RCC

First Patient Dosed in Phase 1b Clinical Trial of Synthekine’s α/β Biased IL-2, STK-012, for Treatment of Solid Tumors

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木曜日, 9月 28, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, HD, Inc., Therapy, Beth Israel Deaconess Medical Center, RCC, Kidney cancer, Therapeutic index, Clinical trial, Pharmacokinetics, Immunity, NK, Toxicity, NSCLC, Lung cancer, Harvard Medical School, Patient, Lymphocyte, Safety, Renal cell carcinoma, Pharmaceutical industry, Medicine

Synthekine Inc. , a leader in engineered cytokine therapeutics, today announced that the company has completed phase 1a dose escalation and dosed the first patient in the Phase 1b portion of a clinical trial evaluating its α/β biased IL-2, STK-012, for the treatment of solid tumors.

Key Points: 
  • Synthekine Inc. , a leader in engineered cytokine therapeutics, today announced that the company has completed phase 1a dose escalation and dosed the first patient in the Phase 1b portion of a clinical trial evaluating its α/β biased IL-2, STK-012, for the treatment of solid tumors.
  • Synthekine recently completed the Phase 1a dose-escalation portion of the study in patients with various advanced solid tumors, with results suggesting a differentiated safety profile and monotherapy efficacy.
  • STK-012 is built from unique insights into IL-2 biology and is the first α/β biased IL-2 with clinical results.
  • Results from the Phase 1a portion of the study will be presented at a future medical meeting.

Merck and Eisai Provide Update on Two Phase 3 Trials Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Patients With Certain Types of Metastatic Non-Small Cell Lung Cancer

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金曜日, 9月 22, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Docetaxel, Senior, Hepatocellular carcinoma, RCC, Lenvatinib, Pembrolizumab, OS, MRK, Lung cancer, Head, Multimedia, NSCLC, Biomarker, PFS, Merck & Co., LEAP, Cancer, Patient, EGFR, Anaplastic lymphoma kinase, ROS1, Esophageal cancer, Stomach, Pemetrexed, NYSE, ORR, ALK, Pharmaceutical industry, Medical imaging, EU, Eisai, Merck

At the study’s final analysis, there was not an improvement in OS for patients treated with KEYTRUDA plus LENVIMA with chemotherapy compared to KEYTRUDA with chemotherapy.

Key Points: 
  • At the study’s final analysis, there was not an improvement in OS for patients treated with KEYTRUDA plus LENVIMA with chemotherapy compared to KEYTRUDA with chemotherapy.
  • Earlier interim analyses did not demonstrate a statistically significant improvement in PFS or objective response rate (ORR), a key secondary endpoint.
  • At the final analysis of the study, there was not an improvement in OS for patients who received KEYTRUDA plus LENVIMA compared to docetaxel.
  • Results from the LEAP-006 and LEAP-008 trials do not affect the current approved indications for the KEYTRUDA plus LENVIMA combination or other ongoing trials from the LEAP clinical program.

FDA Accepts for Priority Review Merck’s Supplemental New Drug Application for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC)

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火曜日, 9月 19, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Progression-free survival, RCC, Everolimus, MRK, Head, PFS, Merck & Co., Shanda, VHL, Patient, Pancreatic neuroendocrine tumor, PDUFA, Data monitoring committee, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, ORR, Food, Pharmaceutical industry, Merck

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental new drug application (sNDA) seeking approval for WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following immune checkpoint and anti-angiogenic therapies.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental new drug application (sNDA) seeking approval for WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following immune checkpoint and anti-angiogenic therapies.
  • The sNDA is based on data from the LITESPARK-005 trial, in which WELIREG demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to everolimus based on a pre-specified interim analysis conducted by an independent Data Monitoring Committee.
  • A statistically significant improvement in the trial’s key secondary endpoint of objective response rate (ORR) was also demonstrated.
  • The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of January 17, 2024.

MHI Thermal Systems Launches New "TEJ35GAM" Electric-Driven Transport Refrigeration Units

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水曜日, 9月 13, 2023
Maintenance, EV, Air conditioning, Mitsubishi Heavy Industries, RCC, Season, Electricity, Refrigeration, Temperature, COP, Running, MHI, Natural Resources, Heat, IEEE Transportation Technologies Award, CO2, Award, Heating, ventilation, and air conditioning

- Heat-pump system enables simultaneous heating and cooling operations; multi-system answers need for simultaneous transport of products requiring multiple temperatures

Key Points: 
  • - Heat-pump system enables simultaneous heating and cooling operations; multi-system answers need for simultaneous transport of products requiring multiple temperatures
    TOKYO, Sept 13, 2023 - (JCN Newswire) - Mitsubishi Heavy Industries Thermal Systems, Ltd. (MHI Thermal Systems), a part of Mitsubishi Heavy Industries (MHI) Group, has launched sales in the domestic market of the TEJ35GAM, an electric-driven transport refrigeration unit exclusively for small and mid-size trucks.
  • The TEJ35GAM joins the already available TE20/30 series, refrigeration units for plug-in hybrid transport, and the TEJ35AM, an electric-driven transport refrigeration unit with heat-pump heating system for EV trucks.
  • In the years ahead, MHI Thermal Systems will continue focusing on the development of technologies and products that will contribute to reducing CO2 emissions and saving energy by taking advantage of advances in electric-driven transport refrigerator inverter control, heat-pump systems, multi-systems, etc.
  • For refrigeration systems, COP is the rated refrigeration capacity (kW) divided by electricity consumption (kW).

BlocPower Awarded $1.2 Million Grant by MassCEC to Launch Workforce Development Program for Returning Citizens

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木曜日, 8月 31, 2023
Workforce, Paradigm, Business development, Partnership, Employment, College, RCC, Codman Square District, Curriculum, Ageing, Greenspace, Organization, Maven, MA, Workforce development, Climate, Commonwealth, Roxbury Community College, Renewable energy, Management, Nursing

BOSTON, Aug. 31, 2023 /PRNewswire-PRWeb/ -- BlocPower, a national climate tech company focused on decarbonizing aging buildings, is proud to announce that it has been awarded a $1.2 million grant by the Massachusetts Clean Energy Center (MassCEC) to create and implement a groundbreaking workforce development program in partnership with local nonprofit, Browning the Green Space. The program will recruit and train returning citizens in high-demand job skills for building electrification, providing them with valuable career opportunities and supporting the transition to a clean energy future.

Key Points: 
  • Donnel Baird, CEO and founder of BlocPower
    The workforce development program will consist of two cohorts, each accommodating 15 participants.
  • "Roxbury Community College (RCC) is pleased to partner with MassCEC and the other renowned program partners to provide training and support to returning citizens," said Salvador Pina, Dean of Workforce and Business Development.
  • BlocPower and its partners are excited to embark on this groundbreaking initiative and empower returning citizens with sustainable employment opportunities.
  • For more information about BlocPower and its workforce development program, please visit blocpower.io/workforce .

Adagene Reports Six Month Financial Results for 2023 and Provides Corporate Update

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木曜日, 8月 31, 2023
Bevacizumab, Senior, ADCC, Neoplasm, Lead, Head, Bioinformatics, GAAP, Information technology, Doctor of Philosophy, Patient, HNSCC, ADCP, Research and development, R, HCC, SAB, CD47, PRS, Therapy, Merck & Co., Net, Cervical cancer, CPS, MSI, ADC, PD-1, PR, Safety, Exercise, AACR, Liver disease, MSS, Roche, Therapeutic index, GenScript Biotech, American Association for Cancer Research, CR, Pembrolizumab, ORR, Renal cell carcinoma, SCC, CRC, RCC, ADS, CMC, Yan Li, Clinical trial, Trae Waynes, Endometrial cancer, Financial toxicity, Poster, Tumor microenvironment, Pharmaceutical industry, Palladium, Medical imaging, Vaccine, Management, Cryptocurrency, Fine chemical, Bank, Legend, Immunoglobulin G, MD, Sanofi, Exelixis

Additionally, Fangyong (Felix) Du, Ph.D, Chief Technology Officer at Adagene since 2020, is stepping down from the board for personal reasons.

Key Points: 
  • Additionally, Fangyong (Felix) Du, Ph.D, Chief Technology Officer at Adagene since 2020, is stepping down from the board for personal reasons.
  • Cash and cash equivalents were US$128.8 million as of June 30, 2023, compared to US$143.8 million as of December 31, 2022.
  • The company uses non-GAAP net loss and non-GAAP net loss per ordinary shares for the period, which are non-GAAP financial measures, in evaluating its operating results and for financial and operational decision-making purposes.
  • The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure.

PLOS ONE Publishes Data on Allarity Therapeutics’ DRP® Companion Diagnostic for Dovitinib

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水曜日, 8月 30, 2023
Partnership, Fibroblast growth factor receptor 1, Therapy, Hepatocellular carcinoma, RCC, Survival, Cancer, Osteosarcoma, Biomarker, Messenger, Patient, PLOS, CDX, Ovarian cancer, PARP, HCC, Allar language, Renal cell carcinoma, Pharmaceutical industry

Data showed that the DRP®-Dovitinib CDx was able to identify a subgroup of advanced renal cell carcinoma (RCC) patients that have improved clinical benefit from treatment with dovitinib, as compared to unselected patients.

Key Points: 
  • Data showed that the DRP®-Dovitinib CDx was able to identify a subgroup of advanced renal cell carcinoma (RCC) patients that have improved clinical benefit from treatment with dovitinib, as compared to unselected patients.
  • “This is the first validated predictive biomarker in renal cell carcinoma, a long-standing goal in potentially improving the treatment of these patients.
  • An additional prospective trial would be required before RCC patients that are candidates for dovitinib can benefit from this diagnostic breakthrough.
  • In addition, in partnership with Allarity , Oncoheroes Biosciences has an ongoing program to develop dovitinib, together with the DRP®-dovitinib CDx, as a treatment for pediatric osteosarcoma.

AREP Partners with Award-Winning Tech Accelerator Unstuck Labs to Ignite a New Era of Innovation at Rosslyn City Center

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月曜日, 8月 28, 2023
Commercial Building & Real Estate, Construction & Property, Other Communications, Consulting, Communications, Professional Services, Technology, Other Technology, Well, Learning, Heart, DNA, Unstuck, Metro, Lighting, Partnership, RCC, City, University, The Arlington, Multimedia, Tenant, Gold's Gym, Creativity, AREP, MD, Gold, BID, Datawatch Corporation, Growth, Ecosystem, Principal, VTS, Icahn Enterprises, Family, Perspiration, Video game, Cryptocurrency, Drug, DMV, United

Today, American Real Estate Partners announced a partnership with Unstuck Labs , an award-winning tech accelerator and mobile app developer that works with early-stage startups, founders, and innovation programs.

Key Points: 
  • Today, American Real Estate Partners announced a partnership with Unstuck Labs , an award-winning tech accelerator and mobile app developer that works with early-stage startups, founders, and innovation programs.
  • With innovation and technology ingrained in its DNA, AREP developed RCC to accommodate the ever-changing customer and digital landscape, incorporating prop tech to elevate the tenant experience.
  • "You know, at Unstuck Labs, we're not just about lighting up creativity or speeding up innovation.
  • Well, it's the perfect place for us to make this happen," said Wa'il Ashshowwaf, CEO and Co-founder of Unstuck Labs.

Merck and Eisai Provide Update on Phase 3 LEAP-010 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Patients With Certain Types of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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金曜日, 8月 25, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Senior, Hepatocellular carcinoma, Progression-free survival, RCC, Neoplasm, Lenvatinib, Pembrolizumab, Overalls, Survival, OS, MRK, Head, TKI, Multimedia, Research, Lung cancer, Immunotherapy, PFS, Merck & Co., LEAP, Cancer, Patient, Esophageal cancer, HNSCC, Data monitoring committee, Stomach, PD-L1, NYSE, ORR, DMC, Pharmaceutical industry, EU, Eisai, Merck

The primary endpoints of the study were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).

Key Points: 
  • The primary endpoints of the study were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).
  • View the full release here: https://www.businesswire.com/news/home/20230825671284/en/
    Two planned interim analyses were conducted by an independent Data Monitoring Committee (DMC) over an 11-month period.
  • In the first analysis, KEYTRUDA plus LENVIMA showed a statistically significant improvement in PFS and ORR versus KEYTRUDA plus placebo.
  • The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination.

Merck Announces WELIREG® (belzutifan) Phase 3 LITESPARK-005 Trial Met Primary Endpoint of Progression-Free Survival in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma

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金曜日, 8月 18, 2023
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, MSD, Progression-free survival, RCC, DOR, Everolimus, OS, MRK, Head, PFS, Merck & Co., HIV disease progression rates, VHL, Patient, Risk, Pancreatic neuroendocrine tumor, Data monitoring committee, Death, NYSE, ORR, Pharmaceutical industry, Merck

LITESPARK-005 is evaluating WELIREG for the treatment of adult patients with advanced renal cell carcinoma (RCC) that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) therapies.

Key Points: 
  • LITESPARK-005 is evaluating WELIREG for the treatment of adult patients with advanced renal cell carcinoma (RCC) that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) therapies.
  • A statistically significant improvement in the trial’s key secondary endpoint of objective response rate (ORR) was also demonstrated.
  • A trend toward improvement in overall survival (OS), a dual primary endpoint, was observed; however, this result did not reach statistical significance.
  • The safety profile of WELIREG in this trial was consistent with that observed in previously reported studies.