Histology

23andMe Therapeutics Announces Positive Preliminary Phase 2 Safety and Efficacy Results for 23ME-00610, targeting CD200R1, at the 2024 ASCO Annual Meeting

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måndag, juni 3, 2024
Nature, IHC, Aes, Asthma, Histology, ASCO, RECIST, Pharmacology, IO, Ovarian cancer, Fatigue, Patient, Dermatitis, AACR, Annual general meeting, Cancer, Genetics, Safety, Society, Ascites, Psoriasis, Therapy, PR, Genome, Risk, CD200, Death, Neoplasm, Itch, Signature, Nausea, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human genetics and biopharmaceutical company, announced positive preliminary Phase 2 safety and efficacy data from 23ME-00610, a first-in-class anti-CD200R1 antibody, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 31-June 4.

Key Points: 
  • 23andMe presented two posters on 23ME-00610, one each from neuroendocrine and ovarian cancer patient cohorts in its ongoing Phase 1/2a clinical trial.
  • 23ME-00610 monotherapy demonstrates acceptable safety and tolerability, and achieves the prespecified targets for maximal pharmacology at 1400 mg dosed every three weeks.
  • In addition to CD200, histology data suggest that immunosuppressed (“cold”) tumors may be more likely to exhibit disease control with 23ME-00610.
  • Patients received 1400 mg given IV every 3 weeks until disease progression, and CT/MRI scans were conducted every ~ 8 weeks.

Century Therapeutics Presents Interim Results from Phase 1 ELiPSE-1 Study at ASCO 2024 Annual Meeting

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måndag, juni 3, 2024
CRS, ASCO, Relapse, Patient, Cell, IPSC, NHL, Ink, Autoimmunity, Society, Graft-versus-host disease, Safety, Pharmacokinetics, CD19, Therapy, Phase 1, Science, DNA, DLT, Histology, Schedule, Doctor of Philosophy, Nucleic acid thermodynamics, NK, Lymphoid leukemia, AUC, CRR, Development, Inflammation, Vaccine

PHILADELPHIA, June 03, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced a poster presentation highlighting interim results from the ongoing Phase 1 ELiPSE-1 study evaluating CNTY-101 in relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) at the American Society of Clinical Oncology (ASCO) Annual Meeting being held May 31 – June 4, 2024 in Chicago, Illinois.

Key Points: 
  • ELiPSE-1 ( NCT05336409 ) is an ongoing Phase 1, multicenter, open-label clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CNTY-101 in patients with R/R, CD19-positive B-cell malignancies.
  • Further, the majority of these cycles have been administered in the outpatient setting, providing additional support for CNTY-101 as a new paradigm for allogeneic cell therapies.
  • In these low dose levels, CNTY-101 demonstrated encouraging early response signals, including two complete responses (CRs) and one partial response (PR).
  • The full poster will be available on the Scientific Resources page of Century’s website at the start of the poster presentation.

Mythic Therapeutics Presents Initial Dose Escalation Data from Ongoing Phase 1 KisMET-01 Study on MYTX-011 at the American Society of Clinical Oncology (ASCO) Annual Meeting

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måndag, juni 3, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Aes, Histology, Therapy, ASCO, Cancer, MMAE, Patient, Mythic, Annual general meeting, NSCLC, Safety, Society, Pharmacokinetics, ADC, Incidence, Research, Lung cancer, DAR 2, Part, Sarah Cannon Research Institute, Pharmaceutical industry

KisMET-01 ( NCT05652868 ) is a multicenter, first-in-human study of MYTX-011 in patients with previously treated, locally advanced or metastatic NSCLC.

Key Points: 
  • KisMET-01 ( NCT05652868 ) is a multicenter, first-in-human study of MYTX-011 in patients with previously treated, locally advanced or metastatic NSCLC.
  • The primary objectives of Part 1 are to assess safety and tolerability and determine the recommended phase 2 dose.
  • As of April 30, 2024, 42 patients had been enrolled and received at least one dose of MYTX-011.
  • We look forward to seeing additional safety and efficacy data from the Phase 1 study.”

