BCMA

Kite and Arcellx Continue Momentum with Advances in Anito-Cel Multiple Myeloma Program

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Giovedì, Maggio 9, 2024
Stem Cells, Biotechnology, FDA, Health, General Health, Pharmaceutical, Oncology, Research, Hospitals, Science, Clinical Trials, Multiple myeloma, Safety, Food, IND, Patient, SOC, Standard of care, BCMA, Investigational New Drug, Pharmaceutical industry

Kite, a Gilead Company (NASDAQ: GILD), and Arcellx, Inc. (NASDAQ: ACLX) today announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program.

Key Points: 
  • Kite, a Gilead Company (NASDAQ: GILD), and Arcellx, Inc. (NASDAQ: ACLX) today announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program.
  • Anito-cel is the first BCMA CAR T to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact D-Domain binder.
  • The companies shared the design of a global, Phase 3 randomized controlled clinical trial, iMMagine-3, which Kite expects to start in the second half of this year.
  • In addition, the completion of the technical transfer to Kite allowed us to accelerate our development program and launch iMMagine-3 globally, which will enable broader and earlier patient access to anito-cel.”

Arcellx and Kite Continue Momentum with Advances in Anito-Cel Multiple Myeloma Program

Retrieved on: 
Giovedì, Maggio 9, 2024
Research, FDA, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Multiple myeloma, GILD, Safety, Food, IND, Patient, SOC, Standard of care, BCMA, Investigational New Drug, Pharmaceutical industry

Arcellx, Inc. (NASDAQ: ACLX) and Kite, a Gilead Company (NASDAQ: GILD), today announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program.

Key Points: 
  • Arcellx, Inc. (NASDAQ: ACLX) and Kite, a Gilead Company (NASDAQ: GILD), today announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program.
  • Anito-cel is the first BCMA CAR T to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact D-Domain binder.
  • The companies shared the design of a global, Phase 3 randomized controlled clinical trial, iMMagine-3, which Kite expects to start in the second half of this year.
  • We know manufacturing quality, reliability, and speed are critically important as every day matters for these patients.”

Fate Therapeutics Reports First Quarter 2024 Financial Results and Business Updates

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Giovedì, Maggio 9, 2024
FDA, Investment, Risk, Destiny, IND, Autoimmune disease, Enrollment, Death, Hospital, GAAP, NK, GEJ, Multiple myeloma, CRS, HER2, Pharmacokinetics, Graft-versus-host disease, Food, Lupus, Data, ADR, BCL, Histology, Therapy, BCMA, Autoimmunity, Safety, Trastuzumab, Research, TRAC, Incidence, IPSC, Chronic lymphocytic leukemia, Acute leukemia, Investigational New Drug, Cancer, Cell, Cmax, Patient, Gene, Society, B-cell lymphoma, BCM, Cytokine release syndrome, Immune system, SLE, Vaccine

SAN DIEGO, May 09, 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 diseases, today reported business highlights and financial results for the first quarter ended March 31, 2024.

Key Points: 
  • The patient was discharged after a three-day hospital stay without any notable adverse events.
  • The Company will conduct a conference call today, Thursday, May 9, 2024 at 5:00 p.m.
  • ET to review financial and operating results for the quarter and full year ended March 31, 2024.
  • The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.fatetherapeutics.com.

Century Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates

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Giovedì, Maggio 9, 2024
Cancer, Investment, Cell, Research, Gene editing, Research and development, Ink, Computational biology, Myasthenia gravis, CRS, Science, Protein engineering, Administration, Rejection, IPSC, CD19, Autoimmune disease, Bristol Myers Squibb, Patient, Acquisition, Pharming, NHL, Century, Malignancy, BMS, AACR, SLE, Therapy, Lymphoid leukemia, GAAP, BCMA, NK, Pharmaceutical industry

Century’s core Allo-Evasion™ edits are designed to overcome the three major pathways of host versus graft rejection: CD8+ T cells, CD4+ T cells and NK cells.

