DCR

Purple Biotech's Randomized Phase 2 CM24 Pancreatic Cancer Study Selected as Late-Breaking Abstract Poster Presentation at ASCO 2024 Annual Meeting

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木曜日, 4月 25, 2024
PFS, Efficacy, Safety, DCR, Risk, Nivolumab, Randomness, SOC, Drug resistance, Death, CM24, Tumor microenvironment, OS, PD-1, PDAC, ASCO, Cancer, Patient, Society, CA19-9, Interim, BMS, Neoplasm, Bristol Myers Squibb, Annual general meeting, Pharmacodynamics, Escape Room, Pharmaceutical industry

REHOVOT, Israel, April 25, 2024 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced that interim results from its randomized, controlled, open label, multicenter Phase 2 study of CM24, a first in class immune checkpoint inhibitor, for the treatment of pancreatic ductal adenocarcinoma (PDAC), have been selected as late-breaking abstract poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting which will take place on May 31 – June 4, 2024 in Chicago, Illinois.

Key Points: 
  • The primary endpoint of the study is overall survival (OS), with progression free survival (PFS) and objective response rate (ORR) as secondary endpoints.
  • The study was designed as Bayesian to evaluate the potential benefit of the experimental arm vs SoC and is not powered for hypothesis testing.
  • Approximately 60 patients have been enrolled in the randomized study in 18 centers in the U.S., Spain and Israel.
  • “We are honored to be selected by the ASCO committee with our late breaking abstract poster presentation and are looking forward to presenting our interim results from our randomized Phase 2 CM24 study at the ASCO 2024 annual meeting.” stated Gil Efron, Chief Executive Officer of Purple Biotech.

Immutep Announces Positive Preliminary Topline Results from TACTI-003 Cohort B

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水曜日, 4月 24, 2024
CPS, Cancer, DCR, HNSCC, Data collection, QOL, Neck, Pembrolizumab, Merck & Co., CQD, ASX, Fast track (FDA), PD-L1, Data, Autoimmune disease, Incidence, Patient, Head, Death, Quality of life, Merck, Neoplasm, IMM, Medical imaging

SYDNEY, AUSTRALIA, April 24, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces preliminary topline results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial evaluating eftilagimod alpha (efti) in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with negative PD-L1 expression.

Key Points: 
  • Head and neck squamous cell carcinomas are a heterogenous disease that represent a high unmet medical need regardless of PD-L1 expression.
  • A total of 33 patients with recurrent or metastatic HNSCC have been enrolled into Cohort B.
  • The final number of evaluable patients in Cohort B is expected to be higher and additional data, including complete response rate, will be released together with Cohort A data.
  • Patients in Cohort A are stratified by CPS >1, CPS 1-19, and CPS >20, and the clinical results for these three CPS groups will be evaluated.

Vishay Intertechnology Automotive Grade IHDF Edge-Wound Inductor With Low 15.4 mm Max. Profile Delivers Saturation Current to 230 A

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水曜日, 4月 24, 2024
DCR, Risk, Vishay Intertechnology, EV, HEV, VSH, AEC, AC, Temperature, VDC, Transformer

MALVERN, Pa., April 24, 2024 (GLOBE NEWSWIRE) -- Vishay Intertechnology, Inc. (NYSE: VSH) today introduced a new Automotive Grade IHDF edge-wound, through-hole inductor with rated current up to 72 A and saturation currents up to 230 A.

Key Points: 
  • MALVERN, Pa., April 24, 2024 (GLOBE NEWSWIRE) -- Vishay Intertechnology, Inc. (NYSE: VSH) today introduced a new Automotive Grade IHDF edge-wound, through-hole inductor with rated current up to 72 A and saturation currents up to 230 A.
  • The edge-wound coil construction provides low DCR of 1.1 mΩ maximum, which minimizes losses and improves rated current performance for increased efficiency.
  • Compared to competing ferrite-based solutions, the IHDF-1300AE-1A offers 75 % higher rated current.
  • Target applications include high current, high temperature automotive systems, such as on-board chargers for electric (EV) and hybrid electric vehicles (HEV).

