Myelocyte

Celldex Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, February 26, 2024

HAMPTON, N.J., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • Celldex is currently planning two Phase 3 studies of barzolvolimab in CSU, which are expected to initiate this summer.
  • Celldex is currently planning for the initiation of a Phase 2 subcutaneous study in prurigo nodularis (PN) in early 2024.
  • The litigation settlement related loss had a ($0.26) impact on net loss per share for the twelve months ended December 31, 2023.
  • Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2023 are sufficient to meet estimated working capital requirements and fund current planned operations into 2026.

aTyr Pharma Announces Expanded Access Program (EAP) for EFZO-FIT™ Clinical Trial Participants

Retrieved on: 
Wednesday, February 21, 2024

SAN DIEGO, Feb. 21, 2024 (GLOBE NEWSWIRE) --  aTyr Pharma, Inc. (Nasdaq: LIFE) (aTyr or the Company), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced plans to initiate an Individual Patient Expanded Access Program (EAP) for its lead therapeutic candidate, efzofitimod, for patients with pulmonary sarcoidosis. The Individual Patient EAP is intended to allow access for patients who complete the Phase 3 EFZO-FIT™ study and wish to receive treatment with efzofitimod outside of the clinical trial.

Key Points: 
  • Individual Patient EAP allows access to efzofitimod for patients who complete the Phase 3 EFZO-FIT™ study in pulmonary sarcoidosis.
  • Company initiating program based on blinded EFZO-FIT™ study investigator and patient participant feedback.
  • The Individual Patient EAP is intended to allow access for patients who complete the Phase 3 EFZO-FIT™ study and wish to receive treatment with efzofitimod outside of the clinical trial.
  • “We are pleased to make efzofitimod available to patients beyond the duration of the EFZO-FIT™ clinical trial through this Individual Patient EAP,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr.

BostonGene Announces Publication in Collaboration with National Cancer Institute and National Institute of Allergy and Infectious Diseases in Cancer Cell

Retrieved on: 
Thursday, March 7, 2024

Throughout its progression, FL tumor B cells undergo significant genetic changes and extensively remodel the lymphoid microenvironment to promote survival and immune evasion.

Key Points: 
  • Throughout its progression, FL tumor B cells undergo significant genetic changes and extensively remodel the lymphoid microenvironment to promote survival and immune evasion.
  • Despite the urgent need, current clinical tools inadequately predict disease behavior, underscoring the necessity for risk stratification methods, particularly for early relapsers.
  • The study, led by researchers at the National Institute of Allergy and Infectious Diseases and National Cancer Institute in collaboration with BostonGene, employed a multi-modal approach to comprehensively examine cell-intrinsic and -extrinsic factors governing disease progression and therapeutic outcomes in FL patients enrolled in a prospective clinical trial.
  • The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

aTyr Pharma to Present Posters Highlighting Importance of Neuropilin-2 in Immune Regulation at Keystone Symposia on Myeloid Cell Diversity

Retrieved on: 
Monday, January 29, 2024

SAN DIEGO, Jan. 29, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that the company will present two posters at the Keystone Symposia on Myeloid Cell Diversity: From Fundamental Biology to Disease States, which is being held January 28 – 31, 2024, in Banff, Alberta, Canada.

Key Points: 
  • Findings further demonstrate that efzofitimod modulates myeloid cells via the neuropilin-2 (NRP2) receptor to promote a unique anti-inflammatory mechanism.
  • Role of NRP2 in immune system validated by activity of NRP2 blocking antibody in preclinical models.
  • aTyr Pharma, San Diego; Faculty of Health and Medical Sciences, Copenhagen, Denmark.
  • These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.

Detailed Analysis of BEXMAB Data Provides Insights into Patient Profiles of Responding HMA-Failed MDS Population

Retrieved on: 
Thursday, January 25, 2024

The new analysis of data from the Phase 1 part of the trial explores the 100% overall response rate (ORR) achieved among both the higher-risk frontline and HMA-failed MDS patients treated with a bexmarilimab/azacitidine combination – 5 out of 5 patients in each population – and examines previous therapies in the patients’ treatment pathways.

