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Tekmira on Track to Move Cancer Drug into Phase II, Name New Clinical Candidate in ‘13

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Officials from Tekmira Pharmaceuticals this week updated the company’s research and development efforts, stating that the company continues to expect its lead drug candidate, the cancer therapy TKM-PLK1, to move into phase II testing later this year.

The company is also on track to select another molecule for clinical development before the end of 2013, according to the officials, who made their comments during a conference call held to discuss Tekmira’s first-quarter financial results.

TKM-PLK1 uses the company's proprietary lipid nanoparticles to deliver siRNAs against polo-like kinase 1, a serine/threonine kinase that is key to cell progression and is over-expressed in a number of cancer types.

In April, the company reported data from an ongoing phase I trial that showed the drug to be safe and potentially efficacious (GSN 4/11/2013).

Among the study results were data from one patient with progressive, metastatic appendiceal carcinoid cancer who experienced a “durable partial tumor response” continuing for more than 10 months. In light of these and other findings, Tekmira has decided to enroll patients with gastrointestinal carcinoid, or neuroendocrine, tumors in the planned phase II trial.

In addition to TKM-PLK1, Tekmira is developing an siRNA-based treatment for Ebola virus infection called TKM-Ebola under a contract with the US Department of Defense (GSN 5/9/2013).

“We recognize that we must demonstrate the clinical value of our pipeline in a range of therapeutically important, commercially attractive markets,” Tekmira President and CEO Mark Murray said during the conference call. “Our strong balance sheet provides added fuel for Tekmira to propel a number of product candidates to various stages of clinical development by 2015.”

He added that the firm continues to expect to unveil a third candidate in its clinical pipeline before year end, but said that the compound has not yet been selected as “a number of targets [are] under consideration.”

Among the potential candidates are TKM-ALDH2, which targets aldehyde dehydrogenase 2, for alcohol dependence, and an siRNA cocktail designed against the cancer targets Wee1 and CSN5.

And while Tekmira remains on the lookout for a partner for its drug candidates, advancement of its research and development efforts are not contingent upon finding one, CFO Ian Mortimer indicated.

“The way that we’ve built our financial model and the guidance we’ve been giving in terms of our cash runway includes us not only taking PLK into phase II development ourselves, but also accounts for us moving additional programs into development ourselves,” he said on the call.

The First Quarter

For the three-month period ended March 31, Tekmira’s net loss fell to $2.6 million, or $0.18 per share, from a year-ago loss of $3.2 million, or $0.25 a share.

Revenues in the quarter slipped to $2.2 million from $3.6 million, in part because of lower revenues than the year-ago quarter from the DoD Ebola contract.

Research and development spending in the first quarter edged up to $4.2 million from $4.1 million, while general and administrative expenses dropped to $900,000 from $1.8 million.

Looking ahead, Tekmira said that it expects to end the year with more than $35 million in the bank, which should be sufficient to fund its product-development initiatives into 2015.

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