Underdog Pharmaceuticals Announces Successful Meeting with MHRA and Launch of Series A Campaign

Underdog Pharmaceuticals, Inc., a pharmaceutical company designing engineered cyclodextrins to address atherosclerosis and other serious diseases of aging, has concluded a successful meeting with the Medicines and Health products Regulatory Agency (MHRA) of the UK. The goals of the meeting were to set standards for Phase 1, lay the groundwork for endpoints demonstrating real disease modification, and determine whether Underdog may be able to enroll asymptomatic patients in the Phase 1 trial.

Underdog received acknowledgement of being on course with its plans for in vivo efficacy and safety testing. Underdog’s program for the development of drug product for the clinical trial raised no significant concerns.

The MHRA supported inclusion of trial participants with asymptomatic, stable, “non-culprit” plaques, as long as subjects have no diagnosed CVD condition. Since Underdog may be allowed to perform multiple, minimally invasive plaque and 7-ketocholesterol (7KC) biomarker measurements, enrollment of asymptomatic subjects presents an opportunity for Underdog to obtain information about the characteristics of the plaque and 7KC burdens in these patients. This is a unique opportunity to acquire valuable human data on target engagement and clinical proof of concept early during the Phase I trial.

Additionally, Underdog was invited to submit an ILAP (the Innovative Licensing and Access Pathway) application. ILAP is a new, exclusive program of the MHRA, National Institute for Clinical Excellence, and National Institute for Health Research resources, and provides advantages similar to the FDA’s accelerated programs, and may allow reimbursement for clinical trials through the NHS. Underdog has submitted its application and has already been granted a review meeting.

With the aim of entering the clinic as soon as reasonable, Underdog has commenced its campaign for Series A funding. Seeking a minimum of $9M, the company will utilize the funding to complete IND enabling studies and the IND filing. Underdog’s current lead investor, Kizoo Technology Ventures, has committed to co-leading the round. “We are honored to have such strong support from our seed-stage investors and are excited to bring on a select few, new, strategic investors. Their confidence in us has us well positioned for continued development of our pipeline and supports our ambition in addressing all diseases caused by plaque formation, an opportunity to save countless lives,” said Mike Kope, co-CEO of Underdog.

About Underdog

Underdog Pharmaceuticals, Inc., uses engineered cyclodextrins to address atherosclerosis and other serious diseases of aging.  The development of arterial plaques, or atherosclerosis, drives many diseases including stroke, COPD, and heart disease. It is the #1 killer in the world.

Underdog’s robust computational chemistry and synthetic chemistry programs were born in the labs of SENS Research Foundation (SRF), the only non‐profit devoted to reversing age‐related disease by addressing their underlying causes.  The company’s novel molecules attack the core cause of atherosclerosis: the oxidized cholesterol derivatives that inhibit the cardiovascular self-repair system. Underdog can target these derivatives safely and effectively, without interfering with key enzymatic systems; offering the possibility of a new class of drugs that could reverse, not merely treat, this deadly disease.  Underdog’s founders, Matthew O’Connor and Michael Kope, were principals of SRF and advocates of genuine rejuvenation biotechnologies. Advisors include world-renowned biomedical gerontologist Aubrey de Grey, leading cyclodextrin expert Lajos Szente, and atherosclerosis expert Professor W. Gray “Jay” Jerome.

 

About Kizoo Technology Ventures

Kizoo provides mentoring and seed and early-stage financing with a focus on rejuvenation biotechnology. Having been entrepreneurs, VCs, and mentors in both high-growth tech and biotech companies for many years, with multiple exits and massive value created for the founders, Kizoo now brings this experience to the emerging field of rejuvenation biotech – a young industry that will eventually become much bigger than today’s largest technology markets.

As part of the Forever Healthy Group, Kizoo directly supports the creation of startups turning research on the root causes of aging into therapies and services for human application. Investments include AgeX, FoxBio, Turn.bio, Elevian, Oisin Biotechnologies, LIfT BioSiences, MAIA Biotechnology, and others. Forever Healthy’s other initiatives include the evaluation of new rejuvenation therapies, evidence-based curation of the world’s cutting-edge medical knowledge, funding research projects on the root causes of aging, and hosting the annual Undoing Aging Conference. For more information, please visit: kizoo.com and forever-healthy.org.

