FDA Authorizes Clinical Trial of Latest Advances in Immunotherapy for Mesothelioma

by Sokolove Law

This week, the U.S. Food and Drug Administration (FDA) accepted an application to develop a new immunotherapy drug for the treatment of mesothelioma, a rare cancer linked exclusively to asbestos exposure.

The Watertown, Massachusetts-based biopharmaceutical company Selecta Biosciences submitted the application to test improvements to a drug trialed by the National Cancer Institute (NCI) in 2016. The company is now working with the NCI on a phase 1 clinical trial for this new treatment and its potential for reducing tumors.

Selecta Biosciences and Mesothelioma

This mesothelioma study, expected to begin in spring 2018, will recruit patients who have undergone at least 1 line of chemotherapy.

After administering treatment in 4 cycles, researchers hope to better understand how safe, tolerable, and effective the drug will be in treating both pleural and peritoneal mesothelioma.

Preclinical data already suggest that Selecta Biosciences’ new drug is safe to use alongside other cancer treatments, including chemotherapy and checkpoint inhibitors.

“Immunotoxins have long been viewed as a drug class that could profoundly impact the treatment paradigm of both solid tumors and blood-borne cancers,” said Werner Cautreels, Ph.D., President and CEO of Selecta.

How Does the Treatment Work?

Selecta Biosciences’ “combination therapy” drug contains 2 key ingredients: SVP (Synthetic Vaccine Particle)-Rapamycin and LMB-100.

SVP-Rapamycin is a nanoparticle technology developed by Selecta to prevent anti-drug antibodies (ADAs), which are produced by the body as a result of unwanted immune responses (immunogenicity).

LMB-100 is an immunotoxin, or form of immunotherapy that delivers a toxin to cancer cells that produce mesothelin.

Mesothelin is an abnormal protein made by most types of cancer. These include mesothelioma, lung cancer, and ovarian cancer – all of which can develop as a result of asbestos exposure. The protein collects on the thin lining of the affected organ to form tumors.

Though helpful in targeting cancer cells, LMB-100 is also a foreign protein that the body would try to reject using ADAs. The SVP-Rapamycin is designed to stop ADAs from targeting LMB-100, leaving the LMB-100 free to inhibit production of mesothelin. With ADAs out of the way, patients can undergo multiple treatment cycles.

The Latest of a Promising New Form of Treatment

In 2016 trials testing LMB-100 on pancreatic cancer and mesothelioma, NCI found that ADAs prevented most patients from receiving more than 1 treatment cycle. But in those who did, tumors regressed. The upcoming trial is a response to these encouraging findings, and show that concurrent administration of SVP-Rapamycin could extend treatment to the intended 4 cycles.

Increased cycles could have a profound impact on mesothelioma management. Since the disease presents a poor chance of recovery and no cure, treatment options are limited and sometimes unsuccessful, making experimental and second-line treatments like immunotherapy all the more important.

Experts believe immunotherapy could even serve as a long-term treatment.

Selecta Biosciences, which specializes in immunotherapies for rare and serious diseases, could soon use its proprietary SVP-Rapamycin technology to provide maximum anti-tumor benefit, according to Cautreels.

“We look forward to working with NCI to advance this promising combination therapeutic candidate into the clinic for patients with mesothelioma, which remains among the most difficult to treat cancers.”

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