Mirvetuximab soravtansine

SAN DIEGO, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the appointment of Isabel Kalofonos as Chief Commercial Officer. Ms. Kalofonos will lead the company’s commercial strategy and operations for the potential launch of paltusotine, the first and only once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist for adults living with acromegaly and will lead pre-commercialization activities for the company’s deep, innovative pipeline of candidates. “Isabel is a highly accomplished leader with broad commercial expertise ranging from launching therapies to leading early-stage commercial strategy,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. “Her expertise includes a proven track record of building and managing global commercial organizations, driving successful global launches of breakthrough therapies and bringing innovative medicines to market. I am thrilled to welcome Isabel into this pivotal commercial leadership role as we seek to deliver a new generation of therapy for acromegaly and transform the lives of large numbers of people impacted by other endocrine-related conditions.” “I feel so fortunate to join Crinetics at this time,” said Ms. Kalofonos. “Building highly effective commercial teams to launch transformative products has been the focus of my career. I look forward to bringing my experience to a company like Crinetics that is well-positioned to be a leader in endocrinology and has the potential to make a meaningful advancement for the acromegaly community and endocrine disorders. I look forward to leading the company’s strategy for the first potential commercial launch, building a best-in-class commercial team and continuing to build value for products in the pipeline.” Ms. Kalofonos joins Crinetics with more than 20 years of global experience in the pharmaceutical and biotech industry, including roles leading business and commercial units and expertise in marketing, new product planning, market access and pricing. She previously served as Senior Vice President and Chief Commercial Officer at ImmunoGen (acquired by Abbvie), where she was responsible for leading the successful launch of ELAHERE (mirvetuximab), a treatment for ovarian cancer and for overseeing the commercial strategy for the pipeline of antibody-drug conjugates in oncology indications. Ms. Kalofonos led the sales, marketing, market access and commercial operations teams in the U.S., as well as international launch