相关的专利（医药）
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32
项与 Masofaniten 相关的新闻（医药）2024-09-22
·药明康德
▎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。
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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. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/13/2945711/0/en/Nxera-s-Partner-Cancer-Research-UK-to-Present-on-Phase-1-2a-Clinical-Trial-with-Cancer-Immunotherapy-Drug-HTL0039732-at-ESMO.html
[24] Scorpion Therapeutics Presents Initial Clinical Data from Its Phase 1/2 Trial of STX-478 Demonstrating Potentially Best-in-Class Mutant-Selective PI3Kα Inhibition for the Treatment of Advanced Solid Tumors at ESMO Congress 2024. Retrieved September 20, 2024, from https://www.scorpiontx.com/press-release/scorpion-therapeutics-presents-initial-clinical-data-from-its-phase-1-2-trial-of-stx-478-demonstrating-potentially-best-in-class-mutant-selective-pi3k%ce%b1-inhibition-for-the-treatment-of-advanced-so/
[25] Satellos Announces Dosing of First Participant in Phase 1 Clinical Study of SAT-3247. Retrieved September 20, 2024, from https://www.businesswire.com/news/home/20240918008946/en/Satellos-Announces-Dosing-of-First-Participant-in-Phase-1-Clinical-Study-of-SAT-3247
[26] Anokion Announces New Data from the Phase 1 MoveS-it Study Supporting ANK-700 as a Novel, Potential Disease Modifying Treatment for Relapsing-Remitting Multiple Sclerosis. Retrieved September 20, 2024, from https://www.businesswire.com/news/home/20240917374019/en/Anokion-Announces-New-Data-from-the-Phase-1-MoveS-it-Study-Supporting-ANK-700-as-a-Novel-Potential-Disease-Modifying-Treatment-for-Relapsing-Remitting-Multiple-Sclerosis
[27] Tectonic Therapeutic Announces Favorable Phase 1a Safety, Tolerability and PK/PD Results for Lead Program TX45. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/19/2949404/0/en/Tectonic-Therapeutic-Announces-Favorable-Phase-1a-Safety-Tolerability-and-PK-PD-Results-for-Lead-Program-TX45.html
[28] Beacon Therapeutics Presents 36-Month Interim Results from Phase I/2 HORIZON Trial of AGTC-501 in Patients with XLRP. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/beacon-therapeutics-presents-36-month-interim-results-from-phase-i2-horizon-trial-of-agtc-501-in-patients-with-xlrp-302252375.html
[29] Edgewise Therapeutics Announces Positive Top-Line Data from Phase 1 Trial in Healthy Subjects and Phase 2 CIRRUS-HCM Trial in Patients with Obstructive Hypertrophic Cardiomyopathy (HCM). Retrieved September 20, 2024, from https://www.businesswire.com/news/home/20240919115598/en/Edgewise-Therapeutics-Announces-Positive-Top-Line-Data-from-Phase-1-Trial-in-Healthy-Subjects-and-Phase-2-CIRRUS-HCM-Trial-in-Patients-with-Obstructive-Hypertrophic-Cardiomyopathy-HCM
[30] TransCode Therapeutics Announces First Patients Treated in Phase 1 Clinical Trial with First-in-Class Lead Therapeutic Candidate. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/17/2947285/0/en/TransCode-Therapeutics-Announces-First-Patients-Treated-in-Phase-1-Clinical-Trial-with-First-in-Class-Lead-Therapeutic-Candidate.html
[31] Prelude Therapeutics’ SMARCA2 Degrader PRT3789 Demonstrated Promising Initial Clinical Activity and Safety Profile in Phase 1 Trial. Retrieved September 20, 2024, from https://investors.preludetx.com/news-releases/news-release-details/prelude-therapeutics-smarca2-degrader-prt3789-demonstrated
[32] Botensilimab/Balstilimab Clinical Responses in Refractory Sarcomas Presented at ESMO 2024. Retrieved September 20, 2024, from https://investor.agenusbio.com/news/news-details/2024/BotensilimabBalstilimab-Clinical-Responses-in-Refractory-Sarcomas-Presented-at-ESMO-2024/default.aspx
[33] CureVac’s CVGBM Cancer Vaccine Induces Promising Immune Responses in Phase 1 Study in Glioblastoma Presented at the ESMO 2024 Congress. 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/
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临床结果快速通道临床2期抗体药物偶联物
2024-09-13
Combination of masofaniten plus enzalutamide continues to be well tolerated with durable reductions in PSA in patients with mCRPC
Phase 2 dose expansion currently underway at the RP2CDs of masofaniten 600 mg BID in combination with enzalutamide 160 mg QD
Across all dosing cohorts, 88% of patients achieved PSA90, 69% of patients achieved PSA90 in less than 90 days, and 63% of patients achieved PSA <0.2ng/mL. After 15.2 months of follow up, median time to PSA progression and radiographic progression free survival have not yet been reached.
