[Translation] A phase II/III, randomized, multicenter, open-label study comparing ulelimab plus toripalimab, toripalimab alone, and pembrolizumab alone in patients with previously untreated locally advanced, unresectable or metastatic PD-L1 and CD73-selective non-small cell lung cancer

II期研究主要目的：在既往未接受过治疗的局部晚期不可切除或转移性PD-L1和CD73选择性NSCLC受试者中，评估尤莱利单抗联合特瑞普利单抗与帕博利珠单抗治疗相比在延长无进展生存期（PFS）方面的获益。 III期研究主要目的：在既往未接受过治疗的局部晚期不可切除或转移性PD-L1和CD73选择性NSCLC受试者中，证实尤莱利单抗联合特瑞普利单抗与帕博利珠单抗治疗相比在延长PFS方面的优效性。

[Translation]

The main purpose of the Phase II study is to evaluate the benefit of Ulelimumab combined with Toripalimab in prolonging progression-free survival (PFS) compared with pembrolizumab in subjects with locally advanced, unresectable or metastatic PD-L1 and CD73 selective NSCLC who have not received previous treatment. The main purpose of the Phase III study is to confirm the superiority of Ulelimumab combined with Toripalimab in prolonging PFS compared with pembrolizumab in subjects with locally advanced, unresectable or metastatic PD-L1 and CD73 selective NSCLC who have not received previous treatment.

Start Date27 Mar 2024

Sponsor / Collaborator

I-MAB Biopharma (Shanghai) Co., Ltd.

CTR20240598 / Active, not recruitingPhase 1

一项评估注射用菲泽妥单抗在中国健康男性成人受试者中的药代动力学可比性、安全性、耐受性和免疫原性（随机、双盲、交叉设计）的Ⅰ期临床研究

[Translation] A Phase I clinical study to evaluate the pharmacokinetic comparability, safety, tolerability and immunogenicity of Fizumab for injection in healthy Chinese male adult subjects (randomized, double-blind, crossover design)

主要研究目的评估受试制剂与参比制剂在健康男性受试者中的药代动力学方面的可比性。次要研究目的评估受试制剂与参比制剂在健康男性受试者中的药代动力学参数，为可能进行的第二阶段试验提供设计依据。评估受试制剂与参比制剂在健康男性受试者中的安全性、耐受性和免疫原性，并描述其药代动力学特征。

[Translation]

Primary study objectives To evaluate the pharmacokinetic comparability of the test formulation and the reference formulation in healthy male subjects. Secondary study objectives To evaluate the pharmacokinetic parameters of the test formulation and the reference formulation in healthy male subjects and provide a design basis for a possible Phase II trial. To evaluate the safety, tolerability and immunogenicity of the test formulation and the reference formulation in healthy male subjects and describe their pharmacokinetic characteristics.

Start Date27 Mar 2024

Sponsor / Collaborator

I-MAB Biopharma (Shanghai) Co., Ltd.

CTR20230090 / RecruitingPhase 3

一项评价注射用来佐利单抗联合阿扎胞苷（AZA）对比阿扎胞苷单药治疗初诊的较高危骨髓增生异常综合征（MDS）患者的随机、对照、开放性、多中心III 期临床研究

[Translation] A randomized, controlled, open-label, multicenter phase III clinical study evaluating levofloxacin injection combined with azacitidine (AZA) versus azacitidine alone in patients with newly diagnosed higher-risk myelodysplastic syndrome (MDS)

主要研究目的：比较来佐利单抗联合AZA与AZA单药一线治疗初诊较高危MDS受试者的总生存期（OS）次要目的评估来佐利单抗联合AZA与AZA单药治疗初诊较高危MDS受试者的无事件生存期（EFS）评估两组受试者的完全缓解率（CR) 评估两组受试者的客观缓解率（ORR，包括：完全缓解[CR]、部分缓解[PR]、骨髓完全缓解[mCR] 、或血液学改善[HI]）评估两组受试者的完全细胞遗传学缓解率（CCR）评估两组受试者的缓解出现时间（TTR）、完全缓解出现时间（TTCR）、缓解持续时间（DoR）、完全缓解持续时间（DoCR)

[Translation]

Main study objectives: Compare the overall survival (OS) of subjects with newly diagnosed higher-risk MDS treated with leszolizumab combined with AZA and AZA monotherapy as first-line treatment Secondary objectives Evaluate the event-free survival (EFS) of subjects with newly diagnosed higher-risk MDS treated with leszolizumab combined with AZA and AZA monotherapy Evaluate the complete remission rate (CR) of the two groups of subjects Evaluate the objective response rate (ORR, including complete remission [CR], partial remission [PR], complete bone marrow remission [mCR], or hematological improvement [HI]) of the two groups of subjects Evaluate the complete cytogenetic remission rate (CCR) of the two groups of subjects Evaluate the time to remission (TTR), time to complete remission (TTCR), duration of remission (DoR), and duration of complete remission (DoCR) of the two groups of subjects

Start Date30 Mar 2023

Sponsor / Collaborator

I-MAB Biopharma (Shanghai) Co., Ltd.

