Brightline-3: A Phase III, Randomized, Open-label, Multi-center Trial of Brigimadlin + Ezabenlimab Compared to Gemcitabine + Docetaxel for Second-line Treatment of Patients With Advanced TP53 Wild-type Soft Tissue Sarcoma Subtypes

This study is open to adults with specific types of advanced soft tissue sarcoma. People with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) can join the study if they have a normal version of the TP53 gene. This is a study for people whose earlier treatment isn't working anymore, and their doctors suggest a new treatment to stop the sarcoma from getting worse.
The purpose of this study is to compare a medicine called brigimadlin in combination with another medicine called ezabenlimab with chemotherapy. Brigimadlin is a so-called MDM2-p53 antagonist that is being developed to treat cancer. Ezabenlimab is an antibody that may help the immune system fight cancer.
Participants are put into 3 groups by chance:
* Ezabenlimab group: Participants receive ezabenlimab as an infusion into a vein every 3 weeks
* Brigimadlin + ezabenlimab group: Participants take brigimadlin as tablets and receive ezabenlimab as an infusion into a vein every 3 weeks
* Chemotherapy group: Participants get chemotherapy as an infusion into a vein on 2 days every 3 weeks. Chemotherapy is a combination of gemcitabine and docetaxel which is often used in the treatment of sarcoma.
There are twice as many participants in the brigimadlin + ezabenlimab group and in the chemotherapy group, compared to those in the ezabenlimab group.
Participants can continue treatment in the study as long as they benefit from it and can tolerate it.
Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. Participants in this study use an app on a mobile phone to regularly answer questions about their health and well-being. This is to find out if their quality of life is changing.

Start Date27 Jun 2024

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT06084689

/ WithdrawnPhase 2IIT

Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures

Phase II, multicenter, open-label, multi-cohort proof-of-concept study designed to evaluate the safety and efficacy of Ezabenlimab combined with BI 907828 in patients with unresectable, locally advanced or metastatic solid tumors.

Start Date14 Jun 2024

Sponsor / Collaborator

Institut Bergonié

[+1]

NCT06091930

/ RecruitingPhase 1

Phase I, Non-randomised, Open-label, Multi-centre Dose Escalation and Expansion Trial of BI 765049 and BI 765049 + Ezabenlimab Administered by Repeated Intravenous Infusion in Asian Patients With Malignant Solid Tumours Expressing B7-H6

This is a study in adults from Asia with different types of advanced cancer (solid tumours). People can join the study if they have cancer of the stomach, large bowel and rectum, pancreas, liver, head and neck or non-small cell lung cancer. This is a study for people for whom previous treatment was not successful or no treatment exists. People can participate if their tumour has the B7-H6 marker.
The purpose of this study is to find the highest dose of BI 765049 that people with advanced cancer can tolerate when taken (alone and) together with ezabenlimab. Another purpose is to check whether BI 765049 taken (alone and) together with ezabenlimab can make tumours shrink. Both medicines may help the immune system fight cancer.
Participants can stay in the study up to 3 years, as long as they can tolerate it and can benefit from it. During this time, they visit the study site about every 3 weeks. At the study site they get BI 765049 alone or in combination with ezabenlimab as an infusion into a vein. BI 765049 is given in 3-week cycles, ezabenlimab is given once every 3 weeks.
The doctors check the health of the participants and note any health problems that could have been caused by BI 765049 or ezabenlimab. Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body.

Start Date16 Feb 2024

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with Ezabenlimab

100 Translational Medicine associated with Ezabenlimab

100 Patents (Medical) associated with Ezabenlimab

Literatures (Medical) associated with Ezabenlimab

01 Dec 2025·Cancer Medicine

The Second Mitochondria‐Derived Activator of Caspases Mimetic BI 891065 in Patients With Advanced Solid Tumors: Results From Two Phase I Studies

Article

Author: Patel, Manish R. ; Harada, Akiko ; Hamilton, Erika P. ; Tachibana, Yoshifumi ; George, Ben ; Graeser, Ralph ; Kretschmar, Gunther ; Eleftheraki, Anastasia ; Yamamoto, Noboru

ABSTRACT:

Introduction:

BI 891065, a second mitochondria‐derived activator of caspases mimetic targets the inhibitor of apoptosis (IAP) family member cIAP1. We describe two first‐in‐human phase 1 trials assessing BI 891065 ± the anti‐programmed cell death protein‐1 (PD1) antibody, ezabenlimab, in advanced solid tumors.

