FPX-01(Fusion Pharmaceuticals, Inc.)

「  本文共：15条资讯，阅读时长约：3分钟 」今日头条云顶新耀引进IgA肾病新药获批上市。云顶新耀引进的布地奈德的创新口服靶向迟释制剂耐赋康®（Nefecon）获新加坡卫生科学局批准上市，用于治疗原发性IgA肾病。Nefecon是全球首款获批的针对IgA肾病的靶向药，在临床试验（NefIgArd）中较安慰剂降低患者27%（P=0.0003）的尿蛋白肌酐比（UPCR），UPCR较基线值减少了31%（vs5%）。云顶新耀拥有该新药在大中华地区、新加坡和韩国开发以及商业化权利。国内药讯1.石药ADC启动头对头Ⅲ期临床。石药集团HER2 ADC新药DP303c在Clinicaltrials.gov网站上注册了一项Ⅲ期临床，拟评估DP303c对比曲妥珠单抗Emtansine治疗HER2阳性晚期乳腺癌患者的有效性和安全性，预计2025年12月初步完成。去年6月，该新药已在国内开展III期临床，评估与曲妥珠单抗对比，联合长春瑞滨/卡培他滨三线及以上治疗HER2阳性晚期乳腺癌的有效性与安全性，该项试验主要研究者为复旦大学附属肿瘤医院胡夕春博士。2.信达眼科双抗II期临床积极。信达生物VEGF/C3补体双靶点药物Efdamrofusp alfa注射液（IBI302）治疗新生血管性年龄相关性黄斑变性（nAMD）的II期临床达到了主要终点。第40周时，IBI302（6.4mg，Q8W；8.0mg，Q12W）组患者研究眼最佳矫正视力（BCVA）较基线提高的均值分别为10.5个和11.0个ETDRS字母数，疗效非劣效于阿柏西普（2.0mg，Q8W，9.8个ETDRS字母数）；中央视网膜厚度（CST）较基线改善的均值分别为-163.19 μm和-184.46 μm，vs-108.23 μm，且药物整体安全性良好。3.华昊中天胃癌新药获孤儿药资格。华昊中天开发的埃博霉素类似物UTD2（优替德隆口服胶囊）获FDA授予孤儿药资格，用于治疗胃癌。优替德隆是一种化疗新分子，其抗肿瘤机制与紫杉醇相似，具备多药耐药和广谱抗肿瘤活性。目前，华昊中天也正在积极推进优替德隆胶囊在中国的胃癌适应症开发，将于今年下半年启动Ⅲ期临床试验。4.思康睿奇抗耐药实体瘤新药获批IND。思康睿奇1类化药3HP-2827片获国家药监局临床许可，拟开发单药或联合用药治疗FGFR2异常的肿瘤患者。3HP-2827是一款FGFR2抑制剂，能够高特异性的抑制FGFR2磷酸化，通过抑制FGFR2信号通路以发挥抗肿瘤作用，为FGFR2异常和耐药患者带来治疗选择。去年12月，该新药已获FDA批准开展新药研究，评估治疗FGFR2突变的不可切除或转移性实体瘤的安全性和疗效。5.德琪中美双报双抗临床前研究见刊。德琪医药PD-L1/4-1BB双特异性抗体ATG-101的临床前研究成果日前发表于Cancer Research期刊上。ATG-101仅可在PD-L1交联条件下激活4-1BB表达阳性的T细胞，这让ATG-101具有较其它4-1BB激动剂更低的肝脏毒性，并有效抑制ICI耐药肿瘤的生长。目前，该新药正在澳大利亚、中国和美国三地同步开展I期临床，评估治疗晚期/转移性实体瘤及B细胞非霍奇金淋巴瘤 （B-NHL）的安全性与有效性。国际药讯1.Idorsia公司新型口服降压药获批上市。Idorsia与强生联合开发的靶向双重内皮素A/B受体（ETA/ETB）的口服拮抗剂Aprocitentan（商品名Tryvio）获FDA批准上市，与其他抗高血压药物联用，治疗难治性高血压患者。Aprocitentan可有效抑制ET-1与ETA和ETB的结合，通过抑制内皮素信息通路来控制血压。在III期PRECISION研究中，aprocitentan联合用药可显著降低顽固性高血压患者的血压，且疗效维持长达48周。2.Optinose公司鼻喷剂获批新适应症。Optinose公司基于专有EDS递送系统开发的创新药物/医疗器械组合产品Xhance（丙酸氟替卡松）鼻喷雾剂获FDA批准新适应症，用于治疗18岁以上无鼻息肉的慢性鼻窦炎患者。该产品能够将鼻部类固醇丙酸氟替卡松递送到发生炎症的部位，尤其是通过标准鼻喷雾剂难以接触的鼻窦和鼻窦引流管。临床研究显示，Xhance治疗能显著缓解患者的症状和鼻窦炎症。3.拜耳FIC更年期新药Ⅲ期临床成功。拜耳潜在“first-in-class”双重神经激肽-1，3（NK-1，3）受体拮抗剂elinzanetant治疗更年期血管舒缩症状（潮热，VMS）的Ⅲ期临床（OASIS 3）结果积极。此前，该项试验已达到主要终点，elinzanetant治疗第12周时患者中重度VMS的频率和严重程度较安慰剂显著降低。52周数据显示，elinzanetant的长期安全性总体与之前进行的研究数据一致。拜耳计划尽快向FDA提交elinzanetant上市申请。4.肢端肥大症激动剂Ⅲ期临床成功。Crinetics公司口服非肽类偏向性SST2激动剂paltusotine（CRN00808）治疗肢端肥大症（acromegaly）患者的Ⅲ期PATHFNDR-2临床达到了主要终点和所有次要终点。与安慰剂相比，paltusotine治疗24周后，患者达到胰岛素样生长因子1（IGF-1）水平≤正常值上限（xULN）1.0倍的比例更高（56%vs5%，p<0.0001），且paltusotine总体耐受性良好。该公司预计今年下半年递交新药申请。5.NASH新药Ⅱ期临床达到主要终点。Inventiva公司口服泛PPAR激动剂lanifibranor联用SGLT2抑制剂恩格列净（empagliflozin）治疗代谢功能障碍相关性脂肪性肝炎（MASH）/非酒精性脂肪性肝炎（NASH）和控制不佳的2型糖尿病（T2D）患者的Ⅱ期试验LEGEND达到了主要终点。24周时，与安慰剂组相比，lanifibranor单药组和lanifibranor联用恩格列净治疗组的糖化血红蛋白（HbA1c）水平显著下降；HbA1c绝对值较基线下降>1%的应答率分别为64%和88%。此外，药物耐受性良好。6.AZ超20亿美元收购核药公司Fusion。阿斯利康宣布将以超20亿美元款项收购放射性偶联药物（RCs）公司Fusion Pharmaceuticals，并获得该公司首发管线FPI-2265，以及其他放射偶联药物管线资产（FPI-1434、FPI-2059和FPI-2068）。FPI-2265是一种基于锕225的PSMA靶向放射偶联药物，目前正在Ⅱ期临床TATCIST中评估用于治疗转移性去势抵抗性前列腺癌（mCRPC）潜力，临床数据预计在今年4月份读出。医药热点1.湖南省：执业医师晋升副高级职称新规定。湖南省卫健委日前印发《湖南省卫生系列执业医师晋升副主任医师前下基层服务工作实施管理办法》。《办法》规定，执业医师在晋升副主任医师前应到基层医疗卫生机构服务一年及以上，每次连续服务不少于6个月，特殊情况按程序备案。下基层服务人员须“全脱产”在基层服务，应积极发挥专业特长，认真完成出门诊、管病床、做手术、带教学和公共卫生服务等医疗教学工作任务。2.北京今年将建设11家老年护理中心。3月20日，在2024年北京市老龄健康工作会议上，北京市卫健委介绍，今年北京将聚力破解“老老人”长期照护难题，11家医疗机构将转型建设老年护理中心，新增床位220张。北京市卫健委鼓励有条件的基层医疗卫生机构根据需要设置和增加提供老年护理床位，引导部分二级及以下医院转型为护理院、护理中心，支持社会力量举办护理院、护理站等长期护理服务机构。同时，安宁疗护服务发展也将加快推进，年内将有8家医疗机构转型建设安宁疗护中心，新增床位280张。3.杭州发布全国首张“七码合一”疫苗身份证。3月20日，浙江省疾控局、杭州市卫健委、杭州西湖区卫健局发布了全国首张“七码合一”疫苗身份证，“七码合一”疫苗身份证是市民在接种疫苗后，系统自动生成的一条包含了疫苗电子监管码、疫苗批号、疾控编码、门诊编码、冷链设备编码、医护编码和受种者编码等7种编码的信息，供受种者查看。评审动态  1. CDE新药受理情况（03月20日) 2. FDA新药获批情况（北美03月19日）股市资讯上个交易日 A 股医药板块 +0.29%涨幅前三     跌幅前三安 必 平+11.10%  宏源药业-10.55%康惠制药+10.01%  *ST 太安-4.79%大理药业+10.00%  新 产 业-3.61%【复星医药】旗下复星雅立峰产品上市注册申请于近期获国家药监局批准，为冻干人用狂犬病疫苗（Vero细胞）。【新诺威】旗下巨石生物于近日收到国家药监局核发的药物临床试验批准通知书，产品抗体药物偶联物（ADC）SYS6023将于近期开展临床试验。【康希诺】公司自愿披露产品“吸附破伤风疫苗”于近日正式启动III期临床试验，并完成首例受试者入组。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

