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Clinical Trial News

Bambusa Therapeutics Doses First Patient with BBT002 Bispecific Antibody and Receives FDA Clearance for BBT001

  • Bambusa Therapeutics has initiated dosing in its Phase 1 clinical trial for BBT002, a novel bispecific antibody designed as a "platform in a molecule" for treating respiratory, dermatology, and gastroenterology conditions.
  • The company received FDA clearance for its BBT001 Investigational New Drug application, expanding clinical development of this atopic dermatitis treatment from Australia to the United States.
  • Both BBT001 and BBT002 represent half-life extended bispecific antibodies with preclinical data suggesting enhanced efficacy and improved dosing convenience compared to approved biologics.
  • The rapid advancement of two differentiated bispecific programs into clinical trials within 12 months of company founding demonstrates Bambusa's execution capabilities in inflammatory disease therapeutics.

A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT06944925RecruitingPhase 1
Bambusa Therapeutics
Posted 5/8/2025

A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)

NCT06808477RecruitingPhase 1
Bambusa Therapeutics
Posted 2/27/2025

PolyActiva Secures $40M Series C to Advance Revolutionary Glaucoma Implant Technology

  • Melbourne-based PolyActiva raised $40 million in Series C funding, including $27 million from Australia's National Reconstruction Fund, to advance its biodegradable glaucoma treatment implant.
  • The company's innovative two-millimeter polymer implant delivers medication directly into the eye over six months, potentially eliminating daily eye drops for glaucoma patients.
  • With Phase 2B clinical trials underway, PolyActiva aims to commercialize the technology by 2029 while maintaining its Australian headquarters and expanding local manufacturing capabilities.
  • The funding addresses a critical need for the 80 million people globally affected by glaucoma, a number expected to reach 111 million by 2040.

Pancreatic Cancer Pipeline Expands with 80+ Companies Advancing Novel Therapies

Targeted TherapyMonoclonal Antibody
  • DelveInsight's 2025 report reveals over 80 companies are actively developing more than 80 pipeline therapies for pancreatic ductal adenocarcinoma treatment.
  • Key pharmaceutical companies including Genentech, Revolution Medicines, and Merck Sharp & Dohme are conducting Phase 3 trials with promising novel therapeutic approaches.
  • Emerging therapies such as Onvansertib, Nadunolimab, and Zimberelimab represent diverse mechanisms of action targeting treatment resistance and immune suppression in pancreatic cancer.
  • Recent regulatory approvals include Anocca's VIDAR-1 Phase I/II trial targeting KRAS-positive advanced pancreatic cancer, demonstrating growing focus on precision medicine approaches.

Myeloid Therapeutics Reports First-in-Human Data for In Vivo mRNA CAR Therapies at ASCO 2025

CAR-T
  • Myeloid Therapeutics presented first-in-human data for MT-302 and MT-303, marking the first clinical applications of systemically administered in vivo mRNA CAR therapies.
  • Single-cell RNA sequencing demonstrated selective CAR expression in myeloid cells with increased pro-inflammatory gene signatures across tumor types for MT-302.
  • The therapies eliminate the need for ex vivo cell manipulation while delivering tumor-specific immune activation and demonstrating successful tumor penetration.
  • Both MT-302 targeting TROP2 and MT-303 targeting GPC3 showed favorable safety profiles and confirmed target engagement through pharmacodynamic markers.

FDA Grants De Novo Clearance for Reflow Medical's Spur Retrievable Stent System for Below-the-Knee Arterial Disease

  • The FDA has granted De Novo clearance for Reflow Medical's Spur Peripheral Retrievable Stent System, the first and only retrievable stent system for treating infrapopliteal arterial disease.
  • The DEEPER REVEAL clinical trial demonstrated 99.2% technical success rate and 97.0% freedom from major adverse limb events at 30 days in 130 patients with chronic limb-threatening ischemia.
  • The innovative Retrievable Scaffold Therapy technology features radially expandable spikes that penetrate lesions to increase luminal diameter and modify vessel compliance.
  • This breakthrough device offers physicians a novel treatment option for complex below-the-knee peripheral arterial disease beyond standard balloon angioplasty alone.

A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)

NCT05358353CompletedNot Applicable
ReFlow Medical, Inc.
Posted 10/18/2022

Enterome's EO4010 Shows Promising Survival Data in Difficult-to-Treat Colorectal Cancer at ASCO 2025

  • Enterome's OncoMimics™ immunotherapy EO4010 combined with nivolumab achieved 40% survival at 12 months in 20 patients with MSS/pMMR metastatic colorectal cancer, with median survival of 11.3 months.
  • The treatment demonstrated excellent safety and tolerability while generating specific immune responses in 80% of patients against tumor-associated antigens.
  • Results from the Phase 1/2 AUDREY trial showed objective responses including tumor shrinkage in liver and lung metastases, a rare outcome in this challenging patient population.
  • Data presented at ASCO 2025 support continued development of EO4010 for colorectal cancer treatment, addressing significant unmet medical needs in MSS/pMMR disease.

EO4010 in Previously Treated Metastatic Colorectal Carcinoma

NCT05589597TerminatedPhase 1
Enterome
Posted 6/1/2023

U.S. Defense Department Partners with CEPI to Advance Nipah Virus Monoclonal Antibody Treatment

Monoclonal Antibody
  • The U.S. Department of Defense and CEPI announced a collaboration on May 28, 2025, to expand global defenses against disease outbreaks, starting with Nipah virus treatment development.
  • The partnership will transfer doses of monoclonal antibody MBP1F5, currently in Phase 1 testing, to CEPI for Phase 1b/2a clinical trials in India and Bangladesh.
  • Nipah virus kills up to 75% of infected individuals and has no approved treatments or vaccines, making this therapeutic development critically important for global health security.
  • The collaboration addresses a significant unmet medical need in regions where Nipah outbreaks occur almost annually, with potential impact on over 2 billion people globally.

BioLineRx Reports Promising Pancreatic Cancer Trial Results with 64% Response Rate for Motixafortide Combination

Oncology
  • BioLineRx's CheMo4METPANC Phase 2 pilot study demonstrated a 64% overall response rate and 91% disease control rate in first-line pancreatic cancer patients treated with motixafortide combination therapy.
  • Four of eleven patients remained progression-free after more than one year, with two patients achieving complete responses and undergoing definitive surgical treatment.
  • The combination therapy increased CD8+ T-cell tumor infiltration across all patients, suggesting enhanced immune system activation against pancreatic tumors.
  • The trial has been expanded from 30 to 108 patients based on encouraging results, representing the first large randomized study of motixafortide with PD-1 inhibitor in pancreatic cancer.

Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma

NCT04543071RecruitingPhase 2
Gulam Manji
Posted 11/9/2020

CSPC Pharmaceutical Announces Potential $5 Billion Drug Licensing Deals Following Q1 Revenue Decline

Oncology
  • CSPC Pharmaceutical Group revealed it is in talks with three parties for licensing deals worth up to $5 billion in potential fees, including a targeted cancer therapy and other novel drug candidates.
  • The announcement came after disappointing Q1 2024 results showing a 21.91% revenue drop to 7.02 billion yuan and 8.36% decline in net profit to 1.48 billion yuan.
  • The company has already completed two major licensing deals this year, including a $150 million upfront payment from BeiGene and a $15 million deal with Radiance Biopharma.
  • Chinese biotech licensing deals with multinational partners are surging, with lawyers reporting at least seven deals in 2023 and five already identified in 2024.

GC Biopharma's Hunterase Shows Significant Efficacy in Phase 3 Trial for Hunter Syndrome

Rare Disease
  • GC Biopharma's Phase 3 clinical trial results for Hunterase (idursulfase beta) in Hunter Syndrome patients have been published in Genetics in Medicine, demonstrating significant improvements in functional mobility and metabolic markers.
  • The study enrolled 24 newly diagnosed Hunter Syndrome patients and showed that Hunterase treatment resulted in patients walking an average of 62.2 meters more in the 6-Minute Walk Test, eight times greater improvement than placebo.
  • Secondary endpoints revealed substantial reductions in urinary GAG levels (71%), heparan sulfate (89%), dermatan sulfate (88%), and organ volumes, with liver and spleen volumes decreasing by 27% and 26% respectively.
  • The treatment demonstrated a favorable safety profile with only 19% of patients developing neutralizing antibodies, significantly lower than the 62.5% observed with existing treatments.

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