The Supply Brain

Breakthroughs in immunotherapy, such as chimeric antigen receptor T cell (CAR-T) therapy  and checkpoint inhibition antibodies, have led to a rejuvenated interest in the human immune system. Insights from basic immunology research drive approaches and innovations in the exploding immunotherapy field (Figure 1). Studies of tumor-infiltrating lymphocytes helped shed light on the complex tumor microenvironment and the mechanisms of cancer immune evasion. Discoveries of neo-antigens, unique biomarkers, and optimization of combination immunotherapy (Figure 1) have led to improved efficacy and patient outcomes. However, we still don’t fully understand the complex relationship between immunity and disease, especially when it comes to cell activation, cytotoxicity, regulation, and memory.

Simple Science: Cardiac Regenerative Medicine

The field of cardiac regenerative medicine is rapidly developing solutions to treat the millions of people around the world affected by cardiac illnesses. The articles summarized in the Simple Science posts below outline a few of the recent advancements in cardiac tissue engineering, disease modeling, and the role of the stem cell secretome in cardiac protection. OrganaBio’s goal in summarizing these complex articles is to translate regenerative medicine articles that excite our scientists into articles that anyone can enjoy, whether they’re looking for information that inspires hope or just looking for a good read. Scientific articles may be written for a research-savvy audience but, in the end, the discoveries they outline affect us all. We hope you enjoy some Simple Science!

Immune Cell-based Therapies for COVID-19: Current Clinical Trial Landscape Data

One element of COVID-19 is a hyper-response of the patient’s immune system, which in turn leads to lung injury and acute respiratory distress syndrome.¹ At the same time, appropriate immune response is decreased due to immune evasion by the virus. ^1,2 Treatment with immune cell-based adoptive therapies is being investigated to combat inflammation to fight SARS-CoV-2 (i.e., T regulatory and NK cells).² Here, we review the current clinical trial landscape utilizing immune cell-based therapies.

MSC-Based Therapies for COVID-19: Current Clinical Trial Landscape Data

Mesenchymal stem/stromal cells (MSCs) are emerging as a potential treatment modality for COVID-19^1-3. MSCs have immunomodulatory properties that can be used to combat the inflammatory response caused by the SARS-CoV-2 coronavirus, and the United States Food and Drug Administration (FDA) has granted accelerated approvals to several MSC-based clinical trials for COVID-19. This brief blog post summarizes the current MSC COVID-19 clinical trial landscape based on data from clinicaltrials.gov.

In late 2019, cases of Coronavirus Disease 2019 (COVID-19) began to emerge out of Wuhan, China. Since then, the disease has proven to be highly contagious and has rapidly spread around the world, becoming a global pandemic. COVID-19 is caused by the Severe Acute Respiratory Distress Syndrome Conoravirus 2 (SARS-CoV-2). SARS-CoV-2 attacks host cells by the binding of its spike protein to the angiotensin I converting enzyme 2 (ACE2) receptor on cell membranes (1). ACE2 receptors are primarily found on lung alveolar type II cells and capillary endothelial cells in the lungs, which helps to explain the prevalence of respiratory distress associated with COVID-19 (2). In addition to the lungs, ACE2 receptors have also been identified in the heart, liver, kidney, and digestive organs which may help to explain why severe COVID-19 patients display myocardial injury, arrhythmia, acute kidney injury, shock, and death from multiple organ dysfunction/failure (1).

De-Risking the Path to Cell & Gene Therapy Commercialization Part 1: You Need Access to a Robust and Reliable Donor Pool

When cell and gene therapy researchers step into the lab each morning, we envision transforming what may be an early stage experiment into a clinical success. Therapeutics developers spend years working tirelessly to generate pre-clinical data so that, when the time comes, their Investigational New Drug (IND) application (or equivalent outside the USA) will be accepted by the appropriate regulatory agency, allowing the therapy to enter clinical trials. However, IND approval is just the first of many significant hurdles that therapeutics developers face on the path to commercialization.

OrganaBio was founded in 2018 by scientists and business leaders motivated to bring next generation regenerative medicine therapies to market. Since then, we have assembled a team of 16 industry veterans, from scientists and engineers with years of bioprocess and therapeutic development experience to those versed in Quality Assurance, Quality Control, Regulatory Affairs and successful business-building. Combined, we have over two centuries of experience in all areas necessary for success in regenerative medicine! Our team is passionate about expediting the development of novel cell and gene therapies, ultimately improving quality of life and/or saving lives for many. We truly believe that regenerative medicine is the future of medicine, and we work relentlessly to help our customers and partners bring their therapies to market.

At OrganaBio, we believe that nothing truly worthwhile is easy…. But we can make it easier for our partners and customers. That’s why we set out to take on a significant challenge – to alleviate bottlenecks in raw material supply and expand the limited options for cGMP manufacturing that are keeping the regenerative medicine industry from reaching its full potential. It’s no news that cell and gene therapy have witnessed substantial growth over the last decade, with the pace of innovation only continuing to accelerate. The headlines yield promising news week after week. Numerous cellular therapies are currently in clinical development, using a variety of cell types. Companies and organizations are increasingly investing money, time, and effort in this space. The engine of unprecedented therapeutic change is churning, but does the industry have the fuel to supply such growth? We want to ensure the answer is a resounding “Yes” – This is why we do it.