Latest news with #BI-1206
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
27-02-2025
- Business
- Yahoo
BioInvent International AB: Year-End Report January 1 - December 31, 2024
LUND, SWEDEN / / February 27, 2025 / BioInvent International (STO:BINV) "2024 was a year with several exciting developments reported from across our broad portfolio of clinical programs. We now have two Phase 2 and four Phase 1 trials running in our six clinical programs leveraging the TNFR2 and FcyRIIB targets. Throughout the year, we pursued building our business by expanding our management team and signing important clinical collaboration and supply agreements with key partners." - Martin Welschof CEO of BioInvent. EVENTS IN THE FOURTH QUARTER First patient enrolled in Phase 1b/2a study of the company's second anti-FcyRIIB antibody, BI-1607, in combination with ipilimumab and KEYTRUDA® (pembrolizumab) in patients with unresectable or metastatic melanoma Expanded management team with appointment of Ashley Robinson as SVP of Strategy and Finance EVENTS AFTER THE END OF THE PERIOD (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 BI-1808 antibody granted in Japan. It also covers the use of the antibody in the treatment of cancer. EARLIER DURING 2024, IN BRIEF (R) Additional positive efficacy data with single agent BI-1808 from the Phase 2a anti-TNFR2 program (R) Phase 1 data for BI-1206 in combination with KEYTRUDA in patients with solid tumors presented at ASCO 2024 (R) Clinical efficacy and excellent safety for anti-TNFR2 agent BI-1808 presented at ASCO 2024 (R) Phase 1/2a data presented at EHA 2024 for BI-1206 with rituximab in NHL (R) CASI Pharmaceuticals reported positive interim Phase 1 data for BI-1206 in the treatment of relapsed/refractory indolent NHL in China ESMO presentations highlighting progress from the Phase 1 trial of BI-1910 monotherapy in solid tumors and Phase 1 trial of the oncoloytic virus BT-001 (anti-CTLA-4) as a single agent and in combination with KEYTRUDA® (pembrolizumab) in patients with solid tumors Two clinical trial collaboration and supply agreements signed with MSD to evaluate BI-1607 in combination with KEYTRUDA and ipilimumab, and to evaluate BI-1910 in combination with KEYTRUDA PAGE 2024 presentation showcased model-informed development of BI-1808 Clinical supply agreement signed with AstraZeneca (LSE/STO/Nasdaq: AZN) to evaluate BioInvent's anti-FcyRIIB antibody, BI-1206, in combination with rituximab and Calquence (acalabrutinib), in a Phase 1/2a study in NHL ANTICIPATED 2025 MILESTONES Additional Phase 2a monotherapy data of BI-1808 in solid tumors and T-cell lymphoma to be shared in mid-2025 Data from the ongoing Phase 2a trial of BI-1206 in combination with rituximab and Calquence (acalabrutinib) in NHL expected in mid-2025 Phase 1 data of BI-1206 as a subcutaneous formulation in combination with KEYTRUDA in solid tumors anticipated in mid-2025 First BI-1910 Phase 2a single agent data expected H2 2025 Phase 1 data from Part B, dose escalation of BI-1910 in combination with pembrolizumab expected H2 2025 Data from Phase 2a dose-expansion study of BI-1808 in combination with KEYTRUDA in patients with advanced solid tumors and T-cell lymphoma anticipated in H2 2025 Initial data from the Phase 1b trial evaluating BI-1607 in combination with ipilimumab and KEYTRUDA in patients with unresectable or metastatic melanoma expected in H2 2025 (R)= Regulatory event FINANCIAL INFORMATIONFourth quarter 2024• Net sales SEK 21.4 (15.3) million.• Profit/loss after tax SEK -116.9 (-97.2) million.• Profit/loss after tax per share before and after dilution SEK -1.78 (-1.48) • Cash flow from operating activities SEK -98.3 (-72.4) million. January - December 2024• Net sales SEK 44.7 (71.5) million.• Profit/loss after tax SEK -429.4 (-330.3) million.• Profit/loss after tax per share before and after dilution SEK -6.53 (-5.02).• Cash flow from operating activities SEK -380.5 (-341.7) million.• Liquid funds, current and long-term investments as of December 31, 2024: SEK 867.2 (1,283.0) million. The complete interim report is available for download below and on the company's website under Financial reports . INVITATION TO PRESENTATION OF THE YEAR-END REPORT 2024BioInvent's CEO Martin Welschof will present the report together with CFO Stefan Ericsson. The presentation will be held in Thursday February 27, 2025, at 4:00 pm CET The webcast can be reached at If you wish to ask questions and participate via telephone, please register at the link below. After registration you will be provided with a phone number and a conference ID to access the The conference call will be made available on the company website after the call. 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 Relations+46 (0)46 286 85 BioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 Attachments BioInvent Q4, 2024 EN Final SOURCE: BioInvent International View the original press release on ACCESS Newswire Sign in to access your portfolio
