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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 Symbiotica, Inc., and exploring the current affairs and future orientation of this emerging New York - 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.
Symbiotica, Inc. is a stealth biotech startup recently spun out of the Institute for Clinical Pharmacodynamics, and developing next-generation anti-microbial therapies with improved efficacy and safety, for the treatment of drug-resistant fungal infections. Their mission is to help patients suffering from challenging infections where improved therapeutics are needed most.
Symbiotica does not currently have any registered trademarks or formal website, besides their parent company’s website also known as the Institute for Clinical Pharmacodynamics, so we had to do some investigating on our own to gather clues about their research and potential products. The business was registered in New York as a C-Corp (with jurisdiction in Wisconsin) on 3/8/2017. Their formal entity address, as noted on a New York business entity search, is found at 242 Broadway, Suite 101, Schenectady, NY 12305, which is also the location of the parent company, Institute for Clinical Pharmacodynamics (ICPD). ICPD serves as a center for translational science collaboration to the entire world. Founded in 2010, they have been helping pharmaceutical and biotechnology companies get safer and more effective drugs to patients through advanced methods of pharmacokinetic and pharmacodynamic system analyses.
The company is categorized as doing work in commercial biotechnical research, and our current estimates show they have annual revenue of around $94,388 and employ approximately 4 staff members. In April 2018, Symbiotica received a $150,000 SBIR grant from the NIH for the development of a natural antifungal product, Selvamicin, for specifically targeting drug resistant fungal infections. Symbiotica’s principal investigator for the NIH grant, Dr. Paul Ambrose, also is the president of the Institute for Clinical Pharmacodynamics in Schenectady. Back in 2016, the institute received a patent for a “method for shortening anti-infective therapy duration in subjects with infection.” With the SBIR funding and workable patent, Symbiotica will push its studies towards optimizing Selvamicin for clinical trials.
Even though there isn’t much online information about their outsourcing needs, their recent investments, SBIR funding, valuable patent, and internal capital shows that Symbiotica is ready to launch a unique development pipeline with innovative and potentially valuable discoveries in therapeutics for anti-microbial resistance. Symbiotica is very early in development and they will be working through the usual steps before reaching the IND stage with potential products. Their prospective pipeline of products consist of therapeutics that demonstrate an effective broad-spectrum activity against drug-resistant fungal infections as well as enhancing these products into a new antifungal class of therapeutics. Any experience in these technologies would be of tremendous benefit to Symbiotica at this point in time.
We think outsourcing partners and solution providers in the realms of small molecule CMOs, preclinical companies with animal model development for drug-resistant fungal infections, and any CROs that have experience with anti-microbial resistance should definitely have Symbiotica on their radar over the next few years.
Symbiotica’s Pipeline and R&D Focus
The current focus of Symbiotica’s pipeline will be optimizing potential drug candidates from all of their funded research and launching successful clinical trials while building strategic relationships with outsourcing partners. Symbiotica has been working on an antibiotic from ants that could be a huge line of business for them in the near future. The bacteria harbored by these fungus-growing ants produce a variety of small molecules that help maintain a complex multilateral symbiosis with their environment. In a survey of antifungal compounds from these bacteria, it was discovered that Selvamicin, an unusual antifungal polyene macrolide, has some very interesting therapeutic potential.  Let’s take a look at some of their research in detail, starting with the development of this novel natural antifungal, Selvamicin, that has the ability to potentially target drug-resistant fungal infections.
Currently there are no effective therapies for all of the emerging resistant fungal pathogens that are threatening the general public. To address this unmet clinical need for the growing immunocompromised patient population, Symbiotica will use their SBIR funding to launch an upcoming Phase 1 project. This clinical trial will be to further develop Selvamicin into a promising new antifungal class of therapeutics. Symbiotica’s preliminary data with Selvamicin has already demonstrated promising broad-spectrum activity against drug-resistant fungi in vitro and in pilot animal studies coupled with the absence of a toxicity signal from early cell and whole animal drug exposure studies. 
The proposed Phase 1 studies will further explore the feasibility for clinical development of this lead antifungal via three IND enabling aims. The first two aims will be focused on expanding preclinical efficacy, pharmacokinetics, and toxicology investigations. The final aim will focus on scaling up compound production and physiochemical characterization by defining a few things, such as the murine PK/PD target in standard FDA utilized models, the safety and therapeutic window for standard end organs, and finally advancing production and chemical analyses towards GLP/GMP capacity for future Phase 2 development. Further characterization will definitely be needed for subsequent GLP production required for Phase 2 toxicology analyses and early human studies. 
- Paul Ambrose - CEO at Symbiotica, Dr. Ambrose’s areas of scientific inquiry primarily involve anti-infective translational science, with the goal of improving patient care through the application of pharmacokinetic-pharmacodynamic (PK-PD) principles. Dr. Ambrose has gained a lot of knowledge through the use of non-clinical (in vitro and animal) PK-PD infection models that are leveraged with human PK data in order to discriminate between potential dosing regimens and thereby increase the probability of positive clinical outcomes while also minimizing the potential for drug-related toxicities. Dr. Ambrose is the author of over 120 peer-reviewed scientific publications and approximately 170 scientific abstracts, and has served as an editor for four textbooks; most notably the 1st and 2nd Editions of Antimicrobial Pharmacodynamics in Theory and Clinical Practice. Paul received his Doctorate of Pharmacy at the University of the Pacific in 1992, and completed his Postdoctoral Fellowship for Infectious Diseases at the Hartford Hospital Department of Research in 1998. 
With a decent amount of SBIR funding, significant progress in scientific benchwork, support from their parent company (ICPD), and a deep technical background from Dr. Ambrose, we believe that Symbiotica will do very well in their early-stage developments and clinical trial studies. Antimicrobial innovation has been dramatically slowed down while an epidemic of antimicrobial-resistant infections surges, threatening our public health. As we mentioned before, the overarching goal for Symbiotica at this time is to develop a novel natural antifungal product, Selvamicin, targeting drug-resistant fungal infections. This molecule was identified from a symbiotic animal environment, and growing evidence suggests this specific environment is a rich and untapped source of novel compounds. More importantly in the laboratory, the molecules from this symbiotic environment exhibit an extremely high rate of both biological activity and animal safety, presumably due to the evolutionary selection of the symbiotic relationship between the antibiotic producing microbe and animal.
We think Symbiotica 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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