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Welcome to another edition of our Sponsor Atlas series, which focuses on startups and young pharmaceutical and biotechnology companies that are in early stages or stealth mode. In the next edition of Sponsor Atlas: Discovering Biotech Startups, we’re looking at Alaunus Biosciences, exploring the current affairs and future orientation of this emerging San Francisco - based stealth biotech startup. To accomplish this, we will give a business overview of their current operations, summarize their outsourcing needs, map out their development goals and decision-makers, and highlight their current strategies for capturing innovation. If you haven’t already read our other blogs on new biotech startups, be sure to check them out here.
Alaunus Biosciences is a stealth biotech startup and a developer of a immune-oncology technology platform designed to address unmet clinical needs in cancer diagnosis and treatment. The company's platform focuses on developing a laboratory-based assay for risk stratification and early detection of pancreatic cancer, enabling healthcare providers to identify pre-malignant cysts in the pancreas before they develop into full tumors. 
Alaunus does not currently have any registered trademarks or operating website, so we had to do some investigating of our own to gather clues about their research and potential products. The business was registered in Delaware as a C-Corp with a filing date on 6/13/2013. Their principal place of business, as noted on an online business entity search, is located at 953 Indiana St., San Francisco, CA 94107. This is also the location of MBC Biolabs, a QB3 startup incubator location that is affiliated with UCSF. QB3 is the University of California’s accelerator hub for innovation and entrepreneurship specifically for life sciences startups. The institute supports UC researchers and empowers Bay Area entrepreneurs to launch startup companies and partner with the biotech industry.
During stealth mode, Alaunus received an SBIR grant for funding of their current research platform. They were awarded a Phase 1 SBIR grant of $235,341 in 2017 for research and development of fluorogenic substrates for the diagnosis of pancreatic cysts, with more details about that below. Alaunus has already received this award to further their discovery efforts, and with that amount of funding to play around with, we believe they are in a great position to outsource a lot of their downstream development work in the near future.
Alaunus Biosciences is located in the booming area of South San Francisco, known to many as the birthplace of biotechnology and the hub of the biotech industry. This organization primarily operates in the biotechnology research industry, and has been operating for approximately 7 years. Alaunus Biosciences is estimated to generate $82,851 in annual revenues, and employs approximately 2-3 people at their primary location. Even though Alaunus has been under the radar for several years and have received a substantial amount of SBIR grant funding, they are still considered a very early startup and open to the possibility of outsourcing activities in the near future.
There isn’t much online information about Alaunus’s outsourcing needs, but with the amount of early research they’re currently exploring at this point in time, we believe they could use assistance from service providers in almost every step of their diagnostic tool pipeline. If your team has experience with diagnostic assay research and medical device development, preclinical services and animal model development targeting cancer, or bioanalysis experience in profiling proteolytic activity in tumor microenvironments for novel therapeutics and diagnostics applications, Alaunus should definitely be on your contact list, and you should be connecting with them for upcoming work in the near future!
Alaunus Biosciences’ Pipeline and R&D Focus
In hospitals all around the world, there has been a dramatic increase in the number of patients being diagnosed with incidental pancreatic cysts, and this troubling statistic represents a unique opportunity to detect and treat cystic precursor lesions before the onset of malignancy. The team at Alaunus Biosciences is developing a minimally invasive and highly sensitive diagnostic assay to identify cysts that also have a high likelihood of progressing into pancreatic cancer. This assay will facilitate early detection of malignancy as well as avoid unnecessary and costly surgeries for cases with benign cystic lesions. It’s known to the public that early diagnosis is the single most important tool to delay or avoid cancer related mortality. Many people undergoing abdominal MRI or CT scans today are found to have cysts in their pancreas which in some cases can evolve into pancreatic cancer, however, it is currently very difficult to predict which cysts are true precursor lesions and which will just remain asymptomatic, hence the unnecessary surgeries. However pancreatic cysts also represent a major clinical challenge because current diagnostics do not adequately reflect the biology of cyst malignant transformation.
Misregulated pericellular proteolysis is a hallmark of invasive cancer, so the research them at Alaunus is exploiting the activities of proteases in cyst fluid to develop an enzyme-based diagnostic test for sensitive and specific identification of pre-malignant pancreatic lesions. The current goal for Alaunus Biosciences is to develop a rapid and minimally invasive assay that improves patient stratification over current standard diagnostic markers and guides clinical decision making to avoid unnecessary surgical intervention. 
The Alaunus Biosciences diagnostic pipeline takes advantage of a substrate profiling technology developed in the Craik Laboratory at UCSF referred to as multiplex substrate profiling by mass spectrometry (MSP-MS). The MSP-MS assay uses a peptide library platform to monitor global protease substrate specificity and kinetic efficiency in complex biological samples and in an unbiased manner. Through applying this substrate profiling approach to small volumes of cyst fluid obtained by endoscopic ultrasound Alaunus has identified proteases that have highly increased activity in pre-malignant cysts and developed a proof of principle fluorogenic substrate assay that achieves improved sensitivity and specificity compared to the current clinical standard CEA. 
Some of the ways business development teams can get their foot in the door at this early stage would be to provide support in the following areas: Bioanalytical method development and method validation, analytical testing with mass spectrometry, preclinical development including in vitro, in vivo and animal model development for their early studies, as well as CRO services that are heavily focused on diagnostic assay development in cancer research, all would be a huge plus for Alaunus Biosciences at this time.
- Dr. Mark Cisneros - President & CEO of Alaunus Biosciences, is an experienced serial entrepreneur with a demonstrated history of working in the biotechnology industry. With multiple biotech and science-related companies under his belt, Mark is skilled in chemistry R&D, FDA regulations, medical device development, and the life sciences industry. Mark received a B.S. in Chemistry from Butler University, an M.B.A. from Louisiana State University, and a Ph.D. focused in Physical Chemistry from Texas A&M University.
- Dr. Charles S. Craik - Co-founder of Alaunus Biosciences, Dr. Craik is currently Professor of Pharmaceutical Chemistry and Director of the Chemistry and Chemical Biology Graduate Program at the University of California in San Francisco. Professor Craik is a world-leading researcher in proteolytic enzymes. He conducts both basic research and applications of proteolytic enzymes in the diagnosis, monitoring and treatment of human diseases. He has published over 300 articles, has 10 patents in the U.S. and founded Catalyst Biosciences and Alaunus Biosciences. He serves on several industry-related scientific advisory boards and is extremely active in pharmaceutical and biotechnology consulting. His current research focuses on structure-function analysis of proteases and their inhibitors. In my lab we use a combination of genetic, biochemical, and biophysical methods, with particular emphasis on identifying the roles and regulating the activity of proteases associated with infectious diseases, cancer, and development. 
Alaunus Biosciences’s innovative approach to building a platform for actionable diagnostic tests will hopefully enable early identification of pre-malignant cysts and transform the clinical management of these challenging lesions. As for future research efforts, the team at Alaunus will use their current activity-based profiling approach to identify additional distinguishing protease markers in an expanded patient cohort and already evident in their existing cyst fluid data. Substrate specificity profiles will then be used to rationally design and optimize specific fluorogenic peptide substrates that are cleaved by the target proteases discovered. Lead candidate substrates will then be benchmarked in a blinded validation cohort for their performance compared to CEA in distinguishing pre-malignant from benign cysts. Overall this is just the beginning for Alaunus, and their innovative platform has the ability to provide early discovery for a number of other diseases in the future.
Dr. Francesco Caiazza, Senior Scientist at Alaunus said about his research, “My current research is focused on developing diagnostic tools and pro-drug therapeutic approaches to address unmet needs in the area of oncology. Leveraging advanced methods for the molecular characterization of patient samples, I am interested in addressing specific questions related to intrinsic and acquired resistance to therapy, alternative biomarkers for treatment and monitoring, and early diagnosis. My ultimate goal is to perform translational research that will benefit patients, and to contribute to the understanding of biological mechanisms of tumorigenesis.”
With a substantial amount of grant funding, significant progress in scientific benchwork, and deep technical backgrounds from their executives, we believe that Alaunus will do very well in their early-stage developments and clinical trial studies. While it’s still fairly difficult to determine everything Alaunus Biosciences will have to offer during stealth mode, we think they are on track to create some interesting discoveries over the next few years. Be sure to keep Alaunus on your radar and look out for our next edition in this series coming soon.
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If you would like a simple solution for keeping an eye on drug sponsor companies, like Alaunus Biosciences, without relying on a database and generic lists of leads each week, we at Zymewire are here to help. Reach out today, and stay tuned for the next installment of the Sponsor Atlas: Discovering new Biotechs. If you enjoy these articles, please feel free to give them a share through the social links below!