izastobart (HIB210) / Novartis, Biogen - LARVOL DELTA

A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: HI-Bio | Recruiting ➔ Completed

Trial completion

Biogen Bolsters Late-Stage Pipeline, Expands Immunology Portfolio with Agreement to Acquire Human Immunology Biosciences (Biogen Press Release) - "Biogen Inc...and Human Immunology Biosciences...today announced the companies have entered into a definitive agreement under which Biogen has agreed to acquire HI-Bio for $1.15 billion upfront and up to $650 million in potential milestone payments....Biogen seeks to retain expertise and talent from HI-Bio and establish a San Francisco Bay Area team focused on expanding our efforts in immune-mediated diseases....In addition to lead program felzartamab, the HI-Bio pipeline includes izastobart/HIB210, an anti-C5aR1 antibody currently in a Phase 1 trial and with potential for continued development in a range of complement-mediated diseases. HI-Bio also has discovery stage mast cell programs with potential in a range of immune-mediated diseases."

M&A • IgA Nephropathy • Immunology

A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: HI-Bio | Not yet recruiting ➔ Recruiting

Enrollment open

A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: HI-Bio

New P1 trial

A Study Evaluating TJ210001 in the Treatment of Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: I-Mab Biopharma Co. Ltd. | Trial completion date: Jan 2023 ➔ Dec 2025 | Trial primary completion date: Jan 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: I-Mab Biopharma Co. Ltd. | Active, not recruiting ➔ Completed

Trial completion • Oncology • Solid Tumor • PD-L1

I-Mab Provides Business and Corporate Updates and Reports Financial Results for the Six Months Ended June 30, 2022 (PRNewswire) - "TJ210/MOR210 - Phase 1 clinical trial in patients with advanced solid tumors: The phase 1 study is ongoing in the U.S., and patient recruitment for dose escalation will be completed in Q3 2022. In addition, the clinical study report of this phase 1 study is expected in Q4 2022. The phase 1 clinical trial in Chinese patients has been approved by China NMPA. Currently, no active clinical study is ongoing....TJ-C64B - TJ-C64B is now under pre-clinical development and the Company plans to submit an IND in the U.S. around mid-2023."

IND • P1 data • Trial status • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Expanded Access Protocol for Subjects With Relapsed or Refractory Advanced Solid Tumors Receiving TJ210001 (clinicaltrials.gov) - P=N/A | N=N/A | Available | Sponsor: I-Mab Biopharma Co. Ltd.

New trial • Oncology • Solid Tumor

Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: I-Mab Biopharma Co. Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2022 ➔ Feb 2023 | Trial primary completion date: Sep 2021 ➔ Oct 2022

Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • PD-L1

MorphoSys and HIBio Enter Into Equity Participation and License Agreements for Felzartamab and MOR210 (Businesswire) - "MorphoSys...announced today that the companies entered into an equity participation agreement and license agreements to allow HIBio to develop and commercialize MorphoSys’ felzartamab, an anti-CD38 antibody, and MOR210, an anti-C5aR1 antibody....This includes pelabresib, our potential best-in-class BET inhibitor, and tafasitamab, our CD19 targeting immunotherapy – two medicines that have the potential to enhance the standard and quality of care in difficult-to-treat and debilitating types of blood cancers."

Licensing / partnership • Immunology • Oncology • Solid Tumor

I-Mab Partner MorphoSys Announces New License Agreements for Felzartamab and TJ210 (Bloomberg) - "'We have made significant progress in the development of felzartamab towards registration in China and we have brought TJ210 to the clinic in the United States. We are excited and look forward to working together with MorphoSys and HIBio to advance clinical development and commercialization of felzartamab and TJ210,' said Dr. Andrew Zhu..."

Media quote

I-Mab Provides Business and Corporate Updates and Reports Financial Results for the Year Ended December 31, 2021 (PRNewswire) - "Lemzoparlimab in combination with rituximab for non-Hodgkin's lymphoma (NHL): The Company expects to report additional data in 2H2022 and, pending approval by the NMPA, potentially initiate a pivotal trial in patients with NHL in China....Phase 1 study is ongoing in US and patient recruitment for dose escalation will complete in Q2 2022. Another non-overlapping phase 1 clinical trial has been approved by China NMPA and is expected to commence in early Q2 2022.. IND for phase 2a clinical trial of TJ210 in combination with toripalimab (a marketed PD-1 antibody) is planned for submission in Q2 2022."

Clinical data • Enrollment status • IND • Gastric Cancer • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

A Study Evaluating TJ210001 in the Treatment of Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: I-Mab Biopharma Co. Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2021 ➔ Mar 2022

Enrollment open • Trial initiation date • Oncology • Solid Tumor

A Study Evaluating TJ210001 in the Treatment of Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=25; Not yet recruiting; Sponsor: I-Mab Biopharma Co. Ltd.; Initiation date: Jul 2021 ➔ Dec 2021

Clinical • Trial initiation date • Oncology • Solid Tumor

I-Mab Provides Business and Corporate Updates and Reports Financial Results for the Six Months Ended June 30, 2021 (PRNewswire) - “Lemzoparlimab in combination with pembrolizumab in patients with solid tumor: A phase 1b clinical trial is ongoing in the U.S. in patients with selected solid tumors. The preliminary clinical results are expected by the end of 2021 or early 2022. A 'basket' clinical trial of lemzoparlimab in combination with a PD-1 antibody in patients with advanced solid tumors is expected to commence in China in Q4 2021; Uliledlimab (TJD5)…In parallel, a phase 2 'basket' clinical trial is expected to be initiated in patients with selected advanced solid tumors in the U.S. in Q4 2021; TJ210….the Company received China NMPA clearance for phase 1 clinical trial of TJ210 in patients with advanced solid tumors. I-Mab expects to commence the study in early 2022.”

New P1 trial • New P2 trial • New trial • P1 data • Oncology • Solid Tumor

A Study Evaluating TJ210001 in the Treatment of Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=25; Not yet recruiting; Sponsor: I-Mab Biopharma Co. Ltd.

Clinical • New P1 trial • Oncology • Solid Tumor

I-Mab Reports Financial Results for Full Year of 2020 and Provides Business Updates (GlobeNewswire) - "Efineptakin alfa (TJ107): The on-going phase 1b clinical trial in China is investigating the safety, tolerability and PK/PD profile of efineptakin alfa in patients with advanced solid tumors. The results of the study are expected in Q2 2021; I-Mab plans to submit an IND in China in 2H 2021 to initiate a phase 2 clinical trial following a basket trial design, in which efineptakin alfa is combined with a PD-1 antibody for the treatment of selected tumor types, including TNBC...TJ210: A phase 1 clinical trial is now enrolling patients in the U.S. to evaluate the safety, tolerability and PK/PD profiles of TJ210 in cancer patients. The program is expected to further evolve into a combination clinical trial with a PD-1 antibody in selected cancer types. In addition, with the IND approved by China’s NMPA in February 2021, I-Mab expects to commence a phase 1b clinical trial in 2H 2021."

New P1 trial • New P2 trial • Non-US regulatory • P1 data • Oncology • Solid Tumor • Triple Negative Breast Cancer

Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: I-Mab Biopharma Co. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor

I-Mab Announces China NMPA Clearance for Phase 1 Study of TJ210/MOR210 in Patients with Advanced Solid Tumors (PRNewswire) - "I-Mab...announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for TJ210/MOR210 to initiate a phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TJ210/MOR210 monotherapy in patients with advanced solid tumors."

Non-US regulatory • Oncology • Solid Tumor

I-Mab and MorphoSys Announce First Patient Dosed in U.S. Phase 1 Study of TJ210/MOR210 in Patients with Advanced Cancer (PRNewswire) - "I-Mab...and MorphoSys...announced that the first patient has been dosed in a phase 1 dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TJ210/MOR210 monotherapy in patients with relapsed or refractory advanced solid tumors in the United States....The phase 1 clinical trial is an open-label dose escalation study with multiple doses in multiple centers in the U.S. to evaluate the safety, tolerability, and PK/PD of TJ210/MOR210 in subjects with advanced solid tumors."

Trial status • Oncology • Solid Tumor

Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: I-Mab Biopharma Co. Ltd.

Clinical • New P1 trial • Oncology • Solid Tumor • PD-L1

MorphoSys Reports Nine Months and Third Quarter 2020 Results (Morphosys Press Release) - "U.S. FDA cleared the Investigational New Drug application (IND) for MorphoSys' investigational human anti-C5aR1 antibody MOR210/TJ210 for the treatment of patients suffering from relapsed or refractory advanced solid tumors in September 2020. The phase 1 clinical trial is expected to begin in Q4 2020...Tafasitamab: All activities on track to start frontMIND study (pivotal phase 3 study in first-line DLBCL) in 2021; enrollment completed for phase 1b firstMIND study. Pivotal phase 3 study in patients with relapsed or refractory follicular lymphoma (r/r FL) will start in 2021."

Enrollment status • New P1 trial • New P3 trial • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

I-Mab Announces Preclinical Data on Differentiated Anti-C5aR Antibody TJ210/MOR210 at SITC 2020 (PRNewswire) - "TJ210/MOR210 selectively binds to the N-terminus of C5aR1 with high affinity and is not cross-reactive to other related GPCRs...Blockade of C5a/C5aR pathway inhibits the recruitment of tumor promoting cells, leading to the significant inhibition of tumor growth when combining with another immuno-oncology therapy"

Preclinical • Oncology • Solid Tumor

[VIRTURL] TJ210 (MOR210), A Differentiated Anti-C5aR Antibody for Anti-Cancer Therapy (SITC 2020) - No abstract available

Oncology

[VIRTUAL] TJ210 (MOR210), A Differentiated Anti-C5aR Antibody for Anti-Cancer Therapy (SITC 2020) - "Conclusions This series of in vitro and in vivo data demonstrate that TJ210 is a differentiated anti-C5aR antibody with unique binding epitope exhibiting superior anti-tumor potential especially in combination with an anti-PD-1 antibody. These data support further clinical studies of TJ210 in patients with solid tumors."

Oncology • Solid Tumor • CD8 • IFNG • ITGAM