CRS

Aulos Bioscience Provides Positive Interim Phase 1/2 Data From AU-007 at 2024 ASCO Annual Meeting

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Giovedì, Maggio 23, 2024
Research, Technology, Clinical Trials, Health Technology, Biotechnology, Pharmaceutical, Health, Science, Oncology, Artificial Intelligence, Patient, Steroid, Pulmonary edema, Lymphocyte, Renal cell carcinoma, PD, Bladder cancer, Colorectal cancer, Clinical trial, CDT, Lung cancer, Head, Serum, NSCLC, Hypertelorism, Lymphocytopenia, Blood, Neoplasm, Avelumab, IL-2, Melanoma, MSI, ASCO, CD25, Poster, IL-6, Society, Artificial intelligence, Therapy, Hand, PD-L1, ADAS, Annual general meeting, MSS, CRS, RCC, Medical imaging

The data will be presented in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago, Illinois.

Key Points: 
  • The data will be presented in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago, Illinois.
  • The durability of the tumor reductions seen in several patients suggests the formation of immune memory of the cancerous cells.
  • “While other developmental IL-2 therapies focus on changing IL-2 itself, AU-007 is a human antibody that is a well-established therapeutic modality.
  • The Phase 2 expansion cohorts of the AU-007 study are continuing to enroll patients with a focus on melanoma and RCC.

iCell Gene Therapeutics Announces Positive Clinical Data from Investigator Initiated Phase 1 Trial Evaluating BCMA-CD19 Compound CAR in Patients with Systemic Lupus Erythematosus/Lupus Nephritis Published in Annals of the Rheumatic Diseases

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Giovedì, Maggio 23, 2024
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, European Alliance, Patient, Survival, Lupus, CCAR, Data, Infection, IIT, COVID-19, Class, Patent, T cell, SLE, Clinical trial, CD19, Immunoglobulin M, IND, Safety, Urinary tract infection, Autoantibody, MFR, Cancer, Autoimmunity, Cyclophosphamide, Hospital, EULAR, B cell, BCMA, Glucocorticoid, Canadian Aviation Regulations, LN, Lupus nephritis, CRS, Pharmaceutical industry

The clinical trial evaluated the safety and efficacy of a complete humoral reset of both long-lived plasma cells and B cells in 13 systemic lupus erythematosus (SLE) patients treated with iCell’s cCAR, including 11 patients with SLE and lupus nephritis (LN).

Key Points: 
  • The clinical trial evaluated the safety and efficacy of a complete humoral reset of both long-lived plasma cells and B cells in 13 systemic lupus erythematosus (SLE) patients treated with iCell’s cCAR, including 11 patients with SLE and lupus nephritis (LN).
  • These patients achieved symptom-free and medication-free remission (MFR), with post-cCAR follow-up to 46 months.
  • There are currently no approved therapies that deliver MFR in SLE/LN patients who are at high risk of long-term organ damage and kidney transplant.
  • The data suggest that cCAR therapy was safe and effective in inducing MFR and depleting disease-causing autoantibodies in SLE and LN patients.

Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi Approved by the U.S. Food and Drug Administration for Relapsed or Refractory Follicular Lymphoma

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Giovedì, Maggio 16, 2024
Research, FDA, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, Science, Oncology, Bristol Myers Squibb, Patient, Prognosis, Hope, Lymphoid leukemia, IRC, Food, Independent Review Committee, Clinical trial, BMY, Commercial, Lymphoma, Disease, USPI, Cytokine release syndrome, Conference, Caregiver, NCCN, National Comprehensive Cancer Network, Multimedia, CRS, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20240515772899/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240515772899/en/
    Product image for download (Photo: Bristol Myers Squibb)
    In relapsed or refractory FL, Breyanzi is delivered as a one-time infusion** with a single dose containing 90 to 110 x 106 CAR-positive viable T cells.
  • “Breyanzi is a cornerstone of our cell therapy portfolio, providing a differentiated profile across a wide array of B-cell malignancies,” said Bryan Campbell, senior vice president, Head of Commercial, Cell Therapy, Bristol Myers Squibb.
  • “In the treatment of relapsed or refractory follicular lymphoma, patients often cycle through treatments with typically shorter responses with each new line of therapy.
  • “The lymphoma community has felt an urgent need for advancements in the treatment of relapsed or refractory follicular lymphoma,” said Meghan Gutierrez, chief executive officer, Lymphoma Research Foundation.

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.

CytomX Therapeutics Announces Positive Initial Phase 1a Dose Escalation Data for Monotherapy CX-904 (EGFRxCD3 PROBODY® T-Cell Engager)

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Mercoledì, Maggio 8, 2024
CD3, Patient, Arthralgia, EDT, HNSCC, CRS, Safety, Pancreatic cancer, Itch, RECIST, PDT, CRC, Trial of the century, Tumor microenvironment, Webcast, Tenosynovitis, Therapy, Vomiting, Arthritis, Rash, Head, Neoplasm, EGFR, Cancer, NSCLC, SAN, Amgen, Lung cancer, Pharmaceutical industry

“These data build on more than a decade of innovation at CytomX, and, we believe, open broad new possibilities for T-cell engagers across many targets and cancer types.

Key Points: 
  • “These data build on more than a decade of innovation at CytomX, and, we believe, open broad new possibilities for T-cell engagers across many targets and cancer types.
  • CX-904 Phase 1a dose escalation and optimization continue, with future enrollment focused on determining a recommended Phase 2 dose, or doses.
  • The Company expects to provide an additional Phase 1a dose escalation update by the end of 2024.
  • These additional data will inform discussions with CytomX partner, Amgen, towards initiation of Phase 1b expansion cohorts in specific EGFR positive tumor types.

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

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Mercoledì, Maggio 8, 2024
MSD, Investment, Pancreatic cancer, Research, TCE, CRC, Trial of the century, Webcast, Drug discovery, EGFR, Bladder cancer, Cancer, CRS, Cytokine, Tumor microenvironment, ADC, Vomiting, Therapeutic index, Kidney, Bristol Myers Squibb, Therapy, Biotechnology, Spacecraft, SAN, Arthralgia, Safety, Pembrolizumab, RECIST, Arthritis, GLP, Melanoma, BMS, Toxicology, CD3, EDT, Itch, Merck & Co., PDT, Camptothecin, Patient, Rash, Head, Epithelial cell adhesion molecule, Amgen, Pharmaceutical industry

Initial data anticipated in 2025 -

Key Points: 
  • Initial data anticipated in 2025 -
    - Management to hold conference call today at 5 p.m. EDT / 2 p.m. PDT -
    SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today reported first quarter 2024 financial results and provided a business update.
  • The Company expects to provide an additional Phase 1a dose escalation update by the end of 2024.
  • The cash balance as of March 31, 2024, does not include the $10.0 million of Astellas milestone achievements earned in the first quarter of 2024.
  • CytomX management will host a conference call and simultaneous webcast today at 5 p.m. EDT (2 p.m. PDT) to discuss the financial results and provide a business update.

Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2024 Financial Results

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Lunedì, Maggio 6, 2024
FDA, Total, ITK, Research, PTCL, PR, Doctor of Philosophy, Webcast, Fungal infection, Atopic dermatitis, RCC, Lymphoma, Vanderbilt University Medical Center, Lung cancer, Conference call, Kidney cancer, Conference, CRS, Peripheral, Assistant, PRS, NSCLC, Patient, Safety, Pembrolizumab, Modified, CTCL, Time management, Clinical trial, Division, Sale, A2A, Adenosine, HNSCC, T-cell lymphoma, Nivolumab, Ipilimumab, B-cell lymphoma, Disease, ALCL, Physician, Head, PTCL-NOS, Pharmaceutical industry

BURLINGAME, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the first quarter ended March 31, 2024.

Key Points: 
  • ET / 1:30 p.m. PT
    BURLINGAME, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the first quarter ended March 31, 2024.
  • Corvus anticipates initiating a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL in the third quarter of 2024.
  • Corvus will host a conference call and webcast today, Monday, May 6, 2024, at 4:30 p.m.
  • ET (1:30 p.m. PT), during which time management will provide a business update and discuss the first quarter 2024 financial results.

Lyra Therapeutics Reports Topline Results from Phase 3 ENLIGHTEN 1 Trial for LYR-210 in Chronic Rhinosinusitis

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Lunedì, Maggio 6, 2024
Sinusitis, CRS, LYRA, Network congestion, Data, Workforce, ITT, Therapy, Nosebleed

WATERTOWN, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), today announced topline results from the Company’s Phase 3 ENLIGHTEN 1 trial evaluating LYR-210 for the treatment of chronic rhinosinusitis (CRS). ENLIGHTEN 1 did not meet its primary endpoint of demonstrating statistically significant improvement compared to sham control in the composite score of the three cardinal symptoms (3CS) of CRS (nasal obstruction, nasal discharge, facial pain/pressure) at 24 weeks. ENLIGHTEN 1 is one of two Phase 3 clinical trials evaluating LYR-210, a bioabsorbable sinonasal implant (7500µg mometasone furoate), as a six-month treatment for chronic rhinosinusitis (CRS).

Key Points: 
  • WATERTOWN, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), today announced topline results from the Company’s Phase 3 ENLIGHTEN 1 trial evaluating LYR-210 for the treatment of chronic rhinosinusitis (CRS).
  • ENLIGHTEN 1 is one of two Phase 3 clinical trials evaluating LYR-210, a bioabsorbable sinonasal implant (7500µg mometasone furoate), as a six-month treatment for chronic rhinosinusitis (CRS).
  • “We are surprised and disappointed by the ENLIGHTEN 1 topline results,” said Maria Palasis, Ph.D., President and Chief Executive Officer, Lyra Therapeutics.
  • The ENLIGHTEN 1 trial is ongoing and data from the 52-week extension phase are expected in Q4 2024.

HAProxy Enterprise 2.9 Sets the Security Standard for Application Delivery

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Lunedì, Maggio 6, 2024
Denial-of-service attack, ModSecurity, RADIUS, CRS, DNS, NTP, XSS, Conference, API, Infobip, HAProxy, Data science, Automation, UDP, Organization, Privacy, RFI, WAF, Intelligence, Critical, OWASP, SQL, RSA, Fraud, Online shopping

"The next-generation HAProxy Enterprise WAF protects our public APIs and user portal and makes a valuable improvement to our overall application security posture," said Andro Galinović, Chief Information Security Officer at Infobip.

Key Points: 
  • "The next-generation HAProxy Enterprise WAF protects our public APIs and user portal and makes a valuable improvement to our overall application security posture," said Andro Galinović, Chief Information Security Officer at Infobip.
  • Flexible integration with HAProxy Enterprise's suite of other powerful security layers (including the next-generation HAProxy Enterprise WAF and Global Rate Limiting) allows customers to tailor their protection and enforcement options based on the context provided by the HAProxy Enterprise Bot Management Module and the other security signals available in HAProxy Enterprise.
  • The release of HAProxy Enterprise 2.9 reinforces HAProxy Technologies’ position as the industry leader in application delivery and security.
  • Application teams using another load balancer or application delivery controller can request a free trial that includes all features of the HAProxy Enterprise suite with no performance limitations.