NEXCELLA


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

Immix Biopharma Presents NXC-201 Data at 65th American Society of Hematology (ASH) Annual Meeting in 63 Relapsed/Refractory Multiple Myeloma Patients

Retrieved on: 
Monday, November 6, 2023
Multiple myeloma, MD, Society, ASH, Neurotoxicity, Hospital, LOS, Exposition, Patient, Financial toxicity, Nursing

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 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, Chief Executive Officer of Immix Biopharma.
  • “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, Chief Financial Officer of Immix Biopharma.
  • “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

Immix Biopharma Subsidiary Nexcella Announces Dr. Michaela Liedtke, Stanford Medicine Cancer Center Hematology Program Lead and Co-Director Stanford Amyloid Center, Joins Scientific Advisory Board

Retrieved on: 
Thursday, October 26, 2023
Multiple myeloma, American Society of Clinical Oncology, American Society of Hematology, Clinical Cancer Research, Coronavirus Scientific Advisory Board, Albert Einstein College of Medicine, MD, Harry Oppenheimer Fellowship Award, Stanford Department of Electrical Engineering, SWOG, Stanford University Medical Center, Society, Memorial, International Society, Patient, ASCO, Nursing, Amyloidosis, Hematology, Hannover Medical School

LOS ANGELES, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”), announced that effective today, Dr. Michaela Liedtke has joined ImmixBio subsidiary Nexcella Scientific Advisory Board.

Key Points: 
  • LOS ANGELES, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”), announced that effective today, Dr. Michaela Liedtke has joined ImmixBio subsidiary Nexcella Scientific Advisory Board.
  • Dr. Liedtke brings decades of experience in hematology/oncology clinical trials, clinical trial design, and thought leadership to Nexcella.
  • “We need more effective treatments to improve the outcomes for patients with relapsed/refractory AL amyloidosis and relapsed/refractory multiple myeloma,” said Dr. Liedtke.
  • We are excited to be working with Dr. Liedtke.”
    Dr. Liedtke is the Stanford University Medicine Cancer Center Program Lead, Hematology; Co-Director, Stanford Amyloid Center; Medical Director, Stanford Adolescent and Young Adult Program; and Member Leukemia Committee, Southwest Oncology Group.

Nexcella Announces Dr. Michaela Liedtke, Stanford Medicine Cancer Center Hematology Program Lead and Co-Director Stanford Amyloid Center, Joins Scientific Advisory Board

Retrieved on: 
Thursday, October 26, 2023
Multiple myeloma, American Society of Clinical Oncology, American Society of Hematology, Clinical Cancer Research, MD–PhD, Coronavirus Scientific Advisory Board, Albert Einstein College of Medicine, MD, Harry Oppenheimer Fellowship Award, Stanford Department of Electrical Engineering, SWOG, Stanford University Medical Center, Society, Memorial, International Society, Patient, ASCO, Nursing, Amyloidosis, Hematology, Hannover Medical School

LOS ANGELES, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), announced that effective today, Dr. Michaela Liedtke has joined the Nexcella Scientific Advisory Board.

Key Points: 
  • LOS ANGELES, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), announced that effective today, Dr. Michaela Liedtke has joined the Nexcella Scientific Advisory Board.
  • Dr. Liedtke brings decades of experience in hematology/oncology clinical trials, clinical trial design, and thought leadership to Nexcella.
  • We are excited to be working with Dr. Liedtke.”
    Dr. Liedtke is the Stanford University Medicine Cancer Center Program Lead, Hematology; Co-Director, Stanford Amyloid Center; Medical Director, Stanford Adolescent and Young Adult Program; and Member Leukemia Committee, Southwest Oncology Group.
  • Dr. Liedtke completed her fellowship at Stanford University Medical Center and Memorial Sloan-Kettering Cancer Center, residency at the Albert Einstein College of Medicine, and received her medical degree from Medizinische Hochschule Hannover.

Nexcella Completes 3rd NXC-201 Engineering Batch at its U.S. CAR-T Manufacturing Site

Retrieved on: 
Monday, October 16, 2023
FDA, Hospital, Engineering, IND, Neurotoxicity, Doctor of Philosophy, LOS, AL amyloidosis, Patient, BCMA, Vaccine, Pharmaceutical industry

LOS ANGELES, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”) today announced the successful completion of its 3rd engineering batch of BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 at its U.S. manufacturing site.

Key Points: 
  • Successful completion supports expansion of its ongoing NEXICART-1 (NCT04720313) NXC-201 CAR-T clinical trial to the U.S.
    LOS ANGELES, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”) today announced the successful completion of its 3rd engineering batch of BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 at its U.S. manufacturing site.
  • NXC-201 will be manufactured for each individual patient using the patient’s own T cells at our state-of-the-art cellular immunotherapy manufacturing facility in California.
  • “We believe the completion of our 3rd U.S. engineering batch represents an important threshold to demonstrate our U.S. manufacturing capability for NXC-201 IND submission in the United States,” said Ilya Rachman, M.D.
  • “NXC-201 has been dosed in a large number of patients across released/refractory AL amyloidosis and relapsed/refractory multiple myeloma.

Immix Biopharma Completes 3rd NXC-201 Engineering Batch at its U.S. CAR-T Manufacturing Site

Retrieved on: 
Monday, October 16, 2023
FDA, Hospital, Engineering, IND, Neurotoxicity, Doctor of Philosophy, LOS, AL amyloidosis, Patient, BCMA, Vaccine, Pharmaceutical industry

Successful completion supports expansion of its ongoing NEXICART-1 (NCT04720313) NXC-201 CAR-T clinical trial to the U.S.

Key Points: 
  • Successful completion supports expansion of its ongoing NEXICART-1 (NCT04720313) NXC-201 CAR-T clinical trial to the U.S.
    LOS ANGELES, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”) today announced the successful completion of its 3rd engineering batch of BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 at its U.S. manufacturing site.
  • NXC-201 will be manufactured for each individual patient using the patient’s own T cells at our state-of-the-art cellular immunotherapy manufacturing facility in California.
  • “We believe the completion of our 3rd U.S. engineering batch represents an important threshold to demonstrate our U.S. manufacturing capability for NXC-201 IND submission in the United States,” said Ilya Rachman, M.D.
  • PhD, Chief Executive Officer of Immix Biopharma.

Nexcella Announces Complete Response in 9th Relapsed/Refractory AL Amyloidosis Patient in NXC-201 Clinical Trial at IMS 20th Annual Meeting

Retrieved on: 
Tuesday, October 3, 2023
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

Immix Biopharma Announces Complete Response in 9th Relapsed/Refractory AL Amyloidosis Patient in NXC-201 Clinical Trial at IMS 20th Annual Meeting

Retrieved on: 
Tuesday, October 3, 2023
Travel, Hematopoietic stem cell transplantation, AUC, AL amyloidosis, Thirty Days, MRD, Hadassah Medical Center, AL, Patient, IMS, Amyloidosis, LOS, Daratumumab, BCMA, Pharmaceutical industry, Hospital, Immunotherapy

One new patient and additional follow-up data from an additional 8 patients (9 total) are included in this update.

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 ImmixBio corporate website at this link: https://immixbio.com/pipeline/#publications
    20th International Myeloma Society Annual Meeting, Athens, Greece

Nexcella Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma

Retrieved on: 
Monday, October 2, 2023
Hematopoietic stem cell transplantation, Hospital, Multiple myeloma, AL amyloidosis, Cell, Clinical data repository, Hadassah Medical Center, Patient, Data, IMS, Amyloidosis, LOS, IND, BCMA, Safety, Pharmaceutical industry, Medical device, Immunotherapy

95% overall response rate observed in relapsed/refractory multiple myeloma patients not previously treated with BCMA-targeted therapy.

Key Points: 
  • 95% overall response rate observed in relapsed/refractory multiple myeloma patients not previously treated with BCMA-targeted therapy.
  • “We feel these overall response rate data are compelling as 72% was the overall response rate reported for ABECMA from its pivotal 100-patient KarMMa trial in relapsed/refractory multiple myeloma.
  • “The waiting lists at major academic medical centers in the United States for multiple myeloma CAR-Ts reflect unmet medical need.
  • This could meaningfully reduce hospital costs and enable NXC-201 CAR-T therapy to be widely adopted.”
    The 20th IMS multiple myeloma poster can be accessed on the Nexcella corporate website at this link: https://nexcella.com/publications/
    Nexcella Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma
    20th International Myeloma Society Annual Meeting, Athens, Greece

Immix Biopharma Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma

Retrieved on: 
Monday, October 2, 2023
Hematopoietic stem cell transplantation, Hospital, Multiple myeloma, AL amyloidosis, Cell, Clinical data repository, Hadassah Medical Center, Patient, Data, IMS, Amyloidosis, LOS, IND, BCMA, Safety, Pharmaceutical industry, Medical device, Immunotherapy

LOS ANGELES, Oct. 02, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”) today announced the presentation of updated data from the ongoing Phase 1b/2 NEXICART-1 (NCT04720313) study of its novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201. The updated dataset consists of 63 multiple myeloma patients (including data on 13 new patients and continued follow-up data on 50 previously enrolled patients), at a poster presentation at the 20th International Myeloma Society Annual Meeting in Athens, Greece on September 27-30, 2023 (72 patient count includes 9 AL Amyloidosis patients which will be announced separately).

Key Points: 
  • 95% overall response rate observed in relapsed/refractory multiple myeloma patients not previously treated with BCMA-targeted therapy.
  • “We feel these overall response rate data are compelling as 72% was the overall response rate reported for ABECMA from its pivotal 100-patient KarMMa trial in relapsed/refractory multiple myeloma.
  • “The waiting lists at major academic medical centers in the United States for multiple myeloma CAR-Ts reflect unmet medical need.
  • This could meaningfully reduce hospital costs and enable NXC-201 CAR-T therapy to be widely adopted.”
    The 20th IMS multiple myeloma poster can be accessed on the ImmixBio corporate website at this link: https://immixbio.com/pipeline/#publications
    Immix Biopharma Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma
    20th International Myeloma Society Annual Meeting, Athens, Greece

U.S. Food and Drug Administration Approves Orphan Drug Designation for Nexcella NXC-201 as a Treatment for Amyloid Light Chain (AL) Amyloidosis

Retrieved on: 
Thursday, September 21, 2023
ODD, MD, Patient, AL amyloidosis, Diagnosis, LOS, Rare, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Amyloidosis

LOS ANGELES, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella” or the “Company”), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) designation for NXC-201 for the treatment of a life-threatening blood disorder, Amyloid Light Chain (AL) Amyloidosis. NXC-201, a next generation CAR-T cell therapy, is currently being evaluated in a Phase 1b/2a clinical trial NEXICART-1 (NCT04720313).

Key Points: 
  • FDA Orphan Drug Designation (“ODD”) qualifies one-time treatment NXC-201 for:
    The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research
    LOS ANGELES, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella” or the “Company”), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) designation for NXC-201 for the treatment of a life-threatening blood disorder, Amyloid Light Chain (AL) Amyloidosis.
  • NXC-201, a next generation CAR-T cell therapy, is currently being evaluated in a Phase 1b/2a clinical trial NEXICART-1 (NCT04720313).
  • The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to 7 years of market exclusivity in the U.S. upon regulatory approval.
  • “We are pleased to receive FDA’s orphan drug designation in AL amyloidosis for NXC-201, the only clinical-stage CAR-T cell therapy in development for AL amyloidosis,” said Ilya Rachman, MD PhD, Executive Chairman of Nexcella, adding, “We are thrilled to potentially expand therapeutic options for relapsed and refractory AL amyloidosis patients, where we have observed to date in our NXC-201 clinical trials a 100% hematologic response rate and demonstrated organ responses in patient hearts, livers and kidneys, for AL amyloidosis patients who received a median of 6 earlier treatments that previously failed to halt the disease.” Gabriel Morris, President of Nexcella, added, “We believe one-time treatment NXC-201 could offer AL amyloidosis patients a convenient therapeutic option.”