Pharmaceutical developers are combining genetic sequencing and precision medicine to create new drug therapies and cancer treatments designed for specific patients

Most anatomic pathologists are aware of the rapid advances in the field of cancer immunotherapy—sometimes also called immune-oncology. This is an area of healthcare where precision medicine and personal genetics become crucial elements in developing more effective drug regimens.

Scientists are combining those two areas of research to develop vaccines designed for specific individuals based on the genetic characteristics of their DNA. This is why there are great hopes that cancer immunotherapy can be used to artificially stimulate the immune system to treat cancer and improve the system’s natural ability to fight cancer.

San Francisco-based Genentech, a subsidiary of Swiss pharmaceutical giant Roche (OTCMKTS:RHHBY), is working with German company BioNTech to develop such personalized vaccines for cancer patients. Each vaccine would be based on the unique deoxyribonucleic acid (DNA) of a patient’s tumor.

Unlike typical vaccines, Genentech’s drug would not be taken as a preventative measure. Instead, patients receive it after being diagnosed with cancer.

Though still being tested, this new line of research indicates that development of personalized cancer treatments is progressing, as scientists strive to customizetreatments tumor by tumor. 

Creating One-Off Vaccines

To create each vaccine, a patient first undergoes a tumor biopsy. The sample tissue is then sent to a genetics laboratory for full genome sequencing. Sophisticated algorithms analyze the genetic data and locate targets within the tumor that have the most potential for training the patient’s immune system to attack the existing cancer. A customized vaccine is then created for and administered to the patient.

“What’s truly revolutionary about this approach is that each vaccine uses a common molecular backbone—mRNA—that is uniquely tailored to an individual patient,” said Todd Renshaw, former Global Head of Clinical Contract Manufacturing at Genentech, in an article posted on the company’s website. “It’s the next step in personalized medicine.”

“You can imagine a scenario where every single cancer patient would benefit from this vaccine,” Ira Mellman, PhD (above), Vice President at Genentech, told MIT Technology Review. “That’s unheard of.” (Photo copyright: Profiles of the National Academy of Sciences.)

Vaccines are typically used to train the body’s immune system to attack specific diseases that infiltrate the body from the outside. However, cancer tumors are formed within the body’s own tissues, making it difficult for the immune system to detect them. Thus, vaccines haven’t shown much promise for treating cancer.

“Vaccines work by exposing the immune system to ‘non-self’ proteins known as antigens, priming it to recognize and eliminate the invaders. But in the case of cancer cells, most proteins are the same as those on healthy cells,” said Lélia Delamarre, Senior Scientist in Cancer Immunology at Genentech, in the online article. “This makes it hard to identify which antigen to use in a vaccine.”

Global testing on the vaccine has commenced with a focus on ten cancers in upwards of 560 patients.

Barriers to Creating Individual Vaccines

The American Cancer Society estimates there were 1,735,350 new cancer diagnoses in the US in 2018—and 609,640 cancer deaths—making it the second leading cause of death in the US after heart disease.

A truly customized cancer treatment in the form of a vaccine could be a major breakthrough in treating this deadly disease. However, there are significant barriers to developing such a vaccine.

For starters, the vaccines cannot be manufactured in batches, packaged, warehoused, or delivered to pharmacies in bulk. The personalized vaccines must be manufactured in single patient doses, which could be prohibitively costly.

Nevertheless, this research represents an exciting opportunity for anatomic pathologists and clinical laboratories with genetics capabilities which would be needed to secure and sequence tumor biopsies for guiding the creating of the customized vaccines.

Pathologists should track this trend closely and work within their group practices to ensure they have the analyzers, informatics, and expertise required to perform this type of testing for patients within their communities. 

—JP Schlingman

Related Information:

We Can Now Customize Cancer Treatments, Tumor by Tumor

A New, Personalized Vaccine is Targeting the Deadliest Cancers in America

Personalized Cancer Vaccines Look Promising in Two New Studies

What’s New in Cancer Immunotherapy Research?

Decoding Cancer

Precision Medicine Institute