SOUTH SAN FRANCISCO, Calif. and VANCOUVER, BC, Sept. 13, 2024 /PRNewswire/ - ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten (formerly EPI-7386) in combination with enzalutamide at the 2024 European Society for Medical Oncology (ESMO) Congress, taking place September 13-17, 2024, in Barcelona, Spain. Masofaniten is a first-in-class N-terminal domain androgen receptor ("AR") inhibitor that suppresses androgen activity through a novel mechanism of action and is being developed for the treatment of prostate cancer. The poster presentation is available on the "Publications" section of the Company's website at .
"We are pleased to be sharing more mature data from the Phase 1 dose escalation study evaluating masofaniten in combination with enzalutamide today at ESMO 2024. The combination continues to be well tolerated with prolonged reductions in circulating prostate-specific antigen ("PSA") levels in patients with metastatic castration-resistant prostate cancer ("mCRPC"). After 15.2 months of follow up, neither median time to PSA progression nor radiographic progression free survival have been reached. These data compare favorably to historical data for single agent enzalutamide treatment in the mCRPC patient population," said David Parkinson, MD, President and CEO of ESSA. "We continue to focus on the enrollment of the Phase 2 dose expansion study evaluating masofaniten in combination with enzalutamide, with 33 sites activated in the US, Canada and Australia and an additional 22 sites anticipated in Europe. We look forward to providing further updates in 2025."
Poster presentation details:
Title: Phase 1/2 trial of oral EPI-7386 (masofaniten) in combination with enzalutamide (Enz) compared with Enz alone in subjects with metastatic castration-resistant prostate cancer (mCRPC): Phase 1 results and Phase 2 design
Presenting Author: Christos Kyriakopoulos, MD, University of Wisconsin-Madison Carbone Cancer Center
Presentation #: 1641P
Date and time: Sunday, September 15, 2024; 12:00-1:30 p.m. CEST/ 6:00-7:30 a.m. ET
Data summary: This Phase 1/2 multicenter, open-label clinical trial enrolled patients with mCRPC who have received androgen deprivation therapy and who are naïve to second-generation antiandrogens but may have been treated previously with one line of prior chemotherapy in the metastatic hormone-sensitive prostate cancer setting. The data presented today includes 18 patients across four cohorts in the Phase 1 dose escalation portion of the study. Masofaniten has no effect on enzalutamide exposure, thus allowing the use of full dose per label (160mg) of enzalutamide in combination. Enzalutamide reduces masofaniten exposure but twice daily dosing of masofaniten appears to mitigate the reduction and maintains clinically relevant drug exposures.
