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OSE Immunotherapeutics Leads €1.3 Million Consortium to Advance mRNA Therapeutics Using Lipid Nanoparticle Technology

Oncology
  • OSE Immunotherapeutics has secured €1.3 million in non-dilutive funding to lead the 36-month "HexARN" program focused on advancing mRNA therapeutics delivered via lipid nanoparticles.
  • The strategic collaboration brings together OSE Immunotherapeutics, Inside Therapeutics, and MiNT Laboratory to overcome challenges in RNA therapy selectivity, safety, target expansion, and manufacturing scalability.
  • The consortium aims to develop novel RNA therapeutics for inflammatory disorders and autoimmune diseases, leveraging advantages over conventional antibody approaches while improving delivery methods.

BioDlink Secures Brazil GMP Certification, Expanding Global Reach for Bevacizumab Biosimilar

Monoclonal AntibodyOncology
  • BioDlink has successfully passed its first on-site GMP inspection by Brazil's ANVISA, a PIC/S member, marking a significant regulatory milestone for the company's Suzhou manufacturing facility.
  • The inspection specifically reviewed production of Pusintin® (bevacizumab), a biosimilar antibody treating non-small cell lung cancer and metastatic colorectal cancer, receiving full approval with no observations.
  • With regulatory certifications now in five countries including Brazil, Indonesia, Egypt, Colombia, and Argentina, BioDlink aims to expand access to affordable oncology biologics across emerging markets.

AI Tools Show Promise in Improving HER2 Breast Cancer Classification and Treatment Eligibility

AIPrecision MedicineOncology
  • A multinational study demonstrates that AI assistance significantly improves pathologists' accuracy in HER2 breast cancer scoring, with accuracy rates increasing from 89.1% to 96.1% when AI tools were utilized.
  • The Digital PATH Project, involving 31 partners including pharmaceutical companies and academic centers, validated AI diagnostic technologies using 1,100 breast cancer tissue samples to assess consistency in HER2 expression identification.
  • AI tools particularly enhanced detection of HER2-low and HER2-ultralow expression levels, reducing misclassification by 24.4% and potentially expanding treatment eligibility for antibody-drug conjugates to patients previously classified as HER2-negative.

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

NCT04494425Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/24/2020

Tecentriq and Avastin Combined with TACE Shows Significant Benefit in Unresectable Liver Cancer Trial

OncologyMonoclonal Antibody
  • The Phase III TALENTACE study demonstrated statistically significant improvement in TACE-progression-free survival for patients with unresectable hepatocellular carcinoma treated with Tecentriq, Avastin, and on-demand TACE.
  • This landmark trial enrolled 342 patients across China and Japan, marking the first Phase III study in Asia showing TACE PFS benefit from combining immunotherapy and targeted therapy with TACE for unresectable HCC.
  • Liver cancer remains the third leading cause of cancer-related death globally with rising mortality rates, with only 20% of patients surviving five years after diagnosis.

Sorafenib Chemoembolization Evaluation Controlled Trial

NCT01906216CompletedPhase 3
Air Force Military Medical University, China
Posted 9/1/2013

A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma

NCT04712643Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 3/12/2021

New Global Report Reveals Comprehensive Landscape of Chemotherapy-Induced Diarrhea Clinical Trials

Oncology
  • A new comprehensive report analyzing the global clinical trial landscape for Chemotherapy-Induced Diarrhea (CID) has been released, providing crucial insights for stakeholders in pharmaceutical R&D.
  • The report details trial distribution across G7 and E7 countries, enrollment trends over five years, and classifies trials by phase, status, endpoint status, and sponsor type.
  • Key companies involved in CID therapeutics include Novartis AG, Jaguar Health, and Guangzhou Zhiyi Biotechnology, with the report drawing data from over 80 clinical trial registries worldwide.

Worldwide Clinical Trials Joins WCG's Avoca Quality Consortium to Enhance Clinical Trial Standards

OncologyRare Disease
  • Worldwide Clinical Trials has joined WCG's Avoca Quality Consortium (AQC), a collaborative network of over 200 life sciences companies focused on elevating clinical trial quality.
  • The strategic partnership aims to enhance quality, efficiency, and regulatory compliance through industry collaboration and best practices, ultimately delivering faster and more reliable outcomes for customers.
  • This membership aligns with Worldwide's commitment to quality assurance across its services, which include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval studies.

Faron Pharmaceuticals Appoints Ralph Hughes as Chief Business Officer to Advance Immunotherapy Pipeline

OncologyMonoclonal Antibody
  • Faron Pharmaceuticals has appointed Ralph Hughes as Chief Business Officer, bringing extensive experience in commercial strategy and market access from his previous roles at PharmaVentures, Mundipharma, and Pfizer.
  • Hughes joins Faron at a critical time as the company advances its lead immunotherapy candidate bexmarilimab, currently in Phase I/II trials for acute myeloid leukemia and myelodysplastic syndrome.
  • Bexmarilimab targets the Clever-1 receptor on macrophages, potentially overcoming cancer treatment resistance by reprogramming the tumor microenvironment and enhancing immune system response against cancer cells.

ME Therapeutics Secures $140,000 in Funding to Advance Novel mRNA Cancer Therapies

Oncology
  • ME Therapeutics has received up to $140,000 in funding from Canada's NRC IRAP to advance its mRNA therapeutic program targeting myeloid cell biology for cancer and inflammatory diseases.
  • The company's proprietary mRNA sequences are engineered to encode proteins that modify immune responses, with preclinical testing showing promising anti-cancer activity in colorectal cancer mouse models.
  • ME Therapeutics is developing tissue-specific mRNA expression modifications to enhance efficacy and safety, potentially offering new treatment options for patients with limited alternatives.

Delhi High Court Overturns Patent Rejection for Taiho Pharmaceutical's Anticancer Compound

Oncology
  • The Delhi High Court has set aside a Patent Office order that rejected Taiho Pharmaceutical's application for an anticancer compound, citing procedural fairness issues in the original decision.
  • The court ruled that the Patent Office failed to identify a specific 'known substance' when rejecting the application under Section 3(d) of the Patents Act, denying the company a fair opportunity to demonstrate enhanced therapeutic efficacy.
  • The matter has been remanded back to the Patent Office for fresh consideration, with instructions to provide Taiho Pharmaceutical a new hearing opportunity and properly evaluate any comparative research data submitted.

AstraZeneca Showcases Groundbreaking Cancer Research at ASCO 2025 with Two Plenary Presentations

OncologyTargeted TherapyPrecision MedicineRare Disease
  • AstraZeneca will present over 80 abstracts at ASCO 2025, including two plenary presentations featuring camizestrant for HR-positive breast cancer and IMFINZI for early gastric cancer, marking their seventh consecutive year with plenary data.
  • The SERENA-6 trial is the first positive Phase III study for a next-generation oral SERD in first-line HR-positive breast cancer, pioneering the use of circulating tumor DNA to guide treatment decisions.
  • DESTINY-Breast09 data shows ENHERTU plus pertuzumab is the first treatment in over a decade to demonstrate superiority over standard care in first-line HER2-positive metastatic breast cancer.

Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas

NCT04924608Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/19/2021

Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors

NCT02564900CompletedPhase 1
Daiichi Sankyo Co., Ltd.
Posted 9/1/2015

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