Excella-Bio: Excellence in Innovation

Excella-Bio is first and foremost a CRO that creates cash flow from doing Phase I-II studies for all biopharmaceutical companies looking to reduce operational inefficiencies in their clinical trial operations as well as obtain a significant reduction in clinical research expenses. Our business model allows Excella-Bio to do studies in less time for less money. Our CRO is unique in not only the fact that we do the studies, but we collect specialized data from each patient in the study which gives us a unique insight into the disease and is beneficial both clinically and financially. This data includes biomarkers and statistical trends that we can then use in the treatment of future patients.

 

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In addition to our CRO, Excella-Bio is looking for an investment to build a Point of Care Cell Therapy Center. Cell therapy is perhaps the most important innovation of this generation. This center would expand our CRO capacity and make us a more valuable partner to our biopharmaceutical sponsors.

Excella-Bio will use this Cell Therapy Center for:

  • Cancer Immunotherapy

  • Personalized Medicine

  • CART-T therapy –developing our own drugs

  • Regenerative Medicine

  • Vaccines

  • Aesthetics

  • Veterinary Medicine

  • Do studies for Big Pharma and Biotech companies.

 

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After the initial investment of building the Cell Therapy Center, we can duplicate it at other locations. Because of the multifaceted use of The Center, we believe we can be profitable at these centers in two years.

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the vision

Science and Industry can come together in a community supported network to develop a new cell therapy treatment modality in a time and cost effective method. This cell therapy center will examine and study the alternative to current toxic therapies.

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Management

Our management team has extensive and unique experience in regulated cell therapy development, including contract research, development and manufacturing across a broad range of science, technologies and process operations. Members of our scientific advisory team are leaders in in the fields of immunology, virology, cell biology clinical immunotherapy, regulatory and data management.  To learn more about our Key Executive team please click here.  

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expertise

Our expertise is focused on advancing product candidates from conception through the clinic by reducing manufacturing risks, shortening the time to regulatory approval and lowering the overall costs of a clinical development program that meet applicable quality standards.

Innovation Through Data Integrity

 

We understand how to reduce operational inefficiencies and bring your clinical project to completion quicker than our competitors by focusing on site and patient-centric solutions.  Founded by clinical research investigators, Excella-Bio brings a unique level of understanding from the site level and knows how to bridge the gap between sponsor goals and Investigative Site needs.  This translates into better protocol compliance, increased patient identification and recruitment, and unparralleled site training.  

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We put great thought and consideration into our corporate strategy in order to manage the Sponsor-Site complex dynamic that is required for every successful clinical trial.

ExcellaBio has developed a five-point strategy, which will lower costs, increase availability and adoption, reduce toxicity and improve effectiveness:

1.  Fully contained cell separation and cell expansion at the point of care.

2.   Strategic partnership with leaders in the field of immunology, virology, cell           biology, regulatory and manufacturing.

3.   A patient tailored driven approach to medical care.

4.   Innovation in trial design, patient follow up and data monitoring.

5.   Ongoing discovery in biomarkers and cell kinetics endpoints.

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Our patient tailored approach attracts interest from industry and academia for ongoing collaborations to test multiple combinations of different classes of therapeutics across different indications.

Aging, inflammation, neoplastic transformation and immunity are the components of the fragile balanced continuum of life. The delivery of therapeutics in the age of cell and gene therapy will demand a more intimate patient doctor relationship. This century doctor will need to literally grow and mix treatments for each patient at the bedside. Our goal is to develop the tools to enable the physician to produce and deliver such therapy.

Our long-term strategy focuses on advancing cell-based therapies in individualized multimodality combinations to assist patients suffering from life-threatening medical conditions. Coupling our clinical development expertise with our process development and manufacturing capabilities, we believe we are positioned to realize potentially meaningful therapeutic advances based on demonstration of proof-of-concept in man through innovative clinical research.

 

Cell Therapy

 

Think of any illness as mainly a combination of dysfunctional processes at the cellular level:

•   immune system imbalance

•   incomplete or inappropriate DNA repair

•   regeneration fatigue

•   unbalanced cellular metabolism

All these disabled processes could be in theory cured by introducing into the patient either "fresh" cells or "modified" cells. 

But a person is also a collection of organs which have separate levels of control, and every person has unique control mechanisms.

Therefore cells alone are not enough, they require biochemical "facilitators" to be effective. These agents may be signaling molecules (think cytokines or insulin), metabolic modulators (think cholesterol drugs), drugs that affect blood vessel integrity (think avastin), drugs that induce cell death or changes in the population of a specific environment (think low dose chemotherapy), molecules that induce opposite behavior in a specific population (tyrosine kinase inhibitors), drugs that affect the inflammatory response (think checkpoint inhibitors) or drugs that speed up growth or slow down death at the cellular level. 

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Patient-Centric Approach

Our highly dedicated team embraces the challenges that the field of cellular therapies presents. With patient benefits at the forefront of our activities, we overcome the considerable challenges through collaboration and the will to succeed.

We aim to generate and use populations of the patient’s own (autologous) naturally occurring T cells. These cells are specifically selected for their ability to recognize cancer-related or viral markers and are activated ex vivo to reverse the inhibition often caused by the tumor micro environment.

Genetically-modified immune cell products

Alternatively, we genetically modify the immune cells with an artificial receptor designed to allow them to specifically recognize and target tumor cells. These artificial receptors are known as chimeric antigen receptors (CARs) as they contain molecular structural elements that are not naturally combined in this way. With our CAR technology we are able to graft a defined specificity onto an immune effector cell.

We apply a similar approach to the artificial modification of the T cell receptor (TCR). This opens up a whole range of additional targetable cancers by allowing the T cell to recognize cancer antigens inside the cancer cell. This is the approach we are employing with this TCR technology.

 
We believe that it is not enough to be able to produce cells, you need to do it safely,  you need to do it rapidly, you need to be able to switch from one cell to another, you need to be able to do it near the patient, you need to be able to price it right, and you need to have redundancy and a built in process of both consistency but also constant improvement and quality control.    But even more importantly one needs to innovate in clinical trial design so that multiple agents can be tested in smaller less expansive trials, in a way circumventing the old paradigm of phase I to IV. And both the screening of the patients and the ability to monitor the "biological" end points needs to be based on completely new rules.    The other key thing is to be able to have these factories in as many point of cares as possible but all connected as to be able to accumulate data.  This is what differentiates Excella-Bio from our competition, we are able to hollistically bring many components of medicine and healthcare under one roof. 

We believe that it is not enough to be able to produce cells, you need to do it safely,  you need to do it rapidly, you need to be able to switch from one cell to another, you need to be able to do it near the patient, you need to be able to price it right, and you need to have redundancy and a built in process of both consistency but also constant improvement and quality control. 

But even more importantly one needs to innovate in clinical trial design so that multiple agents can be tested in smaller less expansive trials, in a way circumventing the old paradigm of phase I to IV. And both the screening of the patients and the ability to monitor the "biological" end points needs to be based on completely new rules. 

The other key thing is to be able to have these factories in as many point of cares as possible but all connected as to be able to accumulate data.  This is what differentiates Excella-Bio from our competition, we are able to hollistically bring many components of medicine and healthcare under one roof. 

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