RECIST

AnaptysBio- and GSK-partnered immuno-oncology agent JEMPERLI (dostarlimab-gxly) meets primary endpoint in Phase 3 RUBY trial in primary advanced or recurrent endometrial cancer

Retrieved on: 
Friday, December 2, 2022

GSK expects to publish full results from the RUBY trial in a medical journal and present at an upcoming scientific meeting.

Key Points: 
  • GSK expects to publish full results from the RUBY trial in a medical journal and present at an upcoming scientific meeting.
  • RUBY is a two-part global, randomised, double-blind, multicentre study of patients with primary advanced or recurrent endometrial cancer.
  • RUBY is part of an international collaboration of European Network of Gynaecological Oncological Trial groups (ENGOT) and the GOG Foundation.
  • AnaptysBio is also developing imsidolimab, our anti-IL-36R antibody in Phase 3 for the treatment of generalized pustular psoriasis, or GPP.

Compass Therapeutics Announces First Patient Dosed in the Phase 1b CTX-471 Combination Trial with KEYTRUDA® (pembrolizumab)

Retrieved on: 
Thursday, December 1, 2022

Patients enrolled in the study will be treated with CTX-471 in combination with KEYTRUDA with the goal of restoring response.

Key Points: 
  • Patients enrolled in the study will be treated with CTX-471 in combination with KEYTRUDA with the goal of restoring response.
  • We are very pleased to be making progress on our CTX-471 clinical program with dosing of the first patient in the combination arm with KEYTRUDA, said Thomas Schuetz, M.D., Ph.D., Chief Executive Officer and Scientific Founder of Compass.
  • CTX-471 has completed a Phase 1 dose escalation and cohort expansion study, where it was shown to be well-tolerated.
  • Compass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases.

Viracta Therapeutics Announces Preliminary Dose-Ranging Data from the Phase 1b/2 Trial of Nana-val in Advanced Epstein-Barr Virus-Positive (EBV+) Solid Tumors at the ESMO Immuno-Oncology Congress

Retrieved on: 
Wednesday, November 30, 2022

Key data reported in the abstract include:

Key Points: 
  • Key data reported in the abstract include:
    Nana-val was well tolerated with no dose limiting toxicities (DLTs) reported.
  • Plasma EBV DNA titers decreased or remained stable in both patients achieving SD, while rising in patients with progressive disease.
  • The company anticipates initiating the Phase 2 randomized expansion portion of the Phase 1b/2 trial in the second half of 2023.
  • This Phase 1b/2 trial ( NCT05166577 ) is an open-label, multinational trial evaluating Nana-val alone and in combination with pembrolizumab.

Memgen Reports Results From Its First-In-Human Clinical Trial of MEM-288 in Solid Tumors Refractory to Checkpoint Inhibitors at SITC 2022

Retrieved on: 
Wednesday, November 30, 2022

The interim results from this ongoing first-in-human Phase 1 trial indicate that MEM-288 is well tolerated and expands tumor-fighting T cells.

Key Points: 
  • The interim results from this ongoing first-in-human Phase 1 trial indicate that MEM-288 is well tolerated and expands tumor-fighting T cells.
  • Seven patients with solid tumors received at least one intratumoral injection of MEM-288 with no dose-limiting toxicity or discontinuation due to toxicity.
  • All 6 NSCLC patients had already received 2 to 4 lines of therapy including one or more lines with checkpoint inhibitors before enrollment.
  • Based on the early results presented at SITC, MEM-288 may successfully deploy the CD40 pathway to stimulate immune responses directed against tumors.

Immutep Enters into Second Clinical Trial Collaboration Agreement with Merck KGaA, Darmstadt, Germany, and Pfizer for New Combination Study of its First-in-Class LAG-3 Candidate, Eftilagimod Alpha, and Avelumab to Treat Urothelial Cancer

Retrieved on: 
Tuesday, November 29, 2022

The first patient is expected to be enrolled and dosed in H1 of calendar year 2023, after completing the necessary ethics and regulatory steps.

Key Points: 
  • The first patient is expected to be enrolled and dosed in H1 of calendar year 2023, after completing the necessary ethics and regulatory steps.
  • Urothelial cancer is a type of cancer in the bladder or urinary tract.
  • Under the Agreement, Immutep and Merck KGaA, Darmstadt, Germany will jointly fund the INSIGHT-005 study.
  • Additional LAG-3 product candidates, including antibodies for immune response modulation, are licensed to and being developed by Immuteps large pharmaceutical partners.

