MD Anderson Cancer Center

International Consortium Publishes Comprehensive Roadmap for the Clinical Implementation of OGM in Hematological Malignancy Applications

Retrieved on: 
Wednesday, January 3, 2024

The authors believe that a proactive approach to the development of standards would be beneficial for global laboratories’ understanding of how best to use an OGM workflow.

Key Points: 
  • The authors believe that a proactive approach to the development of standards would be beneficial for global laboratories’ understanding of how best to use an OGM workflow.
  • Consortium members collaboratively outlined a consensus framework designed to provide guidance to laboratories interested in the adoption and implementation of OGM.
  • The authors covered considerations that need to be addressed when incorporating OGM into a laboratory, including assessment of clinical utility, proof of principle study, method validation, clinical validation, and implementation.
  • The framework addresses these considerations with specific recommendations in three areas: validation, quality control, and analysis and interpretation of variants.

Establishment Labs Announces First U.S. Commercial Procedure with Motiva Flora Tissue Expander

Retrieved on: 
Tuesday, January 2, 2024

The recent FDA clearance and first procedure mark significant developments in the field of plastic and reconstructive surgery.

Key Points: 
  • The recent FDA clearance and first procedure mark significant developments in the field of plastic and reconstructive surgery.
  • "This Flora device is a new resource in our toolkit for breast cancer reconstruction,” Dr. Clemens noted.
  • The Flora® Tissue Expander includes several proprietary innovations, including Establishment Labs’ patented SmoothSilk® surface technology and an RFID-enabled, non-magnetic port, labeled as MR Conditional by the FDA.
  • By being magnet-free, Flora avoids the interference that magnets cause during MRI and may improve the precision of radiation oncology treatment.

Replay and its engineered NK cell therapy company Syena announce exclusive licensing agreement with National Institutes of Health for TCRs targeting cancer neoantigens

Retrieved on: 
Monday, December 18, 2023

These will be developed by Replay’s oncology-focused product company, Syena, to expand its pipeline of engineered T-Cell Receptor-Natural Killer (TCR-NK) cell therapies.

Key Points: 
  • These will be developed by Replay’s oncology-focused product company, Syena, to expand its pipeline of engineered T-Cell Receptor-Natural Killer (TCR-NK) cell therapies.
  • The TCRs, targeting validated cancer neoantigens KRAS, p53, HPV16 and MAGE, were discovered by Steven Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NIH National Cancer Institute’s (NCI) Center for Cancer Research and a pioneer of immunotherapies and gene therapies for advanced cancers.
  • Preclinical development of the new TCR-NK programs will advance alongside the clinical development of Syena’s lead engineered TCR-NK cell therapy candidate targeting NY-ESO-1, and the PRAME program announced today.
  • Adrian Woolfson, Executive Chairman, President, and Co-Founder of Replay, said: “The TCRs licensed from NIH address several cancer neoantigens of medical importance and will significantly expand our first-in-class, engineered TCR-NK therapy operations.

Treadwell Therapeutics Announces a Presentation at the 2023 ASH Annual Meeting and Advisory Board Meeting

Retrieved on: 
Friday, December 15, 2023

TORONTO and SAN MATEO, Calif., Dec. 15, 2023 (GLOBE NEWSWIRE) -- Treadwell Therapeutics, a clinical-stage biotechnology company developing novel first-in-class medicines for unmet needs in cancer, today announced a presentation for the Company's lead program, CFI-400945, a first-in-class inhibitor of Polo-like Kinase 4 (PLK4) being advanced in relapsed/refractory AML, at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held from December 9-12, 2023. Treadwell also conducted a clinical advisory board meeting on December 10th at ASH with experienced experts in the treatment of AML and in clinical trials of novel agents, which included current investigators and thought leaders new to the program.

Key Points: 
  • Treadwell also conducted a clinical advisory board meeting on December 10th at ASH with experienced experts in the treatment of AML and in clinical trials of novel agents, which included current investigators and thought leaders new to the program.
  • "CFI-400945 is demonstrating complete remissions as a single agent and in combination with azacitadine in relapsed, adverse risk AML, including those with TP53 mutant disease.
  • Three of 6 evaluable patients with AML achieved a response (MLFS=2, CRi=1 with MRD+) at the 96mg dose​.
  • PK characteristics support daily dosing of CFI-400945 and PD studies are ongoing​.

Bio-Path Holdings Successfully Completes First Dose Cohort of Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia

Retrieved on: 
Thursday, December 14, 2023

The first dose cohort consisted of a starting dose of 20 mg/m2, and there were no dose limiting toxicities.

Key Points: 
  • The first dose cohort consisted of a starting dose of 20 mg/m2, and there were no dose limiting toxicities.
  • The approved treatment cycle is two doses per week over four weeks for a total of eight doses administered over twenty-eight days.
  • The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients.
  • Gail J. Roboz, M.D., is the National Principal Investigator for the Phase 1/1b trial.

SELLAS to Host Corporate Update Webinar on January 3, 2024 at 8:30 am ET

Retrieved on: 
Wednesday, December 13, 2023

NEW YORK, Dec. 13, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that it will host a corporate update webinar on Wednesday, January 3, 2024, at 8:30 a.m. Eastern Time.

Key Points: 
  • NEW YORK, Dec. 13, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that it will host a corporate update webinar on Wednesday, January 3, 2024, at 8:30 a.m. Eastern Time.
  • Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS, will discuss the Company’s achievements in 2023 and provide an outlook for 2024.
  • Dr. Stergiou will be joined by two key opinion leaders and principal investigators who will discuss the Phase 3 registrational REGAL clinical trial of galinpepimut-S (GPS) in patients with acute myeloid leukemia and the clinical program for SLS009, the Company’s CDK9 inhibitor:
    Dr. Panagiotis Tsirigotis, Professor of Hematology, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece
    Dr. Tapan Kadia, Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston, Texas
    To access the webinar, please use the following information:

Affimed Announces Updated Phase 1/2 Data from Acimtamig in Combination with Allogeneic NK in Hodgkin Lymphoma Patients Who Failed Prior Chemotherapy and Are Double-Refractory to Brentuximab Vedotin (BV) and Checkpoint Inhibitors (CPIs)

Retrieved on: 
Monday, December 11, 2023

Affimed will host a webcast following the presentation to review the data and provide a strategic update on acimtamig’s future development.

Key Points: 
  • Affimed will host a webcast following the presentation to review the data and provide a strategic update on acimtamig’s future development.
  • A total of 42 patients were enrolled in the study with 36 patients treated at the RP2D.
  • 32 of the 36 patients treated at the RP2D were HL patients.
  • For the HL patients treated at the RP2D, median EFS was 9.8 months - with 84% patients alive at 12 months.

Inside information: Faron Presents Phase 1 Data from BEXMAB in Myeloid Malignancies Trial at the 65th American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Monday, December 11, 2023

TURKU, Finland and BOSTON, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON) (“Faron” or the “Company”), a clinical-stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announced very positive Phase 1 data from the ongoing BEXMAB study in myeloid malignancies, being presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition taking place until tomorrow, December 12, 2023, in San Diego, California, and virtually.

Key Points: 
  • “The BEXMAB results continue to improve over time showing remarkable overall response rate in both higher-risk frontline as well as hypomethylating agent (HMA)-failed myelodysplastic syndrome (MDS) patients,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron.
  • "The combination is well-tolerated and generates strong and durable leukemic blast eradication and immune responses.
  • This solidifies bexmarilimab’s unique and leading mechanism of action in the field of myeloid cell re-programming.
  • The data presented at ASH are promising, demonstrating a higher ORR and prolonged response duration in this trial compared to published historical benchmarks.

Cogent Biosciences Announces Positive Initial Data from Phase 2 SUMMIT Trial Evaluating Bezuclastinib in Patients with Nonadvanced Systemic Mastocytosis (NonAdvSM)

Retrieved on: 
Saturday, December 9, 2023

Twenty patients in Part 1a were treated with either bezuclastinib or placebo plus best supportive care for all arms.

Key Points: 
  • Twenty patients in Part 1a were treated with either bezuclastinib or placebo plus best supportive care for all arms.
  • Patients were enrolled with the following sub-types: 18 patients with indolent systemic mastocytosis (ISM) and two patients with smoldering systemic mastocytosis (SSM).
  • In patients with completed questionnaires:
    By week 12, bezuclastinib patients showed a median best improvement of 37% on MC-QoL vs. 24% for placebo patients.
  • Data from Part 1 of the Phase 2 APEX clinical trial evaluating bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) will be presented in a poster session at ASH on Monday, December 11, 2023 at ASH.

Aptose Tuspetinib Clinical Data Featured in Oral Presentation at the 2023 ASH Annual Meeting

Retrieved on: 
Saturday, December 9, 2023

Data were presented in an oral presentation today at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition by lead investigator Naval G. Daver, M.D., Professor, Director Leukemia Research Alliance Program, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.

Key Points: 
  • Data were presented in an oral presentation today at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition by lead investigator Naval G. Daver, M.D., Professor, Director Leukemia Research Alliance Program, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
  • Tuspetinib is a once-daily, oral, precision targeted kinase inhibitor that suppresses select kinases that drive the proliferation of AML.
  • Dr. Daver reported data from more than 100 relapsed/refractory patients from multiple international clinical sites, who had failed prior therapy and then were treated with tuspetinib (TUS) as a single agent or tuspetinib in combination with venetoclax (TUS/VEN).
  • We look forward to reporting our next set of data in the first quarter of 2024.”