AVB-001 / Avenge Bio, Rice University - LARVOL DELTA

A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary (clinicaltrials.gov) - P1/2 | N=14 | Terminated | Sponsor: Avenge Bio, Inc | Trial completion date: Aug 2026 ➔ Apr 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Aug 2026 ➔ Apr 2024; Sponsor Decision to close study

Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • BRCA

A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary (clinicaltrials.gov) - P1/2 | N=14 | Active, not recruiting | Sponsor: Avenge Bio, Inc | Recruiting ➔ Active, not recruiting | N=44 ➔ 14

Enrollment change • Enrollment closed • Breast Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • BRCA

Overcoming immunosuppressive tumors by stimulating the adaptive and innate immune systems (SITC 2023) - P1/2 | "A Phase 1/2 clinical trial of AVB-001 in metastatic peritoneal cancers is actively enrolling (NCT05538624). Our platform enables itself to deliver a diverse set of immunomodulators alone and in combination which is presently being explored."

Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Kidney Cancer • Lung Cancer • Melanoma • Mesothelioma • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • IL2

Avenge Bio to Present at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting (PRNewswire) - "Avenge Bio, Inc...announced their poster presentation at the Society of Immunotherapy of Cancer 38th Annual Meeting (SITC 2023) on November 1-5, 2023, in San Diego, California....Avenge is currently enrolling patients in a First-in-Human, Phase 1/2, multicenter clinical trial (NCT05538624) designed to evaluate the safety and efficacy of AVB-001. The Company has advanced through multiple dose levels in a dose escalation cohort and expects to initiate a Phase 2 dose expansion trial in 1H 2024....The poster will present how a single administration of either AVB-001 or AVB-002, engineered to produce native human IL-2 or native human IL-12 respectively, demonstrated complete responses as monotherapy and provided sustained eradication in various mouse tumor models. In addition, the poster will also present the commonalities and differences between AVB-001 and AVB-002 in modulating the innate and adaptive anti-tumor immune response."

Preclinical • Trial status • Oncology

Avenge Bio Receives FDA Fast Track Designation for AVB-001, a Novel Cell Therapy Leveraging the LOCOcyte Immunotherapy Platform (PRNewswire) - "Regulatory Designation includes platinum-resistant, high grade serous adenocarcinoma of the ovary, primary peritoneum or fallopian tube. Phase 2 Dose expansion trial expected to initiate in 1H 2024....Avenge Bio, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for AVB-001 for treatment of patients with relapsed resistant/refractory ovarian cancer."

Fast track designation • Trial status • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Refractory Ovarian Cancer

A phase 1/2 open-label, multicenter, dose escalation and expansion study of AVB-001, an intraperitoneally administered, cell-generated, human IL-2 immunotherapy in patients with platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube. (ASCO 2023) - P1/2 | "Recruitment in dose level 1 cohort continues. Clinical trial information: NCT05538624."

Clinical • P1/2 data • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • IL2

Avenge Bio Receives FDA Orphan Drug Designation for AVB-001 for the Treatment of Mesothelioma (PRNewswire) - "Avenge Bio...announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to AVB-001 for the treatment of patients with mesothelioma....In March 2023, Avenge received positive feedback from the FDA on its preclinical and clinical development plans for pleural malignant mesothelioma."

Orphan drug • Lung Cancer • Mesothelioma • Oncology • Solid Tumor • Thoracic Cancer

Avenge Bio to Participate in Upcoming Scientific & Investor Conferences (PRNewswire) - "Avenge Bio, Inc...announced participation in the upcoming scientific and investor conferences...American Society of Clinical Oncology (ASCO) Annual Meeting – June 2-6, 2023."

P1/2 data • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor

Avenge Bio Announces Successful Completion of First Dose Level Cohort in Phase 1/2 Clinical Trial of AVB-001 for the Treatment of Ovarian Cancer (PRNewswire) - "Avenge Bio, Inc....announced the successful completion of the first dose cohort in a Phase 1/2 clinical trial of AVB-001 in patients with refractory ovarian cancer....The Phase 1/2 clinical trial is a first-in-human, single-arm, open-label, dose-escalation and expansion study (NCT05538624) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of AVB-001 delivered intraperitoneally (IP) to patients with high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube."

Trial status • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor

A phase 1/2 open-label, multicenter, dose escalation and expansion study of AVB-001, an intraperitoneally administered, cell-generated, human IL-2 immunotherapy in patients with platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube (AACR 2023) - P1/2 | "The first patient was dosed in December 2022. Recruitment in dose level 1 cohort continues."

Clinical • P1/2 data • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • IL2

Favorable preclinical efficacy and safety profile of AVB-001, a novel IL-2 cell-based immunotherapy that eradicates ovarian cancer in mouse tumor models and supports first-in-human clinical development (SGO 2023) - No abstract available

P1 data • Preclinical • Oncology • Ovarian Cancer • Solid Tumor • IL2

Avenge Bio Announces Presentations at Two Key Upcoming Annual Conferences (PRNewswire) - "Avenge Bio, Inc...today announced their posters were selected for presentation at the Society of Gynecologic Oncology's (SGO) 2023 Annual Meeting on Women's Cancer in Tampa, Florida on March 25-28, 2023 and the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando, Florida on April 14-19, 2023."

