On June 22, 2026 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported the initiation of a randomized Phase 1 trial evaluating TG4070, a novel individualized immunotherapy fully designed and developed in-house by Transgene, in combination with nivolumab in the adjuvant treatment of resected non-small cell lung cancer (NSCLC).

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TG4070, Transgene’s second Individualized Neoantigen Therapeutic Vaccine (INTV) candidate, reflects the strategic expansion of the myvac platform. Following TG4050, currently being evaluated in the Phase 2 part of a randomized Phase 1/2 trial in head and neck cancer (NTC4183166), TG4070 supports the expansion of the myvac platform into NSCLC while integrating Transgene’s proprietary AI-driven neoantigen selection and cell line manufacturing capabilities. Like TG4050, it leverages Transgene’s clinically validated Modified Vaccinia Ankara (MVA) viral vector, ensuring technological consistency of the myvac platform.

This integrated proprietary ecosystem strengthens Transgene’s control over critical steps of INTV development, with an optimized manufacturing process, aiming at shortening turnaround time (compared to CEF[3] based production), improving scalability and reproducibility, while potentially accelerating development timelines across multiple indications.

"The initiation of this randomized Phase 1 trial of TG4070 represents an important step in Transgene’s strategy to expand the myvac platform beyond TG4050 in head and neck cancer, into additional early-stage solid tumor indications," said Alessandro Riva, MD, Chairman and Chief Executive Officer of Transgene.

"The program reflects the growing integration of Transgene’s proprietary capabilities across AI-driven neoantigen selection through SNIPER and scalable manufacturing infrastructure designed to support broader platform deployment."

SNIPER: Proprietary AI Platform Enabling High-Precision Neoantigen Selection

To support the development of TG4070 and future myvac-derived candidates, Transgene has developed its own in-house, AI-driven bioinformatics tool, SNIPER (Specific Neoantigen Identification and Prediction of Elicited Response). SNIPER is the central component underpinning the neoantigen selection and design of TG4070.

With its multiple integrated computational models, SNIPER is designed to identify and prioritize highly immunogenic neoantigens through a proprietary scoring framework, including tumor-specific expression and antigen presentation intended to optimize candidate selection and support INTV design.

SNIPER highlights Transgene’s strong capabilities in AI-driven neoantigen selection, empowering robust computational development and enabling the scalable development of myvac-derived candidates across additional oncology indications.

In addition, VacDesignR, fully integrated into the myvac platform, is Transgene’s patented in-house computational design engine that optimizes genetic construct for MVA vectors. This integration streamlines design process and significantly improves production reliability and vector quality – key features to achieving reliable, timely and efficient product supply.

Cell-line optimized manufacturing to support broader development

TG4070 is manufactured using a scalable and transposable cell-line based process designed to support broader deployment of INTV candidates while ensuring reliable vaccine supply. Compared with conventional CEF-based manufacturing, the optimized process enables more efficient and automated production, improved lead times and scalability.

Preclinical data demonstrated comparable performance to CEF-based product, supporting continuity with existing clinical data while significantly enhancing scalability.

This manufacturing evolution supports broader deployment of the myvac platform across additional indications and larger patient populations. Transgene also plans to use cell-line based manufacturing in potential future TG4050 clinical trials. TG4050 is currently being evaluated in Phase 2 in head and neck cancer.

TG4070: Expanding the myvac Platform into resected non-small cell lung cancer

The Phase 1 trial will evaluate the safety and tolerability of TG4070 in combination with nivolumab in resected NSCLC patients after neoadjuvant nivolumab plus chemotherapy (EUCT 2025-520946-31-00).

While a perioperative approach with an immunotherapy-based regimen has reshaped the treatment landscape of early-stage NSCLC, approximately 65% of patients do not achieve a major pathological response[4] and remain at high risk of relapse[5].

