CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [4]

Active Indication

Multiple MyelomaIdiopathic Membranous GlomerulonephritisGlomerulonephritis, IGA+ [6]

Inactive Indication

Renal transplant rejection

Originator Organization

MorphoSys AG

Active Organization

Human Immunology Biosciences, Inc.

Biogen, Inc.

TJ Biopharma Hangzhou Co Ltd

+ [3]

Inactive Organization-

License Organization

Human Immunology Biosciences, Inc.

Biogen, Inc.I-MAB Biopharma Co., Ltd.

+ [4]

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union)

Structure/Sequence

Sequence Code 616722725H

Source: *****

Sequence Code 616722726L

Source: *****

Clinical Trials associated with Felzartamab

NCT07444489

/ Enrolling by invitationPhase 3

An Open-Label Long-Term Extension Study for Participants From the 299AR301 Felzartamab Study

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and then developed a condition called antibody-mediated rejection (AMR). AMR happens when the body's immune system creates antibodies that attack the transplanted kidney. In late AMR, this happens more than 6 months after the kidney transplant. It can lead to serious kidney problems over time.
An earlier study called 299AR301 (TRANSCEND) (NCT06685757) began in 2024 and is investigating felzartamab in participants with AMR. It includes a treatment period of about 1 year. It first compares treatment with felzartamab to placebo for about 6 months and then all participants are given felzartamab to complete the study. This study, 299AR301 LTE, is a long-term extension of the parent study 299AR301. Participants who join this study will have the opportunity to receive felzartamab for up to 4 more years.
The goals of this study are to learn more about the long-term safety and effects of felzartamab in people with AMR. This study is part of a group of studies looking at long-term felzartamab use in people with organ transplants. This study is a substudy of the main study 299AR302.
The main question researchers will answer relate to safety. Namely, how many participants have adverse events during the study and how lab test results change over time. Adverse events are health problems that may or may not be caused by the study drug.
Researchers will perform kidney biopsies to track kidney health. Researchers will also study how felzartamab affects kidney inflammation, kidney function, immune activity, and overall health.
The study will be done as follows:
* Participants who complete the final visit of the treatment period in the parent study can enroll in this study. This includes participants who stopped receiving felzartamab early but still attended their final visits.
* Participants who did not stop receiving felzartamab in the parent study will continue to receive felzartamab for up to 4 more years in this study. Participants may also stop felzartamab during this study at any time.
* Participants who stopped receiving felzartamab in the parent study will only attend study visits for health monitoring- they will not receive felzartamab.
* Felzartamab will be given as an intravenous (IV) infusion, which is a slow injection into a vein using a needle.
* Participants receiving felzartamab may have up to 27 study visits over 200 weeks with an additional safety follow-up visit 4 weeks after their final dose.
* Participants who are not receiving felzartamab may have up to 9 study visits over 200 weeks.

Start Date16 Apr 2026

Sponsor / Collaborator

Biogen, Inc.

NCT07219043

/ RecruitingPhase 2

A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Recipients of Kidney Transplants With Late Isolated Microvascular Inflammation (MVI)

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body. It can lead to serious kidney problems over time.
In many cases, MVI is caused by antibodies that attack the transplanted kidney. But in some people, MVI happens without these antibodies. This type of MVI is called isolated MVI. There are currently no approved treatments for isolated MVI.
The main goal of the study is to learn about the effect felzartamab has on inflammation in the transplanted kidney. The main question researchers want to answer is:
• How many participants have no signs of active inflammation in the transplanted kidney after 24 weeks of treatment with felzartamab?
Researchers will also study how felzartamab affects kidney function, immune activity, and overall health. They will monitor safety through kidney biopsies, lab tests, and by recording adverse events throughout the study.
Adverse events are health problems that may or may not be caused by the study drug.
The study will be done in 2 parts as follows:
* Participants will be randomly assigned to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
* In Part A, participants will receive their assigned drug for 24 weeks. Neither the researchers nor the participants will know who is receiving felzartamab or placebo.
* Part B will last another 28 weeks. All participants will receive felzartamab and both participants and researchers will know this.
* All treatments will be given by intravenous (IV) infusion at the study site.
* Participants will have kidney biopsies at the start of the study, at Week 24, and at Week 52 to help measure changes in inflammation.
* Participants will stay in the study for about 1 year.