In patients evaluable for safety (n=18), masofaniten combined with enzalutamide, continues to be well-tolerated at the dose levels tested through 32 cycles of dosing in some patients. Most frequent adverse events were Grades 1 and 2, related to either AR inhibition or gastrointestinal tract irritation. In Cohort 4, one patient experienced a Grade 3 rash, which was observed immediately following administration of masofaniten combined with enzalutamide and deemed probably related, resulting in the expansion of the cohort from four to seven patients. No additional dose-limiting toxicities (DLTs) were observed, therefore the maximum tolerated dose (MTD) was not reached. The recommended Phase 2 combination doses (RP2CDs) were identified as masofaniten 600 mg twice daily (BID) in combination with enzalutamide 160 mg once daily (QD).
In the patients evaluable for efficacy (n=16), rapid, deep and durable reductions in PSA were observed, regardless of previous chemotherapy status, including in patients who received lower than the full dose of enzalutamide (120 mg). Across all dose cohorts, 88% of patients (14 of 16) achieved PSA50, 88% of patients (14 of 16) achieved PSA90, 69% of patients (11 of 16) achieved PSA90 in less than 90 days, and 63% of patients (10 of 16) achieved PSA <0.2ng/mL. With a current median follow up of 15.2 months, the median time to PSA progression and radiographic progression free survival have not yet been reached.
The randomized, open-label, two arm, Phase 2 dose expansion portion of the study is underway and is designed to evaluate the combination of masofaniten and enzalutamide versus single agent enzalutamide in patients with mCRPC naïve to second generation anti-androgens. The study is currently enrolling at approximately 33 sites in the USA, Canada and Australia, and an additional 22 sites anticipated in Europe.
About Masofaniten
Masofaniten (formerly known as EPI-7386) is a first-in-class investigational, highly selective, oral, small molecule inhibitor of the N-terminal domain ("NTD") of the androgen receptor ("AR"). Masofaniten's unique mechanism of action disrupts the AR signaling pathway, the primary pathway that drives prostate cancer growth, by selectively binding to the NTD, a region of the AR that is not currently targeted by other therapies. Masofaniten is currently being studied in an open-label, randomized Phase 2 clinical trial (NCT05075577) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) naïve to second-generation antiandrogens. ESSA is also conducting a Phase 1 monotherapy study (NCT04421222) in patients with mCRPC whose tumors have progressed on standard-of-care therapies. The U.S. Food and Drug Administration has granted Fast Track designation to masofaniten for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to masofaniten worldwide.
About ESSA Pharma Inc.
ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer. For more information, please visit , and follow us on X and LinkedIn.
Forward-Looking Statement Disclaimer
This release contains certain information which, as presented, constitutes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements include, but are not limited to, statements that relate to future events and often addresses expected future business and financial performance, containing words such as "anticipate", "believe", "plan", "estimate", "expect", and "intend", statements that an action or event "may", "might", "could", "should", or "will" be taken or occur, or other similar expressions and includes, but is not limited to, statements regarding presentations with respect to the Phase 1/2 study, the tolerability of masofaniten in combination with enzalutamide, PSA reductions resulting from masofaniten in combination with enzalutamide, the potential long-term benefits of masofaniten, providing future updates on the Phase 1/2 and Phase 2 studies, the timing of and enrollment in the Company's studies and other statements surrounding the Company's evaluation of masofaniten.
Forward-looking statements are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of ESSA to control or predict, and which may cause ESSA's actual results, performance or achievements to be materially different from those expressed or implied thereby. Such statements reflect ESSA's current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by ESSA as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. In making forward looking statements, ESSA may make various material assumptions, including but not limited to (i) the accuracy of ESSA's financial projections; (ii) obtaining positive results of clinical trials; (iii) obtaining necessary regulatory approvals; and (iv) general business, market and economic conditions.
Forward-looking statements are developed based on assumptions about such risks, uncertainties and other factors set out herein and in ESSA's Annual Report on Form 10-K dated December 12, 2023, under the heading "Risk Factors", a copy of which is available on ESSA's profile on EDGAR at and on SEDAR+ at , and as otherwise disclosed from time to time on ESSA's EDGAR and SEDAR+ profiles. Forward-looking statements are made based on management's beliefs, estimates and opinions on the date that statements are made and ESSA undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as may be required by applicable United States and Canadian securities laws. Readers are cautioned against attributing undue certainty to forward-looking statements.