"Patients with resected non-small cell lung cancer who do not achieve a major pathological response after neoadjuvant chemo-immunotherapy remain at significant risk of relapse. TG4070 represents a compelling approach in this setting, as individualized neoantigen therapeutic vaccines can induce highly specific and durable anti-tumor immune responses. In combination with an immune checkpoint inhibitor such as nivolumab, this strategy has the potential to further enhance T-cell activity and improve outcomes in this high-risk population," said Nicolas Girard, MD, PhD, Professor of Thoracic Oncology at Curie Institute and Principal Investigator of the TG4070 trial.

Transgene will host a webcast on June 29, 2026, at 3:00 p.m. CET / 9:00 a.m. ET (in English).

During this live event, Transgene’s team, including Alessandro Riva, Chairman and CEO, and Prof. Nicolas Girard, MD, PhD, (Institut Curie), will discuss the expansion of the myvac platform, the medical need for early-stage NSCLC patients and the potential benefit of TG4070 in this indication.

(Press release, Transgene, JUN 22, 2026, View Source [SID1234668817])

On June 21, 2026 Antengene Corporation Limited ("Antengene", SEHK: [6996 HK]), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies indications, reported that it has entered into an exclusive license agreement ("License Agreement") with K2 Therapeutics for ATG-106, a preclinical CDH6 x CD3 bispecific T cell engager (TCE) in development for solid tumors. Antengene also announced that it has entered into an option agreement ("Option Agreement") to grant K2 Therapeutics the option to obtain exclusive global rights to develop and commercialize an undisclosed preclinical bispecific TCE candidate. Across both the License Agreement and the Option Agreement, K2 Therapeutics’ rights extend globally, excluding Greater China.

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K2 Therapeutics, established by MPM BioImpact, is a biotech company and scalable hub-and-spoke engine built for global impact, with search and development capabilities unconstrained by modality or geography. MPM BioImpact is a world-leading biotechnology investment firm, with over 30 years’ experience creating and investing in innovative companies.

"We are very pleased to expand our partnerships with our TCE pipeline with this important collaboration around our AnTenGager platform," said Dr. Jay Mei, Founder, Chairman and Chief Executive Officer of Antengene. "We believe ATG-106, our CDH6 x CD3 bispecific TCE reflects the differentiated design of AnTenGager TCEs and their potential in solid tumors. AnTenGager TCEs are designed to address key challenges that have historically limited first-generation TCEs in solid tumors, particularly with respect to safety and tolerability. By combining steric hindrance-based masking with our proprietary fast on/off CD3 binder, AnTenGager TCEs are designed to activate T cells in a disease-associated antigen-gated manner, with the potential to reduce cytokine release syndrome and T cell exhaustion while maintaining potent anti-tumor activity."

Both ATG-106 and the undisclosed program leverage Antengene’s proprietary AnTenGager platform, which offers a differentiated TCE approach, where binding of the TCE arm (CD3) is sterically masked in the absence of target antigen binding providing potent activity and better tolerability.

"We are excited to license ATG-106, a highly differentiated CDH6 x CD3 bispecific TCE, as well as a second promising TCE program enabled by the cutting-edge AnTenGager platform," said Frank Neumann, M.D., Ph.D., Chief Medical Officer of K2 Therapeutics. "CDH6 is an attractive target given its overexpression in tumors such as ovarian and renal cancers, and its limited expression in normal adult tissues. We believe the unique design of ATG-106 has the potential to meaningfully advance the field of solid tumor TCEs. We look forward to advancing ATG-106 toward the clinic and to delivering meaningful benefit to patients."

Under the License Agreement, Antengene is entitled to upfront and near-term considerations of approximately USD 20 million, consisting of cash and a minority equity stake in a newly established asset company and subsidiary of K2 Therapeutics, subject to the satisfaction of certain near-term conditions. Antengene is also eligible to receive developmental, regulatory and sales milestone payments of up to USD 960.5 million related to ATG-106, plus tiered royalties on future net sales.

Under the Option Agreement, upon exercise of the option, Antengene is entitled to receive upfront and near-term considerations of approximately USD 20 million, consisting of an option exercise fee, near-term payment and upfront payment, as well as a minority equity stake in the related asset company. Antengene would also be eligible to receive developmental, regulatory and sales milestone payments of up to USD 960.5 million related to the undisclosed TCE program, plus tiered royalties on future net sales.

