Search Results for “antibody” – Page 23 – media

Positive Results Achieved in Phase III Study of Benmosubimab in Combination with Anlotinib for First-Line Treatment of Advanced Renal Cell Carcinoma

Recently, Chiatai Tianqing Pharmaceutical Group’s randomized, open, positive drug-parallel controlled, multicenter Phase III clinical study of Benmelstobart (TQB2450), a Class 1 innovative biologic drug, in combination with Anlotinib, a Class 1 innovative drug, for the first-line treatment of advanced unresectable or metastatic renal cell carcinoma (RCC) has completed the protocol-prescribed interim analysis of the ETER100 study. ETER100 study) has completed the protocol-prescribed interim analysis, and the Independent Data Monitoring Committee (IDMC) has determined that the primary study endpoint of progression-free survival (PFS, based on independent imaging assessment) has met the protocol-prescribed superiority cut-off, and that the secondary endpoint of overall survival (OS) has shown a trend toward benefit. The Company has communicated with the Center for Drug Evaluation (CDE) of the State Drug Administration of China regarding the marketing application for this indication, and has obtained the CDE’s consent to submit a marketing application for the addition of this new ...
- Source: drugdu
- 149
- May 30, 2024
Datopotamab deruxtecan demonstrates positive results in TROPION-Lung01 Phase III trial

High-level overall survival (OS) results from the TROPION-Lung01 Phase III trial, which previously met the dual primary endpoint of progression-free survival (PFS), numerically favoured datopotamab deruxtecan (Dato-DXd) compared to docetaxel in the overall trial population of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy. Survival results did not reach statistical significance in the overall trial population. In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy. The final analysis of OS builds on the positive progression-free survival (PFS) results presented at the 2023 European Society for Medical Oncology Congress which showed datopotamab deruxtecan demonstrated a statistically significant improvement in PFS in the overall trial population and a clinically meaningful PFS benefit in patients with nonsquamous NSCLC. In TROPION-Lung01, patient enrolment by tumour histology ...
- Source: drugdu
- 103
- May 29, 2024
Degron Therapeutics, Takeda Ink Exclusive License and Collaboration Agreement to Develop Molecule Degraders Targeting Multiple Indications

Don Tracy, Associate Editor Joint venture expected to utilize Degron’s GlueXplorer platform to identify, validate, and optimize molecular glue degraders. Degron Therapeutics announced that it has agreed to terms on a collaboration with Takeda, which will utilize its GlueXplorer to develop molecular glue degraders targeting oncology, neuroscience, and inflammation. Upon completion of the initial stages, Takeda will take over for further development and commercialization. Under terms of the deal, Degron will receive an upfront payment, with the opportunity to receive up to $1.2 billion in milestone payments and tiered royalties on sales. The deal also includes an equity investment by Takeda in Degron and the option to expand to additional targets.1 “We are excited to collaborate with Takeda, expanding the use of our platform into new therapeutic areas,” said Lily Zou, PhD, co-founder, CEO, Degron Therapeutics, in a press release. “Degron’s differentiated and powerful GlueXplorer platform has been validated by ...
- Source: drugdu
- 76
- May 28, 2024
AstraZeneca, Nona Biosciences Strike Global License and Option Deal to Develop Monoclonal Antibodies for Tumor Targeted Therapies

Don Tracy, Associate Editor Under terms of the agreement, Nona Biosciences is expected to receive an upfront payment of $19 million, with the potential of up to $585 million in milestones. Nona Biosciences announced a major global license and option agreement with AstraZeneca, focusing on the development of monoclonal antibodies into targeted therapies for cancer treatment. Under terms of the deal, Nona Biosciences will receive an initial payment of $19 million. Additionally, the company will have the opportunity to receive up to $585 million pending the completion of milestones along with royalty payments on net sales.1 “We are delighted to announce this agreement with AstraZeneca, global leaders in developing tumor targeted therapies, to maximize the potential of our novel antibodies,” said Jingsong Wang, MD, PhD, chairman, Nona Biosciences, in a press release. “This agreement further validates our leading antibody discovery platform, and we look forward to seeing our antibodies developed ...
- Source: drugdu
- 87
- May 27, 2024
Positive Results Achieved in Phase III Study of Benmosubimab in Combination with Anlotinib for First-Line Treatment of Advanced Renal Cell Carcinoma

Recently, Chiatai Tianqing Pharmaceutical Group’s randomized, open, positive drug-parallel controlled, multicenter Phase III clinical study of Benmelstobart (TQB2450), a Class 1 innovative biologic drug, in combination with Anlotinib, a Class 1 innovative drug, for the first-line treatment of advanced unresectable or metastatic renal cell carcinoma (RCC) has completed the protocol-prescribed interim analysis of the ETER100 study. ETER100 study) has completed the protocol-prescribed interim analysis, and the Independent Data Monitoring Committee (IDMC) has determined that the primary study endpoint of progression-free survival (PFS, based on independent imaging assessment) has met the protocol-prescribed superiority cut-off, and that the secondary endpoint of overall survival (OS) has shown a trend toward benefit. The Company has communicated with the Center for Drug Evaluation (CDE) of the State Drug Administration of China regarding the marketing application for this indication, and has obtained the CDE’s consent to submit a marketing application for the addition of this new ...
- Source: drugdu
- 127
- May 27, 2024
The Supplemental Applications of HANDAYUAN(adalimumab injection) for the New Indications Approved by the NMPA

