FDA Ponders Vaccines From Human Tumor Cell Lines

A Food and Drug Administration advisory panel will meet Sept. 19 to discuss the use of cell lines derived from human tumors to manufacture vaccines.

The Vaccines and Related Biological Products Advisory Committee meeting comes as several therapeutic cancer vaccines derived from tumor cell lines are in phase III trials. As applications come in, the agency must determine how to address issues such as genetic stability and product characterization.

NovaRx Corp. reported June 20 that it has completed enrollment in its phase III clinical trial of belagenpumatucel-L (Lucanix), a whole-tumor cell vaccine for non–small cell lung cancer.The first interim analysis of overall survival will occur in the third quarter of 2012. If the independent data-monitoring committee finds that the trial meets statistical significance for the prespecified end points, the company anticipates filing a Biologics License Application (BLA) based on those results.

The allogeneic vaccine is composed of human tumor cells modified to block production of transforming growth factor–beta (TGF-beta). Tumors use TGF-beta to hide from the immune system, so blocking production allows the initiation of strong immune responses to the tumor, according to the company.

Another whole-tumor cell vaccine, algenpantucel-L (HyperAcute Pancreas) from NewLink Genetics Corp., is in phase III trials with stages I and II surgically resected pancreatic cancer patients. Those trials reached the midpoint of enrollment in the second quarter, the company said on June 19.The first interim analysis of data is expected in early 2013.

Algenpantucel- L contains two allogeneic pancreatic cancer tumor cell lines that were modified to express alpha-gal. Each cell line provides a broad range of pancreatic cancer antigens to the vaccine, which is administered by intradermal injection. Phase III patients receive a series of up to 18 treatments over a period of about 6 months, followed by monthly maintenance treatments for 6 months. The primary end point of the trial is overall survival.

The modified cell lines are grown in large cultures, then harvested, irradiated, and packaged, with about 150 million cells of each delivered with each treatment.

An advantage to the whole-tumor cell vaccines is that they are off the shelf, facilitating manufacturing to fit demand and lowering production costs.

This contrasts with autologous vaccines that are customized for each patient. Dendreon Corp. has faced slow sales for its prostate cancer vaccine sipuleucel-T (Provenge), the first therapeutic cancer vaccine to gain FDA approval, largely because of cost and manufacturing complexity.

Encouraged by sipuleucel-T’s approval and undaunted by its slow sales, several autologous vaccines featuring different technologies were on view at the American Society of Clinical Oncology annual meeting in June.

Editor’s note: This story appears courtesy of "The Pink Sheet," a weekly Elsevier publication covering pharmaceutical business and policy issues. To learn more, contact customer care at 800-332-2181 or sign up for a free trial.

A Food and Drug Administration advisory panel will meet Sept. 19 to discuss the use of cell lines derived from human tumors to manufacture vaccines.

The Vaccines and Related Biological Products Advisory Committee meeting comes as several therapeutic cancer vaccines derived from tumor cell lines are in phase III trials. As applications come in, the agency must determine how to address issues such as genetic stability and product characterization.

NovaRx Corp. reported June 20 that it has completed enrollment in its phase III clinical trial of belagenpumatucel-L (Lucanix), a whole-tumor cell vaccine for non–small cell lung cancer.The first interim analysis of overall survival will occur in the third quarter of 2012. If the independent data-monitoring committee finds that the trial meets statistical significance for the prespecified end points, the company anticipates filing a Biologics License Application (BLA) based on those results.

The allogeneic vaccine is composed of human tumor cells modified to block production of transforming growth factor–beta (TGF-beta). Tumors use TGF-beta to hide from the immune system, so blocking production allows the initiation of strong immune responses to the tumor, according to the company.

Another whole-tumor cell vaccine, algenpantucel-L (HyperAcute Pancreas) from NewLink Genetics Corp., is in phase III trials with stages I and II surgically resected pancreatic cancer patients. Those trials reached the midpoint of enrollment in the second quarter, the company said on June 19.The first interim analysis of data is expected in early 2013.

