[Translation] A Phase I study with a safety run-in of BI-1206 (a CD32b [FcγRIIB] monoclonal antibody) in combination with rituximab in patients with relapsed or refractory indolent B-cell non-Hodgkin's lymphoma

主要目的：评价BI-1206在第一阶段的安全性导入部分的安全性、耐受性；评价BI-1206与利妥昔单抗联合治疗复发性或难治性的惰性B细胞非霍奇金淋巴瘤（NHL）的安全性和耐受性；通过确立BI-1206的最大耐受剂量（MTD）（以静脉输注[IV]方式按周次给药，连续4周，与利妥昔单抗联合用药）来选择推荐的Ⅱ期剂量（RP2D）。如果药代动力学（PK）和药效学（PD）数据表明当前剂量为与国外临床研究17-BI-1206-02可比的最佳治疗剂量，则可在达到临床研究17-BI-1206-02获得的MTD之前，由队列审查委员会（CRC）决定暂停剂量递增，并基于PK和PD数据确定RP2D。

[Translation]

Primary objectives: To evaluate the safety and tolerability of BI-1206 in the safety lead-in part of Phase I; To evaluate the safety and tolerability of BI-1206 in combination with rituximab in the treatment of relapsed or refractory indolent B-cell non-Hodgkin's lymphoma (NHL); To select the recommended Phase II dose (RP2D) by establishing the maximum tolerated dose (MTD) of BI-1206 (administered weekly by intravenous infusion [IV] for 4 consecutive weeks in combination with rituximab). If the pharmacokinetic (PK) and pharmacodynamic (PD) data indicate that the current dose is the best therapeutic dose comparable to that obtained in the foreign clinical study 17-BI-1206-02, the cohort review committee (CRC) may decide to suspend dose escalation before the MTD obtained in the clinical study 17-BI-1206-02 is reached, and the RP2D may be determined based on the PK and PD data.

Start Date25 Jul 2022

Sponsor / Collaborator

CASI (China) Pharmaceuticals Technology Co., Ltd.

NCT04219254

/ RecruitingPhase 1/2

A Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Previously Treated with Anti-PD-1 or Anti-PD-L1 Antibodies (KEYNOTE-A04)

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Previously Treated with Anti-PD-1 or Anti-PD-L1 Antibodies

Start Date29 Jun 2020

Sponsor / Collaborator

BioInvent International AB

[+1]

NCT03571568

/ RecruitingPhase 1/2

Phase 1/2a Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab

Start Date16 May 2018

Sponsor / Collaborator

BioInvent International AB

100 Clinical Results associated with BI-1206

100 Translational Medicine associated with BI-1206

100 Patents (Medical) associated with BI-1206

Literatures (Medical) associated with BI-1206

01 Dec 2022·Journal of hematology & oncology

Targeting FcγRIIB by antagonistic antibody BI-1206 improves the efficacy of rituximab-based therapies in aggressive mantle cell lymphoma

Letter

Author: Huang, Shengjian ; Wang, Michael ; Karlsson, Ingrid ; Zhang, Rongjia ; Teige, Ingrid ; Nie, Lei ; Kovacek, Mathilda ; Frendéus, Björn ; Jordan, Alexa ; Liu, Yang ; Li, Yijing ; Jiang, Vivian Changying ; Cai, Qingsong ; Che, Yuxuan ; Leeming, Angela ; Chen, Zhihong ; Mårtensson, Linda ; McIntosh, Joseph

Abstract:

Inevitable relapses remain as the major therapeutic challenge in patients with mantle cell lymphoma (MCL) despite FDA approval of multiple targeted therapies and immunotherapies. Fc gamma receptors (FcγRs) play important roles in regulating antibody-mediated immunity. FcγRIIB, the unique immune-checkpoint inhibitory member of the FcγR family, has been implicated in immune cell desensitization and tumor cell resistance to the anti-CD20 antibody rituximab and other antibody-mediated immunotherapies; however, little is known about its expression and its immune-modulatory function in patients with aggressive MCL, especially those with multi-resistance. In this study, we found that FcγRIIB was ubiquitously expressed in both MCL cell lines and primary patient samples. FcγRIIB expression is significantly higher in CAR T-relapsed patient samples (p < 0.0001) compared to ibrutinib/rituximab-naïve, sensitive or resistant samples. Rituximab-induced CD20 internalization in JeKo-1 cells was completely blocked by concurrent treatment with BI-1206, a recombinant human monoclonal antibody targeting FcγRIIB. Combinational therapies with rituximab-ibrutinib, rituximab-venetoclax and rituximab-CHOP also induced CD20 internalization which was again effectively blocked by BI-1206. BI-1206 significantly enhanced the in vivo anti-MCL efficacy of rituximab-ibrutinib (p = 0.05) and rituximab-venetoclax (p = 0.02), but not the rituximab-CHOP combination in JeKo-1 cell line-derived xenograft models. In patient-derived xenograft (PDX) models, BI-1206, as a single agent, showed high potency (p < 0.0001, compared to vehicle control) in one aggressive PDX model that is resistant to both ibrutinib and venetoclax but sensitive to the combination of rituximab and lenalidomide (the preclinical mimetic of R2 therapy). BI-1206 sensitized the efficacy of rituximab monotherapy in a PDX model with triple resistance to rituximab, ibrutinib and CAR T-therapies (p = 0.030). Moreover, BI-1206 significantly enhanced the efficacy of the rituximab-venetoclax combination (p < 0.05), which led to long-term tumor remission in 25% of mice. Altogether, these data support that targeting this new immune-checkpoint blockade enhances the therapeutic activity of rituximab-based regimens in aggressive MCL models with multi-resistance.

