Pharmacokinetics

Prestige Biopharma Receives FDA Fast Track Designation for PBP1510 in the Treatment of Pancreatic Cancer

Retrieved on: 
Tuesday, March 21, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, PDAC, Pancreatic cancer, International, Pharmacokinetics, Fast Track, Toxicity, Patient, Growth, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cancer, Food, Safety, Pharmaceutical industry

PBP1510 targets Pancreatic Adenocarcinoma Upregulated Factor (PAUF), a tumour-specific protein, found to be overexpressed in majority of pancreatic cancer cases.

Key Points: 
  • PBP1510 targets Pancreatic Adenocarcinoma Upregulated Factor (PAUF), a tumour-specific protein, found to be overexpressed in majority of pancreatic cancer cases.
  • PBP1510 is designed to target these key biological mechanisms that results in limited effectiveness of current treatment options and rapid progression of pancreatic cancer.
  • With Fast Track designation from the FDA, PBP1510 represents a promising advancement in the treatment of pancreatic cancer.
  • Prestige Biopharma intends to take full advantage of the benefits offered by the designation to provide faster access for patients in need.

Alpine Immune Sciences to Present Povetacicept (ALPN-303) Phase 1 (RUBY-1) Study Data and Clinical Pharmacokinetic & Pharmacodynamic Modeling at Upcoming Scientific Conferences

Retrieved on: 
Monday, March 20, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, WCN, Congress, Autoimmunity, Simulation, ALPN, Society, Treatment, International Society, Inflammation, Pharmaceutical industry, Safety, Nephrology, Pharmacokinetics

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, will present posters at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting and at the International Society of Nephrology World Congress of Nephrology (WCN).

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, will present posters at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting and at the International Society of Nephrology World Congress of Nephrology (WCN).
  • Poster Title: Early Clinical PK/PD Modeling and Simulation of Povetacicept, a Potent Dual BAFF/APRIL Antagonist, to Support Clinical Trials in Multiple Autoantibody-and/or B Cell-Related Diseases
    Poster Title: Phase 1 Study in Healthy Adults of the Safety, Tolerability, Pharmacokinetics, & Pharmacodynamics of Povetacicept (ALPN-303), a Dual BAFF/APRIL Antagonist for the Treatment of Autoimmune Glomerulonephritides

Phanes Therapeutics Announces First Patient Dosed in Phase 1 Study of PT886 for Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinomas

Retrieved on: 
Monday, March 20, 2023
Bispecific monoclonal antibody, Pancreatic cancer, CD47, Macrophage, ADCC, ODD, Monoclonal antibody, RECIST, Pharmacokinetics, NK, Trial of the century, APC, Patient, ECOG, SAN, Cancer, ADCP, Neoplasm, Ageing, FDA, Therapy, Safety, Pharmaceutical industry

PT886 was assembled using Phanes' proprietary bispecific antibody platforms PACbody™ and SPECpair™ and was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA last year.

Key Points: 
  • PT886 was assembled using Phanes' proprietary bispecific antibody platforms PACbody™ and SPECpair™ and was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA last year.
  • The anti-CD47 arm of PT886 is highly differentiated and has demonstrated minimum binding to human red blood cells while maintains strong binding activity to CD47 on tumor cells.
  • "PT886 targets a validated tumor associated antigen in claudin 18.2 with enhanced anti-tumor activity and broadened tumor killing spectrum through a best-in-class anti-CD47 arm.
  • It is a product of Phanes' ingenious innovation in creative design of both novel therapeutic approaches and practical technologies," said Dr. Ming Wang, Founder and CEO of Phanes Therapeutics.

RayzeBio Completes Phase 1b Enrollment in ACTION-1 Study, Evaluating RYZ101 (Actinium-225 DOTATATE) in Neuroendocrine Tumors

Retrieved on: 
Monday, March 20, 2023
Oncology, Health, Clinical Trials, Radiology, Pharmaceutical, Biotechnology, Pharmacokinetics, Patient, Safety, Pharmaceutical industry

RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today announced the completion of enrollment in the Phase 1b portion of the ACTION-1 Phase 1b/3 trial of RYZ101 in patients with SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who have progressed on Lutetium-177 labelled somatostatin analogue therapy.

Key Points: 
  • RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today announced the completion of enrollment in the Phase 1b portion of the ACTION-1 Phase 1b/3 trial of RYZ101 in patients with SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who have progressed on Lutetium-177 labelled somatostatin analogue therapy.
  • A total of 17 patients were enrolled in a unique dose de-escalation trial.
  • The purpose of the Phase 1b clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of RYZ101.
  • The interest and enthusiasm is evident based on the over enrollment in Phase 1b.

AAD 2023: Late-Breaking Phase III Results Demonstrate nemolizumab’s Significant Impact on Prurigo Nodularis

Retrieved on: 
Saturday, March 18, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Other Health, Pharmacokinetics, American Academy, Associate, Prurigo, Skin, Patient, AAD, Itch, American Academy of Dermatology, Prurigo nodularis, Nemolizumab, III, Safety, Johns Hopkins School of Medicine, Pharmaceutical industry, Dermatology

Galderma has an extensive presence at the meeting with further updates from its broad portfolio across Therapeutic Dermatology, Dermatological Skincare and Injectable Aesthetics.

Key Points: 
  • Galderma has an extensive presence at the meeting with further updates from its broad portfolio across Therapeutic Dermatology, Dermatological Skincare and Injectable Aesthetics.
  • The phase III OLYMPIA 2 trial met all primary endpoints, showing nemolizumab monotherapy significantly improved pruritus (itch) and skin lesions compared with placebo in adult patients with moderate to severe prurigo nodularis.
  • “We are so pleased that we’re able to bring so much powerful new data to this year’s AAD congress.
  • Its continued commitment to delivering science and innovation across a highly differentiated portfolio is reflected in its extensive presence at AAD.

Samsung Bioepis Presents Phase 1 Study Results of SB17 (Ustekinumab), A Proposed Biosimilar to Stelara, at 2023 AAD Annual Meeting

Retrieved on: 
Friday, March 17, 2023
SB5, PK, EU, Etanercept, Cis, SB2, Adalimumab, Pharmacokinetics, American Academy, Trial of the century, Infliximab, AAD, American Academy of Dermatology, Biosimilar, Ustekinumab, Interval (mathematics), Safety, Generic drug, Cmax

These results will be presented at the 2023 American Academy of Dermatology (AAD) Annual Meeting held in New Orleans, Louisiana, from March 17 to 21, 2023.

Key Points: 
  • These results will be presented at the 2023 American Academy of Dermatology (AAD) Annual Meeting held in New Orleans, Louisiana, from March 17 to 21, 2023.
  • In this Phase 1, randomized, double-blind, single-dose comparative pharmacokinetic study, a total of 201 subjects were randomized 1:1:1 to receive a single dose 45 mg of either SB17, EU-sourced reference ustekinumab, or US-sourced reference ustekinumab via subcutaneous injection.
  • The primary objective of this study was to demonstrate PK similarity by assessing area under the concentration-time curve from time zero to infinity (AUCinf) and maximum serum concentration (Cmax).
  • The secondary objectives were to investigate and compare the safety, tolerability, and immunogenicity between three treatment groups.

Alvotech to Present Clinical Study Data for AVT04, a Proposed Biosimilar to Stelara®, at 2023 American Academy of Dermatology (AAD) Annual Meeting

Retrieved on: 
Friday, March 17, 2023
Volunteering, Biologics license application, EU, Ustekinumab, Pharmacokinetics, American Academy, Marketing, EMA, Patient, AAD, Trial of the century, MAA, European Medicines Agency, FDA, BLA, Food, Safety, Generic drug

Alvotech’s poster, titled “Assessment of Bioequivalence Between Candidate Biosimilar AVT04 and Reference Ustekinumab,” details a pharmacokinetic (PK) study, AVT04-GL-101 , conducted with healthy adult volunteers.

