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TapImmune improves T-cell vaccine formulation ahead of Ph II trials

Melissa Fassbender

By Melissa Fassbender

03-Feb-2017
Last updated on 03-Feb-2017 at 09:02 GMT2017-02-03T09:02:39Z

(Image: TapImmune)
(Image: TapImmune)

TapImmune has completed a multi-gram scale-up and GMP manufacturing of its lead product as it prepares for various Phase II studies.

TapImmune is a clinical-stage immune-oncology company that specializes in developing gene-based immunotherapeutics and vaccines for treating cancer and other diseases. The company’s current lead product, TPIV 200, is a multi-epitope T-cell vaccine targeting folate receptor alpha.

The first TPIV 200 lot was manufactured in early 2016, since which time the company has made improvements to the manufacturing process in order improve scalability.

Dr. Glynn Wilson, Chairman and CEO of TapImmune told us that the basic improvement was in yield and a product that is more amenable to commercialization.

The formulation change also improves the physical appearance and consistency of the final vialed product.

Phase II trials

The second clinical lot of TPIV 200 will support a planned Phase II trial sponsored by Mayo Clinic, which will evaluate the vaccine for the treatment of triple-negative breast cancer.

The batch will also support a separate, ongoing Phase II trial in patients with platinum-resistant ovarian cancer. The TapImmune-sponsored trial will evaluate the vaccine in combination with a checkpoint inhibitor and is currently enrolling patients.

Immunotherapy is the hottest space in oncology right now,” explained Wilson, adding that the success of checkpoint inhibitors, such as Opdivo have shown significant promise.

But in the future these are going to have to be used in combination with other agents, such as T-cell vaccines, in order to improve the overall response rate.” 

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