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Novartis Acquires Mariana Oncology for $1 Billion to Strengthen Radioligand Therapy Pipeline

Oncology
  • Novartis announced a $1 billion acquisition of Mariana Oncology with up to $750 million in milestone payments to expand its radioligand therapy capabilities.
  • The deal provides access to Mariana's lead candidate MC-339, an actinium-based radioligand therapy targeting small cell lung cancer currently in preclinical development.
  • Mariana brings specialized radiopharmaceutical manufacturing capabilities and an oncology radio-conjugation platform using both alpha- and beta-emitting radionuclides.
  • The acquisition strengthens Novartis' position in the competitive radioligand therapy space, following similar billion-dollar deals by AstraZeneca, Bristol Myers Squibb, and Eli Lilly.

IDT Australia Secures Victorian Government Grant to Establish Nation's First Commercial ADC Manufacturing Facility

Monoclonal AntibodyOncology
  • IDT Australia has been awarded a Victorian government grant to establish Australia's first current good manufacturing practice antibody-drug-conjugate manufacturing facility in Boronia.
  • The $3.8 million facility will position Victoria at the forefront of Australia's sovereign capability to manufacture cutting-edge oncological drugs that precisely target cancer cells.
  • The global ADC market is projected to reach $140-211 billion over the next 15 years, with expectations to displace 30-50% of the traditional chemotherapy market.
  • IDT Australia has already secured key partnerships including a master services agreement with Japanese pharmaceutical supplier Nagase & Co, Ltd for ADC component development.

Fresenius Kabi Launches First Actemra® Biosimilar in U.S. Market as Biosimilar Landscape Expands

Drug ApprovalOncologyMonoclonal Antibody
• Fresenius Kabi has launched Tyenne® (tocilizumab-aazg), the first biosimilar of Actemra® to enter the U.S. market, following FDA approval in March 2024 for both intravenous and subcutaneous formulations.
• Accord BioPharma received FDA approval for Hercessi™ (trastuzumab-strf), becoming the sixth Herceptin® biosimilar approved in the U.S., while Xbrane's Xlucane™ (ranibizumab) received a Complete Response Letter from the FDA.
• The expanding biosimilar market continues to challenge reference products with significant annual sales, with Actemra® generating approximately $3 billion, Herceptin® $1.77 billion, and Lucentis® $1.475 billion in 2023.

India's CDSCO Rejects Pfizer's Clinical Trial Waiver for Multiple Myeloma Drug Elranatamab

Oncology
  • India's Subject Expert Committee has rejected Pfizer's request for a local clinical trial waiver for elranatamab, a bispecific antibody targeting relapsed and refractory multiple myeloma.
  • Elranatamab, which received accelerated approval from the US FDA based on Phase II data, is a BCMA-directed CD3 T-cell engager designed for patients who have failed multiple prior therapies.
  • The decision came after the SEC's oncology meeting on April 3-4, 2024, where they reviewed Pfizer's proposal to import and market the injection in 44mg/1.1mL and 76mg/1.9mL formulations.

FDA Approves ImmunityBio's Anktiva for Bladder Cancer, Marking Major Milestone for Soon-Shiong's Immunotherapy Approach

Drug ApprovalOncology
  • The FDA has approved ImmunityBio's lead drug Anktiva for treating a common form of bladder cancer, representing a significant breakthrough after years of development and regulatory challenges.
  • Anktiva harnesses the body's natural killer cells and T-cells to fight cancer, with clinical trials showing the ability to eliminate bladder cancer cells for at least four years.
  • ImmunityBio plans to begin distributing Anktiva to healthcare providers by mid-May 2024, with the company having built a three-year stockpile of the drug during the FDA review process.

Hanmi Pharmaceutical Partners with MSD to Test Novel Bispecific Antibody BH3120 in Combination with KEYTRUDA

Oncology
  • Hanmi Pharmaceutical has entered a Clinical Trial Collaboration and Supply Agreement with MSD to evaluate its novel immunotherapy BH3120 in combination with KEYTRUDA for patients with progressive or metastatic solid tumors.
  • BH3120 utilizes Hanmi's proprietary Pentambody platform, targeting both PD-L1 and 4-1BB simultaneously to enhance anti-tumor immune responses specifically in tumor tissues while minimizing systemic immune activation.
  • The Phase 1 trial, led by Dr. Kim Dong-wan of Seoul National University Hospital, aims to overcome limitations of existing 4-1BB targeting therapies by leveraging BH3120's demonstrated ability to decouple immune activity between tumor microenvironment and normal tissue.

Volastra Therapeutics Initiates Phase Ib Trial of Sovilnesib for Platinum-Resistant Ovarian Cancer

Oncology
• Volastra Therapeutics has dosed the first patient in a Phase Ib trial evaluating sovilnesib for platinum-resistant or refractory high-grade serous ovarian cancer, with the FDA granting Fast Track designation for this indication.
• The randomized dose optimization study aims to establish the recommended Phase 2 dose of once-daily oral sovilnesib, addressing a significant unmet need in a patient population with poor treatment response rates.
• Volastra is advancing two chemically differentiated KIF18A inhibitors—sovilnesib and VLS-1488—in parallel clinical trials, while also developing biomarker approaches to measure chromosomal instability through partnerships with Microsoft, Tailor Bio, and Function Oncology.

A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer

NCT05902988RecruitingPhase 1
Volastra Therapeutics, Inc.
Posted 10/18/2023

A Study of Sovilnesib in Subjects With Ovarian Cancer

NCT06084416RecruitingPhase 1
Volastra Therapeutics, Inc.
Posted 4/4/2024

Study Reveals Most Cancer Drugs with Accelerated FDA Approval Fail to Demonstrate Clinical Benefit After Five Years

Drug ApprovalOncology
  • A new study found that only 43% of cancer drugs granted FDA accelerated approval between 2013-2017 demonstrated clinical benefit in confirmatory trials after more than five years of follow-up.
  • Despite limited evidence of clinical benefit, 63% of these accelerated approval drugs were converted to regular approval, raising concerns about regulatory standards and patient communication.
  • The research highlights the need for better validation of surrogate endpoints and more robust evidence requirements before converting accelerated approvals to regular approvals.
  • Researchers emphasize the importance of clearer communication between physicians and patients about the uncertainty surrounding drugs approved on preliminary measures.

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

NCT02130557CompletedPhase 3
Pfizer
Posted 7/15/2014

Meta-Analysis Confirms Superior Efficacy of Perioperative Immunotherapy Plus Chemotherapy in Resectable NSCLC

Oncology
  • A comprehensive meta-analysis of five phase III trials involving 2,855 patients demonstrates that perioperative immunotherapy combined with chemotherapy significantly improves overall survival, event-free survival, and pathological complete response rates compared to chemotherapy alone in resectable non-small cell lung cancer.
  • The combination therapy reduced the risk of death by 32% (HR=0.68) and achieved a 7.54-fold higher pathological complete response rate, with particular benefits observed in current and former smokers and patients with EGFR-mutation negative tumors.
  • While the treatment increased grade 3+ adverse events and immune-related complications, it maintained surgical feasibility with 100% R0 resection rates and no increase in treatment-related deaths.

Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)

NCT04379635Active, Not RecruitingPhase 3
BeiGene
Posted 5/29/2020

Sandoz Receives FDA Approval for First Denosumab Biosimilars in US and Canada

Monoclonal AntibodyDrug ApprovalOncology
  • Sandoz received FDA approval for Jubbonti and Wyost, the first and only denosumab biosimilars approved in the United States and Canada, marking a significant milestone in biosimilar development.
  • The biosimilars are approved as interchangeable with Amgen's reference medicines Prolia and Xgeva for all indications, including osteoporosis treatment and prevention of cancer-related bone complications.
  • More than 10 million US adults aged 50 and over live with osteoporosis, with half of all women over 50 experiencing an osteoporotic fracture during their lifetime.
  • The approvals are based on robust phase I and phase III clinical studies demonstrating no clinically meaningful differences from the reference medicines.

Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

NCT03974100CompletedPhase 3
Sandoz
Posted 7/2/2019
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