Search Results for “Clinical Trial” – Page 5 – media

Clinical Trial of Keytruda and Lynparza Combination Fails to Meet Primary Endpoint for Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer

Don Tracy, Associate Editor Despite not having a positive outcome, safety profiles for Keytruda and Lynparza were consistent with previous findings. Merck revealed that its Phase III KEYLYNK-006 clinical trial, which tested a combination of Keytruda and Lynparza for the treatment of a subset of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), failed to meet the primary endpoint of improving overall survival (OS) and progression-free survival (PFS). According to the company, its trial compared Keytruda combined with chemotherapy with an additional round of Keytruda plus Lynparza vs. Keytruda with chemotherapy followed by maintenance chemotherapy. However, the safety profiles for both treatments were reported to be consistent with previous findings. Moving forward, Merck said that it plans on continuing to analyze data to share at a later date.1 “As lung cancer continues to be the leading cause of cancer death worldwide, we are committed to exploring Keytruda-based combinations and ...
- Source: drugdu
- 135
- March 26, 2024
Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU

The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU). ACT EU is a collaboration between EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC), which seeks to transform how clinical trials are initiated, designed, and run. During the first meeting of the MSP advisory group that officially kicks-off the platform, María Jesús Lamas, director of the Spanish agency of medicines and medical products, who is regulatory co-chair of the group, said: “The establishment of the multi-stakeholder platform is an important milestone for ACT EU. Our collaborative efforts will drive progress towards more streamlined and efficient clinical trials and allow patients and citizens to benefit from clinical research in Europe.” The launch of the MSP fosters collaboration and promotes open dialogue around the challenges and opportunities represented by ...
- Source: drugdu
- 111
- March 22, 2024
ALS Association partners with myTomorrows to improve clinical trial accessibility

The fatal motor neurone disease currently does not have a cure available to treat patients The ALS Association and myTomorrows have partnered to improve the accessibility of future clinical trials for patients living with amyotrophic lateral sclerosis (ALS). The aim of the partnership is to ensure that patients living with the condition and physicians are up-to-date with information about pre-approval treatment options and clinical trials. ALS is a fatal motor neurone disease that is characterised by the progressive degeneration of nerve cells in the spinal cord and brain, affecting the voluntary control of arms and legs. Usually fatal within five years with no cure available, searching for clinical trials for ALS patients is challenging due to its day-to-day implications and rapid escalation. The US-based ALS Association and myTomorrows aim to tackle these challenges and make it easier for patients and their families to participate in clinical trials. The ALS Association ...
- Source: drugdu
- 148
- March 21, 2024
Merck Sharp & Dohme Announces Plans to Conduct Clinical Trials of New Multivalent HPV Vaccine and Gardasil®9 Single-Dose Vaccination Regimen

Rowe, N.J., March 13, 2024 – Merck Sharp & Dohme (Merck is the corporate trading name of Merck & Co. of Rowe, N.J., U.S.A.) announced at the European Organization for the Study of Genital Infections and Neoplasms (EUROGIN) Congress 2024 plans to initiate a novel multivalent human papillomavirus (HPV) vaccine clinical trial designed to provide broader protection against HPV types. At the same time, Merck Sharp & Dohme also plans to conduct additional clinical trials to evaluate the protective efficacy and safety of Gardasil®9 [nine-valent human papillomavirus vaccine (brewer’s yeast)] single-dose regimen1 compared to the already approved three-dose regimen. Within China, Gardasil®9 is indicated for the prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; cervical intraepithelial neoplasia (CIN grades 1/2/3) and adenocarcinoma in situ (AIS) of the uterine cervix caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and ...
- Source: drugdu
- 122
- March 20, 2024
A Startup’s Flexibility With ADC Cancer Drugs Attracts €128M for Clinical Trials

Tubulis’s next-generation ADC cancer drugs are designed to overcome limitations of currently available therapies in this drug class. The new financing will support clinical trial plans, but first, preclinical proof-of-concept data will be presented during the American Association for Cancer Research annual meeting. By FRANK VINLUAN The concept of an antibody drug conjugate, or ADC, is straightforward: a cancer-killing drug is chemically linked to an antibody that targets the delivery of the therapy to a tumor. This drug class has made progress with several approved products and many more on their heels in clinical development. But there’s still plenty of room to improve on this type of targeted cancer therapy, contends Dominik Schumacher, CEO of Tubulis. When an ADC releases its drug payload too early, it hits healthy tissue and sparks toxic effects, Schumacher said. Also, current ADC designs are restricted in their ability to match the biology of cancer ...
- Source: drugdu
- 150
- March 19, 2024
First Subject Dosed for Phase 1 Clinical Trial of Henlius’ ADC Candidate HLX42

Shanghai, China, March 14, 2024 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the first subject was dosed for a phase 1 clinical trial of HLX42 (NCT06210815), an investigational EGFR-Targeting antibody-drug conjugate (ADC), for the treatment of advanced/metastatic solid tumours. HLX42 was developed by the company based on the collaboration with MediLink Therapeutics and was approved for conducting clinical trial by the National Medical Products Administration (NMPA) and U.S. Food and Drug Administration (FDA). In December 2023, FDA granted Fast Track Designation to HLX42 for the treatment of advanced/metastatic non-small cell lung cancer (NSCLC) patients with disease progression on EGFR targeted therapies. Epidermal growth factor receptor (EGFR) belongs to the receptor tyrosine kinases family and plays an important role in maintaining normal cell functions such as cell proliferation, differentiation and migration. Mutation or overexpression of EGFR is considered to be closely associated with the occurrence of various solid tumours ...
- Source: drugdu
- 83
- March 18, 2024
Hengrui Pharmaceuticals Clinical Trial Approved for Novel PARP Inhibitor HRS-1167 (M9466) Combination Therapy for Advanced Solid Tumors

Recently, Hengrui Pharmaceuticals and its subsidiaries Suzhou Shengdia Biopharmaceutical Co., Ltd. and Chengdu Shengdi Pharmaceutical Co., Ltd. received the Notice of Approval for Drug Clinical Trial approved for issuance by the State Drug Administration, which authorizes the conduct of a clinical trial of HRS-1167 tablets (Merck code: M9466) in combination with injectable SHR-A1921 or in combination with bevacizumab or in combination with abiraterone acetate tablets (I) and Prednisone/Prednisolone (AA-P) for advanced solid tumors in a Phase Ib/II clinical study. In October 2023, Hengrui Pharmaceuticals entered into a strategic cooperation with Merck KGaA of Germany, which obtained the exclusive rights to develop, manufacture and commercialize HRS-1167 (M9466) globally outside of mainland China, which was the first time that Hengrui Pharmaceuticals entered into a strategic cooperation with a large global multinational enterprise. Poly (ADP-ribose) polymerase (PARP) is a class of multifunctional protein post-translational modification enzymes widely found in eukaryotic cells, and plays ...
- Source: drugdu
- 152
- March 18, 2024
BIO-THERA’s BAT8008 (ADC-Trop2) for injection in combination with BAT1308 (PD-1) for the treatment of advanced solid tumors was approved for Phase IB-II clinical trial.

BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177), a global science-based and innovative biopharmaceutical company located in Guangzhou, China, is hereinafter referred to as “BIO-THERA” or the “Company”. The Company today announced that it has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration of the People’s Republic of China (“SDA”), which approved the application for Phase IB-II clinical trial of BAT8008 for injection in combination with BAT1308 for the treatment of advanced solid tumors. BAT8008 is an antibody-drug coupling (ADC) developed by BIO-THERA to target Trop2, a tumor-associated calcium signal transducer (TACSTHERA), to be developed for the treatment of solid tumors. Trop-2 (Trophoblast cell-surface antigens 2, Trop2), a member of the tumor-associated calcium signal transducer (TACSTD) family of genes, is involved in the regulation of intracellular calcium concentration.Trop2 is not expressed or is lowly expressed in normal human tissues, but is highly expressed in a variety ...
- Source: drugdu
- 177
- March 15, 2024
TransThera Announced Global Phase 3 Clinical Trial for Cholangiocarcinoma Authorized in the European Union and Orphan Drug Designation for Tinengotinib to Treat Biliary Tract Cancer Granted by European Medicines Agency

TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced that the randomized, controlled, global multicenter Phase 3 trial (FIRST-308) of tinengotinib versus physician’s choice to evaluate the efficacy and safety in subjects with FGFR-altered, chemotherapy- and FGFR Inhibitor-refractory/relapsed cholangiocarcinoma (CCA), has been authorized by regulatory agencies in the European Union (EU) after the authorizations from US, South Korea and Taiwan region. Furthermore, European Medicines Agency (EMA) granted the Orphan Drug Designation(ODD) for tinengotinib for the treatment of biliary tract cancer (BTC) . Tinengotinib, a next-generation FGFR inhibitor with high potency against a variety of FGFR2 kinase domain mutations, has shown promising clinical benefit in subjects with FGFR-altered metastatic CCA who were heavily pretreated with chemotherapy and refractory/relapsed to FGFRi(s). The results of tinengotinib in CCA from the phase I/II clinical trials were presented orally at 2023 ESMO and 2024 ASCO GI conferences. The FRIST-308 clinical trial ...
- Source: drugdu
- 68
- March 12, 2024
BIO-THERA’s BAT8010 (ADC-HER2) for injection in combination with BAT1006 (HER2) for injection for the treatment of locally advanced or metastatic solid tumors was approved in clinical trial

BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company today announced that it has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration of the People’s Republic of China (“SDA”), which approves the application for a clinical trial of the investigational drug BAT8010 for injection in combination with BAT1006 for injection for the treatment of locally advanced or metastatic solid tumors. BAT8010 consists of recombinant humanized anti-HER2 antibody and toxin small molecule topoisomerase I inhibitor, connected by self-developed shearable linker.BAT8010 has highly efficient anti-tumor activity, the toxin small molecule has strong cell membrane permeability, and it can be released and kill nearby cancer cells after ADC kills the cancer cells, generating the bystander effect, effectively overcoming the tumor cells’ heterogeneity of tumor cells. Meanwhile, BAT8010 has ...
- Source: drugdu
- 164
- March 10, 2024

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