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Sequella Inc.

Location: Rockville, MD

Sector: Life Sciences .

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Sequella is a private, clinical stage pharmaceutical company that addresses the challenge of antibiotic resistant bacterial diseases by discovery and development of first in class antibiotics with novel mechanisms of action.

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MG cp Summary

The clinical stage drugs produced by Sequella Inc. are SQ109 and sutezolid: both are being independently advanced for the treatment of drug resistant tuberculosis (MDR-TB).

SQ109 completed a successful MDR-TB registration trial in Russia: application for commercial approval will be filed and Sequella will receive product royalties. Both SQ109 and sutezolid are ready to enter pivotal trials in the US/EU that, if successful, will lead to NDA filing for accelerated registration in both territories. Registration in the U.S. of SQ109 for MDR-TB will provide Sequella with a priority review voucher (PRV) that can be monetized as part of a financing or at receipt: average sales price of PRV since inception is $178M. SQ109 has also been evaluated in an early stage clinical trial for treatment of gastritis (Helicobacter pylori in-fections).

SQ641 is in late pre-clinical development for the treatment of Clostridium difficile induced diarrhea, a deadly healthcare and community acquired infectious disease. Sequella also has a large chemical library of small molecule compounds created around active pharmacophores that can be screened on other important antibiotic resistant bacteria.

Late-stage products (reduced risk) – One drug, SQ109, has successfully completed a registration trial in Russia, meeting both safety and efficacy endpoints; sutezolid has completed a successful Phase 2a study in TB patients, with excellent early bactericidal activity

 

Drugs that address drug-resistant bacterial infections with novel mechanisms of action – Few companies are developing drugs for antibiotic resistant infections, despite clear need: in particular, few companies have or are developing new drugs for TB and no companies are developing drugs for H. pylori, which our drugs address

 

TB will always be treated with ≥ 3 drugs because of resistance development – Companies that are developing new TB drugs are looking for other compatible drugs with which to pair their drugs and make a new safer and more effective drug regimen, so all companies are collaborators, not competitors

 

Drugs in development are either new or improved versions of existing drugs – SQ109 is a new drug that acts in multiple ways to kill TB, no other drugs in clinical development kill TB in the same way. Sutezolid is an improved version of Zyvox (linezolid) and is expected to have similar efficacy and a better safety profile that allows for long term dosing. SQ641 is from a whole new class of antibiotics never before commercialized.

Carol A. Nacy, Chief Executive Officer Dr. Nacy is an accomplished scientist and businesswoman, with 20 years of basic science research and science management in academic settings (Fellow of the American Academy of Microbiology) and an additional 25 years of starting companies and leading science for product development in three U.S.-based biotechnology companies. She and the management team took her first company public on NASDAQ and her second company was acquired by a large biotechnology company. Her passion is in understanding and devising ways to prevent or treat infectious diseases that are global health threats, especially antibiotic resistant bacteria. She co-founded Sequella in 1997 and has led her team to discover and develop several novel antibiotics now in clinical trials that address diseases that infect billions of people worldwide, kill millions of people annually, and are underserved by pharmaceutical and biotechnology companies.

 

Mark Rampy, Chief Business Officer  Dr. Rampy has over twenty years of experience in the biotechnology and pharmaceutical sectors, including leadership roles at early stage and venture-backed companies, and mid-large cap public pharmaceutical/biotechnology companies.  His areas of expertise include business/corporate strategy, business development, structure, negotiation and closing of complex licensing transactions and strategic alliances, as well as technology and product development.  Prior to Sequella, he was CEO of several start-ups (Theraly Pharmaceuticals, and CohBar, Inc), VP Business Development Biologics and Specialty Products, Teva Pharmaceuticals, Founder and Chief Business Officer of CoGenesys, Inc. a company which was acquired by Teva. Prior to CoGenesys, he was with Human Genome Sciences, Inc. for eleven years, in positions of increasing responsibility in R&D and Business Development, the most senior of which was Head of Business Development.​

 

David Mc Neeley, MD, Chief Medical Officer Dr, Mc Neeley is an MD and specialist in pediatric infectious diseases, public health and tropical medicine. He was on the faculty of Weill Cornell Medical Center in the Division of Pediatric Infectious Diseases, working primarily in HIV and TB clinics, as well as general pediatric infectious disease clinic and in-hospital consultations, including rotations through Memorial Sloan-Kettering Medical Center. He has worked extensively in international health settings, including serving as medical director of an all-service hospital and an extensive community health program serving nearly 250,000 people. He conducted clinical and field research in bacterial infections, tuberculosis, human immunodeficiency virus infection and parasitic diseases such as schistosomiasis and filariasis. For the past 14 years, Dr. Mc Neeley has worked in anti-infective drug development (antibiotics, antivirals, and anti-parasitic drugs). For the past 14 years, Dr. Mc Neeley has worked in anti-infective drug development (antibiotics, antivirals, and anti-parasitic drugs) in large pharmaceutical companies (Johnson & Johnson, Novartis) and brought the first new TB drug, bedaquiline, through the clinic and to worldwide registration for J&J.

 

Leo Einck, VP Industry Affairs Dr. Einck has been building companies for the last 33 years: he was the 1st employee of Hemispherix and built out manufacturing facilities and executed clinical trials; he was the 8th employee of EntreMed and managed the relationship with a Harvard research group whose technology enabled the company to have an initial public offering; and he founded Sequella and Sequella Global TB Foundation with Dr. Nacy and has participated in all aspects of growing the company. His current role includes managing the GMP manufacturing and testing of Sequella’s antibiotics and research on TB diagnostics.