Boston Triathlon to Add New Global Professional Race

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火曜日, 4月 23, 2024
Conservation, DCR, Entrepreneurship, Summer, Recreation, Athlete, Summer Olympic Games, Entertainment

BOSTON, April 23, 2024 /PRNewswire/ -- ethos, a mass participation event organization that produces the Columbia Threadneedle Investments Boston Triathlon and Kids Day at the Boston Tri today announced the addition of supertri Boston to their weekend of exciting racing this coming August. The Boston Triathlon is excited to partner with supertri to bring the fastest professional and Olympic triathletes to Boston. The season opener supertri Boston will include a live, global TV broadcast, giving the world a chance to see top athletes race in the iconic city of Boston. supertri is expanding to North America where it will host two new events in the USA to form a five-stop league that will see some of the world's top triathletes compete in fast, technical, and tactical racing just weeks after competing in the Summer Olympics. The supertri Boston event with take place on Sunday, August 18th, 2024, in South Boston, after the age-group races have concluded.

Key Points: 
  • The Boston Triathlon is excited to partner with supertri to bring the fastest professional and Olympic triathletes to Boston.
  • The season opener supertri Boston will include a live, global TV broadcast, giving the world a chance to see top athletes race in the iconic city of Boston.
  • The supertri Boston event with take place on Sunday, August 18th, 2024, in South Boston, after the age-group races have concluded.
  • "Since we created Boston Triathlon more than 15 years ago, one of the pillars of the race is to be a force for good in the Boston community.

【2024 AACR Late Breaking Research】TransThera announces clinical data of tinengotinib to treat patients with advanced solid tumors harboring actionable FGFR1-3 alterations

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金曜日, 4月 12, 2024
FGFR, Cancer, DCR, Prostate, Protein, Cholangiocarcinoma, 1–3, Neoplasm, Breast, Research, Patient, Fibroblast, Malignancy, Simple squamous epithelium, Head, AACR, Combination therapy, Pharmaceutical industry

Monotherapy for patients with advanced solid tumors harboring actionable FGFR1-3 mutations:

Key Points: 
  • Monotherapy for patients with advanced solid tumors harboring actionable FGFR1-3 mutations:
    Fibroblast growth factor receptor (FGFR) alterations occur across various malignancies and are potent oncogenic drivers in multiple tumor types.
  • However, no effective therapies are available worldwide for patients with advanced solid tumors harboring actionable FGFR1-3 mutations currently.
  • The retrospective analysis of the pooled results from four clinical studies of tinengotinib in advanced solid tumors harboring actionable FGFR1-3 mutations showed efficacy in multiple tumor types, including cholangiocarcinoma, breast, prostate, urothelium, colon and head and neck cancer.
  • The promising results validated the novel mechanism of tinengotinib and clinical applications for potentially FGFR 1-3 altered patients with solid tumors.

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Renal Cancer

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日曜日, 4月 7, 2024
Diagnosis, OS, Nephrectomy, Immunotherapy, DCR, Oncology, Risk, Patient, Shanda, Malignancy, Death, IMDC, Carcinoma, Renal cell carcinoma, Trial of the century, RCC, National Medical Products Administration, ESMO, HKEX, IRC, PFS, Annals of Oncology, Axitinib, Independent Review Committee, Pharmaceutical industry

Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.

Key Points: 
  • Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.
  • There were approximately 77,000 new cases of and 46,000 deaths due to renal carcinoma in China in 2022.
  • Distant metastasis occurred in about one-third of renal carcinoma patients at initial diagnosis, and in 20%-50% of localized patients after nephrectomy.
  • “The approval of toripalimab combined with axitinib addresses the gap in first-line immunotherapy for renal cancer in China.

HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Endometrial Cancer with Priority Review Status

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火曜日, 4月 2, 2024
Toxicity, Radiation, Sintilimab, NMPA, Endometrial cancer, Disease, DCR, New Drug Application, Patient, NDA, Breakthrough therapy, Senior, Priority review, HKEX, Dor, IRC, Prognosis, PFS, Pharmaceutical industry

HONG KONG, SHANGHAI, China & FLORHAM PARK, N.J., April 02, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) and Innovent Biologics, Inc. (“Innovent”) (HKEX:1801) today jointly announce that the New Drug Application (“NDA”) for the combination of fruquintinib and sintilimab for the treatment of patients with advanced endometrial cancer with pMMR1 or non-MSI-H2 tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”).