Key Points: 
  • The new analysis of data from the Phase 1 part of the trial explores the 100% overall response rate (ORR) achieved among both the higher-risk frontline and HMA-failed MDS patients treated with a bexmarilimab/azacitidine combination – 5 out of 5 patients in each population – and examines previous therapies in the patients’ treatment pathways.
  • “Patients with high-risk MDS who have failed HMA therapy face a poor prognosis and median overall survival in refractory MDS is just 4-6 months with no viable treatment options.
  • Yet here we have data showing that patients are surpassing anticipated survival rates and maintaining remission.
  • It is remarkable to see patients going into remission with bexmarilimab/azacitidine after showing disease progression on all the leading azacitidine combinations such as venetoclax, sabatolimab and magrolimab.

aTyr Pharma Announces Howard University President Emeritus Dr. Wayne A. I. Frederick as Advisor

Retrieved on: 
Thursday, January 18, 2024

Dr. Frederick is President Emeritus of Howard University, having served as President from 2014 to 2023.

Key Points: 
  • Dr. Frederick is President Emeritus of Howard University, having served as President from 2014 to 2023.
  • “We are honored to welcome a distinguished physician executive such as Dr. Frederick as an advisor to aTyr,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr.
  • He is also the distinguished Charles R. Drew Professor of Surgery at the Howard University College of Medicine and a practicing cancer surgeon at Howard University Hospital.
  • Dr. Frederick earned a B.S., M.D., and completed his surgical residency training at Howard University Hospital.

OSE Immunotherapeutics Highlights Clinical Portfolio Advancements and Provides 2024 Outlook

Retrieved on: 
Friday, January 19, 2024

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) updates on its clinical portfolio advancements and provides 2024 outlook.

Key Points: 
  • OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) updates on its clinical portfolio advancements and provides 2024 outlook.
  • Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “The Company has a broad portfolio of 5 products in clinical development with significant advances reached in 2023 and key milestones expected in 2024.
  • Our shared ambition at OSE is to create value by leading our two advanced assets in phase 2 and phase 3 to a clinical inflection point allowing a structuring agreement.
  • Thus, from Q1 2024, the Company could have validated doses and therapeutic regimens to consider the implementation of possible other clinical trials.

Inside information: Faron Announces First HMA-failed MDS Patient Dosed with Bexmarilimab as part of Phase 2 of BEXMAB Trial

Retrieved on: 
Tuesday, January 9, 2024

TURKU, Finland and BOSTON, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today announced that the first patient has been dosed in Phase 2 of the BEXMAB trial that evaluates the safety and efficacy of bexmarilimab, in combination with standard of care (SoC) in patients with hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndrome (MDS), an aggressive myeloid leukemia with very few treatment options.

Key Points: 
  • The ongoing, randomized parallel-assigned Phase 2 part is enrolling 32 HMA-failed MDS patients at 3 mg/kg and 6 mg/kg dose levels of bexmarilimab.
  • Patients are being randomized 1:1 between the doses before moving into a Phase 2/3 study expansion.
  • Post selection of final dosing, Faron intends to discuss a potential registrational study plan with the FDA.
  • The Company’s key focus is to pursue an accelerated path to approval in refractory higher risk MDS, where no treatment option exists.

HighField Biopharmaceuticals HF1K16 Phase 1a Data Suggests the New Immuno-Oncology Drug is Safe, Well-Tolerated and Efficacious in Solid Tumors

Retrieved on: 
Monday, January 8, 2024

HighField Biopharmaceuticals, a clinical stage immuno-oncology company using lipid-based therapeutics to treat cancer, announced today it has completed its Phase 1a study of HF1K16.

Key Points: 
  • HighField Biopharmaceuticals, a clinical stage immuno-oncology company using lipid-based therapeutics to treat cancer, announced today it has completed its Phase 1a study of HF1K16.
  • HF1K16 is a drug encapsulated immune modulating liposome containing all-trans retinoic acid.
  • “We were especially encouraged by the outcome being correlated to the treatment duration, with the drug being tolerated for extended periods,” said Dr. Yuhong Xu, CEO of HighField.
  • For more information on the Phase 1a open label trial see NCT05388487 at clinicaltrials.gov.

Human medicines European public assessment report (EPAR): Azacitidine Accord, azacitidine, Date of authorisation: 13/02/2020, Revision: 7, Status: Authorised

Retrieved on: 
Saturday, January 6, 2024

Human medicines European public assessment report (EPAR): Azacitidine Accord, azacitidine, Date of authorisation: 13/02/2020, Revision: 7, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Azacitidine Accord, azacitidine, Date of authorisation: 13/02/2020, Revision: 7, Status: Authorised