Key Points: 
  • Alvotech’s poster, titled “Assessment of Bioequivalence Between Candidate Biosimilar AVT04 and Reference Ustekinumab,” details a pharmacokinetic (PK) study, AVT04-GL-101 , conducted with healthy adult volunteers.
  • The second poster, titled “Assessment of Therapeutic Equivalence Between Candidate Biosimilar ATV04 and Reference Ustekinumab,” details a confirmatory clinical study, AVT04-GL-301 .
  • The posters will be available to view on the conference platform during the conference starting on March 17, 2023.
  • Further information about the 2023 AAD Annual Meeting can be found here .

Alpine Immune Sciences to Present Povetacicept (ALPN-303) Phase 1 (RUBY-1) Study Data at the 2023 American Academy of Dermatology Annual Meeting

Retrieved on: 
Thursday, March 16, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, American Academy of Dermatology, American Academy, Doctor of Philosophy, Development, MD, AAD, ALPN, HV, Treatment, Autoimmunity, Inflammation, Vaccine, Safety, Pharmacokinetics, Research

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, will present an ePoster with an oral presentation at the American Academy of Dermatology (AAD) Annual Meeting, highlighting clinical data from RUBY-1, a phase 1 healthy volunteer (HV) study of povetacicept, a dual B cell cytokine antagonist being developed for multiple B cell and/or autoantibody-related diseases.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, will present an ePoster with an oral presentation at the American Academy of Dermatology (AAD) Annual Meeting, highlighting clinical data from RUBY-1, a phase 1 healthy volunteer (HV) study of povetacicept, a dual B cell cytokine antagonist being developed for multiple B cell and/or autoantibody-related diseases.
  • Poster Title: Phase 1 Study in Healthy Adults of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Povetacicept (ALPN-303), a Dual BAFF/APRIL Antagonist for the Treatment of Autoimmune Blistering Diseases (RUBY-1)
    Presenter: Stanford Peng, MD, PhD, President and Head of Research and Development, Alpine Immune Sciences

SELLAS Life Sciences Reports Full Year 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 16, 2023
MSD, Multiple myeloma, CDK9, Advanced Materials and Processes Research Institute, MPM, Clinical trial, Financial toxicity, Neoplasm, Acquisition, Lymphoma, Merck & Co., Venetoclax, Acute myeloid leukemia, GPS, Doctor of Science, WT1, NCI, Merck, MYC, Research, Mesothelioma, PD, CR2, MD, Medication, Biomarker, Patient, Protocol, Bristol Myers Squibb, Bone marrow, SLS, D, National Cancer Institute, Azacitidine, Merck Sharp & Dohme Federal Credit Union, Ovarian cancer, AML, Pharmacokinetics, IND, Nivolumab, Cryptocurrency, Pharmaceutical industry, Greater China

NEW YORK, March 16, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today reported financial results for the full year ended December 31, 2022 and provided a business update.

Key Points: 
  • This participation will trigger milestone payments totaling $13 million to SELLAS, which are expected during the first half of 2023.
  • Patient enrollment was completed at the end of 2022 and SELLAS expects to report topline data during the first half of 2023.
  • Opdivo® is a registered trademark of Bristol-Myers Squibb Company, New York, NY, USA and is not a trademark of SELLAS.
  • The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products.

Glenmark receives acceptance from U.S. FDA on its IND application for GRC 54276 to proceed with a Phase 1/2, first-in-human clinical study of the molecule for the treatment of patients with advanced solid tumors and lymphomas

Retrieved on: 
Thursday, March 16, 2023
GRC, MD, Regulation of tobacco by the U.S. Food and Drug Administration, Trial of the century, Lymphoma, Patient, HPK1, FDA, Safety, Immune system, Cancer, Food, Pharmacokinetics, IND, Pharmaceutical industry

GRC 54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark.

Key Points: 
  • GRC 54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark.
  • HPK1-regulated functions are involved in nearly every step of the cancer-immunity cycle making it an attractive target for immuno-oncology.
  • By inhibiting HPK1, GRC 54276 is designed to potentially enhance the patient's own immune system to fight cancers.
  • "Now that the FDA has accepted our IND application, we look forward to initiating the ongoing Phase 1/2 study at the US sites.