Notice:

This notice and the information presented herein are for informational purposes and are not an offer to sell or a solicitation of an offer to buy any securities in any company and may not be relied upon in connection with the purchase or sale of any security.

Media contact:

For Underdog: press@underdogpharma.com

Underdog Pharmaceuticals Named A Lighthouse Investment by Kizoo Technology Ventures

Kizoo Technology Capital GmbH has recently announced a $362M commitment to invest in rejuvenation biotechnology. If you haven’t seen the compelling write-up in BioWorld Today, please take a moment to read it here.

Underdog was delighted to be referenced therein as one of Kizoo’s “lighthouse” investments. Kizoo’s continued support in our Series A positions us to become a leader in the rejuvenation biotechnology revolution; their commitment to that industry is unparalleled and will transform the way treat age related disease. Thank you, Michael Greve, for this commitment!

Mike and Oki

Underdog is excited to announce the acceptance of our new manuscript for publication

It covers the computational systems that we built to design and test a new family of chemical compounds in silico, synthesis of several prototypes, all the way through preliminary in vivo testing. It’s the culmination of about 4 yrs of work starting at SENS, finished at Underdog and involving collaborations with leading experts in Spain, Hungary, and China. Give it a look and let us know what you think!

Underdog Pharmaceuticals Announces MD.USE Partnership and Technology Acquisition

MOUNTAIN VIEW, Calif., Jun. 12, 2020 — Underdog Pharmaceuticals, Inc., a pharmaceutical company designing engineered cyclodextrins to address atherosclerosis and other serious diseases of aging, has completed a partnership and technology acquisition agreement with MD.USE Innovative Solutions, SL.

Underdog is built upon the combined power of computational and synthetic chemistry, and the strength of our computational system derives significantly from our long-standing relationship with MD.USE Innovative Solutions, SL, a start-up from Santiago de Compostela University, Spain. Its founders, Drs Ángel Piñeiro and Rebeca Garcia-Fandino, are experienced computational chemists, and the world’s leading specialists in the development of cyclodextrin-specific simulations.

Underdog has worked with MD.USE over two years to build a new software system, Candymer, which can build and parameterize sophisticated molecular dynamics simulations of cyclodextrin-sterol complexes. With it, we can test drug target interactions, off-target impact, and also design entirely new molecules. It’s critical to Underdog both in the testing and optimization of our lead candidates, now, and in the design of potential new therapies tomorrow.

Modeling a Cyclodextrin – 7KC Interaction with Candymer
Therefore, we are delighted to announce a new relationship with MD.USE, under which Underdog receives ownership of Candymer and a related suite of platform technologies*, exclusive access to their services in our field of interest, and Angel and Rebeca join our team. With this platform and these people, our combined computational team is poised to do great things.
The Underdog computational team: Rebeca Garcia-Fandino, Amelia Anderson and Ángel Piñeiro

* The suite of technologies includes UndARdog AR: an augmented reality (AR) tool allowing users to visualize the complexation between CDs and sterols in an immersive environment.

About Underdog

Underdog Pharmaceuticals, Inc., uses engineered cyclodextrins to address atherosclerosis and other serious diseases of aging.

The development of arterial plaques, or atherosclerosis, drives many diseases including stroke, COPD, and heart disease. It is by far the #1 killer in the world.

Our robust computational chemistry and synthetic chemistry programs were born in the labs of SENS Research Foundation (SRF), the only non‐profit devoted to reversing age‐related disease by addressing their underlying causes.

Our novel molecules attack the core cause of atherosclerosis; the oxidized cholesterol derivatives that inhibit the cardiovascular self-repair system. We can target these derivatives safely and effectively, without interfering with key enzymatic systems; offering the possibility of a new class of drugs that could reverse, not merely treat, this deadly disease.

Our founders, Matthew O’Connor and Michael Kope, were principals of SRF and advocates of genuine rejuvenation biotechnologies. Advisors include world-renowned biomedical gerontologist Aubrey de Grey, and leading cyclodextrin expert Lajos Szente.

Underdog completed its initial seed round for $4,000,000 in November, 2019.

