Fortis Therapeutics, Inc.

FibroGen的核心管线Pamrevlumab临床再度宣告失败。 昨日，FibroGen公布了Pamrevlumab针对转移性胰腺导管腺癌的Ⅱ/Ⅲ期临床试验PanCAN Precision Promise以及局部晚期不可切除的胰腺癌的Ⅲ期LAPIS试验的顶线结果，两项临床皆未能达到预先指定的总生存期主要终点。公司决定彻底放弃对该管线的继续开发。 这已是Pamrevlumab遭遇的的第四次临床失败。市场对这个消息依旧给予了负面响应，FibroGen股价下跌了48%，至0.54美元。 试错机会已耗尽 Pamrevlumab是FibroGen开发的一款靶向CTGF的first-in-class抑制剂。CTGF是TGF分子，在纤维化过程中发挥重要作用。Pamrevlumab通过阻断CTGF延缓纤维化的进程。Pamrevluma开发的特发性纤维化（IPF）、杜氏肌营养不良、（DMD）胰腺癌（LAPC）3个适应症均已处于III期临床阶段。 2023年6月7日，FibroGen宣布pamrevlumab治疗12岁以上非卧床杜氏肌营养不良（DMD）DMD Ⅲ期临床试验LELANTOS-1失败。结果显示，与基线相比，Pamrevlumab+皮质类固醇激素治疗组并未在第52周达到上肢功能2.0（PUL 2.0）评分改善的主要终点。 两周后（6月26日），pamrevlumab治疗特发性肺纤维化的Ⅲ期临床ZEPHYRUS-1宣告失败，主要终点和次要终点均未达到。这个结果迫使该公司停止了另一项名为ZEPHYRUS-2的Ⅲ期临床研究。 接连的三项临床失败，令分析师认为pamrevlumab的成功开发的希望变得非常渺茫。 唯一剩下的胰腺癌并没有出乎意料，依旧失败了。PanCAN Precision Promise中，pamrevumab+标准化疗组的中位总生存期为17.3个月，而对照组中位总生存期为17.9个月。 在下面公司先前规划的临床数据读出时间表，pamrevlumab目前所有的Ⅲ期临床全部失败了。 这次胰腺癌的失败终于FibroGen不坚持继续开发pamrevlumab了，为此，公司将实施一项成本削减计划，裁掉美国75%的员工。 失去市场独占权 Roxadustat(罗沙杜司特)，是公司唯一商业化产品，目前在中国上市销售。 2018年12月，Roxadustat在中国首发上市，用于治疗透析（DD）患者因慢性肾病引起的贫血。2019年8月，获批用于治疗非透析依赖性慢性肾病患者的贫血。 相比传统肾性贫血治疗药物，Roxadustat更有效，仅需口服给药，患者依从性高。Roxadustat在国内一经上市，便备受患者青睐，自2020年来，Roxadustat一直主导中国CKD贫血市场，市场份额位居第一。2024年Q1财报中显示，罗沙司他在中国的销售额达到7940万美元，同比增长24%。 不过，罗沙司他在国内市场的独占地位正受到挑战，面临仿制药的冲击。 据CDE专利登记平台显示，罗沙司他化合物专利、组合物专利和医药用途专利在2024年6月4日到期。 目前包括正大天晴、齐鲁制药、倍特药业、万邦医药、济川药业等在内25家企业的罗沙司他胶仿制药提交了上市申请。 2024年7月5日，据NMPA官网公示，石药集团的罗沙司他胶囊（20mg/50mg）获得药监局的药品注册批件，拿下了罗沙司他的中国首仿。倍特药业紧随其后，拿下国内第2款。 未来FibroGen的路依旧难走，公司正在尝试拓展Roxadustat其他的适应症，包括化疗引起的贫血。停止开发pamrevlumab后，FG-3246成为公司的核心管线，这是在2023年经历了三个临床失败后，公司从Fortis Therapeutic买来的临床Ⅰ期ADC药物买来的管线。 参考出处 https://investor.fibrogen.com/news-releases/news-release-details/fibrogen-announces-topline-results-two-late-stage-pamrevlumab https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-report-second-quarter-2024-financial-results 药渡媒体商务合作 媒体公关 | 新闻&会议发稿 张经理：18600036371（微信同号） 点击下方“药渡“，关注更多精彩内容 免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。 微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！👇👇👇

