Neoplasm

BostonGene Announces Presentations at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition

Retrieved on: 
Friday, December 2, 2022

Time and Location: Monday, December 12 | 6:00 PM-8:00 PM, Hall D

Key Points: 
  • Time and Location: Monday, December 12 | 6:00 PM-8:00 PM, Hall D
    Research conducted by Memorial Sloan Kettering Cancer Center and BostonGene.
  • In addition to the poster presentations, the abstracts have been published online in the November supplemental issue of Blood .
  • BostonGene Tumor Portrait Tests reveal key drivers of each tumor, including immune microenvironment properties, actionable mutations, biomarkers of response to diverse therapies, and recommended therapies.
  • Through these comprehensive analyses, BostonGene Tumor Portrait Tests generate a personalized roadmap for therapeutic decision-making for each cancer patient.

UroGen Announces New Data from the OPTIMA II Study that Show Median Durability of Response of 24.4 Months for UGN-102, an Investigational Non-Surgical Chemoablative Treatment for Low-Grade, Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Retrieved on: 
Friday, December 2, 2022

I look forward to additional data on UGN-102, including evidence from the ENVISION Phase 3 study.

Key Points: 
  • I look forward to additional data on UGN-102, including evidence from the ENVISION Phase 3 study.
  • Patients who completed the OPTIMA II study were eligible to participate in this rollover study.
  • At the time of data cut off (February 25, 2022), data were available for 15 of the 25 patients.
  • Patients achieving CR were followed quarterly to 12 months after initiation of study treatment to evaluate safety, efficacy, and durability.

Liquid Biopsy Global Market Report 2022: Cancer Awareness Initiatives Undertaken by Global Health Organizations Drive Growth - ResearchAndMarkets.com

Retrieved on: 
Friday, December 2, 2022

Market growth is driven by factors such as rising global prevalence of cancers and the growing need for early detection coupled with efficient treatment monitoring and recurrence detection is anticipated to support the growth of the global liquid biopsy market.

Key Points: 
  • Market growth is driven by factors such as rising global prevalence of cancers and the growing need for early detection coupled with efficient treatment monitoring and recurrence detection is anticipated to support the growth of the global liquid biopsy market.
  • The assay kits segment accounted for the highest growth rate in the liquid biopsy market, by product & service, during the forecast period
    The liquid biopsy market is segmented into assay kits, instruments, and services based on product & service.
  • In 2021, the assay kits segment accounted for the highest growth rate in the liquid biopsy market.
  • The global liquid biopsy market is segmented into North America, Europe, the Asia Pacific, and the Rest of the World.

EQS-News: First Patients Dosed in Phase I/II Trial of Enlivex’s Off-the-Shelf Cell Therapy Candidate, AllocetraTM

Retrieved on: 
Friday, December 2, 2022

First Patients Dosed in Phase I/II Trial of Enlivexs Off-the-Shelf Cell Therapy Candidate, AllocetraTM

Key Points: 
  • First Patients Dosed in Phase I/II Trial of Enlivexs Off-the-Shelf Cell Therapy Candidate, AllocetraTM
    The issuer is solely responsible for the content of this announcement.
  • On November 13, Enlivex (NASDAQ: ENLV) announced that the first patient has been dosed in its Phase I/II clinical trial of Allocetra.
  • Enlivexs lead drug candidate, AllocetraTM , was developed as an off-the-shelf cell therapy that reprograms macrophages , the immune cells responsible for killing infected or harmful cells in the body.
  • The next step for this new cell therapy is to test whether these promising preclinical results will translate to human studies.

Bio-Thera Solutions Announces BAT8006 (Folate-Receptor-α-ADC) and BAT8008 (Trop2-ADC) Poster Presentations at the 2022 San Antonio Breast Cancer Symposium

Retrieved on: 
Friday, December 2, 2022

Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, today announced the company will present two posters at the 2022 San Antonio Breast Cancer Symposium (SABCS) taking place December 6 - 10, 2022 in San Antonio, Texas.

Key Points: 
  • Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, today announced the company will present two posters at the 2022 San Antonio Breast Cancer Symposium (SABCS) taking place December 6 - 10, 2022 in San Antonio, Texas.
  • Folate Receptor is a naturally occurring receptor that is overexpressed in many types of cancer, including breast cancer and ovarian cancer.
  • Trop-2 is a naturally occurring receptor that is overexpressed in many types of cancer, including triple negative breast cancer and gastric cancer.
  • This news release contains certain forward-looking statements relating to BAT8006, BAT8008 or the product pipelines in general of Bio-Thera Solutions.

