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Covalent Biosciences Inc.

Location: Missouri City, TX

Sector: Healthcare

We plan to commercialize the Catalytic Antibody (Catabody) and the catabody-inducing Electrophilic Vaccine (E-Vaccine) technology platforms for high impact medical needs that are difficult if not impossible to meet by conventional approaches.  The quest for catabodies dates to Linus Pauling, driven by hope that catabodies will prove to be ‘magic bullets’ for on-demand immune destruction of disease-causing protein targets, free of the intrinsic efficacy and safety limitations of ordinary antibodies.

Our 30 year academic R&D discovered discrete monoclonal catabodies that serve as natural anti-aging and anti-infection defenses, and we invented rational algorithms to induce catabodies using E-vaccines.  Together, the R&D generated proof-of-concept for the therapeutic and preventive utility of our technology for Alzheimer and other amyloid diseases, HIV infection, drug-resistant bacteria, and the ever-emerging threat of viruses such as COVID-19 (which is extraordinarily contagious and induces a uniquely dysfunctional ordinary antibody response).

We have unique insight and know-how to bring our technology platform to the market as the basis of more powerful medical interventions compared to conventional approaches, and we are looking for $15.3 Mil capital for implementing the next commercialization steps.

Competitive Advantage

1. We have a validated, on-demand service for generation and delivery of target-specific catabodies to Pharma partners.

Covalent’s patented platform is the only one that can produce on-demand catabodies and irreversible antibodies specific for individual disease-causing target proteins. No other company or academic group has this capability.

2. We have a lead Alzyme catabody and prototype Tauzyme catabodies that remove brain amyloid for treating Alzheimer’s disease.

No other company or academic group has a drug candidate that can quickly remove brain amyloid without causing inflammatory damage that cancels out the benefit of amyloid removal.

3. We have a lead Cardizyme catabody for treating heart and spine disease caused by TTR amyloid.

Cardizyme quickly not only reduces tissue build-up of TTR amyloid but also removes the disease-causing amyloid deposits and toxic oligomers.  Competing drugs (Tafamidis, Patisiran, Inotersen) can only slow disease progression by reducing build-up of tissue amyloid deposits. They do not remove the disease cause (toxic oligomer and amyloid deposits of transthyretin), and they do not reverse the disease.

4. We have a lead HIV E-vaccine for prevention and a functional cure of HIV infection.

No other vaccine induces production of broadly neutralizing antibodies to an immutable HIV region. Covalent’s E-vaccine makes visible a hidden immutable region that is essential for HIV entry into cells but is invisible to oridnary vaccines. Covalent is the only Company (or academic group) with a documented vaccine that can credibly protect against infection caused HIV mutants world-wide, as also the perpetually mutating variant HIV species within a single infected human.

5. We will deliver a lead E-vaccine with effective protection against Staphylococcus aureus infection.

For the first time, E-vaccines make the vulnerable but hidden microbial regions visible to the immune system. No other competing vaccine in development has this capability. We expect the S. aureus E-vaccine to induce robust catabody and irreversible antibodies against the normally hidden bacterial virulence factor regions, with protective efficacy 100X or better than ordinary vaccines.

6. We will deliver a lead E-vaccine that prevents COVID-19 infection, and a lead catabody that treats COVID-19 lung disease.

Coronavirus infections pose unprecedented safety and efficacy challenges. Our proposed COVID-19 E-vaccine is ideally suited to outperform competing conventional vaccines in development in solving these challenges.  Likewise, catabody targeting of the unifying cause of host immunity activated by COVID-19 should unmatched efficacy for patients hospitalized for lung disease compared to competing drugs in development.

Opportunity Highlights

1. The catabody and E-vaccine Platform Technology offers a new way to make the first or better drugs and preventive vaccines for major unmet needs, such as Alzheimer’s disease, heart and spinal disease caused by amyloid, HIV infection, COVID-19 and drug-resistant bacterial infection.

Catabodies and E-vaccines can be developed for treating and preventing any disease. Catabodies have superior efficacy and safety profiles than ordinary antibodies because one catabody molecule can destroy thousands of target molecule. In contrast, an ordinary antibody neutralize the target only at a 1:1 ratio. Further, the catabody removes the target protein without causing inflammation that cancels the benefit of target removal. This eliminates a fundamental flaw that makes ordinary antibodies unusable in diseases like Alzheimer’s disease. E-vaccines teach the body to produce its own catabodies and irreversible antibodies with efficacy better than antibodies. Further, E-vaccines enable for the first time the targeting of vulnerable target protein regions that are normally hidden to ordinary vaccines.

2. Covalent’s lead products and technology platform are protected by patents.

Covalent Bioscience is in the position to develops its own products and bring them to the market with or without a partner pharma company depending on future commercial considerations.

3. Covalent’s catabody generation and delivery service to partner pharma companies will raise short-term and long-term revenue, facilitate development of new products for new diseases, and validate the commercial value of our technology platform.

Covalent Bioscience has unique know-how and patent coverage to generate new catabody lead products rapidly at reasonable cost and validate the lead products prior to their delivery to pharma partner companies for further commercial development.

Management Team

Richard Massey, Co-Founder and CEO

Dr. Richard J. Massey was President and Chief Operating Officer of IGEN International, Inc. (NASDAQ: IGEN), a highly successful biotechnology company, which he co-founded. His extensive experience included managing R&D programs, patents, product development, manufacturing, and business development. Dr. Massey led the quest for catalytic antibodies in industry and was an inventor on multiple patents in the field. He also led the team that discovered the application of electrochemiluminescence for immune and molecular diagnostics that resulted in products that generated multibillion-dollar sales.

He is an inventor on over 200 patents on catalytic antibodies and ECL.  Dr. Massey has additional expertise with FDA submissions for diagnostic and therapeutic products.  He was responsible for the ISO certification at IGEN and managed programs that resulted in the launch of successful products for the healthcare market in the United States, Europe, and Japan. He also played a significant role in raising over $100 million through the sale of private equity and licensing deals.

Dr. Massey received his doctorate in the field of microbiology from the University of Illinois Medical Center in Chicago. He was a senior scientist at the National Cancer Institute Frederick Cancer Center and a professor at Rush Medical Center in Chicago.

Sudhir Paul, Co-Founder, CSO

Paul’s work as a Professor at the Universities of Nebraska and Texas has brought catabodies/E-vaccines from chemical curiosities to the verge of medical use. His research was funded continuously by the NIH, non-profit foundations and biotech companies since 1983. His early discovery patents were bought out (USD 21 MM) by Abgenix in 2001.

He discovered harmful catabodies in autoimmune disease, progressing to devising our on-demand technology platform for generating catabodies and E-vaccines for disease treatment and prevention. He has authored ~200 original research articles and edited several books. Paul co-founded Covalent Bioscience. In 2018, he moved fulltime to Covalent to translate his know-how and inventions for medical benefits.

He completed his B.Sc. with Honors, Punjab University, India and M.Sc. And Ph.D. (Biochemistry), All-India Institute Medical Sciences.

Prior to his faculty appointments, he held an Alexander von Humboldt Fellowship at the University of Kiel, West Germany.

Stephanie Planque, Co-Founder, Principle Scientist

Planque was awarded the Ph.D. degree in 2009 by the University of Texas-Houston Medical School for her advances in applying electrophilic analogs of proteins to decipher the beneficial and harmful functional effects of catabodies.

She then expanded her focus to vaccination and therapeutic catabody identification using proprietary electrophilic target analogs. Her work was published in 49 peer-reviewed scientific articles, she has numerous national/international conference presentations, and she was PI in an NIH-funded STTR grant. She moved fulltime as a co-founder to Covalent in 2018 to focus on rapidly translating our electrophilic vaccine/catabody technologies to clinical reality.

She developed the Catabody and E-Vaccine Technology over 20 years and over 49 peer-reviewed articles throughout her carrier.

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