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Riliprubart Shows Promise as First-in-Class Treatment for Chronic Inflammatory Demyelinating Polyneuropathy

Rare DiseaseNeurologyMonoclonal Antibody
  • Sanofi's riliprubart demonstrated significant disease-controlling benefits across all patient cohorts in a Phase 2 study for chronic inflammatory demyelinating polyneuropathy (CIDP), including those who failed standard treatments.
  • The complement C1s inhibitor showed sustained efficacy for up to 48 weeks, with 87-92% of participants experiencing improvement or disease stabilization after 24 weeks of treatment.
  • Riliprubart reduced neurofilament light chain levels by 35% across all cohorts, suggesting potential reduction in nerve damage, while also improving patient-reported fatigue and quality of life outcomes.

A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work

NCT06290128RecruitingPhase 3
Sanofi
Posted 7/12/2024

A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

NCT06290141RecruitingPhase 3
Sanofi
Posted 8/21/2024

InnoCare Advances Dual Regulatory Milestones with Tafasitamab BLA Acceptance and BCL2 Inhibitor ICP-248 Clinical Trial Approval in China

Monoclonal AntibodyDrug Approval
  • China's NMPA has accepted and granted priority review to InnoCare's biologics license application for tafasitamab plus lenalidomide combination therapy for relapsed or refractory diffuse large B-cell lymphoma patients ineligible for stem cell transplant.
  • The company received separate approval to initiate clinical trials of its novel BCL2 inhibitor ICP-248 in combination with azacitidine for acute myeloid leukemia treatment in China.
  • DLBCL represents the most common non-Hodgkin lymphoma type globally, accounting for 45.8% of all NHL cases in China, highlighting significant unmet medical need.
  • These regulatory advances strengthen InnoCare's hemato-oncology pipeline with complementary mechanisms targeting CD19 and BCL2 pathways across different blood cancer indications.

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

NIH's Novel Five-Drug Combination Shows Promise for Relapsed Aggressive B-Cell Lymphoma

Targeted TherapyOncologyMonoclonal Antibody
  • NIH researchers have developed ViPOR, a non-chemotherapy five-drug regimen that achieved complete remission in 38% of patients with relapsed or refractory diffuse large B-cell lymphoma.
  • The treatment was particularly effective in two specific subtypes: non-GCB DLBCL (62% complete response) and double-hit GCB DLBCL (53% complete response), offering new hope for patients with limited options.
  • At the two-year mark, 36% of all treated patients were still alive and 34% remained disease-free, with some maintaining remission beyond four years despite previously facing poor prognoses.

Formycon Advances Phase III Trial for Keytruda Biosimilar FYB206 in Non-Small Cell Lung Cancer

Monoclonal Antibody
  • Formycon AG has enrolled the first patient in its Phase III "Lotus" trial comparing FYB206 with Keytruda in non-small cell lung cancer patients.
  • The double-blind, multicenter study will evaluate best overall response rate over 17 treatment cycles within 52 weeks, followed by an additional 12 months of therapy.
  • FYB206 targets the world's best-selling drug Keytruda, which generated $25 billion in sales in 2023 and could reach $30 billion by 2026.
  • The biosimilar candidate is expected to enter the market after Keytruda's exclusivity expires in 2029 (USA) and 2030 (EU), with Phase III results anticipated in 2027.

Leqembi's Slow Adoption: Challenges and Progress in Alzheimer's Treatment

Monoclonal AntibodyDrug ApprovalNeurology
  • Leqembi, the first FDA-approved drug shown to slow Alzheimer's progression, has experienced slower-than-expected adoption despite its groundbreaking status in treating the disease.
  • Healthcare systems face significant implementation challenges, including establishing diagnostic protocols, monitoring systems for side effects, and navigating complex insurance coverage issues for the $26,000-per-year treatment.
  • Despite modest clinical benefits and potential side effects like brain swelling and bleeding, some patients report improvements in short-term memory, offering hope as researchers continue developing easier administration methods and complementary treatments.