Company recently announced definitive agreement to be acquired by AstraZeneca FPI-2265 Phase 2/3 registrational program for patients with metastatic castration-resistant prostate cancer (mCRPC) expected to begin in Q2 2024 Interim data from TATCIST study of FPI-2265 to be presented at the 2024 American Association for Cancer Research (AACR) Annual Meeting in April Fusion is now producing and shipping clinical doses of FPI-2265 from its state-of-the-art GMP manufacturing facility HAMILTON, ON and BOSTON, March 20, 2024 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided an update on clinical and corporate developments. Chief Executive Officer John Valliant, Ph.D., commented, "We entered 2024 with strong momentum focused on execution to advance our pipeline of targeted alpha therapies, and we are pleased to recently have achieved several critical milestones. For our lead program, FPI-2265, we expect to initiate the Phase 2 portion of the registrational program in metastatic castration-resistant prostate cancer (mCRPC) in the second quarter of this year. Acknowledging the substantial and expanding market for patients in the post-PLUVICTO™ setting we believe FPI-2265, which is positioned to be the first actinium-based PSMA targeted radiopharmaceutical to market, will effectively address a crucial unmet need for patients with progressive disease. We look forward to presenting data from the TATCIST trial at AACR in April. Dr. Valliant continued, "We also continue to advance our other clinical-stage programs, including the ongoing Phase 1 study of FPI-1434, which has demonstrated a promising safety profile and early evidence of antitumor activity. We expect to provide an update on this program around mid-year 2024. Underpinning our platform, which has produced a robust pipeline of targeted alpha therapies, is our state-of-the-art GMP manufacturing facility now operational and producing clinical doses of FPI-2265. With a strong balance sheet and secured actinium supply, we are well positioned to execute on our commitment of bringing this next generation of radiopharmaceuticals to patients in need." Corporate Update On March 19, 2024, Fusion announced the Company has entered into a definitive agreement to be acquired by AstraZeneca. Under the terms of the agreement, AstraZeneca, through a subsidiary, will acquire all of Fusion's outstanding shares pursuant to a plan of arrangement for a price of $21.00 per share in cash at closing plus a non-transferable contingent value right (CVR) of $3.00 per share in cash payable upon the achievement of a specified regulatory milestone. The upfront cash portion of the consideration represents a transaction value of approximately $2 billion, a 97% premium to Fusion's closing market price of $10.64 on March 18, 2024. Combined, the upfront and maximum potential contingent value payments represent, if achieved, a transaction value of approximately $2.4 billion, a 126% premium to Fusion's closing market price on March 18, 2024. As part of the transaction, AstraZeneca will acquire the cash, cash equivalents and short-term investments on Fusion's balance sheet, which totaled $234 million as of December 31, 2023. The transaction is expected to close in the second quarter of 2024, subject to customary closing conditions, including the approval of Fusion shareholders and regulatory clearances. Portfolio Update FPI-2265: A 225Ac based radiopharmaceutical targeting prostate specific membrane antigen (PSMA) for the treatment of patients with mCRPC. In January 2024, the Company announced alignment with the FDA on its Phase 2/3 protocol for FPI-2265 in patients with mCRPC with progressive disease who have previously been treated with a 177Lu-based PSMA radiotherapy. The development plan includes a Phase 2 dose optimization lead-in, which aims to evaluate whether there are added safety and/or efficacy benefits of various dosing regimens in comparison to the validated regimen of 100kBq/kg every eight weeks, expected to be initiated in the second quarter of 2024. This Phase 2 portion is expected to complete enrollment of approximately 60 patients by the end of 2024. Following analysis of the Phase 2 data and an end of Phase 2 meeting to determine the recommended Phase 3 dosing regimen with the FDA, a Phase 3 global registrational trial in approximately 550 patients is expected to begin in 2025. The TATCIST trial, which began as an investigator sponsored study, is designed to evaluate FPI-2265 in patients with mCRPC with progressive disease, including patients who are naïve to PSMA-targeted radiopharmaceuticals and those who have been pre-treated with 177Lu-based PSMA radiopharmaceutical therapy, completed target enrollment of 25-30 patients. The Company announced that interim data will be presented at the upcoming 2024 American Association for Cancer Research (AACR) Annual Meeting in April. The Company is also pursuing the opportunity to potentially move this therapeutic candidate into earlier lines of treatment with combinations of FPI-2265 and olaparib. Fusion expects to initiate a combination trial in the first half of this year. FPI-1434: Targeting insulin growth factor 1 receptor (IGF1R). In January 2024, Fusion announced encouraging early findings from Cohort 2 in the cold/hot dosing arm of the ongoing Phase 1, multi-center, open-label clinical trial. The trial is designed to investigate the safety, tolerability, and pharmacokinetics of FPI-1434 in patients with solid tumors expressing IGF-1R. The trial is also designed to establish the maximum tolerated dose for FPI-1434 and the recommended Phase 2 dose. No dose limiting toxicities (DLTs) were observed to date in the 25 kBq/kg dose cohort. Two out of three patients completed the DLT period, and one pancreatic cancer patient discontinued treatment due to disease progression. Evidence of anti-tumor activity was observed in a heavily pre-treated patient with Ewing sarcoma after a single dose and a second patient receiving four cycles of therapy demonstrated stable disease as best response. The Company plans to complete and further evaluate results from Cohort 2 and hold a Safety Review Committee (SRC) meeting to evaluate the emerging data. Fusion plans to share more details on the data and the FPI-1434 development program in mid-2024. FPI-2059: Targeting neurotensin receptor 1 (NTSR1). Patient enrollment and dosing is ongoing in the Phase 1, multi-center, open-label clinical trial designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics of FPI-2059 as well as preliminary anti-tumor activity in participants with NTSR1 expressing advanced metastatic solid tumors. Fusion plans to provide guidance on timing for pharmacokinetic, imaging and safety data following early experience with FPI-2059 patient screening and enrollment. FPI-2068: A bispecific IgG-based targeted alpha therapy (TAT) targeting EGFR-cMET. FPI-2068 is currently being evaluated in a Phase 1 study and is being jointly developed with AstraZeneca under the companies' multi-asset collaboration agreement. FPI-2068 is a bispecific IgG-based TAT designed to deliver actinium-225 to various solid tumors that express EGFR-cMET. EGFR and cMET are both validated targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. The investigational new drug (IND) application has been cleared and Fusion is currently activating clinical trial sites. Other Recent Updates In January 2024, Fusion announced it had completed validation of its state-of-the-art GMP manufacturing facility and produced the first clinical dose of a TAT. The facility, which has clinical and commercial scale manufacturing capacity, is designed to support the Company's growing pipeline of TATs and is expected to be capable of producing more than 100,000 doses per year. In February 2024, Fusion announced that it has entered into a licensing agreement with Heidelberg University and Euratom represented by the European Commission, Joint Research Centre (together, the "Licensors"). The license agreement grants Fusion exclusive worldwide rights to utilize, develop, manufacture and commercialize compounds covered by the patent, which includes 225Ac-PSMA I&T ("FPI-2265") for the treatment of prostate specific membrane antigen (PSMA)-expressing cancers. In addition, Fusion and the Licensors have signed an agreement to settle the parties' dispute related to an inter partes review ("IPR") of the patent which was instituted in August 2023 by the United States Patent and Trademark Board. Fourth Quarter 2023 Financial Results Cash and Investments: As of December 31, 2023, Fusion held cash, cash equivalents and investments of $247.3 million, compared to cash, cash equivalents and investments of $186.6 million as of December 31, 2022. Fusion expects its existing cash, cash equivalents and investments as of December 31, 2023, together with net proceeds from sales of common shares under the Company's at-the-market equity offering program received in January and February 2024 and net proceeds of $14.9 million from a draw down under the Company's existing debt facility in January 2024, will be sufficient to fund operations into the fourth quarter of 2025. R&D Expenses: Research and development expenses for the fourth quarter of 2023 were $20.6 million, compared to $17.6 million for the same period in 2022. The increase was primarily due to increased manufacturing-related expenditures, as well as increased personnel-related costs. G&A Expenses: General and administrative expenses for the fourth quarter of 2023 were $7.6 million, compared to $6.9 million for the same period in 2022. The increase was primarily due to increased consulting and personnel-related costs. Net Loss: For the fourth quarter of 2023, Fusion reported a net loss of $28.2 million, or $0.39 per share, compared with a net loss of $24.6 million, or $0.55 per share, for the same period in 2022. Upcoming Presentations Fusion will present data in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting being held in San Diego, CA, April 5-10, 2024. Title: Preliminary efficacy and safety results from the (TACIST) trial: A PSMA-directed targeted alpha therapy with FPI-2265 (225Ac-PSMA-I&T) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) Session: Phase II Clinical Trials 1 Date and Time: Tuesday April 9, 2024 9:00 AM - 12:30 PM PT Location: Poster Section 49 Abstract Number: CT224 About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's clinical-stage development portfolio includes lead program, FPI-2265, targeting prostate specific membrane antigen for metastatic castration resistant prostate cancer currently in a Phase 2 trial and novel targeted alpha therapies (TATs) including next-generation antibody drug conjugates (ADCs). Fusion has a collaboration with AstraZeneca to jointly develop novel TATs and combination programs between Fusion's TATs and AstraZeneca's DNA damage response inhibitors and immuno-oncology agents. Fusion has a fully operational Good Manufacturing Practice compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for the Company's growing pipeline of TATs. The Company has strategic actinium supply agreements with Niowave, Inc. and BWXT Medical. Forward-Looking Statements This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the future business and financial performance of Fusion Pharmaceuticals Inc. (the "Company"). For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the risks related to the satisfaction or waiver of the conditions to closing the proposed transaction (including the failure to obtain necessary regulatory, court and Fusion's shareholder approvals) in the anticipated timeframe or at all, including the possibility that the proposed transaction does not close; risks associated with the disruption of management's attention from ongoing business operations due to the proposed transaction; and unknown liabilities and the risk of litigation and/or regulatory actions related to the proposed transaction; the Company's financial condition, liquidity, and potential drug candidates, including any expressed or implied statements regarding the successful development of FPI-2265 or FPI-1434. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline in or to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected patient recruitment delays or regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company's ability to obtain additional funding required to conduct its research, development and commercialization activities; changes in the Company's business plan or objectives; competition in general; the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries; and the Company partners' ability to advance any technology relating to actinium-225 to development. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's quarterly report on Form 10-Q for the period ended September 30, 2023, as filed with the Securities and Exchange Commission (the "SEC") and in any subsequent periodic or current report that the Company files with the SEC. All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations, or beliefs at any date subsequent to the date of this release. While Fusion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change. Investors and others should note that Fusion communicates with its investors and the public using the Fusion website, , including, but not limited to, company disclosures, investor presentations, SEC filings, and press releases. The information that Fusion posts on this website could be deemed to be material information. As a result, Fusion encourages investors, media and others interested to review the information that Fusion posts there on a regular basis. Contact: Amanda Cray Senior Director of Investor Relations & Corporate Communications (617) 967-0207 [email protected] SOURCE Fusion Pharmaceuticals