Latest news with #SIRPα
National Post
5 days ago
- Business
- National Post
Byondis Announces First Patient Dosed in Phase 1 Clinical Trial of Novel SIRPα-Directed Monoclonal Antibody BYON4228 in Patients With Advanced or Metastatic Solid Tumors
Article content Two-Part Dose Escalation and Expansion Trial Will Evaluate Efficacy and Safety of BYON4228 Alone and in Combination with Pembrolizumab Article content Article content NIJMEGEN, The Netherlands — Byondis B.V., an independent clinical stage biopharmaceutical company creating innovative targeted medicines for patients with cancer, announces the first patient dosed in its Phase 1 dose escalation and expansion BYON4228.002 clinical trial to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of novel SIRPα-directed monoclonal antibody (mAb) BYON4228 alone and in combination with pembrolizumab in patients with advanced or metastatic solid tumors. Article content BYON4228 is a potential best-in-class novel mAb that targets and blocks the CD47-SIRPα axis, responsible for tumors' ability to escape from recognition and destruction by the immune system. By targeting SIRPα and not CD47, BYON4228 offers selective targeting of myeloid cells and avoids disruption of other biologically meaningful CD47-dependent interactions. In preclinical studies, BYON4228 was found to potentiate the tumor killing capacity of tumor-targeting mAbs tested without the toxicity associated with CD47 agents. Article content 'Building on strong preclinical data, we believe that there is broad potential for BYON4228 alone and in combination with tumor-targeting mAbs, checkpoint inhibitors and antibody drug conjugates and other modalities across hematological and solid tumors,' said Louis Denis, MD, Chief Medical Officer, Byondis. 'We look forward to evaluating the results of this trial to support the clinical development of BYON4228 alone and in combination with other agents and to bring a new therapeutic option to patients with high unmet medical need.' Article content Part 1 of the BYON4228.002 trial will evaluate the safety of BYON4228 alone and in combination to determine the maximum tolerated dose (MTD), or optimal biological dose (OBD) if the MTD is not reached, and recommended combination dose regimen(s) for expansion (RDE(s)). The second part of the trial will evaluate the objective tumor response rate (ORR). The secondary objectives of this trial are safety, pharmacokinetics, immunogenicity and preliminary efficacy. The trial will be conducted at multiple sites across Europe, including the United Kingdom, Belgium and Spain. Article content BYON4228 is a novel monoclonal antibody (mAb) from Byondis' next generation immuno-oncology (IO) program that targets and blocks the CD47-SIRPα axis, responsible for tumors' ability to escape from recognition and destruction by the immune system. BYON4228 is currently being studied in two Phase 1 Clinical Trials evaluating BYON4228 alone and in combination with Rituximab in patients with Relapsed/Refractory CD20 positive B-cell Non-Hodgkin's Lymphoma (NHL) (NCT05737628) and BYON4228 alone and in combination with pembrolizumab in patients with advanced or metastatic solid tumors (NCT06932952). Article content Driven to improve patients' lives, Byondis is an independent clinical stage fully integrated biopharmaceutical research and development company creating innovative targeted medicines for cancer. The company is developing new biological entities (NBEs) with a focus on antibody-drug conjugates and antibody-based therapeutics. Article content Byondis' broad development portfolio comprises preclinical and early-stage clinical programs. The product candidates combine Byondis' expertise in linker-drug (LD) technology, antibody-drug conjugation, targeted cytotoxic therapy, immunology, and monoclonal antibody (mAb) development. Byondis' expertise covers all preclinical R&D from early lead finding to production of clinical batches of the selected product candidates, which are all done in-house. Article content Article content Article content Article content Article content Article content
Yahoo
23-05-2025
- Business
- Yahoo
OSE Immunotherapeutics Announces that its Partner Boehringer Ingelheim Will Present Early Clinical Evidence of Innate Immune Modulation and Anti-Tumor Activity via SIRPα Blockade in Two Ongoing Trials at ASCO 2025
OSE Immunotherapeutics Announces that its Partner Boehringer Ingelheim Will 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 SIRPα 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. Nantes, France, 23 May 2025 – OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE), today proudly announced that its partner Boehringer Ingelheim will present new clinical data from two early-stage trials targeting the signal regulatory protein α (SIRPα) innate immune checkpoint 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 SIRPα 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 SIRPα 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 SIRPα 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 SIRPα, 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 Immunotherapeutics, with Boehringer solely responsible for future clinical development and commercialization. Boehringer will move forward with the improved next generation SIRPα 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 SIRPα 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: 6019Session Type/Title: Rapid Oral Abstract – Developmental Therapeutics – ImmunotherapyDate/Time: 01 June 2025 – 11:30am – 1:30pm CDT Title: 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 TumorsAbstract Number: 2515Session Type/Title: Rapid Oral Abstract – Developmental Therapeutics – ImmunotherapyDate/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 54,400 employees serve over 130 markets to build a healthier, more sustainable and equitable tomorrow. Learn more at (Global). OSE ImmunotherapeuticsOSE 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: Click and follow us on LinkedIn. Contacts Boehringer Ingelheim Linda Ruckel+1 Reinhard Malin+49 (6132) OSE ImmunotherapeuticsFiona Dé French Media Contact FP2COMFlorence Portejoiefportejoie@ 6 07 768 283 U.S. Media ContactRooney Partners LLCKate Barrettekbarrette@ 212 223 0561 Forward-looking statementsThis 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, 2025, including the annual financial report for the fiscal year 2024, 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. 