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Yahoo
14-05-2025
- Business
- Yahoo
BioInvent Announces Updated Phase 2a Triple Combination Arm Data of BI-1206, rituximab, and Calquence for the Treatment of Non-Hodgkin's Lymphoma
Latest preliminary data show continued promising clinical activity in NHL patients, with two complete responses (CR), three partial responses (PR), and three stable disease (SD) as best clinical response in the first eight patients evaluated Results equate to an objective response rate (CRs and PRs) of 63% Data from an earlier cutoff date in February are included in an abstract published today by the European Hematology Association (EHA) 2025 conference LUND, SE / / May 14, 2025 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces latest updated data from the ongoing Phase 2a study of BI-1206 in combination with rituximab and Calquence® (acalabrutinib) for the treatment of non-Hodgkin's lymphoma (NHL). Additionally today, an abstract containing data from an earlier February cutoff date has been published by the European Hematology Association (EHA) as part of its 2025 congress due to take place June 12-15 in Milan, Italy. The data released today show the first eight patients in the triple combination arm of BioInvent's ongoing Phase 2a in non-Hodgkin's lymphoma. All patients exhibited disease control at first assessment (DCR 100%), and results show an overall objective response rate of 63% with two patients achieving a complete response (CR) and three patients with partial responses (PR). Stable disease (SD) was observed in the three remaining patients. The combination has been well tolerated in all patients treated at the cut-off-date. These data are further updated compared to the data included in the EHA abstract. "We continue to be encouraged by the early data demonstrating robust clinical activity and manageable safety profile in the ongoing triple combination arm of the Phase 2a study of BI-1206 in combination with rituximab and Calquence in NHL patients who have relapsed after previous lines of treatment," said Martin Welschof, Chief Executive Officer of BioInvent. "The objective responses observed to date highlight the potential of the combination to improve outcomes and overcome resistance, a result we believe is driven by the mechanism of action of BI-1206. Previously we have demonstrated that BI-1206 can restore response to rituximab in relapsed/refractory patients. Now we demonstrate that a BTK inhibitor may be added to this combination without compromising safety. We look forward to advancing the clinical development of this promising and highly convenient treatment." Details of the EHA abstract released today are below: Title: BI-1206, an Antibody Targeting FcγRIIB, given in Combination with Rituximab and Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin's LymphomaLead Author: Laura Fogliatto, Hospital de Clínicas de Porto Alegre, Porto Alegre, BrazilAbstract Number: PB3180 About the studyThe triple combination arm in the ongoing Phase 2a study combines the subcutaneous formulation of BI-1206 and rituximab with Calquence® (acalabrutinib) in subjects with indolent B-cell non-Hodgkin's lymphoma (NHL) relapsed or refractory to rituximab. Approximately 30 patients are expected to be enrolled in Spain, Germany, the US, and Brazil. In February 2024 BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence® for the combination arm. About BI-1206BI-1206 is one of BioInvent's lead drug candidates and is developed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab. The drug candidate is evaluated in two separate clinical programs, one for the treatment of non-Hodgkin's lymphoma (NHL, a type of blood cancer) and one for the treatment of solid tumors. About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: BioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release. This information is information that BioInvent International is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-05-14 15:30 CEST. Attachments BioInvent Announces Updated Phase 2a Triple Combination Arm Data of BI-1206, rituximab, and Calquence for the treatment of non-Hodgkin's lymphoma SOURCE: BioInvent International View the original press release on ACCESS Newswire
Yahoo
29-04-2025
- Business
- Yahoo
BioInvent International AB: Interim Report January
LUND, SE / / April 29, 2025 / BioInvent International (STO:BINV) "The first quarter of 2025 was a highly productive period across clinical development, regulatory milestones, and strategic partnerships - positioning us for strong momentum through the remainder of the year."- Martin Welschof CEO of BioInvent. EVENTS IN THE FIRST QUARTER (R) Positive initial efficacy data from Phase 2a trial of triple combination of the company's lead anti-FcyRIIB antibody BI-1206, rituximab and Calquence ® for the treatment of non-Hodgkin's Lymphoma (NHL) (R) Phase 1 data of the company's second anti-TNFR2 antibody BI-1910 as monotherapy for the treatment of solid tumors BioInvent achieved ISO 26000 Verification, highlighting commitment to ESG and transparency Composition of matter patent for the lead anti-TNFR2 antibody BI-1808 granted in Japan. It also covers the use of the antibody in the treatment of cancer BI-1808 received Orphan Drug Designation from FDA for the treatment of T-cell lymphoma BI-1808 showcased at the 16th Annual T-Cell Lymphoma Forum EVENTS AFTER THE END OF THE PERIOD BioInvent received milestone payment as Takeda moved mezagitamab into Phase 3 (R)= Regulatory event FINANCIAL INFORMATIONFirst quarter 2025 Net sales SEK 22.1 (5.9) million. Profit/loss after tax SEK -116.6 (-77.9) million. Profit/loss after tax per share before and after dilution SEK -1.77 (1.18). Cash flow from operating activities SEK -120.0 (-65.9) million. Liquid funds, current and long-term investments at the end of the period SEK 742.2 (1,219.2) million. The complete interim report is available for download below and on the company's website under Financial reports . About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory drug candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at . For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: BioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 Attachments BioInvent Q1, 2025 EN SOURCE: BioInvent International View the original press release on ACCESS Newswire Sign in to access your portfolio
