Pipeline

Batiraxcept (formerly AVB-500), is an ultra-high affinity decoy protein that binds to GAS6 and thereby prevents AXL signaling to inhibit metastasis and tumor growth and restore sensitivity to anti-cancer agents. Batiraxcept is currently being evaluated in multiple clinical trials.

Batiraxcept has been granted Fast Track Designation by the U.S. FDA for both clear cell renal cell carcinoma and platinum-resistant ovarian cancer and Orphan Drug Designation for pancreatic ductal adenocarcinoma. Batiraxcept has been granted Orphan Drug Designation by the European Commission for platinum resistant recurrent ovarian cancer.

Analysis of all safety data to date showed that batiraxcept has been generally well tolerated with no dose-limiting toxicities or unexpected safety signals. A P1B platinum-resistant ovarian cancer trial (N = 53) demonstrated more than a doubling of progression-free survival in a patient subgroup that represents the P3 population.

Indication

Preclinical

Phase 1

Phase 1* | Phase 1b

Phase 2

Phase 2a | Phase 2b

Phase 3

batiraxcept

Ovarian Cancer

Platinum Resistant (batiraxcept + Paclitaxel)

Phase 3

Clear Cell Renal Cancer

2^nd Line (batiraxcept + Cabozantinib)

Phase 1b

Pancreatic Adenocarcinoma

(Advanced Metastatic) 1^st Line (batiraxcept + Gemcitabine + nab-Paclitaxel)

Phase 1*

batiraxcept
Investigator Sponsored Trials

AVB-500 Investigator Sponsored Trials

Ovarian Cancer

Platinum Resistant (batiraxcept + AstraZeneca’s Durvalumab)

Phase 1*

MD Anderson Cancer Center

Advanced Urothelial Cancer

(batiraxcept + EMD Serono’s Avelumab)

Phase 1*

University of Oklahoma

Anti-CTGF

Bispecific Antibodies (Cancer & Fibrosis)

Cancer and Fibrosis

Preclinical

WuXi Biologics
Collaboration

* Phase 1 was conducted in healthy volunteers, allowing any next AVB-500 study to be either phase 1b or phase 2 study

Expansion into additional oncology indications where pre-clinical and biological rationale is strong

IST= investigator sponsored trial

Platinum Resistant Ovarian Cancer

Ovarian cancer ranks fifth in cancer deaths among women, and it is estimated by the American Cancer Society that there will be approximately 19,710 new cases of ovarian cancer in the United States and approximately 13,270 ovarian cancer deaths in the United States during 2023. Due to the nonspecific nature of disease symptoms and lack of validated screening tools in the general population, most women present with advanced disease. Although aggressive cytoreductive surgery and platinum- and taxane-based combination chemotherapy can place most patients into remission, disease recurrence manifests in greater than 70% of patients. Ultimately, patients who relapse become platinum-resistant and the identification of effective and tolerable treatment options is considered a high unmet clinical need. We are focused on addressing the high unmet need in this patient population and successfully completed a Phase 1b trial of batiraxcept in patients with platinum resistant ovarian cancer. We have completed enrollment in a registrational Phase 3 trial of batiraxcept in platinum resistant ovarian cancer (NCT04729608).

Clear Cell Renal Cell Carcinoma

Kidney cancer is a leading cause of cancer-related deaths in the United States and is among the 10 most common cancers in both men and women. According to the American Cancer Society, it is estimated that there will be approximately 81,800 new cases of kidney cancer and 14,890 people will die from this disease in the United States during 2023. Clear cell renal cell carcinoma is a cancer of the kidney and accounts for more than 75% of malignant kidney tumors. Metastasis to distant organs including the lung, bone, liver, and brain is the primary cause of death in kidney cancer patients, and only 12% of people with metastatic kidney cancer will survive past 5 years. We have completed enrollment in a Phase 1b/2 clinical trial of batiraxcept in patients with clear cell renal cell carcinoma (NCT04300140).

Pancreatic Adenocarcinoma

Pancreatic cancer is the seventh leading cause of cancer death worldwide. There were approximately 495,800 new cases of pancreatic cancer and 466,000 deaths from the disease worldwide in 2020. The American Cancer Society estimates 64,050 people will be diagnosed with pancreatic cancer and 50,550 people will die of pancreatic cancer in 2023. Pancreatic cancer typically has a poor prognosis, and the five-year survival rate is approximately 11%. Pancreatic adenocarcinoma is the most common type of pancreatic cancer, and there is a clear, high, unmet medical need to improve patient survival with new effective treatments that are safe and well-tolerated. Pancreatic cancer is projected to become the third leading cause of cancer death worldwide by 2025 and the second leading cause of cancer death in the U.S. by 2030. We have initiated and are recruiting for a Phase 1b/2 clinical trial of batiraxcept in patients with pancreatic adenocarcinoma (NCT04983407).

Pipeline

Indication

Preclinical

Phase 1

Phase 2

Phase 3

Ovarian Cancer

Phase 3

Clear Cell Renal Cancer

Phase 1b

Pancreatic Adenocarcinoma

Phase 1*

Ovarian Cancer

Phase 1*

MD Anderson Cancer Center

Advanced Urothelial Cancer

Phase 1*

University of Oklahoma

Cancer and Fibrosis

Preclinical

WuXi BiologicsCollaboration

Platinum Resistant Ovarian Cancer

Clear Cell Renal Cell Carcinoma

Pancreatic Adenocarcinoma

WuXi Biologics
Collaboration