Tumor microenvironment

ALS-6000-101 Phase 1a Three-Weekly Dose Escalation Safety Study Data

Retrieved on: 
Wednesday, December 13, 2023

Cohort 7, the final cohort in the three-weekly dose escalation safety study of AVA6000, has completed enrolment and is ongoing

Key Points: 
  • Cohort 7, the final cohort in the three-weekly dose escalation safety study of AVA6000, has completed enrolment and is ongoing
    Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics, is pleased to provide detailed pre-clinical, clinical and pharmacokinetic data from the Phase 1a dose escalation study of its lead pre|CISIONTM programme, AVA6000, a tumour activated form of doxorubicin.
  • The key conclusions drawn from the data for AVA6000 to date are:
    The pre|CISIONTM platform targets the release of a chemotherapy to the tumour as intended.
  • A maximum tolerated dose has not been reached in the three-weekly dose escalation study despite dosing approximately 3.5x the normal level of doxorubicin in the highest and final dose cohort in this part of the Phase 1a study.
  • Given the favourable safety data from the three-weekly dosing study, a fortnightly dosing study, which is now screening patients with high FAP levels in the United States, will assist in optimising the schedule and dose for a potentially pivotal Phase 2 study in 2024.

GigaGen Receives FDA Clearance of IND to Begin Phase 1 Trial of Oncology Drug Candidate, GIGA-564, in Solid Tumors

Retrieved on: 
Tuesday, December 12, 2023

SAN CARLOS, Calif., Dec. 12, 2023 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immune deficiencies, infectious diseases and checkpoint resistant cancers, and a subsidiary of Grifols, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate a Phase 1 trial to evaluate the company’s oncology candidate, GIGA-564, for the treatment of solid tumors.

Key Points: 
  • “We are pleased to have reached this significant milestone, paving the way for our first oncology asset to enter clinical development,” said Carter Keller, senior vice president of Grifols and head of GigaGen.
  • “GIGA-564 introduces a novel approach to CTLA-4 targeting, with the promise of enhanced anti-tumor activity and lower side effects compared with existing anti-CTLA-4 agents.
  • The Phase 1a/1b dose escalation and dose-expansion trial will evaluate GIGA-564 for the treatment of advanced solid tumors.
  • The trial will be conducted by National Institutes of Health’s National Cancer Institute (NCI) researchers in close partnership with the GigaGen team.

Kymera Therapeutics Presents Interim Results from STAT3 Degrader Phase 1 Clinical Trial at American Society of Hematology Annual Meeting

Retrieved on: 
Monday, December 11, 2023

WATERTOWN, Mass., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today shared new data from its ongoing KT-333 Phase 1 trial. KT-333, a first-in-class, potent, highly selective, heterobifunctional small molecule degrader of STAT3, demonstrated early signs of antitumor activity at doses that were generally well-tolerated and associated with substantial STAT3 knockdown in blood and tumor. The data were presented at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition taking place from December 9-12, 2023, in San Diego, California.

Key Points: 
  • The data were presented at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition taking place from December 9-12, 2023, in San Diego, California.
  • The poster provides an interim update with a data cut-off as of October 18, 2023.
  • Dr. Aditi Shastri from Montefiore Medical Center and Albert Einstein College of Medicine, a lead investigator in the study, presented the interim Phase 1 findings.
  • Preclinical data demonstrating the potential of STAT3 protein degraders as a therapeutic approach in venetoclax-resistant Acute Myeloid Leukemia was also presented at the meeting.

Century Therapeutics Presents Initial Data from CNTY-101 Phase 1 ELiPSE-1 Trial Supporting the Potential for a Multi-Dosing Strategy for CAR iNK Enabled by Allo-Evasion™ Edits

Retrieved on: 
Saturday, December 9, 2023

PHILADELPHIA, Dec. 09, 2023 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced the presentation of initial clinical data from a single-patient case study which Century believes support the potential for a multi-dosing strategy for CAR iNK enabled by Allo-Evasion™ edits at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 9-12 in San Diego. The poster, titled, “Multiple Doses of CNTY-101, an iPSC-Derived Allogeneic CD19 Targeting CAR-NK Product, are Safe and Result in Tumor Microenvironment Changes Associated with Response: A Case Study”, is available on the Scientific Resources page of the Company’s website.

Key Points: 
  • “We are thrilled that the initial clinical evidence for CNTY-101 provides support for the potential for Allo-Evasion™ to enable a multi-dosing regimen without the need for continued lymphodepletion.
  • Cycles one and two included three days of lymphodepletion (LD), whereas cycles three through seven were given with no LD.
  • Importantly, tumor microenvironment initial analyses demonstrated a vigorous increase in T cells within 8 days of the 1st CNTY-101 cell infusion.
  • The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website.

TILT Biotherapeutics Announces Positive Clinical Data in Checkpoint Resistant Metastatic Melanoma Phase I Trial at ESMO Immuno-Oncology 2023

Retrieved on: 
Friday, December 8, 2023

This is the first-time clinical data with an oncolytic virus in combination with tumor infiltrating lymphocyte therapy has been presented.

Key Points: 
  • This is the first-time clinical data with an oncolytic virus in combination with tumor infiltrating lymphocyte therapy has been presented.
  • TILT’s approach uses oncolytic viruses to selectively replicate in and lyse cancer cells, while simultaneously stimulating immune responses towards the tumor.
  • The data announcement at ESMO-IO relates to 16 patients with checkpoint inhibitor (CPI) resistant progressive metastatic melanoma, who were treated with multiple intravenous and intratumoral injections of TILT-123 and a one- or two- time treatment with TILs.
  • The company has several trials currently underway, reflecting its commitment to pushing the boundaries of cancer treatment (NCT04217473, NCT05271318, NCT05222932).

Wistar Scientists Identify Esophageal Cancer Biomarkers

Retrieved on: 
Wednesday, December 6, 2023

Philadelphia, PA, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Wistar scientists have developed a new tool that can help identify cancer-associated microbes by using machine learning technology.

Key Points: 
  • Philadelphia, PA, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Wistar scientists have developed a new tool that can help identify cancer-associated microbes by using machine learning technology.
  • Under the leadership of Dr. Noam Auslander — assistant professor in the Ellen and Ronald Caplan Cancer Center’s Molecular & Cellular Oncogenesis Program — the group has analyzed short read RNA-sequencing data to detect biomarkers for esophageal carcinoma, or ESCA.
  • Since 1972, the Institute has held National Cancer Institute (NCI)-designated Cancer Center status.
  • Wistar scientists are dedicated to solving some of the world’s most challenging problems in the field of cancer and immunology, advancing human health through early-stage discovery and training the next generation of biomedical researchers.

ONK Therapeutics and NAYA Biosciences Announce Research Partnership to Advance Combination Therapy of Optimally Engineered Off-the-Shelf Natural Killer Cell Therapies and FLEX-NK™ Bispecific Antibodies

Retrieved on: 
Wednesday, December 6, 2023

Specifically, the partnership will explore the combination of ONK’s ONKT105, CISH + TGFβR2 double knock-out (KO), sIL-15 knock-in (KI) allogeneic NK cell therapy with NAYA’s GPC3-targeted NY-303 FLEX-NK™ bispecific antibody.

Key Points: 
  • Specifically, the partnership will explore the combination of ONK’s ONKT105, CISH + TGFβR2 double knock-out (KO), sIL-15 knock-in (KI) allogeneic NK cell therapy with NAYA’s GPC3-targeted NY-303 FLEX-NK™ bispecific antibody.
  • The companies’ R&D teams will collaboratively evaluate ONK’s optimally gene-edited NK cell therapy, ONKT105, with NAYA’s NY-303 bispecific antibody before selecting the best candidates for potential clinical development.
  • ONK has exclusive, worldwide rights to KO of CISH in NK cells, regardless of the source of the NK cells.
  • They redirect and trigger the killing activity of Natural Killer (NK) cells towards their tumor targets using NKp46 activating receptors.