1 Link to the abstract2 Link to the abstract 3 Lopez-Yrigoyen, M., et al. (2017). Anti-SIRPα antibody immunotherapy enhances neutrophil and macrophage antitumor activity. Proceedings of the National Academy of Sciences, 114(33), 201710877. Attachment EN_250523_ASCO BI_OSE_vfError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
23-05-2025
- Business
- Yahoo
OSE Immunotherapeutics Announces that its Partner Boehringer Ingelheim Will Present Early Clinical Evidence of Innate Immune Modulation and Anti-Tumor Activity via SIRPα Blockade in Two Ongoing Trials at ASCO 2025
OSE Immunotherapeutics Announces that its Partner Boehringer Ingelheim Will 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 SIRPα 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. Nantes, France, 23 May 2025 – OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE), today proudly announced that its partner Boehringer Ingelheim will present new clinical data from two early-stage trials targeting the signal regulatory protein α (SIRPα) innate immune checkpoint 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 SIRPα 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 SIRPα 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 SIRPα 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 SIRPα, 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 Immunotherapeutics, with Boehringer solely responsible for future clinical development and commercialization. Boehringer will move forward with the improved next generation SIRPα 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 SIRPα 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: 6019Session Type/Title: Rapid Oral Abstract – Developmental Therapeutics – ImmunotherapyDate/Time: 01 June 2025 – 11:30am – 1:30pm CDT Title: 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 TumorsAbstract Number: 2515Session Type/Title: Rapid Oral Abstract – Developmental Therapeutics – ImmunotherapyDate/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 54,400 employees serve over 130 markets to build a healthier, more sustainable and equitable tomorrow. Learn more at (Global). OSE ImmunotherapeuticsOSE 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: Click and follow us on LinkedIn. Contacts Boehringer Ingelheim Linda Ruckel+1 Reinhard Malin+49 (6132) OSE ImmunotherapeuticsFiona Dé French Media Contact FP2COMFlorence Portejoiefportejoie@ 6 07 768 283 U.S. Media ContactRooney Partners LLCKate Barrettekbarrette@ 212 223 0561 Forward-looking statementsThis 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, 2025, including the annual financial report for the fiscal year 2024, 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. 1 Link to the abstract2 Link to the abstract 3 Lopez-Yrigoyen, M., et al. (2017). Anti-SIRPα antibody immunotherapy enhances neutrophil and macrophage antitumor activity. Proceedings of the National Academy of Sciences, 114(33), 201710877. Attachment EN_250523_ASCO BI_OSE_vfError while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Business Upturn
22-05-2025
- Business
- Business Upturn
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 (SIRPα) 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. Advertisement In a Phase 1b study conducted by Boehringer, its potential, first-in-class SIRPα 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 SIRPα 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 SIRPα 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 SIRPα, 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 SIRPα 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 SIRPα 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 SIRPα 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 (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: 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 OSE Immunotherapeutics Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
Yahoo
22-05-2025
- Business
- Yahoo
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 SIRPα 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 (SIRPα) 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 SIRPα 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 SIRPα 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 SIRPα 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 SIRPα, 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 SIRPα 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 SIRPα 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 SIRPα 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 (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: 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 Reinhard Malin +49 (6132) OSE Immunotherapeutics Fiona Sylvie Détry French Media Contact FP2COM Florence Portejoie fportejoie@ +33 6 07 768 283 U.S. Media Contact Rooney Partners LLCKate Barrettekbarrette@ +1 212 223 0561 [1] An open-label, phase Ib trial of the SIRPα 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 SIRPα 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-SIRPα antibody immunotherapy enhances neutrophil and macrophage antitumor activity. Proceedings of the National Academy of Sciences, 114(33), 201710877. 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