Transaminase

Immunocore reports updated Phase 1 data of brenetafusp (IMC-F106C), an ImmTAC bispecific targeting PRAME, in immune checkpoint pre-treated cutaneous melanoma patients at ASCO 2024

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星期五, 五月 31, 2024
PRAME, Bristol Myers Squibb, Patient, Infection, Rash, Progression-free survival, Immunocore, Research and development, Pembrolizumab, Transaminase, Gene expression, Translational research, PFS, Therapy, Neoplasm, RECIST, Cytokine release syndrome, ImmTAC, Event, PD-1, Cancer, ASCO, Research institute, OS, PR, Society, Immunohistochemistry, Melanoma, DCR, History, Autoimmune hepatitis, Nivolumab, Annual general meeting, CRS, Pharmaceutical industry

Brenetafusp was shown to be well tolerated, in monotherapy and in combination with anti-PD1, and demonstrated durable clinical benefit.

Key Points: 
  • Brenetafusp was shown to be well tolerated, in monotherapy and in combination with anti-PD1, and demonstrated durable clinical benefit.
  • “We expect brenetafusp PFS to be even higher in first-line based on our analysis of blood T cell fitness.
  • All monotherapy treated patients had received prior immune checkpoint inhibitors (100% anti-PD1, 81% anti-CTLA4).
  • Immunocore will host a conference call today, May 31, 2024 at 7:15 PM ET / 6:15 PM CT, to discuss the Phase 1 PRAME expansion data and Phase 3 registrational trial in cutaneous melanoma.

Rezolute Reports Third Quarter Fiscal 2024 Financial Results and Provides Business Update

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星期三, 五月 15, 2024
Update, Chi, Patient, Pharmacokinetics, Human, Investment, FDA, Trial of the century, Disease, Safety, Transaminase, DME, Primate, Rat, Diabetic retinopathy, Research, Congenital hyperinsulinism, Insulinoma, Pharmaceutical industry

REDWOOD CITY, Calif., May 15, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today reported financial results and provided a business update for the three months ended March 31, 2024.

Key Points: 
  • Additionally, at the 40 mg/kg dose in this study, SD rats had liver abnormalities consistent with previous in-vivo studies.
  • Cash, cash equivalents and investments in marketable securities were $81.6 million as of March 31, 2024, compared with $118.4 million as of June 30, 2023.
  • General and administrative expenses were $3.8 million for the third quarter of fiscal 2024, compared with $2.9 million for the same period a year ago, with the increase primarily attributable to personnel-related expenses due to increased headcount.
  • Net loss was $17.1 million for the third quarter of fiscal 2024 compared with a net loss of $15.7 million for the same period a year ago.

Exegenesis Bio to Present 9-Patient Data from a Phase 1/2 Clinical Trial of EXG001-037, a Novel rAAV Gene Therapy for Spinal Muscular Atrophy (SMA) Type 1: Improved Head Control and Sitting Without External Assistance

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星期四, 四月 25, 2024
Biotechnology, Baby, Maternity, Health, Pharmaceutical, Neurology, Health Technology, Research, Genetics, Consumer, Science, Clinical Trials, Patient, Safety, Poster, SMA, Cell, AAV, Spinal muscular atrophy, Liver, Gene, Society, Transaminase, Clinical trial, Annual general meeting, Atrophy, Pharmaceutical industry

EXG001-307 is a next generation recombinant adeno-associated virus (rAAV) gene therapy in development for Spinal Muscular Atrophy (SMA) Type 1.

Key Points: 
  • EXG001-307 is a next generation recombinant adeno-associated virus (rAAV) gene therapy in development for Spinal Muscular Atrophy (SMA) Type 1.
  • Data from nine patients demonstrate improved head control and sitting without external assistance as early as three months following dosing.
  • EXG001-307 has demonstrated high expression in target spinal cord tissue and reduced off target expression in liver and heart tissue than AAV9.CBA.SMN1.
  • We are excited about the clinical efficacy and safety data emerging from our Phase 1/2 SMA clinical trial in China.

Synthekine Presents Positive Initial Results from Phase 1a/1b Clinical Trial of α/β Biased IL-2, STK-012, for Treatment of Advanced Solid Tumors

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星期二, 四月 9, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Arthralgia, Toxicity, Cell, NSCLC, RECIST, HNSCC, Patient, Diarrhea, Maculopapular rash, Lung cancer, Renal cell carcinoma, Injection site reaction, AACR, Nausea, Lymphocyte, Hypotension, RCC, Transaminase, Poster, Itch, CLS, Capillary leak syndrome, Fatigue, Vomiting, NK, Inc., Pharmaceutical industry

Synthekine Inc ., an engineered cytokine therapeutics company, today announced positive initial results from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, for the treatment of advanced solid tumors.

Key Points: 
  • Synthekine Inc ., an engineered cytokine therapeutics company, today announced positive initial results from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, for the treatment of advanced solid tumors.
  • The data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego.
  • In the results presented, which included 47 patients treated in Phase 1a dose escalation, STK-012 monotherapy demonstrated a favorable safety, efficacy, pharmacokinetic and pharmacodynamic profile.
  • The poster, titled “Initial results from a Phase 1a/1b study of STK-012, a first-in-class α/β IL-2 receptor biased partial agonist in advanced solid tumors (NCT05098132),” will be presented today at AACR from 9 am to 12:30 pm PT.

Largest study to date of high-dose methotrexate associated acute kidney injury supports the use of Voraxaze® (glucarpidase)

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星期一, 十二月 11, 2023
MMSc, Hospital, AKI, Division, Cone Health Women's Hospital, Mortality, Neutropenia, SCR, Society, Odds ratio, Observational study, Acute kidney injury, Transaminase, MPH, Patient, Harvard Medical School, Nursing

West Conshohocken, PA, Dec. 11, 2023 (GLOBE NEWSWIRE) -- BTG Pharmaceuticals, a SERB company, announces the presentation of the largest study to date of patients with high-dose methotrexate (HDMTX) associated Acute Kidney Injury (AKI) treated with and without glucarpidase.

Key Points: 
  • West Conshohocken, PA, Dec. 11, 2023 (GLOBE NEWSWIRE) -- BTG Pharmaceuticals, a SERB company, announces the presentation of the largest study to date of patients with high-dose methotrexate (HDMTX) associated Acute Kidney Injury (AKI) treated with and without glucarpidase.
  • Among the 708 patients with HDMTX-AKI, 209 (29.5%) were treated with glucarpidase and 499 (70.5%) were not.
  • Treatment with glucarpidase was associated with a 2.41-fold higher adjusted odds of kidney recovery at hospital discharge (95% CI, 1.33–4.37) compared to those not treated with glucarpidase.
  • “This is the largest study to date of HDMTX-AKI,” said study author Dr. Shruti Gupta, MD, MPH, Director of Onconephrology in the Division of Renal Medicine, Brigham and Women's Hospital.

ENHERTU® Approved in the EU as the First HER2 Directed Therapy for Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer

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星期一, 十月 23, 2023
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, CR, Female, Neoplasm, ERBB2, Lymphocytopenia, NSCLC, AstraZeneca, Journal of Thoracic Oncology, DOR, Thrombocytopenia, Vomiting, Hypokalemia, HER2, Diarrhea, Lung cancer, News, Nausea, Pneumonia, Transaminase, Lung, ADC, Disease, Daiichi Sankyo, TSE, Immunotherapy, ORR, Anemia, Leukopenia, Safety, European, Patient, Diagnosis, Neutropenia, Mutation, Fatigue, Pharmaceutical industry, Medical imaging, MD, EU

ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).

Key Points: 
  • ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).
  • In DESTINY-Lung02, ENHERTU (5.4 mg/kg) demonstrated a confirmed objective response rate (ORR) of 49.0% (95% confidence interval [CI]: 39.0-59.1) in patients with previously treated advanced or metastatic HER2 mutant NSCLC as assessed by blinded independent central review (BICR).
  • Grade 5 adverse reactions occurred in 1.4% of patients, including interstitial lung disease (1.0%).
  • Following approval in the EU, an amount of $75 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment in HER2 mutant non-small cell lung cancer.

National Liver Health Awareness Month Highlights the Urgent Need for Liver Disease Prevention

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星期三, 十月 4, 2023
Steatosis, Fatty liver disease, NASH, Education, Hepatology, Liver disease, Liver cancer, Cirrhosis, MASH, Transaminase, Houston Methodist Hospital, Metabolism, Hepatitis, Name, Patient, Physician, NAFLD, SLD, Dietary supplement

PARIS, Oct. 4, 2023 /PRNewswire/ -- As we approach October's National Liver Health Awareness Month, Echosens, a manufacturer of non-invasive diagnostic technology, FibroScan®, is urgently calling attention to the importance of prioritizing liver health. The company underscores the significant role of regular liver screenings, particularly non-invasive ones, in detecting and preventing various liver diseases, such as Hepatitis, Fatty Liver Disease, Cirrhosis, and Liver Cancer. Echosens points out that public awareness and information about these diseases are currently insufficient, emphasizing the need for more education and awareness.

Key Points: 
  • The company underscores the significant role of regular liver screenings, particularly non-invasive ones, in detecting and preventing various liver diseases, such as Hepatitis, Fatty Liver Disease, Cirrhosis, and Liver Cancer.
  • This year's focus is increasing awareness of liver disease and highlighting the recent changes in terminology for fatty liver disease, now referred to as steatotic liver disease (SLD).
  • The terms nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) have been superseded by metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH), respectively.
  • For more information about liver health, liver disease, and Echosens' initiatives, please visit www.echosens.com .

Third Harmonic Bio Announces First Quarter 2023 Financial Results

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星期四, 五月 11, 2023
G&A, Medicine, Research, Transaminase, KIT, SAN, R, Inflammation, D, Pharmaceutical industry

SAN FRANCISCO, May 11, 2023 (GLOBE NEWSWIRE) -- Third Harmonic Bio, Inc. (Nasdaq: THRD), a biopharmaceutical company focused on advancing the next wave of medicine for inflammatory diseases, today announced financial results for the first quarter ended March 31, 2023.

Key Points: 
  • SAN FRANCISCO, May 11, 2023 (GLOBE NEWSWIRE) -- Third Harmonic Bio, Inc. (Nasdaq: THRD), a biopharmaceutical company focused on advancing the next wave of medicine for inflammatory diseases, today announced financial results for the first quarter ended March 31, 2023.
  • “We are pleased with our progress on our next generation oral KIT inhibitor program, and plan to announce our new development candidate this year,” said Natalie Holles, Chief Executive Officer of Third Harmonic Bio.
  • Cash Position: Cash and cash equivalents totaled $282.2 million as of March 31, 2023.
  • R&D Expenses: Research and development (R&D) expenses for the three months ended March 31, 2023 increased to $6.7 million from $6.2 million for the same period in 2022.

TURALIO® New Dosing Regimen Now Available in the U.S. for Certain Patients with Tenosynovial Giant Cell Tumor

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星期三, 二月 1, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Capsule, Toxicity, Joint, Physician, Liver injury, Daiichi Sankyo, Patient, Boxed, Cholestasis, Tenosynovial giant cell tumor, HIV disease progression rates, Liver, Disease, Food, Hepatotoxicity, Pharmacy, Risk, Transaminase, TGCT, FDA, Ductopenia, TSE, Mitigation, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, REMS, Pharmaceutical industry, Dietary supplement

A new 125 mg capsule of TURALIO is now available and the 200 mg capsule has been discontinued.

Key Points: 
  • A new 125 mg capsule of TURALIO is now available and the 200 mg capsule has been discontinued.
  • Patients currently taking TURALIO 200 mg capsules can take the 125 mg capsules as the next scheduled dose once the 200 mg capsules have been finished.
  • Patients should consult with their physicians to answer any questions they may have as they transition to the new dose.
  • Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive TURALIO.

US FDA grants regular approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer

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星期五, 二月 10, 2023
GSK plc, GSK, Diarrhea, Rash, DOR, Constipation, RECIST, Patient, Endometrial cancer, Anemia, Vomiting, Food, Senior, A1, Radiation, Transaminase, Urinary tract infection, ORR, FDA, Nausea, US Foods, Pharmaceutical industry, Dostarlimab

Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK, said: "This US regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer.

Key Points: 
  • Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK, said: "This US regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer.
  • We continue to unlock the potential of Jemperli as the backbone for our immuno-oncology development programs to address the unmet needs of patients, including earlier lines of endometrial cancer and other solid tumors."
  • In April 2021, Jemperli received accelerated approval for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer that had progressed on or following prior treatment with a platinum-containing regimen.
  • Cohort A1 evaluated the efficacy of Jemperli in 141 patients with dMMR advanced or recurrent endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.