Week after week and year after year, oncologists keep prescribing the same toxic drugs to shrink tumors, therapies that leave patients nauseous or even bedridden. For over three decades, chemotherapies have remained the foundation of treatment for metastatic cancer patients (patients whose tumors endanger multiple organs). Why? The clinical results are clear. Without chemotherapy, patients, even those on modern antibody or biologic therapies, have shorter life expectancies and are less likely to experience disease remission—freedom from cancer.
Fortunately, the past decade has experienced a boom, with over 200 startups bringing novel cancer therapies—primarily antibodies, viruses, or cells—into clinical trials aiming to find alternatives to toxic chemotherapy. Despite these innovations, chemotherapy remains an essential yet toxic part of cancer care. In Pittsburgh, a small team of scientist-entrepreneurs and oncologists started meeting every Friday morning before work, collaborating to search for a new chemistry, one that could replace toxic chemotherapies. Their search soon focused on compelling research about novel ultra-small nanomedicine chemistry that carried potent drugs deep into solid tumors while sparing healthy organs.
This new nanomedicine chemistry fascinated Dr. Sam Rothstein, a scientist-entrepreneur with 20+ years of nanomedicine research experience spanning academia and industry. "We could make a real positive impact on patients," says Rothstein. "We know that nanomedicines, which keep potent therapies out of healthy organs, improve quality of life. But this novel ultrasmall chemistry could go even further, saving lives by reaching remote cancer cells that current therapies can't touch."
Dr. Rothstein set to work building a new company, calling on connections made over a 10+-year career as a life science startup CEO and CSO, where he founded and grew two nanomedicine startups from academic discoveries. After months of market, regulatory, and business research, Duo Oncology was born.
Duo Oncology's patented nanomedicine platform chemistry mimics the natural assembly of DNA. It creates tiny drug particles ten thousand times thinner than a strand of human hair and 10x smaller than the particles now used in cancer therapy. The uniquely small size and non-stick surface let them carry doses of cancer-fighting medicines deep into tumors, reaching places where even blood vessels and oxygenating red blood cells can't travel. Fortunately, the nanomedicines are also just a little too large to penetrate healthy organs, significantly reducing harmful side effects. Duo's nanomedicines are a new type of drug, called a prodrug, which adds a further layer of safety because it is inactive until it is metabolized within a tumor. Existing nanoparticle technologies such as liposomes or protein complexes lack these features that make Duo's nanomedicines so effective at concentrating in tumors and sparing healthy organs.
Duo Oncology has a broad cancer pipeline that includes products that incorporate chemotherapy, immunotherapy, and precision medicine mechanisms, therefore addressing various aspects of cancer treatment. Their streamlined three-step manufacturing process efficiently produces polymer nanomedicines and allows the stable polymer backbone to be used as a platform for multiple ultrasmall nanomedicine prodrugs. In addition, Duo's lead product demonstrates a favorable toxicology profile, showing less drug concentration and less toxicity in the body compared to current oncology treatments.
The Founding Team
The promise of Duo's new chemistry has attracted top talent. Dr. Rothstein is joined by Katherine Eichinger, PharmD PhD, COO, a pharmaceutical scientist with over 20 years of experience across all stages of drug development, including work at UPMC and Cleveland Clinic. Victoria Manax, MD, serves as CMO, bringing her expertise from leading PanCAN and her role in developing Abraxane for pancreatic cancer at Abraxis and Celgene. Other team experts include Don Berry, PhD, a global leader in Bayesian clinical trial design; Jose Iglesias, MD, former CMO of Abraxane, which was acquired for $2B by Celegene, and Dr. Mark Tracy, production leader on five FDA-approved particle drug products. Finally, all-star clinicians, including Dr. Dan Von Hoff, Dr. Diane Simeone, Dr. Manual Hidalgo, and Dr. Stanley Marks, have contributed to Duo Oncology's clinical trial design, helping ensure the success of Duo's unique nanomedicines as the new chemotherapy for cancer patients.
In the Spotlight
It isn't surprising that this world-class team and its nanomedicines have attracted significant attention and support. The group of practicing oncologists who first recognized the potential impact of Duo's nanomedicine platform invested one million dollars to jump-start development. Recently, BeiGene Pharmaceuticals purchased 40% of the seed round, while Dr. Rothsteing has secured an additional $8 million follow-up term sheet from Prevail Partners, a respected clinical research organization. In addition to investment, the Duo Oncology team has garnered ongoing support from the National Institutes of Health, with over $800,000 in SBIR grants. Likewise, Duo Oncology has received nominations and awards from the Prix Galien Foundation and the National Cancer Institute for its groundbreaking platform.
The future is ultra bright, too.
The entire Duo Oncology team has a lot to be excited about. For one, the company has a de-risked and efficient path to bring its products to market, thanks to a smooth regulatory process and a positive pre-IND meeting with the FDA. Likewise, the company has patents pending internationally. To add to their optimism, their lead product, DUO-207, the intravenous nanomedicine containing two potent chemotherapy agents, favorably completed its final round of toxicology studies required before it could transition to clinical testing of patients with deadly cancers.
"DUO-207 is uniquely designed to safely replace key chemotherapy agents now used to treat some of the deadliest malignancies including pancreatic, bile duct, lung and breast cancer among others," Dr. Rothstein asserts.
Slated to advance into clinical trials in the latter part of this year, Duo Oncology's nanomedicines "hold tremendous potential to improve the lives of millions of patients," emphasizes Dr. Rothstein. With a clear path to market, strong scientific backing, and a dedicated team, Duo Oncology is redefining and vastly improving the standard of care for some of the most challenging and deadly cancers. Join Duo Oncology today and help them redefine the treatment of cancer.
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