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RedHill Biopharma Reports Strong Start to 2025 with Strategic Partnerships and Commercial Growth

  • RedHill Biopharma has out-licensed RHB-102 to Hyloris in a deal potentially worth up to $60 million plus royalties, strengthening their financial position and development capabilities.
  • The company has initiated a Bayer-funded Phase 2 clinical study of opaganib in combination with darolutamide for advanced prostate cancer, expanding their oncology portfolio.
  • Talicia®, RedHill's H. pylori treatment, has surpassed 100,000 prescriptions and secured Humana® Part D Plan coverage, adding access for over eight million Medicare beneficiaries without prior authorization requirements.

Targeted Therapies and Immunotherapy Advances in Non-Small Cell Lung Cancer: A Comprehensive Review

  • Targeted therapies for NSCLC have revolutionized treatment for patients with specific genetic alterations, with EGFR, ALK, and ROS1 inhibitors showing significant improvements in progression-free survival compared to traditional chemotherapy.
  • Immunotherapy, particularly immune checkpoint inhibitors targeting PD-1/PD-L1 and CTLA-4, has become a cornerstone in NSCLC treatment, with newer targets like LAG-3, TIM-3, and TIGIT showing promise in ongoing clinical trials.
  • Advanced cellular therapies including adoptive cell transfer, CAR-T cells, and cancer vaccines represent the next frontier in NSCLC treatment, particularly for patients with "cold tumors" who don't respond to standard immunotherapies.
NCT04348643Unknown StatusPhase 1
Chongqing Precision Biotech Co., Ltd
Posted 2/20/2020
NCT01935154CompletedPhase 2
Vaxon Biotech
Posted 8/1/2012
NCT03789604Active, Not RecruitingPhase 3
CStone Pharmaceuticals
Posted 12/13/2018
NCT05060796RecruitingEarly Phase 1
Second Affiliated Hospital of Guangzhou Medical University
Posted 9/1/2019
NCT04908111SuspendedPhase 1
Cancer Research UK
Posted 10/15/2021
NCT05202561Unknown StatusPhase 1
First Affiliated Hospital Bengbu Medical College
Posted 3/10/2022
NCT02587689Unknown StatusPhase 1
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Posted 10/1/2015
NCT03182816Unknown StatusPhase 1
Shanghai Cell Therapy Research Institute
Posted 6/7/2017
NCT04646330Active, Not RecruitingPhase 1
Akeso
Posted 11/18/2020
NCT03729596TerminatedPhase 1
MacroGenics
Posted 11/21/2018
NCT02349724Unknown StatusPhase 1
Southwest Hospital, China
Posted 12/1/2014
NCT03525782Unknown StatusPhase 1
The First Affiliated Hospital of Guangdong Pharmaceutical University
Posted 2/1/2018
NCT02576574CompletedPhase 3
EMD Serono Research & Development Institute, Inc.
Posted 10/29/2015

Cancer Monoclonal Antibody Partnerships Surge with 599 Deals Recorded Since 2016

  • A comprehensive analysis reveals 599 cancer monoclonal antibody collaboration and licensing deals have been announced since 2016, demonstrating sustained industry investment in this therapeutic area.
  • The deals encompass multicomponent partnerships that typically begin with collaborative research and development and progress to commercialization of therapeutic outcomes.
  • Leading biopharma companies are actively pursuing cancer monoclonal antibody partnerships, with detailed financial terms including upfront payments, milestone payments, and royalty structures being tracked across transactions.
  • The report identifies the top 25 most active companies in cancer monoclonal antibody dealmaking, providing insights into partnership strategies and market dynamics in oncology therapeutics.

Bevacizumab Benefits in Colorectal Cancer Limited to Two-Year Window, New Analysis Reveals

  • A comprehensive review presented at the 2025 ASCO Gastrointestinal Cancers Symposium reveals bevacizumab (Avastin) provides survival benefits in colorectal cancer patients for approximately two years after initial administration.
  • Researchers found that after 20-24 months, the initial survival benefit from bevacizumab diminishes, potentially explaining the crossover of survival curves observed in the PARADIGM trial compared to panitumumab (Vectibix).
  • The study suggests bevacizumab treatment may lead to selection of more aggressive tumor clones over time, characterized by accelerated growth and invasiveness after the initial period of tumor stasis and shrinkage.

Defence Therapeutics Secures Key Patent Allowances for Accum® Multimer Technology and Vaccine Platform

  • Defence Therapeutics received USPTO Notice of Allowance for its Accum®-based multimer technology, covering molecular entities used in AccuTOX® and ARM® anti-cancer programs with patent protection extending to 2043.
  • The company secured US patent no. 12,150,989 for its vaccine platform technology, expanding protection for Accum®-based immunogenicity-enhancing variants derived from steroid acids.
  • Singapore Patent Office allowed Defence's counterpart vaccine technology application, with patent grant expected in early 2025, strengthening the company's global intellectual property portfolio.
  • These patent developments validate Defence's innovative approach and position the company for strategic partnerships and licensing agreements in the biotechnology sector.

Nivolumab Shows Promise in Refractory Biliary Tract Cancer with 22% Response Rate in Phase II Trial

  • A phase II study of nivolumab in 54 patients with refractory biliary tract cancer demonstrated a 22% partial response rate and 60% disease control rate with median overall survival of 14.22 months.
  • The anti-PD-1 antibody was well tolerated with only 20.4% of patients experiencing grade III/IV treatment-related adverse events, and no discontinuations due to toxicity.
  • A separate randomized phase 2 trial combining stereotactic body radiotherapy with nivolumab/ipilimumab showed 31% clinical benefit rate but limited overall response rate of 11.9%.
  • These results support further investigation of immunotherapy approaches in biliary tract cancer, a disease with limited treatment options and poor prognosis.

SystImmune to Present Updated Izalontamab Brengitecan Data for HER2-Negative Breast Cancer at ESMO Breast 2025

  • SystImmune will present updated Phase 1 data on izalontamab brengitecan (iza-bren), a novel EGFRxHER3 bispecific antibody-drug conjugate, at ESMO Breast Cancer 2025 in Munich, Germany.
  • The data shows encouraging efficacy across all HER2 levels in HER2-negative breast cancer patients, including HER2 0 patients, building on previously reported results at SABCS 2024.
  • Iza-bren, jointly developed by SystImmune and Bristol Myers Squibb, demonstrates strong clinical efficacy with a manageable safety profile, potentially addressing significant unmet needs in breast cancer treatment.

Dana-Farber Cancer Institute Launches Phase II Trials Testing Immunotherapy in Meningioma and Melanoma

  • Dana-Farber Cancer Institute is conducting two Phase II clinical trials evaluating immunotherapy approaches for different cancer types, including nivolumab for progressive meningiomas and dostarlimab for resectable melanoma.
  • The meningioma trial (15-490) tests nivolumab alone or in combination with radiation therapy in patients with WHO grade I-III progressive or recurrent meningiomas, including those who have failed prior radiation therapy.
  • The melanoma trial (21-201) evaluates neoadjuvant dostarlimab in patients with cutaneous or unknown primary melanoma at various AJCC stages, requiring measurable disease and adequate organ function.
  • Both studies have specific inclusion criteria regarding prior treatments, with the meningioma trial allowing unlimited prior therapies while the melanoma trial excludes patients with prior PD-1/PD-L1 inhibitor treatment.

CytomX Therapeutics Initiates Combination Therapy Arm in Phase 1 Melanoma Trial

  • CytomX Therapeutics has dosed the first patient in a combination arm studying CX-801 with Keytruda (pembrolizumab) for patients with metastatic melanoma.
  • The Phase 1 trial aims to evaluate safety, tolerability, and preliminary efficacy of this novel combination approach targeting advanced melanoma patients.
  • This study represents a significant step in exploring how CX-801's mechanism may potentially enhance the effectiveness of established immunotherapy treatments.

Doxorubicin Plus Pembrolizumab Shows Promise in Phase 2 Trial for Advanced Soft Tissue Sarcoma

  • A Phase 2 trial evaluating the combination of doxorubicin and pembrolizumab demonstrated encouraging efficacy and manageable safety profile in patients with advanced soft tissue sarcoma.
  • The study reported significant objective response rates and disease control, potentially offering a new treatment approach for this challenging malignancy with limited therapeutic options.
  • Researchers presented these findings at the recent American Society of Clinical Oncology (ASCO) meeting, highlighting the potential of immunotherapy combinations in sarcoma treatment.
NCT04028063RecruitingPhase 2
University of Colorado, Denver
Posted 1/28/2020

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