KU Leuven

AACR 2024: PDC*line Pharma Presents Interim Clinical Results From Last Cohort of Patients in Phase I/II Trial with PDC*lung01 Cancer Vaccine

Retrieved on: 
Monday, April 8, 2024

PDC*lung01 is the company’s off-the shelf therapeutic cancer vaccine candidate for Non-Small Cell Lung Cancer (NSCLC).

Key Points: 
  • PDC*lung01 is the company’s off-the shelf therapeutic cancer vaccine candidate for Non-Small Cell Lung Cancer (NSCLC).
  • The phase I/II trial (PDC-LUNG-101) aimed to assess the safety, tolerability, immunogenicity and preliminary clinical activity of PDC*lung01 in NSCLC patients, alone or in combination with anti-PD-1 treatment.
  • PDC*Line is reporting preliminary efficacy results for 19 evaluable patients in the B2 cohort that reached the 9-month PFS mark.
  • The final analysis of the clinical trial including the 45 patients from the B2 cohort will be conducted in Q3, 2024.

Aligos Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 12, 2024

SOUTH SAN FRANCISCO, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today reported recent business progress and financial results for the fourth quarter and full year 2023.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today reported recent business progress and financial results for the fourth quarter and full year 2023.
  • R&D expenses for the year ended December 31, 2023, were $73.0 million, compared with $85.1 million for the same period of 2022.
  • G&A expenses for the year ended December 31, 2023, were $30.6 million, compared with $26.4 million for the same period of 2022.
  • Total G&A stock-based compensation expense incurred for the year ended December 31, 2023 was $5.8 million, compared with $6.7 million for the same period of 2022.

BioInnovation Institute welcomes innovative smartRNA project to Bio Studio program

Retrieved on: 
Thursday, March 14, 2024

Thus, the aim of the smartRNA project in BII's Bio Studio program is to leverage this proprietary technology to develop treatments for currently untreatable disorders caused by haploinsufficiency or other monogenic diseases caused by reduced protein activity.

Key Points: 
  • Thus, the aim of the smartRNA project in BII's Bio Studio program is to leverage this proprietary technology to develop treatments for currently untreatable disorders caused by haploinsufficiency or other monogenic diseases caused by reduced protein activity.
  • During the 3-year BII Bio Studio program, the objective of smartRNA is to deliver an in vitro proof-of-concept, a pseudo in vivo proof-of-principle, and in vitro benchmarking against established technologies.
  • Anja Mølhart Høg, Entrepreneur-in-Residence heading up the smartRNA project, added: "We are excited to welcome the smartRNA project to BII's Bio Studio program.
  • The Bio Studio program is a recently established BII program with the ambition to build and run a leading life science company creation facility in Europe.

BioInnovation Institute welcomes innovative smartRNA project to Bio Studio program

Retrieved on: 
Thursday, March 14, 2024

Thus, the aim of the smartRNA project in BII's Bio Studio program is to leverage this proprietary technology to develop treatments for currently untreatable disorders caused by haploinsufficiency or other monogenic diseases caused by reduced protein activity.

Key Points: 
  • Thus, the aim of the smartRNA project in BII's Bio Studio program is to leverage this proprietary technology to develop treatments for currently untreatable disorders caused by haploinsufficiency or other monogenic diseases caused by reduced protein activity.
  • During the 3-year BII Bio Studio program, the objective of smartRNA is to deliver an in vitro proof-of-concept, a pseudo in vivo proof-of-principle, and in vitro benchmarking against established technologies.
  • Anja Mølhart Høg, Entrepreneur-in-Residence heading up the smartRNA project, added: "We are excited to welcome the smartRNA project to BII's Bio Studio program.
  • The Bio Studio program is a recently established BII program with the ambition to build and run a leading life science company creation facility in Europe.

European Commission Approves Pfizer’s VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis

Retrieved on: 
Monday, February 19, 2024

Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.
  • “For the 2.6 million people in Europe living with UC, the unpredictable physical, mental, and emotional impacts of the condition can be debilitating.
  • This authorization follows the recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2023.
  • Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of VELSIPITY.

PDC*line Pharma Completes Enrolment of Four Cohorts of Patients in PDC-LUNG-101 Phase I/II Clinical Trial

Retrieved on: 
Wednesday, December 6, 2023

The objectives of the phase I/II trial (PDC-LUNG-101) were to assess the safety, tolerability, immunogenicity and preliminary clinical activity of the drug candidate PDC*lung01, associated or not with anti-PD-1 treatment in NSCLC patients.

Key Points: 
  • The objectives of the phase I/II trial (PDC-LUNG-101) were to assess the safety, tolerability, immunogenicity and preliminary clinical activity of the drug candidate PDC*lung01, associated or not with anti-PD-1 treatment in NSCLC patients.
  • The trial was conducted at 17 clinical sites in France, Belgium, Germany, the Netherlands and Poland.
  • “We are pleased to have achieved full patient enrolment in the PDC-LUNG-101 clinical trial, a key step in the product’s clinical development and another important milestone for PDC*line Pharma.
  • “I would like to extend my gratitude to the investigators and patients across the five countries included in our clinical trial.

Landos Biopharma Provides Company Update and Reports Third Quarter 2023 Results

Retrieved on: 
Thursday, November 9, 2023

NEW YORK, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today provided a business update and announced financial results for the quarter ended September 30, 2023.

Key Points: 
  • NEW YORK, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today provided a business update and announced financial results for the quarter ended September 30, 2023.
  • NEXUS Phase 2 proof-of-concept clinical trial:
    The NEXUS trial of NX-13 remains on track as the Company continues to recruit, screen and randomize patients for the trial.
  • Research and development expenses were $3.1 million for the third quarter of 2023, compared to $4.9 million for the third quarter of 2022.
  • General and administrative expenses were $2.1 million for the third quarter of 2023, compared to $3.0 million for the third quarter of 2022.

Amprius Powered Top Four Solar Cars in Prestigious World Solar Challenge

Retrieved on: 
Monday, October 30, 2023

Amprius Technologies, Inc. (“Amprius” or the “Company”) (NYSE: AMPX), a leader in next-generation lithium-ion batteries with its Silicon Anode Platform, today announced its partner solar cars swept the top four places in the Bridgestone World Solar Challenge .

Key Points: 
  • Amprius Technologies, Inc. (“Amprius” or the “Company”) (NYSE: AMPX), a leader in next-generation lithium-ion batteries with its Silicon Anode Platform, today announced its partner solar cars swept the top four places in the Bridgestone World Solar Challenge .
  • View the full release here: https://www.businesswire.com/news/home/20231030953933/en/
    Amprius Powered Top 4 Solar Cars in Prestigious World Solar Challenge (Photo: Business Wire)
    Amprius-powered collegiate solar car teams crossed the finish line on Oct. 26, three days before the race was slated to conclude on Oct. 29 – taking the top four places, respectively:
    Innoptus Solar Team : built Infinite with a team of students from KU Leuven in Leuven, Belgium.
  • Brunel Solar Team : built Nuna 12 with a team of students from Delft University of Technology in Delft, Netherlands.
  • We’re extremely proud our Silicon Anode Batteries proved capable of increasing vehicle range on the world stage amid extreme environmental conditions.”

Loci Orthopaedics Announces Completion of Patient Enrollment for Its Clinical Feasibility Study of Its “InDx” Thumb Base Joint Replacement

Retrieved on: 
Tuesday, October 3, 2023

Loci Orthopaedics announced today that it has successfully completed enrolment of a 15-patient clinical feasibility study for its patented InDx Implant System.

Key Points: 
  • Loci Orthopaedics announced today that it has successfully completed enrolment of a 15-patient clinical feasibility study for its patented InDx Implant System.
  • The Thumb Hemi-Arthroplasty with Natural Kinematics (THANKS) study is looking at the surgical implantation of the device as well as improvements in pain, grip, and quality of life for those affected by thumb base joint arthritis.
  • View the full release here: https://www.businesswire.com/news/home/20231003168396/en/
    Dr. Brendan Boland, Executive Chairperson of Loci Orthopaedics, said, “Thumb base joint arthritis is a very prevalent and disabling condition that needs a better surgical solution.
  • It is a significant milestone for the company to achieve completed enrolment of this clinical study.

Landos Biopharma to Present New Data on NX-13 from Phase 1b Trial in Ulcerative Colitis at United European Gastroenterology (UEG) Week 2023 Congress

Retrieved on: 
Tuesday, September 19, 2023

NEW YORK, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today announced presentation of new data on the rapid symptomatic relief and improvement in multiple clinical biomarkers observed with NX-13 in its Phase 1b study in UC at the upcoming UEG Week 2023 congress in Copenhagen, Denmark and virtually from October 13 to October 17, 2023.

Key Points: 
  • NEXUS Phase 2 Clinical Trial is Ongoing; Top-line Readout Expected in Q4 2024
    NEW YORK, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today announced presentation of new data on the rapid symptomatic relief and improvement in multiple clinical biomarkers observed with NX-13 in its Phase 1b study in UC at the upcoming UEG Week 2023 congress in Copenhagen, Denmark and virtually from October 13 to October 17, 2023.
  • “We are excited to have the innovative work of the Landos team and our collaborators selected for two oral presentations and one poster presentation at UEG Week - one of the top gastroenterology congresses in the world,” said Gregory Oakes, President and CEO of Landos.
  • “We believe this data continues to strengthen the scientific and clinical foundation for NX-13 and its novel, bimodal mechanism of action targeting NLRX1.
  • First, by showing rapid symptomatic relief to patients as early as two weeks; and second, by demonstrating improvement in multiple biomarkers that correlate with early endoscopic response.