Multiple myeloma

Kronos Bio To Present Three Posters at AACR 2024 Annual Meeting

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Tuesday, March 5, 2024
SAN, IRF4, Senior, KRON, Research, Research and development, Adenoid cystic carcinoma, AACR, Molecular biology, Gene expression, Abstract, Multiple myeloma, CDK9, KAT, Development, Cancer, Pharmaceutical industry

SAN MATEO, Calif. and CAMBRIDGE, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that three abstracts have been selected for presentation at the American Association for Cancer Research (AACR) annual meeting, being held from April 5-10, 2024 in San Diego, California.

Key Points: 
  • SAN MATEO, Calif. and CAMBRIDGE, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that three abstracts have been selected for presentation at the American Association for Cancer Research (AACR) annual meeting, being held from April 5-10, 2024 in San Diego, California.
  • “We are excited to present our data at AACR showing that targeting p300’s enzymatic KAT domain can selectively downregulate IRF4, a long sought after transcription factor dependency in multiple myeloma.
  • Although p300 is an essential gene, our data show that through its relationship as a critical IRF4 cofactor, we can achieve selective antiproliferative effects against myeloma cells,” said Charles Lin, Ph.D., Senior Vice President, Research and Development of Kronos Bio.
  • Details for the AACR 2024 abstracts are as follows:
    Title: A dose escalation and cohort expansion study of the CDK9 inhibitor KB-0742 in relapsed, refractory and transcriptionally addicted solid tumors
    Title: KB-0742, an oral highly selective CDK9 inhibitor, demonstrates preclinical activity in transcription factor fusion driven adenoid cystic carcinoma patient-derived models
    Poster Session: Molecular Biology in Clinical Oncology: Characterizing and Modulating Epigenetics and Gene Expression

Sandoz receives FDA approval for first and only denosumab biosimilars

Retrieved on: 
Tuesday, March 5, 2024
Bone fracture, Fracture, Woman, Hypocalcemia, Osteoporosis, Bone disease, Hypercalcaemia, FDA, Quality of life, Food, Cancer, Denosumab, Metastasis, Risk, Breast, Safety, Mitigation, Novartis, REMS, Benign tumor, Disease, Patent, Patient, Medicine, Multiple myeloma, Ageing, Dietary supplement

Keren Haruvi, President Sandoz North America, said: "Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients.

Key Points: 
  • Keren Haruvi, President Sandoz North America, said: "Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients.
  • I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most."
  • Wyost® and Jubbonti® have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines.
  • Given ongoing patent litigation around these products, Sandoz will not comment on anticipated launch timing or other launch details at this time.

Molecular Templates, Inc. Provides Interim Update

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Monday, March 4, 2024
Therapy, Head, Neoplasm, Neck, CLS, AML, Part, TME, Sale, Pembrolizumab, Multiple myeloma, Bristol Myers Squibb, Symantec Endpoint Protection, TPS, Hyponatremia, Cytokine, Hypertension, Tumor microenvironment, Patient, Immunoglobulin A, MD Anderson Cancer Center, Hyperlipidemia, Disease, Biology, HNSCC, Hypercholesterolemia, CPS, PD-L1, Cancer, Pharmaceutical industry

Unique pharmacodynamic effects demonstrating potent Treg clearance and IL-2 increases were observed at the first dose level.

Key Points: 
  • Unique pharmacodynamic effects demonstrating potent Treg clearance and IL-2 increases were observed at the first dose level.
  • MTEM intends to initiate a study of MT-0169 in CD38+ acute leukemias in collaboration with MD Anderson Cancer Center.
  • Additional details on each of these participant’s clinical profile and response to the investigational treatment are provided below.
  • MTEM plans on initiating an investigator sponsored trial with MD Anderson Cancer Center to evaluate MT-0169 in relapsed or refractory CD38+ AML patients.

Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for Novel MICA/B Antibody, CLN-619, for Relapsed/Refractory Multiple Myeloma

Retrieved on: 
Friday, March 1, 2024
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CAMBRIDGE, Mass., March 01, 2024 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLN-619 in relapsed/refractory multiple myeloma. CLN-619 is a potential first-in-class humanized IgG1 monoclonal antibody that binds to stress-induced ligands, MICA and MICB, which are expressed on a wide variety of solid tumors and hematologic malignancies. The company will commence a Phase 1 dose-escalation and dose-expansion trial of CLN-619.

Key Points: 
  • The company will commence a Phase 1 dose-escalation and dose-expansion trial of CLN-619.
  • “Multiple myeloma remains incurable, and most patients experience sequential relapses.
  • The response to treatment is typically shorter with each relapse, so novel treatments are still needed,” said Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology.
  • “Multiple myeloma is another example of a malignancy where MICA/B shedding from tumor cells allows for immune evasion.

SpringWorks Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Business Updates

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Tuesday, February 27, 2024
Research, New Drug Application, Vomiting, Common, Rash, Multiple myeloma, Patient, Orange Book, Investigational New Drug, Neoplasm, Nausea, Panitumumab, BCMA, Therapy, European Medicines Agency, Food and Drug Administration, Plantar fibromatosis, MAPK, NDA, EGFR, Diarrhea, Patent, B-cell maturation antigen, IND, MEK, NRAS, Security, EMA, Aes, MAA, FDA, Research and development, Food, TEA, RAF, Medicare, NCCN, Administration, Cancer, Pharmaceutical industry

Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.

Key Points: 
  • Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.
  • Presented additional patient-reported outcome data from the Phase 3 DeFi trial at the 2023 Connective Tissue Oncology Society Annual Meeting.
  • Revenues: OGSIVEO net product revenues were $5.4 million in the fourth quarter of 2023, the first partial quarter of the U.S. launch.
  • Cash Position: Cash, cash equivalents and marketable securities were $662.6 million as of December 31, 2023.

Fate Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates

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Monday, February 26, 2024
Neoplasm, Regenerative medicine, CIRM, B-cell lymphoma, Graft-versus-host disease, Investment, TRAC, ADR, CD19, Cytokine release syndrome, Cell, Destiny, HER2, BCMA, Lupus, IPSC, Safety, GAAP, Therapy, Trastuzumab, Pharmacokinetics, Lymphoid leukemia, Patient, NK, Multiple myeloma, SLE, Immunotherapy, Research, CRS, Vaccine

SAN DIEGO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Total Operating Expenses: For the fourth quarter of 2023, GAAP operating expenses were $49.8 million, including research and development expenses of $31.8 million and general and administrative expenses of $17.9 million.
  • Shares Outstanding: Common shares outstanding were 98.6 million, and preferred shares outstanding were 2.8 million, as of December 31, 2023.
  • ET to review financial and operating results for the quarter and full year ended December 31, 2023.
  • The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.fatetherapeutics.com.

Galapagos announces full year 2023 results and outlook for 2024

Retrieved on: 
Thursday, February 22, 2024
Technology transfer, CD19, Filgotinib, Lupus, Multiple myeloma, DL2, Dermatomyositis, Acceleration, Baltic, BCMA, Mantle cell lymphoma, European Commission, Indolent lymphoma, JAK1, Safety, EBMT, RT, TYK2, CFO, PRAC, MAA, Richter's transformation, Euronext, Executive Committee, JAK, UC, Patient, SLE, Pharmaceutical industry

In addition, we entered into a strategic collaboration with BridGene Biosciences to advance our growing early-stage pipeline in precision oncology.

Key Points: 
  • In addition, we entered into a strategic collaboration with BridGene Biosciences to advance our growing early-stage pipeline in precision oncology.
  • Signed an agreement with Boston-based Landmark Bio and started the technology transfer for the decentralized production of Galapagos’ CAR-T cell therapy candidates.
  • Further streamlined our operations with a reduction of approximately 100 positions across the Galapagos organization to align with the Galapagos’ renewed focus on innovation.
  • Signed a strategic collaboration and license agreement with BridGene Biosciences to further strengthen Galapagos' growing early-stage oncology precision medicine pipeline.

Immix Biopharma 12 Month Review Progress Update

Retrieved on: 
Wednesday, February 21, 2024
Boston University, Research, Autoimmune disease, Toxicity, Doctor of Philosophy, Boston Medical Center, PMID, Health, Multiple myeloma, Patient, Poster, Blood, Investigational New Drug, Presentation, Bank, Johnson & Johnson, GMP, BCMA, Amyloidosis, BioMarin Pharmaceutical, Autoimmunity, MBBS, Pfizer, ASH, European, IMS, Conference, ODD, Haematologica, IND, Public, Gene, MD, FDA, Food, U.S. FDA, Cell, ALA, Letter, Society, Publication, BMC, Pharmaceutical industry

LOS ANGELES, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced its 12-month progress update including shareholder letter.

Key Points: 
  • LOS ANGELES, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced its 12-month progress update including shareholder letter.
  • “The past 12 months have seen landmark achievements for Immix Biopharma, cementing our position as a leading cell therapy company in autoimmune disease.
  • NXC-201 is the first and only ‘Single-Day CRS‘ CAR-T, a critical advancement for autoimmune diseases like AL Amyloidosis,” said Ilya Rachman, MD PhD CEO Immix Biopharma.
  • As we reflect on the last 12 months of progress, we wish to connect with you offering an update on Immix Biopharma.

Indapta Therapeutics Receives U.S. FDA Fast Track Designation for Lead Clinical Drug Candidate IDP-023 for Non-Hodgkin’s Lymphoma and Myeloma

Retrieved on: 
Thursday, February 29, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Fast Track, CMV, BLA, Cell, Biologics license application, Cytomegalovirus, Interleukin, Safety, Therapy, Cytokine, Accelerated approval (FDA), Patient, NK, Clinical trial, Multiple myeloma, Rituximab, Lymphoma, Cancer, Priority review, Pharmaceutical industry

Companies granted Fast Track designation may be eligible for more frequent interactions with the FDA, Accelerated Approval and Priority Review, and Rolling Review of a Biologic License Application (BLA).

Key Points: 
  • Companies granted Fast Track designation may be eligible for more frequent interactions with the FDA, Accelerated Approval and Priority Review, and Rolling Review of a Biologic License Application (BLA).
  • “This designation highlights the promise of Indapta’s highly potent NK cell platform and will further accelerate clinical development of our lead drug candidate, IDP-023, for two of the largest unmet needs in B-cell driven blood cancers, non-Hodgkin’s lymphoma and multiple myeloma,” said Dr. Mark Frohlich, CEO of Indapta.
  • Patients being enrolled now in Indapta’s Phase 1 clinical trial are receiving up to three planned doses of IDP-023 with or without interleukin-2.
  • To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors with increased numbers of g-NK cells, with low donor-to-donor variability.

Sebia Receives U.S. FDA Clearance for the FLC Kappa & Lambda Assays

Retrieved on: 
Thursday, February 29, 2024
Research, Medical Devices, FDA, Other Health, Biotechnology, General Health, Health, Science, Oncology, Other Science, FLC, EIA, Multiple myeloma, Food, ELISA, Willrich, DSM-IV codes, Patient, Diagnosis

Sebia, a global specialty diagnostic company providing innovative solutions for screening and diagnostics in oncology, metabolic diseases, genetic disorders and autoimmune diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the FLC Kappa & Lambda assays.

Key Points: 
  • Sebia, a global specialty diagnostic company providing innovative solutions for screening and diagnostics in oncology, metabolic diseases, genetic disorders and autoimmune diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the FLC Kappa & Lambda assays.
  • These are the first EIA tests receiving 510(k) from the FDA for the quantitative detection of both kappa and lambda free light chains in human serum specimens, intended for both aid of diagnosis and monitoring of Multiple Myeloma and Immunoglobulin Light-Chain (AL-) amyloidosis.
  • Clinical evaluation of Sebia FLC kappa and FLC lambda assay has shown comparable clinical sensitivity with the Freelite assay (96.6% on 177 samples from patients diagnosed with MM) and improved clinical specificity (85.1% on 189 non-myeloma/non-amyloidosis subjects with various clinical conditions).
  • The ELISA format overcomes main challenges in analytical performance often seen in alternative testing methods” said Arnaud Collin, Sebia Group Vice President Global Regulatory Affairs & Quality.