Anemia

Bio-Path Holdings Presents Data from Ongoing Phase 2 Combination Study of Prexigebersen for Treatment of Acute Myeloid Leukemia at American Society of Clinical Oncology (ASCO) Annual Meeting

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måndag, juni 3, 2024

Maro Ohanian, D.O., Department of Leukemia, University of Texas MD Anderson Cancer Center, presented data showing prexigebersen continues to be well-tolerated and has demonstrated compelling efficacy results in two reporting cohorts including newly diagnosed AML patients and refractory/relapsed AML patients, both of which exceeded outcomes with frontline therapy.

Key Points: 
  • Maro Ohanian, D.O., Department of Leukemia, University of Texas MD Anderson Cancer Center, presented data showing prexigebersen continues to be well-tolerated and has demonstrated compelling efficacy results in two reporting cohorts including newly diagnosed AML patients and refractory/relapsed AML patients, both of which exceeded outcomes with frontline therapy.
  • “We were honored to have our data selected for oral presentation at ASCO as it underscores not only the quality of our data, but also highlights the continued unmet need for these most vulnerable cancer patients,” said Peter Nielsen, Chief Executive Officer of Bio-Path.
  • Twelve patients (55% of evaluable; 32% of enrolled) achieved CR/CRi/CRh; one patient achieved PR, eight patients achieved SD and one patient had treatment failure.
  • Given these promising interim results, Bio-Path expects to continue enrollment of up to 98 and 54 evaluable patients for Cohorts 1 and 2, respectively.

SYS6002 (CRB-701) A Next-Generation Nectin-4 Targeting Antibody Drug Conjugate Continues to Demonstrate Encouraging Safety and Efficacy Observed in Patients with Nectin-4 Positive Tumors in a Clinical Update Presented at ASCO 2024

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lördag, juni 1, 2024

Patients were enrolled based on Nectin-4 staining with the exception of metastatic urothelial cancer (mUC) patients who were considered to be Nectin-4 positive.

Key Points: 
  • Patients were enrolled based on Nectin-4 staining with the exception of metastatic urothelial cancer (mUC) patients who were considered to be Nectin-4 positive.
  • “This latest data update provides additional insight following the initial observations from our partner CSPC’s January 2024 data cut,” said Dr. Dominic Smethurst, Chief Medical Officer at Corbus.
  • “This larger set of patient data, along with additional confirmed responses, increases our confidence that CRB-701 is clinically active.
  • Similarly, we find the emerging safety data reassuring with its low rates of skin rash and peripheral neuropathy and very few grade 3 adverse events.

ImmuneOncia Announces Biomarker Results from Phase 1 Clinical Trial of CD47 Antibody at ASCO

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måndag, juni 3, 2024

ImmuneOncia (CEO Heung Tae Kim) announced the results of its solid tumour Phase 1a clinical trial of IMC-002, an anti-CD47 mAb, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA on June 1, 2024 (local time).

Key Points: 
  • ImmuneOncia (CEO Heung Tae Kim) announced the results of its solid tumour Phase 1a clinical trial of IMC-002, an anti-CD47 mAb, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA on June 1, 2024 (local time).
  • These results include updates on the Phase 1a clinical trial outcomes, along with biomarker findings achieved through collaboration with Lunit (CEO; Brandon Suh), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics.
  • View the full release here: https://www.businesswire.com/news/home/20240603017832/en/
    ImmuneOncia Announces Biomarker Results from Phase 1 Clinical Trial of CD47 Antibody at ASCO (Graphic: ImmuneOncia Therapeutics, Inc.)
    The study, a dose escalation part of Phase 1, enrolled a total of 12 patients across four dose cohorts starting from May 2022.
  • He further stated, "With the Phase 1b trial for IMC-002 initiated last November, we anticipate additional efficacy confirmation for IMC-002 in specific solid tumours with high unmet needs."