For Underdog: press@underdogpharma.com

7-Ketocholesterol in disease and aging

Hydroxypropyl Beta Cyclodextrin molecule

Scientists from Underdog Pharmaceuticals, in conjunction with Professor Jay Jerome of Vanderbilt University Medical Center, have published an article in the journal Redox Biology, covering the role of the toxic biomolecule 7-ketocholesterol, especially in the development of diseases of aging.

You can find the open access link here:
  

Abstract

7-Ketocholesterol (7KC) is a toxic oxysterol that is associated with many diseases and disabilities of aging, as well as several orphan diseases. 7KC is the most common product of a reaction between cholesterol and oxygen radicals and is the most concentrated oxysterol found in the blood and arterial plaques of coronary artery disease patients as well as various other disease tissues and cell types. Unlike cholesterol, 7KC consistently shows cytotoxicity to cells and its physiological function in humans or other complex organisms is unknown. Oxysterols, particularly 7KC, have also been shown to diffuse through membranes where they affect receptor and enzymatic function. Here, we will explore the known and proposed mechanisms of pathologies that are associated with 7KC, as well speculate about the future of 7KC as a diagnostic and therapeutic target in medicine.

Kizoo Technology Capital leads seed round financing at Underdog Pharmaceuticals

SRF announces leadership appointments

MOUNTAIN VIEW, Calif., Nov. 14, 2019 (GLOBE NEWSWIRE) — Underdog Pharmaceuticals, Inc. (Underdog), and SENS Research Foundation (SRF) today announced the launch of Underdog and the completion of its seed round, providing $3.95 million to promote Underdog’s development of disease-modifying treatments for atherosclerosis and other age-related diseases. SRF also announced two senior appointments.

The Underdog round is led by Michael Greve’s Kizoo Technology Capital, part of the Forever Healthy Group and one of the premier organizations focusing on accelerating rejuvenation biotechnologies. It also includes Oculus co-founder Michael Antonov through Tubus, LLC, and financier Harald McPike through Chambray Worldwide, Ltd.

Underdog was built from an SRF flagship program that has driven two years of applied development designed to explore and repair the underlying causes of cardiovascular disease. Its co-founders are Matthew O’Connor, Ph.D. and Michael Kope, formerly the V.P. of Research and the founding CEO, respectively, of SRF.

“We’ve taken a well-known and extremely safe compound,” said O’Connor, “and have created novel derivatives that can specifically target the toxic biomolecule that drives the development of atherosclerosis, the cause of most heart attacks and strokes.”

Underdog’s research has combined computational and synthetic chemistry programs to create custom-engineered cyclodextrins (polysaccharides with known industrial and pharmaceutical excipient uses) to capture, and remove from cells, oxidized cholesterol derivatives such as 7-ketocholesterol, which are broadly toxic molecules with no known biological function. “Underdog will take a classic pharmaceutical approach and use it to attack the root causes of cardiovascular disease,” said Kope.  “If we’re successful, we won’t just be ameliorating the disease, but reversing it.”

Underdog’s advisors include world-renowned cyclodextrin expert Dr. Lajos Szente. “This elegant approach has the potential to be truly revolutionary,” Szente said. “I’m delighted to be working with them on this important advancement in the field.”

“I came to Aubrey de Grey years ago so that we could work together to accelerate the availability of human rejuvenation therapies,” said Greve. “I am proud to help SRF grow a flagship research program into a genuine company and to help unlock the required capital to develop a true rejuvenation therapy. I’m gratified that we’ve done this while continuing to allow for the health and growth of SRF itself, one of our most important engines for the rejuvenation pipeline.”

The agreement between the organizations will provide equity, royalties, and milestones for the future support of SRF programs.

As Underdog spins out, the V.P. of Research position at SRF has been assumed by Prof. Alexandra Stolzing. Stolzing, a long-standing SRF Research Advisory Board member, received her PhD from the Humboldt University in Berlin, was a postdoctoral fellow at Sheffield University, UK, group leader at the Fraunhofer Institute for Cell Therapy and Immunology, Germany, and then Professor for Biogerontological Engineering at Loughborough University, UK. With over 70 peer-reviewed publications, she has participated in several international research consortia in areas including regenerative medicine, cell and gene therapy development, and neurodegenerative diseases. Her industry experience includes startup CSO and VP of Research roles. Said Stolzing, “I’ve always been passionate about translational research in aging, and I’m very excited to join SRF, where I look forward to translating SRF’s basic science projects, initiating new projects, and helping generate the next wave of healthspan spinouts.”

