DSMB

Panbela Provides Business Update and Reports Q3 2023 Financial Results

Retrieved on: 
Thursday, November 9, 2023
Pancreatic cancer, MSN, Acquisition, Safety, Oncology Drug Advisory Committee, Therapy, Castration, Data monitoring committee, Exercise, Clinical trial, Sanofi, Patient, DSMB, Intellectual property, Research, ODAC, Patent, DFMO, Doctor of Philosophy, CPP, PBLA, Eflornithine, Pharmaceutical industry

MINNEAPOLIS, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter ended September 30, 2023.

Key Points: 
  • MINNEAPOLIS, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter ended September 30, 2023.
  • The independent Data Safety Monitoring Board (DSMB) of the ASPIRE trial completed its pre-specified review of safety data for treated patients in the trial.
  • The aggregate gross proceeds from the exercise of the existing warrants totaled approximately $1.9 million, before deducting financial advisory fees.
  • Third Quarter ended September 30, 2023 Financial Results
    General and administrative expenses were $1.1 million in the third quarter of 2023, compared to $1.3 million in the third quarter of 2022.

aTyr Pharma Announces Third Quarter 2023 Results and Provides Corporate Update

Retrieved on: 
Thursday, November 9, 2023
NRP2, Research, Safety, SAN, Neuropilin, PST, D, BLA, Sarcoidosis, ILD, Scleroderma, International, Investment, Systemic scleroderma, ERS, Clinical trial, Patient, European Respiratory Society, DSMB, Rheumatoid arthritis, ATyr Pharma, American College, American College of Rheumatology, Small RNA, The Journal, Frontiers, Skin, ACR, Poster, Biologics license application, Pharmaceutical industry, Pharmacology, Kyorin

SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced third quarter 2023 results and provided a corporate update.

Key Points: 
  • Ended the third quarter of 2023 with $105.6 million in cash, cash equivalents and investments.
  • SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced third quarter 2023 results and provided a corporate update.
  • Based on current enrollment projections, the Company expects to complete enrollment in the study early in the second quarter of 2024.
  • G&A Expenses: General and administrative expenses were $2.6 million for the third quarter of 2023.

Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 9, 2023
ALP, Safety, SAN, Therapy, PSC, Primary sclerosing cholangitis, Data monitoring committee, AASLD, Investment, Biotechnology, Serum, Patient, DSMB, Idiopathic pulmonary fibrosis, Tumor microenvironment, Research, Enrollment, Week, IPF, Pharmacokinetics, Liver, TGF, Alkaline phosphatase, Novartis, Duchenne muscular dystrophy, Biomarker, Cirrhosis, Integrin, ELF, DMD, Fibrosis, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today provided a corporate update and reported third quarter 2023 financial results.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today provided a corporate update and reported third quarter 2023 financial results.
  • “The third quarter was highlighted by positive interim data from the INTEGRIS-PSC trial of bexotegrast demonstrating a favorable safety profile and encouraging antifibrotic activity in PSC.
  • Positive safety and efficacy data from INTEGRIS-PSC Phase 2a trial in patients with primary sclerosing cholangitis (PSC).
  • These data were selected for an oral late-breaker presentation at next week’s American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® 2023.

Abcuro Initiates Part B of Registrational Phase 2/3 MUSCLE Clinical Trial of Ulviprubart (ABC008) for the Treatment of Inclusion Body Myositis

Retrieved on: 
Monday, November 13, 2023
Health, Clinical Trials, General Health, Research, Science, Biotechnology, MUSCLE, Clinical trial, IBM, Trial of the century, Safety, Patient, DSMB, Part, NK, Cancer, Data monitoring committee, Pharmaceutical industry

Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, today announced initiation of Part B of the registrational Phase 2/3 MUSCLE clinical study, an ongoing clinical trial of ulviprubart (ABC008) for the treatment of inclusion body myositis (IBM).

Key Points: 
  • Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, today announced initiation of Part B of the registrational Phase 2/3 MUSCLE clinical study, an ongoing clinical trial of ulviprubart (ABC008) for the treatment of inclusion body myositis (IBM).
  • “Advancing to Part B of the Phase 2/3 MUSCLE clinical trial, combined with the positive DSMB review of the data to date, is an important milestone for both Abcuro and IBM patients.
  • The Phase 2/3 MUSCLE clinical trial ( NCT05721573 ) is a randomized, double-blind, placebo-controlled, parallel multicenter trial evaluating ulviprubart (ABC008) in patients with IBM.
  • The three-part, registrational Phase 2/3 clinical trial will enroll more than 200 patients across 30 global sites.

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
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Data, Safety, NY-ESO-1, Non-small-cell lung cancer, Clinical trial, ESMO, Patient, DSMB, Pembrolizumab, MUC1, PD-1, MAGE, Dendritic cell, Cancer, PDC, KU Leuven, Mutation, Pharmaceutical industry, Vaccine, NSCLC

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.

MaaT Pharma Provides Third Quarter 2023 Business Update and Reports Financial Results

Retrieved on: 
Thursday, November 9, 2023
Biotechnology, Pharmaceutical, Health, Bone marrow, Annual general meeting, Charcot disease, European Medicines Agency, Maat, ICI, HSCT, Randomized controlled trial, CFO, ASH, Artificial intelligence, EMA, Patient, DSMB, PICASSO, Medi-Cal Access Program, Aryl hydrocarbon receptor, Hematopoietic stem cell transplantation, Immunotherapy, EUR, Therapy, Symantec Endpoint Protection, ORR, Cancer, Survival, MET, SITC, ARES, CGMP, Development, Society, Pharmaceutical industry, Vaccine, ALS

We are proud to achieve these milestones and we will continue to work on generating value for our shareholders,” stated Siân Crouzet, CFO of MaaT Pharma.

Key Points: 
  • We are proud to achieve these milestones and we will continue to work on generating value for our shareholders,” stated Siân Crouzet, CFO of MaaT Pharma.
  • MaaT Pharma reported revenues from its compassionate access program of EUR 0.4 million for the quarter ended September 30, 2023 comparable with the third quarter of 2022.
  • 2 The Company would like to correct a clerical error that was present in its Q2 results press release of July 27, 2023.
  • The EUR 0.9 million figure was the difference in revenue between H1 2023 and H1 2022 (EUR 1.4 million vs. EUR 0.5 million).

SERA PROGNOSTICS ANNOUNCES PRIMARY ENDPOINT CRITERIA MET IN PIVOTAL PRIME STUDY INTERIM LOOK - ENROLLMENT TO STOP DUE TO SUCCESS

Retrieved on: 
Wednesday, December 6, 2023
Premature, Health, Patient, AVERT, DSMB, Mother, Data monitoring committee, Dietary supplement, Pharmaceutical industry

The Company has adopted the DSMB's recommendation and will stop PRIME study enrollment to focus on analyzing and reporting the available data.

Key Points: 
  • The Company has adopted the DSMB's recommendation and will stop PRIME study enrollment to focus on analyzing and reporting the available data.
  • "We are excited by this report of efficacy from the DSMB," said Zhenya Lindgardt, President and CEO of Sera Prognostics.
  • "It is unexpected for trials to stop early for efficacy since most statistical power is typically reserved for the final analysis, which makes this event that much more encouraging.
  • We look forward to sharing top-line results once we have had a chance to analyze the interim look data.

TC BioPharm Announces Successful Completion of Safety Cohort and Positive DSMB Results

Retrieved on: 
Tuesday, November 14, 2023
Safety, Acute myeloid leukemia, PLC, Data monitoring committee, Clinical trial, Patient, DSMB, TC, Cancer, Toxic leukoencephalopathy, Holding, Pharmaceutical industry

EDINBURGH, Scotland, Nov. 14, 2023 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, announces today that the Company has successfully completed its Safety Cohort and received positive review from the Data Safety Monitoring Board (DSMB).

Key Points: 
  • EDINBURGH, Scotland, Nov. 14, 2023 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, announces today that the Company has successfully completed its Safety Cohort and received positive review from the Data Safety Monitoring Board (DSMB).
  • The DSMB review was held after completion of enrollment of the initial cohort of the ACHIEVE trial and examined the safety data from all patients enrolled to ensure of no dose limiting toxicities or drug related serious adverse events.
  • TC BioPharm's trial involves administering TCB008, dubbed OmnImmune® in the UK, to treat Acute Myeloid Leukemia in a large swathe of patient population.
  • "This positive safety review marks an important milestone in the development of our allogeneic gamma delta platform, building on the strong safety profile that we previously established for our novel therapeutic," said Bryan Kobel, Chief Executive Officer of TC BioPharm.

Annovis Bio Announces Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, November 8, 2023
Patient, FDA, Research, Gian Maria Annovi, Standard of care, Kinetics, AD, PD, Patent, III, II, Human, Neurodegenerative disease, ADCS, Axonal transport, News, Conference, CNS, Inflammation, Data, PHL, ThinkEquity, Mouse, AAIC, American City Business Journals, Neurology, University of Washington School of Medicine, University, Brain, Safety, Movement, European, Death, Communication, Cognition, DSMB, Pharmaceutical industry, Vaccine, Cryptocurrency, Palladium

With planned enrollment completed and the DSMB endorsement, Annovis expects topline results at the end of January 2024.

Key Points: 
  • With planned enrollment completed and the DSMB endorsement, Annovis expects topline results at the end of January 2024.
  • Financial Results (for the quarter ending September 30, 2023)
    Cash and cash equivalents were $6.4 million.
  • Maria Maccecchini, Ph.D, Annovis founder, president, and CEO, has been named a 2023 Woman of Influence by the Philadelphia Business Journal.
  • The crystalline form of buntanetap will allow us to have a new 20-year patent protection for Annovis Bio to continue to move forward.

BioCardia Reports Third Quarter 2023 Business Highlights and Financial Results

Retrieved on: 
Wednesday, November 8, 2023
FDA, Research, Security (finance), N-terminal prohormone of brain natriuretic peptide, Heart failure, Arrest, Heart, Therapy, Facial muscles, Medicare, Microsoft Exchange Server, Mortality, Data, BCDA, Pharmaceuticals and Medical Devices Agency, Maintenance, Ischemia, Phase, Quality of life, Data monitoring committee, PMDA, LVAD, Clinical trial, Risk, Marketing, III, Safety, Trial of the century, Patient, DSMB, Pharmaceutical industry, Medical device, Cryptocurrency, Helix

The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.

Key Points: 
  • The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.
  • During the third quarter of 2023, BioCardia worked with the DSMB to unblind a small committee within the Company to review the closed session DSMB report of interim study results to better understand the rationale behind their recommendation.
  • The Company expects to complete the roll-in cohort of patients in the fourth quarter of 2023 and begin the randomized phase of the trial.
  • Third Quarter 2023 Financial Results:
    Revenues were approximately $357,000 for the three months ended September 2023, compared to approximately $212,000 for the three months ended September 2022.