Graphical Abstract:

01 Sep 2020·Journal of veterinary diagnostic investigation : official publication of the American Association of Veterinary Laboratory Diagnosticians, IncQ4 · AGRICULTURAL & FORESTRY SCIENCE

Preparation, identification, and functional analysis of monoclonal antibodies against atypical porcine pestivirus NS3 protein

Q4 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Yang, Wenting ; Huang, Jingling ; Chen, Jianing ; Yan, Miaomiao ; Liu, Guangliang

Atypical porcine pestivirus (APPV) had been detected in many countries. However, to date, a commercial detection kit is not available because of a lack of specific monoclonal antibodies (mAbs) to APPV. We generated 7 mAbs targeting the NS3 protein of APPV. Isotyping results indicated that all of these mAbs are IgG1 with a kappa light chain. We analyzed the epitopes recognized by mAbs 2B6, 6G11, 8D1, 8D3, and 8F12, which recognized the same linear epitope (GRIKSAYSDE); the 6H3 and 7E10 mAbs recognized 2 different conformational epitopes. Applications of these antibodies were verified by ELISA, western blot, indirect immunofluorescence assay, and flow cytometry. The antibodies were functionally workable for these immunoassays except for 8F12, which could not be used in flow cytometry.

01 Sep 2016·Experimental parasitologyQ4 · MEDICINE

Insights into the biological features of the antigenic determinants recognized by four monoclonal antibodies in redia and adult stages of the liver fluke Fasciola hepatica

Q4 · MEDICINE

Article

Author: Hernández, Hilda ; Mosqueda, Maryani ; Sánchez, Jorge ; Rodríguez, Suanel Y ; Marcet, Ricardo ; Alfonso, Carlos ; Sarracent, Jorge ; Otero, Oscar ; Capó, Virginia ; Alba, Annia

Fasciola hepatica is a digenean trematode which infects a wide variety of domestic animals and also humans. Previous studies have demonstrated that four monoclonal antibodies (Mabs) against the total extract of F. hepatica redia (named as 1E4, 6G11, 4E5 and 4G11) also recognized the excretion - secretion antigens (ES Ag) of adult parasites, which is a biologically-relevant mixture of molecules with functional roles during infection and immune evasion on definitive hosts. In the present report we describe the partial characterization of the epitopes recognized by these Mabs by heat treatment, mercaptoethanol reduction, pronase proteolysis and sodium peryodate oxidation, which suggested their predominant protein and conformational nature. Also, a comparative study using immunodetection assays on crude extracts and on histological sections of both rediae and adults of F. hepatica were performed to explore the expression pattern of the antigenic determinants in these developmental stages. From these experiments it was found that the Mabs reacted most likely with the same proteins of approximately 64 and 105 kDa present on both rediae and adult's extracts. However, the 1E4, 6G11 and 4E5 Mabs also recognized other molecules of the total extract of F. hepatica adults, a fact that constitutes an evidence of the antigenic variation between both stages and points at a certain biological relevance of the recognized antigenic determinants. Immunolocalization studies on histological sections revealed that all Mabs reacted with the tegument of F. hepatica in both rediae and adults stages, while the epitopes recognized by 1E4, 6G11 and 4E5 antibodies were also preferentially localized in the intestinal caeca and in different organs of the reproductive system of adult specimens. The immunogenicity of these antigenic determinants, their conserved status among different stages of the life cycle of F. hepatica and their presence in both tegument and ES Ag of adult parasites, are suitable features that suggest their potential use for developing an epitope-based vaccine for fasciolosis control.

News (Medical) associated with BI-1206

14 May 2025

·www.bioinvent.com

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, Sweden – 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 www.bioinvent.com. For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: cecilia.hofvander@bioinvent.comBioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.comThe 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.

Phase 2ImmunotherapyClinical ResultLicense out/in

29 Apr 2025

·www.bioinvent.com

BioInvent International AB: Interim report January - March 2025

“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 www.bioinvent.com. For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: cecilia.hofvander@bioinvent.com BioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.com

Clinical ResultOrphan DrugPhase 1ImmunotherapyPhase 3

27 Feb 2025

·www.bioinvent.com

BioInvent International AB: Year-end report January 1 – December 31, 2024

“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 English.When: Thursday February 27, 2025, at 4:00 pm CET The webcast can be reached at https://bioinvent.events.inderes.com/q4-report-2024. 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 conference.https://conference.inderes.com/teleconference/?id=5002731. 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 www.bioinvent.com. For further information, please contact:Cecilia Hofvander, VP Investor Relations+46 (0)46 286 85 50cecilia.hofvander@bioinvent.com BioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.com

Phase 1Phase 2Clinical Result

100 Deals associated with BI-1206

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Hodgkin Lymphoma	Phase 2	United Kingdom	CASI (China) Pharmaceuticals Technology Co., Ltd.	30 Jan 2022
Advanced Malignant Solid Neoplasm	Phase 2	United States	BioInvent International AB	29 Jun 2020
Advanced Malignant Solid Neoplasm	Phase 2	United States	Merck Sharp & Dohme Corp.	29 Jun 2020
Advanced Malignant Solid Neoplasm	Phase 2	Sweden	Merck Sharp & Dohme Corp.	29 Jun 2020
Advanced Malignant Solid Neoplasm	Phase 2	Sweden	BioInvent International AB	29 Jun 2020
Metastatic melanoma	Phase 2	United States	Merck Sharp & Dohme Corp.	29 Jun 2020
Metastatic melanoma	Phase 2	United States	BioInvent International AB	29 Jun 2020
Metastatic melanoma	Phase 2	Sweden	BioInvent International AB	29 Jun 2020
Metastatic melanoma	Phase 2	Sweden	Merck Sharp & Dohme Corp.	29 Jun 2020
Non-Small Cell Lung Cancer	Phase 2	United States	BioInvent International AB	29 Jun 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03571568 (Accesswire) Manual	Phase 1/2	Non-Hodgkin Lymphoma	2	BI-1206+Calquence+Rituximab	ivxjnqbtzr(toulyeiesh) = cujrvxtmdb ruwgdcyrhp (sqnuixtkox ) View more	Positive	08 Jan 2025
NCT03571568 (Company_Website) Manual	Phase 2	Non-Hodgkin Lymphoma	2	BI-1206 + rituximab + Calquence	jeczmhtile(crbemhqizf) = caamsbmcbo wmoyvfzngp (iooduspirq ) View more	Positive	08 Jan 2025
NCT04219254 (Phase 1/2a clinical trial of BI-1206, ASCO2024)	Phase 1/2	Advanced Malignant Solid Neoplasm CD32b (FcγRIIB)	15	BI-1206 IV	cpjuqaiomf(nwhspizykx) = The most frequent related adverse events were infusion-related reactions, thrombocytopenia and elevated liver enzymes. All were transient without any clinical consequences, and adequate pre-medication with corticosteroids or split dose administration reduced the risk and/or intensity of these events. veopmvkmpz (hcljnitaew ) View more	Positive	24 May 2024
EHA2024 Manual	Phase 1/2	Indolent B-Cell Non-Hodgkin Lymphoma CD32B (FCGRIIB)	-	BI-1206 Irituximab	zclyldkqdi(hfgezrncun) = the most frequent related treatment-emergent adverse events after BI-1206 IV wasthrombocytopenia and elevated transaminases. Thrombocytopenia ≥G3 occurred in 4 out of 10 subjectswithout premedication and 6 out of 13 subjects with premedication. No associated bleeding occurred. Allevents were resolved with a median duration of 5 days. Elevated liver enzymes ≥G3 occurred in 4 out of 10subjects without premedication and 3 out of 13 subjects with premedication. Events were resolved with amedian duration of 4 days without any clinical complication. tjdgygerws (qtuvmhuhda ) View more	Positive	14 May 2024
EHA2024 Manual	Phase 1/2	Indolent B-Cell Non-Hodgkin Lymphoma CD32B (FCGRIIB)	-	BI-1206 +rituximab (SC)		Positive	14 May 2024
CTR20220706 (Company_Website) Manual	Phase 1	Non-Hodgkin Lymphoma	8	BI-1206	cwgzewfpbw(zphhsnbqke) = gefbujitsd kmvkcqupqq (tstgapajcb ) View more	Positive	05 Mar 2024
NCT02933320 (CTgov)	Phase 1/2	Chronic Lymphocytic Leukemia \| Waldenstrom Macroglobulinemia \| B-Cell Malignant Neoplasm	14	BI-1206 single agent dose escalation phase (Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase)	fgajtgczyk = wxbkljovjw qjhyolqnts (nuvcqzusai, jhrovsjpcz - mlfmdyiqci) View more	-	08 Jul 2021
NCT02933320 (CTgov)	Phase 1/2		14	BI-1206+rituximab (Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase)	fgajtgczyk = dyhzhmcymn qjhyolqnts (nuvcqzusai, uwgqwstdkr - pixxkploon) View more	-	08 Jul 2021

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