Science and technology investor and longtime SRF board member Jim O’Neill has stepped in to lead the SENS Research Foundation as interim CEO. He will also spearhead the search for the incoming permanent CEO. O’Neill has advised, invested in, and nurtured more than sixty science and technology companies. While running the Thiel Foundation, he co-founded the Thiel Fellowship and helped create deep science fund Breakout Labs. Previously, he helped lead the U.S. Department of Health and Human Services as the principal associate deputy secretary, where he was responsible for overseeing policy and regulations at NIH, FDA, and CDC and led two major reforms of FDA. He supported the creation of the Armed Forces Institute for Regenerative Medicine, served on the steering committee of the Biomedical Advanced Research and Development Authority, and represented the United States on the U.S. delegation to the World Health Assembly. “Over the past decade, Mike and Aubrey built a team of scientists dedicated to damage repair and turned skeptics into advocates along the way,” said O’Neill. “The growing interest in technologies that can reverse aging is proof of their vision and determination. I’m excited to advance SRF’s vision to bring the benefits of such technologies to the public.”

“This is an historic moment for SENS Research Foundation,” said Dr. Aubrey de Grey, co-founder and Chief Science Officer of SRF. “Underdog may well become one of the most significant endeavors in the rejuvenation biotechnology industry, and Mike and Oki are the perfect team to make it a success. And with Jim’s deep experience in investment and policy, and Alex’s brilliance in research and teaching, I’ve no doubt our mission is in good hands. I’m delighted to have their leadership and expertise at SRF.”

About Underdog

Underdog Pharmaceuticals, Inc., is pursuing a mission to treat the underlying causes of age-related disease. The company develops simple and direct interventions targeting toxic forms of cholesterol using rationally designed molecules to provide the first true diseasemodifying treatments for age-related diseases such as atherosclerosis, hypercholesterolemia, heart failure, and macular degeneration. Its products are based on novel derivatives of a well-known, safe compound and a new way of looking at cardiovascular disease created through a SENS Research Foundation program. For more information, please visit underdogpharma.com.

About SENS Research Foundation

SENS Research Foundation is a 501(c)(3) nonprofit that works to research, develop and promote comprehensive regenerative medicine solutions for the diseases of aging.  SRF supports research projects focused on a damage repair paradigm at universities and institutes around the world with the goal of curing such age-related diseases as heart disease, cancer, and Alzheimer’s disease. SRF educates the public and trains researchers to support a growing regenerative medicine field through advocacy campaigns and educational programs. For more information, please visit sens.org.

About Kizoo

Kizoo provides mentoring and seed and early-stage financing with a focus on rejuvenation biotechnology. Having been entrepreneurs, VCs, and mentors in both high-growth tech and biotech companies for many years, with multiple exits and massive value created for the founders, Kizoo now brings this experience to the emerging field of rejuvenation biotech – a young industry that will eventually become much bigger than today’s largest technology markets.

As part of the Forever Healthy Group, Kizoo directly supports the creation of startups turning research on the root causes of aging into therapies and services for human application. Investments include AgeX, FoxBio, Turn.bio, Elevian, Oisin Biotechnologies, LIfT BioSiences, MAIA Biotechnology, and others. Forever Healthy’s other initiatives include the evaluation of new rejuvenation therapies, evidence-based curation of the world’s cutting-edge medical knowledge, funding research projects on the root causes of aging, and hosting the annual Undoing Aging Conference. For more information, please visit: kizoo.com and forever-healthy.org.

Notice:

This press release is not an offer to sell or a solicitation of an offer to buy securities in any jurisdiction.  No securities commission or regulatory authority has approved or disapproved the information contained herein. Media contacts:

For Underdog: press@underdogpharma.com

For SRF: media@sens.org

For Kizoo: fs@kizoo.com

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