The Throne Biotechnologies offering is now closed and is no longer accepting investments.

Throne Biotechnologies

Find a cure type 1 diabetes, alopecia areata, and other autoimmune diseas...

Throne Biotechnologies

Find a cure type 1 diabetes, alopecia areata, and other autoimmune diseas...

Paramus, NJ
Biotechnology
Throne offers the Practical Cure for type 1 diabetes, alopecia areata, and other autoimmune diseases through its patented technology, Stem Cell Educator therapy — a one-time, dialysis-like treatment that fundamentally “re-educates” the defective immune system back to health. Throne is in the pre-revenue clinical stage of development.

$198,118

raised
101
Investors
$120M
Valuation
$7.59
Price per Share
$349.14
Min. Investment
Common
Shares Offered
Equity
Offering Type
$1.01M
Offering Max
0
Days Left

$198,118

raised
101
Investors
$120M
Valuation
$7.59
Price per Share
$349.14
Min. Investment
Common
Shares Offered
Equity
Offering Type
$1.01M
Offering Max
0
Days Left
This offering ended on May 01, 2022 and is no longer accepting investments.

Reasons to Invest

Throne Has a Globally-Leading Curative Patent Technology for Type 1 Diabetes (T1D) and Other Autoimmune Diseases: Over last 10 years, international multicenter clinical trials in the United States, China, and Spain have strongly demonstrated the clinical safety and efficacy of Stem Cell Educator therapy in more than 200 patients aged from 3 to 70 years old. Clinical studies and basic research revealed the molecular and cellular mechanisms underlying Stem Cell Educator therapy with over 30 peer-reviewed publications. Collectively, Educator therapy has the potential to revolutionize the treatment of T1D and other autoimmune diseases, without the safety and ethical concerns associated with conventional immune and/or stem cell-based approaches.
Experienced Team: Throne Biotechnologies (Throne) is a clinical-stage therapeutic company with a disruptive stem cell technology that can, for some patients, fundamentally reverse T1D and other autoimmune diseases. To commercialize the Stem Cell Educator therapy, Throne has built up the strong Team with renowned scientists, immunologist, endocrinologist, diabetologist, dermatologist, expert in cellular therapy, and entrepreneurs from big pharmaceutical/biotech companies and famous universities.
It Is Close to the US FDA Marketing Approval through Regenerative Medicine Advanced Therapy (RMAT) Program: Currently, Stem Cell Educator therapy has gained three phase 2 clinical trial approvals by the United States FDA to treat T1D, alopecia areata and severe COVID-19 patients. As a global-leading technology in the field of T1D treatment (Juvenile Diabetes Cure Alliance Report, 2021, New York), it is highly expected that Educator therapy will achieve the expedited FDA approval for commercialization under the designation of RMAT, due to an unmet medical need for the T1D and alopecia patients. The T1D market in 2019 was approximately $2 billion and is expected to grow at a 5% CAGR (Compound Annual Growth Rate). The Alopecia market in 2020 was approximately $7.6 billion and is expected to grow at an 8.1% CAGR.

OVERVIEW


Autoimmune diseases can be reversed with Throne’s Stem Cell Educator® Therapy 


There’s a difference between a treatment and a cure. A big one.


Throne’s Stem Cell Educator® Therapy technology is designed to reverse autoimmune diseases, namely, type 1 diabetes and alopecia areata. We do this by targeting the root causes of these diseases and 're-educating' the immune system to stop attacking itself. Our international multicenter clinical trials have demonstrated 70% efficacy in type 1 diabetic patients.




Throne Has a Globally-Leading Curative Patent Technology for Type 1 Diabetes (T1D) and Other Autoimmune Diseases


The above results may not be indicative of the results to all patients and is not a guarantee of future performance or success. Gerald Ostrov is a Director of the company.

Stem Cell Educator® Therapy has also demonstrated efficacy in alopecia areata, where patients experienced sustained hair regrowth after one treatment.

THE PROBLEM


Conventional treatments for type 1 diabetes and other autoimmune diseases are only symptomatic patches, not cures


The immune system is meant to protect the body, not destroy it. Defects in a patient’s immune system and environmental factors are what cause autoimmune diseases. When there is immune dysfunction, different areas of the patient’s body are attacked. For example, an autoimmune attack on the pancreas causes type 1 diabetes, while an autoimmune attack on hair follicles causes alopecia. 


Current conventional treatments on the market for type 1 diabetes (insulin therapy) and autoimmune diseases (immunosuppressants drugs) only aim to treat the symptoms and they fail to correct the root causes of the diseases. As a result, patients may experience severe side effects and a guaranteed disease relapse if they stop the medications. Despite significant improvements in diabetic care, most patients can not achieve the desired glycemic targets with an increased risk of complications, including cardiovascular diseases, stroke, blindness, amputation, and loss of life.




An autoimmune diagnosis is like receiving a life sentence — patients feel helpless as they look ahead into the future. For type 1 diabetics, this life sentence includes an average annual “fine” of $16,752 for health care costs. And that’s before they factor in the physical limitations and recurring feelings of uncertainty and isolation.  