Bispecific Antibodies Show Promise in Multiple Myeloma Treatment Across Different Patient Populations

OncologyCAR-TMonoclonal Antibody
  • Talquetamab demonstrated a 71.4% objective response rate and 28.6% complete response rate in heavily pretreated relapsed/refractory multiple myeloma patients, including those with poor functional status and prior CAR-T therapy.
  • The teclistamab combination with daratumumab and lenalidomide achieved a 92.3% overall response rate and 80.8% complete response rate in newly diagnosed multiple myeloma patients ineligible for transplant.
  • Both bispecific antibody treatments showed manageable safety profiles with cytokine release syndrome as the primary toxicity, though infection risk requires careful monitoring and prophylaxis.
  • These findings expand treatment options for multiple myeloma patients across the disease spectrum, from newly diagnosed to heavily pretreated cases.

Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT03399799Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/16/2017

A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma

NCT05552222RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/25/2022

Sandoz Launches First Ustekinumab Biosimilar Autoinjector in Europe with Pyzchiva

Monoclonal Antibody
  • Sandoz has launched Pyzchiva (ustekinumab) as the first ustekinumab biosimilar autoinjector commercially available in Europe, developed by Samsung Bioepis.
  • The biosimilar is approved to treat multiple chronic inflammatory conditions including plaque psoriasis, psoriatic arthritis, Crohn's disease, and pediatric plaque psoriasis in patients aged six and older.
  • The autoinjector features automatic dosing, reduced injection pain, compact design, and flexible storage options to potentially improve treatment adherence for chronic inflammatory diseases.
  • Pyzchiva has launched in 23 European markets with the autoinjector now available in Spain, representing a strategic milestone for Sandoz's immunology biosimilar portfolio.

EMA Validates Marketing Applications for HLX14 Denosumab Biosimilar in Osteoporosis Treatment

Monoclonal Antibody
  • The European Medicines Agency has validated marketing authorization applications for HLX14, an investigational biosimilar to denosumab (Prolia/Xgeva) developed by Shanghai Henlius Biotech and Organon for osteoporosis treatment.
  • The applications are supported by positive phase 3 trial data showing HLX14 met both primary efficacy and pharmacodynamic endpoints when compared to reference denosumab in postmenopausal women with osteoporosis.
  • With an estimated 32 million Europeans aged 50 or above having osteoporosis in 2019, including 25.5 million women, this biosimilar could provide expanded treatment access for this significant patient population.

A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture

NCT05352516Active, Not RecruitingPhase 3
Shanghai Henlius Biotech
Posted 6/17/2022

Outlook Therapeutics Advances ONS-5010 Toward Potential First Approved Ophthalmic Bevacizumab for Retinal Diseases

Monoclonal Antibody
  • Outlook Therapeutics received a positive opinion from the European Medicines Agency's CHMP for ONS-5010/LYTENAVA™ (bevacizumab gamma) for wet AMD treatment, with European Commission decision expected in Q2 2024.
  • The company has submitted a Marketing Authorization Application in the UK and is progressing with the NORSE EIGHT clinical trial in the US, with over 30% of subjects enrolled and topline results expected in Q4 2024.
  • If approved, ONS-5010 would be the first authorized ophthalmic formulation of bevacizumab for treating retinal diseases, potentially launching in the EU and UK in early 2025 and in the US later that year.

Blackstone Launches Uniquity Bio with $300M to Advance Anti-TSLP Therapy for Asthma and COPD

Monoclonal Antibody
  • Blackstone Life Sciences has launched Uniquity Bio with up to $300 million in funding to develop solrikitug, a monoclonal antibody targeting TSLP for immune and inflammatory conditions.
  • The company will begin Phase 2 clinical trials in chronic obstructive pulmonary disease and asthma within the next month, targeting diseases that affect millions globally.
  • Solrikitug was in-licensed from Merck and is positioned as a highly potent anti-TSLP antibody that could address significant unmet medical needs in respiratory and gastrointestinal indications.
  • The global immunology market is projected to grow from $98 billion in 2023 to $257 billion in 2032, highlighting the commercial potential of this therapeutic area.

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