FibroGen has not seen any late-stage success with pamrevlumab, with the therapy failing to meet primary endpoints in Phase III trials across multiple indications. Image Credit: Tatiana Stulbo / Shutterstock. FibroGen has implemented cost reduction measures in the US as two Phase III trials investigating the company’s lead oncology candidate pamrevlumab failed to meet their primary endpoints. The company plans to suspend the development of pamrevlumab and fire 75% of its US workforce. Following the announcement, FibroGen’s shares took a nosedive and dropped by approximately 40% in premarket trading today, compared to the market close on the previous day. The combination treatment of pamrevlumab and chemotherapy failed to meet the primary endpoint of overall survival in patients with locally advanced, unresectable pancreatic cancer in the Phase III LAPIS trial (NCT03941093). The same combination treatment also failed to achieve the primary endpoint of overall survival in patients with metastatic pancreatic ductal adenocarcinoma in a Phase II/III PanCAN’s Precision Promise trial (NCT04229004). FibroGen has not seen any late-stage success with pamrevlumab, with the therapy also failing to show efficacy in patients with Duchenne muscular dystrophy (DMD). Last year, the company announced disappointing results from two Phase III trials in DMD patients, after both failed to meet primary endpoints. Pamrevlumab is a monoclonal antibody that inhibits the activity of connective tissue growth factor (CTGF), which is involved in multiple tumour development and tissue fibrosis pathologies. See Also: FDA approves J&J’s multiple myeloma therapy Pharmaceutical Technology Excellence Awards 2024: SecureCHEK AI The company added that whilst it is winding down R&D activities for pamrevlumab, the commercial agreements for its anaemia therapy, roxadustat, will remain in place. Astellas holds the development and commercialisation rights to roxadustat in Japan, Europe, Turkey, Russia, the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen has licensed roxadustat’s commercial rights in China and South Korea to AstraZeneca , where the drug is approved under the brand name Evrenzo . The company is expecting an approval decision for roxadustat in chemotherapy-induced anaemia (CIA) in China in H2 2024, which, if positive, will trigger a $10m milestone payment from AstraZeneca. Another oncology candidate in FIbroGen’s pipeline is a CD-46 targeting antibody-drug conjugate (ADC), FG-3246. The company licensed the therapy from Fortis Therapeutics in May 2023. In April, the company reported positive data from a Fortis-sponsored Phase I trial (NCT03575819) of the therapy involving metastatic castration-resistant prostate cancer patients. It demonstrated a median progression-free survival of 8.7 months and a prostate-specific antigen decrease of 50% or more in 36% of participants.

SAN FRANCISCO, June 18, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced it will host the second part of its virtual KOL investor event series on Wednesday, June 26, 2024 at 10:00 AM ET. To register, click here. The event will feature Rahul Aggarwal, M.D. (University of California San Francisco), who will discuss the unmet need and evolving treatment landscape for prostate cancer, as well as the clinical development program for FG-3246* (also known as FOR46), a CD46 targeting antibody-drug conjugate (ADC) with first-in-class potential for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The initiation of a Phase 2 monotherapy trial in mCRPC is expected in the second half of 2024. The event will additionally review data from the Phase 1b/2 study evaluating FG-3246 in combination with enzalutamide in mCRPC presented at the 2024 American Society of Clinical Oncology (ASCO) meeting. A live question and answer session will follow the formal presentation. This series is intended for investor audiences only. About Rahul Aggarwal, MDRahul Aggarwal, MD is a Professor of Medicine and Thomas Perkins Distinguished Professor of Cancer Research at the University of California San Francisco. He is the Associate Director for Clinical Research in the UCSF Helen Diller Family Comprehensive Cancer Center and the Program Leader for the Genitourinary Oncology program. He specializes in translational and clinical research in prostate cancer, with a particular emphasis on the development of novel therapeutic and imaging modalities for men with advanced prostate cancer. He has led numerous phase 1, 2, and 3 clinical trials in prostate cancer across a number of treatment modalities including small molecule targeted therapies, radioligand therapies, antibody-drug conjugates, and bi-specific T cell engagers. About FG-3246FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3246 is currently in an ongoing Phase 1b/2 study being conducted at UCSF as an investigator-sponsored trial to evaluate FG-3246 in combination with enzalutamide. An additional investigator-sponsored radiopharmaceutical marker trial using a zirconium-89 positron emission tomography (PET) tracer for CD46 that utilizes the YS5 antibody is also underway at UCSF. The initiation of the Phase 2 monotherapy trial in metastatic castration-resistant prostate cancer is anticipated in the second half of 2024. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority. About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Pamrevlumab, a fully human anti-CTGF monoclonal antibody, is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of an associated CD46-targeted PET biomarker. In addition, FibroGen has expanded its research and development portfolio to include two immuno-oncology product candidates for the treatment of solid tumors. For more information, please visit www.fibrogen.com. Forward-Looking StatementsThis release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its clinical programs for FG-3246. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential success of FibroGen product candidates, and statements about FibroGen’s plans and objectives and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s most recent quarterly and annual reports on Form 10-Q and Form 10-K, respectively, as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law. *FG-3246 is an investigational drug and not approved for marketing by any regulatory authority. For Investor Inquiries:David DeLucia, CFAVice President, Head of Investor Relations and Corporate FP&Air@fibrogen.com For Media Inquiries:Simon MillerVice President, Marketing and Corporate Communicationsmedia@fibrogen.com