Clinical Trials
32
11 active
Approvals
2
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
Active, not recruiting
11
34.4%
Completed
11
34.4%
Recruiting
6
18.8%
Terminated
4
12.5%
- An international research consortium led by VIB and Ghent University has developed a novel genetically engineered mouse model that accurately replicates human Fc gamma receptor biology, addressing critical limitations in antibody drug testing. - The platform solves the problem of species differences in immune responses that have led to costly late-stage clinical failures and unexpected safety issues, including dangerous blood clotting risks that were previously undetectable in standard preclinical models. - The new system enables head-to-head comparisons of antibody variants and provides more reliable early-stage data, potentially reducing development costs and accelerating delivery of effective treatments to patients. - Published in Science Immunology, this breakthrough aligns with FDA expectations for more sophisticated preclinical models and represents a collaboration between VIB-Ghent University, argenx, genOway, and Innate Pharma.
- Innate Pharma announced FDA clearance to proceed with TELLOMAK 3, a confirmatory Phase 3 trial of lacutamab in patients with Sézary syndrome and Mycosis fungoides who failed prior systemic therapy. - The randomized, open-label study will compare lacutamab against standard treatments with progression-free survival as the primary endpoint, targeting trial initiation in H1 2026. - FDA provided encouraging feedback on a potential accelerated approval pathway for Sézary syndrome once the Phase 3 trial is underway, building on positive Phase 2 data. - Lacutamab is a first-in-class anti-KIR3DL2 antibody that has received multiple regulatory designations including Fast Track, PRIME, Orphan Drug, and Breakthrough Therapy status.
- Innate Pharma will host an investor event on October 28, 2025, to discuss lacutamab's path to potential accelerated approval in Sézary syndrome based on Phase 2 TELLOMAK trial data. - The first-in-class anti-KIR3DL2 antibody has received FDA Fast Track, EMA PRIME, and Breakthrough Therapy designations for treating cutaneous T-cell lymphoma patients with high unmet medical needs. - Real-world claims data reveals a larger eligible CTCL patient population in the U.S. than previously reported, strengthening the commercial opportunity as the company prepares for Phase 3 initiation.
- Innate Pharma received FDA Breakthrough Therapy Designation for lacutamab in Sézary syndrome and is nearing completion of Phase 3 trial protocol preparation following regulatory discussions. - The company's Nectin-4 ADC IPH4502 is progressing through Phase 1 enrollment with first patient data expected in H1 2026, while AstraZeneca's PACIFIC-9 trial with monalizumab completed enrollment. - Innate plans to reduce staffing by approximately 30% and focus resources on three highest-value assets: IPH4502, lacutamab, and monalizumab, with cash runway extending to Q3 2026. - Sanofi invested €15 million in new equity while the company reported €70.4 million in cash position as of June 30, 2025.
- The first tetraspecific antibody approval is expected by 2029, marking a significant milestone in multispecific immunotherapy development. - Sichuan Baili Pharmaceutical's Emfizatamab is currently in Phase II trials for hematological malignancies, representing a leading candidate in the field. - The bispecific antibody market has already exceeded $10 billion, with tetraspecific antibodies expected to capture even greater market share due to their enhanced targeting capabilities. - China and the USA are dominating the tetraspecific antibody clinical development landscape, with multiple companies advancing candidates through trials.
- A comprehensive 2025 market report analyzes the global clinical trial landscape for mycosis fungoides, providing insights into trial distribution across regions and phases. - Major pharmaceutical companies including Pfizer, Bristol-Myers Squibb, Johnson & Johnson, and Novartis are actively participating in mycosis fungoides therapeutic development. - Recent clinical developments include Innate Pharma's durable responses with lacutamab and BioInvent's FDA Fast Track designation for BI-1808 in cutaneous T-cell lymphoma treatment. - The report covers enrollment trends over five years and provides strategic analysis for investment decisions in this rare cancer indication.
- Innate Pharma's IPH6501, a tetraspecific NK cell engager targeting CD20 B cells for Non-Hodgkin Lymphoma, will be featured at the European Hematology Association Congress in June 2025. - The ANKET® platform technology represents a new class of cancer immunotherapies that co-engage multiple receptors on NK cells while targeting tumor antigens, potentially offering superior efficacy to existing antibody treatments. - Preclinical data has shown IPH6501 demonstrates better anti-tumor efficacy than approved benchmark antibodies, with the compound currently being evaluated in a Phase 1/2 trial for relapsed/refractory CD20-expressing B-cell lymphomas.
- CD39-targeted therapies are emerging as a promising strategy to modulate immune responses in various diseases by influencing the purinergic signaling pathway. - Inhibition of CD39 activity may restore immune functionality and improve patient outcomes in oncology, chronic viral infections, autoimmune disorders, and sepsis. - Several CD39-targeting therapies are progressing through clinical trials, with IPH5201 being a leading candidate showing encouraging outcomes in early-phase investigations. - The integration of anti-CD39 antibodies with other treatments may offer synergistic effects, but challenges remain in balancing immune activation and suppression.
- Innate Pharma has initiated a Phase 1 clinical trial (NCT06781983) to evaluate the safety and tolerability of IPH4502 in patients with advanced solid tumors expressing Nectin-4. - IPH4502 is a novel antibody-drug conjugate (ADC) that targets Nectin-4, a cell adhesion molecule overexpressed in various solid tumors, including urothelial carcinoma and lung cancer. - The Phase 1 trial is an open-label, multi-center study that includes dose escalation and optimization phases, aiming to enroll approximately 105 patients with different types of advanced solid tumors. - Preclinical data suggest that IPH4502 is well-tolerated and demonstrates anti-tumor activity, offering a potential new therapeutic option for patients with limited treatment options.
- Innate Pharma and the Institute for Follicular Lymphoma Innovation (IFLI) have entered into an agreement to clinically study IPH6501 in follicular lymphoma. - IFLI will invest an initial $3 million in Innate shares, with potential additional investments up to $4.9 million based on milestone achievements. - The collaboration will expand Innate’s Phase 1/2 trial of IPH6501 to include patients with relapsed/refractory follicular lymphoma. - IPH6501, an anti-CD20 ANKET®, is being investigated for safety, tolerability, and preliminary antineoplastic activity in CD20-expressing Non-Hodgkin Lymphoma.
