• By
• Timothy Hay
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The Tablo dialysis system

Outset Medical

The hundreds of thousands of patients in the U.S. who get kidney dialysis face multiple appointments at the clinic each week, where they hook up to big, bulky machines for hours at a time.

The technology involved, which essentially does the work for kidneys that are malfunctioning, hasn’t been significantly upgraded in decades.

One startup medical-technology company, San Jose, Calif.-based Outset Medical Inc., aims to make the experience easier on patients, and eventually turn dialysis into something that can be done in the home.

The company is making a small, lightweight system that can do the same work that today is done by machines that take up most of a room, Chief Executive Leslie Trigg said.

Outset Medical is in the midst of raising a large Series B round to get its system into dialysis clinics, and begin the process of moving the technology into patients’ homes, Ms. Trigg said.

The company has thus far closed on $45 million in new equity investment plus $15 million from converted warrants in a Series B round that is expected to grow significantly larger in the near future, she said.

The funding was provided by return investors Warburg Pincus and Vertical Group, as well as new public-equity investors whose names the company isn’t disclosing. The second phase of funding, which is expected to close soon, will also involve new and returning investors, Ms. Trigg said.

Among Outset Medical’s innovation is the miniaturization of the water-filtration component, a breakthrough that could lead to the first consumer version of dialysis with a device small enough to be kept in the home.

Read the full article about Outset Medical’s funding, including more about the company’s technology, at Dow Jones VentureWire.

Write to Timothy Hay at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .  Follow him on Twitter at @timwhay

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The combination of AGS-003 and sunitinib yielded supportive immunologic responses and extended survival in intermediate- or poor-risk patients with metastatic renal cell carcinoma, according to data from a phase 2 trial.

AGS-003 (Argos Therapeutics) is a novel autologous immunotherapeutic agent created from the patient’s own dendritic cells co-electroporated with amplified tumor RNA and synthetic CD40L RNA, according to study background.

Asim Amin, MD, PhD,a medical oncologist at the Levine Cancer Institute in Charlotte, North Carolina, and colleagues conducted the phase 2 trial to determine the efficacy and safety of the combination of AGS-003 and sunitinibin patients who were newly diagnosed with intermediate- or poor-risk metastatic renal cell carcinoma (mRCC) following nephrectomy.

The primary endpoint was complete response rate. Secondary endpoints were safety, PFS, OS and clinical benefit.

The analysis included 21 patients who were treated continuously with sunitinib (4 weeks on each 6-week cycle). After the first cycle, patients received AGS-003 every 3 weeks for five doses and then every 12 weeks until disease progression or the study concluded.

Sixty-two percent of patients experienced clinical benefit, including nine patients who achieved partial response and four patients who achieved stable disease. However, there were no complete responses and enrollment terminated early.

The median PFS was 11.2 months (95% CI, 6-19.4) and the median OS was 30.2 months (95% CI, 9.4-57.1) from the time of registration for all patients.

Seven patients (33%) survived for a minimum of 4.5 years and five patients (24%) survived more than 5 years. Two patients remained progression-free with durable responses at the time the study concluded.

 AGS-003 was associated with mild injection site reactions, but the most common adverse events were related to the toxicity profile of sunitinib.

“In comparison to the benchmarks established for similar risk mRCC patients treated with targeted therapy, the outcomes in this study were encouraging,” Amin said in a press release. “Mature data from this phase 2 study suggest the combination of AGS-003 plus sunitinib was safe, well tolerated and associated with doubling of the expected median survival and encouraging long-term and 5-year survival.”

The researchers also noted the degree of an increase in CD8-positive, CD28-positive and CD45RA-negative effector/memory T cells after five doses of AGS-003 was associated with improved OS.

Robert Figlin

“AGS-003 is designed to generate a patient and tumor-specific immune response,” study researcher Robert Figlin, MD, FACP, the Steven Spielberg Family chair in hematology oncology and professor of medicine and biomedical sciences at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Center, Los Angeles, said in the release. “Observations from this study indicate than an increase in memory T cells after five doses of AGS-003 was associated with prolonged survival. These important findings are being further evaluated in the ongoing phase 3 ADAPT study.” – by Anthony SanFilippo

Disclosure: The study was funded by Argos Therapeutics. Amin reports no relevant financial disclosures. Figlin reports research funding from and consultant/advisory roles with Argos, Bristol-Myers Squibb, Galena, GlaxoSmithKline, Immatics, Novartis, Onyx and Pfizer. Please see the study for a full list of all other researchers’ relevant financial disclosures.

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