Contacts
ESSA Pharma, Inc.
Peter Virsik, Chief Operating Officer
778.331.0962
[email protected]
Investors and Media:
Argot Partners
212.600.1902
[email protected]
SOURCE ESSA Pharma Inc
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临床结果临床1期临床2期快速通道
2024-08-05
On track to report updated Phase 1 masofaniten plus enzalutamide dose escalation data in patients with mCRPC naïve to second generation antiandrogens in the second half of 2024
Presentation of Phase 1b monotherapy results expected to be reported in the second half of 2024
Phase 2 dose expansion underway evaluating masofaniten plus enzalutamide in patients with mCRPC naïve to second generation antiandrogens; ESSA projecting completion of enrollment in the first quarter of 2025, with preliminary data expected in mid-2025
Cash runway sufficient to fund operations well beyond 2025
SOUTH SAN FRANCISCO, California and VANCOUVER, Canada, Aug. 5, 2024 /PRNewswire/ - ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today provided a corporate update and reported financial results for the fiscal third quarter ended June 30, 2024.
"With continued focus on execution, we are progressing towards a stream of significant milestones throughout the next nine to twelve months, with the first being the presentation at ESMO of more mature durability data from the Phase 1 dose escalation study evaluating masofaniten combined with enzalutamide in patients with metastatic castration-resistant prostate cancer naïve to second-generation antiandrogens," said David Parkinson, MD, President and CEO of ESSA. "We are focused on the enrollment of the Phase 2 dose expansion study evaluating masofaniten in combination with enzalutamide, with 25 sites activated in the US, Canada and Australia and an additional 14 sites being activated in Europe. We look forward to reporting key data across these trials throughout the remainder of this year through 2025."
Third Quarter Fiscal 2024 and Recent Highlights
Masofaniten Combination Studies
Phase 1/2 study is still ongoing evaluating masofaniten in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer ("mCRPC") naïve to second-generation antiandrogens but may have been treated with chemotherapy in the metastatic castration-sensitive setting. The latest reported results, which were presented at the ASCO-GU symposium in January 2024, demonstrated that the combination regimen continues to be well tolerated at the dose levels tested in up to 25 cycles of dosing in some patients. Reductions in PSA were observed across evaluable patients for efficacy in all dosing cohorts (n=16). Across all dosing cohorts, 88% of patients achieved PSA50, 81% of patients achieved PSA90, 69% of patients achieved PSA90 in less than 90 days, and 63% of patients achieved PSA <0.2ng/mL. While the data for time to PSA progression were still maturing, the median time to PSA progression was reported as 16.6 months with a median follow up at that time of 11.1 months. ESSA plans to report updated data from the Phase 1 dose escalation study at the European Society for Medical Oncology (ESMO) 2024 congress.
Masofaniten continues to be evaluated in combination with enzalutamide compared to enzalutamide monotherapy in a Phase 2 dose randomized study in patients with mCRPC naïve to second-generation antiandrogens but who may have been treated with chemotherapy in the metastatic castration-sensitive setting. Enrollment in the Phase 2 portion of this Phase 1/2 study is expected to be completed during the first quarter of 2025. The study is currently enrolling at approximately 25 sites in the US, Canada, and Australia. Expansion to European clinical sites is in progress with an additional 14 clinical sites planned to be activated by the third quarter of 2024. ESSA is on track to report preliminary data from the Phase 2 dose expansion portion of the study in mid-2025.
Two additional masofaniten combination arms are continuing enrollment as part of the ongoing Phase 1 masofaniten study. One arm is evaluating masofaniten in combination with abiraterone acetate and prednisone in patients with either metastatic castration-sensitive prostate cancer or mCRPC, while the second arm is evaluating masofaniten in combination with apalutamide in patients with non-metastatic castration-resistant prostate cancer after 12 weeks of masofaniten single agent.
