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Underdog Pharmaceuticals Awarded ‘Innovation Passport’ by UK Regulators

Press Release

Mountain View, CA, U.S., September 8, 2021 –Underdog Pharmaceuticals, Inc. (Underdog), a pre-clinical stage pharmaceutical company focusing on the treatment and reversal of age-related diseases, has been awarded an Innovation Passport under the United Kingdom’s Innovative Licensing and Access Pathway (ILAP), to pursue fast patient access to its groundbreaking treatment for cardiovascular disease.

Accounting for more than 40% of deaths in Europe and the United States, and with annual treatment costs more than £29 billion in the UK alone, cardiovascular disease is by far the world’s most life-threatening condition, and its primary cause is atherosclerosis. Underdog’s engineered synthetic carbohydrate compound, UDP-003, is designed to target and remove toxic oxidized cholesterol, a key driver of arterial plaque accumulation. Underdog is one of the first companies, and UDP-003 one of the very few pre-clinical therapies, to receive an ILAP designation.

ILAP, introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) in January, is designed to accelerate development of and access to promising medicines of significant potential public health benefit. The program provides enhanced early input and interactions with MHRA, the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and the National Health Service (NHS). The ILAP program also provides the potential for significant downstream regulatory advantages, including rolling clinical reviews, accelerated assessment, and supervised early reimbursed use under adaptive authorization.

“This is an honor for us and a wonderful step forward for our program,” said Matthew S. O’Connor, Underdog CEO of Scientific Affairs. “There is an enormous public need for drugs which can significantly reverse established atherosclerosis, rather than manage or delay its onset.”

“I believe the MHRA is sending a powerful message by reviewing and admitting preclinical stage programs like UDP-003 into ILAP,” noted Mike Kope, Underdog CEO of Corporate Affairs. “We’re pursuing a new target, with a new compound and seeking evidence of genuine disease modification; and though the potential is fascinating, the clinical challenges are real. The advice and consultation we’ll receive will be invaluable to the success of the program.”

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 oxidized cholesterol using rationally designed molecules, to provide the first true disease-modifying treatments for common age-related conditions such as atherosclerosis, heart attack and stroke. Its products are based on novel derivatives of a well-known, safe compound and a new way of looking at cardiovascular disease. For more information, please visit www.underdogpharma.com or send an email to press@underdogpharma.com

Forward Looking Statements

The information and statements contained herein contain forward-looking statements, which are subject to risks and uncertainties that could cause actual results to differ materially from such forward-looking statements and should not be considered as an indication or guarantee of future performance. Forward-looking statements involve known and unknown risks and uncertainties which could cause the Company’s prospects or actual results to differ materially from those in the forward-looking statements. The Company does not undertake any obligation to update the information or forward-looking statements contained herein whether as a result of new information or future events or otherwise.

Contact:

Mike Kope
Co-CEO
Underdog Pharmaceuticals Inc
press@underdogpharma.com

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

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