Alliance for Clinical Trials in Oncology

GlycoMimetics Reports Highlights and Financial Results for Third Quarter 2023

Retrieved on: 
Friday, November 3, 2023

GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today reported its financial results and highlights for the third quarter ended September 30, 2023.

Key Points: 
  • GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today reported its financial results and highlights for the third quarter ended September 30, 2023.
  • With the addition of the time-based analysis, the company expects topline results by the end of Q2 2024.
  • Third Quarter 2023 Financial Results:
    Cash position: As of September 30, 2023, GlycoMimetics had cash and cash equivalents of $49.4 million as compared to $47.9 million as of December 31, 2022.
  • A live webcast of the call will be available on the “ Investors ” tab on the GlycoMimetics website.

Foundation Medicine Announces Participation in National Cancer Institute’s ComboMATCH Initiative to Connect Patients with New Anti-Cancer Drug Combinations

Retrieved on: 
Thursday, October 26, 2023

Foundation Medicine, Inc., today announced its participation in the National Cancer Institute’s (NCI) Combination Therapy Platform Trial with Molecular Analysis for Therapy Choice (ComboMATCH) initiative to test new therapy combinations in select groups of adults and children with cancer.

Key Points: 
  • Foundation Medicine, Inc., today announced its participation in the National Cancer Institute’s (NCI) Combination Therapy Platform Trial with Molecular Analysis for Therapy Choice (ComboMATCH) initiative to test new therapy combinations in select groups of adults and children with cancer.
  • Foundation Medicine is one of nearly 40 participating Designated Laboratories, meaning that oncologists at participating ComboMATCH clinical sites may utilize their patients' FoundationOne®CDx commercial testing results to help determine their eligibility for ComboMATCH treatment trials.
  • ComboMATCH tests whether therapy selected in this manner to treat cancer may provide better patient outcomes than the current standard of care.
  • Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

Detailed Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced Neuroendocrine Tumors Presented at ESMO 2023

Retrieved on: 
Sunday, October 22, 2023

Exelixis, Inc. (Nasdaq: EXEL) today announced detailed results from CABINET, a phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) compared with placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort of patients with advanced pancreatic neuroendocrine tumors (pNET) and a second cohort of patients with advanced extra-pancreatic NET (epNET).

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced detailed results from CABINET, a phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) compared with placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort of patients with advanced pancreatic neuroendocrine tumors (pNET) and a second cohort of patients with advanced extra-pancreatic NET (epNET).
  • “Although progress has been made in recent years, there remains a critical need for new and effective therapies for patients with advanced neuroendocrine tumors.
  • Results from the CABINET study presented today at ESMO demonstrate that treatment with cabozantinib resulted in compelling improvements in PFS based both on local review and on independent blinded central radiology review.
  • The safety profile of cabozantinib observed in each cohort was consistent with its known safety profile; no new safety signals were identified.

Merck’s KEYTRUDA® (pembrolizumab) Met Primary Endpoint of Disease-Free Survival (DFS) in Certain Patients With Muscle-Invasive Urothelial Carcinoma (MIUC) After Surgery

Retrieved on: 
Thursday, October 5, 2023

At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in DFS versus observation in these patients after surgery.

Key Points: 
  • At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in DFS versus observation in these patients after surgery.
  • The trial will continue to evaluate its other dual primary endpoint of overall survival (OS).
  • The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.
  • Merck provided funding and support through a Cooperative Research and Development Agreement between Merck and NCI.

Exelixis Announces Positive Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced Pancreatic and Extra-Pancreatic Neuroendocrine Tumors

Retrieved on: 
Thursday, August 24, 2023

CABINET is evaluating cabozantinib (CABOMETYX®) compared with placebo in patients with either advanced pancreatic neuroendocrine tumors (pNET) or advanced extra-pancreatic neuroendocrine tumors (also referred to as carcinoid tumors) who experienced progression after prior systemic therapy.

Key Points: 
  • CABINET is evaluating cabozantinib (CABOMETYX®) compared with placebo in patients with either advanced pancreatic neuroendocrine tumors (pNET) or advanced extra-pancreatic neuroendocrine tumors (also referred to as carcinoid tumors) who experienced progression after prior systemic therapy.
  • Cabozantinib substantially prolonged the time without disease progression or death in both of the trial’s cohorts.
  • CABINET is sponsored by the National Cancer Institute (NCI) and is led by The Alliance for Clinical Trials in Oncology.
  • “These promising findings from the CABINET trial, in which cabozantinib showed an efficacy benefit for patients with pancreatic and extra-pancreatic neuroendocrine tumors, are welcome news and show the potential for cabozantinib to address important unmet needs for this community.”

Myriad Genetics and Intermountain Health Participate in ComboMATCH, a National Clinical Trial to Advance Cancer Treatment

Retrieved on: 
Tuesday, August 8, 2023

ComboMATCH is a coordinated platform of clinical oncology trials sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health.

Key Points: 
  • ComboMATCH is a coordinated platform of clinical oncology trials sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health.
  • ComboMATCH includes a Patient Registration Trial led by ECOG-ACRIN, along with several treatment trials designed and led by the Alliance for Clinical Trials in Oncology, Children’s Oncology Group, ECOG-ACRIN Cancer Research Group, NRG Oncology, and SWOG Cancer Research Network.
  • To be selected for the trial, combinations must show evidence they may be more effective than single therapy in treating cancer.
  • Both the Myriad and Intermountain tests are now able to be used to identify patients that may be eligible for enrollment in a treatment study under ComboMATCH.

Parexel Appoints Scott Smith, M.D., Ph.D. as New Head of Hematology

Retrieved on: 
Wednesday, April 19, 2023

In this role, Dr. Smith will lead Parexel’s Hematology therapeutic area and global team within our Oncology Center of Excellence in the development of new treatments for malignant hematology diseases as well as in the development of new therapies to treat non-malignant hematology diseases.

Key Points: 
  • In this role, Dr. Smith will lead Parexel’s Hematology therapeutic area and global team within our Oncology Center of Excellence in the development of new treatments for malignant hematology diseases as well as in the development of new therapies to treat non-malignant hematology diseases.
  • Prior to joining Parexel, Scott held several positions of increasing responsibility at Loyola Medicine's Cardinal Bernardin Cancer Center, including Director, Cancer Clinical Trials Office; Director, Bone Marrow Transplant Program; Section Chief of Hematology; and Associate Director, Clinical Research.
  • Dr. Smith’s experience also includes serving as Executive Officer for the Alliance of Clinical Trials in Oncology in Chicago, leading the group’s hematology research portfolio.
  • “At Parexel, we are passionate about achieving better outcomes for patients,” added Peyton Howell, Chief Operating and Growth Officer.

GlycoMimetics Reports Highlights and Financial Results for Fourth Quarter and Year-end 2022

Retrieved on: 
Wednesday, March 29, 2023

GlycoMimetics, Inc. (Nasdaq: GLYC) a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today reported its financial results and highlights for the quarter and year ended December 31, 2022.

Key Points: 
  • GlycoMimetics, Inc. (Nasdaq: GLYC) a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today reported its financial results and highlights for the quarter and year ended December 31, 2022.
  • Fourth Quarter and Year-end 2022 Financial Results:
    Completion of some early-commercial and manufacturing activities for uproleselan now enable the company to project its cash runway to the end of 2024.
  • G&A Expenses: The company’s general and administrative expenses increased to $4.7 million for the quarter ended December 31, 2022, as compared to $4.5 million for the fourth quarter of 2021.
  • Of these proceeds, $4.2 million were received in the fourth quarter of 2022 and $28.7 million in the first quarter of 2023.

Actinium Signs Cooperative Research and Development Agreement with National Cancer Institute to Further Enhance Clinical and Non-clinical Development of Actimab-A for the Treatment of Acute Myeloid Leukemia and Other Hematologic Malignancies

Retrieved on: 
Monday, February 6, 2023

NEW YORK, Feb. 6, 2023 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes for Health (NIH), to develop Actimab-A for the treatment of patients with acute myeloid leukemia (AML) and other hematologic malignancies. Under the terms of the CRADA, the NCI will serve as the regulatory sponsor for any clinical trials mutually approved by both parties to study Actimab-A while Actinium will be responsible for supplying and distributing Actimab-A to participating clinical sites and providing additional support as needed. The CRADA will provide broad support for the development of Actimab-A alone or in combination with chemotherapy, immunotherapy, targeted agents and other novel combinations, in line with Actinium's strategy of leveraging Actimab-A's targeted radiotherapy mechanism to elicit synergistic effects.

Key Points: 
  • The CRADA studies will be overseen by NCI in collaboration with Actinium's clinical development team.
  • Actimab-A studies may also be conducted through NCI's MyeloMATCH program.
  • Dr. Avinash Desai, Chief Medical Officer of Actinium Pharmaceuticals, commented, "NCI's broad support under the CRADA is a strong encouragement for us to together explore Actimab-A's potential for the treatment of AML and other hematologic malignancies.
  • We look forward to working collaboratively with the NCI and all investigators through this CRADA to complete multiple clinical trials to further realize Actimab-A's therapeutic potential."

Biocept to Host KOL Webinar Today to Discuss its Proprietary CNSide™ Assay to Detect and Quantify Cancer that Metastasized to the Central Nervous System

Retrieved on: 
Friday, October 14, 2022

She is dedicated to patient care and moving the study of brain tumors forward primarily through her leadership on clinical trials.

Key Points: 
  • She is dedicated to patient care and moving the study of brain tumors forward primarily through her leadership on clinical trials.
  • In this role, she oversees the conception and development of clinical trials from early phase through registration studies.
  • Dr. Kumthekar is board certified in neurology and is a member of the American Board of Psychiatry and Neurology.
  • She treats patients with primary brain tumors and metastatic disease to the brain and nervous system.