Bioengineering fully human antibodies

Antibody humanization is a central problem in antibody therapeutics. Approved recombinant antibodies are exclusively blood circulating IgG and lack fully human constant sites and glycan groups that effectively direct T cell elimination. Mucosal tissue is the primary vector for viral, bacterial and fungal infection and yet no prior group has biosynthesized sufficient quantities of secretory sIgA for prophylactic use.

NeutraSiga Therapeutics has discovered a novel fully human bioreactor design that produces fully human antibodies of all isotypes, subtypes, oligomers and allotypes. We are currently focused on demonstrating engineerability of neutralizing variable sites to neutralize disease throughout the body. In-development therapeutic formulations include respiratory NeutraSiga sIgA aerosol, gastrointestinal human milk with sIgA, and blood circulating IgG IGIV for complete full body neutralization.

NeutraSiga prophylactic spray can have an impact in providers and first responders on the frontlines of the pandemic and patients at high risk of death around the world.

As of this writing, 8,034,461 people have tested positive for Covid-19 and 436,899 have died. Antiviral drugs are not very effective and the threat of Covid-19 infection has paralyzed economies around the world.

Prior groups have struggled to produce dimerized secretory IgA at therapeutics quantities. All prior antibodies approved by FDA are IgG blood circulating antibodies.

The primary vector of infection for viral, bacterial and fungal disease is mucosal membranes. The body produces about 8 grams secretory sIgA every day to keep mucosal membranes coated with sIgA, so in every breath taken new viral and bacteria particles rain down onto mucosal membranes into a seas of sIgA which immediately neutralizes the potential for infection throughout life.

When a new antigen like Covid is introduced to the body, the body begins evolving new antibodies to neutralize the antigen. For older and immunocompromised patients, they don't evolve antibodies fast enough nor proliferate high affinity antibodies in time to prevent death from Covid.

Vaccines cannot stop a pandemic, Covid spreads too fast and single stranded run mutates too quickly. Covid-20 will be here before everyone is vaccinated against Covid-19.

NeutraSiga Therapeutics was formed from successful incubation of the human milk project and human antibody project at 108Labs,LLC.

NeutraSiga is engineering humanized antibodies of all isotypes, subtypes and oligomers in a novel bioreactor that can produce the world's first fully human antibodies.

The antibodies are then formulated into a full body therapeutic solution that constitutes the world's first full body antibody neutralization therapy as well as the world's first mucosal antibody prophylactic therapy.

The human antibody bioreactor is entirely novel, fully human bioreactor resulting in 3 formulations:

1) NeutraSiga: Respiratory application primarily comprised of sIgA

2) NeutraGastro: Respiratory application primarily comprised of sIgA and human milk adjuvants

3) NeutraPlasma: Blood circulating application primarily comprised of IgG and IgA.

NeutraSiga is both a therapeutic application for neutralizing viral, bacterial, cancer and fungal infection in the lungs, and will become the world's first mucosal passive immunity prophylactic that can prevent frontline providers and first responders or patients at high risk of death from contracting and spreading Covid-19.

Once NeutraSiga has demonstrated full engineer ability of the NeutraSiga antibody platform, NeutraSiga will turn focus to superbugs, mucosal cancers like lung cancer and mucosal fungal disease.

Anyone with severe Covid disease can benefit from full body NeutraSiga therapeutics. Patients at high risk of death such as elderly or immunocompromised or patients with co-morbidities could be treated aggressively with NeutraSiga full body therapeutics.

Doctors and nurses on the frontlines of the pandemic can benefit from prophylactic that can coat the respiratory tract with Covid-neutralizing sIgA antibodies that can last 7 days and direct from T cell destruction of Covid particles.

Beyond the immediate needs in the global Covid pandemic, there are many patients who can benefit from NeutraSiga therapeutics.

After demonstrating engineerability of antibody variable sites, the NeutraSiga platform can have an impact across a wide range of human health challenges.

7000 babies die daily according to WHO due to lack of access to human milk with antibodies.