Key Points: 
  • Century’s core Allo-Evasion™ edits are designed to overcome the three major pathways of host versus graft rejection: CD8+ T cells, CD4+ T cells and NK cells.
  • In April 2024, the Company announced plans to expand clinical development of CNTY-101 into additional autoimmune disease indications beyond SLE.
  • In the second half of 2024, Century intends to submit additional regulatory filings for CNTY-101 in autoimmune disease indications with limited current treatment options and high unmet need.
  • Century plans to share additional data from its Phase 1 ELiPSE-1 trial in R/R non-Hodgkin lymphoma (NHL) at the upcoming ASCO Annual Meeting, being held May 31-June 4, 2024, in Chicago, IL.

Cartesian Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update

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Mercoledì, Maggio 8, 2024
Corporate headquarters, FDA, Multiple myeloma, Safety, Risk, Pharmacokinetics, Food, Research, Orphan, Cell, CGMP, Autoimmune disease, Patient, Gene, Society, Messenger, SLE, Therapy, BCMA, Growth, Pharmaceutical industry

GAITHERSBURG, Md., May 08, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today reported financial results for the first quarter ended March 31, 2024, and recent corporate updates.

Key Points: 
  • Recently granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of MG.
  • Dosing of first patient in Phase 2 trial of Descartes-08 in patients with SLE expected in second quarter of 2024.
  • Transitioning Corporate Headquarters to Frederick, Maryland
    In March 2024, the Company announced plans to transition its corporate headquarters to Frederick, Maryland.
  • General and administrative expenses were $9.5 million for the quarter ended March 31, 2024, compared to $5.7 million for the quarter ended March 31, 2023.

EQS-News: Heidelberg Pharma AG: Interim Management Statement on the First Three Months of 2024

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Venerdì, Maggio 3, 2024
USD, Sale, FDA, CFO, ATAC, Multiple myeloma, CAIX, Priority review, Teaching, Food, Research, Depreciation, BCMA, EUR, Biologics license application, Disease, ADC, Research and development, Patient, Chemistry, Supervisory board, BLA, Diagnosis, Marketing, Interim, Bank statement, Clinical trial, ODD, HPHA, Pharmaceutical industry

Ladenburg, Germany, 25 April 2024 - Heidelberg Pharma AG (FSE: HPHA) today reported on the first three months of fiscal year 2024 (1 December 2023 – 29 February 2024) and the Group’s financial figures.

Key Points: 
  • Ladenburg, Germany, 25 April 2024 - Heidelberg Pharma AG (FSE: HPHA) today reported on the first three months of fiscal year 2024 (1 December 2023 – 29 February 2024) and the Group’s financial figures.
  • Professor Pahl has been Head of Research & Development at Heidelberg Pharma since 2012 and has been a member of the Executive Management Board since 2016.
  • The Heidelberg Pharma Group – as of the reporting date comprising Heidelberg Pharma AG and its subsidiary Heidelberg Pharma Research GmbH – reports consolidated figures.
  • The complete figures for the interim financial statements can be downloaded from http://www.heidelberg-pharma.com/ ”Press & Investors > Announcements > Financial Reports > Interim management statement on the first three months of 2024".

Kelonia Therapeutics to Participate in Upcoming Scientific Conferences

Retrieved on: 
Giovedì, Maggio 2, 2024
Oncology, Health, Genetics, Other Science, Science, Pharmaceutical, Biotechnology, Kélonia, Multiple myeloma, Date, Ex vivo, Cell, Protein, Patient, Gene, Society, PEGS, Medicine, Therapy, BCMA, Pharmaceutical industry

“Preclinical data continues to demonstrate exquisite T cell specificity and profound CAR T cell activity with low dose levels of our in vivo Gene Placement System (iGPS®),” said Kevin Friedman, Ph.D., Chief Executive Officer and Founder of Kelonia.

Key Points: 
  • “Preclinical data continues to demonstrate exquisite T cell specificity and profound CAR T cell activity with low dose levels of our in vivo Gene Placement System (iGPS®),” said Kevin Friedman, Ph.D., Chief Executive Officer and Founder of Kelonia.
  • “Combining this platform with our proprietary, fully-human, and highly active BCMA CAR candidate creates a medicine with the potential to transform the treatment of multiple myeloma.
  • With KLN-1010 poised to be the first in vivo CAR-T cell therapy for multiple myeloma, we aim to provide a potentially life-changing solution for patients that need it most.
  • ET
    PEGS Boston Summit – Therapeutics: In Vivo Cell and Gene Engineering
    Date and Time: Friday, May 17, 2024 at 9:30 – 10:00 a.m.

