Immunotherapy

Creative Medical Technology Holdings, Inc. Receives FDA Orphan Drug Designation for CELZ-101 in Key Transplantation Therapy

Retrieved on: 
Wednesday, March 6, 2024

Timothy Warbington, CEO of Creative Medical Technology Holdings, stated, "The FDA's Orphan Drug Designation for CELZ-101 underscores our commitment to developing groundbreaking therapies.

Key Points: 
  • Timothy Warbington, CEO of Creative Medical Technology Holdings, stated, "The FDA's Orphan Drug Designation for CELZ-101 underscores our commitment to developing groundbreaking therapies.
  • “The Orphan Drug Designation by the FDA highlights CELZ-101's potential to meet a significant unmet need in the prevention of allograft rejection during pancreatic islet cell transplantation which was recently approved by the FDA.
  • Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ) is dedicated to progressing CELZ-101 through the necessary regulatory pathways, with the goal of transforming the therapeutic landscape for patients in need of islet transplantation.
  • This achievement underscores the company's dedication to leveraging the natural regenerative capabilities of the human body to create lasting health solutions.

MAIA Biotechnology Announces Strong Efficacy of THIO as Third-Line Treatment for Non-Small Cell Lung Cancer Patients

Retrieved on: 
Wednesday, March 6, 2024

MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced positive efficacy data for third-line treatment in its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC).

Key Points: 
  • MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced positive efficacy data for third-line treatment in its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC).
  • “Around 60-70% of NSCLC patients do not have a targetable mutation and cannot benefit from a biomarker-targeted therapy, making it the greatest unmet medical need population in lung cancer.
  • Two third-line patients in the 180mg dose cohort did not have recorded scans at the data cutoff.
  • THIO-101 is expected to be the first completed clinical study of a telomere-targeting agent in the field of cancer drug discovery and treatment.

Ankyra Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Dose Escalation Cohort Evaluating ANK-101, an Anchored Immune Medicine, for Solid Tumors

Retrieved on: 
Tuesday, March 5, 2024

Ankyra Therapeutics, a clinical stage biotechnology company pioneering anchored immunotherapies to treat cancer, today announced the first patient dosed in the dose escalation cohort in a Phase 1 clinical study evaluating ANK-101, a tumor-directed, anchored immune medicine for solid tumors.

Key Points: 
  • Ankyra Therapeutics, a clinical stage biotechnology company pioneering anchored immunotherapies to treat cancer, today announced the first patient dosed in the dose escalation cohort in a Phase 1 clinical study evaluating ANK-101, a tumor-directed, anchored immune medicine for solid tumors.
  • ANK-101 is currently under investigation in patients with advanced solid tumors who have failed standard of care treatments.
  • In multiple preclinical models, ANK-101 demonstrated increased immune cell infiltration into tumors without systemic toxicity.
  • “These data will provide a roadmap for advancing ANK-101 through clinical development and for identifying appropriate clinical indications for future trials,” said Joe Elassal, M.D., MBA, Chief Medical Officer of Ankyra Therapeutics.

Transgene, NEC, and BostonGene Expand Collaboration for Phase I/II Clinical Trial of Neoantigen Cancer Vaccine TG4050

Retrieved on: 
Tuesday, March 5, 2024

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240305404031/en/
    BostonGene is partnering with NEC and Transgene to continue performing tumor molecular profiling and microenvironment analysis and provide high-throughput sequencing services.
  • The partnership with BostonGene will enable fast turnaround of next-generation sequencing (NGS) data, and sophisticated analytics will enable comprehensive profiling of patient immune contexture.
  • “Our collaboration with BostonGene has provided in-depth information on patient phenotypes in the Phase I trial.
  • “We are committed to supporting Transgene and NEC as they advance these clinical trials,” said Nathan Fowler, MD, Chief Medical Officer at BostonGene.

Verastem Oncology Announces Preclinical Presentations for New Oral G12D Inhibitor and for Avutometinib and Defactinib Combination as a Backbone of Therapy for RAS/MAPK Driven Cancers at AACR Annual Meeting 2024

Retrieved on: 
Tuesday, March 5, 2024

The presentations will highlight anti-tumor efficacy of GFH375 (VS-7375), a potent and selective orally bioavailable KRAS G12D (ON/OFF) inhibitor, and will also show data of RAF/MEK clamp plus FAK inhibition in pancreatic ductal adenocarcinoma (PDAC) models supporting the ongoing RAMP 205 trial.