Two additional investigator-sponsored studies testing combinations of masofaniten with darolutamide or enzalutamide in different patient populations are currently enrolling: a) an Australian investigator-sponsored neoadjuvant study evaluating neoadjuvant use of the combination of masofaniten and darolutamide compared to darolutamide monotherapy in high-risk patients undergoing prostatectomy and b) an investigator-sponsored study which is testing masofaniten and enzalutamide in metastatic castration-sensitive prostate cancer patients.
Masofaniten Monotherapy Study
ESSA remains on track to complete the Phase 1b masofaniten monotherapy study evaluating masofaniten in patients with mCRPC resistant to second-generation antiandrogens. The initial results from the monotherapy study were reported at the 2023 ASCO-GU Symposium, and demonstrated that masofaniten monotherapy was well-tolerated, achieved clinically significant exposures, and showed preliminary signals of anti-tumor activity in a subset of patients. ESSA plans to present the complete Phase 1b monotherapy results in the second half of 2024 at a medical conference.
Summary Financial results
(Amounts expressed in U.S. dollars)
Net Loss. ESSA recorded a net loss of $7.2 million for the third quarter ended June 30, 2024, compared to $7.3 million for the third quarter ended June 30, 2023.
Research and Development ("R&D") expenditures. R&D expenditures for the third quarter ended June 30, 2024, were $5.5 million compared to $6.3 million for the third quarter ended June 30, 2023, and include non-cash costs related to share-based payments of $851,971 for the third quarter ended 2024 compared to $599,621 for the third quarter ended 2023. The decrease is largely attributable to reductions in preclinical work with the focus on ongoing clinical trials.
General and Administration ("G&A") expenditures. G&A expenditures for the third quarter ended June 30, 2024, were $3.2 million compared to $2.6 million for the third quarter ended June 30, 2023, and include non-cash costs related to share-based payments of $1,748,227 for the third quarter ended 2024 compared to $561,452 for the third quarter ended 2023. The net decrease (net of share-based payments) relates to the timing of corporate projects and lower insurance premiums for the current period.
Liquidity and Outstanding Share Capital
As of June 30, 2024, the Company had available cash reserves and short-term investments of $130.7 million. The Company's cash position is expected to be sufficient to fund current and planned operations beyond 2025.
As of June 30, 2024, the Company had 44,368,959 common shares issued and outstanding.
In addition, as of June 30, 2024, there were 2,920,000 common shares issuable upon the exercise of prefunded warrants at an exercise price of $0.0001.
About ESSA Pharma Inc.
ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer. For more information, please visit , and follow us on X and LinkedIn.
Forward-Looking Statement Disclaimer
This release contains certain information which, as presented, constitutes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements include, but are not limited to, statements that relate to future events and often addresses expected future business and financial performance, containing words such as "anticipate", "believe", "plan", "estimate", "expect", and "intend", statements that an action or event "may", "might", "could", "should", or "will" be taken or occur, or other similar expressions and includes, but is not limited to, statements regarding the Company's plans to report updated data from its studies, the Company's advancement and evaluation of masofaniten, the timing of the Company's studies, enrollment in the Company's studies, the presentation of Phase 1a and 1b monotherapy results and the Company's expected cash runway.
Forward-looking statements are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of ESSA to control or predict, and which may cause ESSA's actual results, performance or achievements to be materially different from those expressed or implied thereby. Such statements reflect ESSA's current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by ESSA as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. In making forward-looking statements, ESSA may make various material assumptions, including but not limited to (i) the accuracy of ESSA's financial projections; (ii) obtaining positive results of clinical trials; (iii) obtaining necessary regulatory approvals; and (iv) general business, market and economic conditions.