Nuvation Bio Announces Data from Pivotal Phase 2 TRUST-I Study of its Investigational ROS1 Inhibitor, Taletrectinib, are Published in the Journal of Clinical Oncology and Reported at 2024 ASCO Annual Meeting

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lördag, juni 1, 2024

Data were reported from 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who were treated with taletrectinib.

Key Points: 
  • Data were reported from 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who were treated with taletrectinib.
  • After median follow-up of 23.5 months in TKI-naïve patients, median duration of response (IRC-assessed) and median progression-free survival (IRC-assessed) were not reached.
  • After median follow-up of 9.7 months in TKI-pretreated patients, median duration of response and median progression-free survival were 10.6 months and 7.6 months, respectively.
  • Taletrectinib’s safety profile was consistent with previous reports, with a low incidence of neurologic treatment-emergent adverse events (TEAEs).

Samsung Bioepis to Present Post-hoc Analysis of Phase 3 Study for EPYSQLI™ (SB12; Eculizumab Biosimilar), at the European Hematology Association (EHA) Congress 2024

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torsdag, maj 30, 2024

INCHEON, Korea, May 30, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that a post-hoc analysis of the Phase 3 clinical study results for EPYSQLI™ (SB12), a biosimilar to Soliris1 (eculizumab), will be presented at the 29th European Hematology Association 2024 (EHA2024) Hybrid Congress held in Madrid, Spain and virtually, from June 13 to 16, 2024.

Key Points: 
  • INCHEON, Korea, May 30, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that a post-hoc analysis of the Phase 3 clinical study results for EPYSQLI™ (SB12), a biosimilar to Soliris1 (eculizumab), will be presented at the 29th European Hematology Association 2024 (EHA2024) Hybrid Congress held in Madrid, Spain and virtually, from June 13 to 16, 2024.
  • SB12 has shown equivalent efficacy with reference eculizumab (ECU) by lactate dehydrogenase (LDH) and comparable safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles in paroxysmal nocturnal hemoglobinuria (PNH) through the pivotal Phase 3 study.2
    The post-hoc analysis of SB12 pivotal Phase 3 study presented at EHA2024 compared the proportion of patients remaining transfusion-free (“transfusion avoidance”) among those treated with SB12 or ECU, respectively.
  • Eculizumab is known to significantly reduce hemolysis resulting in improvements in anemia as indicated by increased hemoglobin stabilization and reduced need for red blood cell (RBC) transfusions.3
    “We are excited to present this data at EHA2024, that adds to the growing body of evidence that supports comparable clinical efficacy of SB12 with reference eculizumab in treating PNH patients,” said Hyejin Kim, Vice President and Medical & Lifecycle Safety Team Leader at Samsung Bioepis.
  • In March 2024, EPYSQLI was granted an indication expansion for the treatment of adults and children with atypical haemolytic uremic syndrome (aHUS).4

Clinical Data Published at ASCO Support the Potential of VIVUS’ PANCREAZE® to Stabilize Weight and Improve Gastrointestinal Outputs in Patients with Pancreatic Cancer

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torsdag, maj 30, 2024

The data also suggest that PANCREAZE may reduce stool frequency and improve stool consistency.

Key Points: 
  • The data also suggest that PANCREAZE may reduce stool frequency and improve stool consistency.
  • VIVUS provided PANCREAZE and funding to support the clinical trial.
  • PANCREAZE is approved in the United States and Canada for the treatment of EPI due to cystic fibrosis or other conditions.
  • The data was published in an ePoster at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31-June 4, 2024, in Chicago, IL and online.

Meaningful Improvement in Overall Survival (OS) and Tolerability Observed in Patients Receiving Trilaciclib in Combination with a TROP2 Antibody-Drug Conjugate (ADC)

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tisdag, maj 28, 2024

(abstract number 1091) describes the mature results from a Phase 2 trial of trilaciclib in combination with SG in patients with mTNBC.

