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DRUG:

batiraxcept (AVB-500)

i
Other names: AVB-500, AVB 500, Aravive S-6, AVB S6 500, Ruga-S6, Aravive S6, Aravive-S6, AVBS6500, AVB-S6-500, 3D229
Company:
3DMed, Aravive, WuXi AppTec
Drug class:
AXL inhibitor, GAS6 inhibitor
3d
AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
P1/2, N=12, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Aug 2025 --> Oct 2024
Trial completion • Trial completion date
|
Imfinzi (durvalumab) • batiraxcept (AVB-500)
30d
AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer (clinicaltrials.gov)
P1, N=0, Withdrawn, Washington University School of Medicine | N=36 --> 0 | Not yet recruiting --> Withdrawn
Enrollment change • Trial withdrawal
|
HER-2 (Human epidermal growth factor receptor 2) • MSI (Microsatellite instability)
|
MSI-H/dMMR
|
paclitaxel • batiraxcept (AVB-500)
2ms
AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
P1/2, N=12, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Aug 2024 --> Aug 2025
Trial completion date • Combination therapy
|
Imfinzi (durvalumab) • batiraxcept (AVB-500)
5ms
AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
P1/2, N=12, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2025 --> Aug 2024 | Trial primary completion date: Feb 2025 --> Aug 2024
Trial completion date • Trial primary completion date • Combination therapy
|
Imfinzi (durvalumab) • batiraxcept (AVB-500)
5ms
AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer (clinicaltrials.gov)
P1, N=36, Not yet recruiting, Washington University School of Medicine | Trial completion date: Jan 2034 --> Jun 2034 | Trial primary completion date: Jan 2029 --> Jun 2029
Trial completion date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • MSI (Microsatellite instability)
|
paclitaxel • batiraxcept (AVB-500)
6ms
Phase 1b study of batiraxcept in combination with durvalumab in patients with platinum-resistant ovarian cancer. (PubMed, iScience)
Batiraxcept effectively reduced serum GAS6 levels at 1-h post-treatment, resulting in trough levels below the limit of detection in all cases but one. In conclusion, the combination of batiraxcept and durvalumab was safe and tolerable but did not demonstrate anti-tumor activity in a heterogenous population of patients with recurrent PROC.
P1 data • Journal • Combination therapy
|
GAS6 (Growth arrest specific 6)
|
Imfinzi (durvalumab) • batiraxcept (AVB-500)
10ms
AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer (clinicaltrials.gov)
P1, N=36, Not yet recruiting, Washington University School of Medicine | Trial completion date: Aug 2033 --> Nov 2033 | Initiation date: Dec 2023 --> Mar 2024 | Trial primary completion date: Aug 2028 --> Nov 2028
Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • MSI (Microsatellite instability)
|
MSI-H/dMMR
|
paclitaxel • batiraxcept (AVB-500)
10ms
AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
P1/2, N=12, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
Trial completion date • Trial primary completion date • Combination therapy
|
Imfinzi (durvalumab) • batiraxcept (AVB-500)
10ms
Enrollment change • Combination therapy
|
Imfinzi (durvalumab) • batiraxcept (AVB-500)
1year
AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer (clinicaltrials.gov)
P1, N=36, Not yet recruiting, Washington University School of Medicine | Trial completion date: Apr 2033 --> Aug 2033 | Initiation date: Sep 2023 --> Dec 2023 | Trial primary completion date: May 2028 --> Aug 2028
Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • MSI (Microsatellite instability) • GAS6 (Growth arrest specific 6)
|
MSI-H/dMMR
|
paclitaxel • batiraxcept (AVB-500)
1year
AVB500-RCC-003: Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma (clinicaltrials.gov)
P1b/2, N=72, Terminated, Aravive, Inc. | Trial completion date: Mar 2025 --> Aug 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2024 --> Aug 2023; Due to business reasons
Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
|
GAS6 (Growth arrest specific 6)
|
Opdivo (nivolumab) • Cabometyx (cabozantinib tablet) • batiraxcept (AVB-500)
1year
ENGOT OV66: Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer (clinicaltrials.gov)
P3, N=366, Terminated, Aravive, Inc. | There was no detriment to overall survival. No new safety signals were identified.
Trial completion date • Trial termination • Combination therapy
|
paclitaxel • batiraxcept (AVB-500)
1year
AVB500-PC-005: Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov)
P1b/2, N=34, Terminated, Aravive, Inc. | N=99 --> 34 | Trial completion date: Oct 2025 --> Aug 2023 | Recruiting --> Terminated | Trial primary completion date: Oct 2024 --> Aug 2023; Due to business reasons
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
|
GAS6 (Growth arrest specific 6)
|
gemcitabine • albumin-bound paclitaxel • batiraxcept (AVB-500)
1year
COAXIN: Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma (clinicaltrials.gov)
P1, N=19, Active, not recruiting, University of Oklahoma | Trial primary completion date: Aug 2023 --> Jan 2024
Trial primary completion date • Combination therapy • Metastases
|
Bavencio (avelumab) • batiraxcept (AVB-500)
over1year
Phase Ib/II study of batiraxcept (BT, AVB-S6-500, an AXL pathway inhibitor) in combination with cabozantinib (cabo) in patients with advanced clear cell renal cell carcinoma (ccRCC) who failed first-line (1L) therapy (ESMO 2023)
Table: 1889P Conclusions BT + cabo demonstrated acceptable tolerability and promising efficacy in treatment-refractory ccRCC pts. BT + cabo will be further studied in a P3 trial of 2L+ ccRCC patients whose disease has progressed following IO and VEGF-TKI therapies.
Clinical • P1/2 data • Combination therapy • Metastases
|
AXL (AXL Receptor Tyrosine Kinase) • GAS6 (Growth arrest specific 6)
|
Cabometyx (cabozantinib tablet) • batiraxcept (AVB-500)
over1year
New P1 trial • Combination therapy
|
GAS6 (Growth arrest specific 6)
|
paclitaxel • docetaxel • batiraxcept (AVB-500)
over1year
Targeting AXL Using the AVB-500 Soluble Receptor and through Genetic Knockdown Inhibits Bile Duct Cancer Growth and Metastasis. (PubMed, Cancers (Basel))
Most importantly, AVB-500 was highly effective at decreasing tumor dissemination of bile duct tumor cells in the peritoneal cavity. This study strongly supports the idea of using the AXL receptor as a new therapeutic target to treat the growth and progression of biliary cancer.
Journal
|
AXL (AXL Receptor Tyrosine Kinase)
|
AXL expression
|
batiraxcept (AVB-500)
over1year
Trial completion
|
GAS6 (Growth arrest specific 6)
|
paclitaxel • pegylated liposomal doxorubicin • batiraxcept (AVB-500)
over1year
Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov)
P1b/2, N=99, Recruiting, Aravive, Inc. | Trial completion date: Apr 2024 --> Oct 2025 | Trial primary completion date: Apr 2023 --> Oct 2024
Trial completion date • Trial primary completion date • Metastases
|
GAS6 (Growth arrest specific 6)
|
gemcitabine • albumin-bound paclitaxel • batiraxcept (AVB-500)
almost2years
AVB500-RCC-003: Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma (clinicaltrials.gov)
P1b/2, N=80, Active, not recruiting, Aravive, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Mar 2025 | Trial primary completion date: Dec 2022 --> Dec 2024
Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
GAS6 (Growth arrest specific 6)
|
Opdivo (nivolumab) • Cabometyx (cabozantinib tablet) • batiraxcept (AVB-500)
2years
GAS6-AXL inhibition by AVB-500 overcomes resistance to paclitaxel in endometrial cancer by decreasing tumor cell glycolysis. (PubMed, Mol Cancer Ther)
We showed that chemotherapy-resistant endometrial cancer cells (ARK1, uterine serous carcinoma and PUC198, grade 3 endometrioid adenocarcinoma) had improved sensitivity and synergy with paclitaxel and carboplatin when treated in combination with AVB-500. Finally, multiple glycolytic metabolites were lower in the tumors treated with AVB-500 + paclitaxel than in tumors treated with paclitaxel alone. Our study provides strong pre-clinical rationale for combining AVB-500 with paclitaxel in aggressive endometrial cancer models.
Journal
|
AURKA (Aurora kinase A) • GAS6 (Growth arrest specific 6)
|
AXL expression
|
carboplatin • paclitaxel • batiraxcept (AVB-500)
over2years
AVB-S6-500, a Receptor Tyrosine Kinase AXL Inhibitor, Improves the Therapeutic Efficacy of Trastuzumab in Uterine Serous Cancers. (SRI 2022)
The GAS6/AXL inhibitor AVB-500 potentiated the effect of Trastuzumab to decrease uterine serous cancer cell proliferation and invasion in vitro and tumor burden in vivo. There was co-localization of AXL and HER2 receptors seen in both uterine serous cancer cell lines. Our data suggest that the addition of AVB-S6-500 increased the therapeutic efficacy of Trastuzumab therapy in uterine serous cancers.
Clinical
|
AURKA (Aurora kinase A)
|
HER-2 expression
|
Herceptin (trastuzumab) • batiraxcept (AVB-500)
almost3years
AVB-S6-500, a receptor tyrosine kinase AXL inhibitor, improves the therapeutic efficacy of trastuzumab in uterine serous cancers (SGO 2022)
Learning Objective: Conclude that the combination of Trastuzumab and AVB500 lead to decrease uterine serous cancer cell proliferation and invasion in vitro and tumor burden in vivo in uterine serous cancer cell lines that express both AXL and HER2/neu receptors.
Clinical
|
HER-2 (Human epidermal growth factor receptor 2) • AXL (AXL Receptor Tyrosine Kinase)
|
HER-2 expression
|
Herceptin (trastuzumab) • batiraxcept (AVB-500)
almost3years
Inhibition of AXL and VEGF-A Has Improved Therapeutic Efficacy in Uterine Serous Cancer. (PubMed, Cancers (Basel))
In addition, intraperitoneal mouse models demonstrated a significant decrease in tumor burden in two cell lines. The combination of AVB-500 and bevacizumab reduced tumor burden in vivo and reduced morphogenesis and migration in vitro which are vital to the process of angiogenesis.
Clinical • Journal
|
AXL (AXL Receptor Tyrosine Kinase) • CD31 (Platelet and endothelial cell adhesion molecule 1)
|
Avastin (bevacizumab) • batiraxcept (AVB-500)
3years
GAS6/AXL inhibition enhances ovarian cancer sensitivity to chemotherapy and PARP inhibition through increased DNA damage and enhanced replication stress. (PubMed, Mol Cancer Res)
Compared to chemotherapy alone, AVB-500 plus carboplatin and/or paclitaxel led to decreased ovarian cancer cell survival in vitro and tumor burden in vivo. Implications: GAS6/AXL is a novel target to sensitize ovarian cancers to carboplatin and olaparib. Additionally, GAS6 levels can be associated with response to carboplatin treatment.
Journal • PARP Biomarker
|
HRD (Homologous Recombination Deficiency) • AXL (AXL Receptor Tyrosine Kinase) • RAD51 (RAD51 Homolog A) • GAS6 (Growth arrest specific 6)
|
Lynparza (olaparib) • carboplatin • paclitaxel • batiraxcept (AVB-500)
3years
A Phase 1b/2 randomized study of AVB-S6-500 in combination with cabozantinib versus cabozantinib alone in patients with advanced clear cell renal cell carcinoma who have received front-line treatment (KCRS 2021)
Key eligibility criteria: ≥ 18 years, histologically confirmed metastatic ccRCC, and progression after 1st line therapy. Enrollment began December 2020.
Clinical • P1/2 data • Combination therapy
|
HIF1A (Hypoxia inducible factor 1, alpha subunit) • GAS6 (Growth arrest specific 6)
|
AXL overexpression • HIF1A expression
|
Cabometyx (cabozantinib tablet) • batiraxcept (AVB-500)
3years
AVB500-OC-002: Efficacy and Safety Study of AVB-S6-500 in Patients With Platinum-Resistant Recurrent Ovarian Cancer (clinicaltrials.gov)
P1b/2, N=53, Active, not recruiting, Aravive, Inc. | Trial primary completion date: Dec 2021 --> Jan 2021
Clinical • Trial primary completion date • Combination therapy
|
GAS6 (Growth arrest specific 6)
|
paclitaxel • pegylated liposomal doxorubicin • batiraxcept (AVB-500)
3years
Phase 1b study of AVB-500 in combination with paclitaxel or pegylated liposomal doxorubicin platinum-resistant recurrent ovarian cancer. (PubMed, Gynecol Oncol)
AVB-500 was well-tolerated in combination with PAC or PLD and contributed to the clinical activity of PAC in PROC patients. Subgroup analyses identified a population of PROC patients who may benefit the most from AVB-500 treatment, which will be further assessed in an ongoing Phase 3 PROC trial.
P1 data • Journal • Combination therapy
|
GAS6 (Growth arrest specific 6)
|
Avastin (bevacizumab) • paclitaxel • pegylated liposomal doxorubicin • batiraxcept (AVB-500)
3years
[VIRTUAL] INHIBITION OF CANCER CELL-DEPENDENT GLYCOLYSIS THROUGH AVB-500, A SELECTIVE INHIBITOR OF GAS6-AXL, IN COMBINATION WITH PACLITAXEL IN HIGH-GRADE ENDOMETRIAL CANCER (IGCS 2021)
We demonstrate that the addition AVB-500 to paclitaxel improves endometrial cancer chemo-sensitivity. We show that this therapeutic combination decreases basal glycolysis through reduced PI3K/AKT signaling. This provides a metabolic mechanism for increasing uterine cancer sensitivity to chemotherapy.