Key Points: 
  • The presentations will highlight anti-tumor efficacy of GFH375 (VS-7375), a potent and selective orally bioavailable KRAS G12D (ON/OFF) inhibitor, and will also show data of RAF/MEK clamp plus FAK inhibition in pancreatic ductal adenocarcinoma (PDAC) models supporting the ongoing RAMP 205 trial.
  • Additional presentations will support the use of avutometinib and FAK inhibitor combination in cutaneous melanoma models to overcome resistance to BRAF and MEK inhibitors, resistance to immunotherapy, and brain metastasis.
  • “For the first time, GenFleet and Verastem will present potency, selectivity, anti-tumor efficacy, and bioavailability data on GFH375 (VS-7375), a potential best-in-class orally active KRAS G12D (ON/OFF) inhibitor.
  • We look forward to an IND submission by GenFleet in China in H1 2024,” said Jonathan Pachter, Ph.D., chief scientific officer of Verastem Oncology.

Biomunex Signs Exclusive Licensing Agreement With Institut Curie to Develop MAIT Engagers, a New Class of Bispecific Antibodies in Immuno-oncology

Retrieved on: 
Monday, March 4, 2024

This agreement covers the development of a new class of antibodies, capable of specifically targeting and engaging MAIT cells to kill cancer cells.

Key Points: 
  • This agreement covers the development of a new class of antibodies, capable of specifically targeting and engaging MAIT cells to kill cancer cells.
  • Biomunex, which was already co-inventor and a 50% co-owner of this unique innovative approach, now holds full worldwide rights.
  • In addition, MAIT cells present the MDR-12 protein on their surface, providing them with a natural resistance to some major chemotherapies.
  • “The research performed at Institut Curie has led to a major discovery which now opens up promising new therapeutic options.

Global Healthy Living Foundation Announces irAE Consortium to Address Immune-Related Adverse Events in Cancer Immunotherapy Patients

Retrieved on: 
Monday, March 4, 2024

The nonprofit Global Healthy Living Foundation (GHLF) announced its collaboration as a co-founding member of the irAE Consortium, a newly formed collaborative effort uniting clinicians, researchers, and patients to tackle a critical issue facing cancer patients undergoing immunotherapy treatment: adverse reactions.

Key Points: 
  • The nonprofit Global Healthy Living Foundation (GHLF) announced its collaboration as a co-founding member of the irAE Consortium, a newly formed collaborative effort uniting clinicians, researchers, and patients to tackle a critical issue facing cancer patients undergoing immunotherapy treatment: adverse reactions.
  • The inaugural meeting of the Immune-Related Adverse Events (irAE) Consortium is scheduled for March 7-8, 2024, at the Cleveland Clinic in Ohio.
  • This initiative aims to address the unmet needs of cancer patients who experience adverse reactions to immunotherapy, a novel treatment approach.
  • Immunotherapy has revolutionized cancer treatment, offering new hope to patients by harnessing the body’s immune system to fight cancer.

CEL-SCI Corporation Issues Letter to Shareholders

Retrieved on: 
Wednesday, March 6, 2024

CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.

Key Points: 
  • CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.
  • This letter will be sent to the Company’s shareholders along with the proxy to the upcoming annual meeting.
  • In October 2023, the new data were presented at the 2023 European Society for Medical Oncology (ESMO) Congress.
  • These features make it easy to write a label for Multikine, which is essential for drug approval.

TriSalus Life Sciences Announces Real-World Data Demonstrating the Ability of TriNav® to Successfully Treat Patients with Higher Disease Burden and to Improve Delivery of Therapeutics to Liver Tumors

Retrieved on: 
Thursday, February 29, 2024

Key findings include that TriNav patients, despite a higher baseline disease burden and clinical complexity, showed overall clinical results comparable to patients with lower disease burden.

Key Points: 
  • Key findings include that TriNav patients, despite a higher baseline disease burden and clinical complexity, showed overall clinical results comparable to patients with lower disease burden.
  • In a matched cohort comparison, TriNav patients had fewer 30-day inpatient visits post-procedure than non-TriNav patients.
  • TriNav TARE patients with liver metastases had fewer clinical complications post-procedure vs. non-TriNav patients in a matched cohort comparison.
  • “This large sample size study underscores the particular benefits of the TriNav device compared to standard drug delivery systems.”

Playground Global Promotes Benjamin Kim PhD to Partner

Retrieved on: 
Wednesday, February 28, 2024

Playground Global , an early-stage, deep-tech venture firm that invests in founders building category-defining businesses at the forefront of science and technology, today announced that Benjamin Kim PhD, has been promoted to Partner.

Key Points: 
  • Playground Global , an early-stage, deep-tech venture firm that invests in founders building category-defining businesses at the forefront of science and technology, today announced that Benjamin Kim PhD, has been promoted to Partner.
  • View the full release here: https://www.businesswire.com/news/home/20240228985705/en/
    Ben joined Playground as a Venture Fellow in 2019 while completing his PhD in bioengineering at Stanford University.
  • “It’s an honor to contribute to the Playground life sciences ecosystem and support our portfolio companies in evolving deeply technical breakthroughs into transformational businesses,” said Ben Kim, PhD, Partner at Playground.
  • “Ben brings an infectious passion for and incredible knowledge of bioengineering and biophysics to the Playground team,” said Jory Bell , General Partner at Playground.