lemzoparlimab (ABBV-IMAB-TJC4) / I-Mab - LARVOL DELTA

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2 | N=105 | Completed | Sponsor: I-Mab Biopharma Co. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Dec 2023 | Trial primary completion date: Dec 2024 ➔ Dec 2023

Combination therapy • Monotherapy • Trial completion • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome (clinicaltrials.gov) - P1 | N=40 | Terminated | Sponsor: AbbVie | Phase classification: P1b ➔ P1 | Completed ➔ Terminated; Strategic considerations

Adverse events • Combination therapy • Phase classification • Trial termination • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2 | N=105 | Active, not recruiting | Sponsor: I-Mab Biopharma Co. Ltd. | Trial completion date: Feb 2024 ➔ Dec 2024 | Trial primary completion date: Oct 2023 ➔ Dec 2024

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

I-Mab Signs Agreement to Divest its Assets and Business Operations in China (PRNewswire) - "I-Mab...announced that as part of its strategy to become a U.S.-based biotech, its Chinese subsidiaries have entered into definitive agreements with I-Mab Biopharma (Hangzhou) Co., Ltd. (the 'Hangzhou Company'), an unconsolidated affiliate of the Company, and a group of China-based investors to divest the Company's assets and business operations in China....Once the transaction is completed, the Hangzhou Company will acquire I-Mab drug assets in China, including the Greater China rights for...uliledlimab, givastomig, and lemzoparlimab; bear all future development costs of these assets; and be responsible for the operations of the research & development (R&D) center of I-Mab Shanghai and the manufacturing facility of the Hangzhou Company."

Licensing / partnership • Oncology

IMAB Regains Global Rights to Lemzoparlimab A New Chapter Begins (Best Stocks) - "On September 22, 2023, I-MAB received a notice from AbbVie Global Enterprises, terminating the license and collaboration agreement between the two companies. As a result, I-MAB has regained complete global rights to lemzoparlimab. This agreement, which was initially established on September 3, 2020, was a significant strategic partnership for differentiated immuno-oncology therapy between I-MAB and AbbVie....Under this collaboration, I-MAB had the opportunity to retain exclusive rights to develop and commercialize lemzoparlimab in mainland China, Macau, and Hong Kong."

Licensing / partnership • Oncology

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2 | N=105 | Active, not recruiting | Sponsor: I-Mab Biopharma Co. Ltd. | Trial completion date: Aug 2023 ➔ Feb 2024 | Trial primary completion date: Apr 2023 ➔ Oct 2023

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

KEYNOTE KN-A21: Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma (clinicaltrials.gov) - P1 | N=98 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed | Trial completion date: Sep 2023 ➔ Jan 2023 | Trial primary completion date: Sep 2023 ➔ Jan 2023

Combination therapy • Metastases • Trial completion • Trial completion date • Trial primary completion date • Hematological Malignancies • Indolent Lymphoma • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer

Novel agents in relapsed/refractory diffuse large B-cell lymphoma (ICML 2023) - "In recent years, numerous agents have been approved specifically for patients with DLBCL (RED) including tafasitamab, loncastuximab tesirine, polatuzumab vedotin, selinexor, rituximab, and pembrolizumab (for patients with Primary Mediastinal B-cell lymphoma)...Significant grade 3-4 toxicities were neutropenia and thrombocytopenia with 48.6% of patients requiring dose modifications, and 22.9% discontinuing treatment for toxicity.12 Ongoing and planned trials with loncastuximab include a phase III trial with rituximab, gemcitabine, and oxaliplatin (R-GemOx) (Tables 1 and 3)...Encouraging clinical activity, without unanticipated toxicities was observed when polatuzumab was combined with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) with an ORR of 89% (CR 61%).24 Combination of polatuzumab with lenalidomide and rituximab (R2) in 49 patients demonstrated an ORR of 35% (CR 29%), with median DOR, PFS, and OS of 8.1, 6.3, and 10.9 months, respectively...One notable..."

IO biomarker • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • CARD11 • CD79B • CDKN1A • CRBN • CTLA4 • EZH2 • IKZF1 • IRAK4 • LYN • MALT1 • MCT1 • MYC • MYD88 • NF-κβ • PD-L1 • ROR1 • SIRPA • SYK • XPO1

Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome (clinicaltrials.gov) - P1b | N=40 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed | N=80 ➔ 40

Adverse events • Combination therapy • Enrollment change • Trial completion • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

FILGOTINIB FOR RHEUMATOID ARTHRITIS - AN OBSERVATIONAL STUDY TO ASSESS CLINICAL EFFECTIVENESS IN NHS LOTHIAN (EULAR 2023) - "Background Filgotinib (Jyseleca) is a Janus-kinase (JAK) inhibitor which in 2021 was approved for use in the UK in moderate or severe rheumatoid arthritis (RA) either as monotherapy or in combination with Methotrexate...Post-treatment counts were recorded in 46 (31.7%), with mean TJC 4.65 and SJC 2.91...The cohort is limited by the lack of accurate DAS-28 recording in the clinical record. This may in part reflect the Lothian model of treating imaging-confirmed synovitis in the absence of a DAS-28 result."

Clinical • Observational data • Cardiovascular • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Oncology • Pulmonary Disease • Renal Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Venous Thromboembolism

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2 | N=105 | Active, not recruiting | Sponsor: I-Mab Biopharma Co. Ltd. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Monotherapy • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

I-Mab doses first patient in MDS combo therapy trial in China (Clinical Trials Arena) - "...Dr Andrew Zhu said: 'We are excited to have dosed the first patient in the Phase III study for lemzoparlimab in higher-risk MDS, a disease with very limited treatment options.' 'This milestone represents a significant step towards addressing the unmet medical needs of MDS patients and underscores our commitment to developing innovative therapies that could make a meaningful difference in their lives.' 'We are hopeful that lemzoparlimab could become the first-to-market CD47-targeting therapy in China, providing a potentially new, safer, and effective treatment option for patients in need.'"

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I-Mab (NASDAQ:IMAB) Q4 2022 Earnings Call Transcript (Insider Monkey) - "Andrew Zhu...I want to take this opportunity to discuss our key business update and major progress in core asset development for the year ended December 31st, 2022. Since the start of 2022, the company faced multiple challenges, including, but not limited to geopolitical issues such as ADR delisting risks, macroeconomic factors, including interest rate hikes and COVID-19 pandemic. In response to these challenges, the company made several strategic efforts to reposition the overall business and prioritize its pipeline. These measures resulted in a streamlined corporate structure and workforce as well as focused development of five key assets, leading to a significant reduction in the cash burn rate in 2022 and beyond."

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I-Mab Announces First Patient Dosed in Phase 3 Registrational Study of CD47 Antibody Lemzoparlimab in MDS in China (PRNewswire) - "I-Mab...announced that the first patient in a Phase 3 registrational trial (ClinicalTrials.gov Identifier: NCT05709093) in China for patients with higher-risk myelodysplastic syndrome (MDS) has been treated with lemzoparlimab, a novel CD47 antibody, in combination with azacitidine (AZA). The Phase 3 trial is a randomized, controlled, open-label, multi-center study to evaluate the efficacy and safety of lemzoparlimab in combination with AZA versus AZA monotherapy as first-line therapy in subjects with higher-risk MDS. This is the first approved Phase 3 trial for anti-CD47 therapies in mainland China."

Trial status • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

I-Mab Provides Business and Corporate Updates and Reports Financial Results for the Year Ended December 31, 2022 (PRNewswire) - "'Going into 2023, we are now in a strong position to deliver on our innovative pipeline and corporate milestones, as well as to make expected progress in global partnerships and commercial partnerships given that business development remains a key strategic priority of the Company. We will stay laser-focused on creating value for our shareholders while extending the cash runway to support key business operations in the coming years,' Dr. Zhu concluded."

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I-Mab Provides Business and Corporate Updates and Reports Financial Results for the Year Ended December 31, 2022 (PRNewswire) - "As the studies progress, the Company expects to have two potential near-term BLA submissions in China (potentially by the end of 2023 or early 2024 for eftansomatropin alfa and at a later time for felzartamab), two key assets entering into Phase 3 or pivotal trials in China (lemzoparlimab for myelodysplastic syndromes (MDS) in Phase 3 and uliledlimab for NSCLC in a pivotal clinical trial) and one asset entering into Phase 2 (givastomig) in 2023....Phase 3 trial for pediatric growth hormone deficiency (PGHD)...The study aims to evaluate the efficacy, safety, and pharmacokinetics (PK) of eftansomatropin alfa in PGHD, as compared to Norditropin^®, a daily rhGH marketed in China. The study is on track, and the final dataset is anticipated in the second half of 2023, which is expected to be followed by a BLA submission by the end of 2023 or early 2024."

New P2 trial • New P3 trial • Non-US regulatory • Trial status • Growth Hormone Deficiency (Pediatric) • Hematological Malignancies • Lung Cancer • Myelodysplastic Syndrome • Non Small Cell Lung Cancer • Oncology

A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P3 | N=552 | Recruiting | Sponsor: I-Mab Biopharma Co. Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Monotherapy • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

[VIRTUAL] A first-in-human study of lemzoparlimab, a differentiated anti-CD47 antibody, in subjects with relapsed/refractory malignancy: initial monotherapy results (SITC 2020) - P1 | "Part 1 consists of lemzoparlimab monotherapy dose escalation and 2 separate dose escalations of combination therapy with pembrolizumab or rituximab. No TRAEs greater than Grade 2 have been observed. Results will be updated at presentation including available tumor response data."

Clinical • Monotherapy • P1 data • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Molecular Biomarker Analyses for Exploring the Therapeutic Mechanism of Lemzoparlimab and Azacitidine (AZA) in Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (ASH 2022) - P1/2 | "Here we show that an increased CALR expression in CD33+ blasts after lemzoparlimab and AZA combination treatment and higher immune infiltrates including total, CD91+ macrophages and CD8/Treg ratio in bone marrow at baseline is associated with better clinical response, suggesting the important role of activation of tumor derived pro-phagocytic signal and effector immune cells in the anti-tumor activity mediated by combination treatment. In addition, TP53 mutant patients with a higher increase in CALR expression and immune infiltrates in bone marrow showed a better clinical response than those with WT TP53. Our results pinpoint the potential mechanism of clinical benefits observed with lemzoparlimab and AZA treatment in HR-MDS and provide insight into future combination strategies."

Biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • CALR • CD33 • CD47 • CD68 • CD8

[VIRTUAL] 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 (ASH 2020) - P1/2 | "The preliminary efficacy observed was encouraging. Dose escalation will continue until MTD or RP2D is reached."

Clinical • P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • CD33

Lemzoparlimab: Initiation of P3 trial (NCT05709093) in combination with azacitidine for 1L high-risk MDS in 2023 (I-Mab Biopharma) - Corporate Presentation

Trial initiation date • Myelodysplastic Syndrome • Oncology

A Study of Single Drug TJ011133 and Toripalimab Combine Treatment for Advanced Solid Tumor (clinicaltrials.gov) - P1/2 | N=7 | Terminated | Sponsor: I-Mab Biopharma Co. Ltd. | N=96 ➔ 7 | Trial completion date: Sep 2025 ➔ Feb 2023 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2023 ➔ Feb 2023; Company Development strategy adjustment

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P3 | N=552 | Not yet recruiting | Sponsor: I-Mab Biopharma Co. Ltd.

Combination therapy • Monotherapy • New P3 trial • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Exploration of the Therapeutic Effects of CD47 and CD38 Antibody Combination in Relapsed or Refractory Multiple Myeloma (rrMM) and the Correlation with CD47 and CD38 Expression (ASH 2022) - "Combination of lemzoparlimab and felzartamab showed enhanced in vitro ADCP and in vivo anti-tumor efficacy in these CD47 high and CD38 low high-risk MM cells which were resistant to felzartamab or daratumumab mono-treatment. Our study provides preclinical evidence to explore the combination of lemzoparlimab and felzartamab in the treatment of high-risk MM patients."

IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • CD47 • SIRPA • TGFB1

Lemzoparlimab, a Differentiated Anti-CD47 Antibody in Combination with Rituximab in Relapsed and Refractory Non-Hodgkin’s Lymphoma: Initial Clinical Results (ASH 2021) - P1 | "The combination therapy exhibited evidence of clinical activity in heavily pre-treated R/R NHL patients who had progressed on prior CD20 targeted therapies. The results provide the basis for RP2D and impetus for accelerated clinical development for NHL."

Clinical • Combination therapy • Anemia • Cardiovascular • Constipation • Dermatology • Diffuse Large B Cell Lymphoma • Fatigue • Follicular Lymphoma • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pruritus • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia