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Crescent Biopharma Appoints Jan Pinkas as Chief Scientific Officer to Advance Oncology Pipeline

Oncology
  • Crescent Biopharma has appointed Jan Pinkas, Ph.D., as chief scientific officer, bringing over two decades of oncology drug development experience including expertise in antibody-drug conjugates.
  • The company expects to begin dosing patients in a global Phase 1 trial of CR-001, a PD-1 x VEGF bispecific antibody, in early 2026.
  • Crescent anticipates submitting an IND application for CR-002, a novel antibody-drug conjugate, in mid-2026.
  • Dr. Pinkas previously served as chief scientific officer at Pyxis Oncology and contributed to the development of ELAHERE, an approved ADC for platinum-resistant ovarian cancer.

Veeda Lifesciences Partners with Mango Sciences to Deploy AI-Powered Platform for Enhanced Clinical Trial Diversity

AIOncology
  • Veeda Lifesciences has announced an investment in Boston-based Mango Sciences to leverage AI capabilities for enhancing clinical trial speed, efficiency, and quality across its global network.
  • The partnership will deploy Mango Sciences' AI-powered Querent platform to automate patient identification with precision and expand reach across Europe, particularly focusing on oncology drug development.
  • The collaboration aims to improve diversity in clinical trials through broader representation of non-Caucasian populations, meeting regulatory expectations and pharmaceutical company demands.
  • The integration of Large Language Models and Generative-AI into the Querent platform will drive operational efficiencies and improve real-world evidence for better patient-drug matching.

Biorce Secures €5M to Transform Clinical Trials with AI-Driven Platform

AIOncology
  • Barcelona-based healthtech startup Biorce raised €5 million from Norrsken VC to scale its AI-driven platform that addresses clinical trial inefficiencies.
  • The company's Jarvis platform aims to reduce the 70% of clinical trials that face startup delays and 60% that require costly amendments averaging $250K-$450K each.
  • Biorce's AI technology has already streamlined over 300 clinical trial protocols across oncology and neurology, with potential to unlock $13-25 billion in industry value.
  • The funding will support US market expansion, team growth, and product development as the clinical trial market grows from $84 billion in 2024 to $150 billion by 2034.

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

NCT05318573Active, Not RecruitingPhase 2
Fujifilm Pharmaceuticals U.S.A., Inc.
Posted 6/1/2022

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

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.

(Summit) a Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients with Indolent or Smoldering Systemic Mastocytosis

NCT05186753Active, Not RecruitingPhase 2
Cogent Biosciences, Inc.
Posted 6/27/2022

Pakistan Approves Chinese Biosimilar Cancer Drug to Expand Access to Affordable Bevacizumab Treatment

Drug ApprovalOncology
  • Pakistan's drug regulator has approved a biosimilar version of bevacizumab, a costly cancer drug, manufactured by Chinese firm TOT Biopharm and marketed by Kexing Biopharm.
  • The approval addresses critical healthcare needs in Pakistan, where over 118,000 cancer deaths occur annually, with lung, colorectal, and ovarian cancers among major contributors.
  • The biosimilar offers a more affordable alternative to Roche's Avastin, which costs several hundred dollars per dose and remains unaffordable for most patients in the country of 240 million people.
  • This development strengthens Pakistan-China health cooperation and aligns with Pakistan's 2018 drug pricing policy promoting generic and biosimilar medicines to reduce healthcare costs.

Eli Lilly and Loxo Oncology Advance Phase 3 Trial Testing Pirtobrutinib Combination for Previously Treated CLL/SLL

Oncology
  • Eli Lilly and Loxo Oncology are conducting the BRUIN CLL-322 Phase 3 trial evaluating pirtobrutinib combined with venetoclax and rituximab versus standard venetoclax-rituximab therapy in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma patients.
  • The randomized, open-label study compares fixed-duration treatment with the experimental three-drug combination against the current two-drug standard of care, with pirtobrutinib and venetoclax administered orally and rituximab given intravenously.
  • The trial, which began in September 2021, is currently active but no longer recruiting participants, with the most recent update submitted in July 2025.
  • Results from this study could significantly impact the companies' market position in the competitive oncology landscape and influence treatment standards for CLL/SLL patients.

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.

Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

NCT02588677CompletedPhase 2
AB Science
Posted 4/1/2013

A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)

NCT06968741RecruitingNot Applicable
UroMems SAS
Posted 5/19/2025

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

NCT04640623Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 12/18/2020

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.

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