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BIOFEST INVEST APPLICANT
Vitanova Biomedical, Inc.
- Vitanova biomedical 222 Sidney Baker Street, Kerrville, Texas 78028, US
- www.vitanovabiomedical.com
Company Contact:
Legal Entity Type: C-Corp
Company Type: Biotechnology
Company Stage: Development
No. of Employees: 3
Desired Financial Amount: $7,000,000
Background
Company Background
VNB is a San Antonio, Texas-based preclinical stage biotechnology company developing for commercialization a patented cancer therapy invented at the University of Texas at San Antonio (UTSA) laboratory of Dr. Matthew Gdovin, one of VNB’s founders. Through his academic research focusing on the neural control of respiration, Dr. Gdovin identified the application of the disruption of a cells ability to regulate pH to killing cancer cells. In 2014, Dr. Gdovin formally incorporated VNB and UTSA performed the initial patent search for his new cancer therapy based on the ability to focally induce Light-Activated Intracellular Acidosis (LAIA) with the capability of inducing cell death in multiple cancer cell types. In February 2015, Dr. Gdovin submitted a provisional patent to the U.S. Patent Office followed by international filings in February of 2016. Over time, VNB was granted patents in the following countries/regions: United States, Canada, Mexico, European Union, Australia, and Japan. From 2014 through 2016, Dr. Gdovin continued to focus on his duties as full-time Professor at UTSA. In October 2016, Tom Roberts was hired as CEO to provide executive leadership and strategic direction for all business development and commercialization strategies including talent acquisition, funding, technology development, the regulatory pathway, and strategic partnerships. Since that time, VNB has negotiated a fully-owned license agreement through the University of Texas, Raised $1.3 million (private investments and government grants) which has facilitated the full development of VNB’s novel nanoparticle-based drug, completed promising in vivo proof of principle studies, secured all partnerships necessary to facilitate LAIA to commercialization, and entered into discussions with a multinational billion-dollar strategic partner for possible investment and or licensing. In 2018, Dr. Gdovin accepted the role as full-time Chief Science Officer at VNB.
Management
VNB’s current structure consists of three tiers including the Executive Team (Full-time Chief Science Officer and part-time Chief Financial Officer) reporting to the CEO, the CEO reporting to the Board of Directors (BODs), and a four person BODs. The Executive Team consists of the following individuals:
Tom Roberts, B.S., M.B.A, Chairman & Chief Executive Officer (San Antonio, TX). Tom has 30 years of experience in significant leadership roles and executive management at large corporations, mid-caps, and start-ups in the medical device and biotech sectors. He has held senior leadership positions at Acelity and Hoffmann-La Roche, including Head of Product Development and Global Marketing for a billion-dollar healthcare brand. In this role, Tom led the global development, regulatory clearance, and commercialization of 10+ healthcare technology products globally. Prior to joining VNB, Tom served as CEO/Board Director at Invictus Medical, Inc. (San Antonio, TX), a start-up healthcare technology company where he successfully raised $10M in financing and directed the full development, regulatory clearance, and commercialization of a novel University of Texas-licensed healthcare technology. Tom received his B.S (Biology) from Denison University and M.B.A. from Indiana Wesleyan University.
Matthew Gdovin, Ph.D., Founder, Chief Scientific Officer & Board Director (San Antonio, TX). After receiving his Ph.D. in Physiology at Dartmouth College, Dr. Gdovin completed his post-doctoral fellowship at The University of Calgary Faculty of Medicine. From 1997 to 2018, he was an Assistant and Full Professor at the UTSA. During his academic tenure, Dr. Gdovin incorporated VNB becoming its full-time Chief Science Officer in 2018. In this role, he helped raise $1.28M in financing, participated in the solidification of critical strategic partnerships, and led the development of VNB’s drug. Dr. Gdovin has been awarded over $3.2M by the NIH for research in respiratory control and neurobiology.
Greg Espenhover, CPA, Founder, Chief Financial Officer & Board Director (San Antonio, TX) Greg is a successful entrepreneur and CPA with 30+ years’ experience in providing accounting, tax, and business consulting services. Since 1988, he has been a CPA under the Texas State Board of Accountancy, as well as a member of the American Institute of Certified Public Accountants and Texas Society of Certified Public Accountants and holds Certified Information Technology Professional AICPA designation. In 1999, Greg became a Shareholder and Partner with Davidson Freedle Espenhover & Overby, P.C., providing accounting, auditing, consulting, and tax services for private companies.
In addition to the Executive Leadership Team, VNB has secured the expert guidance of the following professionals:
George Peoples, M.D., FACS, Clinical Advisor (San Antonio, TX). Dr. Peoples is Founder/Director of Cancer Vaccine Development Program (CVDP), affiliated with Uniformed Services University of Health Sciences (USUHS; Bethesda, MD). He is Professor (adjunct) of Surgical Oncology at MD Anderson Cancer Center and CEO of boutique CRO Cancer Insight, which has 20+ years of clinical trial development and management, 1,500+ patients dosed Phase 1/2 trials, and 9 INDs. Dr. Peoples is a cancer immunotherapy expert with 5 licensed cancer vaccines and 305+ peer-reviewed manuscripts, abstracts, and chapters. Dr. Peoples provides critical insight pertaining to Cancer therapy development, IND-enabling studies, and human clinical studies.
Michael Liss, M.D., Collaborator (San Antonio, TX). Dr. Liss specializes in genitourinary system cancers (prostate, kidney). After graduating with honors from the Medical School of Wisconsin, he attended University of California, Irvine, and trained under leaders in laparoscopic and robotic urology. Dr. Liss is the current site PI for SWOG (formerly Southwest Oncology Group), one of the biggest cooperative clinical trial groups in the world. He serves as medical director of clinical research at UT Health (San Antonio, TX) and is an active member of the May’s Cancer Center’s Genetics and High-risk Cancer Screening Clinic. Dr. Liss provides critical insight pertaining to IND-enabling studies and human clinical studies.
Barry Burgdorf, B.B.A., M.B.A., J.D., Partner, Hogan Lovells, Corporate Law Firm (Austin, TX). Mr. Burgdorf helps public and private companies, emerging companies, and venture capital, private equity, universities, and higher education clients, with a variety of complex mergers, acquisitions, financings, IP, and other corporate transactions in the life sciences sector, with particular focus on technology, commercialization, research, and development. Barry, provides critical insight pertaining to governance, financing, and strategic partnerships.
Luis De Taboada, Vice President of Advanced Research, DJO Global Inc., Scientific Advisor (Vista, CA). Luis is a medical device executive with broad experience in all aspects of the medical device enterprise, with specific training and experience in the use of electrophysical agents (particularly, lasers) as therapeutic interventions in musculoskeletal and neurological conditions. He has lead teams at startups, mid-size, and large companies through the development of several medical devices – from conceptualization, through clinical studies and regulatory approvals, to successful commercialization. Luis provides critical insight pertaining to laser light delivery parameters regarding animal and human testing.
In addition to the before mentioned Advisors, VNB will actively recruit and partner with the necessary expertise to successfully execute the overall regulatory strategy including IND-enabling studies, IND application preparation and filing, and human clinical studies. To that end, the company is in discussions with, and has solicited proposals from Guidehouse Consulting, Charles River Consulting, and LabCorp. Once the necessary funding is secured, VNB will formally engage the appropriate partner.
Board of directors
Tom Roberts, B.S., M.B.A, Chairman & Chief Executive Officer (San Antonio, TX). Tom has 30 years of experience in significant leadership roles and executive management at large corporations, mid-caps, and start-ups in the medical device and biotech sectors. He has held senior leadership positions at Acelity and Hoffmann-La Roche, including Head of Product Development and Global Marketing for a billion-dollar healthcare brand. In this role, Tom led the global development, regulatory clearance, and commercialization of 10+ healthcare technology products globally. Prior to joining VNB, Tom served as CEO/Board Director at Invictus Medical, Inc. (San Antonio, TX), a start-up healthcare technology company where he successfully raised $10M in financing and directed the full development, regulatory clearance, and commercialization of a novel University of Texas-licensed healthcare technology. Tom received his B.S (Biology) from Denison University and M.B.A. from Indiana Wesleyan University.
Matthew Gdovin, Ph.D., Founder, Chief Scientific Officer & Board Director (San Antonio, TX). After receiving his Ph.D. in Physiology at Dartmouth College, Dr. Gdovin completed his post-doctoral fellowship at The University of Calgary Faculty of Medicine. From 1997 to 2018, he was an Assistant and Full Professor at the UTSA. During his academic tenure, Dr. Gdovin incorporated VNB becoming its full-time Chief Science Officer in 2018. In this role, he helped raise $1.28M in financing, participated in the solidification of critical strategic partnerships, and led the development of VNB’s drug. Dr. Gdovin has been awarded over $3.2M by the NIH for research in respiratory control and neurobiology.
Greg Espenhover, CPA, Founder, Chief Financial Officer & Board Director (San Antonio, TX) Greg is a successful entrepreneur and CPA with 30+ years’ experience in providing accounting, tax, and business consulting services. Since 1988, he has been a CPA under the Texas State Board of Accountancy, as well as a member of the American Institute of Certified Public Accountants and Texas Society of Certified Public Accountants and holds Certified Information Technology Professional AICPA designation. In 1999, Greg became a Shareholder and Partner with Davidson Freedle Espenhover & Overby, P.C., providing accounting, auditing, consulting, and tax services for private companies.
Product / Service
disease area / application
solid tumor cancer therapeutic
product / Service
Significant Unmet Patient Need: In 2021, there were an estimated 248,530 newly diagnosed prostate cancer patients in the U.S. and anticipated 34,130 deaths. The World Cancer Research Fund International estimated the global incidence of prostate cancer in 2012 was 1.1 million men per year. The prevalence for men diagnosed with all stages of prostate cancer in the U.S. is approximately 3.3 million patients, with over 80% of all prostate cancer patients being diagnosed with local prostate cancer. In current practice, the three most common treatment options offered to men with local prostate cancer are radical prostatectomy (with or without hormone therapy), radiation therapy (RT) (with or without hormone therapy), and active surveillance (AS). Scher, (2015) reported that 33% of men with local prostate disease would progress to more lethal forms of prostate cancer. Resnick et al., (2013) reported that 15 years after either prostatectomy or radiotherapy, prostate cancer patients had urinary incontinence (18.3% and 9.4%, respectively), insufficient erection for intercourse (87.0% and 93.9%, respectively), and bowel urgency (21.9% and 37.7%, respectively). In 2010-2013, the election of AS by early-stage prostate cancer patients increased to 40%. However, the popularity of AS wanes after a few years following prostate cancer diagnosis. The 10-year Prostate Cancer Research International Active Surveillance (PRIAS) Project, the largest study on AS in low-risk prostate cancer (2006-2016), showed 65% (n=500) of men discontinued AS after a median of 2.3 years. Notably, men on AS eventually request active treatment, not due to disease progression, but due to the anxiety of living with untreated cancer.
