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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.

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

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

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

Pharmaceutical Industry Leadership Shuffle: Major Executive Appointments Signal Strategic Shifts Across Biotech and Pharma

CAR-TOncologyFDA Approval
  • AbbVie promoted long-time COO Robert Michael to CEO, marking the end of an extensive leadership search with an internal succession plan.
  • Multiple European biotechs appointed new CEOs, including OneChain Immunotherapeutics, Maxion Therapeutics, and StromaCare, reflecting strategic pivots in cancer immunotherapy development.
  • Astellas created its first chief digital and transformation officer role, signaling the pharmaceutical industry's increasing focus on digital transformation initiatives.
  • Acumen Pharmaceuticals strengthened its Alzheimer's drug development capabilities by appointing James Doherty, a neuroscience veteran with two FDA approvals under his belt.

Biovica Signs Master Service Agreement to Support Next-Generation CDK4/6 Inhibitor Development for Breast Cancer

Oncology
• Biovica International has secured a master service agreement with a biopharmaceutical company to provide TKa testing services for evaluating cell proliferation in drug development studies, with an initial work order valued at 1.2 MSEK.
• The agreement enables Biovica to contribute to the development of first-in-class next-generation CDK4/6 inhibitor therapeutics for breast cancer, potentially leading to a Companion Diagnostic product.
• This partnership adds to Biovica's existing portfolio of 13 master service agreements with pharmaceutical and biotech companies, highlighting growing industry demand for their blood-based cancer monitoring technology.

Promontory Therapeutics Completes Enrollment in Phase 2 Trial of PT-112 for Late-Stage Metastatic Prostate Cancer

Oncology
  • Promontory Therapeutics has completed enrollment of 109 patients in its Phase 2 trial of PT-112 for metastatic castration-resistant prostate cancer (mCRPC) across 32 clinical sites in the US and France.
  • PT-112, the first small-molecule conjugate of pyrophosphate in clinical oncology development, works by inhibiting ribosomal biogenesis to induce immunogenic cell death in "immune-cold" prostate cancer.
  • The study targets heavily pre-treated patients who have received at least three prior therapies, with topline safety and efficacy results expected in late 2024 following planned FDA meetings.

A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts

NCT02266745Active, Not RecruitingPhase 2
Promontory Therapeutics Inc.
Posted 7/1/2014

India's Indigenous CAR T-Cell Therapy Revolutionizes Cancer Treatment at One-Tenth Global Cost

CAR-TOncologyDrug Approval
  • India has successfully developed NexCAR19, its first indigenous CAR T-cell therapy for blood cancers, priced at approximately Rs 40 lakh ($50,000) compared to $400,000 in the United States.
  • Clinical trials involving 64 patients with advanced lymphoma or leukemia showed promising results, with 67% experiencing significant cancer reduction and about half achieving complete remission.
  • Unlike U.S. approved therapies that use mouse-derived antibody fragments, India's "humanized" CAR T-cells caused fewer severe side effects, with no reported neurologic complications and only 5% experiencing severe cytokine release syndrome.
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