Key Points: 
  • The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase II study investigating fruquintinib in combination with sintilimab in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy.
  • Data from FRUSICA-1 will be submitted for presentation at an upcoming medical conference.
  • “This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab.
  • “Endometrial cancer remains one of the most common gynecological malignancies.

Omega Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Strategic Update

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木曜日, 3月 28, 2024
HCC, Research, Epigenomics, Toxicity, Obesity, Cell death, Growth, Burns, Gene expression, Novo Nordisk, NSCLC, AASLD, Appetite, OMEGA, DCR, Patient, Lung, Tissue, Cohort, CXCL9, CXCL10, Omega, G&A, Cancer, Messenger, Lung cancer, Human, Life expectancy, Liver regeneration, DLT, Fibrosis, Thermogenesis, Therapy, MYC, Liver, Pharmacokinetics, Hepatitis, CXCL11, LNP, Pharmaceutical industry

Research and development (R&D) expenses for the fourth quarter of 2023 were $15.5 million, compared to $26.0 million for the fourth quarter of 2022.

Key Points: 
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $15.5 million, compared to $26.0 million for the fourth quarter of 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 were $6.2 million, compared to $5.7 million for the fourth quarter of 2022.
  • Net loss for the fourth quarter of 2023 was $20.2 million, compared to $30.8 million for the fourth quarter of 2022.
  • The decrease in net loss for 2023 compared to 2022 was primarily due to decreases in R&D expenses.

HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC

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木曜日, 3月 28, 2024
OS, Savolitinib, Conference, NMPA, AstraZeneca, NSCLC, Grade 3, DCR, New Drug Application, WCLC, Patient, Neoplasm, Cerebral edema, Gamma-glutamyltransferase, MET, Lung cancer, HKEX, Dor, Safety, PFS, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the supplemental New Drug Application (“sNDA”) for savolitinib, in adult patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) with mesenchymal epithelial transition factor (“MET”) exon 14 skipping alteration, has been accepted for review by the China National Medical Products Administration (NMPA). If approved, the new label indication for savolitinib will be expanded to include treatment-naïve patients in China.

Key Points: 
  • Savolitinib was previously granted conditional approval in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
  • Savolitinib was launched and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca for this patient population, representing the first selective MET inhibitor approved in China.
  • More than a third of the world’s lung cancer patients are in China and, among those with NSCLC globally, approximately 2-3% have tumors with MET exon 14 skipping alterations.
  • The data from this study provide confirmatory evidence for savolitinib as a targeted treatment option for treatment-naïve or previously treated patients with MET exon 14 skipping alteration NSCLC.

AACR 2024: PDC*line Pharma Presents Interim Clinical Results From Last Cohort of Patients in Phase I/II Trial with PDC*lung01 Cancer Vaccine

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月曜日, 4月 8, 2024
Stem Cells, Biotechnology, Health, Pharmaceutical, Biometrics, Oncology, Other Science, Research, Genetics, Science, Clinical Trials, KU Leuven, Mutation, Database, Survival, Best, DCR, Patient, Data, Aes, Șaeș, Progression-free survival, AACR, Kaplan–Meier estimator, Clinical trial, Cancer, Injection, ESMO, Safety, Symantec Endpoint Protection, DSMB, Poster, PFS, Vaccine, PDC

PDC*lung01 is the company’s off-the shelf therapeutic cancer vaccine candidate for Non-Small Cell Lung Cancer (NSCLC).

Key Points: 
  • PDC*lung01 is the company’s off-the shelf therapeutic cancer vaccine candidate for Non-Small Cell Lung Cancer (NSCLC).
  • The phase I/II trial (PDC-LUNG-101) aimed to assess the safety, tolerability, immunogenicity and preliminary clinical activity of PDC*lung01 in NSCLC patients, alone or in combination with anti-PD-1 treatment.
  • PDC*Line is reporting preliminary efficacy results for 19 evaluable patients in the B2 cohort that reached the 9-month PFS mark.
  • The final analysis of the clinical trial including the 45 patients from the B2 cohort will be conducted in Q3, 2024.