100 Clinical Results associated with I-MAB Biopharma (Shanghai) Co., Ltd.

0 Patents (Medical) associated with I-MAB Biopharma (Shanghai) Co., Ltd.

Literatures (Medical) associated with I-MAB Biopharma (Shanghai) Co., Ltd.

05 Nov 2020·Blood

A Phase I/IIa Study of Lemzoparlimab, a Monoclonal Antibody Targeting CD47, in Patients with Relapsed and/or Refractory Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS): Initial Phase I Results

Author: Wang, Jianxiang ; Jiang, Bo ; Cao, Xinxin ; Zhang, Yanni ; Huang, Wei ; Meng, Yuan ; MA, Xiaoyu ; Jia, Yingmin ; Jiang, Bin ; Guo, Jiyuan ; Li, Jian ; Qi, Junyuan ; Liu, Hongzhong ; Zhang, Meixiang

BackgroundLemzoparlimab (also known as TJC4 or TJ011133), a novel, RBC-sparing CD47 antibody with a unique epitope, is in early phase clinical development in both the U.S. and China. Like other anti-CD47 antibodies, lemzoparlimab blocks the interaction of CD47 and SIRPα, leading to phagocytosis of various CD47+ tumor cell lines and primary AML cells. Mono-treatment of lemzoparlimab inhibited tumor growth completely and extended the overall survival of treated mice in a patient-derived AML xenograft model. Here we report initial findings in the ongoing phase I trial which is to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of lemzoparlimab in relapsed and/or refractory (r/r) AML and MDS patients.MethodsThe trial (NCT04202003) adopted a modified 3+3 dose escalation design with weekly lemzoparlimab at dose levels of 1, 3, 10, 20 and 30 mg/kg. The initial two lower dose cohorts (1 mg/kg and 3 mg/kg) was designed to enroll one patient each, and the study would escalate to the next level (10 mg/kg) if no DLT and no predefined toxicity events (e.g. grade 2 or above drug-related non hematologic toxicity, except for isolated lab abnormality with no clinical manifestation) were observed. If the first DLT or predefined toxicity event was observed, the cohort size would be expanded at the current dose level and the study would revert to the standard 3+3 design. Safety, PK/PD parameters, and preliminary efficacy were evaluated.ResultsAs of 24 July 2020, 5 r/r AML patients (pts) including 1 relapsed, 1 relapsed/refractory and 3 primary refractory, were enrolled across 3 dose cohorts (1 at 1 mg/kg, 1 at 3 mg/kg and 3 at 10 mg/kg). Patients had 2-4 prior therapies. Median age was 45 years (range 25-66). Four of 5 pts developed treatment emergent AEs. Most of the AEs were grade 1 or 2. Treatment-related AEs that occurred in > 1 patient included thrombocytopenia (2/5 pts, 1 with grade 1 and 1 with grade 3) and positive anti-erythrocyte antibody (2/5 pts). No dose dependent hematologic toxicities have been observed so far. There was no treatment-related dose interruption or dose discontinuation. No patient developed treatment-related SAE or death. The maximum tolerated dose (MTD) has not yet been reached and the drug was well tolerated in r/r AML pts in the background of significantly impaired hematopoietic function with or without supportive blood transfusion. The anti-CD47 interferences on the blood bank testing were mitigated before blood transfusion.With doses from 1 mg/kg to 10 mg/kg, lemzoparlimab exhibited a supraproportional increase in exposure, which can be attributed to target (CD47) mediated drug disposition at low doses. CD47 receptor occupancy (RO) was evaluated as a PD marker. The mean RO on peripheral T cells at Cmax was 74.0%, 82.0% and 84.9% for 1, 3 and 10 mg/kg, respectively. The mean RO on CD33+ tumor cells at Cmax was 45.9%, 75.8% and 82.2% for 1, 3 and 10 mg/kg, respectively. Of note, one patient with primary refractory AML achieved morphologic leukemia-free state (MLFS) after 2 cycles of lemzoparlimab treatment at 1 mg/kg.ConclusionLemzoparlimab was well tolerated in r/r AML pts in the doses tested and importantly, consistent with preclinical data, there were no serious hematological AEs so far. No DLTs or MTD was observed up to 10 mg/kg weekly dosing so far. The PK/PD profile of lemzoparlimab is also consistent with preclinical findings. The preliminary efficacy observed was encouraging. Dose escalation will continue until MTD or RP2D is reached.DisclosuresNo relevant conflicts of interest to declare.

News (Medical) associated with I-MAB Biopharma (Shanghai) Co., Ltd.

31 Oct 2024

·www.prnewswire.com

I-Mab to Release Q3 2024 Financial Results on November 14, 2024

ROCKVILLE, Md., Oct. 31, 2024 /PRNewswire/ -- I-Mab (NASDAQ: IMAB) (the "Company"), a US-based, global biotech company, exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer, today announced that it plans to release financial results for the third quarter ended September 30, 2024, on Thursday, November 14, 2024, pre-market Eastern Time. The Company will not host a conference call to discuss its third quarter 2024 financial results. The Company intends to host an investor update call in conjunction with its 2024 full-year financial results to discuss its clinical pipeline, corporate strategy, and objectives. Information about financial results, conference calls, webcasts, and other information is posted on the Company's website. About I-Mab I-Mab (NASDAQ: IMAB) is a US-based, global biotech company, exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer. I-Mab has established operations in Rockville, Maryland, and Short Hills, New Jersey. For more information, please visit and follow us on LinkedIn and X. I-Mab Investor & Media Contacts Tyler Ehler Senior Director, Investor Relations [email protected] SOURCE I-Mab Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementImmunotherapy

30 Oct 2024

·www.prnewswire.com

I-Mab to Present Givastomig Phase 1 Optimal Dose Estimation Data at SITC 2024

- Poster to be presented in a late-breaking abstract session at the Society for Immunotherapy of Cancer (SITC) on Saturday, November 9, 2024 ROCKVILLE, Md., Oct. 30, 2024 /PRNewswire/ -- I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer, today announced the presentation of a poster highlighting Phase 1 optimized dose estimation data for givastomig monotherapy (TJ033721/ABL111), a novel first-in-class Claudin18.2 (CLDN18.2) and 4-1BB bispecific antibody, at SITC 2024. The conference is being held in Houston, Texas, from November 6-10, 2024. Presentation Details: Title: Optimal dose estimation using an integrated approach from Phase I data of givastomig, a novel Claudin18.2×4-1BB bispecific antibody Poster #: 1474 Presenter: J.A. Yanez, I-Mab Session: Poster Hall, George R. Brown Convention Center Session Date: Saturday, November 9, 2024 Session Time: 9:00 am CDT to 8:30 pm CDT, Level 1 – Exhibit Halls AB A full copy of the poster will be available on the I-Mab website under the "Innovation, Publications & Presentations" tab on November 9, 2024. About Givastomig Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin (CLDN) 18.2-positive tumor cells. It conditionally activates T cells through the 4-1BB pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig appears to maintain strong tumor binding and anti-tumor activity, attributable to a synergistic effect of proximal interaction with CLDN18.2 and 4-1BB, while minimizing liver toxicity and systemic immunotoxicity commonly seen with other emerging 4-1BB-based product candidates. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for givastomig for the treatment of gastric cancer, including cancer of the gastroesophageal junction. A Phase 1b study is ongoing evaluating givastomig, in combination with standard-of-care nivolumab plus chemotherapy, in treatment-naïve patients with gastric cancers, including gastroesophageal cancer (NCT04900818). The program is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding China and South Korea, equally with ABL Bio. About I-Mab I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer. I-Mab has established operations in Rockville, Maryland, and Short Hills, New Jersey. For more information, please visit and follow us on LinkedIn and X. I-Mab Investor & Media Contacts Tyler Ehler Senior Director, Investor Relations [email protected] SOURCE I-Mab Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 1Orphan DrugAACRASCO

28 Oct 2024

·www.prnewswire.com

I-Mab to Participate at the Truist Securities BioPharma Symposium

ROCKVILLE, Md., Oct. 28, 2024 /PRNewswire/ -- I-Mab (NASDAQ: IMAB), a US-based, global, biotech company, exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer, today announced that management will participate in one-on-one and small group meetings with investors at the Truist Securities BioPharma Symposium on November 7, 2024. Event Details For more information, please contact your Truist Securities representative. About I-Mab I-Mab (NASDAQ: IMAB) is a US-based, global biotech company exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer. I-Mab has established operations in Rockville, Maryland, and Short Hills, New Jersey. For more information, please visit and follow us on LinkedIn and X. For more information, please contact: Tyler Ehler Senior Director, Investor Relations [email protected] SOURCE I-Mab Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyAACR

100 Deals associated with I-MAB Biopharma (Shanghai) Co., Ltd.

100 Translational Medicine associated with I-MAB Biopharma (Shanghai) Co., Ltd.

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Pipeline

Pipeline Snapshot as of 22 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Phase 1 Clinical

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Uliledlimab ( CD73 )	Non-Small Cell Lung Cancer More	Phase 3 Clinical
Felzartamab ( CD38 )	Multiple Myeloma More	Phase 3
Eftansomatropin alfa ( GHR )	Growth hormone deficiency More	Phase 3
Lemzoparlimab ( CD47 )	Myelodysplastic Syndromes More	Phase 3
Olamkicept ( IL-6 )	Crohn Disease More	Phase 2

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