What is the critical gap in cancer treatment that you are addressing?
Colorectal cancer (CRC) is the third most common cancer in both men and women in the United States. Most cases of CRC are diagnosed at early/mid stage, when the cancer is localized and confined to the colon and lymph nodes. Unfortunately, the recommended treatment for almost all early to mid stage CRC is surgery (i.e. laparoscopic and open colorectal) to remove polyps, cancer growths, the lymph nodes and the nearby healthy colon. This is sometimes followed by chemotherapy. While colorectal surgery has been deemed “curative,” many patients experience a combination of physical and emotional problems for a long period of time after surgery. Symptoms such as fatigue, pain and disturbed bowel function, as well as problems in social and role functioning, inevitably affect the patients’ wellbeing. There is a clear need for better CRC treatments that work AND address postoperative quality of life issues.
Siva’s Therapeutics is a Austin,Texas based biotech dedicated to developing a thermal cancer therapy called “Targeted Hyperthermia™.” Siva’s main product in development can provide a valuable tool for early intervention without the risks of surgery or drugs. This creates an opportunity to use Targeted Hyperthermia™ on an outpatient basis for the treatment CRC. If widely implemented, Targeted Hyperthermia™ could be a desired alternative to the current surgical practices for treating early to mid stage CRC.
What is Targeted Hyperthermia™? It is a minimally invasive procedure that involves the systemic injection of precision polymer-coated gold nanorods (called SivaRods™) and the use of an infrared light device (SivaLum™) coupled to a flexible endoscope. CRC patients will go to the clinic for an injection of SivaRods™ and return 12-18 hours later for a 10-minute treatment with infrared light using a SivaLum™ light device in a flexible sigmoidoscopy procedure. The injected SivaRods™ concentrate in tumors due to the “leakiness” of tumor vasculature, and they absorb infrared light and convert it into heat very efficiently, resulting in therapeutic heat (111°F/44°C) that emanates from within tumors and ultimately kills them. SivaRods™ are very safe and non-toxic, and they are excreted from the body within 2 weeks after administration. Pre-clinical studies indicate that one injection of SivaRods, and one treatment with infrared light will dramatically improve patient outcomes and reduce the need for surgery and drug therapy.
What is the key product development milestone you seek to fund?
As Siva’s Targeted Hyperthermia™ moves closer to initial human clinical studies, a key element of product development will be to create awareness of the benefits of this valuable new cancer therapy. Because of this, we are seeking funding for an outreach coordinator who will share the benefits of our Targeted Hyperthermia™ approach to physicians, providers, payers, patients and patient advocacy groups. Awareness of new cancer treatments is an essential, and sometimes underrecognized, part of the product development cycle, and the funds raised from this campaign will enable Siva to address this need.
How will funds be used?
Our fundraising goal is $70,000 for the first year. We intend to use these funds to hire an outreach coordinator position; if more than this is raised, the additional funds will be used to support and extend the position. The hired coordinator will raise awareness on the benefits of Targeted Hyperthermia™ with patients and patient advocate groups, physicians, providers, and payers as we enter the clinic.
What key resources have/will you acquire to facilitate the accomplishment of the above product development milestone?
Siva is actively raising $2.1 million, with over $400,000 closed, to fund completion of preclinical work and to gain clearance to begin human clinical studies. We are optimistic that we will close this round in Q1, 2022, and move forward. Key resources for preclinical studies and preparation for clinical studies will be: 1) manufacture of a supply of SivaRods™ gold nanorods and 2) development of a second generation SivaLum™ light engine. Finally, we plan to hire key personnel to support this work.
Funds from our campaign will provide a powerful message and leverage for patient advocacy groups for CRC, some of which we have already been in touch with. Growing the awareness of the potential for safe, effective hyperthermia treatment for cancer by patients and patient advocacy groups will accelerate the acceptance of these valuable tools for mainstream use. The CRC community, in particular, is asking for better treatments, and we plan to provide an important first step in that direction.