G1 Therapeutics Presents New Post Hoc Analyses Indicating That Patients Who Previously Received Trilaciclib Have Improved Overall Survival with Subsequent Anticancer Therapy

Retrieved on: 
Tuesday, December 5, 2023

RESEARCH TRIANGLE PARK, N.C., Dec. 05, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced the presentation of new data describing the long-term positive survival impact of previous treatment with trilaciclib and cytotoxic chemotherapy (gemcitabine/carboplatin; GCb) in patients with metastatic triple negative breast cancer (mTNBC) who participated in G1’s Phase 2 trial (NCT02978716). The poster is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), held December 5th to 9th in San Antonio, TX, and is available on the G1 Therapeutics website here.

Key Points: 
  • Administering trilaciclib with cytotoxic chemotherapy also led to improved survival in patients unable to receive SACT.
  • “These new analyses indicate that trilaciclib can protect the bone marrow and immune system against the harmful effects of cytotoxic therapy, leading to significantly improved survival outcomes among patients who receive subsequent anticancer therapies,” said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics.
  • After a median follow-up of 12.7 months on study, deaths were observed in 22/43 patients in the trilaciclib plus GCb group and 17/20 patients in the GCb-only group (no trilaciclib).
  • Median time on treatment was 5.5 months in the trilaciclib plus GCb group and 3.3 months in the GCb-only group.

INmune Bio Inc. Demonstrates that INB03 Enhances the Uptake of Trastuzumab Deruxtecan in HER2+ Breast Cancer with MUC4 Expression in Poster Presented at San Antonio Breast Cancer Symposium

Retrieved on: 
Wednesday, November 29, 2023

Boca Raton, Florida, Nov. 29, 2023 (GLOBE NEWSWIRE) --  INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, is presenting data on the use of INB03, a dominant-negative TNF inhibitor of soluble TNF (sTNF) in the treatment of high-risk MUC4 expressing HER2. Roxana Schillaci, Ph.D., of Instituto de Biología y Medicina Experimental in Buenos Aries, Argentina, will present her work at the 46th annual San Antonio Breast Cancer Symposium, which runs from December 5 to 9.

Key Points: 
  • Roxana Schillaci, Ph.D., of Instituto de Biología y Medicina Experimental in Buenos Aries, Argentina, will present her work at the 46th annual San Antonio Breast Cancer Symposium, which runs from December 5 to 9.
  • “This work demonstrates another way that MUC4 expression causes resistance to HER2-targeted immunotherapy in women with resistant breast cancer," said Dr. Schillaci, who is also associated with CONICET and is senior author of this work.
  • INB03 decreases MUC4 expression on the surface of the breast cancer cells increasing the ability of the antibody to bind to the HER2 target on the cancer cell.
  • Resistance to trastuzumab immunotherapy can be predicted prospectively based on simple immunohistochemistry stains detecting tumor expression of MUC4.

SELLAS Life Sciences Reaches Target Enrollment ex-China in Phase 3 REGAL Trial of Galinpepimut-S in Acute Myeloid Leukemia

Retrieved on: 
Wednesday, November 29, 2023

“Reaching target enrollment ex-mainland China in this important study represents a significant milestone for SELLAS, the GPS development program, and the AML patient community,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

Key Points: 
  • “Reaching target enrollment ex-mainland China in this important study represents a significant milestone for SELLAS, the GPS development program, and the AML patient community,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.
  • REGAL is the most comprehensive study conducted by a biotech company to date in this orphan disease setting.
  • GPS has received Fast Track Designation in the United States and Orphan Drug Designation in both the United States and the European Union for AML.
  • For more information on the REGAL Phase 3 trial of GPS for the treatment of AML, please visit ClinicalTrials.gov and reference Identifier NCT04229979.