Key Points: 
  • (abstract number 1091) describes the mature results from a Phase 2 trial of trilaciclib in combination with SG in patients with mTNBC.
  • Prolonged OS was observed in patients receiving trilaciclib with the ADC who had an initial breast cancer diagnosis of TNBC, prior use of checkpoint inhibitors, and no prior oral CDK4/6 inhibitor use.
  • The poster also describes the significant on-target benefit of trilaciclib in reducing adverse events associated with this ADC, including diarrhea, neutropenia, anemia, and thrombocytopenia.
  • In this patient population, median OS among patients receiving trilaciclib was 17.9 months vs. 12.1 for SG alone.

Bowmar Nutrition Announces Launch of Supplements to Support Immune System and Overall Health

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onsdag, maj 22, 2024

Des Moines, Iowa--(Newsfile Corp. - May 22, 2024) - Bowmar Nutrition , founded by certified nutrition specialists and ISSA fitness trainers Josh and Sarah Bowmar, is thrilled to announce the launch of three new premium products.

Key Points: 
  • Des Moines, Iowa--(Newsfile Corp. - May 22, 2024) - Bowmar Nutrition , founded by certified nutrition specialists and ISSA fitness trainers Josh and Sarah Bowmar, is thrilled to announce the launch of three new premium products.
  • Bowmar Nutrition's meticulously crafted offerings—including protein powders, pre-workout supplements, and protein-rich snacks—are manufactured in a GMP-certified and FDA-accredited facility, ensuring unparalleled quality and purity through rigorous third-party testing.
  • Since they were first available on the Bowmar Nutrition website in 2023, these capsules have sold out six times.
  • Bowmar Nutrition's Oyster Capsules can help:
    Support bladder and urinary tract health, adrenal function, and thyroid health.

Sobi to present new myelofibrosis data at the ASCO 2024 Annual Meeting

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fredag, maj 24, 2024

WALTHAM, Mass., May 24, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced the presentation of three abstracts that highlights data from its myelofibrosis treatment option at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from May 31 – June 4, 2024.

Key Points: 
  • WALTHAM, Mass., May 24, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced the presentation of three abstracts that highlights data from its myelofibrosis treatment option at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from May 31 – June 4, 2024.
  • Sobi’s commitment to delivering innovative treatments for people living with hematological diseases is seen in global studies spanning multiple rare disorders, including myelofibrosis.
  • The number of patients experiencing treatment emergent Grade 3 anaemia was similar between pacritinib and BAT groups.
  • For details on how to contact the Sobi Investor Relations Team, please click here .

Tizona Therapeutics Presents Phase 1b TTX-080 Clinical Data in Advanced Colorectal Cancer and Head and Neck Squamous Cell Carcinoma at ASCO 2024

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torsdag, maj 23, 2024

SOUTH SAN FRANCISCO, Calif., May 23, 2024 (GLOBE NEWSWIRE) -- Tizona Therapeutics, Inc., a privately held, clinical-stage company developing cancer immunotherapies, today announced first-in-human Phase 1b clinical data of TTX-080, a novel, first-in-class, antibody targeting HLA-G, in patients with metastatic colorectal cancer (mCRC) and locally advanced/metastatic head and neck squamous cell carcinoma (mHNSCC). The preliminary data will be presented during a poster session on June 1, 2024, at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024 in Chicago, IL.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., May 23, 2024 (GLOBE NEWSWIRE) -- Tizona Therapeutics, Inc., a privately held, clinical-stage company developing cancer immunotherapies, today announced first-in-human Phase 1b clinical data of TTX-080, a novel, first-in-class, antibody targeting HLA-G, in patients with metastatic colorectal cancer (mCRC) and locally advanced/metastatic head and neck squamous cell carcinoma (mHNSCC).
  • The preliminary data will be presented during a poster session on June 1, 2024, at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024 in Chicago, IL.
  • “Metastatic colorectal cancer is a global health issue, affecting men and women equally and with rising incidence among young adults.
  • “These Phase 1b clinical results boost our confidence that TTX-080 in combination with cetuximab may improve clinical outcomes in patients with biomarker-defined advanced colorectal cancer and head and neck squamous cell carcinoma,” said Swami Murugappan, M.D., Ph.D., Consulting Chief Medical Officer at Tizona Therapeutics.