Associated tags: Patient, Pharmaceutical industry, Amyloidosis, Multiple myeloma, AL amyloidosis, LOS, BCMA, MD, AL
Locations: NETHERLANDS, AL, ISRAEL, PARIS, FRANCE, GREECE, EUROPE, MAYO, LOS ANGELES, CA, US, RA, CALIFORNIA
LOS ANGELES, April 18, 2024 (GLOBE NEWSWIRE) -- Nexcella, an Immix Biopharma, Inc. subsidiary (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 it is on track to dose NXC-201 patients in the U.S. with no change in patient enrollment timing.
Key Points:
- “We are on track to dose relapsed/refractory AL Amyloidosis NXC-201 patients at our New York City lead site and other leading U.S. sites in mid-2024.
- U.S. site clinical trial agreements have been signed, and site initiation visits are being scheduled,” said Ilya Rachman, MD PhD CEO of Immix Biopharma and Executive Chairman of Nexcella.
- “Building on our existing NXC-201 clinical dataset, our U.S. relapsed/refractory AL Amyloidosis clinical trial design is focused on patients with adequate cardiac function who are most likely to experience the greatest clinical benefit from NXC-201.
- We are committed to providing additional treatment alternatives for relapsed/refractory AL Amyloidosis patients, where there are no FDA approved drugs today.”
Retrieved on:
Thursday, January 4, 2024
Survival,
Skinner,
Editor-in-chief,
Boston Medical Center,
Doctor of Philosophy,
Research,
Rutgers University,
Standard of care,
AL amyloidosis,
International Society,
Hematology,
Boston University,
Daratumumab,
Internal medicine,
Patient,
Journal,
BMC,
Medical device LOS ANGELES, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), announced that effective today, Vaishali Sanchorawala, MD, has joined the Nexcella Scientific Advisory Board.
Key Points:
- LOS ANGELES, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), announced that effective today, Vaishali Sanchorawala, MD, has joined the Nexcella Scientific Advisory Board.
- I am excited to join the Nexcella team’s efforts to advance NXC-201, a promising CAR-T in relapsed/refractory AL Amyloidosis," commented Dr. Sanchorawala.
- "Dr. Sanchorawala joining our scientific advisory board further demonstrates our leadership in relapsed/refractory AL Amyloidosis, where NXC-201 is the only CAR-T in development.
- Dr. Sanchorawala completed residency at Rutgers Health/New Jersey Medical School and her fellowship in hematology/oncology at Boston University Medical Center.
Retrieved on:
Monday, December 18, 2023
Associate,
MD–PhD,
Immunotherapy,
Immunology,
Autoimmune disease,
UTHSC,
Biology,
Autoimmunity,
Research,
Drexel University,
SLE,
APS,
Lupus,
MD,
Amyloidosis,
Biochemistry,
Genetics,
University,
LOS,
Rheumatoid arthritis,
Science Translational Medicine,
Patient,
Vaccine LOS ANGELES, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), announced that effective today, Marko Radic PhD, has joined the Nexcella Scientific Advisory Board. Dr. Radic brings decades of experience in autoimmune cell therapy, and thought leadership to Nexcella.
Key Points:
- Dr. Radic brings decades of experience in autoimmune cell therapy, and thought leadership to Nexcella.
- I believe recent developments in the CAR-T field allow for novel approaches to treat autoimmune diseases,” said Dr. Radic.
- “I am excited about joining the Nexcella scientific advisory board and continuing to contribute to expanding treatment options to patients with debilitating autoimmune diseases.”
"It is a pleasure to welcome Dr. Radic as a member of our Scientific Advisory Board.
- Prior to joining UTHSC in 2000, Dr. Radic was an Associate Professor in the Department of Microbiology at Drexel University.
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:
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.”
Multiple myeloma,
MD,
Society,
ASH,
Neurotoxicity,
Hospital,
LOS,
Exposition,
Patient,
Toxic epidermal necrolysis,
Nursing LOS ANGELES, Nov. 06, 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 updated NXC-201 relapsed/refractory multiple myeloma clinical data has been selected for 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:
- “75% of patients on multiple myeloma CAR-T waiting lists at U.S. hospitals do not receive the CAR-T therapy.
- As CAR-Ts are expected to be approved for earlier lines of treatment, we believe demand is likely to increase,” said Ilya Rachman, MD PhD, Executive Chairman of Nexcella.
- “We are working tirelessly to make NXC-201 an option for these patients waiting for multiple myeloma CAR-Ts.”
“Today, only 5% of U.S. hospitals offer multiple myeloma CAR-Ts due to toxicities,” said Gabriel Morris, President of Nexcella.
- “Our N-GENIUS technology platform, which we believe overcomes neurotoxicity, aims to allow the remaining 95% of U.S. hospitals, including community hospitals, to offer our CAR-T NXC-201.”
65th ASH Annual Meeting and Exposition, San Diego, CA
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