Solution: VNB is developing an innovative approach to treating cancer with LAIA as a targeted, energy-based therapy, based upon three accepted principles of cancer therapy: 1) Intracellular acidosis causes pH-induced cancer cell death; 2) Compounds, such as porphyrins, can be activated by specific wavelengths of light to elicit a desired biological response; and 3) Nanoparticles have been selectively targeted to cancer using antibody-antigen or ligand-receptor conjugates. LAIA is used in conjunction with deep penetrating near infrared (NIR) light to elicit rapid intracellular acidosis and concomitant pH-induced apoptosis of the targeted prostate cancer cells. LAIA technology involves the photo-activation of nitrobenzaldehyde (NBA), an acid donor, which releases H+ in response to ultraviolet light. VNB improved the ability to deliver LAIA’s light activation to deeper tissue by conjugating NBA to a yttrium (Yt)-based UCNP. This improvement allows for photo-activation by deep penetrating 980 nm NIR light, causing the UCNP to convert 980 nm light to the 351 nm light required to release H+ from NBA. Additionally, VNB has improved LAIA’s specific targeting by conjugating prostate specific membrane antibody (PSMAb) to the surface of the NBA:Yt UCNP. This PSMA-targeted UCNP (VNBp-1), will only enter cancer cells expressing PSMA on their surface. By targeting VNBp-1 to only prostate cancer cells expressing PSMA, LAIA will effectively kill prostate cancer without damaging nearby healthy tissue, a major advantage to current prostate therapies.
Value Proposition: VNB’s LAIA therapy is a platform technology which utilizes nanoparticles to actively target multiple cancer indications. LAIA therapy with VNBp-1, specifically targeted for the treatment of early-stage local prostate cancer, offers flexibility in delivery, the active targeting to only prostate cancer cells, minimally invasive photo-activation, and the inability to develop resistance in the treatment of solid tumors. Additionally, LAIA therapy with VNBp-1 will cause prostate-specific cancer cell death in a targeted manner, reducing damage to nearby non-cancerous healthy tissue, and eliminating the unwanted side effects associated with surgery, external beam, and internal RT. Lastly, LAIA therapy with VNBp-1 will prevent the consequence of cancer progression to a more advanced clinical state resulting from AS.
technology / ip
Vitanova Biomedical, Inc. (VNB) is a San Antonio, Texas-based early-stage biotechnology firm utilizing patented technology licensed from the University of Texas (UT). The company’s platform cancer therapy is based upon the ability to focally induce Light-Activated Intracellular Acidosis (LAIA), which is proven capable of producing a natural cell death in multiple cancer cell types in vitro (breast, pancreatic, and prostate), and in triple negative breast and prostate cancer in vivo While eliminating the devastating side effects caused by the current standard of care therapies including surgery, radiation, and chemotherapy.
VNB has fully-owned license agreement through UT. The company submitted a provisional patent based upon the the ability to light activate NBA to cause intracellular acidosis, followed by a provisional patent filing of a Patent Cooperation Treaty patent submission (PCTUS1517862) on February 26, 2015. Currently, the company has Freedom to Operate with issued patents in the US, CA, MX, EU, AU, and JP. The issued claims are directed to methods of using NBA to treat a cancerous tumor in a patient by lowering intracellular pH by photo-activation.
distribution channels
VNB’s goal is to monetize our technology with a pharmaceutical and/or medical diagnostic partner (human and/or animal health sectors) through licensing or acquisition within a three to seven-year period of closing our $7M Seed financing, and upon the estimated successful completion of our Phase I/IIA trial. As LAIA therapy is a true platform technology and is designed as a combination therapy (therapeutic + medical device), VNB has a variety of possible acquisition, licensing, and strategic partnership opportunities in multiple different healthcare technology sectors including therapeutics, medical device, diagnostic, human health, and animal health.
Considering a full commercialization by VNB scenario, the company will be focusing on three primary target customers during the early commercialization phase of our technology. First, the company will target Key Opinion Leaders (KOLs) within the cancer therapy sector. To that end, there are approximately 1,500 cancer clinics in the US. VNB will first target the top 71 of these treatment clinics defined as National Cancer Institute (NCI) designated cancer centers. These NCI designated clinics represent 4% of the total number of cancer clinics and are located throughout 36 different states. Examples of NCI designated clinics include MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and the Mayo Clinic. Second, the Value Add Committee within these top clinics is the gatekeeper that will determine clinic access to LAIA therapy. Third, the oncology urologist is the end user and the most likely early adopter health care professional to be receptive to a novel prostate cancer treatment that can be delivered in a clinic setting and does not involve the traditional SOC treatments of surgery and/or RT. In 2020, there were 13,352 practicing urologists in the US; 41% of these practicing urologists have a subspecialty with oncology being one of the top two subspecialties. To that end, VNB will target the Value Add Committees of the top oncology urologist practices in the country (as defined by practice size, reputation, and subspecialty). By targeting the Value Add Committees, KOLs at NCI designated cancer centers, and select urology clinics, VNB will focus our early commercialization efforts in a targeted, efficient, and cost effective, manner. In an early exit scenario, the exit partner company will develop and execute a commercialization plan congruent with their competencies.