Antibiotics are breeding new classes of superbugs that NeutraSiga will be able to neutralize to end the superbug problem.

Mucosal and gastrointestinal cancers suffer from lack of effective human antibodies that can direct the natural T cell functions to completely eliminate cancer throughout the body.

NeutraSiga can target all the epitopes of all the viral, bacterial, cancer and fungal diseases to have a major impact in human health.

The pandemic is the worst thing to happen to everyone alive today. It has destroyed life and wealth faster than wars and great depressions. The world is terrified to leave their houses and vaccines will never stop pandemics that can spread worldwide in weeks.

NeutraSiga was a serendipitous discovery made by a cell biologist and organic chemist who woke up on March 18th staring at deep proteomics from UC Davis before realizing suddenly that we created something amazing no one else has ever created.

Simply put, NeutraSiga can end the pandemic, end superbugs, cure lung cancer and many save lives.

NeutraSiga is the world's first full human antibodies created in a fully human bioreactor.

sIgA is the most important antibody type for preventing mucosal infections and no prior group has produced sIgA at sufficient quality and quantity for therapeutic use, despite the common knowledge that sIgA is the most effective antibody for preventing viral and bacterial infection and directing immune response throughout the respiratory and gastrointestinal tract.

Human milk biosynthesis is also novel discovery and can be seen as new gastrointestinal platform for safe and effective drug delivery of sIgA and other drugs. Human milk has been shown to improve efficacy of sIgA such that 20% sIgA survives passage through the gastrointestinal tract when consumed with milk, compared to 0% without.

The lack of fully human antibodies in IgG therapeutics reduces the coordination of T cell destruction of neutralized viral particles and bacteria.

Fully human antibodies can direct efficient elimination of pathogens and cancer perhaps orders of magnitude more effectively than prior recombinant antibody therapeutics.

The human milk bioreactor is novel bioengineering and produces human milk and quantities never before achieved. The details are proprietary, but the bioreactor is fully human and serum free and produces non-toxic supernatant comprising all the key components of milk.

The human antibody bioreactor is novel bioengineering and produces the world's first human antibodies at a cost competitive with recombinant antibodies with effectiveness potentially orders of magnitude greater than recombinant.

NeutraSiga utilizes classic cell biology in new ways to produce fully human milk and fully human antibodies.

The summer 2020 NeutraSiga scientific proofs are focused on very specific goals which will impact the future trajectory of the project.

The most important input as scientific proof is demonstrating that NeutraSiga can genetically engineer fully human antibodies, and we're working with Dana Farber recombinant engineering core to do so.

With this engineering proof in hand, NeutraSiga can have a major impact in the major fields of infection and cancer simply by identifying all the neutralizing variable sites that can neutralize all the viral, bacterial, cancer and fungal diseases in the world.

Shayne Guiliano, President and Scientific Director

NeutraSiga works with NIH Cores and CROs to conduct research.

Dana-Farber/Harvard Recombinant Core - Genetic engineering of therapeutics.

UC Davis Barile Lab - Milk and antibody analytics

UNC Chapel Hill NCore - Analytics

Mt Sinai, Dr. Rebecca Powell - Covid survivor B cell collection and antibody discovery.

NeutraSiga is pioneers of human milk and human antibodies with patent protection and amazing academic and private partnerships that guarantee we will succeed.

NeutraSiga is also backed by SSC Ventures which is enabling NeutraSiga to focus on the science while SSC focuses on the business development.

NeutraSiga works with NIH Cores and CROs to conduct research.

Dana-Farber/Harvard Recombinant Core - Genetic engineering of therapeutics.

UC Davis Barile Lab - Milk and antibody analytics

UNC Chapel Hill NCore - Analytics

Mt Sinai, Dr. Rebecca Powell - Covid survivor B cell collection and antibody discovery.

To save the world.

Will work with CROS and NIH Cores.

NeutraSiga can have a huge impact in the pandemic.

Human milk can have a huge impact for mothers and babies.

NeutraSiga is the most important project in the world.

NeutraSiga can save lives around the world.