NETRIS Pharma Doses First Patient in Phase 2 Study of NP137 for Checkpoint Inhibitor Resistance

Retrieved on: 
Tuesday, November 29, 2022

The enrollment of the first patient in ImmunoNET is a new clinical milestone for NETRIS Pharma.

Key Points: 
  • The enrollment of the first patient in ImmunoNET is a new clinical milestone for NETRIS Pharma.
  • Based on a unique mode of action of NP137 and biomarker studies conducted in Phase 1, we believe we can enlarge the fraction of responding patients and potentially prevent resistance, said Patrick Mehlen, CEO of NETRIS Pharma.
  • ImmunoNET has been specifically designed by clinicians to provide new solutions for patients suffering from resistance to immune-checkpoint inhibitors.
  • NETRIS Pharma, a clinical-stage company designs and develops anti-cancer therapeutic molecules, particularly monoclonal antibodies, to block the interaction between dependence receptors and their ligands.

Gilead and Arcus Biosciences Announce Positive Update on Joint TIGIT Program From Interim Analysis of ARC-7 Study in Non-small Cell Lung Cancer

Retrieved on: 
Monday, November 28, 2022

The protocol-specified fourth interim analysis was conducted when the trial reached full enrollment, with a clinical data cutoff date of August 31, 2022.

Key Points: 
  • The protocol-specified fourth interim analysis was conducted when the trial reached full enrollment, with a clinical data cutoff date of August 31, 2022.
  • We will continue to accelerate our TIGIT development program with Arcus, with four ongoing registrational studies in NSCLC and upper GI malignancies.
  • All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
  • The Arcus name and logo are trademarks of Arcus Biosciences, Inc., and Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

Gilead and Arcus Biosciences Announce Positive Update on Joint TIGIT Program From Interim Analysis of ARC-7 Study in Non-Small Cell Lung Cancer

Retrieved on: 
Monday, November 28, 2022

The protocol-specified fourth interim analysis was conducted when the trial reached full enrollment, with a clinical data cutoff date of August 31, 2022.

Key Points: 
  • The protocol-specified fourth interim analysis was conducted when the trial reached full enrollment, with a clinical data cutoff date of August 31, 2022.
  • We will continue to accelerate our TIGIT development program with Arcus, with four ongoing registrational studies in NSCLC and upper GI malignancies.
  • All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
  • The Arcus name and logo are trademarks of Arcus Biosciences, Inc., and Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

Arterys, a Leader in Cloud Medical Imaging, Grows Product and Partner Lineup, Supports Launch of Amazon HealthLake Imaging

Retrieved on: 
Tuesday, November 22, 2022

DeepLook Medical Arterys and DeepLook Medical have joined forces to offer physicians efficiency and remove subjectivity from their oncology workflow.

Key Points: 
  • DeepLook Medical Arterys and DeepLook Medical have joined forces to offer physicians efficiency and remove subjectivity from their oncology workflow.
  • Amazon Web Services (AWS) Arterys is working with AWS to launch Amazon HealthLake Imaging, a new HIPAA-eligible capability for storing, sharing, and analyzing medical images at petabyte scale, now available in preview.
  • HealthLake Imaging enables access to medical imaging data with sub-second image retrieval latencies at scale powered by cloud-native APIs and applications from AWS Partners.
  • Arterys' medical imaging platform, with industry-leading FDA-cleared medical imaging applications and AI, delivers customers a high return on investment, combined with a low cost to implement and manage.

Monopar Announces Encouraging Clinical Data from Ongoing Camsirubicin Phase 1b Trial

Retrieved on: 
Wednesday, November 16, 2022

WILMETTE, Ill., Nov. 16, 2022 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR),a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today released encouraging data from its ongoing Phase 1b open-label clinical trial of camsirubicin in advanced soft tissue sarcoma patients.

Key Points: 
  • WILMETTE, Ill., Nov. 16, 2022 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR),a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today released encouraging data from its ongoing Phase 1b open-label clinical trial of camsirubicin in advanced soft tissue sarcoma patients.
  • The current Phase 1b study is designed to evaluate whether camsirubicin can be dosed even higher than previously achieved and continue for longer than doxorubicin.
  • The Phase 1b trial is an open label dose escalation design to determine the maximum tolerated dose of camsirubicin in advanced soft tissue sarcoma (ASTS) patients.
  • The Phase 1b clinical trial has enrolled 11 patients (8 female and 3 male) to-date ranging in age from 26 to 81 years (median = 49 years).