Methods:

Trials were conducted in the USA (NCT03166631) and Japan (NCT04138823). Dose escalation of BI 891065 monotherapy (part A) and combined with ezabenlimab (part B) was guided by a Bayesian Logistic Regression Model with overdose control. Primary endpoints were maximum tolerated dose (MTD) and number of patients with dose‐limiting toxicities (DLTs) in Cycle 1. Other endpoints included objective response (RECIST v 1.1), pharmacokinetics, and changes in peripheral blood mononuclear cell (PBMC) and tumor cIAP1 levels.

Results:

Twenty‐five patients (USA study) received 5–400 mg daily BI 891065 monotherapy; 12 patients (Japan study) received 100 mg daily, 200 mg daily, or 200 mg twice‐daily BI 891065 monotherapy. No DLTs occurred in the USA study; three occurred in the Japan study: grade 3 increased bilirubin ( n = 2) and maculopapular rash ( n = 1). Neither study reached MTD for monotherapy. Treatment‐related adverse events (TRAEs) occurred in 52% and 75% of patients, respectively. BI 891065 plus ezabenlimab combination (USA study part B only) was received by 37 patients (50–400 mg daily, 200 mg twice‐daily) plus ezabenlimab (240 mg fixed‐dose, Day 1 of 21‐day cycles). One DLT occurred (grade 2 pneumonitis). MTD was not reached. TRAEs occurred in 81% of patients. Neither study reported objective responses; 25%–40% and 35% of patients achieved stable disease with BI 891065 monotherapy and the combination, respectively. cIAP1 levels were reduced in PBMCs and biopsies.

Conclusions:

BI 891065 was tolerable in patients with advanced solid tumors, demonstrating target engagement as monotherapy and combined with ezabenlimab. Both studies ended early due to efficacy data that were insufficiently promising to justify continuation.

Trial Registration:

NCT03166631, NCT04138823

01 Dec 2025·LANCET ONCOLOGY

Ezabenlimab and induction chemotherapy followed by adaptive chemoradiotherapy in patients with stage 3 squamous cell anal carcinoma (INTERACT-ION): an open-label, single-arm, phase 2 trial

Article

Author: Tougeron, David ; Ghiringhelli, Francois ; Rebucci-Peixoto, Magali ; Boustani, Jihane ; Chennoufi, Sarah ; Quero, Laurent ; Coutzac, Clélia ; Nguyen, Thierry ; Kim, Stefano ; Borg, Christophe ; Chibaudel, Benoist ; Vienot, Angélique ; Meurisse, Aurélia ; Maritaz, Christophe ; Vernet, Chloé ; Vernerey, Dewi ; Bouché, Olivier ; Iseas, Soledad ; Evesque, Ludovic

BACKGROUND:

The standard of care for patients with locally advanced squamous cell anal carcinoma (SCAC) is concurrent chemoradiotherapy; however, recurrence rates are almost 40% and severe toxic effects include treatment-related colostomy. Anti-PD-1 agents are effective in those with treatment-naive recurrent or metastatic SCAC. We aimed to evaluate the activity and safety of the PD-1 inhibitor ezabenlimab plus modified docetaxel, cisplatin, and fluorouracil (mDCF) in patients with treatment-naive stage 3 SCAC.

METHODS:

This open-label, single-arm, phase 2 trial was conducted at ten French hospitals and university hospitals. Eligible patients (aged ≥18 years with stage 3 SCAC [TxN1 or T4N0], Eastern Cooperative Oncology Group performance status score of 0-1, and adequate haematological and end-organ function) received induction treatment with intravenous mDCF every 2 weeks for four cycles (docetaxel 40 mg/m² on day 1, cisplatin 40 mg/m² on day 1, and fluorouracil 1200 mg/m² on days 1 and 2) and intravenous ezabenlimab 240 mg every 3 weeks for three cycles. After induction at 8 weeks, patients were assessed using Response Evaluation Criteria in Solid Tumours (version 1.1). Those without disease progression received two additional cycles of mDCF and one additional cycle of ezabenlimab. Patients with a major response (defined as a radiological objective response [≥30% tumour reduction]) and pathological complete or near-complete response (<10% viable cells) at biopsy and biological complete response (defined as no residual HPV circulating tumour DNA) received intensity-modulated radiotherapy with involved-node chemoradiotherapy (INRT), then seven cycles of ezabenlimab maintenance therapy (240 mg intravenously every 3 weeks). Patients who did not respond received standard concurrent chemoradiotherapy. The primary endpoint was clinical complete response at 40 weeks (with a lower 90% CI greater than 65%), assessed in the modified intention-to-treat (mITT) population (defined as all evaluable patients who received at least one cycle of treatment). This study is registered with ClinicalTrials.gov, NCT04719988 (active, not recruiting).

FINDINGS:

Between Jan 4, 2022, and Nov 20, 2023, 60 patients were assessed for eligibility, five were ineligible, 55 were enrolled, and 54 were evaluable (mITT population). The median age was 63·9 years (IQR 57·1-72·3). 42 (76%) of 55 patients were female and 13 (24%) were male. After induction, 41 (84%) of 49 evaluable patients reached a pathological complete or near-complete response and 36 (90%) of 40 had a biological complete response. 38 (75%) of 51 patients received INRT and 13 (26%) received standard concurrent chemoradiotherapy. Clinical complete response rates at 40 weeks were 86·8% (90% CI 74·3-94·7) with INRT in 33 patients and 69·2% (42·7-88·7) with concurrent chemoradiotherapy in nine patients (overall 77·8% [66·5-86·7]). Grade 3 or worse treatment-related adverse events were neutropenia (three [6%]), nausea, diarrhoea, anaemia, and asthenia (two [4%] each) during induction; lymphopenia (17 [45%]), neutropenia (seven [18%]), epithelitis (six [16%]), anal inflammation (five [13%]), and thrombocytopenia (three [8%]) during INRT; lymphopenia (13 [100%]), thrombocytopenia, anal inflammation (three [23%]), neutropenia (two [15%]), and diarrhoea (two [15%]) during concurrent chemoradiotherapy; and lipase increase, CMV colitis, and lichen planus (one [3%] each) during maintenance. Serious adverse events occurred in 20 (36%) patients; the most common were diarrhoea, nausea, and neutropenia during induction (two [4%] each). Seven (13%) of 55 patients died during the study, with three attributed to adverse events. There were no treatment-related deaths during the study.

INTERPRETATION:

Our study met the primary endpoint, showing antitumour activity (clinical complete response rates) and a manageable safety profile for ezabenlimab and mDCF induction when given with INRT in patients with locally advanced SCAC, enabling personalised INRT, and supporting phase 3 trials of this treatment in patients with stage 3 SCAC.

FUNDING:

Centre Hospitalier Universitaire de Besançon and Boehringer Ingelheim.

01 Jul 2024·Ophthalmology and therapy

RETRACTED ARTICLE: Cystoid Macular Oedema in a Patient Treated with STING Agonist and Ezabenlimab for Disseminated Melanoma

Article

Author: Kiraly, Peter ; Fischer, M Dominik

IntroductionWe describe a case of cystoid macular oedema associated with combination treatment using a STING agonist and ezabenlimab for disseminated melanoma.Case ReportA 66-year-old male patient presented with worsening vision and cystoid macular oedema in the right eye, along with a small accumulation of subretinal fluid in the left eye. The patient has been undergoing treatment for melanoma since 2014. Five months prior to the ocular presentation, the patient was enrolled in a first-in-human trial with a STING agonist and ezabenlimab. Topical treatment with dexamethasone 0.1% drops and ketorolac 0.5% drops was prescribed, and he continued with systemic immunotherapy. After 6 weeks, morphological and functional improvement was noted; however, cystoid macular oedema persisted. Consequently, systemic immunotherapy was temporarily suspended. After an additional 4 weeks, cystoid macular oedema regressed in the right eye and subretinal fluid completely resolved in the left eye.ConclusionsIn the first-in-human trial with a STING agonist and ezabenlimab for melanoma, cystoid macular oedema emerged as a notable ocular side effect with vision worsening. This case highlights the importance of careful ocular monitoring in patients receiving this combination therapy. The cGAS-STING pathway is an important target for future research in treating ocular inflammatory conditions.

