1B

Cogent Biosciences Announces Positive Part 1b Data from SUMMIT Trial Evaluating Bezuclastinib in Patients with Nonadvanced Systemic Mastocytosis

Retrieved on: 
Thursday, February 22, 2024
Poster, AAAAI, PD, KIT, Week, TSS, ISM, Safety, Quality of life, News, SSM, Overalls, Edema, Cogent, GIST, Deficit spending, Webcast, Mast cell, Patient, SAE, 1B, APEX, American Academy, Pharmaceutical industry

WALTHAM, Mass. and BOULDER, Colo., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported positive Part 1b data from the Company’s ongoing SUMMIT trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM) at the 2024 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) meeting taking place February 23-26, 2024 in Washington, D.C.

Key Points: 
  • “The magnitude and speed of symptomatic reductions, along with corresponding improvements in quality-of-life, reported by patients in SUMMIT Part 1b has not been seen previously with other treatment options in this patient population.
  • Thirty-four patients in Part 1b were treated with either bezuclastinib or placebo plus best supportive care.
  • Patients were enrolled with the following sub-types: 33 patients with indolent systemic mastocytosis (ISM) and one patient with smoldering systemic mastocytosis (SSM).
  • Thirty-four patients enrolled in SUMMIT Part 1b were evaluated for signs of clinical activity over 12 weeks, including well-accepted biomarkers of disease burden.

Veracyte’s Decipher Prostate Test Receives Highest Evidence-Level Rating Among Molecular Tests in Updated Prostate Cancer NCCN Guidelines

Retrieved on: 
Tuesday, February 27, 2024
Software, Research, Professional Services, Oncology, Biometrics, Technology, Medical Devices, Artificial Intelligence, Health Technology, Data Analytics, Science, Biotechnology, Health, Clinical trial, Risk, Disease, Prostate, Criterion, Biomarker, NCCN, Classification, Prostate cancer, Patient, 1B, Medical imaging

(Nasdaq: VCYT), a leading cancer diagnostics company, today announced that its Decipher Prostate Genomic Classifier is the only gene expression test to receive a “Level 1B” evidence rating in the 2024 NCCN* Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a prognostic tool for the risk stratification of patients with localized prostate cancer.

Key Points: 
  • (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that its Decipher Prostate Genomic Classifier is the only gene expression test to receive a “Level 1B” evidence rating in the 2024 NCCN* Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a prognostic tool for the risk stratification of patients with localized prostate cancer.
  • Level 1B was assigned to Decipher Prostate based on the evidence in both the post-biopsy and post-prostatectomy settings.
  • Additionally, because of this classification, the Decipher Prostate test is the only gene expression test for which the guidelines synthesize the available published data in a separate table that summarizes treatment implications for patients based on both their NCCN risk classification and Decipher score.
  • They summarize the treatment implications for patients based on their Decipher score and the published evidence from analyses of multiple randomized, phase 3 clinical trials.

Jnana Therapeutics Reports Positive Topline Results from Phase 1a Clinical Study of JNT-517, a Potential First-in-Class Oral Treatment for PKU

Retrieved on: 
Wednesday, May 31, 2023
1B, Senior, Genetics, Phenylketonuria, Pharmacokinetics, RAPID, PKU, Phenylalanine, Therapy, Safety, Pharmaceutical industry, SLC6A19

BOSTON, May 31, 2023 (GLOBE NEWSWIRE) -- Jnana Therapeutics, a clinical-stage biotechnology company leveraging its next-generation chemoproteomics platform to discover medicines for challenging-to-drug targets, today announced positive topline results from the Phase 1a clinical trial of JNT-517 in healthy volunteers. Data from the study indicate that JNT-517 was safe and well tolerated with no serious adverse events and demonstrate compelling proof of mechanism.

Key Points: 
  • Data from the study indicate that JNT-517 was safe and well tolerated with no serious adverse events and demonstrate compelling proof of mechanism.
  • JNT-517 is a small molecule inhibitor of the phenylalanine (Phe) transporter SLC6A19 and is in development as a potential first-in-class oral treatment for phenylketonuria (PKU).
  • “We are encouraged by the positive results from the Phase 1a portion of our first-in-human trial of JNT-517.
  • The Phase 1a enrolled 64 healthy adults in a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of JNT-517.

Nova Opens New Large-Scale Clean Room in Israel

Retrieved on: 
Thursday, March 23, 2023
1B, NOVA, Growth, ESG, Environment, Element, Automation

REHOVOT, Israel, March 23, 2023 /PRNewswire/ -- Nova (Nasdaq: NVMI) announced today the opening of its new production facility in Israel.

Key Points: 
  • REHOVOT, Israel, March 23, 2023 /PRNewswire/ -- Nova (Nasdaq: NVMI) announced today the opening of its new production facility in Israel.
  • The state-of-the-art clean room aims at expanding Nova's production capacity and complements the existing facilities, allowing the Company to improve production procedures and yields.
  • The new, highly advanced clean room facility supports the Company's long-term growth strategy by establishing the required manufacturing environment to produce Nova's most advanced platforms.
  • "The new clean room in Israel can support higher yield for our established products but also accommodate high-volume manufacturing of our new products.

Xilio Therapeutics Announces Encouraging Preliminary Phase 1 Dose-Escalation Data for XTX101, a Tumor-Selective Anti-CTLA-4, and Reports Pipeline and Business Updates and Second Quarter 2022 Financial Results

Retrieved on: 
Tuesday, August 9, 2022
MSD, U.S. Securities and Exchange Commission, Patient, GLP, GLOBE, R, Neoplasm, MTD, SEC, Cancer, Clinical trial, Research, Renal cell carcinoma, Pembrolizumab, Research and development, Tumor microenvironment, G&A, Food, Immune system, Part, Private Securities Litigation Reform Act, Patent, General Administration of Sport of China, Merck, Toxicology, Merck & Co., Biotechnology, Safety, Immunotherapy, Pharming, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MSS, CD8, Therapeutic index, Index (publishing), Therapy, Cell, COVID-19, FC, TME, Cytokine, RCC, PK, Goal, Melanoma, Ipilimumab, FDA, NK, PD, IND, 1B, Twitter, GPS, LinkedIn, Colorectal cancer, Administration, Adult, Pharmaceutical industry, Cryptocurrency, Generic drug

XTX202, a tumor-selective, engineered IL-2, is being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors.

Key Points: 
  • XTX202, a tumor-selective, engineered IL-2, is being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors.
  • Xilio anticipates the data for Part 1A will include available safety and anti-tumor activity, as well as peripheral PK and PD data.
  • Xilio anticipates the data for Part 1B will include available safety and anti-tumor activity, as well as intra-tumoral PK and PD data.
  • Net Loss: Net loss was $24.6 million for the second quarter of 2022, compared to $23.2 million for the second quarter of 2021.