Century Therapeutics Strengthens Position in Autoimmune Disease with Strategic Pipeline Expansion Supported by $60 Million Private Placement and Acquisition of Clade Therapeutics

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Giovedì, Aprile 11, 2024
NK, Sale, Cancer, LLP, Lazard, Investment, News, Safety, Security (finance), Ink, Myasthenia gravis, Research, Exchange, Haematopoiesis, Lymphoma, IPSC, CD19, Autoimmune disease, Patient, Acquisition, Pharming, NHL, Inflammation, BofA Securities, SLE, Clinical trial, Therapy, Lymphoid leukemia, Autoimmunity, BCMA

PHILADELPHIA, April 11, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory diseases, today announced plans to expand clinical development for its lead program, CNTY-101, a CD19-targeting iNK cell therapy, into additional autoimmune disease indications. CNTY-101 is currently being evaluated in a clinical trial in B-cell malignancies (ELiPSE-1) as well as a planned clinical trial in systemic lupus erythematosus (SLE) (CALiPSO-1), which is on track to be initiated in the first half of 2024. Century plans to pursue additional autoimmune disease indication regulatory filings in 2024. Century’s increased research and development activities in autoimmune diseases are further supported by a $60 million private placement of its common stock to certain institutional investors. Concurrently, Century announced pipeline and platform enhancements through the acquisition of Clade Therapeutics, Inc. (“Clade”), a privately-held biotech company focused on discovering and delivering engineerable, off-the-shelf, scalable, and consistent stem cell-based medicines, with a focus on iPSC-derived αβ T cells. The acquisition brings additional iPSC-focused pipeline programs and technology to Century spanning across cancer and autoimmune diseases.

Key Points: 
  • Century plans to pursue additional autoimmune disease indication regulatory filings in 2024.
  • Century’s increased research and development activities in autoimmune diseases are further supported by a $60 million private placement of its common stock to certain institutional investors.
  • The acquisition brings additional iPSC-focused pipeline programs and technology to Century spanning across cancer and autoimmune diseases.
  • With support from a distinguished group of investors, coupled with the acquisition of Clade, we are poised for continued success,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century.

Cartesian Therapeutics to Present at the ASGCT 27th Annual Meeting

Retrieved on: 
Lunedì, Aprile 22, 2024
Biotechnology, Health, Clinical Trials, Messenger, Annual general meeting, Therapy, Gene, Cell, Society, BCMA, Patient

Cartesian Therapeutics, Inc. (NASDAQ:RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that recently reported twelve-month follow-up data from its Phase 2a trial of Descartes-08 in patients with generalized myasthenia gravis will be featured during an oral presentation at the upcoming American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting being held May 7-11, 2024 in Baltimore, MD.

Key Points: 
  • Cartesian Therapeutics, Inc. (NASDAQ:RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that recently reported twelve-month follow-up data from its Phase 2a trial of Descartes-08 in patients with generalized myasthenia gravis will be featured during an oral presentation at the upcoming American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting being held May 7-11, 2024 in Baltimore, MD.
  • Descartes-08, the Company’s lead product candidate, is an autologous anti-B cell maturation antigen (BCMA) mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T).
  • Details of the presentation are as follows:

EQS-News: Heidelberg Pharma granted orphan drug designation by FDA for its proprietary ATAC candidate HDP-101

Retrieved on: 
Mercoledì, Aprile 10, 2024
ODD, Diagnosis, RRMM, BCMA, Patient, Multiple myeloma, Spacecraft, Amanitin, AACR, Antibody, Safety, HPHA, FDA, B-cell maturation antigen, ATAC, Food, Pharmaceutical industry

Ladenburg, Germany, 27 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101.

Key Points: 
  • Ladenburg, Germany, 27 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101.
  • Heidelberg Pharma is investigating the candidate in a clinical Phase I/IIa study for the treatment of relapsed/refractory multiple myeloma (RRMM).
  • Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, commented: “We are delighted that our proprietary ATAC candidate HDP-101 has been granted Orphan Drug Designation by the FDA, providing further validation of its potential benefit as a therapeutic for patients with multiple myeloma.
  • The designation provides significant incentives to promote the development of the drug including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval.