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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 Soteria Biotherapeutics, 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.
Soteria Biotherapeutics, Inc. is a stealth biotech startup recently spun out of the lab of Dr. Jim Wells at UCSF, and developing next-generation T-cell therapies with improved efficacy and safety, for the treatment of cancer.
Soteria does not currently have any registered trademarks or operating website, besides a simple landing page, so we had to do some investigating on our own to gather clues about their research and potential products. The business was registered in Delaware as a C-Corp on 5/4/2018. Their formal entity address, as noted on a California business entity search, is found at 953 Indiana Street, San Francisco, CA 94107, which is also the location of the University of California’s QB3-MBC BioLabs accelerator facility. Most of their actual operations are taking place at the MBC BioLabs accelerator facility. MBC Biolabs, established in 2013, features 24,000 sq. ft. of lab and office space in San Francisco's Dogpatch neighborhood, just a short walk from the UCSF Mission Bay Campus. Soteria Biotherapeutics is primarily categorized under Biotherapeutics. Current estimates show this company has an annual revenue of $593,094 and employs a staff of approximately 3.
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. With five incubators, multiple locations, two seed-stage venture capital firms, and a special initiative in medical devices, through the UCSF Rosenman Institute, QB3 helps early biotech startups create high-value jobs and brings over $750 million into the Bay Area each year.
The information on the outsourcing needs of Soteria Biotherapeutics are few and far between, but their recent funding from an SBIR grant and an accelerator-backed deal from MBC BioLabs are both good signs they have some capital to play around with for R&D, drug discovery, and even outsourcing early preclinical work. During stealth mode, Soteria received an SBIR grant for funding of their current research platform. They were awarded a Phase 1 SBIR grant in 2019 for research and development of a chemically regulated immunotherapy for B-cell malignancies, with more details about that below. Soteria has already received this award to further their research efforts, and with some grant money to play around with we can definitely expect to see an increased amount of outsourcing activities in the near future.
Soteria will be working through the usual steps for a while before reaching the IND stage with potential products. So far the company has done a very good job of staying under the radar, especially with their recent grant funding and investor backing. Soteria Biotherapeutics will use their current funding to further research in novel T-cell therapies. We think business development teams in the realms of large molecule CMOs with experience in the preparation of plasmids and transient transfections of mammalian expression cell lines, preclinical CROs with experience in bispecific and engineered antibodies, Biotech companies with experience in the design, construction and sequencing to verify new vectors for antibody expression, and Bioanalytical CROs with prior experience with CAR T cells or bispecific T cell-engaging antibodies should definitely have Soteria on their radar over the next few years.
Soteria’s Pipeline and R&D Focus
The current focus of Soteria’s pipeline will be optimizing potential drug candidates from all of their funded research above and launching successful clinical trials while building strategic relationships with new outsourcing partners. The research team at Soteria is working on the early development of novel T-cell therapies with some solid research already underway.
The promising field of T-cell based cancer therapies is hindered by safety concerns, including patient deaths in clinical trials. Soteria Biotherapeutics’s current research pipeline involves the development of safer and more efficacious T-cell therapies by using novel small-molecule-gated biological switches to control T-cell activation. Their successful R&D and subsequent clinical trials will advance the development of new T-cell therapies for the potential treatment of human cancers, which will ultimately improve outcomes for patients with B-cell malignancies in the near future. Current R&D will focus on optimization of AbCID expression in a mammalian-cell expression system, evaluation of chemically regulated T-cell activation and cytotoxicity with in vitro primary cell models, and quantification of the in vivo pharmacokinetic properties of the lead AbCID T-cell therapy in mice. Completion of these research aims will directly increase the commercial viability of Soteria’s lead AbCID-based T-cell therapy product and will lay the groundwork for in vivo efficacy experiments in mouse models in a future Phase II project. The successful commercial development of an AbCID-based T-cell therapy will introduce a novel therapeutic option for the treatment of B-cell malignancies and will improve outcomes for patients. 
- Zachary Hill, Ph.D. - is the CSO and Co-Founder of Soteria Biotherapeutics. Prior to founding Soteria, Zach was a postdoctoral fellow in the laboratory of Professor Jim Wells at UCSF, where he helped to co-invent the technological basis for Soteria’s founding. While at UCSF, Zach was a Helen Hay Whitney Fellow, as well as the recipient of a NIH K99/R00 Transition Award from the NCI. Zach received his Ph.D. in organic chemistry from the University of Washington, where he worked under the direction of Professor Dustin Maly on the development of bivalent inhibitors of protein kinases. Zach’s scientific interests sit at the interface of proteins and small molecules, with an emphasis on developing novel therapeutics. 
- James A. Wells, Ph.D. - is Professor in the Department of Pharmaceutical Chemistry at UCSF. The Wells’ group pioneered the engineering of proteins, antibodies, and small molecules that target catalytic, allosteric, and protein-protein interaction sites; and technologies including protein phage display, alanine-scanning, engineered proteases for improved hydrolysis, bioconjugations, N-terminomics, disulfide “tethering” (a novel site-directed fragment based approach for drug discovery), and more recently an industrialized recombinant antibody production pipeline for the proteome. These lead to important new insights into protease mechanisms, growth factor signaling, hot-spots in protein-protein interfaces, role of caspases in biology, and more recently determining how cell surfaces change in health and disease. His team was integral to several protein products including Somavert for acromegaly, Avastin for cancer, Lifitegrast for dry eye disease, and engineered proteases sold by Pfizer, Genentech, Shire and Genencor, respectively. He is an elected member of the US National Academy of Science, American Association of Arts and Science, and the National Academy of Inventors. 
With a good amount of grant funding, significant progress in scientific benchwork, and deep technical backgrounds from their management, we believe that Soteria Biotherapeutics will do very well in their early-stage developments and clinical trial studies. T-cell therapies have shown an incredible promise as treatments for previously intractable relapsed and refractory hematologic cancers. Unfortunately, the incredible efficacy of the current therapies has also been accompanied by life-threatening side effects caused by overactivation of the immune system, including cytokine release syndrome and neurotoxicity. In other clinical trials, these side effects have even resulted in patient deaths. For T-cell therapies, such as what Soteria is developing, they will be able to reach their full potential and will be applied to a wide range of targets and types of cancer, and will subsequently be very critical to improve their safety profiles.
One of the current methods to improve safety is by incorporating molecular switches into T-cell therapies that would allow for better control over the timing and magnitude of T-cell activity. Chemically induced dimerizers (CIDs) have proven to be powerful tools for controlling cellular signaling pathways and, in turn, biological activity. Unfortunately, classical CID systems have some molecular properties that make them undesirable candidates for switches in human T-cell therapies. The research team at Soteria Biotherapeutics is working on these limitations using antibody-based chemically induced dimerizers (AbCIDs), a new type of molecular switch that was specifically designed for use in human cell therapies. By integrating an AbCID-based molecular switch, the activity of a T-cell therapy will be controllable by a physician through administration of a small molecule drug. This will allow the physician to increase T-cell activity when more efficacy is needed and reduce activity when side effects become apparent. 
For Soteria’s SBIR phase I project, they will be optimizing their chemically regulated AbCID safety switch design and will implement it in an improved T-cell therapy for malignancies. Their proprietary technology, based upon the initial research by UCSF professor Dr. Jim Wells, will enable precise control of T-cell activation and targeting technologies. These innovative control mechanisms will be the key to safer and more efficacious treatments of cancer in the future.
We think Soteria Biotherapeutics is on track to have some major innovations in the biotech industry, and it’s difficult to say exactly when they will come out of stealth mode, but we’re thinking it should be within the next few years, so be sure to keep them on your schedule 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 Soteria Biotherapeutics, 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 Biotech Startups. If you enjoy these articles, please feel free to give them a share through the social links below!