Serum

GeminiBio's Aseptic Assurance System™ Supports Closed System Manufacturing for Cell Therapies

Retrieved on: 
Thursday, March 14, 2024
Risk, AB, Workflow, NK, Serum, Vaccine

where there are extensive downstream purification steps after the initial cell culture process, cell therapy manufacturing has limited purification prior to patient administration.

Key Points: 
  • where there are extensive downstream purification steps after the initial cell culture process, cell therapy manufacturing has limited purification prior to patient administration.
  • To address the risk of contamination in the cell therapy manufacturing process, global regulatory bodies have encouraged the industry to adopt closed system manufacturing technologies that reduce or eliminate open processes.
  • To support closed system processing by cell therapy manufacturers using human AB serum as a cell culture supplement, GeminiBio is introducing Aseptic Assurance System™ packaging for all clinical grade human AB serum products.
  • It is very gratifying to help our customers transition to a closed system and simultaneously streamline their workflow."

EQS-News: Immunic Presents Data From Phase 2 CALLIPER and CALVID-1 Trials of Vidofludimus Calcium at the ACTRIMS Forum 2024

Retrieved on: 
Wednesday, March 13, 2024
Cleveland Clinic, Research, Biotechnology, MD, Quality of life, Treatment, Hope, Multiple sclerosis, COVID-19, EBV, AFL, Fatigue, COVID, PMS, Patient, Clinical trial, Serum, Pharmaceutical industry

“Having two poster presentations on our lead asset, vidofludimus calcium, at the prestigious ACTRIMS Forum is a testament to the strength of the data we have generated,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic.

Key Points: 
  • “Having two poster presentations on our lead asset, vidofludimus calcium, at the prestigious ACTRIMS Forum is a testament to the strength of the data we have generated,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic.
  • We believe that the data set provides biomarker evidence that vidofludimus calcium’s activity extends beyond the previously observed anti-inflammatory effects, further reinforcing its neuroprotective potential.
  • Recent third-party data in post COVID patients identified EBV reactivation as a potential cause for fatigue in this patient group.
  • Fox, MD, Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio

Press Release: New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis

Retrieved on: 
Monday, March 11, 2024
Eosinophil, Fever, Week, Headache, OX40L, Conjunctivitis, Scleroderma, Teaching hospital, Atopic dermatitis, Upper respiratory tract infection, Part, Asthma, TARC, Conference, AAD, Safety, Biomarker, Part Two, Hidradenitis suppurativa, IGA, Patient, Inflammation, Chills, Moa, Serum, American Academy, Pharmaceutical industry

The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.

Key Points: 
  • The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.
  • Overall rates of treatment-emergent adverse events (TEAEs) were 69.8% for continued amlitelimab treatment, 71.9% for the amlitelimab withdrawal-arm and 66.7% for placebo.
  • TEAEs more commonly observed included headache (11.6% amlitelimab continuation, 3.9% amlitelimab withdrawal, 6.7% placebo), upper respiratory tract infection (9.3% amlitelimab continuation, 5.5% amlitelimab withdrawal, 20% placebo).
  • Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Kymera Therapeutics Presents Preclinical Data for STAT6 and TYK2 First-In-Class, Oral Degrader Immunology Programs at the American Academy of Dermatology Annual Meeting

Retrieved on: 
Friday, March 8, 2024
Janus, Model, Spleen, STAT6, Doctor of Philosophy, Inflammation, Atopic dermatitis, Immunoglobulin E, Resource, JAK, Therapy, Inflammatory bowel disease, Protein, TYK2, TPD, Stem cell, Biology, Serum, Phase 1, American Academy, Pharmaceutical industry

WATERTOWN, Mass., March 08, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced that its preclinical data demonstrating the therapeutic potential of its potent and selective heterobifunctional degraders of STAT6 (KT-621) and TYK2 (KT-294) are being presented in the poster session at the American Academy of Dermatology’s Annual Meeting in San Diego, California. Kymera’s oral STAT6 and TYK2 degraders have the potential to address multiple immune-mediated diseases and overcome the limitations of existing technologies and agents. Today’s poster presentations mark the first time that data from a STAT6 targeted agent and a TYK2 degrader have been shared at a major medical meeting. Based on the results generated to date, Kymera intends to initiate Phase 1 testing for KT-621 and KT-294 in the in the second half of 2024 and the first half of 2025, respectively. Data from both Phase 1 trials are expected to be reported in 2025.

Key Points: 
  • Kymera’s oral STAT6 and TYK2 degraders have the potential to address multiple immune-mediated diseases and overcome the limitations of existing technologies and agents.
  • Today’s poster presentations mark the first time that data from a STAT6 targeted agent and a TYK2 degrader have been shared at a major medical meeting.
  • “Our differentiated strategy to targeted protein degradation has resulted in an industry-leading immunology pipeline of oral degrader medicines, each with the potential to treat multiple complex immuno-inflammatory diseases.
  • At low daily oral doses, preclinical studies with KT-621 demonstrated near full in vivo STAT6 degradation in disease-relevant tissues that was well-tolerated.

Wave Life Sciences Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, March 6, 2024
Therapy, Facial muscles, Pharmacology, Central nervous system, Research, GSK, MD, Liver disease, Dystrophin, Obesity, Cerebrospinal fluid, N-Acetylgalactosamine, HD, Weight loss, DMD, Duchenne muscular dystrophy, Lof, Exercise, Lipolysis, Exon, MBA, Conference, Wave, Activin and inhibin, AATD, Health, Safety, Biomarker, RNA, Greenshoe, Genetics, Pharmacokinetics, Webcast, Patient, Clinical trial, HTT, Q&A, Small RNA, Serum, Episcopal conference, Human, Coronary artery disease, Pharmaceutical industry

In the fourth quarter of 2023, Wave initiated dosing in RestorAATion-1, which resulted in a $20 million milestone payment from GSK.

Key Points: 
  • In the fourth quarter of 2023, Wave initiated dosing in RestorAATion-1, which resulted in a $20 million milestone payment from GSK.
  • Revenue was $29.1 million for the fourth quarter of 2023 as compared to $1.2 million in the prior year quarter.
  • Net loss was $16.3 million for the fourth quarter of 2023 as compared to $43.7 million in the prior year quarter.
  • ET to review the fourth quarter and full year 2023 financial results and pipeline updates.

Apogee Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases, Exceeding its Trial Objectives Ahead of Sc

Retrieved on: 
Tuesday, March 5, 2024
Paragon, Well, SAD, PD, Injection, I&I, Waldman, Headache, Inflammation, Quality of life, Management, Atopic dermatitis, Asthma, TARC, AUC, Volunteering, Cmax, Chronic obstructive pulmonary disease, Outline of health sciences, Safety, Biomarker, Therapy, CQD, Chronic pain, Immunology, IGA, Webcast, Sleep, Patient, MPH, Half-life, Serum, Pharmaceutical industry

Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.

Key Points: 
  • Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.
  • At Apogee, we refuse to stop at good enough and are dedicated to advancing innovative solutions for patients.
  • The Phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled study designed to evaluate safety and PK of APG777 in healthy volunteers.
  • A live webcast of the call will be available on the Investor Relations page of Apogee’s website at https://investors.apogeetherapeutics.com/news-events/events .

GRI Bio Receives MHRA Authorization to Conduct Phase 2a Biomarker Study Evaluating GRI-0621 in the United Kingdom

Retrieved on: 
Monday, March 4, 2024
Oxygen, IPF, Idiopathic disease, Serum, Doctor of Philosophy, Blood, Homeostasis, Idiopathic pulmonary fibrosis, Inflammation, Vital signs, Safety, Health care, BAL, Biomarker, Pharmacokinetics, Patient, NKT, Natural killer T cell, Bronchoalveolar lavage, NIHR, Movement, GRI, CTA, Immune system, Pharmaceutical industry

LA JOLLA, CA, March 04, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the authorization of its Clinical Trial Application (CTA) by the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF in the UK.

Key Points: 
  • The MHRA is the UK regulatory authority, a government agency, for medicines and medical devices.
  • The MHRA is responsible for the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents.
  • “We are pleased to receive authorization from the MHRA and take a step in the global expansion of our clinical development for GRI-0621.
  • We are focused on driving this program forward and generating important data readouts this year,” Marc Hertz, PhD, Chief Executive Officer of GRI Bio.

COSRX Returns to TikTok with the #PatThePeptide Campaign, Highlighting the Accessibility of Peptide Skincare

Retrieved on: 
Thursday, March 7, 2024
Cream, Collection, Absorption, Skin, Hyperpigmentation, Peptide, Vitamin C, Vitamin, Serum, Vaccine

The #PatThePeptide campaign aims to showcase and emphasize how COSRX's popular product, The 6 Peptide Skin Booster Serum , has made skincare more accessible than ever.

Key Points: 
  • The #PatThePeptide campaign aims to showcase and emphasize how COSRX's popular product, The 6 Peptide Skin Booster Serum , has made skincare more accessible than ever.
  • Easy Derm Skincare: The serum seamlessly integrates into all skincare routines, offering comfort and ease of use without fear of irritation.
  • Skincare for All: COSRX products are clinically verified, hypoallergenic, and suitable for all skin types, including sensitive skin.
  • Additionally, the top 90 winners will receive The 6 Peptide Skin Booster Serum and a randomly selected COSRX product from COSRX's collection.

REGENXBIO ANNOUNCES NEW POSITIVE INITIAL EFFICACY DATA FROM AFFINITY DUCHENNE® TRIAL

Retrieved on: 
Tuesday, March 5, 2024
Jess, CK, Hospital, Duchenne muscular dystrophy, Arkansas Children's Hospital, Safety, Human, Immunosuppression, Patient, Phase, Ageing, Serum, Pharmaceutical industry

ROCKVILLE, Md., March 5, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today reported additional interim safety and efficacy data in the Phase I/II AFFINITY DUCHENNE® trial of RGX-202 in patients with Duchenne muscular dystrophy (Duchenne) ages 4 to11 years old, including RGX-202 microdystrophin expression from dose level 2 and video of trial clinic assessments demonstrating initial evidence of strength and functional improvement.

Key Points: 
  • ROCKVILLE, Md., March 5, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today reported additional interim safety and efficacy data in the Phase I/II AFFINITY DUCHENNE® trial of RGX-202 in patients with Duchenne muscular dystrophy (Duchenne) ages 4 to11 years old, including RGX-202 microdystrophin expression from dose level 2 and video of trial clinic assessments demonstrating initial evidence of strength and functional improvement.
  • "RGX-202 at dose level 2 is demonstrating significantly increased microdystrophin expression in a 12-year-old patient," said Kenneth T. Mills, President and CEO, REGENXBIO.
  • In addition, we are encouraged by the safety data at both dose levels and initial caregiver observations of strength and motor function improvement in boys treated with RGX-202.
  • "I am very pleased with the new microdystrophin expression data from RGX-202 dose level 2.

BRAINBox Solutions to Present Updated Data at Three Leading Conferences from HeadSMART II and NIH-funded Geriatrics Clinical Trials of BRAINBox TBI Concussion Test

Retrieved on: 
Monday, March 4, 2024
Doctor of Philosophy, Concussion, Emergency, TBI, Poster, Diagnosis, Bangladesh Technical Education Board, School, Alzheimer's disease, Algorithm, Geriatrics, NIH, Emergency medicine, FESC, FACC, Brainbox, Trauma, FACEP, Traumatic brain injury, ATE, Conference, Prognosis, Biomarker, Clinical trial, Serum, Medical school, Blood, Risk, Patient, Baylor College of Medicine, Update, Parkinson's disease, Medical device

RICHMOND, Va., March 4, 2024 /PRNewswire/ -- BRAINBox Solutions today announced current and upcoming presentations of clinical trends and data at three leading, upcoming medical conferences from the HeadSMART II pivotal trial in adult patients and the National Institutes of Health (NIH) funded clinical trial in geriatric patients of its BRAINBox TBI™ concussion diagnostic and prognostic test.  Concussion is also known as ATE (Acute Traumatic Encephalopathy) or mTBI (mild traumatic brain injury).

Key Points: 
  • The presentation title is, "Biomarker Profiles Distinguish Geriatric Acute TBI from Dementias:  Results from the HeadSMARTII Geriatric Feasibility Study.
  • "  The poster title is: "Biomarker Profiles Distinguish Geriatric TBI from Dementias:  Results From the HeadSMART Geriatric Feasibility Study."
  • "These presentations highlight the breadth of clinical data being assembled to evaluate the diagnostic and prognostic potential of the BRAINBox TBI test across a spectrum of age groups.
  • "These two trials have made substantial progress, as enrollment in both is expanding and, in the case of HeadSMART II, almost completed," said Donna Edmonds, BRAINBox Solutions' CEO.