01.18.23
BioCentriq, a New Jersey-based, cell and gene therapy contract development and manufacturing organization (CDMO), has 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 January 9, 2023, 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. AVB-001, developed in the LOCOcyte platform, consists of proprietary engineered allogeneic human cells.
"We're very enthusiastic about the advances our client has made in the development of their novel allogeneic cell therapy. Our goal now is to continue offering strong support and process development and manufacturing expertise as Avenge advances through their program," said Haro Hartounian, CEO, BioCentriq.
Avenge Bio's 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.
The cells are encapsulated in a pro-inflammatory biomaterial that are delivered to the local tumor environment and generate high, sustained concentrations of native IL-2. The product initiates a robust and durable, local and systemic immune response while avoiding toxicities associated with systemic immunotherapies.
Doug Carlson, chief operating and financial officer at Avenge Bio, said, "This major milestone comes at a time when there are limited treatment options for those with relapsed refractory ovarian cancer. Ovarian cancer is notoriously difficult to treat and ranks fifth in cancer deaths among women. Our LOCOcyte platform addresses existing challenges and is a promising new potential treatment option for patients.
Additionally, Avenge Bio announced on the January 9, 2023, 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. AVB-001, developed in the LOCOcyte platform, consists of proprietary engineered allogeneic human cells.
"We're very enthusiastic about the advances our client has made in the development of their novel allogeneic cell therapy. Our goal now is to continue offering strong support and process development and manufacturing expertise as Avenge advances through their program," said Haro Hartounian, CEO, BioCentriq.
Avenge Bio's 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.
The cells are encapsulated in a pro-inflammatory biomaterial that are delivered to the local tumor environment and generate high, sustained concentrations of native IL-2. The product initiates a robust and durable, local and systemic immune response while avoiding toxicities associated with systemic immunotherapies.
Doug Carlson, chief operating and financial officer at Avenge Bio, said, "This major milestone comes at a time when there are limited treatment options for those with relapsed refractory ovarian cancer. Ovarian cancer is notoriously difficult to treat and ranks fifth in cancer deaths among women. Our LOCOcyte platform addresses existing challenges and is a promising new potential treatment option for patients.
