-- Metastatic non-small cell lung cancer (NSCLC) patients treated in the first line setting with IO102-IO103 in combination with Keytruda® demonstrated promising activity with an overall response rate of 55% unconfirmed/48% confirmed, disease control rate of 81%, and approximately 50% of patients without disease progression at 12 months; median duration of response not reached -- -- Safety profile consistent with prior studies with the combination, showing no unexpected toxicities compared to an

2024年11月16日，海森生物正在研发的新型第三代PCSK9抑制剂Lerodalcibep（以下简称HST101）完成III期临床试验首例受试者入组给药，标志着该项目在获得临床试验许可后，海森生物再次迈出了具有研发里程碑意义的重要一步。 本研究是一项随机、双盲、安慰剂对照的III期临床试验(CTR20242095/NCT06568471)，旨在评价HST101在中国高胆固醇血症包括杂合子型家族性高胆固醇血症(HeFH)患者中的有效性和安全性。该研究由北京大学第一医院霍勇教授牵头，计划在全国共35家研究中心开展。 近几十年来，中国人群血脂异常患病率明显增加，以高胆固醇血症的增加最为明显。大量研究证实低密度脂蛋白胆固醇（LDL-C）是动脉粥样硬化性心血管疾病(ASCVD)最重要且容易改变的致病性危险因素之一，已被国内外血脂管理指南确定为防治ASCVD的首要干预靶点，但国内患者的LDL-C达标率仍很不理想。HST101作为新型第三代融合蛋白PCSK9抑制剂，具有分子量小、容易储存和安全性等方面的潜在优势，期待在中国开展的HST101III期临床试验能产生出高质量的研究数据，顺利获批上市

2024年11月18日，丹诺医药宣布其用于治疗幽门螺杆菌感染的潜在“first-in-class”新药TNP-2198成功完成3期临床试验并达到研究预设的主要终点指标，同铋剂四联相比体现多方面优势。 这是一项多中心、随机、双盲、铋剂四联对照的3期临床试验，旨在评价TNP-2198联合阿莫西林和雷贝拉唑三联方案在初治患者中根除幽门螺杆菌的有效性和安全性。这项研究由北京大学第三医院周丽雅教授牵头，在中国40家医院开展。研究共纳入700例既往未接受过根除治疗、碳-13尿素呼气试验（UBT）阳性并经组织学确认的幽门螺杆菌感染者，患者按1:1随机分配至TNP-2198三联方案（试验组）或铋剂四联方案（对照组），接受每天2次，连续14天治疗，有效性终点为治疗结束后4~6周的UBT检测结果。 这项3期临床试验的整体执行情况良好，脱落率仅为3%，服药依从性高达96%，基线幽门螺杆菌培养成功率高达87%。试验组和对照组在人口学及基线药敏特征方面没有影响研究结果的显著差异。本研究中感染者克拉霉素、甲硝唑、左氧氟沙星和阿莫西林的耐药率分别达到41%、68%、35%和8%，与近期文献报道结果一致，表明中国

Primary efficacy endpoint met – significant analgesia across all doses Significant improvement in all signs and symptoms of osteoarthritis for all doses Well tolerated with no increase in incidence of rapid joint deterioration compared to placebo First-in-class novel biologic under development as non-addictive pain treatment Oral presentation at 8am EST on 19 November Nov. 14, 2024 -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for ost

Nov. 13, 2024 -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a biotechnology leader in regenerative medicine, is pleased to announce the successful completion of an independent interim safety review by the Data Safety Monitoring Board (DSMB) for its ADAPT clinical trial. The trial evaluated CELZ-201, a novel therapeutic perinatal tissue derived cell product, designed to treat chronic lower back pain associated with degenerative disc disease. The DSMB reviewed safety data from th

Phase 2 trial initiation in patients with sleep /wake disorders results in milestone payment of US$3.5 million to Nxera 13 November 2024 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – notes that Centessa Pharmaceuticals has initiated a Phase 2 trial of ORX750, an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2),

Nov. 14, 2024 -- Alumis Inc. (Nasdaq: ALMS), a clinical stage biopharmaceutical company developing oral therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated diseases, today announced the company will give two data presentations at ACR Convergence 2024, the annual meeting of the American College of Rheumatology (ACR), being held November 14–19, 2024, in Washington, D.C. Data to be presented at ACR show that treat

– Long-term follow-up data highlight further reductions in tumor size, increase in ORR with additional CRs, sustained improvement in desmoid tumor symptoms, and consistent safety profile, now with a median duration of therapy of approximately 3 years – Nov. 07, 2024 -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that long-term efficacy and safety data from the Phase 3 DeFi trial of niroga

Preliminary data demonstrate durable and dose-dependent T cell responses targeting KRAS mutations and induced responses to patient-specific neoantigens Correlation observed between disease-free survival (“DFS”) and T cell response ELI-002 Phase 1 safety and tolerability profile remains favorable ELI-002 Phase 2 interim event-driven DFS analysis expected in H1 2025 Nov. 07, 2024 -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology compan

BDC-4182 demonstrated compelling anti-tumor activity and an acceptable safety profile in preclinical studies BDC-4182 outperformed cytotoxic claudin 18.2 ADCs in syngeneic model Learnings from BDC-1001 data suggest Boltbody™ ISACs with enhanced immune activation could offer greater efficacy, warranting further testing Nov. 07, 2024 -- Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today presented upda