fascin

NEW YORK, Feb. 25, 2025 /PRNewswire/ -- Novita Pharmaceuticals, Inc. ("Novita"), a privately held, clinical-stage pharmaceutical company dedicated to developing novel cancer drugs through its proprietary fascin inhibitor technology, today announced additional results from its Phase 2 study (NCT05023486) evaluating NP-G2-044 in combination with SOC anti-PD-1 therapy in patients with advanced solid tumors resistant to prior anti-PD-1 therapy at the American Association for Cancer Research Immuno-oncology (AACR IO) Annual Meeting. The data was presented in a poster presentation titled "Phase 2 Study of NP-G2-044, a Novel Fascin Inhibitor, in Combination with Anti-PD-1 Therapy in Patients with Solid Tumors Resistant to Prior Anti-PD-1 Therapy." Findings indicate that NP-G2-044 provides a novel therapeutic opportunity when combined with ICIs. "We are very pleased with the findings generated to date in our Phase 2 trial of NP-G2-044 both as a monotherapy and in combination with anti-PD-1 immune checkpoint inhibitors (ICIs) in ICI-resistant patients with advanced and metastatic solid tumors," said Jillian Zhang, Ph.D., President & Chief Scientific Officer of Novita. "The strong safety and durable efficacy we have observed with our first-in-class fascin inhibitor further support the simultaneous inhibition of metastasis and enhancement of cancer immunotherapy as a promising and innovative approach in cancer treatment with broad applications for many solid tumors. We look forward to sharing additional data from the Phase 2 expansion cohort of NP-G2-044 in combination with ICI in the second half of 2025." Among the 45 patients treated with NP-G2-044 as of the last data cutoff (Oct. 2024), 80% had progressed on prior anti-PD-(L)1 therapies. The anti-PD-1 Combination RP2D for NP-G2-044 was 1600 mg QD with 4-week cycles. The primary endpoint was objective response rate (ORR), and secondary endpoints included progression-free survival (PFS), metastasis-free interval (MFI), overall survival (OS), safety, and tolerability. Key highlights include: A Disease Control Rate of 76% (includes patients with Stable Disease and Objective Responses) An ORR of 21% (95% CL 9-38.9%) including 4 patients with Partial Response (PR) and 3 patients with Complete Responses (CR) including Pathologic Complete Response Results indicate durable responses and tumor control in a significant proportion of patients across at least seven cancer types, including cases converted from ICI-non-responsive to ICI-responsive. Long lasting objective responses have been observed. Notable outcomes include a CR in a cervical cancer patient, target lesion CR in an endometrial cancer patient, pathological CRs in a pancreatic cancer patient and a patient with gastroesophageal junction adenocarcinoma and PRs in cutaneous squamous cell carcinoma, non-small cell lung cancer, and cholangiocarcinoma. Seven patients are still on treatments, with the longest duration of 18+ months in an endometrial cancer patient and a patient with pancreatic cancer. An amendment to the study is underway to open additional cohorts. These new cohorts aim to further evaluate the combination of NP-G2-044 with anti-PD-1 therapy across patient populations and solid tumor subtypes, providing a broader understanding of its therapeutic potential. Future analysis will also explore biomarkers for response prediction and mechanisms of resistance, guiding personalized approaches in treatment-resistant cancer. Novita is on track to begin enrollment in its pivotal Phase 3 study of NP-G2-044 + PLD in platinum resistant ovarian cancer in the third quarter of 2025. About Novita's Pioneering Research in Fascin Inhibition Cancer metastasis is the primary cause of over 90% of cancer-related deaths, yet there is currently no drug on the market specifically targeting metastasis. Furthermore, while Immuno-Oncology (IO) therapies, particularly immune checkpoint inhibitors, have made significant strides in cancer treatment, a large proportion of patients do not respond to existing IO treatments. Novita aims to address both of these critical medical needs by developing fascin inhibitors, which target a key protein involved in tumor cell motility and highly expressed in tumor cells and antigen-presenting cells within tumor tissues. The Company's lead asset, NP-G2-044, is a small-molecule fascin inhibitor that has demonstrated the ability to block metastasis in both preclinical and clinical studies. Additionally, when combined with immune checkpoint inhibitors, NP-G2-044 has shown potential to reinvigorate anti-tumor immune responses. Novita's multicenter Phase 2 clinical trial, titled "NP-G2-044 as Monotherapy and Combination Therapy in Patients with Advanced or Metastatic Solid Tumor Malignancies," is currently ongoing. About Novita Pharmaceuticals, Inc. Novita Pharmaceuticals, Inc. is a privately held, clinical-stage biopharmaceutical company focused on developing groundbreaking therapies using its proprietary fascin inhibitor technology to prevent and treat cancer metastasis while simultaneously enhancing anti-cancer immune responses. For more information, visit Cautionary Note Regarding Forward-Looking Statements This press release contains certain forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in the forward-looking statements. These statements are based on a number of assumptions and estimates that are inherently subject to significant uncertainties and contingencies, many of which are beyond the Company's control, and respect future business decisions, which are subject to change. Among those factors that could cause actual results to differ materially from those described in the forward-looking statements are the risks associated with the Company's being a development stage company with uncertain revenue streams; uncertain results or outcomes during clinical trials; failure to raise necessary capital in the future; the loss of key personnel; competition from other larger, better-capitalized peers; the Company's reliance on incorrect assumptions regarding the market for its products, the costs of developing, manufacturing and marketing the Company's products, and the timing and receipt of regulatory approval for the Company's products; adverse economic conditions; and other risks. In light of the significant uncertainties inherent in the forward-looking statements, the inclusion of any such statement should not be regarded as a representation by Novita or any other person that the Company's objectives or plans will be achieved. Media Contact: Argot Partners (media) David Rosen 212.600.1902 [email protected] Investor Contact: Argot Partners (investors) Noor Pahlavi 212.600.1902 [email protected] SOURCE Novita Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

