AL amyloidosis

Immix Biopharma Announces Major Comprehensive Cancer Center as Lead Site for NXC-201 AL Amyloidosis Clinical Trial

Retrieved on: 
Wednesday, March 20, 2024
MD, Amyloidosis, Patient, AL amyloidosis, Pharmaceutical industry

LOS ANGELES, CA, March 20, 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 Memorial Sloan Kettering Cancer Center as lead clinical site for its NXC-201 relapsed/refractory AL Amyloidosis multi-site clinical trial.

Key Points: 
  • LOS ANGELES, CA, March 20, 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 Memorial Sloan Kettering Cancer Center as lead clinical site for its NXC-201 relapsed/refractory AL Amyloidosis multi-site clinical trial.
  • “We are looking forward to this important multi-site clinical trial with NXC-201 CAR-T for patients with AL Amyloidosis,” said Heather Landau, MD, Memorial Sloan Kettering Cancer Center Amyloidosis Program Director.
  • “NXC-201 represents a novel direction in the treatment landscape for relapsed or refractory AL Amyloidosis patients.”

Immix Biopharma Announces “Be Proactive in AL” AL Amyloidosis Awareness Initiative

Retrieved on: 
Tuesday, March 5, 2024
Spleen, Liver, Bangladesh Technical Education Board, Autoimmune disease, NIH, Physician, Extrapyramidal system, Weight loss, Dizziness, AL amyloidosis, Amyloidosis, Diagnosis, Joint, Hypoesthesia, Fatigue, Patient, Heart, Tissue, Mortality

LOS ANGELES, CA, March 05, 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 autoimmune disease, today announced its new AL Amyloidosis awareness campaign Be Proactive in AL™.

Key Points: 
  • LOS ANGELES, CA, March 05, 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 autoimmune disease, today announced its new AL Amyloidosis awareness campaign Be Proactive in AL™.
  • The campaign seeks to increase awareness about the critical need to recognize and diagnose AL Amyloidosis early, while also educating AL Amyloidosis patients about available treatment options.
  • AL amyloidosis is a life-threatening immunological disorder in which an abnormal protein called amyloid builds up in tissues and organs.
  • “Today, it is common for AL Amyloidosis patients to see 3 or 4 different physicians and wait months to years before being definitively diagnosed with AL amyloidosis,” said Dena Heath, Amyloidosis Research Consortium Board Secretary and Facilitator, Northern California Amyloidosis Support Group.

Immix Biopharma Awarded European Union Orphan Drug Designation for NXC-201 in AL Amyloidosis

Retrieved on: 
Wednesday, February 7, 2024
Civil service commission, European, Amyloidosis, MD, Prevalence, Patient, Bone marrow, Diagnosis, EMA, Marketing, European Commission, Autoimmune disease, Disease, AL amyloidosis, European Medicines Agency, Committee, Pharmaceutical industry

Los Angeles, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced that the European Commission (EC) has granted orphan drug designation to NXC-201 for the treatment of AL Amyloidosis.

Key Points: 
  • European Orphan Drug Designation (“ODD”) qualifies NXC-201 for:
    Reduced fees for EU protocol assistance, marketing authorization applications, inspections before authorization, applications for changes to marketing authorizations made after approval, and reduced annual fees
    U.S. observed prevalence of relapsed/refractory AL Amyloidosis is growing 12% per year according to Staron, et al Blood Cancer Journal, estimated to reach 29,712 patients in 2023
    Los Angeles, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced that the European Commission (EC) has granted orphan drug designation to NXC-201 for the treatment of AL Amyloidosis.
  • “European Union orphan drug designation for NXC-201 represents an important milestone in our global strategy,” said Ilya Rachman, MD PhD, Chief Executive Officer, Immix Biopharma.
  • To qualify for orphan drug designation, a candidate therapy must be intended for the treatment, prevention or diagnosis of a life-threatening or chronically debilitating disease that occurs in not more than five in 10,000 people in the EU.
  • The designation provides regulatory, financial and commercial incentives to develop therapies for rare diseases where there are either no satisfactory treatment options or significant benefit to those affected by the disease.

Immix Biopharma Statement On January 2024 FDA Labeling Change Notification For Approved CAR-T Products

Retrieved on: 
Wednesday, January 24, 2024
Doctor of Philosophy, Autoimmune disease, AL amyloidosis, Patient, Amyloidosis, Neurotoxicity, MD, FDA, Pharmaceutical industry

LOS ANGELES, CA, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced a statement on January 2024, FDA labeling change notifications for approved CAR-T products:

Key Points: 
  • LOS ANGELES, CA, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced a statement on January 2024, FDA labeling change notifications for approved CAR-T products:
    “We applaud FDA’s vigilance.
  • Relapsed/refractory AL Amyloidosis remains an unmet medical need with limited treatment options.
  • In our interim clinical data to date, we have not observed any secondary T-cell malignancies,” said Ilya Rachman, MD, PhD, Immix Biopharma Chief Executive Officer.
  • Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “We believe NXC-201 will be uniquely suited to treat AL Amyloidosis and other autoimmune indications, given our interim clinical data in 73 patients to-date.”

Nexcella Announces Dr. Vaishali Sanchorawala, AL Amyloidosis Thought Leader, Director of the Amyloidosis Center at Boston University and Boston Medical Center, Joins Scientific Advisory Board

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.

Immix Biopharma Announces Dr. Vaishali Sanchorawala, AL Amyloidosis Thought Leader, Director of the Amyloidosis Center at Boston University and Boston Medical Center, Joins Scientific Advisory Board

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

LOS ANGELES, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq:IMMX), announced that effective today, Vaishali Sanchorawala, MD, has joined ImmixBio subsidiary Nexcella Scientific Advisory Board.

Key Points: 
  • LOS ANGELES, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq:IMMX), announced that effective today, Vaishali Sanchorawala, MD, has joined ImmixBio subsidiary 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.

Nexcella Announces 100% Overall Response Rate (n=10); 23.7 months Best Response Duration (ongoing) for CAR-T NXC-201 in Relapsed/Refractory AL Amyloidosis Patients at ASH 2023

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

Immix Biopharma Announces 100% Overall Response Rate (n=10); 23.7 months Best Response Duration (ongoing) for CAR-T NXC-201 in Relapsed/Refractory AL Amyloidosis Patients at ASH 2023

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

Immix Biopharma to Host KOL Event to Discuss its BCMA-Targeted CAR-T Cell Therapy Candidate NXC-201 for Relapsed/Refractory AL 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.

Immix Biopharma Announces FDA Approval of IND Application for CAR-T NXC-201, Enabling U.S. Patient Dosing

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.”