Algenpantucel- L contains two allogeneic pancreatic cancer tumor cell lines that were modified to express alpha-gal. Each cell line provides a broad range of pancreatic cancer antigens to the vaccine, which is administered by intradermal injection. Phase III patients receive a series of up to 18 treatments over a period of about 6 months, followed by monthly maintenance treatments for 6 months. The primary end point of the trial is overall survival.

The modified cell lines are grown in large cultures, then harvested, irradiated, and packaged, with about 150 million cells of each delivered with each treatment.

An advantage to the whole-tumor cell vaccines is that they are off the shelf, facilitating manufacturing to fit demand and lowering production costs.

This contrasts with autologous vaccines that are customized for each patient. Dendreon Corp. has faced slow sales for its prostate cancer vaccine sipuleucel-T (Provenge), the first therapeutic cancer vaccine to gain FDA approval, largely because of cost and manufacturing complexity.

Encouraged by sipuleucel-T’s approval and undaunted by its slow sales, several autologous vaccines featuring different technologies were on view at the American Society of Clinical Oncology annual meeting in June.

Editor’s note: This story appears courtesy of "The Pink Sheet," a weekly Elsevier publication covering pharmaceutical business and policy issues. To learn more, contact customer care at 800-332-2181 or sign up for a free trial.

A Food and Drug Administration advisory panel will meet Sept. 19 to discuss the use of cell lines derived from human tumors to manufacture vaccines.

The Vaccines and Related Biological Products Advisory Committee meeting comes as several therapeutic cancer vaccines derived from tumor cell lines are in phase III trials. As applications come in, the agency must determine how to address issues such as genetic stability and product characterization.

NovaRx Corp. reported June 20 that it has completed enrollment in its phase III clinical trial of belagenpumatucel-L (Lucanix), a whole-tumor cell vaccine for non–small cell lung cancer.The first interim analysis of overall survival will occur in the third quarter of 2012. If the independent data-monitoring committee finds that the trial meets statistical significance for the prespecified end points, the company anticipates filing a Biologics License Application (BLA) based on those results.

The allogeneic vaccine is composed of human tumor cells modified to block production of transforming growth factor–beta (TGF-beta). Tumors use TGF-beta to hide from the immune system, so blocking production allows the initiation of strong immune responses to the tumor, according to the company.

Another whole-tumor cell vaccine, algenpantucel-L (HyperAcute Pancreas) from NewLink Genetics Corp., is in phase III trials with stages I and II surgically resected pancreatic cancer patients. Those trials reached the midpoint of enrollment in the second quarter, the company said on June 19.The first interim analysis of data is expected in early 2013.

Algenpantucel- L contains two allogeneic pancreatic cancer tumor cell lines that were modified to express alpha-gal. Each cell line provides a broad range of pancreatic cancer antigens to the vaccine, which is administered by intradermal injection. Phase III patients receive a series of up to 18 treatments over a period of about 6 months, followed by monthly maintenance treatments for 6 months. The primary end point of the trial is overall survival.

The modified cell lines are grown in large cultures, then harvested, irradiated, and packaged, with about 150 million cells of each delivered with each treatment.

An advantage to the whole-tumor cell vaccines is that they are off the shelf, facilitating manufacturing to fit demand and lowering production costs.

This contrasts with autologous vaccines that are customized for each patient. Dendreon Corp. has faced slow sales for its prostate cancer vaccine sipuleucel-T (Provenge), the first therapeutic cancer vaccine to gain FDA approval, largely because of cost and manufacturing complexity.

Encouraged by sipuleucel-T’s approval and undaunted by its slow sales, several autologous vaccines featuring different technologies were on view at the American Society of Clinical Oncology annual meeting in June.

Editor’s note: This story appears courtesy of "The Pink Sheet," a weekly Elsevier publication covering pharmaceutical business and policy issues. To learn more, contact customer care at 800-332-2181 or sign up for a free trial.