IMV preps pivotal trials for ovarian cancer T cell therapy

February 26, 2020 11:00 am

The following article is provided by The Clearity Foundation to support women with ovarian cancer and their families. Learn more about The Clearity Foundation and the services we provide directly to women as they make treatment decisions and navigate emotional impacts of their diagnosis.

IMV says new results from its phase 2 trial of lead drug DPX-Survivac, designed to stimulate a T cell response in ovarian cancer, have set it on course for a registration trial.

The Canadian biotech revealed data from the 22-patient DeCidE1 study shows that the drug stabilised disease in 79% of 19 evaluable patients with advanced, recurrent ovarian cancer, with more than half (53%) seeing their tumours shrink, when given in combination with cyclophosphamide chemotherapy.

Durable clinical benefits – lasting six months or more – were seen in 37% of the patients, according to IMV, with partial responses (30% or greater tumour reduction) seen in 21% of them.

IMV says it is now seeking a meeting with the FDA to try to work out the design of a larger phase 2b trial that could support accelerated approval of DPX-Survivac, which has already been awarded fast-track status by the US regulator.

It said the results were impressive given that the patients were a very hard-to-treat group, having received at least three prior lines of therapy. Investors seemed less enthusiastic about the data however, and shares in the biotech fell back almost 41% after the announcement.

Wells Fargo analyst Jim Birchenough said he had downgraded the chance of a successful outcome for the programme as the response rate is hard to separate from the background rate with cyclophosphamide given on its own, which makes a path to regulatory approval unclear.

HC Wainwright analyst Jospeh Pantginis has a different take however, calling the data “quite encouraging” for what is billed as the first in vivo T cell therapy to show clinical activity in hard-to-treat solid tumours.

Undeterred, IMV’s chief executive Frederic Ors said the readout is “a pivotal milestone” for the company and “a breakthrough for targeted T cell immunotherapies”, given that patients in this position are running out of treatment options.

At the moment the only treatments are single-agent chemotherapy, which only has a response rate of around 12%, he pointed out.

DPX-Survivac consists of five unique surviving peptides formulated in a proprietary delivery platform (DPX) and is designed to induce a cytotoxic CD8+ T cell response against surviving-expressing cancer cells.

“These results also continue to validate the unique mechanism of our DPX platform and the relevance of surviving as a cancer target, as we await updated phase 2 data from two additional studies of DPX-Survivac in the first half of this year,” said Ors.

The therapy is being tested alongside Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) in two phase 2 studies, including an investigator-led trial in patients with advanced-stage diffuse large B-cell lymphoma (DLBCL) and another spanning multiple solid tumour types.

This article was published by PMLiVE.

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