精彩内容 近日，北京双鹤润创科技申报的1类新药DC50292A片获得临床试验默示许可，适应症为甲硫腺苷磷酸化酶(MTAP)缺失的晚期或转移性实体瘤。在抗肿瘤领域，华润双鹤有3款1类新药在研。米内网数据显示，2023年中国三大终端六大市场（统计范围详见本文末）抗肿瘤药（化药+生物药）销售额超过1400亿元。 DC50292A片是一款化药1类创新药，其临床申请于2024年12月获得CDE承办受理，并于近日顺利获批临床，用于治疗甲硫腺苷磷酸化酶(MTAP)缺失的晚期或转移性实体瘤。 米内网数据显示，近年来中国三大终端六大市场抗肿瘤药（化药+生物药）销售额均达千亿规模，2023年超过1400亿元，同比增长约4%，2024年上半年以约10%的增速继续增长至超700亿元。 从细分终端销售看，公立医院（城市公立+县级公立）为抗肿瘤药销售主渠道，但零售药店（城市实体药店+网上药店）总体增速亮眼，占比亦呈逐年递增的态势。 近年来中国零售药店终端抗肿瘤药（化药+生物药）销售情况（单位：万元）来源：米内网格局数据库 在抗肿瘤新药方面，华润双鹤开发的2类改良型新药巯嘌呤片(Ⅱ)于2025年1月获批上市，为国内首家获批，适用于儿童急性淋巴细胞白血病(ALL)及急性非淋巴细胞白血病，慢性粒细胞白血病的急变期。此外，3款1类新药处于获批临床及以上阶段，其中DC05F01已处于Ib/IIa期临床，用于治疗复发/难治性卵巢癌等晚期实体瘤。DC05F01是作用于Fascin蛋白的小分子化合物，前期研究发现其能够有效抑制Fascin蛋白活性，从而降低肿瘤侵袭和转移，未来可作为一种潜在控制肿瘤转移的口服药物。 华润双鹤国内在研的抗肿瘤新药来源：米内网中国申报进度（MED）数据库 近年来，华润双鹤以“创新驱动”为发展目标，加速研发创新转型。2023年公司研发费用5.61亿元，同比增长16.37%；2024年前三季度研发费用4.73亿元，同比增长14.33%。 步入2025年，华润双鹤产品研发进展不断：2.2类改良型新药巯嘌呤片(Ⅱ)获批上市，美索巴莫注射液获批生产并视同过评，依达拉奉注射液、阿奇霉素分散片、碳酸氢钠注射液通过一致性评价，1类新药DC50292A片首次获批临床等。 资料来源：米内网数据库、CDE官网等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至2月14日，如有疏漏，欢迎指正！ 本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 ●温馨提示● 因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。 把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下： 【分享、点赞、在看】点一点不失联哦

NEW YORK, Feb. 13, 2025 /PRNewswire/ -- Novita Pharmaceuticals, Inc., a privately held, clinical-stage pharmaceutical company dedicated to developing novel cancer drugs through its proprietary fascin inhibitor technology, today announced that the Company will present additional data from the Phase 2 trial of its novel fascin inhibitor, NP-G2-044, at the American Association for Cancer Research Immuno-Oncology Conference 2025 (AACR IO), being held February 23-26, 2025 in Los Angeles, California. Details of the poster presentation are below. Title: Phase 2 Study of NP-G2-044, a Novel Fascin Inhibitor, in Combination with Anti-PD-1 Therapy in Patients with Solid Tumors Resistant to Prior Anti-PD-1 Therapy Session: Poster Session B Date and Time: Tuesday, February 25, 2025 at 1:45-4:00 p.m. PT Presenting Author: Anup Kasi, M.D., M.P.H., University of Kansas Medical Center The poster will be available on Novita's website following the presentation. For more details about the AACR IO Annual Meeting, please visit their website here. About Novita's Pioneering Research in Fascin Inhibition Cancer metastasis is the primary cause of over 90% of cancer-related deaths, yet there is currently no drug on the market specifically targeting metastasis. Furthermore, while Immuno-Oncology (IO) therapies, particularly immune checkpoint inhibitors, have made significant strides in cancer treatment, a large proportion of patients do not respond to existing IO treatments. Novita aims to address both of these critical medical needs by developing fascin inhibitors, which target a key protein involved in tumor cell motility and highly expressed in tumor cells and antigen-presenting cells within tumor tissues. The Company's lead asset, NP-G2-044, is a small-molecule fascin inhibitor that has demonstrated the ability to block metastasis in both preclinical and clinical studies. Additionally, when combined with immune checkpoint inhibitors, NP-G2-044 has shown potential to reinvigorate anti-tumor immune responses. Novita's multicenter Phase 2 clinical trial, titled "NP-G2-044 as Monotherapy and Combination Therapy in Patients with Advanced or Metastatic Solid Tumor Malignancies," is currently ongoing and approaching completion. About Novita Novita Pharmaceuticals, Inc. ("Novita" or the "Company") is a privately held, clinical-stage biopharmaceutical company focused on developing groundbreaking therapies using its proprietary fascin inhibitor technology to prevent and treat cancer metastasis while simultaneously enhancing anti-cancer immune responses. For more information, visit . Media Contact: Argot Partners (media) David Rosen 212.600.1902 [email protected] Investor Contact: Argot Partners (investors) Noor Pahlavi 212.600.1902 [email protected] SOURCE Novita Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED