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FUJIFILM's FF-10832 Receives FDA Orphan Drug Designation for Biliary Tract Cancer Treatment

OncologyRare Disease
  • The FDA has granted orphan drug designation to FF-10832, FUJIFILM's investigational liposomal formulation of gemcitabine, for treating biliary tract cancer.
  • Phase 1 study results presented at ASCO 2025 demonstrated that FF-10832 is well tolerated and shows anti-tumor activity in patients with advanced biliary tract cancer.
  • The novel liposomal formulation is designed to enhance anti-tumor activity by prolonging plasma half-life and improving targeted delivery to tumors.
  • Biliary tract cancer affects approximately 16,000 new patients annually in the U.S., with most presenting with unresectable or metastatic disease and poor survival rates.

A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer

NCT03440450Active, Not RecruitingPhase 1
Fujifilm Pharmaceuticals U.S.A., Inc.
Posted 3/22/2018

A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer

NCT05318573RecruitingPhase 2
Fujifilm Pharmaceuticals U.S.A., Inc.
Posted 6/1/2022

Bezuclastinib Achieves 87% Response Rate in Pivotal Trial for Non-Advanced Systemic Mastocytosis

Rare DiseasePrecision MedicineOncology
  • Cogent Biosciences' bezuclastinib demonstrated superior symptom improvement with a placebo-adjusted difference of 8.91 points in total symptom score at 24 weeks (p=0.0002) in the SUMMIT trial.
  • The drug showed remarkable efficacy on mast cell burden, with 87.4% of patients achieving at least 50% reduction in serum tryptase compared to 0% in the placebo group.
  • Bezuclastinib exhibited a favorable safety profile with most adverse events being low-grade, supporting its potential for chronic use in systemic mastocytosis patients.
  • The company plans to submit a New Drug Application to the FDA by the end of 2025 based on these positive results from the registration-directed trial.

ArriVent BioPharma Raises $75 Million to Advance Firmonertinib and Cancer Pipeline

Oncology
  • ArriVent BioPharma successfully priced a $75 million public offering of common stock and pre-funded warrants at $19.50 per share to fund its oncology pipeline development.
  • The proceeds will support the company's lead candidate firmonertinib and other pipeline programs including next-generation antibody drug conjugates for cancer treatment.
  • Goldman Sachs, Citigroup, and Guggenheim Securities are serving as joint book-running managers for the offering, which is expected to close on July 3, 2025.
  • ArriVent is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics to address unmet medical needs in cancer treatment.

AB Science's Masitinib Receives FDA and EMA Authorization for Confirmatory Phase 3 Trial in Metastatic Castrate-Resistant Prostate Cancer

Oncology
  • AB Science announced that both FDA and EMA have authorized a confirmatory phase 3 trial of masitinib in combination with docetaxel for metastatic castrate-resistant prostate cancer, using biomarker-driven patient selection.
  • The 600-patient study will target patients with less advanced metastatic disease based on baseline alkaline phosphatase levels, potentially establishing the first targeted combination with docetaxel in nearly two decades.
  • Previous phase 3 results demonstrated masitinib plus docetaxel achieved a 21% reduction in progression risk with a hazard ratio of 0.79 in patients with alkaline phosphatase ≤250 IU/L.
  • The treatment addresses a significant unmet medical need, as there is currently no drug registered for combination with docetaxel in mCRPC patients despite docetaxel's approval almost 20 years ago.

Imugene Secures AU$5.87 Million R&D Tax Refund to Advance Immuno-Oncology Pipeline

OncologyCAR-T
  • Imugene Limited received AU$5.87 million in R&D tax refunds from the Australian Government's incentive program, providing up to 48.5% refundable offset for eligible research activities.
  • The funding will accelerate clinical development of the company's innovative immunotherapy pipeline, including allogeneic CAR T therapy azer-cel for blood cancers and CF33 oncolytic virus therapy for solid tumors.
  • Imugene continues advancing multiple oncology programs including B-cell vaccine candidates, leveraging cutting-edge technology to improve cancer outcomes and transform patient care.

Godavari Biorefineries Secures European Patent for Novel Anticancer Molecule Targeting Cancer Stem Cells

Oncology
  • Godavari Biorefineries Ltd has obtained a European patent for a novel anticancer molecule with proven efficacy against both cancer cells and cancer stem cells, validated in Spain, the UK, and under the Unitary Patent system.
  • The patented compound falls under the company's Anti-Cancer Research Segment and represents a significant advancement in targeting cancer stem cells, a crucial focus area in modern oncology research.
  • This patent milestone strengthens Godavari Biorefineries' global footprint in biotech innovation and reinforces its commitment to developing breakthrough solutions in cancer therapy.

AstraZeneca and Summit Therapeutics in Advanced Talks for $15 Billion Ivonescimab Licensing Deal

OncologyDrug Approval
  • AstraZeneca is negotiating with Summit Therapeutics for a potential $15 billion licensing deal for ivonescimab, an experimental lung cancer drug that has shown promising results in late-stage trials.
  • The deal could include an upfront payment of several billion dollars plus milestone payments, representing one of the largest pharmaceutical licensing agreements in recent years.
  • Ivonescimab demonstrated statistically significant improvement in progression-free survival when combined with chemotherapy in previously treated lung cancer patients, though it failed to achieve statistical significance for overall survival.
  • Summit secured rights to ivonescimab through a $5 billion deal with China-based Akeso in 2022, and the drug is already approved in China as of May 2023.

Jacobio Pharma Receives IND Acceptance for BET Inhibitor JAB-8263 in Autoimmune Diseases

Oncology
  • Jacobio Pharma's Phase I/II IND application for BET inhibitor JAB-8263 in autoimmune diseases has been accepted by China's Center for Drug Evaluation, with review expected within 30 working days.
  • The oral BET inhibitor represents a potential breakthrough for autoimmune diseases, which affect 5%-9% of the global population and are currently treated primarily with intravenous monoclonal antibodies.
  • JAB-8263 previously demonstrated good tolerability in Phase I trials for solid tumors and hematological malignancies, with data presented at the 2024 ASH Annual Meeting.
  • This regulatory milestone marks Jacobio's expansion of JAB-8263 from oncology into autoimmune diseases, potentially benefiting a broader patient population with an oral therapeutic option.

Australia Opens First Antibody-Drug Conjugate Manufacturing Facility to Advance Precision Cancer Treatment

Precision MedicineOncology
  • IDT Australia has opened the nation's first facility dedicated to manufacturing antibody-drug conjugates (ADCs) for oncology therapies, establishing the Ehrlich Bioconjugation Centre in Victoria.
  • The facility represents a $3.8 million investment and will create 88 highly skilled local jobs while positioning Australia as a global leader in advanced cancer treatment manufacturing.
  • ADCs significantly improve patient survival rates and quality of life by delivering potent chemotherapy agents directly to cancer cells with high specificity, particularly benefiting breast cancer patients.
  • The global ADC market is forecast to reach US$140 billion over the next 15 years and is expected to displace 30-50% of the traditional chemotherapy market.

Lixte Biotechnology Secures $5 Million Private Placement to Advance Cancer Therapy Development

Oncology
  • Lixte Biotechnology Holdings completed a $5 million private placement on June 30, 2025, with proceeds designated for general corporate purposes and working capital to support ongoing cancer therapy development.
  • The company's lead compound LB-100, a first-in-class PP2A inhibitor, has demonstrated tolerability in cancer patients at doses associated with anti-cancer activity and represents a pioneering approach in activation lethality cancer biology.
  • Proof-of-concept clinical trials for LB-100 are currently underway for colon, small cell lung, and sarcoma cancers, with the compound showing potential to enhance both chemotherapies and immunotherapies.
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