Biological activity

SAB Biotherapeutics Announces Commencement of the HUMAN Phase 1 Clinical Trial with SAB-142, a Potential Disease-Modifying Treatment for Type 1 Diabetes

Retrieved on: 
Wednesday, November 29, 2023

SIOUX FALLS, S.D., Nov. 29, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing fully-human anti-thymocyte immunoglobulin (hIgG) for disease-modification of Type 1 Diabetes (T1D) through delaying the onset and/or progression of the disease, today announced that the first participants of a HUMAN trial (Fully HUman anti-thymocyte biologic in first-in-MAN clinical study) have been dosed in Australia. This Phase 1 randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous SAB-142 in healthy volunteers and participants with T1D. SAB-142 is a first-in-class fully-human anti-thymocyte immunoglobulin being developed as a disease-modifying treatment to delay the onset and progression of T1D.

Key Points: 
  • SAB-142 is a first-in-class fully-human anti-thymocyte immunoglobulin being developed as a disease-modifying treatment to delay the onset and progression of T1D.
  • In October 2023 , SAB received approval by the Australian Human Research Ethics Committee (HREC) to commence the Phase 1 clinical trial investigating safety, tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of SAB-142.
  • More information about the Phase 1 clinical trial with SAB-142 (ACTRN:12623001089628) can be found here .
  • “We are grateful to partner with SAB on this Phase 1 investigation that will explore the therapeutic potential of a new, potentially best-in-class immunotherapeutic option for patients.”

South Rampart Pharma to Participate in Upcoming Investor Events

Retrieved on: 
Tuesday, October 10, 2023

NEW ORLEANS, Oct. 10, 2023 /PRNewswire/ -- South Rampart Pharma, Inc. ("South Rampart" or the "Company"), a clinical-stage life science company developing SRP-001, a first-in-class non-opioid candidate for the treatment of chronic and acute pain, today announced the Company's executive team will be participating in the upcoming investor events throughout October 2023:

Key Points: 
  • South Rampart's Co-founder and CEO, Dr. Hernan Bazan, will present a Corporate Overview followed by a questions and answers session.
  • Dr. Bazan's presentation will discuss SRP-001's unique mechanisms of action as well as Phase 1 clinical trial data.
  • In addition to the Corporate Overview, Dr. Bazan will be featured as a speaker on a panel exploring best practices for translation and commercialization of innovation spun out from academia.
  • 17th Annual Pain Therapeutics Summit (San Diego, CA):
    Title: "Transcriptomic Signature, Bioactivity and Safety of a Non-hepatoxic Novel Non-opioid Analgesic: From Discovery to the Clinic."

Sapience Therapeutics Announces Presentation of ST101 Clinical Data at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Retrieved on: 
Wednesday, September 20, 2023

ST101 is a first-in-class antagonist of C/EBPβ that has demonstrated clinical proof-of-concept in advanced solid tumors.

Key Points: 
  • ST101 is a first-in-class antagonist of C/EBPβ that has demonstrated clinical proof-of-concept in advanced solid tumors.
  • ST101 is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors ( NCT04478279 ).
  • The poster to be presented will summarize clinical data from ST101's recurrent Glioblastoma (rGBM) Phase 2 expansion cohort of 30 patients.
  • Title: "Clinical and Biological Activity of ST101, a Peptide Antagonist of C/EBPβ, in Recurrent Glioblastoma (rGBM) Patients.

RAPT Therapeutics Announces FLX475 Poster Presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
Wednesday, April 26, 2023

SOUTH SAN FRANCISCO, Calif., April 26, 2023 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today announced it will present a poster on FLX475, its lead oncology drug candidate, at the 2023 American Society of Clinical Oncology (ASCO) annual meeting taking place June 2-6, 2023 at the McCormick Place Convention Center in Chicago, IL.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., April 26, 2023 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today announced it will present a poster on FLX475, its lead oncology drug candidate, at the 2023 American Society of Clinical Oncology (ASCO) annual meeting taking place June 2-6, 2023 at the McCormick Place Convention Center in Chicago, IL.
  • Clinical and Biological Activity of FLX475, an Oral CCR4 Antagonist, in Advanced Cancer

Cassava Sciences Reports Full-year 2022 Financial Results and Operating Updates

Retrieved on: 
Tuesday, February 28, 2023

AUSTIN, Texas, Feb. 28, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced financial results for the year ended December 31, 2022, and provided operating updates.

Key Points: 
  • AUSTIN, Texas, Feb. 28, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced financial results for the year ended December 31, 2022, and provided operating updates.
  • Simufilam is Cassava Sciences’ oral drug candidate for the proposed treatment of Alzheimer’s disease dementia.
  • “Setting aside headwinds, 2022 was highlighted by positive developments with patient enrollment in our Phase 3 clinical studies of simufilam in Alzheimer’s disease”, said Remi Barbier, President & CEO.
  • Cassava Sciences is currently evaluating simufilam tablets for Alzheimer’s disease dementia in two Phase 3 clinical studies.

Hot Topics in Neonatology® 2022 Conference Will Include Symposium on Benefits of Vat Pasteurization for Human Donor Milk

Retrieved on: 
Monday, December 5, 2022

DUARTE, Calif., Dec. 5, 2022 /PRNewswire/ -- Prolacta Bioscience®, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, announced today that Dr. David Dallas, PhD, of Oregon State University will present published data on the effects of various manufacturing methods on bioactive proteins in donor human milk at the Hot Topics in Neonatology® 2022 conference in National Harbor, Maryland, on Tuesday, Dec. 6, at 12:15 p.m.

Key Points: 
  • Sponsored by Nemours Children's Health, Hot Topics in Neonatology has been the premiere neonatal conference for more than 30 years, drawing more than 1,000 neonatologists and perinatologists from around the world.
  • The major difference between cow milk-based and human milk-based nutritional products is the composition notably, the bioactive components that are unique to human milk.
  • Prolacta maintains the industry's strictest quality and safety standards for screening, testing, and processing donor human milk.
  • Operating the world's first pharmaceutical-grade human milk processing facilities, Prolacta uses vat pasteurization and a patented, FDA-reviewed manufacturing process to ensure pathogen inactivation while protecting the nutritional composition and bioactivity of its human milk-based products.

Prolacta Clinical Advisory Board Members Present Webinar on Improved Growth Metrics for Preterm Infants Fed an Exclusive Human Milk Diet

Retrieved on: 
Thursday, December 1, 2022

DUARTE, Calif., Dec. 1, 2022 /PRNewswire/ -- Prolacta Bioscience®, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, announced today that two members of the Prolacta Clinical Advisory Board (PCAB) will present a webinar for clinicians who care for preterm infants titled "Improved Growth Metrics for Preterm Infants Supported With a Human Milk Diet" on Thursday, Dec. 1, at 9 a.m. PT.

Key Points: 
  • Stacia Pegram, MA, RDN, LD, and Patti Perks, MS, RDN, CNSC, will present "Improved Growth Metrics for Preterm Infants Supported With a Human Milk Diet" on Dec. 1
    DUARTE, Calif., Dec. 1, 2022 /PRNewswire/ -- Prolacta Bioscience , the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, announced today that two members of the Prolacta Clinical Advisory Board (PCAB) will present a webinar for clinicians who care for preterm infants titled "Improved Growth Metrics for Preterm Infants Supported With a Human Milk Diet" on Thursday, Dec. 1, at 9 a.m. PT.
  • Perks and Pegram are members of the Prolacta Clinical Advisory Board (PCAB), a group of neonatologists, neonatal nursing leaders, and neonatal dietitians with broadly recognized clinical expertise.
  • Prolacta's 100% human milk-based nutritional products have been evaluated in more than 20 clinical studies published in peer-reviewed journals.
  • Prolacta maintains the industry's strictest quality and safety standards for screening, testing, and processing donor human milk.

OcuTerra Reports Publication of OTT166 Safety and Biological Activity Data from Phase 1b Study in Diabetic Eye Disease

Retrieved on: 
Wednesday, October 19, 2022

The data show that OTT166 eyedrops were well-tolerated and demonstrated biological activity, warranting further evaluation for the treatment of diabetic eye disease.

Key Points: 
  • The data show that OTT166 eyedrops were well-tolerated and demonstrated biological activity, warranting further evaluation for the treatment of diabetic eye disease.
  • Based on these findings, the Phase 2 DR:EAM study is underway to evaluate safety and efficacy of OTT166 in diabetic retinopathy.
  • In early clinical trials in patients with diabetic retinal disease, OTT166 eye drops have demonstrated preliminary evidence of tolerability and biological activity.
  • The Phase 1b DR/DME clinical trial (NCT02914613) was a prospective, randomized, double-masked, first-in-human study of OTT166 (formerly designated SF0166) eye drops in patients with DR/DME, i.e.

Lumos Pharma Announces a Clinical Collaboration with Massachusetts General Hospital (MGH) to Evaluate Oral LUM-201 in Nonalcoholic Fatty Liver Disease (NAFLD) in a Phase 2 Investigator-Initiated Trial

Retrieved on: 
Thursday, May 5, 2022

Lumos Pharma is honored to partner with Dr. Dichtel and Massachusetts General Hospital to evaluate LUM-201 in NAFLD, commented Rick Hawkins, CEO and Chairman of Lumos Pharma.

Key Points: 
  • Lumos Pharma is honored to partner with Dr. Dichtel and Massachusetts General Hospital to evaluate LUM-201 in NAFLD, commented Rick Hawkins, CEO and Chairman of Lumos Pharma.
  • Nonalcoholic fatty liver disease is estimated to be prevalent in approximately 25% of adults worldwide.
  • This investigator-initiated Phase 2 trial is a single-site, 6-month, open-label pilot study of daily oral LUM-201 in adults with NAFLD.
  • The trial will evaluate a dose of 25 mg/day of LUM-201 in 10 men and women with NAFLD.

Axcella Therapeutics Reports Third Quarter Financial Results and Provides Update on Long COVID, OHE and NASH Clinical Trials

Retrieved on: 
Wednesday, November 10, 2021

The third quarter of 2021 was a time in which Axcella focused heavily on both execution and expansion, said Bill Hinshaw, President and Chief Executive Officer of Axcella.

Key Points: 
  • The third quarter of 2021 was a time in which Axcella focused heavily on both execution and expansion, said Bill Hinshaw, President and Chief Executive Officer of Axcella.
  • Progressed Screening and Enrollment in EMMPOWER and EMMPACT Clinical Trials: Patient screening and enrollment continues in Axcellas recently initiated EMMPOWER Phase 2 clinical trial in overt hepatic encephalopathy (OHE) and EMMPACT Phase 2b clinical trial in nonalcoholic steatohepatitis (NASH).
  • Published AXA1125 Data in The American Journal of Gastroenterology: The American Journal of Gastroenterology recently published results from Axcellas AXA1125-003 clinical study.
  • The companys unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials.