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InnoCare Presents Promising Clinical Data for Multiple Oncology Pipeline Candidates at Major Medical Conferences

Monoclonal Antibody
  • InnoCare presented clinical data for multiple oncology pipeline candidates at the 2025 ASCO Annual Meeting and EHA 2025 Congress, demonstrating significant therapeutic potential across various cancer types.
  • The BCL2 inhibitor mesutoclax (ICP-248) showed 100% overall response rates in both BTK-naïve chronic lymphocytic leukemia and mantle cell lymphoma patients, with combination therapy achieving 97.6% response rates in treatment-naïve patients.
  • The pan-TRK inhibitor zurletrectinib (ICP-723) demonstrated 100% confirmed response rates in pediatric patients with NTRK fusion-positive solid tumors and 83.7% response rates in adult patients.
  • The anti-CCR8 antibody ICP-B05 achieved 33.3% partial response rates in relapsed/refractory cutaneous T-cell lymphoma patients, with an 82.5% six-month progression-free survival rate.

Atezolizumab Plus Chemotherapy Reduces Recurrence Risk by 50% in Stage III dMMR Colon Cancer

Monoclonal AntibodyOncology
  • The phase 3 ATOMIC trial demonstrated that adding atezolizumab to standard chemotherapy reduced the risk of recurrence or death by 50% in patients with stage III dMMR colon cancer.
  • Three-year disease-free survival improved significantly from 76.6% with chemotherapy alone to 86.4% with the combination treatment across 712 patients.
  • This represents the first successful immunotherapy adjuvant study in colon cancer and establishes a new standard of care for this patient population.
  • The safety profile was manageable, with only a slight increase in nonfebrile neutropenia compared to known profiles of each individual treatment.

Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient DNA mismatch repair (ATOMIC)

2024-517269-18-00Active, Not RecruitingPhase 3
National Cancer Institute, AIO-Studien gGmbH
Posted 10/16/2017

AstraZeneca Advances AZD0022, Novel Oral KRASG12D Inhibitor, in First-in-Human Phase I/IIa Trial

Monoclonal AntibodyTargeted TherapyOncology
  • AstraZeneca is developing AZD0022, a potent oral KRASG12D-selective inhibitor that demonstrates robust pathway inhibition and anti-tumor activity in preclinical models.
  • The drug is currently being investigated in the ALAFOSS-01 study, a first-in-human Phase I/IIa trial for patients with KRASG12D-mutated solid tumors.
  • Preclinical data shows enhanced therapeutic responses when AZD0022 is combined with cetuximab, with sustained tumor regressions observed in colorectal and pancreatic cancer models.
  • The clinical trial includes both monotherapy and combination therapy modules, targeting multiple cancer types including colorectal, lung, and pancreatic cancers.

A trial to learn how safe AZD0022 is, how well it works, and how it moves throughout the body over time in adults with tumors that have a KRAS-G12D mutation, when given alone and with other cancer drugs

2024-516699-14-00RecruitingPhase 1/2
AstraZeneca AB
Posted 10/18/2024

Dual Immunotherapy Combination Significantly Extends Survival in Advanced Cutaneous Squamous Cell Carcinoma

Monoclonal AntibodyOncology
  • A phase II clinical trial demonstrated that combining avelumab and cetuximab nearly quadrupled median progression-free survival compared to avelumab alone in patients with advanced cutaneous squamous cell carcinoma.
  • The combination therapy achieved a median progression-free survival of 11.1 months versus 3.0 months for avelumab monotherapy, with a hazard ratio of 0.48 and statistical significance.
  • The study enrolled 57 evaluable patients with advanced cSCC, showing that dual immunotherapy targeting both PD-L1 and EGFR pathways creates synergistic anti-tumor effects.
  • Results provide valuable insights for future trials combining standard-of-care immunotherapies with cetuximab to improve outcomes in this aggressive skin cancer.

Avelumab with or Without Cetuximab in Treating Patients with Advanced Skin Squamous Cell Cancer

NCT03944941Active, Not RecruitingPhase 2
Alliance for Clinical Trials in Oncology
Posted 6/17/2019

Frontotemporal Dementia Therapeutics Enter New Era as Gene and Antibody Therapies Advance Toward Market

Monoclonal AntibodyOrphan DrugPrecision Medicine
  • Alector's Latozinemab (AL001) leads the frontotemporal dementia pipeline as a monoclonal antibody targeting progranulin deficiency, currently in pivotal Phase III trials with potential approval by 2026-2027.
  • Gene therapy companies AviadoBio and Passage Bio are developing AAV-based treatments AVB-101 and PBFT02 to restore progranulin expression through one-time administration, with readouts expected in late 2027 or early 2028.
  • The FTD therapeutic landscape is shifting from symptom management to disease modification, with multiple approaches including monoclonal antibodies, gene therapies, and oral small molecules targeting genetic biomarkers.
  • By 2028, the FTD market may include personalized therapies aligned with genetic profiles, potentially transforming clinical outcomes for patients aged 45-64 who currently lack disease-modifying treatment options.

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.

Itepekimab Shows Mixed Results in Phase 3 COPD Trials, Meeting Primary Endpoint in One of Two Studies

Monoclonal Antibody
  • The AERIFY-1 phase 3 trial met its primary endpoint, demonstrating a statistically significant 27% reduction in moderate or severe COPD exacerbations at week 52 in former smokers treated with itepekimab compared to placebo.
  • The AERIFY-2 phase 3 trial failed to meet the same primary endpoint despite showing early benefits, with only a 2% reduction in exacerbations at week 52 for the every-two-week dosing regimen.
  • Itepekimab demonstrated a favorable safety profile across both trials, with adverse event rates comparable to placebo and consistent with previous clinical studies.
  • Sanofi and Regeneron are reviewing the data and plan to discuss next steps with regulatory authorities to evaluate the path forward for this IL-33 targeting monoclonal antibody.

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

NCT04701983Active, Not RecruitingPhase 3
Sanofi
Posted 12/16/2020

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

NCT04751487Active, Not RecruitingPhase 3
Sanofi
Posted 2/12/2021

Investigational Monoclonal Antibody TB006 Shows Promise in Reversing Alzheimer's Disease Through Galectin-3 Targeting

Monoclonal Antibody
  • TB006, an investigational monoclonal antibody developed by TrueBinding, Inc., targets galectin-3 protein and has shown potential to reverse Alzheimer's disease in studies.
  • The drug is currently available through the FDA's Expanded Access Program for eligible Alzheimer's patients with no other treatment options, with only seven doctors in Texas authorized to administer it.
  • TB006 is also being investigated for treating Parkinson's disease and Autism Spectrum Disorder, with reported improvements in patients with these conditions.
  • The treatment costs $5,000 per month for four monthly treatments totaling $20,000, though insurance coverage is hoped for in the future.

Beyfortus Demonstrates Superior Real-World Efficacy Against RSV Compared to Maternal Vaccination

Monoclonal AntibodyReal World Evidence
  • Sanofi's Beyfortus reduced infant RSV hospitalizations by 69% in Spain's immunization program, significantly outperforming the UK's maternal RSVpreF vaccination program which achieved only 26.7% reduction.
  • New durability data from the HARMONIE Phase 3b study show Beyfortus maintained 82.7% efficacy against RSV hospitalizations through six months, exceeding the typical five-month RSV season length.
  • The REACH study represents the first multi-country public health impact analysis comparing different RSV prevention strategies, providing crucial real-world evidence for infant immunization programs.
  • With over six million infants immunized across 40 studies spanning four continents, Beyfortus has established the largest body of real-world evidence for infant RSV protection.

Disc Medicine Presents Comprehensive Hematology Portfolio Data at EHA 2025 Congress

Monoclonal Antibody
  • Disc Medicine will present data from multiple hematology programs at the European Hematology Association 2025 Congress, including long-term extension trial results for bitopertin in erythropoietic protoporphyria.
  • The company will showcase additional durability data from Phase 1b studies of DISC-0974 in myelofibrosis anemia patients and new data from DISC-3405 studies in healthy volunteers.
  • Management plans to host a corporate update conference call on June 16 to review the presented data as the company progresses toward major milestones in the second half of 2025.

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