European Hematology Association

Shaare Zedek Medical Center Uses SOPHiA GENETICS to Advance Research of Myeloid Disorders

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星期五, 九月 29, 2023

BOSTON and ROLLE, Switzerland, Sept. 29, 2023 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native software company and a leader in data-driven medicine, today announced that Shaare Zedek, the largest multi-disciplinary medical center in Jerusalem, is now live on the SOPHiA DDM™ Platform. The Platform will enable Shaare Zedek to advance its insights the treatment of myeloid disorders and further develop the application of precision medicine.

Key Points: 
  • The Platform will enable Shaare Zedek to advance its insights the treatment of myeloid disorders and further develop the application of precision medicine.
  • Myeloid disorders affect millions of people worldwide, and while there are various types and classification of these disorders, collectively all myeloid disorders originate from hematopoietic disruptions in the myeloid lineage1.
  • Shaare Zedek Medical Center has been providing top-level medical research and care for the people of Jerusalem since 1902.
  • With the SOPHiA DDM™ Platform, Shaare Zedek Medical Center will retain complete ownership of its database, supporting the research team as it continues to increase its expertise.

Gracell Biotechnologies Doses First Patient in Phase 1b/2 Clinical Trial in U.S. Evaluating GC012F for Treatment of Relapsed/Refractory Multiple Myeloma

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星期二, 九月 26, 2023

The Phase 1b portion of the open-label multi-center trial has been initiated and will be conducted at several top medical centers in the United States.

Key Points: 
  • The Phase 1b portion of the open-label multi-center trial has been initiated and will be conducted at several top medical centers in the United States.
  • The Phase 2 portion is intended to evaluate the efficacy of GC012F in RRMM patients and further characterize the safety of GC012F.
  • “Gracell has amassed a body of compelling evidence supporting the dual-targeting approach of GC012F for treatment of RRMM.
  • “Dosing the first patient in the Phase 1b portion of the U.S. trial is another important step toward validating this treatment for RRMM patients.

Revolutionary Cancer Treatment Advances Promise Brighter Future Amid Federal Funding Uncertainty

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星期五, 九月 22, 2023

VANCOUVER, British Columbia, Sept. 22, 2023 /PRNewswire/ -- USA News Group - Despite the potential federal funding challenges due to the recent debt ceiling deal, optimism in the battle against cancer persists, thanks in large part to the audacious "Cancer Moonshot" initiative. This ambitious plan, aimed at halving cancer rates within the next quarter-century, continues to fuel hope even as concerns about the stability of National Institutes of Health (NIH) funding arise. In these turbulent times, the resilience and ingenuity of the biotech sector provide a beacon of hope. For instance, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Zymeworks Inc. (NASDAQ: ZYME), Jazz Pharmaceuticals plc (NASDAQ: JAZZ), Protagonist Therapeutics, Inc. (NASDAQ: PTGX), and Amgen Inc. (NASDAQ: AMGN), have each demonstrated inspiring progress and unwavering commitment in advancing cancer treatments, highlighting their vital role in the future of cancer therapy.

Key Points: 
  • The oral presentation shared at the event described how they've been testing a treatment for advanced breast cancer, and it's looking very promising.
  • The treatment combines Oncolytics' flagship drug, pelareorep, with a well-known cancer medicine, paclitaxel.
  • Pelareorep is a unique drug that targets and kills cancer cells by making them self-destruct while leaving healthy cells unharmed.
  • It even lowered the risk of the cancer getting worse by a significant 71% compared to just using paclitaxel.

Revolutionary Cancer Treatment Advances Promise Brighter Future Amid Federal Funding Uncertainty

Retrieved on: 
星期五, 九月 22, 2023

VANCOUVER, British Columbia, Sept. 22, 2023 /PRNewswire/ -- USA News Group - Despite the potential federal funding challenges due to the recent debt ceiling deal, optimism in the battle against cancer persists, thanks in large part to the audacious "Cancer Moonshot" initiative. This ambitious plan, aimed at halving cancer rates within the next quarter-century, continues to fuel hope even as concerns about the stability of National Institutes of Health (NIH) funding arise. In these turbulent times, the resilience and ingenuity of the biotech sector provide a beacon of hope. For instance, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Zymeworks Inc. (NASDAQ: ZYME), Jazz Pharmaceuticals plc (NASDAQ: JAZZ), Protagonist Therapeutics, Inc. (NASDAQ: PTGX), and Amgen Inc. (NASDAQ: AMGN), have each demonstrated inspiring progress and unwavering commitment in advancing cancer treatments, highlighting their vital role in the future of cancer therapy.

Key Points: 
  • The oral presentation shared at the event described how they've been testing a treatment for advanced breast cancer, and it's looking very promising.
  • The treatment combines Oncolytics' flagship drug, pelareorep, with a well-known cancer medicine, paclitaxel.
  • Pelareorep is a unique drug that targets and kills cancer cells by making them self-destruct while leaving healthy cells unharmed.
  • It even lowered the risk of the cancer getting worse by a significant 71% compared to just using paclitaxel.

Blood Cancer: AOP Health Announces New Findings in Patients With Polycythemia Vera Published in Medical Journal Leukemia

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星期二, 九月 19, 2023

AOP Orphan Pharmaceuticals GmbH (AOP Health) announced the publication of final results on the recently developed interferon therapy, ropeginterferon alfa-2b, in patients with polycythemia vera (PV) in the prestigious journal Leukemia1.

