Amgen Submits MAA for Melanoma Treatment

Two or three companies that I know of are working in this area–oncolytic agents. The idea is to inject a compound into the melanoma lesion, but to have an effect on distant tumors. In Amgen's case the compound, also called T-vec, is a modified virus.

Viruses are much, much smaller than human cells and are basically a box with genetic material inside. In a normal cycle, a virus will attach to the cell wall, punch a hole in the membrane and inject it's own genetic material in the cell. That material moves into the cell nucleus, binds to the the normal DNA and tells the DNA to start making copies of itself. In essence, the genetic material of the virus hijacks the cell's DNA and turns the cell into a cloning machine. After a while, so many copies of the virus have been made they literally burst–or "lyse"–the cell. This causes the viruses to spill out into the area, attach to other cells, and repeat the cycle.

Amgen's drug is a modified virus that only attaches to melanoma cells. In this sense it is "oncolytic"; it "lyses" (bursts) cancer cells. This kills the melanoma cells, but also loads up the area with cellular debris that can help trigger the immune system to find and destroy other melanoma cells.

It also does something else. Part of the modification of the virus means that when the melanoma cell reproduces the viral genetic material it also codes for production of GM-CSF. This is a compound that stimulates the immune system. 

In theory, this drug kills cells, triggers the immune response, then provides a localized booster to the immune system.  Early results of clinical trials have been interesting. Not a home run, but maybe another important component available for fighting melanoma. The best benefit may ultimately be in combination with other drugs, such as an anti-PD-1 drug.

Great news to have another potential drug in the mix.

Tim–MRF

Two or three companies that I know of are working in this area–oncolytic agents. The idea is to inject a compound into the melanoma lesion, but to have an effect on distant tumors. In Amgen's case the compound, also called T-vec, is a modified virus.

Viruses are much, much smaller than human cells and are basically a box with genetic material inside. In a normal cycle, a virus will attach to the cell wall, punch a hole in the membrane and inject it's own genetic material in the cell. That material moves into the cell nucleus, binds to the the normal DNA and tells the DNA to start making copies of itself. In essence, the genetic material of the virus hijacks the cell's DNA and turns the cell into a cloning machine. After a while, so many copies of the virus have been made they literally burst–or "lyse"–the cell. This causes the viruses to spill out into the area, attach to other cells, and repeat the cycle.

Amgen's drug is a modified virus that only attaches to melanoma cells. In this sense it is "oncolytic"; it "lyses" (bursts) cancer cells. This kills the melanoma cells, but also loads up the area with cellular debris that can help trigger the immune system to find and destroy other melanoma cells.

It also does something else. Part of the modification of the virus means that when the melanoma cell reproduces the viral genetic material it also codes for production of GM-CSF. This is a compound that stimulates the immune system. 

In theory, this drug kills cells, triggers the immune response, then provides a localized booster to the immune system.  Early results of clinical trials have been interesting. Not a home run, but maybe another important component available for fighting melanoma. The best benefit may ultimately be in combination with other drugs, such as an anti-PD-1 drug.

Great news to have another potential drug in the mix.

Tim–MRF

Two or three companies that I know of are working in this area–oncolytic agents. The idea is to inject a compound into the melanoma lesion, but to have an effect on distant tumors. In Amgen's case the compound, also called T-vec, is a modified virus.

Viruses are much, much smaller than human cells and are basically a box with genetic material inside. In a normal cycle, a virus will attach to the cell wall, punch a hole in the membrane and inject it's own genetic material in the cell. That material moves into the cell nucleus, binds to the the normal DNA and tells the DNA to start making copies of itself. In essence, the genetic material of the virus hijacks the cell's DNA and turns the cell into a cloning machine. After a while, so many copies of the virus have been made they literally burst–or "lyse"–the cell. This causes the viruses to spill out into the area, attach to other cells, and repeat the cycle.

Amgen's drug is a modified virus that only attaches to melanoma cells. In this sense it is "oncolytic"; it "lyses" (bursts) cancer cells. This kills the melanoma cells, but also loads up the area with cellular debris that can help trigger the immune system to find and destroy other melanoma cells.

It also does something else. Part of the modification of the virus means that when the melanoma cell reproduces the viral genetic material it also codes for production of GM-CSF. This is a compound that stimulates the immune system. 

In theory, this drug kills cells, triggers the immune response, then provides a localized booster to the immune system.  Early results of clinical trials have been interesting. Not a home run, but maybe another important component available for fighting melanoma. The best benefit may ultimately be in combination with other drugs, such as an anti-PD-1 drug.

Great news to have another potential drug in the mix.

Tim–MRF