Start Date05 Jan 2026

Sponsor / Collaborator

Biogen, Inc.

NCT06962800

/ RecruitingPhase 3

An Open-Label, Multicenter, Randomized Phase 3 Study Evaluating the Efficacy and Safety of Felzartamab in Participants With Primary Membranous Nephropathy (PMN) [PROMINENT]

In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney. Antibodies are proteins that help the body fight off infection. An autoantibody is a type of antibody that mistakenly targets and attacks the body's own tissues. Glomeruli are the filters of the kidney that remove waste and extra fluid from the body. In PMN, the build-up of autoantibodies in the glomeruli causes damage to the kidneys.
Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with PMN. Symptoms of PMN can include swelling in the legs and body, tiredness, and high blood pressure. If left untreated, PMN can eventually lead to kidney failure.
In this study, researchers will learn more about how a study drug called felzartamab affects people with PMN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce autoantibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works compared to a drug called tacrolimus. Tacrolimus is another drug given to people with PMN and kidney disease.
The main question that researchers want to answer is:
* How many participants achieve a complete response after 104 weeks of treatment?
* A complete response means that their urine protein levels decrease to a low level and their kidney function remains stable.
Researchers will also learn about:
* How long it takes before the participants' disease gets worse
* How long the participants' urine protein levels stay low
* How many participants develop antibodies against felzartamab in the blood?
* How many participants achieve a complete response after 76 weeks of treatment
* How many participants have medical problems during the study
* How felzartamab is processed by the body
* How felzartamab affects participants' tiredness and overall physical health
The study will be done as follows:
* Participants will be screened to check if they can join the study. This may take up to 42 days.
* Participants will be randomized to receive either felzartamab as intravenous (IV) infusions or tacrolimus, taken orally as tablets.
* If participants have worsening kidney function or worsening proteinuria, or if their PMN relapses, or if they show no signs of improvement in their PMN, they will have a chance to receive rescue treatment.
* If a participant stops treatment early, there will be follow-up visits every 12 weeks until they reach Week 104.
* In total, participants will have up to 23 study visits. Participants who do not need rescue treatment will stay in the study for up to 104 weeks. Participants who need rescue treatment will stay in the study for up to 156 weeks.

Start Date22 May 2025

Sponsor / Collaborator

Biogen, Inc.

100 Clinical Results associated with Felzartamab

100 Translational Medicine associated with Felzartamab

100 Patents (Medical) associated with Felzartamab

Literatures (Medical) associated with Felzartamab

01 Jan 2026·Journal of Immunology Research

Resolving the Interference of Anti‐CD38 Antibodies on Blood Compatibility Assays Using CD38 “Baitbodies” Approach

Article

Author: Hust, Michael ; Steinke, Stephan ; Garritsen, Hendrikus S P ; Gnann, Dianne Celine

Blood transfusion safety depends on swift blood compatibility testing. Alloantibodies recognizing these blood group antigens determine blood compatibility, and the transfusion of incompatible blood can lead to life‐threatening hemolytic transfusion reactions. Recently, the landscape of blood compatibility testing has been complicated due to the interference caused by therapeutic antibodies targeting CD38, a key target in cancer immunotherapy that is also expressed on red blood cells. The presence of anti‐CD38 antibodies in blood samples has been found to bind to test or donor red blood cells, resulting in false positive tests. This interference poses a serious risk as it can potentially mask immunogenic alloantibodies and cause delays in supplying safe blood products. We present the development and application of fragment crystallizable (Fc)‐fusion constructs, referred to as “baitbodies”, designed to neutralize anti‐CD38 antibodies and mitigate false positive test outcomes. The extracellular domain of CD38 was fused to the Fc domain of a murine immunoglobulin G. These baitbody constructs were thoroughly characterized and applied in both serological microcolumn agglutination and automated solid‐phase red cell adherence assays. The CD38‐mFc baitbody successfully prevented agglutination reactions induced by three clinically relevant anti‐CD38 monoclonal antibodies—daratumumab, felzartamab and isatuximab—in spiked samples. This allowed the detection of alloantibodies of the Rhesus, Kell and Duffy blood groups without interference. The CD38‐mFc construct also demonstrated potential in a head‐to‐head comparison with commercial mitigation reagents, DaraEx and Grifols sCD38. Finally, the CD38‐mFc baitbody effectively neutralized daratumumab in patient samples, preventing false positive test outcomes.

22 Dec 2025·Cureus Journal of Medical Science

Emerging Therapies in IgA Nephropathy: From A Proliferation-Inducing Ligand (APRIL) and B-cell Activating Factor (BAFF) Inhibitors to Precision Medicine

Review

Author: Panta, Raju ; Sharma, Ishwor

IgA nephropathy (IgAN) is the most prevalent primary glomerular disease worldwide and a significant contributor to end-stage kidney disease (ESKD). Traditional management has centered on supportive care and non-specific immunosuppression, but recent advances in the understanding of pathogenic pathways have catalyzed the development of targeted therapies. This review synthesizes current evidence on evolving treatments, with a focus on A Proliferation-Inducing Ligand (APRIL) and B-cell Activating Factor (BAFF) (e.g., sibeprenlimab, atacicept, povetacicept, telitacicept), complement pathway modulators (e.g., iptacopan, cemdisiran, ravulizumab), and novel agents such as felzartamab and sparsentan. It also explores precision medicine strategies, including biomarker-guided therapy, individualized risk stratification, and combination regimens. Supported by high-quality recent clinical trial data and the latest kidney disease outcome guidelines, these innovations represent a paradigm shift toward personalized, disease-modifying treatment in IgAN, offering a new horizon for improved renal outcomes and long-term disease control.

01 Oct 2025·KIDNEY INTERNATIONAL

Randomized, double-blind, placebo-controlled phase 2a study assessing the efficacy and safety of felzartamab for IgA nephropathy

Article

Author: Lafayette, Richard ; Manser, Paul T ; Faulhaber, Nicola ; Kräft, Tabea ; Barbour, Sean J ; Shah, Millie ; Floege, Jürgen ; Thakur, Anjali ; Kivman, Lisa ; Härtle, Stefan ; Barratt, Jonathan ; Schwartz, Brian ; Patel, Uptal D

INTRODUCTION:

Felzartamab is a fully human anti-CD38 monoclonal antibody under investigation for treatment of IgA nephropathy (IgAN). IGNAZ (NCT05065970) is a randomized, double blind, placebo-controlled Phase 2a study that assessed the efficacy and safety of felzartamab in 54 patients with biopsy-confirmed IgAN despite maximal renin angiotensin system blockade.

METHODS:

In part 1, patients were randomized in the 6-month treatment period to receive intravenous placebo (12 patients) or felzartamab in three arms: two doses in 15 days (2-dose, 12 patients), five doses in 2 months (5-dose, 11 patients), or nine doses in five months (9-dose, 13 patients). In part 2, six Japanese patients received the felzartamab 9-dose schedule open-label. Follow-up in parts 1 and 2 was 24 and 12 months, respectively, after the first dose. The primary endpoint was change in proteinuria (urine protein to creatinine ratio [UPCR]) at nine months.

RESULTS:

Treatment with felzartamab versus placebo led to rapid (within 3-6 months) reduction in least-squares mean UPCR sustained at nine months (placebo, -5.7%; 2-dose, -12.5%; 5-dose, -12.8%; 9-dose, -29.5%; part 2, -44.8%) and at 18 months after ending treatment (24 months), particularly in the 9-dose arm (-44.5%). Mean decreases in estimated glomerular filtration rate were lower with felzartamab than with placebo through 24 months in part 1 and 12 months in part 2. Felzartamab safety was consistent with prior observations; adverse events were predominantly grade 1 or 2.