Key Points: 
  • AOP Orphan Pharmaceuticals GmbH (AOP Health) announced the publication of final results on the recently developed interferon therapy, ropeginterferon alfa-2b, in patients with polycythemia vera (PV) in the prestigious journal Leukemia1.
  • The full publication expands on results presented at the Annual Meeting of the European Hematology Association.
  • Results of long-term treatment in the CONTINUATION-PV study provide further evidence of the disease modifying capacity of ropeginterferon alfa-2b in PV.
  • Event-free survival in patients with polycythemia vera treated with ropeginterferon alfa-2b versus best available treatment.

Ryvu Therapeutics Reports 2023 Half-Year Financial Results and Provides Corporate Update

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星期三, 九月 13, 2023

Updated clinical and preclinical data on RVU120 were presented at the European Hematology Associated (EHA) Congress in June 2023.

Key Points: 
  • Updated clinical and preclinical data on RVU120 were presented at the European Hematology Associated (EHA) Congress in June 2023.
  • $14M in non-dilutive grant funding was secured from the Medical Research Agency (ABM) – the largest grant obtained to date by Ryvu.
  • KRAKOW, Poland, Sept. 13, 2023 (GLOBE NEWSWIRE) -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported today financial results for the first half of 2023 and provided a corporate update.
  • “The last months of 2023 were a productive period for Ryvu as we made significant developments across our clinical programs, collaboration activity, and strengthening our balance sheet”, said Pawel Przewiezlikowski, CEO of Ryvu Therapeutics.

Geron Announces Data Presentations from IMerge Phase 3 Evaluating Imetelstat in Lower Risk MDS at Society of Hematologic Oncology Annual Meeting

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星期四, 九月 7, 2023

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced poster presentations of data from IMerge, the Company’s Phase 3 clinical trial evaluating its first-in-class investigational telomerase inhibitor imetelstat vs. placebo in patients with lower risk myelodysplastic syndromes (MDS) at the eleventh annual Society of Hematologic Oncology Annual Meeting (SOHO) held in Houston, Texas and virtually.

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced poster presentations of data from IMerge, the Company’s Phase 3 clinical trial evaluating its first-in-class investigational telomerase inhibitor imetelstat vs. placebo in patients with lower risk myelodysplastic syndromes (MDS) at the eleventh annual Society of Hematologic Oncology Annual Meeting (SOHO) held in Houston, Texas and virtually.
  • Statistically significant and clinically meaningful efficacy results were achieved across key MDS subgroups irrespective of ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category.
  • Patient-reported outcomes (PRO) data reported a sustained meaningful improvement in fatigue for imetelstat-treated patients vs. placebo.
  • Consistent with prior imetelstat clinical experience, the most common serious adverse events were primarily short-lived, manageable cytopenias.

FDA Accepts Application for Genentech’s Crovalimab for the Treatment of PNH, a Rare Life-Threatening Blood Condition

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星期三, 九月 6, 2023

The acceptance was based on results from the pivotal Phase III COMMODORE 2 study, which demonstrated that in people with PNH, crovalimab achieved disease control and was well-tolerated.

Key Points: 
  • The acceptance was based on results from the pivotal Phase III COMMODORE 2 study, which demonstrated that in people with PNH, crovalimab achieved disease control and was well-tolerated.
  • Results from the Phase III COMMODORE 1 study, demonstrating the consistent benefit-risk profile of crovalimab, also supported the application.
  • “Crovalimab could provide an option to self-administer as infrequently as every four weeks, thereby reducing clinic visits for people with this lifelong condition.”
    PNH is a rare and life-threatening blood condition, which affects approximately 20,000 people worldwide.
  • In PNH, red blood cells are destroyed by the complement system – part of the innate immune system.

X4 Pharmaceuticals Announces Submission of New Drug Application (NDA) to U.S. FDA for Mavorixafor in WHIM Syndrome

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星期二, 九月 5, 2023

“The submission of our first NDA is a significant milestone in X4's journey to transform the care of those living with rare immunodeficiencies,” said Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals.

Key Points: 
  • “The submission of our first NDA is a significant milestone in X4's journey to transform the care of those living with rare immunodeficiencies,” said Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals.
  • “We’re excited that this submission moves us one step closer to introducing what could be the first approved product in the U.S. for those with WHIM syndrome.
  • X4 has requested priority review for the application which, if granted, would provide a target FDA review period of six months from the application acceptance for filing date.
  • The NDA submission is supported by the results of the global, pivotal, 4WHIM Phase 3 clinical trial of once-daily, oral mavorixafor in individuals with WHIM syndrome.

Faron Reports Half-Year Financial Results, January 1 – June 30, 2023

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星期二, 八月 29, 2023

TURKU, Finland and BOSTON, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces unaudited half-year financial results for January 1 to June 30, 2023 (the "period").

Key Points: 
  • Mr. Leopoldo Zambeletti stepped down from the Board to assume a business development consulting role at Faron.
  • TURKU, Finland and BOSTON, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces unaudited half-year financial results for January 1 to June 30, 2023 (the "period").
  • "I am extremely proud of the progress we made in the first half of 2023,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron.
  • On June 30, 2023, the Company had outstanding borrowings of EUR 9.8 million under a loan facility with IPF Partners which is subject to financial covenants.