Shanghai, China, May 22, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications of its independently developed adalimumab biosimilar HANDAYUAN for the four new indications of polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, Crohn’s disease and pediatric Crohn’s disease have been approved by the National Medical Products Administration (NMPA), providing more treatment options for adult and pediatric patients with autoimmune diseases in China. HANDAYUAN has previously been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. To date, HANDAYUAN has been approved for eight indications in China, covering all indications of originator adalimumab in China. It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases [1]. TNF-α (tumor necrosis factor-α) plays a key role in the pathogenesis of a variety of autoimmune diseases [2]. It has been proven that many autoimmune diseases such as ...
- Source: drugdu
- 113
- May 24, 2024
AstraZeneca Plans $1.5B Manufacturing Site for Global Production of ADC Cancer Drugs

The Singapore manufacturing site will be AstraZeneca’s first facility capable of handling all steps of antibody drug conjugate production. AstraZeneca aims to open the facility in 2029.Antibody drug conjugates have fast become a big piece of AstraZeneca’s revenue growth. The drugmaker is taking steps to ensure it has the production capacity to meet market demand for these cancer drugs, revealing plans for a $1.5 billion manufacturing site in Singapore to support its global supply of ADC medicines. Construction of the ADC manufacturing facility will receive support from the Singapore Economic Development Board, AstraZeneca said Monday. The company expects to begin design and construction of the facility by the end of this year. Construction of a new drug manufacturing site and receiving the regulatory approvals for commercial production can take several years. AstraZeneca aims to open its new site for ADC production in 2029. An ADC is a cancer therapy made ...
- Source: drugdu
- 80
- May 23, 2024
Henlius to Release Latest Clinical Data of HLX22 at 2024 ESMO GI

The 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) is set to take place from June 26 to June 29 in Munich, Germany. Henlius will share the latest clinical data of phase 2 study (HLX22-GC-201) of its novel anti-HER2 monoclonal antibody (mAb), HLX22, combined with HANQUYOU (trastuzumab, HLX02, trade name: HERCESSI™️ in U.S. and Zercepac® in Europe) and chemotherapy for the first-line treatment of HER2-positive gastric/gastroesophageal junction (G/GEJ) cancer with Professor Jin Li of Shanghai East Hospital, School of Medicine, Tongji University as the leading principal investigator of this study. The results from HLX22-GC-201 were first released at the 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI) in January 2024, which showed that adding HLX22 to HLX02 (trastuzumab) and chemotherapy prolonged progression-free survival and enhanced antitumour response in patients with HER2-positive G/GEJ cancer in the first-line setting, with a manageable safety profile. The data released at 2024 ESMO GI are as follows: ...
- Source: drugdu
- 84
- May 23, 2024
Amgen and AstraZeneca ponder label expansion for Tezspire in COPD

Amgen and AstraZeneca have highlighted the potential of Tezspire (tezepelumab) in chronic obstructive pulmonary disease (COPD) in a subgroup of patients in a Phase IIb study even though the trial missed the primary endpoint. The therapy failed to show a significant reduction in the annual rate of moderate to severe exacerbations compared to the placebo, the trial’s primary endpoint. The data from the placebo-controlled Phase IIa COURSE trial (NCT04039113) was presented at the American Thoracic Society (ATS) International Conference taking place in San Diego, US, from 16 to 21 May. However, a pre-determined subgroup analysis of COPD patients based on the levels of eosinophils, measured as baseline eosinophil count (BEC), showed significant reductions in COPD exacerbations. The therapy also demonstrated a 48% reduction in severe exacerbations compared to the placebo. Patients who received Tezspire while having a BEC of 150 cells/μL or more, which is associated with increased COPD-related emergency ...
- Source: drugdu
- 73
- May 22, 2024
J&J expands dermatology portfolio with $850m Proteologix acquisition

In a bid to solidify its footing in dermatology, Johnson & Johnson (J&J) has announced that it will purchase the immune-mediated disease-focused biotech Proteologix in a $850m cash buyout, with the potential for additional milestone payments. The host of bispecific antibodies brought by Proteologix to the deal will add depth to J&J’s immunology pipeline, and more specifically, bolster its position to address atopic dermatitis (AD). Among Proteologix’s assets is PX128, a bispecific antibody designed to target interleukin (IL)-13, as well as the cytokine TSLP, which is being developed for the treatment of patients with moderate to severe AD and moderate to severe asthma. The acquisition also covers the preclinical stage candidate, PX130, a bispecific antibody designed to target both IL-13 and IL-22 to inhibit inflammation, restore the skin barrier, and prevent environmental trigger-mediated inflammation of the skin. The asset is under development for the treatment of moderate to severe AD. ...
- Source: drugdu
- 83
- May 21, 2024

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