CONCLUSIONS:

Treatment with felzartamab results in sustained reduction of proteinuria, suggesting disease improvement. Further evidence is needed to understand the impact of felzartamab on preservation of kidney function in high-risk patients with IgAN.

TRIAL REGISTRATION:

Registered at ClinicalTrials.gov with study number NCT05065970.

127

News (Medical) associated with Felzartamab

21 Apr 2026

·www.prnewswire.com

TJ Biopharma Enters into Agreement with Biogen for Felzartamab Assets in the Greater China Region

With this transaction, Biogen now owns exclusive worldwide development and commercialization rights to felzartamab, consolidating global rights under one owner Advancing felzartamab – a CD38-directed antibody with potential broad applicability across a range of immune-mediated conditions – in the Greater China Region presents an important opportunity in a key global market Agreement builds on TJ Biopharma's development success of felzartamab in China and productive clinical collaboration in Biogen-led Phase 3 trials for IgAN and PMN since April 2025 April 20, 2026 -- Biogen Inc. (Nasdaq: BIIB) and TJ Biopharma ("TJ Bio") today announced that the companies have entered into a definitive agreement under which Biogen has agreed to acquire TJ Bio's exclusive rights to felzartamab in the Greater China Region. With this agreement, Biogen now owns exclusive worldwide rights to felzartamab, which is currently being evaluated in global Phase 3 clinical studies across multiple immune-mediated diseases. Under the terms of the agreement, TJ Bio will receive a $100 million upfront payment and is eligible to receive up to $750 million in potential commercial and sales milestone payments, for a total potential consideration of up to $850 million, plus mid-single-digit to low-double-digit percentage of royalties on potential net sales in the Greater China Region. The upfront payment is expected to be recorded by Biogen as an Acquired In-Process Research and Development expense in the second quarter of 2026. With this transaction, Biogen will assume responsibilities for milestone payment and royalty obligations under the prior MorphoSys (a wholly-owned subsidiary of Novartis) licensing agreement. "This deal is important to Biogen as it further expands the global opportunity for felzartamab, a potential pipeline-in-a-product with broad applicability across a range of immune-mediated conditions," said Fraser Hall, President of Biogen's Intercontinental Region. "We are pleased to reach this agreement with TJ Bio to grow our development portfolio in this key market. We look forward to continuing to evaluate felzartamab in Phase 3 studies and the opportunity to bring this potentially differentiated treatment to patients in the Greater China Region." Biogen acquired the worldwide rights (excluding the Greater China Region) to felzartamab through the acquisition of HI-Bio in July 2024 and has since initiated global Phase 3 trials in antibody-mediated rejection (AMR) in kidney transplant recipients, IgA nephropathy (IgAN) and primary membranous nephropathy (PMN) with planned expansions into other indications. The agreement builds on the productive collaboration between the two companies. In April 2025, TJ Bio joined two Biogen-sponsored Phase 3 International Multi-Center Trials (IMCT) evaluating felzartamab in IgAN and PMN in China. IgAN is the most common form of primary glomerulonephritis and a leading cause of end-stage kidney disease (ESKD) in young adults in China1. PMN has emerged as a leading cause of adult nephrotic syndrome in China, characterized by a rapidly increasing incidence and a significant risk of progression to ESKD2. China is believed to have one of the largest patient populations globally for both IgAN and PMN, underscoring the importance of advancing innovative treatment options in this market. "With Biogen's strong global capabilities and a proven track record of commercial success in the region, we are confident that they are the right partner to progress felzartamab in this important market," said Dr. Lili Qian, General Manager of TJ Biopharma. "This transaction sharpens our strategic focus and validates our 'fast-to-market' and 'tiered value realization' business models. It generates near- and long-term value for TJ Bio, supporting continued investment in our differentiated pipeline while enabling us to participate in the future success of felzartamab in China." Biogen will continue to lead development of the immunology indications and will now also lead manufacturing and commercial efforts for felzartamab in the Greater China Region. A Biologics License Application (BLA) for felzartamab for the treatment of multiple myeloma, submitted by TJ Bio in December 2024, is currently under review by China's National Medical Products Administration. Biogen will lead post-approval efforts in the region as part of the agreement. For the multiple myeloma indication, TJ Bio will serve as the manufacturer for felzartamab at its Hangzhou GMP facility. Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on plasma cells, plasmablasts, and natural killer, or NK, cells. Felzartamab is a potential first-in-class therapeutic candidate with promise as a pipeline-in-a-product across a range of immune-mediated diseases. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies. Felzartamab was originally developed by MorphoSys AG (now MorphoSys GmbH, a Novartis company). Human Immunology Biosciences (HI-Bio) exclusively licensed the rights to develop and commercialize felzartamab across all indications in all countries and territories excluding the Greater China Region. Biogen acquired HI-Bio in July 2024. Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority, and its safety and effectiveness have not been established. Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. TJ Biopharma is a fully integrated biotech company advancing next-generation therapies in autoimmune diseases, immuno-oncology and metabolic disorders. Anchored by comprehensive R&D centers in Shanghai and Beijing and a state-of-the-art GMP manufacturing facility in Hangzhou, the Company has built a clearly differentiated two-wave pipeline. The first wave includes products currently under regulatory review, together with additional late-stage assets in registrational or pre-Phase 3 development, while the second wave comprises novel antibody conjugates with first-in-class potential powered by the Company's proprietary AntibodyPLUS technology platforms, with programs advancing through Phase 1 studies or preparing for clinical entry. Over the years, TJ Biopharma has established a robust network of development and commercialization partnerships with Jumpcan, CSPC, Sanofi, and other leading industry players. The Company is committed to delivering innovation through a diversified and sustainable revenue model that integrates global asset transactions, contract manufacturing services, and future product sales. References: Scientific Committee of the China IgA Nephropathy Network (IIgANN-China); Chinese Preventive Medicine Association′s Committee for the Prevention and Control of Kidney Diseases. [Clinical practice guidelines for adult patients with IgA nephropathy and IgA vasculitis-associated nephritis in China (2025)]. Zhonghua Nei Ke Za Zhi. 2025 Oct 1;64(10):918-944. Chinese. doi: 10.3760/cma.j.cn112138-20250707-00396. PMID: 41083387. Tang L, Yao J, Kong X, Sun Q, Wang Z, Zhang Y, Wang P, Liu Y, Li W, Cui M, Zhen J, Xu D. Increasing prevalence of membranous nephropathy in patients with primary glomerular diseases: A cross-sectional study in China. Nephrology (Carlton). 2017 Feb;22(2):168-173. doi: 10.1111/nep.12739. PMID: 26854278. The content above comes from the network. if any infringement, please contact us to modify.

License out/inImmunotherapy

20 Apr 2026

·www.fiercebiotech.com

Biogen inks $850M biobucks deal with TJ Biopharma for China rights to late-stage immune antibody

In 2024, Biogen obtained those ex-China rights through its $1.15 billion acquisition of HIBio, announcing plans to advance the anti-CD38 monoclonal antibody into phase 3 trials across several rare immune-mediated indications.\n Following its move to secure ex-China rights to the CD38-directed antibody felzartamab, Biogen is doubling down and building on an existing partnership with local drugmaker TJ Biopharma.The Massachusetts Big Biotech has signed an $850 million biobucks agreement with TJ Biopharma, securing exclusive China rights to the multi-indication candidate.In an April 20 release, Cambridge-based Biogen said it will pay TJ $100 million upfront to expand its rights to felzartamab. The drug is currently being evaluated in global phase 3 studies across multiple immune-related conditions. The deal could generate up to $750 million in commercial and sales milestone payments, along with mid single-digit to low double-digit royalties in Greater China.Felzartamab was originally developed by German biopharma MorphoSys. Its ex-China rights were acquired by Human Immunology Biosciences (HIBio) in 2022 in a deal valued at up to $1 billion.In 2024, Biogen obtained those ex-China rights through its $1.15 billion acquisition of HIBio, announcing plans to advance the anti-CD38 monoclonal antibody into phase 3 trials across several rare immune-mediated indications.Since the acquisition, Biogen has initiated studies of the drug in antibody-mediated rejection (AMR) in kidney transplant recipients, IgA nephropathy (IgAN) and primary membranous nephropathy (PMN), with plans to expand into additional indications.Biogen’s intercontinental region president, Fraser Hall, said in a statement that felzartamab has the potential to evolve from a single product into a broader pipeline asset due to its applicability across multiple indications.The latest deal expands the partnership between Biogen and China-based TJ Biopharma, which began in April 2025 when TJ joined two Biogen-sponsored phase 3 trials evaluating felzartamab in IgAN and PMN in China. Under that deal, TJ was tasked with leading regulatory interactions on the candidate in China. With the new agreement, Biogen will continue to lead development in immunology indications and will assume responsibility for manufacturing and commercialization of felzartamab in Greater China. The drug is currently under review by China’s National Medical Products Administration after TJ submitted a Biologics License Application for multiple myeloma in 2024.“This transaction sharpens our strategic focus and validates our ‘fast-to-market’ and ‘tiered value realization’ business models,” Dr. Lili Qian, general manager of TJ Biopharma, said in the release.IgAN is a leading cause of end-stage kidney disease (ESKD) among young adults in China, which is believed to have one of the largest patient populations for both IgAN and PMN, according to the release.

