Trabectedin

SHELTON, Conn., May 29, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, announces that the Company will be presenting a Trials in Progress poster outlining its Phase 3 INVINCIBLE-3 clinical trial of INT230-6 for the treatment of metastatic soft tissue sarcomas. The poster will be shown at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting held at McCormick Place in Chicago May 30-June 5, 2025. The poster, titled, "A Multicenter, Randomized, Global Phase 3 Study to Assess the Efficacy and Safety of Intratumoral (IT) INT230-6 (SHAO, VINblastine, Cisplatin) as Monotherapy Compared with Standard of Care Systemic Chemotherapy in Adults with Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (STS) (INVINCIBLE-3)," will be presented by Sant P. Chawla M.D., Director, Sarcoma Oncology Center of Southern California, during the "Sarcoma" session to be held on Saturday May 31, 2025 from 9:30 AM to 12 PM on panel 66a. An abstract of the poster, which outlines the Company's Phase 3 study protocol, can be found here. "The INVINCIBLE-3 trial is breaking new ground in metastatic sarcoma with a unique, new, investigational product, INT230-6. Following direct intratumoral injection, this drug product results in significant necrosis and the formation of cysts within tumors, with little residual cancer remaining in those injected tumors. A successful outcome of the INVICIBLE-3 study will require practicing physicians to think differently about setting dose and disease endpoints. INT230-6's dose per tumor is set by the tumor size. In this protocol, survival advantage is the gold standard upon which the efficacy of a novel investigational agent such as INT230-6 would be ultimately based," said Dr. Chawla. "We have designed a unique Phase 3 protocol comparing our local therapy to the best systemic standard of care based on our completed Phase 1/2 trial. In our first study, refractory, metastatic sarcoma patients whose disease continued to progress following a median of three prior lines of therapy received INT230-6 alone," said Lewis H. Bender, Intensity Therapeutics Founder, President, and CEO. "Those sarcoma patients showed immune engagement post-dose, uninjected tumors regressing, a disease control rate of 93%, and a median overall survival of 21.3 months with minimal treatment-associated adverse events. Eight regulatory agencies, including the U.S. FDA, have authorized the Phase 3 study. Until sufficient additional funding is obtained, new enrollment for the Phase 3 has been paused. We are continuing to treat the enrolled patients, maintain pharmacovigilance, monitor sites, and look forward to reinitiating recruitment as soon as sufficient resources are available." About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor resulting in a favorable safety profile. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient's malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which so often occurs with systemic chemotherapy. About INVINCIBLE-3 INVINCIBLE-3 is a study to evaluate a novel, new drug product administered intratumorally by an interventional radiologist or an equivalently trained physician using image guidance compared to systemically dosed second- or third-line US standard of care chemotherapy. Patients will be randomized 2 to 1 to INT230-6 or pazopanib, trabectedin, or eribulin (selection of SOC depends on the sarcoma subtype). As this is a survival study, there is no crossover allowed between US SOC and INT230-6. Disease progression will be determined by the World Health Organization (WHO) Criteria in conjunction with evaluation of the post-treatment scans. Dosing beyond radiographic progression is allowed should tumors have low levels residual cancer on scans post baseline. Participants will be prospectively stratified into 1 of 3 histologically defined aSTS strata: leiomyosarcoma, liposarcoma (dedifferentiated, myxoid, round cell and pleomorphic) and undifferentiated pleomorphic sarcoma The participants will undergo in 4 phases: screening, treatment, maintenance, and follow-up in the study. Study visits, tumor and endpoint assessments will occur as indicated in the procedural outlines as part of a schedule of events. Important inclusion criteria include: histologically proven, unresectable, locally advanced, or metastatic STS only of the following Participant must have a pathology report indicating the diagnosis of their STS. Participants must have received at least 1 line of therapy for STS and must have progressed following anthracycline-based or alternative standard therapies, except if medically contraindicated or refused by the participant. A participant cannot have received more than 2 prior regimens for unresectable, locally advanced or metastatic STS. Participants must have measurable disease per RECIST 1.1 criteria. Participants must have at least 1 target tumor ≥ 2 cm suitable for injection using routine image guidance, measurable by CT or MRI. Key exclusion criteria include: Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable as well as off steroid therapy for at least 2 months. History of severe hypersensitivity reactions to US SOC agents and vinblastine or cisplatin or other products of the same class and their excipients. Histologically proven, unresectable, locally advanced or metastatic STS subtypes other than those specified, for example, excluded subtypes include liposarcoma (well differentiated), desmoid or dermatofibrosarcoma protuberans. Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the participant has been disease-free for at least 2 years. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of the investigational new drug, INT230-6, to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies and enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, SAKK (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's SEC filings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations, and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik Justin@coreir.com CORE IR (516) 222-2560 Media Contact: Jules Abraham CORE IR pr@coreir.com View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-incs-phase-3-invincible-3-sarcoma-study-selected-for-presentation-at-the-american-society-of-clinical-oncology-asco-2025-annual-meeting-302466668.html SOURCE Intensity Therapeutics Inc.

中国北京，2025年5月15日，北京华昊中天生物医药股份有限公司（下称“华昊中天”，股票代码：2563.HK），一家依托于合成生物学研发平台专注于开发具有自主知识产权抗癌新药的生物医药公司，今日宣布，其重要海外管线之一，优替德隆胶囊（UTD2）对比研究者选择的化疗用于治疗铂耐药晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌患者的多中心、开放、随机、对照的II/III期临床研究（BG02-2501）获得国家药品监督管理局药品审评中心（CDE）的临床试验默示许可。卵巢癌是女性癌症第五大死亡原因[1]，大多数卵巢癌患者在诊断时已为晚期[2]。铂类联合紫杉醇是卵巢癌术后一线标准治疗方法[3]，然而55%~75%的患者在完成治疗后2年内复发[4]，大多数患者会对铂类治疗产生耐药。铂耐药卵巢癌患者预后较差，对后续化疗的客观缓解率（ORR）低于15%，中位无进展生存期（PFS）仅为3~4个月[5]。因此，铂耐药卵巢癌患者亟需新的治疗方法。优替德隆在既往临床研究中针对卵巢癌的治疗展现出不俗潜力。一项优替德隆注射液（UTD1）单药治疗晚期实体瘤患者的II期临床研究（BG01-2002）于晚期卵巢癌队列共入组15例患者，既往中位治疗线数为4线，其中10例可评价疗效患者中1例部分缓解（PR）、3例疾病稳定（SD），临床获益率40%；一项优替德隆胶囊（UTD2）单药治疗晚期实体瘤的美国I期临床研究（BG02-2201）共入组18例患者，其中12例可评价疗效患者中1例完全缓解（CR）、1例PR和8例SD，临床获益率83.3%，获得CR和PR均为卵巢癌患者，且既往治疗线数分别为7线和9线。上述结果均展示优替德隆在晚期卵巢癌患者中良好的有效性和临床获益趋势。优替德隆与紫杉类药物具有相似的作用机制，但与紫杉类药物难以开发成口服剂型不同，优替德隆不易被P-糖蛋白泵出胞外，具有口服给药的优势。华昊中天利用特有的合成生物学技术平台开发了优替德隆口服胶囊（UTD2），已顺利完成美国I期临床，安全性和优效性得到充分验证（详见新闻：华昊中天优替德隆胶囊美国I期临床完成全部患者入组）。UTD2将显著提升患者用药便利性和依从性，有助于长期的辅助和维持治疗，减轻患者治疗成本，展现巨大的应用潜力和市场空间。本研究是华昊中天针对UTD2开展的继一线治疗胃癌（详见新闻：FDA批准华昊中天优替德隆胶囊一线治疗晚期胃癌II/III期国际多中心临床）后第二项国际多中心II/III期注册临床研究，进一步夯实UTD2国际化开发布局。关于BG02-2501研究 BG02-2501研究代指“优替德隆胶囊（UTD2）对比研究者选择的化疗用于治疗铂耐药晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌患者的多中心、开放、随机、对照的II/III期临床研究”。其中，II期部分拟入组72例受试者，计划在中国和美国的多个中心开展，主要目的为评估UTD2单药治疗卵巢癌不同给药方案的安全性、疗效和药代动力学特征、推荐III期剂量；III期部分拟入组480例受试者，计划在中国、美国、欧洲及其他国家和地区的多个中心开展。主要终点为PFS，次要终点包括总生存期（OS）、ORR等。参考文献[1] American Cancer Society. Cancer Facts & Figures 2015. Atlanta: American Cancer Society; 2015.[2] Cannistra SA. Cancer of the ovary. N Engl J Med. 2004 Dec 9;351(24):2519-29.[3] Du Bois A, Pfisterer J, Meier W, Wagner U. Improving first-line therapy of advanced ovarian cancer - the AGO Ovarian Cancer Study Group perspective. Int J Gynecol Cancer. 2003 NovDec;13 Suppl 2:169-71.[4] Edwards SJ, Barton S, Thurgar E, Trevor N. Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for advanced recurrent or refractory ovarian cancer: a systematic review and economic evaluation. Health Technol Assess. 2015 19(7) 1-480.[5] Davis A, Tinker AV, Friedlander M. "Platinum resistant" ovarian cancer: what is it, who to treat and how to measure benefit? Gynecol Oncol. 2014 Jun;133(3):624-31.往期回顾华昊中天荣登2025年度生物制造·未来智药TOP10斩获ASCO 2025口头报告丨华昊中天优替德隆多项临床研究成果齐亮相FDA批准华昊中天优替德隆胶囊一线治疗晚期胃癌II/III期国际多中心临床一图回顾华昊中天2024年度进展 Biostar 2024 Annual Review华昊中天荣获“年度卓越创新力IPO”奖强强联合，携手共赢丨华昊中天与百洋医药达成战略合作华昊中天成功登陆香港联交所主板，合成生物学引领创新药研发新时代华昊中天“优替德隆注射液乳腺癌新辅助Ⅲ期注册临床试验”研究者会议圆满召开