Masofaniten

Efficacy signals observed will not achieve ESSA's target product profile in patients with metastatic castration-resistant prostate cancer naïve to second-generation antiandrogens A futility analysis conducted as part of a protocol-specified interim review of the safety, PK and efficacy data showed the single-agent enzalutamide control arm performing better than historical controls and similar to the combination of masofaniten and enzalutamide and therefore, unlikely to achieve the primary endpoint of the study Additional clinical studies with masofaniten including the combination study with abiraterone acetate and apalutamide as well as the remaining investigator sponsored trials will also be terminated and the IND and CTAs in different geographies will be withdrawn Company will initiate a process to explore and review strategic options focused on maximizing shareholder value SOUTH SAN FRANCISCO, California and VANCOUVER, Canada, Oct. 31, 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 that it has made the decision to terminate the Phase 2 clinical trial evaluating in a 2:1 randomization masofaniten combined with enzalutamide versus enzalutamide single agent in patients with metastatic castration-resistant prostate cancer ("mCRPC") naïve to second-generation antiandrogens. This decision, mutually agreed upon by both senior management and the board of directors, was based on a protocol-specified interim review of the safety, PK and efficacy data, which showed a much higher rate of PSA90 response in patients treated with enzalutamide monotherapy (which is standard of care for this patient population) than were expected based upon historical data. In addition, there was no clear efficacy benefit seen with the combination of masofaniten plus enzalutamide compared to enzalutamide single agent. A futility analysis determined a low likelihood of meeting the prespecified primary endpoint of the study. The combination of masofaniten plus enzalutamide was well-tolerated with no new safety signals and a safety profile similar to that seen in Phase 1 studies. "Providing a meaningful clinical benefit to patients in our clinical trials, along with a robust safety profile, is of utmost importance to us at ESSA," said David Parkinson, MD, President and CEO. "We designed this randomized study to rigorously evaluate the clinical benefit of adding masofaniten to enzalutamide. We made the difficult decision to terminate this Phase 2 study following the interim analysis because we concluded that the emerging efficacy profile of masofaniten combined with enzalutamide would not likely meet the primary endpoint of the study, nor our internal requirements for a prostate cancer therapy candidate. We would like to thank our partners, investigators, employees, and most importantly, the patients and their families involved in our clinical trials." Richard Glickman, LLD, Chairman of the Board of Directors of ESSA, commented, "Senior management, together with the board of directors, are actively focused on preserving capital and will initiate a strategic process to explore and review a range of strategic options focused on maximizing shareholder value." The Phase 2 study (NCT05075577) was designed as an open label, two-arm randomized (2:1) trial and was planned to enroll a total of 120 patients (80 in the combination arm and 40 in the enzalutamide single agent arm). The efficacy interim analysis included 52 enrolled patients (48% of the total planned patients) who had at least one PSA measurement after baseline and 41 patients (34% of total planned patients) who completed at least three months follow up. Enrolled patients were from clinical sites located in the United States, Canada, Australia and France. The primary study endpoint is the proportion of patients reaching PSA90. Additional PSA-based secondary endpoints included PSA50 response as well as PSA50 and PSA90 response rates at 12 weeks as well as time to event parameters (which were not mature at the time of the interim analysis). Primary and PSA-related Secondary Endpoints of the Study As part of the effort to focus its resources, ESSA is also planning to terminate the other remaining company-sponsored and investigator-sponsored clinical studies evaluating masofaniten either as a monotherapy or in combination with other agents. Liquidity and Outstanding Share Capital As of September 30, 2024, the Company had available cash reserves and short-term investments of $126.8 million and net working capital of $124.3 million (unaudited figures). The Company has no long-term debt facilities. As of September 30, 2024, the Company had 44,388,551 common shares issued and outstanding, and there were 2,920,000 common shares issuable upon the exercise of prefunded warrants at an exercise price of $0.0001. About the Phase 2 Study The Phase 2 dose expansion portion of this Phase 1/2 study is a two-arm, randomized, open-label study (NCT05075577) that evaluated the safety, tolerability and preliminary efficacy of masofaniten, and was expected to enroll approximately 120 patients. Criteria for entry into the Phase 2 dose expansion were similar to those in the Phase 1 dose escalation. Patients continued to receive androgen deprivation therapy and were randomized 2:1 to receive either the combination of masofaniten (600mg twice-daily ("BID")) and enzalutamide (160mg once daily ("QD")) or enzalutamide (160mg QD) as a single agent. Patients were eligible to remain on study treatment as long as they tolerated treatment without disease progression based on RECIST v1.1 and/or Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria. About Masofaniten Masofaniten (formerly known as EPI-7386) is a first-in-class investigational oral, small molecule inhibitor of the androgen receptor ("AR"). Masofaniten's unique mechanism of action disrupts the AR signaling pathway, the primary pathway that drives prostate cancer growth. 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 applicable 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 termination of the Company's clinical studies of masofaniten, the Company's financial resources, the evaluation of the Company's strategic alternatives, the primary and PSA-related endpoints of the Phase 2 study 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

▎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. 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/ 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