License out/inPhase 3AcquisitionImmunotherapy

20 Apr 2026

·endpoints.news

Merck partner reveals bispecific data; Biogen pays $100M for antibody rights

Merck partner reveals first human data for PD-1xVEGF bispecific: Sino Biopharm revealed that six of 11 lung cancer patients responded to a low dose of the drug, known as MK-2010, while four of nine patients responded to a higher dose. It’s the first data in humans revealed for MK-2010, which was developed by LaNova Medicines (Sino acquired LaNova in July 2025). The data remain early, but “in line with peers” in lung cancer, Leerink analyst Daina Graybosch wrote in a Sunday note to investors. — Max Gelman Biogen gets China rights to CD38 antibody: The company will pay TJ Biopharma $100 million upfront and up to $750 million in biobucks for the rights to felzartamab in Greater China. Biogen has billed the CD38-targeting antibody as a “pipeline in a product.” It’s currently in multiple Phase 3 trials for immune-mediated diseases such as IgA nephropathy and primary membranous nephropathy. Biogen will now have exclusive worldwide rights, after getting the ex-China rights from the acquisition of HI-Bio in 2024. — Nicole DeFeudis Hansoh shares early lung cancer data for B7-H3-directed ADC: The biotech’s risvutatug rezetecan combined with Jiangsu Hengrui Pharmaceuticals’ anti-PD-L1 drug adebrelimab achieved a 47.1% ORR in patients with advanced non-squamous non-small cell lung cancer. Results from the open-label Phase 1 trial in China were presented Monday at the American Association for Cancer Research annual meeting in San Diego. The risvutatug rezetecan regimen also attained a median PFS of 14 months. GSK acquired ex-China rights to the drug from Hansoh in a 2023 deal, which featured $185 million upfront . — Ayisha Sharma Monopar trumpets Phase 3 rare disease data: The biotech said its drug ALXN1840, designed to treat the rare genetic disorder Wilson’s disease, led to “higher rates of improvement and lower rates of worsening” when compared to standard of care. Monopar expects to file an FDA submission in mid-2026. ALXN1840 was originally developed by Alexion, and AstraZeneca culled the program in 2023 while taking a $244 million writedown. — Max Gelman Genmab terminates cancer drug from ProfoundBio: The company terminated a Phase 1/2 study for GEN1286, according to the federal clinical trials database, because of an “unfavorable benefit-risk profile.” Genmab had halted enrollment in the study earlier this year. Genmab acquired ProfoundBio for $1.8 billion in 2024. — Max Gelman Replimune further reduces headcount after FDA rejection: The Woburn, MA-based drugmaker expects to lay off 63 staffers through Friday, according to the state’s WARN tracker . That brings the company’s total number of staff cuts in April to more than 200. Earlier this month, Replimune received a CRL from the FDA for its skin cancer drug. — Ayisha Sharma Agenus touts positive data in gastroesophageal cancer: The Lexington, MA-based biotech company said 77% of patients who received its experimental antibodies botensilimab and balstilimab in combination with MiNK Therapeutics’ allo-iNKT cell therapy agenT-797 achieved disease control in a Phase 2 trial. Patients also received ramucirumab and paclitaxel. Those who were treated with an induction cycle before the full combination had longer progression-free survival, Agenus said, “supporting the potential importance of immune priming and treatment sequencing.” Agenus is developing botensilimab and balstilimab to work together against cancer, and the combination is currently in a Phase 3 trial in colorectal cancer. — Nicole DeFeudis Lumira Ventures’ fifth fund: The Canadian and US VC firm is targeting $200 million, or 275 million Canadian dollars, for its fifth fund. The firm invests in medical technology and biotech startups in North America. — Kyle LaHucik Mabwell eyes Hong Kong IPO next week: The Shanghai-based biotech expects to trade on the Hong Kong Stock Exchange later this month and is penciling in $1.18 billion Hong Kong dollars (about $150 million) in net proceeds from the float. Mabwell is familiar with US drug developers by way of partnerships with Aditum Bio and Alphabet’s Calico . The biotech has been listed on the Shanghai Stock Exchange since 2022. Its portfolio includes four commercialized products and 10 drug candidates, including ADCs, monoclonal antibodies and other modalities. — Kyle LaHucik Endpoints is fielding the next Biopharma Sentiment Index (BPSI) — a concise, three-minute survey that distills thousands of industry views into a clear quarterly benchmark. This year is pivotal for biopharma, and we need your perspective on where things are going. Take the survey here.

100 Deals associated with Felzartamab

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16375

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Myeloma	NDA/BLA	China	TJ Biopharma Hangzhou Co Ltd	08 Jan 2025
Idiopathic Membranous Glomerulonephritis	Phase 3	United States	TJ Biopharma Hangzhou Co Ltd	22 May 2025
Idiopathic Membranous Glomerulonephritis	Phase 3	United States	Biogen, Inc.	22 May 2025
Idiopathic Membranous Glomerulonephritis	Phase 3	China	Biogen, Inc.	22 May 2025
Idiopathic Membranous Glomerulonephritis	Phase 3	Japan	Biogen, Inc.	22 May 2025
Idiopathic Membranous Glomerulonephritis	Phase 3	Japan	TJ Biopharma Hangzhou Co Ltd	22 May 2025
Idiopathic Membranous Glomerulonephritis	Phase 3	Argentina	Biogen, Inc.	22 May 2025
Idiopathic Membranous Glomerulonephritis	Phase 3	Argentina	TJ Biopharma Hangzhou Co Ltd	22 May 2025
Idiopathic Membranous Glomerulonephritis	Phase 3	Australia	Biogen, Inc.	22 May 2025
Idiopathic Membranous Glomerulonephritis	Phase 3	Australia	TJ Biopharma Hangzhou Co Ltd	22 May 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05065970 (IGNAZ, ASN2025)	Phase 2	Glomerulonephritis, IGA	54	Felzartamab	oozqeiclor(pyyertezjp) = nbktxoikxl xlptmcoeie (pyakhgobva ) View more	Positive	07 Nov 2025
NCT05065970 (IGNAZ, Pubmed \| Kidney Int \| ASN2025)	Phase 2	Glomerulonephritis, IGA	54	Felzartamab 2-dose	cemlienblu(uwfybxqcfq) = Felzartamab safety was consistent with prior observations; adverse events were predominantly grade 1 or 2. zaqrwezthr (qnfkjjhlnd )	Positive	01 Oct 2025
				Felzartamab 5-dose
NCT05065970 (IGNAZ, ASN2024) Manual	Phase 2	Glomerulonephritis, IGA	54	Felzartamab (2 doses in 15 days)	ejwloraqjz(mzvabjwcet) = Treatment with felzartamab led to rapid, clinically meaningful reductions in UPCR vs PBO, with the greatest effect in the M3 arm. ueublibjxu (eduvucyxzy ) View more	Positive	26 Oct 2024
				Felzartamab (5 doses in 2 months)
NCT04145440 (M-PLACE, Pubmed) Manual	Phase 1/2	Idiopathic Membranous Glomerulonephritis anti-Phospholipase A2 receptor autoantibody-positive	31	Felzartamab 16 mg/kg	hhnjohxhij(fpnpjiwohm) = tdvqolbrko nreahgural (jxictychum ) View more	Positive	20 Jun 2024
				Felzartamab 16 mg/kg (newly diagnosed or relapsed PMN)	msznvlcjwm(rosmakfdpv) = gbpbunwreb tvthatqwxn (nydubjegbi )
NCT05021484 (NEWS) Manual	Phase 2	Renal transplant rejection	22	Felzartamab	pepfnvpdod(lwyuktrwzm) = felzartamab showing an acceptable safety profile and most adverse events being mild or moderate. psudwofwfq (nsiqxjgtsw )	Positive	27 May 2024
				Placebo
NCT05065970 (IGNAZ, PRNewswire) Manual	Phase 2	Glomerulonephritis, IGA	54	Felzartamab	tlopiksgxt(lqqvvjofra) = tomdwcrpuc wbtoepbasa (mpootbczzn )	Positive	24 May 2024
				Placebo	-
NCT04145440 (M-PLACE, ASN2023) Manual	Phase 1/2	Idiopathic Membranous Glomerulonephritis First line	31	Felzartamab	fvujhzjbdk(ldrprriopc) = fnzuuoqvju rngegpnxdf (phvdlkccnd ) View more	Positive	02 Nov 2023
				Felzartamab (newly diagnosed or relapsed patients)	hblkihfplc(rtlyuudizd) = xyluxwvqkr qnnvaeztwt (ogxxttrfkv ) View more
NCT04145440 (M-PLACE, ASN2023)	Phase 1/2	Idiopathic Membranous Glomerulonephritis aPLA2R+	31	Felzartamab (Cohort 1)	bnnsmuriym(ipzflicedx) = ocxaqgsatw ysgmemhjjg (oqaojcrdqf ) View more	Positive	02 Nov 2023
				Felzartamab (Cohort 2)	syaxqbebel(espkpvekyt) = aqxxctxlnv iogngfwufy (vfjdxdzsqk ) View more
NCT04145440 (M-PLACE, ASN2022)	Phase 1/2	Glomerulonephritis, Membranous anti-PLA2R Abs	31	Felzartamab (MOR202) 16 mg/kg	oeldjeeowv(dmfunyyemo) = jucrjomryc hxnbzpzfyl (fbqapkmsqq )	Positive	05 Nov 2022
NCT01421186 (ASCO 12017 \| ASCO 22017) Manual	Phase 1/2	Multiple Myeloma	44	dexamethasone+MOR202	jynwdpvanp(dfdbnurxhz) = The MTD of MOR202 was not reached krcjdlpzog (qoyozfqdpw )	Positive	05 Jun 2017
				dexamethasone+lenalidomide+MOR202

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