CID-103 / CASI, Alesta Therap, Precision Autoimmune Therap - LARVOL DELTA

A Dose-escalation Study Followed by a Dose Optimal Study to Evaluate the Safety and Efficacy of CID-103 in Adults With Chronic Immune Thrombocytopenia (clinicaltrials.gov) - P1/2 | N=75 | Recruiting | Sponsor: CASI Pharmaceuticals, Inc.

New P1/2 trial • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

CASI Pharmaceuticals Enters Into Definitive Agreement for the Divestiture of Assets in China (ACCESSWIRE) - "CASI Pharmaceuticals...announced that it has entered into a definitive Equity and Assets Transfer Agreement...with Kaixin Pharmaceuticals Inc...and CEO of the Company and two direct wholly-owned subsidiaries of the Company in China...pursuant to which the Company shall sell and transfer, and Kaixin Pharmaceuticals shall purchase and acquire, 100% equity interests in both Target Companies...and all licensing rights, distribution rights, supply arrangements and related rights related to BI-1206 (in China), CID-103 (in Asia excluding Japan) and Thiotepa (in China excluding Hong Kong, Macau and Taiwan)...for an aggregate purchase price of $20.0 million, which shall include assumption of up to $20.0 million of indebtedness of the Company....After the closing of the Transaction, the Company expects to retain the rights related to CID-103 (in Japan and non-Asian regions), EVOMELA, FOLOTYN, CNCT19 and CB-5339, and remain firmly committed to progressing CID-103 at an accelerated pace."

Commercial • Hematological Malignancies • Immunology • Solid Tumor

CID-103 (Anti-CD38 Antibody) in Previously Treated Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: CASI Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Multiple Myeloma • Oncology

CASI Announces First Patient Dosed in Phase 1/2 Clinical Trial of CID-103 in Immune Thrombocytopenia (ACCESSWIRE) - "CASI Pharmaceuticals...announced that the first patient has been dosed in the Phase 1/2 trial to evaluate the safety and tolerability of CID-103 in adult patients with chronic Immune Thrombocytopenia (ITP) in China."

Trial status • Thrombocytopenia

CASI Pharmaceuticals Receives CTA Approval From China's NMPA for CID-103 in Immune Thrombocytopenia (ACCESSWIRE) - "CASI Pharmaceuticals...announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved the Company's Clinical Trial Application (CTA) to proceed with a phase 1/2 study of CID-103 in adults patients with chronic Immune Thrombocytopenia (ITP) in China. This China study is part of the global study that was approved by the US FDA in May 2024."

New P1/2 trial • Immune Thrombocytopenic Purpura • Thrombocytopenia

CASI Pharmaceuticals Announces Plan To Submit IND Application For CID-103, an Anti-CD 38 Antibody in Antibody-Mediated Rejection, and Receipt of a Non-Binding Proposal to Acquire Entire China Business of the Company (PRNewswire) - "CASI Pharmaceuticals...announced today that the Company is planning to submit an Investigational New Drug ('IND') application to the U.S. Food and Drug Administration ('FDA') for CID-103 for the treatment of antibody-mediated rejection ('AMR') in kidney transplant recipients by the end of 2024....CASI also announced that its board of directors (the 'Board') received a preliminary non-binding proposal letter (the 'Proposal Letter') dated June 21, 2024...to acquire the entire business operations of the Company in China and all license-in, distribution and related rights in Asia (excluding Japan) related to all of the Company's pipeline products...for an aggregate purchase price of $40.0 million, which shall include assumption of up to $20.0 million of indebtedness of the Company (the 'Proposed Transaction')."

IND • M&A • Antibody-mediated Rejection • Transplant Rejection

CASI Pharmaceuticals Receives FDA Clearance On The Investigational New Drug (IND) Application For CID-103 In Immune Thrombocytopenia (ITP) (PRNewswire) - "CASI Pharmaceuticals...On April 12, 2024 CASI submitted the IND application to the FDA for CID-103 to support a phase 1/2 study of CID-103 in adults with chronic Immune Thrombocytopenia (ITP). On May 13, 2024 CASI received a letter from FDA indicating that study may proceed."

IND • New P1/2 trial • Immunology

CASI PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2023 BUSINESS AND FINANCIAL UPDATES (PRNewswire) - "'Some of our noteworthy recent achievements include the license transfer of Folotyn^® with an expected launch in Q1 2024, progress in the clinical development of BI-1206, transitioning CID-103 development to China for malignant hematology indications.'...Revenue consists of product sales of EVOMELA^®. Revenue was $8.8 million for the three months ended September 30, 2023, compared to $10.2 million for the three months ended September 30, 2022....Research and development expenses for the three months ended September 30, 2023 were $2.4 million, compared with $3.9 million for the three months ended September 30, 2022. The decrease is mainly attributable to reduced research and development expenses on certain projects, such as CID-103."

Commercial • Launch • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

CID-103 (Anti-CD38 Antibody) in Previously Treated Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: CASI Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting | N=60 ➔ 10

Enrollment change • Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology

CASI PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2022 FINANCIAL RESULTS (PRNewswire) - "'Through our partner Juventas, the CNCT-19 New Drug Application (NDA) submission to the National Medical Products Administration (NMPA) is on track, and we are in preparation for the anticipated CNCT-19 launch in China....We expect CB-5339 to receive Clinical Trial Application approval from the NMPA in early 2023; Meanwhile, our CID-103's Phase I study continues'."

New trial • Non-US regulatory • Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

CASI Pharmaceuticals Announces Dosing Of First Patient Of CID-103 In Phase 1 Clinical Trial For Relapsed Or Refractory Multiple Myeloma (PRNewswire) - “CASI Pharmaceuticals…announced First-Patient-In in the Phase 1 dose escalation and expansion study of CID-103, an investigational novel anti-CD38 monoclonal antibody, in patients with previously treated, relapsed or refractory multiple myeloma. The study is designed to assess the safety, tolerability, pharmacology and clinical activity of CID-103…‘This Phase 1 trial will generate valuable information and has the potential to provide early evidence of clinical activity in the treatment of multiple myeloma."

Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

CASI Pharmaceuticals Announces First Quarter 2021 Financial Results (PRNewswire) - “‘With respect to our commercial asset CNCT-19 (CD19 CAR-T), our partner Juventas is making excellent progress with their current registration trials in B-NHL and B-ALL and is expecting to file NDAs in China by the end of 2021. Our CID-103 (anti-CD38 monoclonal antibody) Phase I trial remains on track with first patient dosing expected later this month, BI-1206 (anti-FcyRIIB monoclonal antibody) is on track with our China IND submission expected this year.’”

Non-US regulatory • Trial status • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

CID-103 (Anti-CD38 Antibody) in Previously Treated Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: CASI Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

CASI Pharmaceuticals Announces Preliminary Fourth Quarter And Full-Year 2020 Revenues And Provides Business Updates (PRNewswire) - “Key Highlights for 2021…we expect Juventas to initiate the Phase II registration study in B-ALL in Q1 2021. The commercial team is making preparations for the launch of CNCT19, for which Juventas is expecting to file an NDA with the NMPA in 2021; CASI intends to file an IND for BI-1206 with the NMPA in 2021 to start the clinical trials in China; CASI is targeting the CID-103 Phase 1 study initiation in the first quarter of 2021.”

New P1 trial • Non-US regulatory • Trial status

CID-103 (Anti-CD38 Antibody) in Previously Treated Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: CASI Pharmaceuticals, Inc.

Clinical • New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

HS-GC-IMS with PCA to analyze volatile flavor compounds across different production stages of fermented soybean whey tofu. (PubMed, Food Chem) - "A PCA based on the signal intensity of the detected volatile compounds revealed effective differentiation of samples from different stages into comparatively independent spaces. These results showed that the flavor fingerprints of the samples from different stages of FSWT production can be successfully built using HS-GC-IMS and PCA based on the detected volatile compounds."

Journal

CASI Pharmaceuticals Announces Third Quarter 2020 Financial Results (PRNewswire) - ‘”With respect to our commercial asset CNCT-19 (CD19 CAR-T), our partner Juventas is making good progress with their current Phase 1 trials in B-NHL and B-ALL, and is expecting to initiate registration trials by the end of 2020. We expect to initiate our Phase 1 study for CID-103 (anti-CD38 monoclonal antibody) in the EU during the first quarter of 2021.’”

New P1 trial • Trial status • Acute Lymphocytic Leukemia • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

[VIRTUAL] CID-103, an Anti-CD38 Monoclonal Antibody Demonstrates Decreased RBC Binding and Decreased Interference with Pretransfusion Test Methods (AABB 2020) - "Abstract Background/Case Studies: Daratumumab (DARA) and isatuximab (ISAT) are two FDA-approved anti-CD38 monoclonal antibody therapies for treatment of multiple myeloma. CID-103 demonstrated very low binding to RBCs that was not detected by most blood bank test methods independent of the concentration of drug. Gel column testing was the most sensitive to interference giving weak variable reactivity, and Ortho AHG was less likely to detect the microscopic binding to RBCs. No interference was seen using automated Tango and IH1000."

Hematological Malignancies • Multiple Myeloma • Oncology

CASI Pharmaceuticals Announces Second Quarter 2020 Financial Results (PRNewswire) - '"The current Phase 1 trials for CNCT19, a CD19 CAR-T therapy, conducted by our development partner, Juventas, are well underway. Juventas expects to complete trials in B-NHL and B-ALL and initiate registration trials in the first quarter 2021, followed by NDA filing in China in early 2022'…'With regard to CID-103, our anti-CD38 monoclonal antibody, we recently submitted our IMPD application with MHRA, the British health authority, to initiate our Phase 1 clinical study in the UK. Clinical centers in the EU continue to be impacted by COVID-19; however, we expect to initiate our study in the first quarter 2021 assuming the centers open back up for clinical trial activities.'"

New P1 trial • Non-US regulatory • Trial status • Acute Lymphocytic Leukemia • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

CASI Pharmaceuticals announces submission of Clinical Trial Application (IND) to conduct phase 1 study for anti-38 monoclonal antibody program (PRNewswire) - "CASI Pharmaceuticals, Inc…announced that it submitted a Clinical Trial Application (CTA) (IND) with the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) for CID-103, its novel anti-CD38 monoclonal antibody for the treatment of multiple myeloma and other hematological malignancies…Based on the current environment and timetable of our clinical sites, we are targeting the study initiation in late 2020 or early 2021.'"

European regulatory • Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology