ARMO BioSciences Initiates Phase 1 Clinical Trial of First-In-Class Cancer Immunotherapy

REDWOOD CITY, Calif., Nov. 25, 2013 /PRNewswire/ -- ARMO BioSciences, Inc., a clinical-stage biotechnology company, today announced that it initiated the first cohort of patients with advanced solid tumors in a Phase 1 clinical trial of AM0010, a PEGylated form of recombinant human interleukin-10 (IL-10). Based on extensive clinical and preclinical data, ARMO plans to develop this unique molecule for known indications and innovative applications including cancer, fibrosis, hypercholesterolemia/atherosclerosis and inflammatory diseases. 

"Since its founding in December 2012, ARMO raised $20 million in a Series A round, licensed the PEGylated human IL-10 polypeptide from Merck, purchased the Prevascar (rHuIL-10) assets from Renovo Ltd. and assembled an outstanding scientific team with remarkable depth and knowledge of IL-10 to bring AM0010 into the clinic in record time," said Beth Seidenberg, M.D., partner at Kleiner Perkins Caufield & Byers and a member of the ARMO board of directors. "We see enormous potential in the development of this promising molecule."

"Multiple studies have shown that AM0010 directly activates tumor specific CD8⁺ killer T lymphocytes, which completely eradicate large tumor masses while establishing a lasting anti-tumor immune surveillance and significantly reduce metastatic disease in preclinical models," said Peter Van Vlasselaer, Ph.D., president and chief executive officer of ARMO.  "We expect our exceptional momentum in advancing AM0010 into development to continue, with initiation of additional clinical studies potentially in fibrosis, homozygous familial hypercholesterolemia and other indications in 2014, and anticipate results from our first study as soon as mid-2014."

The Phase 1 clinical trial is designed to establish the safety and tolerability of AM0010 in patients with advanced solid tumors. Additional objectives include the exploration of anti-tumor and biomarker responses to allow dose determination and potential patient stratification in subsequent studies. The trial will enroll patients at four locations in the United States.

"In addition to its potential in cancer, recombinant IL-10 has demonstrated anti-inflammatory and anti-fibrotic activities as well as cholesterol lowering abilities in preclinical disease models and in human subjects," commented Carl L. Gordon, Ph.D., C.F.A., partner and co-head of global private equity at OrbiMed, and a member of the ARMO board of directors. "We believe that ARMO is ideally positioned to explore the unique mechanisms of action for this important immunotherapy compound, with possible breakthrough potential in several indications."

ARMO has over 45 issued and pending US and foreign patents and applications covering compositions of matter, methods of use, and methods of manufacturing of AM0010.

About ARMO BioSciences, Inc.

ARMO BioSciences is focused on developing immunotherapies for the treatment of cancer, fibrosis, hypercholesterolemia/atherosclerosis and inflammatory diseases. ARMO believes that by harnessing the body's own capability to arm itself against dysregulated cells, it may provide safer and more effective drugs for patients suffering from grievous diseases. ARMO's medicines are designed to normalize the underlying biology of disease through immunotherapeutic mechanisms for sustained and durable responses. Founded in 2012, ARMO is backed by investors Kleiner Perkins Caufield & Byers, OrbiMed and DAG Ventures. 

About Kleiner Perkins Caufield & Byers

Kleiner Perkins Caufield & Byers (KPCB) has backed entrepreneurs in more than 500 ventures leading to 150 IPOs, 350,000 jobs and a deep strategic network. The firm has helped build pioneering companies like Amazon, Electronic Arts, Genentech, Google, Intuit, Juniper Networks, Netscape, Symantec and VeriSign. KPCB partners serve on the boards of Amazon, Apple, Bloom Energy, Flipboard, Google, Hewlett-Packard, Nest, Square, Twitter and Zynga, among others. KPCB accelerates the success of entrepreneurs with a team of partners delivering company-building services including strategy, operational scaling, recruiting, business development and product delivery. The firm invests in all stages from seed and incubation to growth companies. KPCB operates from offices in Menlo Park, San Francisco, Shanghai and Beijing. http://www.kpcb.com

About OrbiMed

OrbiMed is a leading investment firm dedicated exclusively to the healthcare sector, with over $8 billion in assets under management. OrbiMed invests globally across the spectrum of healthcare companies, from venture capital start-ups to large multinational companies. OrbiMed's team of more than 80 employees manages a series of private equity funds, public equity funds, royalty/debt funds and other investment vehicles. OrbiMed maintains its headquarters in New York City, with additional offices in San Francisco, Shanghai, Mumbai and Herzliya.

About DAG Ventures

A mid-stage venture capital partnership with a service-oriented mindset. DAG Ventures supports visionary entrepreneurs and the elite early-stage VCs who've backed them.

SOURCE ARMO BioSciences, Inc.