Genialis and Pancreatic Cancer Action Network (PanCAN) Partner to Progress KRAS Diagnostics

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fredag, maj 31, 2024
Software, Research, General Health, Oncology, Data Management, Technology, Artificial Intelligence, Genetics, Clinical Trials, Science, Other Science, Health, Partnership, RAS, Patient, Progression-free survival, DNA, AACR, Doctor of Philosophy, Disease, Artificial intelligence, Histology, Cancer, Pancreatic cancer, AUROC, MMSc, Pancreatic Cancer Action Network, Biomarker, ASCO, Poster, RNA, Society, Physician, Survival rate, Receiver, Medicine, Annual general meeting

Genialis , the RNA-biomarker company, today announced a new partnership with the Pancreatic Cancer Action Network (PanCAN) to expand the validation of the Genialis™ krasID biomarker in the pancreatic cancer histology.

Key Points: 
  • Genialis , the RNA-biomarker company, today announced a new partnership with the Pancreatic Cancer Action Network (PanCAN) to expand the validation of the Genialis™ krasID biomarker in the pancreatic cancer histology.
  • Overactivation of KRAS is implicated in up to 95 percent of pancreatic cancers, predominantly G12D, for which there are no approved drugs.
  • Genialis krasID is a biologically complex RNA-based biomarker panel predictive of response and benefit of KRAS inhibitor therapies and is designed to work across histologies.
  • “Pancreatic cancer is a tough disease with few treatment options, and currently the 5-year survival rate is 13 percent.

Kessler Topaz Meltzer & Check, LLP Reminds Investors of Deadline for Securities Fraud Class Action Lawsuit Filed Against Akero Therapeutics, Inc. (AKRO)

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lördag, juni 1, 2024
Class Action Lawsuit, Professional Services, Legal, Patient, Non-alcoholic fatty liver disease, News, HERE, FDA, Therapy, Sale, Drug development, Fatty liver disease, Histology, 8-K, NASH, Cirrhosis, LLP, EFX, Fibrosis, District court, Lead, Pharmaceutical industry

The action charges Akero with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company’s business, operations, and prospects.

Key Points: 
  • The action charges Akero with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company’s business, operations, and prospects.
  • As a result of Akero’s materially misleading statements and omissions to the public, Akero’s investors have suffered significant losses.
  • If you suffered Akero losses, you may CLICK HERE or go to: https://www.ktmc.com/new-cases/akero-therapeutics-inc?utm_source=PR&utm_...
    You can also contact attorney Jonathan Naji, Esq.
  • Kessler Topaz Meltzer & Check, LLP encourages Akero investors who have suffered significant losses to contact the firm directly to acquire more information.

EVOKE-01 Study Results in Metastatic NSCLC to Be Presented at an Oral Session at ASCO 2024

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fredag, maj 31, 2024
Oncology, Health, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, Merck & Co., Patient, Progression-free survival, Diarrhea, Doctor of Philosophy, Survival, Pembrolizumab, Neutropenia, Docetaxel, Lung cancer, PFS, Histology, Safety, NSCLC, ADC, MD, Gilead Sciences, Science, Death, Abstract, Neoplasm, Incidence, ASCO, Merck, Journal, Hospital, OS, Fatigue, Society, Aes, Standard of care, Annual general meeting, Pharmaceutical industry

Gilead Sciences, Inc. (Nasdaq: GILD) today announced detailed results from the Phase 3 EVOKE-01 study that will be presented during an oral session (Abstract #LBA8500) today (2:45-5:45pm CT) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced detailed results from the Phase 3 EVOKE-01 study that will be presented during an oral session (Abstract #LBA8500) today (2:45-5:45pm CT) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • The company previously announced that the study did not meet the primary endpoint of overall survival (OS) in previously treated metastatic non-small cell lung cancer (NSCLC).
  • “Treating patients with metastatic NSCLC who have progressed on available treatments continues to be a challenge.
  • Longer-term results from Cohort A of the Phase 2 EVOKE-02 study of Trodelvy in combination with KEYTRUDA® (pembrolizumab) in first-line metastatic PD-L1 ≥50% NSCLC will also be presented in a poster session (Abstract #8592) on June 3, 2024.

HistoWiz Expands Histology and Pathology Service Offerings to Include GLP

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torsdag, maj 30, 2024
Technology, Research, Health Technology, Software, Health, Data Management, Other Science, Science, Artificial Intelligence, Ziehl–Neelsen stain, IHC, H&E, Immunohistochemistry, Good laboratory practice, Marie Cassidy, FDA, Cosmetics, Histology, Food, Chemical safety, GLP

HistoWiz , a leader in digital pathology services, announces the addition of GLP-compliant lab services including routine histology (H&E, trichrome, etc.)