Combination therapy
|
AXL (AXL Receptor Tyrosine Kinase) • AURKA (Aurora kinase A) • GAS6 (Growth arrest specific 6)
|
AXL overexpression
|
paclitaxel • batiraxcept (AVB-500)
3years
Safety and Efficacy Study of AVB-S6-500 in Patients With Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov)
P1b/2, N=80, Recruiting, Aravive, Inc. | Not yet recruiting --> Recruiting
Enrollment open
|
GAS6 (Growth arrest specific 6)
|
gemcitabine • albumin-bound paclitaxel • batiraxcept (AVB-500)
over3years
Clinical • Enrollment open • Combination therapy
|
GAS6 (Growth arrest specific 6)
|
paclitaxel • batiraxcept (AVB-500)
almost4years
[VIRTUAL] Phase I study of GAS6/AXL inhibitor (AVB-500) in recurrent, platinum-resistant ovarian carcinoma (SGO 2021)
The purpose of this study was to evaluate safety, tolerability, and preliminary efficacy of AVB-500 in combination with pegylated liposomal doxorubicin (PLD) and paclitaxel (Pac) and determine the RP2D...Exploratory analysis also suggested that improved response rates may be observed in patients who have not been exposed to bevacizumab. AVB-500 is a novel Fc fusion protein that binds the GAS6 ligand and targets GAS6/AXL pathway. AVB-500was found to be safe and tolerable in this Ph1B trial in combination with Paclitaxel or PLD. The RP2D was based upon PK/PD parameters.
P1 data
|
GAS6 (Growth arrest specific 6)
|
Avastin (bevacizumab) • paclitaxel • pegylated liposomal doxorubicin • batiraxcept (AVB-500)
almost4years
[VIRTUAL] GAS6 inhibition induces platinum sensitivity through increased replication stress in ovarian cancer (SGO 2021)
We hypothesized that GAS6 inhibition with AVB-500 (AVB) sensitizes platinum-resistant cells to platinum chemotherapy by stalling replication forks and increasing replication stress...For DNA fiber assays, cells were labeled with the thymidine analog IdU for 20 minutes followed by CldU for 60 minutes and treatment with carbo, cisplatin (cis), or AVB...Combenefit analyses confirmed AVB and carboplatin were synergistic... Inhibition of the GAS6 pathway with AVB improves sensitivity of platinum-resistant cells to platinum chemotherapy by increasing replication stress and DNA damage and decreasing HR. GAS6 is a potential biomarker predictive of poor response to platinum-based neoadjuvant chemotherapy and might identify patients who would benefit from treatment with AVB.
BRCA Biomarker
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • RAD51 (RAD51 Homolog A) • TP53BP1 (Tumor Protein P53 Binding Protein 1)
|
cisplatin • carboplatin • batiraxcept (AVB-500)
almost4years
Clinical • Combination therapy
|
AXL (AXL Receptor Tyrosine Kinase) • GAS6 (Growth arrest specific 6)
|
paclitaxel • batiraxcept (AVB-500)
almost4years
Combination therapy
|
AXL (AXL Receptor Tyrosine Kinase) • GAS6 (Growth arrest specific 6)
|
paclitaxel • batiraxcept (AVB-500)
almost4years
Clinical • New P3 trial • Combination therapy
|
GAS6 (Growth arrest specific 6)
|
paclitaxel • batiraxcept (AVB-500)
4years
AVB500-OC-002: Efficacy and Safety Study of AVB-S6-500 in Patients With Platinum-Resistant Recurrent Ovarian Cancer (clinicaltrials.gov)
P1b/2, N=53, Active, not recruiting, Aravive, Inc. | Recruiting --> Active, not recruiting | N=196 --> 53
Clinical • Enrollment closed • Enrollment change • Combination therapy
|
GAS6 (Growth arrest specific 6)
|
paclitaxel • pegylated liposomal doxorubicin • batiraxcept (AVB-500) • doxorubicin liposomal
over4years
Inducing 'BRCAness' by inhibiting the GAS6/AXL pathway in high-grade serous ovarian cancer (SGO 2020)
Our objective was to determine whether GAS6/AXL inhibition with AVB500 (AVB) can increase platinum and poly(ADP-ribose) polymerase inhibitor (PARPi) response through inducing "BRCAness" in sporadic high-grade serous ovarian cancer (HGSC) models and identify the ligand GAS6 as a marker for poor response to platinum...Patient-derived xenograft (PDX) and OVCAR5 intraperitoneal (IP) mouse models were used to determine response to carboplatin, paclitaxel, and AVB (C+P+A) as well as olaparib and AVB (O+A)... Inhibition of this GAS6/AXL pathway with AVB induces BRCAness in sporadic HGSC, which leads to an improved sensitivity to carboplatin and olaparib. In addition, high levels of GAS6 can identify patients who have worse response to platinum-based chemotherapy and may benefit from this novel GAS6/AXL inhibitor.
BRCA Biomarker • PARP Biomarker
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • GAS6 (Growth arrest specific 6)
|
Lynparza (olaparib) • carboplatin • paclitaxel • batiraxcept (AVB-500)