Latest Hotspot

Immix Biopharma's IND for CAR-T NXC-201 approved by FDA, enabling treatment for U.S. patients

29 November 2023
3 min read

Immix Biopharma, Inc., a company specializing in the clinical phase of biopharmaceuticals and committed to pioneering personalized treatments for cancer and immunity, revealed today that the FDA has approved the Investigational New Drug submission for BCMA CAR-T NXC-201 (formerly HBI0101).

👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug.

图形用户界面, 文本, 应用程序, 电子邮件

描述已自动生成

 With the approval in place, NEXICART-2 is set to extend the trials of NXC-201 in patients with relapsed/refractory AL Amyloidosis in the U.S. Its positive tolerability could potentially be utilized for further expansion into autoimmune applications.

"We're enthusiastic about the promising clinical evidence of NXC-201 so far, and the fact that a number of top-notch U.S facilities are on track to register patients in the following months," commented Ilya Rachman, MD PhD, Chief Executive Officer at Immix Biopharma. "There is no sanctioned treatment available as of now for relapsed/refractory AL Amyloidosis."

Outside of the U.S, NXC-201 has been administered to 72 patients. The relapsed/refractory AL Amyloidosis dosage scales were: 150 x 106 (n=1), 450 x 106 (n=2), 800 x 106 (n=6) CAR+T cells, showcasing a 100% general response rate (9/9) (with a median of 6 lines of previously used therapy). Dosage scales for relapsed/refractory multiple myeloma were: 150 x 106 (n=6), 450 x 106 (n=7), 800 x 106 (n=50) CAR+T cells, showing a 95% overall response rate with a median follow up period of 11.9 months.

Gabriel Morris, Chief Financial Officer at Immix Biopharma, attributed this IND approval in accordance with their initially communicated schedules to their top-tier cell-therapy expert team. He stated, “The encouraging tolerability record of NXC-201, including the capacity to mitigate neurotoxicity, may allow for its use beyond AL Amyloidosis into autoimmune disorders.”

👇Please click on the picture link below for free registration or login directly if you have freemium accounts, you can browse the latest research progress on drugs, indications, organizations, clinical trials, clinical results, and drug patents related to this target.

图形用户界面, 文本

描述已自动生成

According to the data provided by the Synapse Database, As of November 28, 2023, there are 186 investigational drugs for the BCMA target, including 40 indications, 172 R&D institutions involved, with related clinical trials reaching 396, and as many as 12970 patents.

NXC-201 is a BCMA-targeted investigational chimeric antigen receptor T cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, relapsed/refractory multiple myeloma, and potentially expanding into autoimmune indications: systemic lupus erythematosus, myasthenia gravis, and multiple sclerosis. NXC-201 has been awarded Orphan Drug Designation by the FDA in both AL Amyloidosis and multiple myeloma.

图形用户界面, 文本, 应用程序

描述已自动生成

Unveiling the Secrets of IL-23 Inhibitors: Stay Updated with the Latest Advances
Unveiling the Secrets of IL-23 Inhibitors: Stay Updated with the Latest Advances
28 November 2023
IL-23 inhibitors are a class of drugs that target the cytokine IL-23, playing a crucial role in treating inflammation and autoimmune diseases.
Read →
Omnix Medical gets green light from U.S. FDA for Phase II testing of its advanced anti-infective agent OMN6
Latest Hotspot
3 min read
Omnix Medical gets green light from U.S. FDA for Phase II testing of its advanced anti-infective agent OMN6
28 November 2023
The biopharmaceutical company Omnix Medical, known for creating advanced anti-infectives to combat serious infections, has reported today that their upcoming Phase II trial for their innovative anti-infective, OMN6, has received approval from the FDA.
Read →
Revumenib: A Quick Look at Its R&D Progress and Clinical Results from the 2023 ASH
Revumenib: A Quick Look at Its R&D Progress and Clinical Results from the 2023 ASH
28 November 2023
The latest clinical findings of Revumenib will be unveiled at the 2023 ASH Congress, demonstrating its potential effect and setting the stage for subsequent investigations.
Read →
The OCEANIC-AF research was prematurely terminated due to insufficient effectiveness
Latest Hotspot
3 min read
The OCEANIC-AF research was prematurely terminated due to insufficient effectiveness
28 November 2023
The OCEANIC-AF phase III trial comparing asundexian and apixaban in stroke-risk atrial fibrillation patients will end early. This is based on the Independent Data Monitoring Committee's recommendation, as asundexian showed lower efficacy than the control. Bayer will analyze the data further and share the results later.
Read →
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.