IDMC

TRACON Pharmaceuticals Provides Update on Ongoing ENVASARC Phase 2 Pivotal Trial Following Independent Data Monitoring Committee Recommendation to Continue the Trial as Planned

Retrieved on: 
Wednesday, April 3, 2024
Sarcoma, TCON, Patient, SAN, PDP, Safety, UPS, MFS, Therapy, IDMC, Medical imaging

SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent Product Development Platform (PDP) to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced the independent data monitoring committee (IDMC), following a review of ongoing safety and efficacy data on April 2, recommended the ENVASARC Phase 2 pivotal trial continue as planned. The ENVASARC Phase 2 pivotal trial completed enrollment in March 2024 with a total of 82 evaluable patients in cohort C of treatment with single agent envafolimab at 600 mg SQ every three weeks and final data are expected in the third quarter of 2024.

Key Points: 
  • The ENVASARC Phase 2 pivotal trial completed enrollment in March 2024 with a total of 82 evaluable patients in cohort C of treatment with single agent envafolimab at 600 mg SQ every three weeks and final data are expected in the third quarter of 2024.
  • The IDMC reviewed interim safety and efficacy data from 73 patients enrolled into cohort C who had the opportunity to complete two on-treatment scans (a minimum of 12 weeks of treatment).
  • The objective response rate (ORR) is currently 11% by investigator review and the confirmed ORR by blinded independent central review (BICR) is currently 5.5% (four patients).
  • Envafolimab has been well tolerated without the development of a single drug-related serious adverse event of grade 3 or higher.

SELLAS Life Sciences Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 28, 2024
Ovarian cancer, SLS, Survival, Lymphoma, Fast track (FDA), PTCL, National Cancer Institute, CMC, Clinical trial, Committee, Research, NCI, European School, Bone marrow, AML, GPS, Pembrolizumab, Doctor of Science, Nivolumab, Safety, MRD, CDK9, BLA, Food, CR2, Zanubrutinib, Mesothelioma, BIW, MD, Completeness, WT1, FDA, DLBCL, IDMC, Therapeutic index, Type, Fast Track, Biomarker, BTK, Pharmaceutical industry

The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.

Key Points: 
  • The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.
  • The first patient who achieved a complete response continues on the study and remains leukemia-free 9 months post-enrollment.
  • The net proceeds from the offering strengthen the Company’s financial position and will be used for research and development activities, working capital, and general corporate purposes.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled approximately $2.5 million.

SELLAS Announces Positive Topline Data from the Phase 2a Study of SLS009 in r/r AML and Provides Steering Committee Update on Phase 3 REGAL Study

Retrieved on: 
Tuesday, March 26, 2024
Corporation, Toxicity, SLS, Survival, AML, Committee, Biomarker, GPS, Death, BIW, Enrollment, MD, Date, Trial of the century, Doctor of Science, Safety, IDMC, Pharmaceutical industry

The Company will host a webinar to discuss the data and the REGAL update today at 8:15 am ET.

Key Points: 
  • The Company will host a webinar to discuss the data and the REGAL update today at 8:15 am ET.
  • “We are extremely grateful to the patients, their families, and investigators who have helped us achieve this significant milestone.
  • Additionally, we are pleased to share that the Steering Committee has reviewed the study as of the March 1, 2024, cutoff date.
  • Dr. Stergiou continued: “We are extremely excited to share positive topline data from the Phase 2a trial of SLS009 in AML patients resistant to venetoclax combination therapies.

Theriva™ Biologics Reports Full-Year 2023 Operational Highlights and Financial Results

Retrieved on: 
Monday, March 25, 2024
Research, SJD, IDMC, Conference call, Conference, Retinoblastoma, Telephone, Patient, Acquisition, Cancer, VCN, Insurance, Bank statement, GMP, Clinical trial, Safety, Sant Joan, Therapy, Intravenous therapy, HCT, Pharmaceutical industry

ROCKVILLE, Md., March 25, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today reported financial results for the full-year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • The trial is expected to enroll 92 evaluable patients and remains on track to complete enrollment in H1 2024.
  • Other income for the year ended December 31, 2023 is primarily comprised of interest income of $1,439,000 and an exchange gain of $3,000.
  • Cash and cash equivalents totaled $23.2 million as of December 31, 2023, compared to $41.8 million as of December 31, 2022.
  • ET to discuss its financial results for the full-year ended December 31, 2023 and provide a corporate update.

Taysha Gene Therapies Reports Full Year 2023 Financial Results and Provides Corporate and Clinical Updates

Retrieved on: 
Tuesday, March 19, 2024
Diary, Patient, IND, Adolescence, Pediatrics, Therapy, FAAP, Rett syndrome, Research, Central nervous system, Risk, Webcast, CNS, Ageing, CHU, Safety, AAV, Mutation, Development, MECP2, Disease, Associate, Sleep, Șaeș, Dysrhythmia, FRCP, MTD, Movement, IDMC, VG, Hyperventilation, Principal, Administration, Index, Seizure, CTA, Female, MHRA, Phenotype, ID, Frasier, Pharmaceutical industry

Notably, she has vastly increased interest in social communication and activities at week 35 compared to earlier post-treatment assessments.

Key Points: 
  • Notably, she has vastly increased interest in social communication and activities at week 35 compared to earlier post-treatment assessments.
  • Dr. Schultz is a board-certified, licensed pediatric neurologist experienced in treating patients with Rett syndrome and leading gene therapy clinical trials.
  • She brings more than 17 years of clinical experience and will lead the Company’s clinical development, clinical operations, medical affairs and safety activities.
  • ET to review its financial and operating results and to provide corporate and clinical updates.

ADC Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Wednesday, March 13, 2024
AXL, PIN, Neutropenia, Growth, Rituximab, Sarcoma, ALT, NSCLC, ASH, FY, Progression-free survival, Skin infection, Patient, Follicular lymphoma, S&M, Research, EDT, Aes, Periodic breathing, G&A, University, Lung cancer, Insurance, AACR, DLT, Pancreatic cancer, Hyperglycemia, Society, Therapy, Clinical trial, Diffuse large B-cell lymphoma, PFS, CD22, ADC, Data, Fatigue, MD Anderson Cancer Center, FDA, DLBCL, Marketing, PSMA, IDMC, Pharmaceutical industry

LAUSANNE, Switzerland, March 13, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided business updates.

Key Points: 
  • “In the fourth quarter we saw results of our strategy in action across a number of key areas.
  • A return to sequential quarter-over-quarter growth in the fourth quarter of 2023 followed the restructuring of the commercial model, with sales volume increasing in both community and academic settings.
  • R&D expenses were $30.3 million for the fourth quarter and $127.1 million for full year 2023, compared to $48.1 million and $186.5 million, respectively, for the fourth quarter and full year 2022.
  • ADC Therapeutics management will host a conference call and live audio webcast to discuss fourth quarter and full year 2023 financial results and provide a company update today at 8:30 a.m. Eastern Time.

Informatica Launches Saudi Arabia’s First AI-Powered Intelligent Data Management Cloud Platform

Retrieved on: 
Tuesday, April 2, 2024
Professional Services, Data Management, Technology, Data Analytics, Networks, Internet, Cloud, Organization, AI, KSA, Vision 2030, Data management, Cloud computing, GDP, Print on demand, INFA, Multimedia, USD, IDMC, Video game

Informatica (NYSE: INFA), the enterprise cloud data management leader, today launched its AI-powered Intelligent Data Management Cloud™ (IDMC) in Saudi Arabia, a first for the Kingdom.

Key Points: 
  • Informatica (NYSE: INFA), the enterprise cloud data management leader, today launched its AI-powered Intelligent Data Management Cloud™ (IDMC) in Saudi Arabia, a first for the Kingdom.
  • The investment includes establishing a new Point of Delivery (PoD) in Riyadh, and reflects a commitment to support local, scalable, cloud-first data management services.
  • View the full release here: https://www.businesswire.com/news/home/20240402439288/en/
    Informatica is launching its AI-powered Intelligent Data Management Cloud™ in Saudi Arabia, a first for the Kingdom.
  • By establishing a regional PoD in Riyadh, Informatica will be able to better support local partners and organisations with its cloud data management platform in line with local regulations.

Vertex Advances Inaxaplin (VX-147) into Phase 3 Portion of Adaptive Phase 2/3 Clinical Trial for the Treatment of APOL1-Mediated Kidney Disease

Retrieved on: 
Monday, April 1, 2024
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, BTD, Orphan drug, APOL1, RPD, Disease, Patient, Apolipoprotein L1, FSGS, Standard of care, EMA, UPCR, European Medicines Agency, Vertex Pharmaceuticals, Clinical trial, Vertex, Proteinuria, Food, FDA, IDMC, VRTX, Pharmaceutical industry

The clinical trial is designed to assess the impact of inaxaplin on kidney function and proteinuria for people living with proteinuric kidney disease mediated by two variants in the APOL1 gene, known as AMKD.

Key Points: 
  • The clinical trial is designed to assess the impact of inaxaplin on kidney function and proteinuria for people living with proteinuric kidney disease mediated by two variants in the APOL1 gene, known as AMKD.
  • In addition, the trial has been expanded to include adolescents with AMKD ages 10 to 17 years.
  • The IDMC also recommended enrolling adolescents with AMKD ages 10 to 17 years in the Phase 3 portion of the study.
  • The European Medicines Agency (EMA) has also granted inaxaplin Priority Medicines (PRIME) and Orphan Drug designations for AMKD.

Informatica Named a Leader in the 2024 Gartner® Magic Quadrant™ for Data Quality Solutions 16 Consecutive Times

Retrieved on: 
Monday, March 11, 2024
Internet, Data Management, Technology, Artificial Intelligence, Software, Cloud, Automation, Completeness, ADQ, Research, AI, Publication, Data management, Metadata, INFA, MAGIC, Magic Quadrant, IDMC, Magic

Informatica ® (NYSE: INFA), an enterprise cloud data management leader, announced that Gartner, Inc. has once again recognized the company as a Leader in the 2024 Gartner® Magic Quadrant™ for Augmented Data Quality Solutions report.

Key Points: 
  • Informatica ® (NYSE: INFA), an enterprise cloud data management leader, announced that Gartner, Inc. has once again recognized the company as a Leader in the 2024 Gartner® Magic Quadrant™ for Augmented Data Quality Solutions report.
  • Data quality capabilities are part of Informatica's Intelligent Data Management Cloud (IDMC), a comprehensive AI-powered cloud-native data platform.
  • Gartner defines augmented data quality (ADQ) solutions as a set of capabilities for enhanced data quality experience aimed at improving insight discovery, next-best-action suggestions and process automation by leveraging AI/machine learning (ML) features, graph analysis and metadata analytics.
  • “Data quality and observability are foundational to driving trusted digital transformation, regardless of the industry,” said Jitesh S. Ghai, Chief Product Officer at Informatica.

Taysha Gene Therapies Announces Updates to TSHA-102 Clinical Program in Rett Syndrome

Retrieved on: 
Thursday, February 29, 2024
Central nervous system, Index, Adolescence, FDA, MTD, Food, MECP2, IDMC, Rett syndrome, Safety, CNS, Patient, VG, Mutation, AAV, Ageing, Pharmaceutical industry

DALLAS, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (“Taysha” or “the Company”), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of severe monogenic diseases of the central nervous system (CNS), today announced updates to its TSHA-102 program in clinical evaluation for the treatment of Rett syndrome. The Independent Data Monitoring Committee (IDMC) approved the Company’s request to proceed to dose escalation in the REVEAL Phase 1/2 adolescent and adult trial, enabling earlier advancement to the high dose cohort of 1x1015 total vg. The IDMC also approved the dosing of the second patient in cohort one (low dose) of 5.7x1014 total vg in the REVEAL Phase 1/2 pediatric trial. The decisions follow IDMC review of available clinical data from the patients dosed with TSHA-102. The Company also announced the expansion of its ongoing REVEAL Phase 1/2 adolescent and adult trial in Canada into the United States (U.S.) following submission of the adolescent and adult trial protocol to the U.S. Food and Drug Administration (FDA).

Key Points: 
  • The decisions follow IDMC review of available clinical data from the patients dosed with TSHA-102.
  • The trial is taking place in Canada and the U.S. TSHA-102 is administered as a single lumbar intrathecal injection.
  • Update on available clinical data from completed cohort one of 5.7x1014 total vg expected in the first quarter of 2024.
  • Initial safety and efficacy data from cohort two (high dose, n=3) of 1x1015 total vg expected in the second half of 2024.