Yahoo
07-02-2025
- Business
- Yahoo
Epitopea Appoints Klaus Edvardsen M.D., Ph.D. as Chief Medical Officer
CAMBRIDGE, United Kingdom and MONTREAL, Feb. 07, 2025 (GLOBE NEWSWIRE) -- Epitopea, a transatlantic cancer immunotherapeutics company developing accessible off-the-shelf RNA-based immunotherapies, announces the appointment of Dr. Klaus Edvardsen as its new Chief Medical Officer (CMO). Dr. Edvardsen, an accomplished oncology innovator and development leader, brings decades of clinical and strategic expertise to Epitopea as the company advances its pipeline of transformational cancer immunotherapies. Klaus joins Epitopea after serving as Chief Development Officer (CDO) at Nykode Therapeutics, where he oversaw clinical development, regulatory affairs, and project management across oncology, infectious diseases, and autoimmune diseases. Prior to Nykode, he was CDO and CMO at CureVac, where he led development programs spanning oncology, infectious diseases, and rare diseases. He was also Senior Vice President and Head of Global Oncology Development at Merck Healthcare KgaA, where he was accountable for all aspects of early and late-stage development in oncology. During his four-year tenure at AstraZeneca as Senior Vice President, Head of Global Medicines Development Oncology, Klaus played a pivotal role in the development and regulatory approvals of groundbreaking therapies, including Tagrisso®, Lynparza®, and Calquence®. His leadership was instrumental in securing the fastest FDA and EMA approval for Tagrisso in non-small cell lung cancer and in advancing Lynparza for multiple indications, including ovarian and metastatic breast cancers. Klaus has also driven strategic partnerships, such as the joint development of Lynparza with Merck/MSD. Earlier in his pharmaceutical industry career, Klaus held senior oncology-focused positions at GSK, Genmab, and Aventis (Sanofi). During his academic career he was a Professor in Experimental Cancer Research at Lund University, Sweden, a Professor in Cell Biology at the University of Bergen, Norway, and an Associate Professor in the Protein Laboratory at the University of Copenhagen, Denmark. Dr. Klaus Edvardsen, Epitopea's new Chief Medical Officer, commented, 'I am truly honored to join Epitopea at this pivotal time in its journey. The company's pioneering work in leveraging Cryptigens™ as a novel class of tumor-specific antigens offers a unique opportunity to redefine cancer immunotherapy. I look forward to collaborating with Epitopea's talented team to drive the development of transformational therapies that can address significant unmet needs for patients with hard-to-treat cancers.' Dr. Alan C. Rigby, CEO of Epitopea, said, 'We are thrilled to welcome Klaus to our executive leadership team at such an important stage in Epitopea's growth. Klaus's experience and expertise in oncology drug development and his proven track record of leading innovative therapies from concept to regulatory approval will be instrumental as we advance our pipeline into clinical trials. His leadership undoubtedly strengthens our mission to develop durable, off-the-shelf cancer immunotherapies that can profoundly improve patient outcomes.' Dr. Edvardsen's appointment comes as Epitopea continues to build on its groundbreaking discoveries of Cryptigens™, a new class of aberrantly expressed tumor-specific antigens uniquely shared across multiple patients with the same tumor type. Using its proprietary CryptoMap™ platform, Epitopea is pioneering the identification and exploitation of these antigens to develop RNA-based immunotherapies targeting cancers with significant unmet medical needs. The expansion of Epitopea's leadership team and scientific expertise continue to position the company as a trailblazer in the field of RNA-immunotherapy that remains committed to advancing its mission of creating transformative solutions for patients worldwide. Notes To Editors Contact InformationEpitopea Dr. Alan C. Rigby – Scius Communications Katja Stout +44 7789 435990 katja@ Daniel Gooch +44 7747 875479 Daniel@ About EpitopeaEpitopea is a transatlantic cancer immunotherapeutics company developing accessible off-the-shelf RNA-based immunotherapies for use in hard-to-treat cancers by targeting a new class of untapped tumor-specific antigens, which are known as Cryptigen™ TSAs, that are broadly shared across multiple patients with the same tumor type. The company has created an extensive library of novel Cryptigen™ TSAs, discovered by its proprietary CryptoMap™ platform that leverages immunopeptidomics, genomics, and a bioinformatics pipeline, allowing the identification of aberrantly-expressed, tumor-specific antigens (aeTSA's) that are hidden within cancer's 'junk' DNA. These hidden Cryptigen™ TSAs were first discovered through research led by Drs. Claude Perreault and Pierre Thibault at the Institute for Research in Immunology and Cancer at the Université de Montréal. Epitopea is backed by leading life science investors including Advent Life Sciences, CTI Life Sciences, Cambridge Innovation Capital, Le Fonds de Solidarité FTQ, Investissement Québec, adMare BioInnovations, Jonathan Milner, the Harrington Discovery Institute, IRICoR and Novateur Ventures. To date the company has raised financing of more than USD $45 million. Epitopea was founded in 2021 and consists of sister companies based in Cambridge, UK and in Montreal, Canada. For additional information, please visit and follow us on in to access your portfolio