News (Medical) associated with Ezabenlimab

29 May 2025

·www.prnewswire.com

John Theurer Cancer Center Presents Innovative Cancer Research at Major Annual Cancer Meeting, Offering New Hope for Patients

Presentations and publications address novel therapeutics, molecular biology studies, and global trends for blood cancers and solid tumors HACKENSACK, N.J., May 29, 2025 /PRNewswire/ -- Investigators from Hackensack Meridian John Theurer Cancer Center (JTCC)—part of the National Cancer Institute-designated Lombardi Comprehensive Cancer Center at Georgetown University—and Hackensack University Medical Center are reporting research findings from 32 studies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting is the premier event for cancer professionals and takes place in Chicago from May 30 to June 3. "The future of cancer treatment begins with the pioneering exploration being carried out today," notes Andre Goy, MD, chair, vice president, physician-in-chief of oncology, at Hackensack Meridian John Theurer Cancer Center. "We are fortunate to be in a time where many cancers will respond to standard treatments. But for those cancers that don't, it's critical that patients have access to a world-class research program that will yield innovative therapies. At John Theurer Cancer Center, our globally recognized investigators continue to drive the latest oncology advances in cellular therapy, immunotherapy and other areas, enabling improved outcomes for patients across the Hackensack Meridian Health network and beyond." Several studies address novel drug combinations for multiple myeloma, as well as racial disparities in treatment outcomes and the expression of key biomarkers. Investigators are also presenting data on emerging immunotherapies for leukemia and lymphoma, molecular markers predicting disease relapse, and innovative treatment regimens such as all-oral therapies for acute myeloid leukemia. Solid tumor studies focus on disparities in gastric cancer, machine learning applications for breast cancer metastasis, and promising antibody-drug conjugates for lung cancer. Investigations related to melanoma and skin cancer examine circulating tumor DNA as a marker for disease progression, comparative survival analyses based on biomarkers, and the identification of targetable mutations across different skin cancer types. These findings underscore the breadth of ongoing efforts at John Theurer Cancer Center—New Jersey's largest cancer center—to refine therapeutic strategies, enhance precision oncology, and improve patient outcomes. Multiple Myeloma Research Carfilzomib, iberdomide, and dexamethasone in patients with transplant-eligible newly diagnosed multiple myeloma: Updated results from phase 1/2 study Updated results from phase 2b study of selinexor in combination with carfilzomib, daratumumab, or pomalidomide in patients with multiple myeloma relapsing on current therapy Real-world outcomes of patients with multiple myeloma treated with T-cell engagers compared to those treated on clinical trials Impact of racial disparities on efficacy and safety outcomes for patients with relapsing/refractory multiple myeloma receiving T-cell engagers Heterogeneity in the expression of GPRC5D between patients with multiple myeloma Evaluation of immune checkpoint inhibitors and concurrent radiation therapy for the treatment of extramedullary multiple myeloma Global burden of multiple myeloma: Analysis from 1980 to 2021 Efficacy and safety of less frequent dosing with elranatamab in patients with relapsed or refractory multiple myeloma: A US subgroup analysis from MagnetisMM-3 Leukemia and Lymphoma Peripheral blood cell-free DNA testing as a predictor for relapse post-allogeneic