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Cantargia's Nadunolimab Receives FDA Fast Track Designation for Metastatic Pancreatic Cancer

Monoclonal AntibodyOncology
  • The FDA has granted Fast Track Designation to nadunolimab, Cantargia's anti-IL1RAP antibody, for treating previously untreated metastatic pancreatic ductal adenocarcinoma with high IL1RAP expression levels.
  • The designation follows strong clinical data from the CANFOUR study showing 35% two-year survival, 14.2 months overall survival, and 48% overall response rate in patients with high IL1RAP expression.
  • Fast Track Designation provides benefits including more frequent FDA meetings, eligibility for Accelerated Approval and Priority Review, and rolling review opportunities for the Biologic License Application.
  • The recognition addresses the high unmet medical need in metastatic pancreatic cancer, where current treatment options are limited and overall survival after first-line treatment is typically less than 12 months.

A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors

NCT03267316CompletedPhase 1
Cantargia AB
Posted 9/19/2017

Nadunolimab in Combination with Gemcitabine Plus Carboplatin in Patients with Advanced Triple Negative Breast Cancer.

NCT05181462Active, Not RecruitingPhase 1
Cantargia AB
Posted 1/11/2022

Memo Therapeutics Demonstrates Therapeutic Antibodies Can Cross Kidney Barrier, Supporting BK Virus Treatment Approach

Monoclonal Antibody
  • Memo Therapeutics published research in Frontiers in Pharmacology showing that intravenously administered therapeutic IgG antibodies can cross the kidney endothelial barrier and be detected in urine.
  • The study found that 0.015% (median) of serum rituximab concentration appears in urine, with levels reaching up to 4.2%, challenging previous assumptions about size-exclusion limitations.
  • These findings provide scientific support for the dosing strategy of potravitug, MTx's investigational anti-BK polyomavirus antibody currently in Phase II trials for kidney transplant recipients.
  • BKV nephropathy affects up to 70% of kidney transplant recipients with established BK viremia and is associated with compromised graft function and reduced long-term survival.

BioInvent's BI-1206 Shows Promising Phase 1 Results in Combination with Pembrolizumab for Solid Tumors

Monoclonal AntibodyOncology
  • BioInvent's Phase 1 study of BI-1206 combined with pembrolizumab demonstrated encouraging clinical activity in heavily pre-treated solid tumor patients, with one complete response and one partial response among 36 evaluable patients.
  • The combination therapy was well-tolerated and showed potential to overcome resistance mechanisms to anti-PD-1 treatment by targeting FcγRIIB expressing immune cells.
  • Based on these promising results, BioInvent plans to initiate Phase 2a expansion cohorts in H2 2025 for treatment-naïve patients with advanced NSCLC and uveal melanoma.
  • The study supports transitioning from intravenous to subcutaneous formulation of BI-1206, which may enhance therapeutic impact and improve safety profiles.

A Study of BI-1206 in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors (KEYNOTE-A04)

NCT04219254RecruitingPhase 1
BioInvent International AB
Posted 6/29/2020

Hemab Therapeutics Advances Bleeding Disorder Pipeline with Promising Clinical Data at ISTH 2025

Monoclonal AntibodyOrphan Drug
  • Sutacimig (formerly HMB-001) demonstrates promising interim Phase 2 safety and efficacy results for Glanzmann thrombasthenia, receiving WHO International Non-Proprietary Name designation.
  • HMB-002 shows initial proof of mechanism clinical data in Von Willebrand disease patients through the ongoing VELORA Pioneer study, supported by comprehensive preclinical data.
  • Natural history studies reveal significant disease burden, with 88% of Glanzmann thrombasthenia patients reporting at least one bleed weekly and 34% requiring medical treatment.
  • Hemab will present 11 abstracts across multiple bleeding disorder programs at the International Society on Thrombosis and Haemostasis Congress in Washington, DC.

A Study Assessing HMB-002 in Participants With Von Willebrand Disease

NCT06754852RecruitingPhase 1
Hemab ApS
Posted 2/6/2025

A Study of Bleeding and Treatment in Participants With Von Willebrand Disease

NCT06610201Recruiting
Hemab ApS
Posted 8/30/2024

A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann Thrombasthenia

NCT06211634Active, Not RecruitingPhase 1
Hemab ApS
Posted 12/13/2022

FDA Approves Merck's ENFLONSIA for RSV Prevention in Infants with Single Weight-Independent Dose

Drug ApprovalMonoclonal Antibody
  • The U.S. FDA has approved Merck's ENFLONSIA (clesrovimab-cfor), a long-acting monoclonal antibody for preventing RSV lower respiratory tract disease in newborns and infants entering their first RSV season.
  • ENFLONSIA demonstrated a 60.5% reduction in RSV-associated medically attended lower respiratory infections and an 84.3% reduction in RSV-related hospitalizations compared to placebo in the pivotal CLEVER trial.
  • The therapy offers the first weight-independent dosing approach for RSV prevention, using a single 105 mg dose regardless of infant weight to provide protection through a typical 5-month RSV season.
  • Ordering is expected to begin in July 2025, with shipments delivered before the 2025-2026 RSV season, pending CDC Advisory Committee recommendations later this month.

Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)

NCT04767373CompletedPhase 2
Merck Sharp & Dohme LLC
Posted 4/7/2021

Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

NCT04938830Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 11/30/2021

Scottish Health Authority Rejects Alzheimer's Drug Donanemab Despite UK Regulatory Approval

Monoclonal Antibody
  • The Scottish Medicines Consortium rejected donanemab (Kisunla) for NHS Scotland use, citing uncertainty around the drug's modest clinical benefit despite UK regulatory approval in October.
  • This marks the second Alzheimer's drug rejection by Scottish authorities in three months, following a similar decision on lecanemab (Leqembi).
  • Alzheimer Scotland advocates are calling for a specialized Dementia Drugs Fund and reformed assessment processes, arguing current evaluation methods are inadequate for addressing the UK's leading cause of death.
  • Donanemab works by targeting amyloid protein buildup in the brain through antibody infusions, potentially slowing Alzheimer's progression by up to two years in some cases.

Axio BioPharma and Likarda Form Strategic Partnership to Integrate AI Manufacturing with Advanced Drug Delivery

Monoclonal Antibody
  • Axio BioPharma and Likarda announced a strategic partnership combining AI-powered protein manufacturing with advanced drug delivery technologies to accelerate biologic drug development timelines.
  • The collaboration integrates Likarda's Core-Shell Spherification® hydrogel technology for encapsulation and controlled release with Axio's discovery-to-GMP manufacturing capabilities.
  • The partnership aims to enhance workflows for monoclonal antibodies, bispecifics, and Fc-fusions while providing clients with more efficient and scalable paths to clinical manufacturing.
  • Both companies emphasize integrating delivery technologies earlier in the development process to improve stability, efficacy, and patient outcomes while reducing development friction.

Pharmacist-Led Interventions Generate $9 Million in Cancer Care Cost Savings Through Remote Clinical Reviews

Monoclonal Antibody
  • Clinical review pharmacists at The US Oncology Network identified 1,271 cost-saving interventions across 5,600 patients, with 1,180 accepted interventions generating nearly $9 million in total cost of care reductions.
  • The initiative focused on six primary strategies including pembrolizumab dose banding, monoclonal antibody dose rounding, and biosimilar therapeutic interchange, with drug costs representing 63% of patient total cost of care.
  • Each clinical review pharmacist position cost approximately $25,000 but delivered significant financial returns while streamlining medication protocols and saving provider time in value-based care models.
  • Research from University of California San Diego revealed that 9% of inpatient chemotherapy treatments were due to transportation or housing barriers, resulting in over $7 million in potentially avoidable hospital costs over five years.

High Placebo Response Rates Challenge Lupus Drug Development as Researchers Develop New Trial Strategies

Monoclonal Antibody
  • High placebo response rates of approximately 40% in systemic lupus erythematosus trials are obscuring the true efficacy of investigational biologics, as patients continue receiving powerful background medications like glucocorticoids and hydroxychloroquine.
  • Researchers have identified four core strategies to address the "placebo problem," including stabilizing background therapy, applying central expert review, controlling rescue therapy, and acknowledging evolving standard-of-care treatments.
  • New trial design innovations include enriching study populations with high-disease-activity patients, employing more stringent sustained endpoints, and implementing adaptive features to better detect drug efficacy signals.
  • Clinical practice approaches now focus on realistic patient expectations for biologics like belimumab and anifrolumab, emphasizing gradual benefit timelines of 3-4 months and steroid-sparing goals rather than miracle cures.

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

NCT00410384CompletedPhase 3
Human Genome Sciences Inc.
Posted 12/1/2006

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

NCT01649765Active, Not RecruitingPhase 2
GlaxoSmithKline
Posted 9/7/2012

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

NCT00424476CompletedPhase 3
Human Genome Sciences Inc.
Posted 5/1/2007

A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

NCT00137969CompletedPhase 2
Genentech, Inc.
Posted 5/10/2005

PCI Pharma Services Unveils Advanced Sterile Manufacturing Facility to Boost Biologic Production Capacity

Monoclonal Antibody
  • PCI Pharma Services is launching a new 50,000-square-foot sterile fill-finish facility in Bedford, NH, expected to reach full GMP production by summer 2025.
  • The facility features high-speed integrated fillers capable of producing up to 300,000 vials at speeds of 400 per minute, with twin 430-square-foot lyophilizers and fully isolated containment systems.
  • This marks PCI's third high-throughput sterile fill-finish facility built since 2021, enhancing capacity for late-phase clinical and commercial biologic drugs including monoclonal antibodies and fusion proteins.
  • The company is also establishing a Development Center of Excellence at the Bedford campus, expected to be operational by early 2026, handling both small molecules and biologics including antibody-drug conjugates.

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