AL amyloidosis,
Amyloidosis,
MD,
Cell,
Patient,
Gene,
Society,
LOS,
Hematopoietic stem cell transplantation,
Cell therapy,
Dentistry Updated clinical data for next-generation CAR-T NXC-201 in relapsed/refractory AL amyloidosis will be presented in Baltimore May 7-11, 2024
Key Points:
- Updated clinical data for next-generation CAR-T NXC-201 in relapsed/refractory AL amyloidosis will be presented in Baltimore May 7-11, 2024
LOS ANGELES, April 15, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us” or “IMMX”), a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other autoimmune diseases, today announced that updated NXC-201 clinical data has been selected for presentation at the upcoming 27th Annual Meeting of The American Society of Gene & Cell Therapy (ASGCT) to be held in Baltimore May 7-11, 2024.
- “We are delighted to present continued clinical progress developing what we believe is the only CAR-T in AL Amyloidosis at the upcoming 27th Annual Meeting of The American Society of Gene & Cell Therapy,” said Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and principal study investigator for the NEXICART-1 Phase 1b/2a clinical trial of NXC-201.
- “A potential one-time treatment such as CAR-T NXC-201 for relapsed/refractory AL amyloidosis patients would be a welcome option for this devastating disease.”
Event: 27th Annual Meeting of The American Society of Gene and Cell Therapy, Baltimore, MD
Retrieved on:
Monday, December 11, 2023
Patient,
Bone marrow,
MGUS,
Cyclophosphamide,
IND,
Prevalence,
Disease,
NYHA,
BCMA,
MD,
Daratumumab,
Society,
Standard of care,
AL amyloidosis,
ASH,
Dexamethasone,
LOS,
Bortezomib,
Hematopoietic stem cell transplantation,
Treatment,
CRS,
Heart failure,
Pharmaceutical industry “We continue to be encouraged by NXC-201’s 100% overall response rate, including in this 10th relapsed/refractory AL amyloidosis patient.”
Key Points:
- “We continue to be encouraged by NXC-201’s 100% overall response rate, including in this 10th relapsed/refractory AL amyloidosis patient.”
“We believe NXC-201 is the first and only CAR-T in clinical development for AL amyloidosis.
- With our recent IND clearance, we are thrilled to be now activating sites to bring this first-of-a-kind study to U.S. relapsed/refractory AL Amyloidosis patients,” said Ilya Rachman, M.D., Ph.D., Executive Chairman of Nexcella.
- Patients were infused with CAR+T cells at doses of 150 x 106 (n=1), 450 x 106 (n=2), and 800 x 106 (n=7).
- MGUS, Amyloidosis and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical and Epidemiological: From Light Chain to Fibril-Novel Diagnostics to Treatments for Amyloidosis
Retrieved on:
Monday, December 11, 2023
Patient,
Bone marrow,
MGUS,
Cyclophosphamide,
IND,
Prevalence,
Disease,
NYHA,
BCMA,
MD,
Daratumumab,
Society,
Standard of care,
AL amyloidosis,
ASH,
Dexamethasone,
LOS,
Bortezomib,
Hematopoietic stem cell transplantation,
Treatment,
CRS,
Heart failure,
Pharmaceutical industry LOS ANGELES, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, today announced new clinical data from its Phase 1b/2a NEXICART-1 (NCT04720313) study of novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy, NXC-201, in patients with relapsed/refractory AL Amyloidosis (R/R ALA) at an oral presentation by study investigator Moshe E. Gatt, MD at the 65th American Society of Hematology (ASH) Meeting being held in San Diego, CA. The updated results include follow-up and clinical data from one new patient. All patients were relapsed/refractory to standard-of-care Dara-CyBorD (daratumumab combined with cyclophosphamide, bortezomib, and dexamethasone) and had experienced a median of 6 prior lines of therapy that failed to stop worsening of disease prior to receiving NXC-201.
Key Points:
- “We continue to be encouraged by NXC-201’s 100% overall response rate, including in this 10th relapsed/refractory AL amyloidosis patient.”
“We believe NXC-201 is the first and only CAR-T in clinical development for AL amyloidosis.
- With our recent IND clearance, we are thrilled to be now activating sites to bring this first-of-a-kind study to U.S. relapsed/refractory AL Amyloidosis patients,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma.
- Patients were infused with CAR+T cells at doses of 150 x 106 (n=1), 450 x 106 (n=2), and 800 x 106 (n=7).
- MGUS, Amyloidosis and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical and Epidemiological: From Light Chain to Fibril-Novel Diagnostics to Treatments for Amyloidosis
Retrieved on:
Wednesday, November 22, 2023
University of Alabama,
IND,
FDA,
Multiple myeloma,
BCMA,
ODD,
Society,
Amyloidosis,
University,
AL amyloidosis,
Hematology,
Poster,
Patient,
KOL,
Assistant professor,
Pharmaceutical industry To register for the event, click here.
Key Points:
- To register for the event, click here.
- NXC-201 is a BCMA-targeted investigational CAR-T cell therapy.
- NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma.
- A live question and answer session will follow the formal presentations.
Retrieved on:
Tuesday, November 21, 2023
Exposition,
Food,
IND,
Autoimmunity,
CCR,
FDA,
Cell,
IMS,
Multiple myeloma,
BCMA,
MD,
Gene,
Society,
Amyloidosis,
EBMT,
Investigational New Drug,
AL amyloidosis,
ASH,
LOS,
Clinical Cancer Research,
Patient,
Publication,
Pharmaceutical industry With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States.
Key Points:
- With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States.
- “Building on encouraging NXC-201 clinical data to-date, we are thrilled that multiple leading U.S. sites are currently planning to enroll patients in the coming months,” said Ilya Rachman, MD PhD, Chief Executive Officer of Immix Biopharma.
- “We credit our world-class cell-therapy expert team in achieving this IND clearance in-line with our previously communicated timelines,” said Gabriel Morris, Chief Financial Officer of Immix Biopharma.
- “NXC-201’s favorable tolerability profile, including overcoming neurotoxicity, potentially enables expansion beyond AL Amyloidosis into autoimmune indications.”
Retrieved on:
Tuesday, November 21, 2023
Exposition,
Food,
IND,
Autoimmunity,
CCR,
FDA,
Cell,
IMS,
Multiple myeloma,
BCMA,
MD,
Gene,
Society,
Amyloidosis,
EBMT,
Investigational New Drug,
AL amyloidosis,
ASH,
LOS,
Clinical Cancer Research,
Patient,
Publication,
Pharmaceutical industry With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States.
Key Points:
- With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States.
- “Building on encouraging NXC-201 clinical data to-date, we are thrilled that multiple leading U.S. sites are currently planning to enroll patients in the coming months,” said Ilya Rachman, MD PhD, Chief Executive Officer of Immix Biopharma.
- “We credit our world-class cell-therapy expert team in achieving this IND clearance in-line with our previously communicated timelines,” said Gabriel Morris, Chief Financial Officer of Immix Biopharma.
- “NXC-201’s favorable tolerability profile, including overcoming neurotoxicity, potentially enables expansion beyond AL Amyloidosis into autoimmune indications.”
Retrieved on:
Tuesday, November 21, 2023
Exposition,
Food,
IND,
Autoimmunity,
CCR,
FDA,
Cell,
IMS,
Multiple myeloma,
BCMA,
MD,
Gene,
Society,
Amyloidosis,
EBMT,
Investigational New Drug,
AL amyloidosis,
ASH,
LOS,
Clinical Cancer Research,
Patient,
Publication,
Pharmaceutical industry LOS ANGELES, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for BCMA CAR-T NXC-201 (formerly HBI0101). With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States. Favorable tolerability enables potential expansion into autoimmune indications.
Key Points:
- With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States.
- Favorable tolerability enables potential expansion into autoimmune indications.
- “We credit our world-class cell-therapy expert team in achieving this IND clearance in-line with our previously communicated timelines,” said Gabriel Morris, President of Nexcella.
- “NXC-201’s favorable tolerability profile, including overcoming neurotoxicity, potentially enables expansion beyond AL Amyloidosis into autoimmune indications.”
AL,
Treatment,
MD,
AL amyloidosis,
Society,
ASH,
LOS,
MGUS,
Exposition,
Patient,
Pharmaceutical industry,
Amyloidosis LOS ANGELES, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (Nasdaq:IMMX) (“Nexcella”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that additional NXC-201 clinical data in relapsed/refractory AL Amyloidosis has been selected for oral presentation at the upcoming 65th American Society of Hematology (ASH) Annual Meeting to be held in San Diego, California, December 9-12, 2023.
Key Points:
- “NXC-201 is the only CAR-T being studied as a treatment for AL amyloidosis patients who relapsed, or are refractory to, 4-drug combination daratumumab-CyBorD,” said Ilya Rachman, MD PhD, Executive Chairman of Nexcella.
- “NXC-201 attacks the root cause of AL Amyloidosis: disease-causing plasma cells, representing a potential one-time treatment option.”
“30,000 – 45,000 patients in the United States and Europe are living with AL Amyloidosis, for many of whom there are no additional approved treatment options beyond Dara-CyBorD,” said Gabriel Morris, President of Nexcella.
- “We are pleased to present our progress on advancing NXC-201 at the upcoming 65th annual ASH meeting in San Diego.”
65th ASH Annual Meeting and Exposition, San Diego, CA
Session Name: 654.
- MGUS, Amyloidosis and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical and Epidemiological: From Light Chain to Fibril–Novel Diagnostics to Treatments for Amyloidosis
AL,
Treatment,
MD,
AL amyloidosis,
Society,
ASH,
LOS,
MGUS,
Exposition,
Patient,
Pharmaceutical industry,
Amyloidosis LOS ANGELES, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq:IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, today announced that additional NXC-201 clinical data in relapsed/refractory AL Amyloidosis has been selected for oral presentation at the upcoming 65th American Society of Hematology (ASH) Annual Meeting to be held in San Diego, California, December 9-12, 2023.
Key Points:
- “NXC-201 is the only CAR-T being studied as a treatment for AL amyloidosis patients who relapsed, or are refractory to, 4-drug combination daratumumab-CyBorD,” said Ilya Rachman, MD PhD, Chief Executive Officer of Immix Biopharma.
- “NXC-201 attacks the root cause of AL Amyloidosis: disease-causing plasma cells, representing a potential one-time treatment option.”
“30,000 – 45,000 patients in the United States and Europe are living with AL Amyloidosis, for many of whom there are no additional approved treatment options beyond Dara-CyBorD,” said Gabriel Morris, Chief Financial Officer of Immix Biopharma.
- “We are pleased to present our progress on advancing NXC-201 at the upcoming 65th annual ASH meeting in San Diego.”
65th ASH Annual Meeting and Exposition, San Diego, CA
Session Name: 654.
- MGUS, Amyloidosis and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical and Epidemiological: From Light Chain to Fibril–Novel Diagnostics to Treatments for Amyloidosis
Travel,
Hematopoietic stem cell transplantation,
AUC,
AL amyloidosis,
MRD,
Hadassah Medical Center,
AL,
Patient,
IMS,
Amyloidosis,
LOS,
Daratumumab,
BCMA,
Pharmaceutical industry,
Immunotherapy LOS ANGELES, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), today announced presentation of additional AL Amyloidosis clinical data from its Phase 1b/2a NEXICART-1 (NCT04720313) study of novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy, NXC-201, at an oral presentation at the 20th International Myeloma Society Annual (IMS) Meeting being held in Athens, Greece on September 27-30 2023. One new patient and additional follow-up data from an additional 8 patients (9 total) are included in this update. All patients were DARZALEX® (daratumumab) combination therapy relapsed/refractory and experienced a median of 6 earlier treatments that failed to stop worsening of disease (lines of therapy) prior to receiving NXC-201.
Key Points:
- One new patient and additional follow-up data from an additional 8 patients (9 total) are included in this update.
- “NXC-201’s 100% response rate in relapsed/refractory AL amyloidosis patients, including t(11;14) and cardiac involved, indicates a potential broad mechanism of action.
- Median follow-up was 7.3 months (range: 2.5 – 16.5 months) as of the September 20, 2023 data cutoff.
- Data highlights:
Best responder had a duration of response of 19.2 months as of the data cutoff of September 20, 2023, with response ongoing
For the 7 relapsed/refractory AL Amyloidosis patients with cardiac involvement:
4 patients with t(11;14) relapsed/refractory AL Amyloidosis:
The 20th IMS AL Amyloidosis presentation can be accessed on the Nexcella corporate website at this link: https://nexcella.com/publications/
20th International Myeloma Society Annual Meeting, Athens, Greece