stem cell transplant for acute myeloid leukemia An all-oral regimen of decitabine-cedazuridine plus venetoclax in patients with newly diagnosed acute myeloid leukemia ineligible for intensive induction chemotherapy: Results from a phase 2 cohort of 101 pts Employing novel pan-cancer targets for immunotherapy in leukemias and solid tumors MRD negativity after end of induction in the phase 3 PhALLCON trial: A post hoc analysis Results from the completed dose-finding part of phase 2 study of the innate cell engager acimtamig (AFM13) in combination with AlloNK (AB-101) in relapsed or refractory classical Hodgkin lymphoma (LuminICE-203) Novel analysis of 3-y results from the pivotal EPCORE NHL-1 study: Outcomes in patients with relapsed/refractory large B-cell lymphoma and complete response at 2 years with epcoritamab monotherapy TITANium: An open-label, global multicenter phase 1/2 study of AZD5492, a first-in-class subcutaneous CD8-guided tri-specific T-cell engager, in patients with relapsed or refractory B-cell malignancies Solid Tumor Research Limited changes in the central nervous system immune microenvironment in patients with breast cancer metastasis and capturing these changes using machine learning Relationship between FOLR1 expression and pan-cancer subgroup of tumors with specific transcriptomic profile Disparities and trends in gastric cancer: Incidence, mortality, and stage-specific trends Prevalence of the HPV, EBV, and TTV viral RNA in the plasma of patients with solid and hematologic neoplasms and the detection of a specific immune signature Global trends in soft tissue and extraosseous sarcomas (1980–2021): Regional and economic disparities ZL-1310, a DLL3 antibody-drug conjugate, in patients with extensive stage small cell lung cancer: Phase 1 trial update Ongoing phase 1/2 trial of the hematopoietic progenitor kinase 1 (HPK1) inhibitor NDI-101150 as monotherapy or in combination with pembrolizumab: Clinical safety and efficacy update in clear cell renal cell carcinoma Ipilimumab and nivolumab in patients with metastatic clear cell renal cell carcinoma treated on the phase 3 PDIGREE (Alliance A031704) trial: Results from Step 1 analysis Initial safety and efficacy results from a first-in-human, phase 1/2 study of SAR445877, an anti-PD-1/IL-15 fusion protein, for patients with advanced solid tumors An open-label, phase I trial of the SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab in patients with advanced solid tumors A phase 1 dose escalation and dose expansion study for LNCB74, a B7-H4 targeted antibody drug conjugate, as monotherapy in participants with advanced solid tumors A phase 1, open-label, multi-center study of the safety, tolerability, and efficacy of IPH4502 as a single agent in advanced solid tumors A phase 2 safety and efficacy study of PRT3789 in combination with pembrolizumab in patients with advanced or metastatic solid tumors and a SMARCA4 mutation Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) for newly diagnosed localized prostate cancer Melanoma and Other Skin Cancers Comparison of ctDNA and hematologic ratios as markers of disease progression in early versus late-stage melanoma: A single-center retrospective study Survival analysis based on markers of progression in melanoma: A single-center comparison of survival in patients with high vs low biomarkers Targetable mutations in cutaneous skin cancers: A comparative study across melanoma, squamous cell carcinoma, basal cell carcinoma, and Merkel cell carcinoma SOURCE Hackensack Meridian John Theurer Cancer Center WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 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ASCOClinical ResultImmunotherapyPhase 1Phase 2

22 May 2025

·www.einpresswire.com

Boehringer Ingelheim to present early clinical evidence of innate immune modulation and anti-tumor activity via SIRPα blockade in two ongoing trials at ASCO 2025

· BI 765063 in combination with programmed cell death-1 (PD1) inhibitor antibody ezabenlimab + cetuximab demonstrated a well-tolerated safety profile and potentially promising efficacy signals as second-line treatment in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). · Next generation SIRP α inhibitor BI 770371 was shown to be well tolerated alone and in combination with PD1 inhibitor ezabenlimab in a dose escalation trial in patients with advanced solid tumors. BI 770371 is currently being further investigated in a Phase 1b study in first-line patients with R/M HNSCC. Ingelheim, Germany, 22 May 2025 – Boehringer Ingelheim today announced that new clinical data from two early-stage trials targeting the signal regulatory protein α (SIRP α ) innate immune checkpoint will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 - June 3, 2025, in Chicago, IL, USA. In a Phase 1b study conducted by Boehringer, its potential, first-in-class SIRP α monoclonal antibody, BI 765063, demonstrated a manageable safety profile as well as preliminary signs of immune activation and additive antitumor activity when combined with PD-1 inhibitor ezabenlimab and cetuximab in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). [1] Additionally, in an open-label, Phase I trial conducted by Boehringer, its next-generation SIRP α monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab, was shown to be well tolerated in patients with advanced solid tumors. There were no dose-limiting toxicities in either treatment arm, and the maximum tolerated dose was not reached in either group. [2] “The preliminary results from these early-stage programs are encouraging and further strengthen Boehringer’s robust immuno-oncology pipeline aimed at accelerating next-generation cancer therapies to address high unmet patient needs,” said Mike Akimov, Head of Medicine, Therapy Area Oncology at Boehringer Ingelheim. “Boehringer is developing various complementary approaches to activate the immune system against cancer cells and SIRP α blockade paired with a PD-1 inhibitor is a promising strategy. We look forward to seeing if this dual activation may lead to a broader and more sustained anti-tumor response as the programs progress. ” BI 765063 and BI 770371 are designed to block the “don’t eat me” signal that cancer cells use to hide from the immune system. By targeting SIRP α , these antibodies help immune cells like macrophages recognize and destroy tumor cells, bolstering the body’s natural defenses. [3] Both antibodies have been developed in partnership with OSE, with Boehringer solely responsible for future clinical development and commercialization. Boehringer will move forward with the improved next generation SIRP α inhibitor antibody BI 770371, which will now be tested in a Phase 1b study. Presentation Details: Title: An Open-Label, Phase Ib Trial of the SIRP α Inhibitor BI 765063 in Combination with the PD-1 Inhibitor Ezabenlimab and Cetuximab in Patients (pts) with Head and Neck Squamous Cell Carcinoma Abstract Number: 6019 Session Type/Title: Rapid Oral Abstract – Developmental Therapeutics – Immunotherapy Date/Time: 01 June 2025 – 11:30am – 1:30pm CDT Title: An Open-label, Phase I Trial of the SIRP α Monoclonal Antibody, BI 770371, Alone and in Combination with the PD-1 Inhibitor Ezabenlimab in Patients with Advanced Solid Tumors Abstract Number: 2515 Session Type/Title: Rapid Oral Abstract – Developmental Therapeutics – Immunotherapy Date/Time: 01 June 2025 – 11:15am – 12:45pm CDT Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer Ingelheim takes a long-term perspective, embedding sustainability along the entire value chain. More than 54,500 employees serve over 130 markets to build a healthier, more sustainable and equitable tomorrow. Learn more at https://www.boehringer-ingelheim.com (Global). OSE Immunotherapeutics OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com . Click and follow us on LinkedIn. Intended Audiences Notice This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business. Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2024, including the annual financial report for the fiscal year 2023, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. Contacts Boehringer Ingelheim Linda Ruckel +1 203-791-6672 linda.ruckel@boehringer-ingelheim.com Reinhard Malin +49 (6132) 77-90815 reinhard.malin@boehringer-ingelheim.com OSE Immunotherapeutics Fiona Olivier fiona.olivier@ose-immuno.com Sylvie Détry sylvie.detry@ose-immuno.com French Media Contact FP2COM Florence Portejoie fportejoie@fp2com.fr +33 6 07 768 283 U.S. Media Contact Rooney Partners LLC Kate Barrette kbarrette@rooneypartners.com +1 212 223 0561 [1] An open-label, phase Ib trial of the SIRP α inhibitor BI 765063 in combination with the PD-1 inhibitor ezabenlimab and cetuximab in patients (pts) with head and neck squamous cell carcinoma. - ASCO [1] An open-label, phase I trial of the SIRP α monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab in patients with advanced solid tumors. - ASCO [3] Lopez-Yrigoyen, M., et al. (2017). Anti-SIRP α antibody immunotherapy enhances neutrophil and macrophage antitumor activity. Proceedings of the National Academy of Sciences, 114(33), 201710877. https://doi-org.sutd.idm.oclc.org/10.1073/pnas.1710877114*:contentReference[oaicite:2]{index=2} Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 1ImmunotherapyASCOClinical Result

03 Jul 2024

·www.pharmaceutical-technology.com

AbbVie licenses OSE’s chronic inflammation therapy for $48m upfront

OSE-230 is a ChemR23, a G-Protein coupled receptor (GPCR) targeting monoclonal antibody. Image Credit: Poetra.RH / Shutterstock. AbbVie has signed a partnership and licensing agreement with OSE Immunotherapeutics for the latter’s monoclonal antibody OSE-230 in a deal worth up to $713m. OSE-230 is a monoclonal antibody that targets ChemR23, a G-Protein coupled receptor (GPCR). The therapy can potentially resolve chronic inflammation and modulate the function of macrophages and neutrophils. It is currently in preclinical development. Following the news, OSE’s stock was up by more than 55% in trading today. The French pharmaceutical company’s market cap stands at $111.2m. Under the collaboration agreement, AbbVie will pay $48m in upfront payment for the exclusive global licence of the therapy. OSE will also be in line to receive up to $665m in milestone-based payments along with tiered royalties on net sales. OSE has a pipeline of multiple monoclonal antibody candidates that it is developing in collaboration with other pharmaceutical companies. The company is developing two signal regulatory protein α (SIRPα) targeting monoclonal antibodies—BI 765063/ OSE-172 and BI 770371—in collaboration with Boehringer Ingelheim. BI 765063 is being evaluated as a combination therapy with different cancer therapies such as Boehringer’s ezabenlimab, BI 836880, chemotherapy, and Eli Lilly’s Erbitux (cetuximab) in a Phase I trial (NCT05249426). BI 770371 is being evaluated as a monotherapy and in combination with a PD1 inhibitor, BI 754091, in an international Phase I dose escalation and expansion trial (NCT05327946) in patients with solid tumours. OSE is also developing an anti-CD28 selective monoclonal antibody FR104/VEL-101 in partnership with Denmark-based Veloxis Pharmaceuticals. It is being researched as a treatment to help prevent organ rejection in people who have had a kidney transplant. In February 2022, the therapy received a fast track designation by the FDA for prophylaxis against transplant rejection. Veloxis is planning Phase II trials for the subcutaneous therapy. AbbVie has also made recent investments related to antibody therapies. In December 2023, it partnered with BigHat Biosciences to identify and develop antibody therapies in oncology and neuroscience indications. On a larger scale, in November 2023, AbbVie announced a $10.1bn ImmunoGen acquisition deal. The antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine-gynx) was a central part of the deal. The therapy was granted priority review by the US Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) action date of 5 April 2024.

Phase 1License out/inPriority ReviewFast TrackADC

100 Deals associated with Ezabenlimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Soft Tissue Sarcoma	Phase 3	-	Boehringer Ingelheim GmbH	27 Jun 2024
myxoid MFH	Phase 3	-	Boehringer Ingelheim GmbH	27 Jun 2024
Biliary Tract Neoplasms	Phase 2	France	Boehringer Ingelheim GmbH	14 Jun 2024
Microsatellite instability-high colorectal cancer	Phase 2	France	Boehringer Ingelheim GmbH	14 Jun 2024
Soft Tissue Sarcoma	Phase 2	France	Boehringer Ingelheim GmbH	14 Jun 2024
Triple Negative Breast Cancer	Phase 2	France	Boehringer Ingelheim GmbH	14 Jun 2024
Anal canal squamous cell carcinoma	Phase 2	South Korea	Boehringer Ingelheim GmbH	14 Sep 2020
Anus Neoplasms	Phase 2	South Korea	Boehringer Ingelheim GmbH	14 Sep 2020
Adenocarcinoma of Esophagus	Phase 2	United States	Boehringer Ingelheim GmbH	19 Mar 2019
Adenocarcinoma of Esophagus	Phase 2	Canada	Boehringer Ingelheim GmbH	19 Mar 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02952248 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm	110	Ezabenlimab (Phase Ia Dose Escalation: 80 mg Ezabenlimab)	ntivwaeaem = soqlybeige bbjeflxnzu (gakbgrpfcm, ikgshatbay - vymidhqjqf) View more	-	27 Jan 2026
				Ezabenlimab (Phase Ia Dose Escalation: 240 mg Ezabenlimab)	ntivwaeaem = oripwghnny bbjeflxnzu (gakbgrpfcm, wxqgembrdp - hdvmnsvefo) View more
NCT03697304 (CTgov)	Phase 2	Solid tumor \| Adenocarcinoma of Esophagus \| Endometrial Carcinoma ... View more	211	BI 836880+Ezabenlimab (Module C, Cohort 1: GEC Patients)	pntglthhut = yptmctbgxz kizspbbsup (qdixvyhpwi, klmqayobfu - bhrioovnoj) View more	-	27 Jan 2026
				BI 836880+Ezabenlimab (Module C, Cohort 2: 2ary Resistance Patients)	pntglthhut = gcebjpujll kizspbbsup (qdixvyhpwi, gaefyupplk - xkyqavncqd) View more
NCT03780725 (CTgov)	Phase 1	Squamous Cell Carcinoma of Head and Neck \| Advanced Lung Non-Small Cell Carcinoma	8	BI 754111+BI 754091 (Part 1: Ezabenlimab 240mg + BI 754111 600mg)	dmqiljeeoa(hsatqffaoo) = udrdtcialk unzagyejxe (jgchjoqtfj, 1.0) View more	-	13 Jan 2026
				BI 754111+BI 754091 (Part 2: Ezabenlimab 240mg + BI 754111 40mg)	ekemwbujab(fuhxkgaryq) = lshechcxjo mdkwulhfrw (zgdmxojclh, 4.4) View more
NCT03433898 (CTgov)	Early Phase 1	Advanced Malignant Solid Neoplasm	146	Ezabenlimab (Part I - ezabenlimab 240 mg)	oayhsprcfe = tekkkymdko gtnjvgbxrg (vnnjucodbs, szxnofbsxo - apdzngcfkd) View more	-	19 Dec 2025
				BI 754111+Ezabenlimab (Part II - ezabenlimab 240 mg + BI 754111 400 mg)	dfdhqkvhss = iztgrzmlhf umeepsoftv (ixgfvqlcuv, ufusyzuojg - eufzrhcjzq) View more
NCT03972150 (Phase I study of the VEGF/Ang-2 inhibitor BI 836880, CTgov)	Phase 1	Advanced Malignant Solid Neoplasm \| Advanced cancer	21	BI 836880 (Part 1: 360 mg BI 836880)	xayyjdrtas = kgbwfocdax mfgyipheyo (kzdkbjsgby, ohveafmxdv - bdcqcoiwor) View more	-	06 Oct 2025
				BI 836880 (Part 1: 720 mg BI 836880)	xayyjdrtas = uohthfyqvs mfgyipheyo (kzdkbjsgby, isqujkwpta - wizkjyxdon) View more
NCT05249426 (ASCO2025) Manual	Phase 1	Squamous Cell Carcinoma of Head and Neck Second line	17	BI 765063 + Ezabenlimab + Cetuximab	uistlsznpj(svexcdiubs) = fcoufsblhk njucwdomxs (dcyjaodixx ) View more	Positive	30 May 2025
NCT05327946 (Phase I trial of the SIRPα monoclonal antibody, ASCO2025)	Phase 1	Advanced Malignant Solid Neoplasm	-	BI 770371 monotherapy	ezslfcnwpp(tvqfdeqnmn) = resolved within 1 week snujwnvyyh (wgftmtbnio )	Positive	30 May 2025
				BI 770371 + ezabenlimab combination
NCT05446129 (CTgov)	Phase 1	Colorectal Cancer	2	BI 765063+Ezabenlimab (Ezabenlimab + BI 765063)	qlughwsvgn = ayramiwdnq ddjwyunvdx (crexjhbzsw, plmntlbreu - tuovuozsed) View more	-	13 Mar 2025
				Pembrolizumab+BI 765063 (Pembrolizumab + BI 765063)	qlughwsvgn = rtmmwqxxdj ddjwyunvdx (crexjhbzsw, qfxpjnwcwl - deqjsaoffj) View more
NCT03972150 (Phase I study of the VEGF/Ang-2 inhibitor BI 836880, Pubmed \| Cancer Chemother Pharmacol)	Phase 1	Advanced Malignant Solid Neoplasm	21	BI 836880 360 mg	vaelsgzkpu(rglpeyzocw) = MTD was not reached xspnfgourp (ebbcwhjrtx ) View more	Positive	01 Jun 2023
				BI 836880 720 mg
NCT04839471 (BEAR, ESMO_ASIA2022) Manual	Phase 2	Esophageal Squamous Cell Carcinoma	19	afatinib 30 mg+BI-754901 240 mg	aautwdpbzx(gyfgavwncz) = phxdggxcrk bhlszkozwe (yzbajlteyu, 3.8 - 6.1) View more	Positive	03 Dec 2022

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