Key Points: 
  • HistoWiz , a leader in digital pathology services, announces the addition of GLP-compliant lab services including routine histology (H&E, trichrome, etc.)
  • The addition of GLP leverages HistoWiz’s deep expertise in pre-clinical research pathology processes from wet tissue to slide digitization.
  • “The expansion into GLP reflects our commitment to provide the highest standards of reliability and accuracy and makes HistoWiz one of the most comprehensive contract research pathology service platforms in the industry,” explains Jerry Kuang, chief operating officer of HistoWiz.
  • For more information about HistoWiz’s GLP service, or to request an audit , contact HistoWiz directly at [email protected] .

Valar Labs Announces $22 Million Series A to Advance Vesta, First AI Diagnostic Test to Predict Treatment Response in Bladder Cancer, and Catalyze Expansion in Other Cancers

Retrieved on: 
torsdag, maj 30, 2024
Technology, Health Technology, Software, Other Health, Biotechnology, Health, Science, Oncology, Artificial Intelligence, Other Science, Uncertainty, Patient, Doctor of Philosophy, General partnership, American Urological Association, AUA, Bladder cancer, H&E, Neoplasm, Disease, Histology, Publication, AI, Cancer, Biomarker, Pear VC, Labs, Valar in Middle-earth, BCG, Abstract, CHAI, Physician, Annual general meeting

Valar Labs , the developer of computational histology AI (CHAI) tests for predicting response to cancer therapies, announced a $22 million Series A financing.

Key Points: 
  • Valar Labs , the developer of computational histology AI (CHAI) tests for predicting response to cancer therapies, announced a $22 million Series A financing.
  • The funding follows Valar Labs’ completion of a recent international, multi-institution validation study and subsequent launch of Vesta, the first AI-based diagnostic test to predict response to first line treatment in bladder cancer.
  • And bladder cancer is only the beginning; we can’t wait to see where they take the technology next.”
    Valar Labs was founded to reduce uncertainty in cancer treatment decisions.
  • “Valar Labs could transform how we approach cancer treatment decisions for a large number of patients today,” said Vineeta Agarwala, MD, PhD, general partner at a16z Bio + Health.

Unicycive Therapeutics Delivers Multiple Presentations on Oxylanthanum Carbonate (OLC) and UNI-494 at the European Renal Association Congress

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tisdag, maj 28, 2024
Patient, European Renal Association, Pharmacokinetics, ATP, SAD, AKI, Acute kidney injury, Kidney disease, LOS, Dialysis, Index, DGF, BID, Therapy, Histology, Safety, NGAL, Chronic kidney disease, MD, Congress, Animal, CKD, Rat, Incidence, Biomarker, Kidney, Nanotechnology, Poster, TID, Hyperphosphatemia, Aes, Sevelamer, ERA, Pharmaceutical industry

LOS ALTOS, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that several presentations were delivered on the Company’s two product candidates, oxylanthanum carbonate (OLC) and UNI-494, at the 61st European Renal Association (ERA) Congress. OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator initially targeting acute kidney injury (AKI).

Key Points: 
  • UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator initially targeting acute kidney injury (AKI).
  • This data compliments our previously reported data in the intravenous (IV) form of UNI-494.
  • The study concluded that UNI-494 is a potential candidate for prevention of delayed graft function (DGF) and other clinical conditions resulting from AKI.
  • Oxylanthanum Carbonate (OLC) Presentation Details:
    Results: This oral presentation evaluated the effects of tenapanor and OLC on phosphate excretion in rats.

Akero Therapeutics, Inc. (AKRO) Investors: June 25, 2024 Filing Deadline in Securities Class Action - Contact Kessler Topaz Meltzer & Check, LLP

Retrieved on: 
torsdag, maj 23, 2024
Patient, Non-alcoholic fatty liver disease, News, HERE, FDA, Therapy, Drug development, Sale, Fatty liver disease, Histology, 8-K, NASH, Cirrhosis, LLP, EFX, Fibrosis, District court, Lead, Pharmaceutical industry

The action charges Akero with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company’s business, operations, and prospects.

Key Points: 
  • The action charges Akero with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company’s business, operations, and prospects.
  • If you suffered Akero losses, you may CLICK HERE or go to: https://www.ktmc.com/new-cases/akero-therapeutics-inc?utm_source=PR&utm_...
    You can also contact attorney Jonathan Naji, Esq.
  • Kessler Topaz Meltzer & Check, LLP encourages Akero investors who have suffered significant losses to contact the firm directly to acquire more information.
  • The class action complaint against Akero, Klobus v. Akero Therapeutics, Inc., et al., Case No.