market size
In 2021, there were an estimated 248,530 newly diagnosed prostate cancer patients in the U.S. and anticipated 34,130 deaths. The World Cancer Research Fund International estimated the global incidence of prostate cancer in 2012 was 1.1 million men per year. The prevalence for men diagnosed with all stages of prostate cancer in the U.S. is approximately 3.3 million patients, with over 80% of all prostate cancer patients being diagnosed with local prostate cancer.
The SOC for treating most cancers is represented by a few well-established treatment options including surgery, RT, and chemotherapy. While overcoming these traditional therapy treatments will be challenging, VNB has a distinct opportunity with men diagnosed with early-stage prostate cancer as 40% of these men are prescribed AS, and two-thirds of these men seek more aggressive treatment options within two years after diagnosis. VNB has estimated a preliminary U.S. value-based price in the range of $27,000-$31,000 per dose, which is within the range of available SOC surgery, RT, and other ablative prostate cancer therapies. Utilizing a minimum estimated pricing of $27,000 for one treatment per patient, LAIA therapy has the forecasted market potential to impact 119,000 patients which approaches $500 million in gross revenue during its peak year, eight years from the initial launch date in the US. VNB has not yet estimated markets for the rest of the world.
Adequate reimbursement is critical to the successful adoption of any new therapy/drug treatment. VNB will engage third party reimbursement specialists to provide a more detailed reimbursement assessment and strategy specific to obtaining reimbursement for LAIA therapy for the treatment of solid tumors for early-stage prostate cancer in an expeditious manner.
competition
On a broad scale, VNB’s technology competitors include the SOC early-stage prostate cancer treatments of surgery, RT, chemotherapy and AS. VNB’s LAIA technology is uniquely differentiated from current cancer treatments for solid tumors in three ways: 1) LAIA is a true platform technology and can be targeted to any type of solid tumor; 2) Specific antibody targeting of UCNP spares nearby healthy tissue; and 3) LAIA eliminates unwanted side effects of current solid tumor cancer therapies.
The prostate cancer diagnostics and therapy industry is considered more consolidated as opposed to fragmented with the market being dominated by few large major players including Abbott Laboratories, AstraZeneca, Bayer HealthCare AG, Sanofi-Aventis, GE Healthcare, Rakuten Medical, and F. Hoffmann-La Roche AG. While a consolidated market makes it more difficult for small to mid-sized company to compete, larger companies often have more disposable investment funds for continually improving its products, processes, and technologies. In many cases, larger companies seek to stay competitive by acquiring a smaller startups who are developing or have already developed novel technologies. Additionally, The SOC for treating most cancers is represented by a few well-established treatment options including surgery and RT. While overcoming these traditional therapy treatments will be challenging, VNB has a distinct opportunity with men diagnosed with early-stage prostate cancer as 40% of these men are prescribed AS, and two-thirds of these men seek more aggressive treatment options within two years of being diagnosed.
Financials
Desired financial amount
$7,000,000
previous funding
As of February 2023, VNB received a total of $1,280,000 in funding resulting from a successful Friends and Family financing of $470,000 and a Seed financing (currently open) of $810,000. This total funding amount includes $995,000 in Convertible Promissory Notes (CPN)s from a total of thirteen (13) individual private investors, $275,000 in non-dilutive grant funding including $225,000 from the National Science Foundation in the form of a Small Business Innovation-Research Phase I Grant. These funds have allowed VNB to fully develop our UCNP drug and demonstrate efficacy in several animal models The company is currently seeking $7 million in Seed funding to facilitate our technology to an Investigational New Drug Application with the FDA.
current financials
Currently the founders are financing the company as we await the anticipated awarding of government grants and an additional influx of capital. current burn rate is approximately $35,000/month
financial use
1. In conjunction with NanoComposix, San Diego, CA: Final Drug optimization and characterization in preparation for Investigational New Drug (IND)-enabling studies
2. In conjunction with NanoComposix, San Diego, CA: The implementation of a fully-integrated GMP drug manufacturing process.
3. In conjunction with LabCorp, Burlington, NC: The initiation and completion of all necessary IND-enabling studies.
4. In conjunction with Guidehouse Consulting, Chicago, IL: The preparation and completion of all necessary IND regulatory requirements including IND application preparation and submission.
5. Operational expenses
revenue
The SOC for treating most cancers is represented by a few well-established treatment options including surgery, RT, and chemotherapy. While overcoming these traditional therapy treatments will be challenging, VNB has a distinct opportunity with men diagnosed with early-stage prostate cancer as 40% of these men are prescribed AS, and two-thirds of these men seek more aggressive treatment options within two years after diagnosis. VNB has estimated a preliminary U.S. value-based price in the range of $27,000-$31,000 per dose, which is within the range of available SOC surgery, RT, and other ablative prostate cancer therapies. Utilizing a minimum estimated pricing of $27,000 for one treatment per patient, LAIA therapy has the forecasted market potential to impact 119,000 patients which approaches $500 million in gross revenue during its peak year, eight years from the initial launch date in the US. VNB has not yet estimated markets for the rest of the world.
Adequate reimbursement is critical to the successful adoption of any new therapy/drug treatment. VNB will engage third party reimbursement specialists to provide a more detailed reimbursement assessment and strategy specific to obtaining reimbursement for LAIA therapy for the treatment of solid tumors for early-stage prostate cancer in an expeditious manner.
Considering a full commercialization by VNB scenario, the company will be focusing on three primary target customers during the early commercialization phase of our technology. First, the company will target Key Opinion Leaders (KOLs) within the cancer therapy sector. To that end, there are approximately 1,500 cancer clinics in the US. VNB will first target the top 71 of these treatment clinics defined as National Cancer Institute (NCI) designated cancer centers. These NCI designated clinics represent 4% of the total number of cancer clinics and are located throughout 36 different states. Examples of NCI designated clinics include MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and the Mayo Clinic. Second, the Value Add Committee within these top clinics is the gatekeeper that will determine clinic access to LAIA therapy. Third, the oncology urologist is the end user and the most likely early adopter health care professional to be receptive to a novel prostate cancer treatment that can be delivered in a clinic setting and does not involve the traditional SOC treatments of surgery and/or RT. In 2020, there were 13,352 practicing urologists in the US; 41% of these practicing urologists have a subspecialty with oncology being one of the top two subspecialties. To that end, VNB will target the Value Add Committees of the top oncology urologist practices in the country (as defined by practice size, reputation, and subspecialty). By targeting the Value Add Committees, KOLs at NCI designated cancer centers, and select urology clinics, VNB will focus our early commercialization efforts in a targeted, efficient, and cost effective, manner. In an early exit scenario, the exit partner company will develop and execute a commercialization plan congruent with their competencies.
exit strategy
VNB’s goal is to monetize our technology with a pharmaceutical and/or medical diagnostic partner (human and/or animal health sectors) through licensing or acquisition within a five to seven-year period of closing our $7M Seed financing, and upon the estimated successful completion of our Phase I/IIA trial. As LAIA therapy is a true platform technology and is designed as a combination therapy (therapeutic + medical device), VNB has a variety of possible acquisition, licensing, and strategic partnership opportunities in multiple different healthcare technology sectors including therapeutics, medical device, diagnostic, human health, and animal health.