If your Technology were to disappear in the “Valley of Death” funding bottleneck how might this impact society?
Targeted Hyperthermia™ is a new approach to cancer therapy that could complement other cancer therapies already in use and offer better patient experience and quality of life outcomes. For CRC patients diagnosed with early to mid stage disease, Targeted Hyperthermia™, if widely available, could drastically improve treatment outcomes. Should this technology fail to reach patients who could benefit, cancer treatment as we know it would continue to burden the quality of life for individuals and society. At Siva Therapeutics, we intend to change this.
Len Pagliaro
Founder & Chief Executive Officer
Len has 23 years of experience with successful commercialization of biotechnology products, services, and technology licensing. He has managed R&D and business teams, and developed product, service, and technology licensing programs from inception to revenues to profitability in 2 previous biotech startups. He managed P&L for a business unit of ThermoFisher Scientific, selling tools and services for drug discovery, after successful acquisition of BioImage A/S, a Danish biotech he helped found. Len started commercialization at BioImage from concept to $1M in revenue in 1 year, revenues tripled in each of the following 2 years, and after acquisition and integration by Thermo, his P&L grew to $26M. A small molecule oncology therapeutic project he led was successfully partnered with TopoTarget and is now in the clinic. Following the acquisition of BioImage by Thermo, he co-founded Siva Therapeutics, where he has provided seed funding, recruited a management and operational team, assembled a strong and growing IP portfolio, and raised over $2.5M in grants and equity investment. Over the past 3 years Siva has acquired strong lab bench and animal data which demonstrate safety and efficacyof the Company’s photothermal cancer therapy approach. A meeting with the FDA has clarified the regulatory route to market, and the Company is currently raising a second round of financing. From 2018 to 2020 Len served as acting CEO of Dynamic Light, Inc., a spinout from the University of Texas at Austin, and brought to company through initial clinical studies to first revenues before recruiting a CEO for the new company. Prior to his industrial career, Len was a professor of Bioengineering and Laboratory Medicine at the University of Washington, where his laboratory studied basic aspects of cellular metabolism, with an emphasis on cancer and inflammatory disease. Len received his Ph.D. in cell biology from Wesleyan University, and completed postdoctoral training in biophysics at Carnegie Mellon University, and has participated in postgraduate professional business training.
Colin Shepherd
Chief Operating Officer
Colin has 16 years of experience working as an entrepreneur and manager at biotechnology companies. He has been involved in three startup companies, of which he founded or co-founded two. In 2006 he started AimsBio, Inc. a developer of high-throughput analytical assays for a variety of industries and was successful in signing over 50 clients to the service. In 2009 he co-founded PhylloTech Inc. as Chief Operating Officer and led the operations and financial units of the firm as well as performing as scientist on successive NSF and USDA SBIR grants and leading the protein production platform development. In 2011 he joined Siva Therapeutics, Inc. as Director of R&D and Chief Financial Officer and led the finance, operations, and early-stage R&D of the firm. He was instrumental in bringing in $1.1M in late 2012 from a mixture of grants and equity investments. At Siva, he led a team of 4 scientists and laboratory technicians in varying R&D and preclinical projects critical for the firm to progress through FDA regulatory phases. In 2015, he was appointed Chief Operating Officer at Siva Therapeutics and is managing new product development and commercialization as well as providing strategies on company operations, technology positioning, IP, and R&D. Colin received his B.S in biotechnology from the University of Kentucky, a Ph.D. in Genetics from Iowa State University, and an MBA from Iowa State University.
Steve Kregstein
Founder & Chief Counsel
Steve is responsible for all legal matters concerning the Company, including commercial transactions, FDA and other regulatory compliance, intellectual
property, supply agreements, joint ventures, and licensing. Steve has extensive public company and startup legal, financial and executive experience. He co-founded and grew ClearVision Laser Centers, a privately held company providing laser vision correction services, into a national company having 54 surgery centers and 350-plus employees in 14 states. He successfully sold this company at a $120M valuation to institutional investors, yielding a 12x return to early investors.