(Press release, Antengene, JUN 21, 2026, View Source [SID1234668816])

On June 21, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that the first patient has been dosed in the Chinese pivotal Phase 3 clinical trial (TriadicMM-1) of its self-developed innovative anti-GPRC5D, BCMA and CD3 tri-specific antibody IBI3003 for the second to fifth-line treatment of patients with relapsed or refractory multiple myeloma (R/R MM). IBI3003 is China’s first self-developed anti-GPRC5D/BCMA/CD3 tri-specific antibody to enter the pivotal registrational Phase III clinical trial, aiming to bring a promising next-generation immunotherapy option for Chinese R/R MM patients.

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TriadicMM-1 (NCT07623798) is a multicenter, randomized, controlled, open-label Phase 3 clinical trial designed to evaluate the efficacy and safety of IBI3003 versus investigator’s choice of regimen (pomalidomide, bortezomib and dexamethasone [PVd] or daratumumab, pomalidomide and dexamethasone [DPd]). The primary endpoint of the study is progression-free survival (PFS) assessed by the Independent Review Committee (IRC).

Clinical data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 7, 2025 [Link], demonstrated a tolerable safety profile and promising efficacy signals for IBI3003 in patients who had failed ≥2 prior lines of myeloma therapy:

Thirty-nine patients with R/R MM who had previously received at least a PI, an IMiD, and an anti-CD38 monoclonal antibody were treated with IBI3003 at dose levels ranging from 0.1 μg/kg to 800 μg/kg and underwent at least one tumor assessment after baseline. As of the data cutoff date of November 7, 2025, the median follow-up duration was 3.25 months (range: 0.4–7.4), and the median treatment duration was 12.14 weeks (range: 1.0–33.0).
Among patients treated at doses ≥120 μg/kg (n=24), the overall response rate (ORR) was 83.3%, including 4 stringent complete responses (sCR), 7 very good partial responses (VGPR), and 9 partial responses (PR). In this cohort, the ORR was 80% among 10 patients with extramedullary disease (EMD) and 77.8% among 9 patients previously treated with BCMA- and/or GPRC5D-directed therapies. Among patients who achieved complete response or better, the minimal residual disease (MRD) negativity rate was 100% (n=4), as assessed by validated next-generation sequencing, with a threshold of 10-5, performed at a central laboratory.
All cases of cytokine release syndrome (CRS) were Grade 1-2, with only 2 cases of Grade 1-2 immune effector cell-associated neurotoxicity syndrome (ICANS) reported. Most treatment-emergent adverse events (TEAEs) related to GPRC5D targeting, including those affecting the oral cavity, skin, and nails, were Grade 1–2, with two patients experiencing Grade 3 rash.
Relevant dose optimization data (including RP2D selection) from this Phase 1/2 study will be presented at future academic conferences.
In addition, IBI3003 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) earlier this year. This designation applies to the treatment of R/R MM in patients who have received four or more lines of previous anti-myeloma therapies, that include at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody. The Phase I/II clinical trial in the United States is currently underway.
Professor Peng Liu from Zhongshan Hospital Affiliated to Fudan University, the Principal Investigator of the TriadicMM-1 Study, stated: "We are delighted that the first patient has been enrolled in TriadicMM-1 at our hospital. This is the first domestic pivotal Phase 3 clinical trial of a tri-specific antibody with independent intellectual property rights for the treatment of R/R/MM in China. Furthermore, IBI3003 is also the second tri-specific antibody globally to have advanced into pivotal Phase III clinical development in the R/R MM setting. Although multiple myeloma has multiple treatment options, the disease still recurs most frequently and is incurable. With each recurrence, symptoms reappear, quality of life declines, and both the likelihood and duration of treatment response typically decrease. Therefore, there remains a significant and urgent unmet medical need for novel therapeutic agents targeting alternative mechanisms of action to better control the disease, achieve deeper and more durable responses, and improve long-term outcomes including maintaining health-related quality of life. We highly anticipate that the Phase III study TriadicMM-1 will validate the potential of IBI3003 and establish IBI3003 as a new standard of care for 2-5 line R/R MM."

Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent Biologics, stated: "The successful completion of the first patient’s first dose in the Chinese pivotal Phase III study TriadicMM-1 of IBI3003 is an important milestone for Innovent in advancing its first tri-specific antibody program into the registrational stage. IBI3003 is built on Innovent’s proprietary Sanbody platform. The promising efficacy data and manageable safety profile observed in preclinical and clinical studies are expected to bring a promising next-generation immunotherapy option for patients with multiple myeloma. Looking ahead, Innovent will deepen its dual innovation in ADC and immunotherapy, and is committed to delivering cutting-edge therapies to patients worldwide."

About Multiple Myeloma

Multiple Myeloma is a malignant hematological malignancy originating from plasma cells in the bone marrow, ranking as the second most common blood cancer globally. Abnormal, clonal expansion of these malignant plasma cells crowding the bone marrow disrupts normal hematopoiesis and secretes abnormal monoclonal immunoglobulins (M protein). This process leads to a series of severe clinical complications, classically characterized by bone destruction, anemia, renal impairment, and hypercalcemia.

Driven by an aging global population, the incidence of multiple myeloma is continuously rising. Although the introduction of innovative therapies—such as proteasome inhibitors, immunomodulatory drugs, and targeted agents—has significantly improved patient prognosis over the past decades, multiple myeloma remains largely incurable. The vast majority of patients who initially achieve remission will inevitably experience a relentless cycle of relapse and drug resistance.

For patients with relapsed/refractory multiple myeloma who have already progressed through 1-4 lines of therapy, subsequent treatment options become severely limited. With each successive line of therapy, the duration of remission shortens, and the prognosis worsens drastically. Consequently, there is a critical and unmet medical need for novel therapeutic regimens with superior efficacy, manageable safety profiles, and distinct mechanisms of action to overcome resistance, prolong overall survival, and preserve patient quality of life.

About IBI3003

IBI3003, constructed on Innovent’s proprietary Sanbody platform, is a novel trispecific antibody targeting G protein–coupled receptor, family C, group 5, member D (GPRC5D), B-cell maturation antigen (BCMA) and CD3. This molecular design aims to overcome single tumor antigen escape. Its antitumor activity in preclinical mouse models is superior to that of marketed bispecific antibody benchmarks, and it exhibits particularly potent tumor killing efficacy in in vitro cell models with low expression of BCMA and GPRC5D.

Currently, a Phase I/II clinical trial of IBI3003 is underway in China, Australia and U.S. (NCT06083207) to explore the safety, tolerability and efficacy of IBI3003 in subjects with R/R MM. In China, the program has advanced into pivotal registration stage with TriadicMM‑1 (NCT07623798), a randomized, controlled, open‑label Phase III study comparing IBI3003 to investigator’s choice of regimens (DPd or PVd). The primary endpoint is progression‑free survival (PFS) assessed by an independent review committee (IRC).

(Press release, Innovent Biologics, JUN 21, 2026, View Source [SID1234668815])

On June 19, 2026 Sanofi reported that the Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide and dexamethasone (Pd), or with carfilzomib for the treatment of relapsed or refractory MM (R/R MM) and in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM).

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A regulatory submission for the CirCLIQ on-body injector (OBI), based on the enFuse platform and submitted by Enable Injections, is under review in Japan. If approved, Sarclisa SC could become the first anticancer treatment to be administered via an OBI, and the first MM medicine in Japan to offer both manual SC injection and OBI administration.

In recent years, new MM diagnoses have increased steadily in Japan, creating a need for new treatment approaches particularly in the front-line setting. MM is the third most common hematologic malignancy in Japan.

"Today’s approval of Sarclisa subcutaneous represents an important evolution in how we deliver care for multiple myeloma patients in Japan," said Olivier Nataf, Global Head of Oncology at Sanofi. "This new formulation significantly eases treatment burden and enhances convenience for patients compared to intravenous administration – with the potential to become Japan’s first anticancer therapy to be administered via an on-body injector."

The approval is based on results from the IRAKLIA phase 3 study in R/R MM (clinical study identifier: NCT05405166), which demonstrated non-inferiority of the SC formulation compared to IV, as well as supportive studies. In addition to manual SC injection, these studies evaluated Sarclisa SC administered through an OBI, and were conducted using Enable Injections’ enFuse hands-free OBI, an automated injector for subcutaneous delivery of Sarclisa.

In the IRAKLIA study, Sarclisa SC administered via an OBI in combination with pomalidomide and dexamethasone (Pd) resulted in a 71.1% objective response rate (ORR), compared to 70.5% with Sarclisa IV-Pd, establishing non-inferiority (risk ratio: 1.008; 95% confidence interval: 0.903-1.126; p=0.0006), in adult patients with R/R MM who had received at least one prior line of treatment. The overall safety profile of Sarclisa SC-Pd observed in this study was consistent with the established safety profile of Sarclisa IV-Pd. While 25% of patients treated with Sarclisa IV-Pd experienced infusion reactions, 1.5% of patients treated with Sarclisa SC-Pd experienced those reactions. No new safety concerns were observed, except for low-grade local injection site reactions (ISRs) that occurred in 0.4% of OBI injections (n=19/5,145 injections). Nearly all ISRs were grade 1, except for one episode of grade 2.

The most common grade ≥3 non hematologic adverse events were pneumonia (14.8% OBI, 15.5% IV), COVID-19 (2.7%, 1.9%), and upper respiratory tract infection (1.5% both arms). The most common grade ≥3 hematologic laboratory abnormalities were neutropenia (84.7% OBI, 74.3% IV), thrombocytopenia (26.1%, 23%), and anemia (17.6%, 19.5%).

In Japan, Sarclisa IV is currently approved across five indications, including in combination with VRd in NDMM, as well as four different treatment regimens in R/R MM (in combination with Pd, in combination with carfilzomib and dexamethasone (Kd), in combination with dexamethasone alone, or as a monotherapy). Sarclisa SC administered via both the CirCLIQ OBI and manual injection was approved in the EU for the treatment of MM patients across all currently approved indications and combinations for Sarclisa IV formulation in June 2026. An application for Sarclisa SC administered via both OBI and manual injection is currently under review in the US.

About the IRAKLIA study
IRAKLIA (clinical study identifier: NCT05405166) was a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa administered at a fixed dose SC via OBI versus weight-based dosed Sarclisa IV in combination with Pd in adult patients with R/R MM who have received at least one prior line of therapy. The co-primary outcomes assessed were ORR, defined as the proportion of patients with stringent complete response (CR), CR, very good partial response, and partial response according to the 2016 International Myeloma Working Group criteria assessed by Independent Review Committee, and observed Sarclisa mean concentration before dosing (Ctrough) at steady state (pre-dose at cycle 6, dose 1 [C6D1]), defined as observed Sarclisa plasma concentrations.

About Enable Injections
Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of the enFuse On-Body Delivery System. An innovative wearable technology, the enFuse system is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. For more information, visit www.enableinjections.com.

About Sarclisa
Sarclisa (isatuximab) has been approved in almost 60 countries across four indications for certain patients with NDMM and R/R MM. Sarclisa-based regimens have been prescribed to treat more than 70,000 patients worldwide.

Sarclisa SC is approved in the EU and the UK in combination with approved standard-of-care regimens for the treatment of patients with MM across all currently approved indications for Sarclisa IV in these countries. It is the first anticancer treatment to be administered through an OBI, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both SC OBI and manual injection administration.

Sarclisa SC is approved in Japan in combination with VRd, for the treatment of adult patients with NDMM, as well as Pd and Kd for the treatment of patients with R/R MM.

At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need.