Forward-looking statements are developed based on assumptions about such risks, uncertainties and other factors set out herein and in ESSA's Annual Report on Form 10-K dated December 12, 2023, under the heading "Risk Factors", a copy of which is available on ESSA's profile on EDGAR at and on SEDAR+ at , and as otherwise disclosed from time to time on ESSA's EDGAR and SEDAR+ profiles. Forward-looking statements are made based on management's beliefs, estimates and opinions on the date that statements are made and ESSA undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as may be required by applicable United States and Canadian securities laws. Readers are cautioned against attributing undue certainty to forward-looking statements.
Contacts
ESSA Pharma, Inc.
David Wood, Chief Financial Officer
778.331.0962
[email protected]
Investors and Media:
Argot Partners
212.600.1902
[email protected]
ESSA PHARMA INC.
CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS
(Unaudited)
Amounts in thousands of United States dollars
ESSA PHARMA INC.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
Amounts in thousands of United States dollars, except share and per share data
ESSA Pharma, Inc.
David Wood, Chief Financial Officer
778.331.0962
[email protected]
Investors and Media:
Argot Partners
212.600.1902
[email protected]
SOURCE ESSA Pharma Inc
临床1期临床2期临床结果财报
100 项与 Masofaniten 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 |
|---|---|---|---|---|
| 前列腺腺癌 | 临床2期 | 美国 | 2024-05-16 | |
| 去势敏感前列腺癌 | 临床2期 | 美国 | 2024-05-16 | |
| 激素依赖性前列腺癌 | 临床2期 | 美国 | 2024-05-16 | |
| 前列腺癌 | 临床2期 | 美国 | 2023-04-12 | |
| 转移性去势抵抗性前列腺癌 | 临床2期 | 澳大利亚 | 2021-12-21 | |
| 转移性去势抵抗性前列腺癌 | 临床2期 | 美国 | 2021-12-21 | |
| 转移性去势抵抗性前列腺癌 | 临床2期 | 加拿大 | 2021-12-21 | |
| AR突变肿瘤 | 临床前 | 美国 | 2022-01-30 |
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临床结果
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 |
|---|
临床1/2期 | 18 | (選夢願壓網願積顧蓋醖) = 淵願鹹網膚築築選鑰齋 顧獵醖選鑰襯艱鑰醖壓 (廠膚窪願範夢糧廠膚觸 ) 更多 | 积极 | 2024-09-15 | |||
临床1/2期 | 16 | (鹽鑰夢壓選襯觸簾網齋) = 築鬱蓋製壓遞鬱醖網選 鹹選壓簾鏇醖製憲鹽積 (遞廠選積鏇糧獵顧淵廠 ) 更多 | 积极 | 2024-01-25 | |||
临床1/2期 | 11 | (衊醖構鹹積糧糧網襯構) = consistent with second-generation antiandrogens (e.g., Grade 1 or 2 AEs of fatigue and hot flashes). 網膚艱製簾糧製獵鹽壓 (選鹽鬱選蓋艱鹽齋築艱 ) 更多 | 积极 | 2023-10-22 | |||
临床1/2期 | 7 | (夢壓鏇繭齋餘簾鹽糧築) = 網醖鹽襯積製壓繭鹽壓 願獵遞顧廠積鏇鹽觸鹹 (繭遞壓艱襯鑰繭窪衊襯 ) 更多 | 积极 | 2023-02-21 | |||
临床1期 | 39 | (艱壓範壓窪鬱膚構製淵) = 艱衊鏇窪廠繭鏇廠齋積 襯餘膚齋淵衊簾構築鏇 (壓鏇鹹膚窪願窪網鑰醖 ) | 积极 | 2023-02-21 | |||
临床1期 | 36 | (糧齋製簾鬱夢選願觸餘) = EPI-7386 was safe and well-tolerated at all dose levels and schedules tested with plasma target concentrations achieved and clinically important efficacy signals 鏇構簾淵製廠淵築鬱壓 (鬱艱淵鏇艱蓋齋醖襯鏇 ) | 积极 | 2022-06-27 |
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