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Provectus Biopharmaceuticals Launches Preclinical Study of Oral PV-10 for Bladder Cancer Treatment

Oncology
  • Provectus Biopharmaceuticals has initiated a preclinical study evaluating oral PV-10 in an orthotopic bladder cancer model, with results expected in Q1 2026.
  • The study will assess PV-10's performance across multiple treatment approaches including oral and intravesical monotherapy and combination with anti-PD-1 checkpoint inhibitors.
  • PV-10 is formulated from pharmaceutical-grade rose bengal sodium, a first-in-class synthetic small molecule from the halogenated xanthene family.
  • Successful results could expand PV-10's investigational new drug application and support broader immuno-oncology applications across solid tumor and hematologic cancers.

AbbVie to Launch Ovarian Cancer Drug Elahere in UK at US List Price

Oncology
  • AbbVie announced it will launch its ovarian cancer drug Elahere in the UK at a list price matching that in the U.S., following President Trump's most-favored-nation pricing policy demands.
  • The company is currently in discussions with Britain's National Institute for Health and Care Excellence to ensure fair valuation, which will determine the drug's UK launch timeline.
  • Elahere belongs to the antibody-drug conjugate class of treatments that precisely target cancer cells, potentially reducing toxicity compared to traditional therapies.
  • This pricing strategy follows Bristol Myers Squibb's similar decision to launch schizophrenia drug Cobenfy in the UK at U.S. list price levels.

Genmab Announces $5.2 Billion Acquisition of Merus to Expand Late-Stage Oncology Pipeline

Oncology
  • Genmab will acquire Merus for $97.00 per share, representing a 41% premium and totaling approximately $5.2 billion in the largest deal in Genmab's history.
  • The acquisition centers on petosemtamab, Merus's EGFRxLGR5 bispecific antibody that has received two FDA Breakthrough Therapy Designations for head and neck cancer treatment.
  • Phase 2 data presented at ASCO 2025 demonstrated substantially higher overall response rates and median progression-free survival compared to standard of care therapies.
  • Two Phase 3 trials are currently underway with topline interim readouts anticipated in 2026, potentially enabling commercial launch in 2027 subject to regulatory approvals.

A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)

NCT06525220RecruitingPhase 3
Merus N.V.
Posted 9/25/2024

A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients

NCT06496178RecruitingPhase 3
Merus N.V.
Posted 6/25/2024

A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors

NCT03526835RecruitingPhase 1
Merus N.V.
Posted 5/2/2018

Factor Bioscience Sues AstraZeneca and Cellectis Over Gene-Editing Patent Infringement

Gene EditingOncology
  • Factor Bioscience filed a patent lawsuit against Cellectis and AstraZeneca in Delaware federal court, alleging infringement of three foundational gene-editing patents related to mRNA TALEN technology.
  • The lawsuit claims Cellectis copied Factor's patented technology for designing gene-edited cells for cancer therapies, particularly for treating leukemia and lymphoma.
  • AstraZeneca is accused of violating patent rights through its 2023 licensing agreement with Cellectis for gene-editing technology development in oncology and other therapeutic areas.
  • Factor CEO Matt Angel warns that allowing large pharmaceutical companies to exploit smaller biotech innovations could chill future research and delay new therapy development.

Qurient and Synaffix Partner to Develop First-in-Class CDK7 Dual-Payload ADC for Refractory Cancers

Oncology
  • Qurient has signed a licensing agreement with Synaffix to develop a dual-payload ADC combining Qurient's CDK7 inhibitor mocaciclib with Synaffix's exatecan-based technology.
  • This represents the first known use of a CDK7 inhibitor as a dual payload in ADC development, addressing unmet medical needs in solid tumor treatment.
  • The collaboration leverages Synaffix's site-specific ADC platform and Lonza's manufacturing expertise to create a therapy designed to enhance efficacy and mitigate resistance in refractory cancers.
  • Dual-payload ADCs deliver two different mechanisms of action to targeted cancer cells, potentially expanding treatment scope while minimizing toxicity to healthy tissues.

FDA Grants Third Orphan Drug Designation to Biostar's Utidelone for Pancreatic Cancer Treatment

Oncology
  • The FDA has granted Orphan Drug Designation to Biostar Pharma's Utidelone for pancreatic cancer treatment, marking the third such designation for the drug following previous approvals for breast cancer brain metastases and gastric cancer.
  • Preliminary Phase II clinical trial results showed Utidelone combined with gemcitabine achieved a 27.27% objective response rate and 72.72% disease control rate in 11 evaluable patients with unresectable advanced pancreatic cancer.
  • Pancreatic cancer remains one of the most challenging malignancies with only a 10% five-year survival rate, and current gemcitabine-based treatments often fail due to drug resistance development.
  • Utidelone is a genetically engineered microtubule inhibitor that demonstrates advantages over traditional taxanes, including better safety profile, effectiveness against multidrug-resistant tumors, and ability to cross the blood-brain barrier.

Utidelone Injection Combined With Gemcitabine in First-line Chemotherapy for Unresectable Advanced Pancreatic Cancer

NCT05795920RecruitingPhase 2
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Posted 3/8/2023

Pfizer Presents Breakthrough Cancer Data at ESMO 2025, Showcasing Unprecedented Survival Results

Oncology
  • Pfizer will present data from more than 45 abstracts at ESMO 2025, including unprecedented survival results from the Phase 3 EV-303 trial evaluating PADCEV plus KEYTRUDA in muscle-invasive bladder cancer patients.
  • The company will showcase final overall survival results from the Phase 3 EMBARK trial of XTANDI in non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence.
  • Updated survival data from the Phase 2 PHAROS study demonstrates the potential of BRAFTOVI plus MEKTOVI combination in BRAF V600E-mutant metastatic non-small cell lung cancer.
  • The presentations highlight Pfizer's strategy of earlier interventions with innovative medicines to deliver greater impact across multiple cancer types.

Pi Health Partners with GSK to Accelerate Phase 2 Oncology Trial Using AI-Powered Platform

AIOncology
  • Pi Health has entered a Master Clinical Services Outsourcing Agreement with GSK to provide fully outsourced clinical research services for a global Phase 2 oncology clinical trial.
  • The collaboration leverages Pi Health's proprietary FICS platform, which integrates artificial intelligence capabilities to make study conduct 50% faster while maintaining audit-ready data quality.
  • Pi Health will manage all aspects of the trial including site selection, patient enrollment, real-time monitoring, and regulatory submissions through its technology-driven service model.
  • The partnership aims to accelerate development of cancer treatments by removing inefficiencies that can slow clinical trial progress.

Kashiv BioSciences and JAMP Pharma Launch Neutropenia Biosimilars in Canada

Oncology
  • Kashiv BioSciences and JAMP Pharma have commercially launched Pexegra and Filra, biosimilar alternatives to Neulasta and Neupogen respectively, in the Canadian market.
  • Both biosimilars are indicated for treating neutropenia in cancer patients undergoing chemotherapy, with Pexegra reducing infection incidence and Filra addressing severe neutropenia conditions.
  • The launch marks JAMP Pharma's entry into oncology biosimilars through its BioJAMP division, expanding treatment options for Canadian patients.
  • The products are available as pre-filled syringes with safety features and represent part of JAMP's commitment to providing affordable biosimilar alternatives in Canada.

Ipca Laboratories Partners with BioSimilar Sciences for US Manufacturing of Cancer and Autoimmune Biosimilars

Monoclonal AntibodyOncology
  • Ipca Laboratories and BioSimilar Sciences PR LLC announced a definitive technology transfer and joint development agreement for next-generation monoclonal antibody biosimilars targeting cancer and autoimmune diseases.
  • The partnership will transfer late-stage development, clinical manufacturing, and commercial supply to BSS's 200,000-square-foot sterile facility in Puerto Rico, with the first biosimilar launch planned for 2027.
  • BSS will hold exclusive rights for the US and Canada markets, while Ipca will receive milestone fees and royalties on net sales once commercialized.
  • The collaboration leverages OcyonBio's sterile filling capacity of 60 million units annually and is expected to create hundreds of high-paying biotech jobs in Puerto Rico.

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