P1/2 data • Preclinical • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

BioCentriq Announces Successful Tech Transfer From Avenge Bio for Manufacturing of Drug Product AVB-001 Resulting in Dosing of First Patient in Phase 1/2 Clinical Trial (PRNewswire) - "BioCentriq...announced today that they have successfully completed tech transfer of AVB-001 from client Avenge Bio and initiated manufacturing of clinical grade material, which will support Avenge Bio's ongoing phase 1/2 clinical trial....Additionally, Avenge Bio announced on the 9th of January that they successfully dosed the first patient in a First-in-Human Phase 1/2 clinical trial evaluating AVB-001 in relapsed refractory ovarian cancer."

Commercial • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor

Avenge Bio Announces Dosing of First Patient in Phase 1/2 Clinical Trial Evaluating AVB-001 for the Treatment of Ovarian Cancer (PRNewswire) - "Avenge Bio...announced dosing of the first patient in a First-in-Human Phase 1/2 clinical trial evaluating AVB-001 in relapsed refractory ovarian cancer....This first-in-human, single-arm, open-label, dose-escalation and expansion study (NCT05538624) is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of AVB-001 delivered intraperitoneally (IP) to patients with high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube."

Trial status • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor

A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary (clinicaltrials.gov) - P1/2 | N=44 | Recruiting | Sponsor: Avenge Bio, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor • BRCA

Favorable preclinical efficacy and safety profile of AVB-001 a novel IL-2 cell-based immunotherapy that eradicates ovarian cancer in mouse tumor models and supports first in human clinical development (SITC 2022) - "Background Aldesleukin, recombinant human IL-2 has been approved by the FDA for the treatment of melanoma and renal cancer. Avenge Bio aims to pursue a Phase 1 First in Human study of AVB-001 in ovarian cancer patients. The LOCOcyte TM platform enables delivery of a diverse set of cytokines alone or in combination which is presently being explored."

IO biomarker • P1 data • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Kidney Cancer • Melanoma • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • IL2

Avenge Bio to Present Preclinical Data at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting (PRNewswire) - "Avenge Bio...announced that three abstracts were selected for presentation as posters at the Society of Immunotherapy of Cancer (SITC) 37th Annual Meeting on November 10-11, 2022....Avenge's most advanced product candidate, AVB-001, produces native IL-2 immunotherapy and is initially being studied in metastatic peritoneal cancers such as ovarian cancer....The Phase 1, multicenter clinical trial is expected to be initiated in Q4 2022."

New P1 trial • Preclinical • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary (clinicaltrials.gov) - P1/2 | N=44 | Not yet recruiting | Sponsor: Avenge Bio, Inc

New P1/2 trial • Breast Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor • BRCA

Avenge Bio Announces Peer-Reviewed Publication on Preclinical Proof-of-Concept for LOCOcyte Platform Technology in Malignant Mesothelioma (PRNewswire) - "Avenge Bio, Inc...announced a publication in the peer-reviewed journal Clinical Cancer Research describing the foundational, preclinical data establishing the efficacy and safety of pleural administered LOCOcyte™ for the treatment of pleural malignant mesothelioma...Overall, we observed a significant reduction of tumor burden in mice treated with IL2 monotherapy and complete eradication of tumor burden in mice treated with IL2 and an immune checkpoint inhibitor combination therapy....Avenge announced that Food and Drug Administration ('FDA') cleared the Investigational New Drug ('IND') application for AVB-001 for the treatment of platinum resistance ovarian cancer. The Phase 1, multi-center clinical trial is expected to be initiated in the second half of 2022."

New P1 trial • Preclinical • Gynecologic Cancers • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Ovarian Cancer • Solid Tumor

Avenge Bio Announces FDA Clearance of the AVB-001 IND for the Treatment of Ovarian Cancer, a Novel Cellular Therapy Leveraging the LOCOcyte Immunotherapy Platform (PRNewswire) - "Avenge Bio, Inc...announced that the Food and Drug Administration ('FDA') cleared the Investigational New Drug ('IND') application for AVB-001 in peritoneal malignancies....The Phase 1, multi-center clinical trial is expected to be initiated in the second half of 2022 and will evaluate the tolerability of AVB-001, determine a recommended dose for Phase 2, measure immunological changes in the blood and peritoneal environment, and assess anti-tumor activity."

IND • New P1 trial • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Avenge Bio Presents Preclinical Data at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting (PRNewswire) - "Avenge Bio...announced that two abstracts were selected for presentation as posters at the 25th Annual American Society of Gene & Cell Therapy (ASGCT) Meeting on May 17 and 18, 2022. 'We are excited to present additional preclinical data that support our lead development program, AVB-001, as we advance towards filing an IND in Q2 2022 and a Phase 1 clinical trial in ovarian cancer in 2H 2022'..."

IND • New P1 trial • Preclinical • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor