Multiple myeloma

TriNetX Joins CERTAINTY Project to Enhance Cancer Immunotherapy

Retrieved on: 
Wednesday, January 31, 2024
Multiple myeloma, Immunotherapy, Fraunhofer Society, Cell therapy, Machine learning, Patient, Cellular, Immunology, Data, Data collection, Medical imaging

CAMBRIDGE, Mass., Jan. 31, 2024 /PRNewswire/ -- TriNetX, LLC ("TriNetX"), the global network of healthcare organizations driving real-world research to accelerate the development of new therapies, is proud to announce its participation in the CERTAINTY project.

Key Points: 
  • CAMBRIDGE, Mass., Jan. 31, 2024 /PRNewswire/ -- TriNetX, LLC ("TriNetX"), the global network of healthcare organizations driving real-world research to accelerate the development of new therapies, is proud to announce its participation in the CERTAINTY project.
  • CERTAINTY, short for CEllulaR ImmunoTherapy Avatar for personalized cancer treatment, is an international research endeavor led by the Fraunhofer Institute for Cell Therapy and Immunology IZI.
  • Bringing together a consortium of partners from academia, industry, and healthcare, this project is focused on revolutionizing cancer immunotherapy.
  • The initial focus of the CERTAINTY project is on creating a virtual twin for multiple myeloma (MM), a bone marrow malignancy.

Delcath Systems Receives Permanent J-Code (J9248) for HEPZATO™ (melphalan/Hepatic Delivery System) Effective April 1, 2024

Retrieved on: 
Wednesday, January 31, 2024
Multiple myeloma, Delcath Systems, Lymph, Patient, Mum, FDA, Lung, Radiation, CMS, Liver, Medicare, Hospital

The J-code will become effective on April 1, 2024.

Key Points: 
  • The J-code will become effective on April 1, 2024.
  • J-codes are a form of Healthcare Common Procedure Coding System Level II identifiers used by payors to streamline the billing of Medicare Part B drugs.
  • "We believe that the establishment of the permanent J-code for HEPZATO will facilitate patient access to this important treatment," said Gerard Michel, Delcath's Chief Executive Officer.
  • "This is a significant step towards accurate and efficient reimbursement of the HEPZATO KIT, facilitating access for patients."

Ichnos and Glenmark take a collaborative leap to accelerate innovation in Cancer Treatment with their alliance - 'Ichnos Glenmark Innovation'

Retrieved on: 
Tuesday, January 30, 2024
IGI, Multiple myeloma, Collaboration, Acute myeloid leukemia, Research, Science, Bone marrow, Drug discovery, Navi Mumbai, Drug development, Autoimmune disease, Pharmaceutical industry

This alliance brings together drug innovation capabilities of Ichnos and Glenmark to develop cutting-edge therapies for the treatment of hematological malignancies and solid tumors.

Key Points: 
  • This alliance brings together drug innovation capabilities of Ichnos and Glenmark to develop cutting-edge therapies for the treatment of hematological malignancies and solid tumors.
  • NEW YORK, Jan. 30, 2024 /PRNewswire/ -- Ichnos Sciences Inc. (Ichnos), a global, fully integrated, clinical-stage biotech company and Glenmark Pharmaceuticals Ltd. (Glenmark), a leading, research-driven, global pharmaceutical company, today announced the launch of their alliance – Ichnos Glenmark Innovation – to accelerate new drug discovery in cancer treatment.
  • "We are proud to announce the Ichnos Glenmark Innovation alliance, which brings together the legacy of Glenmark and passion of Ichnos to accelerate the search for curing cancer.
  • remarked Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals Ltd.
    Cyril Konto, President and CEO, Ichnos Glenmark Innovation, said, "Ichnos Glenmark Innovation is a collaborative venture backed by a strong, collective pipeline of novel multispecifics and small molecules.

Gracell Biotechnologies Announces FDA Clearance of IND Application for Phase 1 Clinical Trial of FasTCAR-T GC012F as Early-Line Treatment of Multiple Myeloma

Retrieved on: 
Monday, January 29, 2024
Patient, SAN, IIT, Society, Cancer, Autoimmune disease, RRMM, CD19, IND, Food, Multiple myeloma, Safety, FDA, BCMA, Pharmaceutical industry

“We are extremely pleased to receive our third U.S. IND clearance for our lead FasTCAR candidate GC012F, now expanding company-sponsored investigation into early-line multiple myeloma,” said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell.

Key Points: 
  • “We are extremely pleased to receive our third U.S. IND clearance for our lead FasTCAR candidate GC012F, now expanding company-sponsored investigation into early-line multiple myeloma,” said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell.
  • This is the third U.S. IND clearance for GC012F.
  • In addition to the ELMM study, GC012F is being evaluated in an ongoing Phase 1b/2 U.S. IND study for the treatment of relapsed/refractory multiple myeloma (RRMM) and in a Phase 1/2 clinical trial for the treatment of refractory systemic lupus erythematosus (rSLE) that will initiate in 2024.
  • GC012F is also being evaluated in four investigator-initiated trials (IIT) for the treatment of rSLE, RRMM, newly-diagnosed multiple myeloma (NDMM) and B-cell non-Hodgkin lymphoma (B-NHL).

Cellectar Biosciences Announces Tranche A Warrants Fully Exercised, Providing Proceeds of $44.1 Million

Retrieved on: 
Thursday, January 25, 2024
Cancer, Tranche, Multiple myeloma, NDA, FDA, Exercise, Macroglobulinemia, CNS, Pharmaceutical industry

All participants in the previous financing, led by Rosalind Advisors, exercised their warrants with gross proceeds totaling approximately $44.1 million.

Key Points: 
  • All participants in the previous financing, led by Rosalind Advisors, exercised their warrants with gross proceeds totaling approximately $44.1 million.
  • In connection with the September 2023 private placement, Cellectar also issued to investors five-year Tranche B warrants for potential aggregate proceeds of approximately $34.3 million.
  • “We believe that the exercise of 100 percent of the available Tranche A warrants is a testament to the confidence our investors have in our company and lead asset, iopofosine I 131,” said James Caruso, president and CEO of Cellectar.
  • In parallel, we continue our clinical development of iopofosine in cancers with significant unmet clinical needs, such as multiple myeloma, pediatric high-grade gliomas, CNS lymphoma and others.”

The International Myeloma Foundation Mourns the Passing of IMF Board Member Dr. Edith Mitchell

Retrieved on: 
Tuesday, January 23, 2024
Mentorship, Research, Principal, City, IMF, Internal medicine, AACR, Cancer, NCI, Public key certificate, FACC, Multiple myeloma, International Myeloma Foundation, National Cancer Institute, MACP, ECOG, African Americans, Medical college, Air force, National Medical Association, Breast, Health equity, Student, American Cancer Society, Radiation therapy, Thomas Jefferson University, Blue-ribbon committee, Military, NMA, Air National Guard, Human, FCPP, Oncology, Patient, Sadness, Partnership, ASCO, Distinguished Service Award, Friends, Society, Travel, LAPS, FRCP, Alpha Kappa Alpha, Clinical trial, Nursing

Dr. Edith Mitchell has been a member of the IMF Board of Directors for over twenty years.

Key Points: 
  • Dr. Edith Mitchell has been a member of the IMF Board of Directors for over twenty years.
  • In 2023, Dr. Mitchell received the Pennsylvania Medical Society’s (PAMED) Distinguished Service Award—the highest award presented by PAMED.
  • Edith Mitchell’s passing is such a profound loss for the IMF, the IMF Board of Directors, and the myeloma community at large.
  • The International Myeloma Foundation sends its deepest sympathies, thoughts, and prayers to Dr. Mitchell’s family members, friends, colleagues, and loved ones.

Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Abecma (idecabtagene vicleucel) in Earlier Lines of Therapy for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma

Retrieved on: 
Friday, January 26, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Death, Patient, Immunomodulatory imide drug, European, CHMP, Progression-free survival, Neurotoxicity, European Medicines Agency, Cytopenia, Civil service commission, European Commission, Society, EMA, Risk, Head, Cytokine release syndrome, CRS, Multiple myeloma, Food, PFS, FDA, ASH, Committee, BMY, Pharmaceutical industry

The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

Key Points: 
  • The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.
  • “This positive CHMP opinion represents an important step toward bringing our potentially transformative first-in-class anti-BCMA CAR T cell therapy, Abecma, to more patients earlier in the multiple myeloma treatment paradigm to improve outcomes,” said Anne Kerber, M.D., senior vice president and head, Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), Bristol Myers Squibb.
  • Treatment with Abecma exhibited a well-established safety profile, with mostly low-grade and transient occurrences of cytokine release syndrome (CRS) and neurotoxicity.
  • In the EU, the EC delivers its final decision approximately two months following receipt of the CHMP opinion.

Oricell Announces FDA Clearance of IND Application for OriCAR-017, a novel GPRC5D Targeted CAR-T Cell Therapy Utilizing the Company's Proprietary Platform, for the Treatment of Relapsed/Refractory Multiple Myeloma.

Retrieved on: 
Monday, January 29, 2024
The Lancet, Hope, CMC, Patient, ISS, MRD, Therapy, GPRC5D, ASCO, EMD, CRS, IND, Food, Multiple myeloma, EHA, FDA, Investigational New Drug, BCMA, POLARIS, NMPA, Pharmaceutical industry

OriCAR-017 is a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D.

Key Points: 
  • OriCAR-017 is a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D.
  • The therapy leverages Oricell's proprietary platforms including Ori®Ab antibodies, Ori®CAR construct and unique CMC know-how to achieve optimal binding and superior persistence and anti-tumor efficacy out of rejuvenated CAR-T cells.
  • The IND enables Oricell to initiate the clinical development for OriCAR-017 in the US immediately.
  • "The evidenced superior safety, efficacy and durability profile of OriCAR-017 is truly exciting and will significantly benefit multiple myeloma patients on a global scale.

Florida Cancer Specialists & Research Institute Best Practices Program Improves Treatment Response and Survival for Patients with Multiple Myeloma

Retrieved on: 
Thursday, January 25, 2024
Real-World Evidence, Death, Incidence, RN, BSN, Bachelor of Pharmacy, Partnership, Survival, RRMM, Multiple myeloma, CAPM, Bone marrow, Data, FDA, Current Oncology, FCS, Doctor of Philosophy, RPH, OCN, BP, Infrared spectroscopy correlation table, Immune system, Nursing

FORT MYERS, Fla., Jan. 25, 2024 /PRNewswire/ -- A best practices program developed at Florida Cancer Specialists & Research Institute (FCS) has been shown to improve outcomes for adult patients prescribed selinexor for the treatment of relapsed/refractory multiple myeloma (RRMM).

Key Points: 
  • A real-world study by FCS authors details a program to improve patient outcomes for multiple myeloma.
  • Results obtained from a one-year retrospective observational study using data collected by FCS' Real-World Evidence team were recently published in Current Oncology.
  • He added, "Our findings, as detailed in this article, support the hypothesis that a best practices program designed around specific anticancer drugs can optimize prescribing practices, leading to better disease control and improvements in a patient's cancer care journey."
  • The FCS Real-World Evidence team works with internal and external partners providing insights to improve treatment decisions and clinical outcomes based on evidence generated using real-world data.

Conversations on Cancer: Transforming Patient Lives by Therapeutic and Regulatory Innovations, European Medicines Agency, Amsterdam, the Netherlands, from 1 February 2024, 15:30 (CET) to 1 February 2024, 17:00 (CET)

Retrieved on: 
Friday, January 19, 2024
Role, Patient, OCE, Accelerated approval (FDA), Melanoma, European Medicines Agency, EMA, Outline, Location, Multiple myeloma, Therapy, Acute leukemia, Pharmaceutical industry

The conversation will focus on the introduction of certain innovative therapeutic classes in the past two decades that have revolutionized the care for patients with chronic myeloid leukemia, multiple myeloma, and melanoma.

Key Points: 
  • The conversation will focus on the introduction of certain innovative therapeutic classes in the past two decades that have revolutionized the care for patients with chronic myeloid leukemia, multiple myeloma, and melanoma.
  • The discussion will provide an overview of regulatory programs that expedite access to patients, including FDA’s Breakthrough therapy designation and Accelerated Approval; and EMA’s Prime and Conditional Approval.
  • The panel of patients, investigators and regulators aims to highlight successes from development to approval.
  • We’ll specifically outline:
    - Patient experiences with new innovative therapeutic classes;
    - Investigator approaches in development;
    - Role of regulatory collaboration and programs to expedite development and approval of novel, safe, and effective therapeutics.