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Breakthrough Immunotherapy Combination Shows Promise Against Common Colorectal Cancer in Phase 1 Trial

Monoclonal Antibody
  • A phase 1 trial of 148 patients demonstrated that the combination of botensilimab and balstilimab immunotherapy drugs successfully treated microsatellite stable metastatic colorectal cancer, the most common form that has historically not responded to immunotherapy.
  • The study found that 61% of patients experienced tumor shrinkage or stabilization after six months of treatment, marking the first time consistent and durable responses to immunotherapy have been reported in this difficult-to-treat patient population.
  • The treatment was well-tolerated with common side effects including diarrhea and fatigue, and showed particular effectiveness in patients without liver metastases.
  • Agenus Inc. is planning to seek FDA approval and has initiated a phase 3 clinical trial, potentially offering new hope for colorectal cancer patients who face limited treatment options.

Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

NCT03860272Active, Not RecruitingPhase 1
Agenus Inc.
Posted 3/20/2019

Global Breast Cancer Therapeutics Market Expected to Reach $78.61 Billion by 2033

OncologyTargeted TherapyMonoclonal AntibodyAIPrecision MedicineDrug Approval
• The global breast cancer therapeutics market, valued at $32.93 billion in 2023, is projected to reach $78.61 billion by 2033, growing at a CAGR of 9.09% over the next decade.
• North America dominates the market with a 38.61% revenue share, driven by high breast cancer prevalence and presence of key pharmaceutical companies including Pfizer, Roche, and Novartis.
• Targeted therapies hold the largest market segment at 64.85%, with hormone receptor-positive treatments accounting for 66.97% of the market as precision medicine approaches gain traction.

Novartis' Ianalumab Advances in Phase 3 Trial for Lupus Nephritis as CDSCO Approves Protocol Amendment

Monoclonal Antibody
  • India's CDSCO expert committee has approved Novartis' protocol amendment for the Phase 3 SIRIUS-LN trial evaluating ianalumab in patients with active lupus nephritis.
  • Ianalumab is a novel BAFF-targeting monoclonal antibody that prevents BAFF signaling through its receptor and depletes BAFF-R-expressing B-cells through antibody-dependent cellular cytotoxicity.
  • The approval follows Novartis' presentation of protocol amendment version 03 dated December 14, 2023, potentially accelerating the development pathway for this investigational therapy for autoimmune conditions.

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 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

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

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.

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

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

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.

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