(Press release, Sanofi, JUN 19, 2026, View Source [SID1234668814])

On June 19, 2026 Incyte Biosciences Japan G.K. reported that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

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"This approval provides a new option for patients in Japan living with relapsed or refractory DLBCL, an aggressive disease with historically limited treatment options," said Yasuyuki Ishida, General Manager, Incyte Biosciences Japan. "We are committed to helping address critical unmet needs for patients and their families affected by this challenging cancer."

DLBCL is the most common subtype of non-Hodgkin lymphoma and is an aggressive malignancy of B lymphocytes. While many patients respond to initial therapy, outcomes remain poor for those with relapsed or refractory disease, particularly for patients who are not eligible for autologous stem cell transplant.1

The approval is based on results from the MOR208C203 Trial: L-MIND (NCT02399085), an international Phase II trial, and INCMOR 0208-102 Trial Part 4 (Group 6): J-MIND (NCT04661007), a domestic Phase Ib/II trial in Japan, both of which evaluated the safety and efficacy of Minjuvi in combination with lenalidomide in patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT).2,4 In the L-MIND trial, based on an independent review committee assessment (data cutoff date: November 20, 2018), the overall response rate (ORR) was 58.8% (primary endpoint), with a complete response (CR) rate of 41.3% and a partial response (PR) rate of 17.5%.3 The median duration of response (mDOR) had not been reached at a median follow-up of 44 months or more.3 Furthermore, based on the independent review committee’s assessment in the J-MIND trial (data cutoff date: August 31, 2023), the response rate was 71.4%, with a complete response (CR) rate of 45.2% and a partial response (PR) rate of 26.2%.4 The main adverse events included neutropenia and thrombocytopenia.4,5 Overall, Minjuvi in combination with lenalidomide demonstrated a clinically meaningful response, and the side effects were manageable.4,5

This approval represents the second regulatory approval for Minjuvi in Japan. Minjuvi in combination with rituximab and lenalidomide was previously approved by the MHLW for the treatment of adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

About L-MIND
L-MIND was a single-arm, open-label Phase 2 study evaluating tafasitamab in combination with lenalidomide in adults with relapsed or refractory diffuse large B-cell lymphoma who had received at least one, but no more than three, prior lines of therapy (including an anti-CD20 therapy such as rituximab) and who were not eligible for, or refused, high-dose chemotherapy followed by autologous stem cell transplant.2 The primary endpoint was overall response rate; secondary endpoints included duration of response, progression-free survival, and overall survival.2

For more information about the study, please visit View Source

About J-MIND
J-MIND Trial Part 4 (Group 6) (NCT04661007) is a Japanese Phase Ib/II clinical trial evaluating the efficacy and safety of tafasitamab in combination with lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Patients enrolled in this trial had received one to three prior systemic therapies, including CD20-targeted therapy, and were deemed by the principal investigator to be ineligible for or unresponsive to autologous hematopoietic stem cell transplantation.4

The primary endpoint of this trial was the objective response rate (ORR) as assessed by an independent review committee based on the Lugano criteria; secondary endpoints included complete response (CR), progression-free survival (PFS), and overall survival (OS).4

For more information about the study, please visit View Source

About Minjuvi (tafasitamab)
Minjuvi (tafasitamab) is a humanized, Fc-modified, cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi (tafasitamab-cxix) received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).6 Additionally, Monjuvi is approved by the U.S. FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).6

In Europe, Minjuvi (tafasitamab) received conditional marketing authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.7 Additionally, Minjuvi is approved in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1–3a) after at least one line of systemic therapy in Europe.7

In Japan, Minjuvi is approved in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in Japan.8 Minjuvi is also approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

XmAb is a registered trademark of Xencor, Inc.

Monjuvi and Minjuvi are registered trademarks of Incyte.

Important Safety Information
Please refer to the Minjuvi Product Information (PI) for indications, dosage and administration, precautions, and safety information in Japan, as well as the Pharmaceuticals and Medical Devices Agency (PMDA) website.

(Press release, Incyte, JUN 19, 2026, View Source [SID1234668813])