SHI receives first order for next-generation proton therapy system from Taichung Veterans General Hospital

Retrieved on: 
Friday, December 2, 2022

Sumitomo Heavy Industries, Ltd. (TOKYO:6302) (head office: Shinagawa City, Tokyo; President and CEO: Shinji Shimomura; hereinafter "SHI") has received an order from Taichung Veterans General Hospital (Taiwan) for a next-generation proton therapy system (*).

Key Points: 
  • Sumitomo Heavy Industries, Ltd. (TOKYO:6302) (head office: Shinagawa City, Tokyo; President and CEO: Shinji Shimomura; hereinafter "SHI") has received an order from Taichung Veterans General Hospital (Taiwan) for a next-generation proton therapy system (*).
  • The next-generation system will be installed at a new proton therapy center to be established in Taichung City, Taiwan, and proton therapy is scheduled to begin in 2026.
  • Taichung Veterans General Hospital is a national hospital located in central Taiwan and provides safe and high-quality medical services with new medical technologies and outstanding talents.
  • Taichung Veterans General Hospital plans to conduct research on new treatment technologies, such as FLASH, in collaboration with SHI.

Cohen Milstein Files Lawsuit on Behalf of Northwest Biotherapeutics Against Major Market Makers for Market Manipulation

Retrieved on: 
Friday, December 2, 2022

"We're looking forward to holding these market makers responsible for the harm they have caused, and bringing critical and necessary transparency to these markets."

Key Points: 
  • "We're looking forward to holding these market makers responsible for the harm they have caused, and bringing critical and necessary transparency to these markets."
  • In a market free from manipulation, the market response should have been strongly positive, not dramatically negative, in response to the positive news.
  • Northwest Biotherapeutics alleges that it sold over 49 million shares at manipulated and devalued prices as a result of the market makers' actions.
  • Northwest Biotherapeutics is represented by national law firm Cohen Milstein Sellers & Toll PLLC.

Y-mAbs Announces Complete Response Letter for Omburtamab Biologics License Application

Retrieved on: 
Thursday, December 1, 2022

The letter indicates that the FDA completed the review of the application and determined that it is unable to approve the BLA in its current form.

Key Points: 
  • The letter indicates that the FDA completed the review of the application and determined that it is unable to approve the BLA in its current form.
  • Y-mAbs is assessing the implications of the CRL and its plans for the omburtamab program.
  • We are disappointed by the CRL but not surprised based on the outcome of the ODAC meeting on October 28.
  • Researchers at MSK developed omburtamab, which is exclusively licensed by MSK to Y-mAbs.

EQS-News: Israeli Ministry Of Health Clears Way For Human Trials Of AllocetraTM, A Proprietary Off-the-Shelf Immunotherapy For Solid Tumors

Retrieved on: 
Thursday, December 1, 2022

Israeli Ministry Of Health Clears Way For Human Trials Of AllocetraTM, A Proprietary Off-the-Shelf Immunotherapy For Solid Tumors

Key Points: 
  • Israeli Ministry Of Health Clears Way For Human Trials Of AllocetraTM, A Proprietary Off-the-Shelf Immunotherapy For Solid Tumors
    The issuer is solely responsible for the content of this announcement.
  • The Israeli Ministry of Health (MOH) approved a Phase I/II trial of Enlivex Therapeutics Ltd.s (NASDAQ: ENLV) proprietary immunotherapy drug-candidate AllocetraTM.
  • Then, it can turn that macrophage into a pro-tumor ally that will suppress any immune response trying to kill the cancer.
  • The results of early-stage trials may differ significantly from the results of more developed, later-stage trials.

Oncolytics Biotech® Receives FDA Fast Track Designation for the Treatment of Advanced/Metastatic Pancreatic Cancer

Retrieved on: 
Thursday, December 1, 2022

SAN DIEGO, and CALGARY, AB, Dec. 1, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This represents pelareorep's second FDA Fast Track designation.

Key Points: 
  • This represents pelareorep's second FDA Fast Track designation.
  • Fast Track designation is designed to facilitate the development and expedite the review of therapies to treat serious conditions and fill an unmet medical need.
  • For conditions where an available treatment exists, a therapy must show some advantage over the available treatment, such as superior effectiveness, to be granted a Fast Track designation.
  • In addition, clinical programs with Fast Track designation may be eligible for Accelerated Approval and Priority Review, if relevant criteria are met.