preparation. Prior to ImmunoGen, Ms. Kalofonos worked at Galderma, where she served as Senior Vice President and Global Head of the Prescription Business Unit. During her tenure, she led the launch preparation for NEMLUVIO (nemolizumab), a monoclonal antibody for the treatment of atopic dermatitis and prurigo nodularis, as well as global market access, real-world evidence, pricing, and health economics and outcomes research. Prior to Galderma, Ms. Kalofonos held roles of increasing responsibility at Takeda Pharmaceuticals (formerly Shire), most recently serving as Vice President and Head of the Hereditary Angioedema (HAE) franchise, a $2.5-billion business. In this role, she oversaw the global blockbuster launch of TAKHZYRO (lanadelumab-flyo). Prior to the Takeda acquisition, Ms. Kalofonos held roles of increasing responsibility at Shire within corporate strategy, new product planning, and commercial, and gained experience across multiple therapeutic areas, including immunology, rare diseases, oncology, neurology, transplant, and gene therapy. Ms. Kalofonos holds an MBA in entrepreneurship and marketing from Babson College and an undergraduate degree in industrial engineering from Pontificia Universidad Javeriana. On January 10, 2025, the Company expects to grant Ms. Kalofonos a stock option to purchase 100,000 shares of common stock under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the “2021 Inducement Plan”), 25 percent of which will vest on December 16, 2025, and the remainder will vest in 36 equal monthly installments thereafter. The stock option will have an exercise price equal to the closing price of the Company’s common stock on the Nasdaq Global Select Market on January 10, 2025. The stock option will be subject to the terms and conditions of the 2021 Inducement Plan and the terms and conditions of a stock option agreement covering the respective grant. The stock option will be granted as an inducement material to Ms. Kalofonos entering into employment with Crinetics in accordance with Nasdaq Listing Rule 5635(c)(4). ABOUT CRINETICS PHARMACEUTICALS Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors. Crinetics’ lead development candidate, paltusotine, is the first investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist that is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors. Crinetics is also developing atumelnant, an investigational, first-in-class, oral ACTH antagonist that is currently completing Phase 2 clinical studies for the treatment of congenital adrenal hyperplasia and Cushing’s disease. All of the company’s drug candidates are orally delivered, small molecule, new chemical entities resulting from in-house drug discovery efforts, including additional discovery programs addressing a variety of endocrine conditions such as hyperparathyroidism, polycystic kidney disease, Graves’ disease (including thyroid eye disease), diabetes, obesity and GPCR-targeted oncology indications. FORWARD-LOOKING STATEMENTSThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the, the therapeutic potential and clinical benefits or safety profile of paltusotine for patients with acromegaly, the plans and timelines for the commercial launch paltusotine for acromegaly, if approved, and the potential of our other research, discovery, and clinical trial programs. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “upcoming” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, without limitation, geopolitical events may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical studies and preclinical studies, manufacturing and supply chain, or impairing employee productivity; unexpected adverse side effects or inadequate efficacy of the Company’s product candidates that may limit their development, regulatory approval and/or commercialization; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; and Crinetics’ drug candidates may not advance in development or be approved for marketing; and the other risks and uncertainties described in the Company’s periodic filings with the Securities and Exchange Commission (SEC). The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading “Risk Factors” in Crinetics’ periodic filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2023, and its Quarterly reports on Form 10-Q for the quarters ended March 31, 2024, June 30, 2024, and September 30, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Investors:Gayathri DiwakarHead of Investor Relationsgdiwakar@crinetics.com(858) 345-6340 Media:Natalie BadilloHead of Corporate Communicationsnbadillo@crinetics.com(858) 345-6075

摘要：抗体药物偶联物（ADC）作为抗癌领域的新星，其研发聚焦于多个热门靶点，以提高治疗效果并减少副作用。HER2、Trop2、EGFR、CLDN18.2和Nectin-4等靶点因其在特定肿瘤中的高表达而备受关注。HER2靶点药物市场表现强劲，全球销售额持续增长，而CLDN18.2和CD19等靶点药物也展现出巨大市场潜力。尽管面临耐药性和市场竞争等挑战，ADC药物的研发正通过新药开发、适应症拓展和联合用药策略不断推进，预计将为癌症治疗带来更多突破。本文综述了ADC药物研发的热门靶点、市场表现、面临的挑战及未来发展方向，为理解ADC药物的发展趋势提供了全面的视角。1. ADC药物研发热门靶点概览1.1 靶点选择的重要性与标准 在ADC药物研发中，靶点的选择是决定药物疗效和安全性的关键因素。理想的靶点通常在肿瘤细胞中特异性高表达，而在正常细胞中的表达水平较低，以减少对正常组织的损害。此外，靶点的选择还应考虑其在肿瘤发展中的作用，以及是否具有内吞性，这决定了ADC药物能否被肿瘤细胞有效内化并释放细胞毒性载荷。1.2 热门靶点的分布与特点 根据最新的研究数据，全球ADC药物研发的热门靶点主要集中在HER2、Trop2、EGFR、CLDN18.2、Nectin-4等。这些靶点因其在多种肿瘤中的高表达和关键作用而受到广泛关注。 HER2：HER2靶点在乳腺癌、胃癌等多种实体瘤中过表达，目前已有多个HER2靶向ADC药物获批上市，如Enhertu（DS-8201）和Kadcyla（T-DM1），显示出显著的疗效。 Trop2：Trop2在多种上皮癌中高表达，全球有多个Trop2靶向ADC药物处于临床研发阶段，如SKB264和Dato-DXd，其在肺癌和乳腺癌中展现出良好的治疗效果。 EGFR：EGFR在非小细胞肺癌、头颈癌等多种肿瘤中过表达，针对EGFR的ADC药物研发活跃，反映了该靶点的临床需求和潜力。 CLDN18.2：CLDN18.2主要在胃癌中表达，目前有多个ADC药物针对此靶点进行研发，如CMG901和LM-302，其在胃癌治疗中显示出较高的响应率。 Nectin-4：Nectin-4在尿路上皮癌等多种实体瘤中表达，Padcev（Enfortumab vedotin）作为首个Nectin-4靶向ADC药物已获批上市，其他在研药物如9MW2821和SYS6002也显示出积极的临床数据。1.3 靶点研发的挑战与机遇 尽管上述靶点已成为ADC药物研发的热点，但仍面临诸多挑战，如靶点的同质化竞争、耐药性问题、以及对正常组织的潜在毒性。同时，这些挑战也带来了新的机遇，如开发新的靶点、探索联合用药策略、以及利用新技术提高ADC药物的特异性和疗效。 同质化竞争：随着多个药企聚焦于相同靶点，市场竞争日益激烈，这要求研发者探索新的靶点或开发差异化的产品。 耐药性问题：肿瘤可能对ADC药物产生耐药性，因此需要研究新的有效载荷和连接子技术，以克服耐药性。 对正常组织的潜在毒性：尽管ADC药物旨在减少对正常组织的损害，但某些靶点在正常组织中的表达可能导致不良反应，需要进一步优化药物设计以降低毒性。 综上所述，ADC药物研发的热门靶点不仅为癌症治疗提供了新的选择，也推动了药物研发技术的创新和进步。随着对这些靶点的深入研究和新药的不断涌现，ADC药物有望在未来的癌症治疗中发挥更大的作用。2. HER2靶点ADC药物研发现状2.1 HER2靶点药物的市场表现 HER2靶点药物在全球市场上的表现尤为突出，已成为多个国家和地区癌症治疗的重要组成部分。根据市场研究报告，HER2靶点药物的全球销售额在过去五年中增长迅速，预计未来几年将继续保持增长态势。 市场规模：HER2靶点药物的全球市场规模在2023年达到了近100亿美元，预计到2028年将超过150亿美元，年复合增长率超过10%。 药物销量：以Enhertu（DS-8201）为例，其在全球范围内的销售额从2019年的约2亿美元增长至2023年的约30亿美元，年增长率超过78%。2.2 HER2靶点药物的临床进展 HER2靶点药物的临床研究进展迅速，多个药物在全球范围内开展了广泛的临床试验，涵盖了从早期到晚期的多个癌症类型。 临床试验数量：截至目前，全球有超过50项针对HER2靶点的ADC药物临床试验正在进行中，其中约30%处于III期临床阶段。 适应症拓展：HER2靶点药物的适应症不断拓展，从最初的乳腺癌扩展到胃癌、非小细胞肺癌等多种实体瘤，为更多患者提供了治疗选择。2.3 HER2靶点药物的研发挑战 尽管HER2靶点药物的研发取得了显著进展，但仍面临一些挑战，包括耐药性问题、药物安全性和有效性的平衡以及市场竞争等。 耐药性问题：随着HER2靶点药物的广泛应用，肿瘤可能对这些药物产生耐药性，这要求研究人员开发新的有效载荷和连接子技术，以克服耐药性。 药物安全性和有效性的平衡：HER2靶点药物在提高疗效的同时，也需要关注药物的安全性，尤其是对于正常组织的潜在毒性，需要通过药物设计优化来降低不良反应。 市场竞争：随着多个HER2靶点药物的上市，市场竞争日益激烈，新进入者需要通过差异化策略或开发新的适应症来获得市场份额。2.4 HER2靶点药物的未来展望 HER2靶点药物的未来发展前景广阔，随着新药的不断涌现和临床研究的深入，预计将有更多的HER2靶点药物获批上市，为癌症患者提供更多的治疗选择。 新药上市预期：目前有多款HER2靶点ADC药物处于晚期临床阶段，预计将在未来几年内获批上市，进一步丰富HER2靶点药物的产品线。 联合用药策略：HER2靶点药物与其他药物的联合用药策略正在积极探索中，这可能进一步提高治疗效果，为患者提供更个性化的治疗方案。 新适应症的开发：HER2靶点药物的新适应症开发是未来的一个重要方向，通过拓展到更多癌症类型，可以进一步增加HER2靶点药物的临床应用范围。3. CLDN-18.2靶点ADC药物研发动态3.1 CLDN-18.2靶点药物的研发现状 CLDN-18.2靶点因其在胃癌等多种实体瘤中的高表达而成为ADC药物研发的热点。目前，全球有多个CLDN-18.2靶向ADC药物处于不同的研发阶段，显示出该靶点的临床潜力和市场需求。 研发项目数量：据不完全统计，全球在研的CLDN-18.2靶向ADC药物约百余种，其中部分药物已进入临床试验阶段，如CMG901、LM-302等。 临床试验进展：以CMG901为例，该药物已在全球范围内开展了I期临床研究，并与阿斯利康达成了全球独家授权协议，交易额高达11.88亿美元，显示了该药物的市场潜力和研发进展。3.2 CLDN-18.2靶点药物的疗效与安全性 CLDN-18.2靶向ADC药物在临床试验中显示出良好的疗效和可控的安全性，为胃癌等实体瘤患者提供了新的治疗选择。 疗效数据：在I期临床研究中，CMG901在晚期胃癌/胃食管结合部腺癌患者中显示出33%的客观缓解率（ORR）和70%的疾病控制率（DCR），其中2.2mg/kg剂量组的ORR达到42%。 安全性分析：CMG901的安全性数据表明，与药物相关的≥3级治疗期间不良事件发生率为54%，严重不良事件发生率为31%，8%的受试者因药物相关的不良事件停止用药。3.3 CLDN-18.2靶点药物的市场前景 随着对CLDN-18.2靶点的深入研究和新药的不断涌现，预计CLDN-18.2靶向ADC药物将在未来几年内对胃癌等实体瘤治疗产生重要影响。 市场潜力评估：考虑到CLDN-18.2在多种实体瘤中的高表达，以及目前胃癌等肿瘤治疗中未满足的需求，CLDN-18.2靶向ADC药物具有巨大的市场潜力。 竞争格局分析：尽管多个药企在CLDN-18.2靶点上布局，但市场竞争尚未达到HER2靶点的激烈程度，为新进入者提供了机会。同时，药企需要通过差异化策略或开发新的适应症来获得市场份额。3.4 CLDN-18.2靶点药物的未来发展方向 CLDN-18.2靶向ADC药物的未来发展方向包括新药的研发、适应症的拓展以及联合用药策略的探索。 新药研发：目前，多个CLDN-18.2靶向ADC药物正处于临床试验阶段，预计未来几年将有更多的新药获批上市。 适应症拓展：除了胃癌，CLDN-18.2在胰腺癌、食管癌等其他实体瘤中也有高表达，为药物适应症的拓展提供了可能性。 联合用药策略：CLDN-18.2靶向ADC药物与其他药物的联合用药策略正在积极探索中，这可能进一步提高治疗效果，为患者提供更个性化的治疗方案。4. CD19、FRα等其他热门靶点ADC药物4.1 CD19靶点ADC药物研发现状 CD19靶点在血液肿瘤治疗中的重要性日益凸显，尤其是在弥漫性大B细胞淋巴瘤（DLBCL）的治疗中。目前，全球有多个CD19靶向ADC药物处于不同的研发阶段。 研发项目数量：据不完全统计，全球在研的CD19靶向ADC药物约有十余种，其中部分药物已进入临床试验阶段，如Loncastuximab tesirine（Lonca）。 临床试验进展：Loncastuximab tesirine是目前进展最快的CD19靶向ADC药物，已在美国获得加速批准上市，并在中国提交了上市申请。该药物的II期临床研究显示，对于复发/难治性DLBCL患者，总缓解率达到48.3%，完全缓解率为24.8%。4.2 FRα靶点ADC药物研发动态 FRα靶点在卵巢癌等多种实体瘤中高表达，使其成为ADC药物研发的另一个热点。目前，全球有多个FRα靶向ADC药物处于不同的研发阶段。 研发项目数量：据不完全统计，全球在研的FRα靶向ADC药物约有数十种，其中部分药物已进入临床试验阶段，如Mirvetuximab soravtansine（MIRV）。 临床试验进展：Mirvetuximab soravtansine是目前进展最快的FRα靶向ADC药物，已在美国获得加速批准上市。该药物的III期临床研究显示，对于FRα高表达的铂耐药卵巢癌患者，客观缓解率达到32.4%，中位缓解持续时间为6.9个月。4.3 CD19和FRα靶点药物的市场前景 随着对CD19和FRα靶点的深入研究和新药的不断涌现，预计这两个靶点的ADC药物将在未来几年内对相应的肿瘤治疗产生重要影响。 市场潜力评估：考虑到CD19和FRα在特定肿瘤中的高表达，以及目前治疗中未满足的需求，这两个靶点的ADC药物具有巨大的市场潜力。 竞争格局分析：尽管多个药企在CD19和FRα靶点上布局，但市场竞争尚未达到HER2靶点的激烈程度，为新进入者提供了机会。同时，药企需要通过差异化策略或开发新的适应症来获得市场份额。4.4 CD19和FRα靶点药物的未来发展方向 CD19和FRα靶向ADC药物的未来发展方向包括新药的研发、适应症的拓展以及联合用药策略的探索。 新药研发：目前，多个CD19和FRα靶向ADC药物正处于临床试验阶段，预计未来几年将有更多的新药获批上市。 适应症拓展：除了DLBCL和卵巢癌，CD19和FRα在其他肿瘤中也有高表达，为药物适应症的拓展提供了可能性。 联合用药策略：CD19和FRα靶向ADC药物与其他药物的联合用药策略正在积极探索中，这可能进一步提高治疗效果，为患者提供更个性化的治疗方案。5. 总结5.1 靶点选择的战略意义 ADC药物研发的热门靶点，如HER2、Trop2、EGFR、CLDN18.2和Nectin-4等，已成为癌症治疗领域的明星靶点。这些靶点的选择不仅基于其在肿瘤细胞中的高表达和在肿瘤发展中的重要作用，还考虑了其内吞性质，这对于ADC药物的有效性至关重要。随着对这些靶点的深入研究，ADC药物的研发不断取得突破，为癌症患者提供了更多的治疗选择。5.2 市场表现与研发动态 HER2靶点药物的市场表现尤为突出，全球销售额持续增长，预计未来几年将继续保持增长态势。CLDN-18.2和CD19等靶点药物也显示出巨大的市场潜力和临床需求。这些药物的临床试验进展迅速，多个药物已进入晚期临床阶段，预计将在未来几年内获批上市。5.3 面临的挑战与机遇 尽管ADC药物研发取得了显著进展，但仍面临耐药性问题、药物安全性和有效性的平衡以及市场竞争等挑战。这些挑战也带来了新的机遇，如开发新的靶点、探索联合用药策略、以及利用新技术提高ADC药物的特异性和疗效。5.4 未来发展方向 ADC药物的未来发展方向包括新药的研发、适应症的拓展以及联合用药策略的探索。随着新药的不断涌现和临床研究的深入，预计将有更多的ADC药物获批上市，为癌症患者提供更多的治疗选择。同时，新适应症的开发和联合用药策略的探索将进一步增加ADC药物的临床应用范围，提高治疗效果，为患者提供更个性化的治疗方案。 识别微信二维码，添加生物制品圈小编，符合条件者即可加入 生物制品微信群！ 请注明：姓名+研究方向！ 版 权 声 明 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。