THE SOLUTION


A life-saving solution designed to fundamentally heal autoimmune diseases


Finally, a global-leading solution that we believe will halt autoimmune destruction and restore health is here! Meet our patented Stem Cell Educator® Therapy.




This curative Stem Cell Educator® technology acts as an “immune system reset” designed to restore the immune balance and fundamentally reverse type 1 diabetes, alopecia areata, and other autoimmune diseases. It achieves this by focusing on the root causes of the disease through a one-time, dialysis-like treatment that involves  a minimally invasive procedure.





Stem Cell Educator® Therapy is a procedure where a patient’s immune cells are first drawn, incubated (educated) in our Stem Cell Educator® device coated with our proprietary CB-SC stem cells, and then returned to the body via an infusion. This procedure fundamentally ‘re-educates’ the immune system to stop attacking itself and empowers the body to restore its own healing from the inside out. Based on our previous clinical studies, we’ve found the side effects to be minimal to negligible, typically only those associated with apheresis (blood drawing) and infusion.


Major differences in our stem cell approach compared to conventional stem cell therapies include:


1. We believe we are one of the first companies in the world to use the patented CB-SC stem cell to modulate (aka 'educate') immune cells.

2. We do not use immune suppressing drugs because their many side effects can be very harmful

3. We do not inject or transplant the stem cells because they stay inside the device permanently. Only the patient’s own ‘educated’ immune cells enter back into the patient’s body. This ensures 100% immune acceptance and zero risk of rejection.







PATENTS


Throne has a portfolio of seven international patents covering major global territories, including the discovery of CB-SC stem cells, its clinical applications through the Stem Cell Educator® Therapy, and disruptive technologies for additional diseases. These can be licensed to other territories and institutions for the continued development or research of additional technologies. Throne Biotechnologies will receive licensing fees and royalties in return.


GO TO MARKET BUSINESS PLAN


Upon US FDA approval, Throne Biotechnologies will administer Stem Cell Educator® Therapy to patients through clinical partnerships such as hospitals and clinics. US FDA approval would also greenlight the regulatory approvals for commercialization in other countries. It is our goal to price the treatment reasonably for our patients and equitably for our shareholders. There are many factors that will ultimately impact the commercial price of the therapy (cellular therapies are significantly more involved and costly than conventional drug manufacturing). We project the commercial price of the therapy to be in the low to mid five-figure range. We expect insurance/payers will cover this therapy through an outcome-based model.



We currently own and operate a 1,700 sq ft, ISO 5, GMP cleanroom facility in Paramus, New Jersey. Additionally, we also own and operate an onsite, state-of-the-art research laboratory. Our facility will be used in the clinical trials and seamlessly transition to serve the commercialization of the technology in the New York City Metro area (New York, New Jersey, Pennsylvania, and Connecticut).

THE MARKET



We believe we’re the uniquely safer, effective choice within a $9.6 billion market


Between type 1 diabetes and alopecia, there is a combined $9.6 billion market to compete in. Through our research, we've determined that Throne has one of the most effective and safe solutions among competitors. The shortage of true curative solutions both scientifically and commercially allows us to potentially be the first-to-market with the most efficacious solution. 






The type 1 diabetes market was approximately $2 billion in 2019 and is expected to grow at a CAGR of 5%. By 2026, it’s anticipated to reach around $2.8 billion. 

Currently, there are 1.6 million type 1 diabetic patients in the US, which is expected to grow to 5 million by 2050. 


The alopecia market was approximately $7.6 billion in 2020 and is expected to grow at a CAGR of 8.1%. Currently, there are 6.8 million alopecia areata patients in the United States.



We believe Stem Cell Educator® Therapy is the curative stem cell solution closest to the market for type 1 diabetes and other autoimmune diseases. Almost every other stem cell technology in development or on the market uses embryonic, induced pluripotent (iPS), hematopoietic, or mesenchymal (MSC) stem cells in the form of injections or transplantations. Functional limitations accompany each of these approaches, leading to potential immune rejection and severe side effects.


Other stem cell treatments such animal stem cells (i.e. pigs and goats) and embryonic stem cells, which are associated with abortion, pose safety, religious, and ethical concerns to patients. We take an entirely different approach.


Stem Cell Educator® Therapy uses our proprietary CB-SC stem cells, which are derived from donated human umbilical cord blood. As CB-SC stem cells treat patient immune cells outside of the body, immune acceptance is ensured and safety is upheld. 


Ten years of clinical evidence have demonstrated safety and clinical efficacy in over 200 patients with multiple diseases, from 3 to 70 years old. Among this figure, over 100 type 1 diabetic patients have been treated and demonstrated 70% clinical efficacy. Some of these findings have been published among 30 peer-reviewed articles. 

WHY INVEST


Partner with Throne in securing the FDA approval to give 8.6 million people their lives back 


Doctors are currently limited in the treatment options available to autoimmune disease patients. Insulin and immune-suppressing drugs are temporary and do not sustainably address the root of immune dysfunction the way Stem Cell Educator® Therapy does. Our vision is to gain FDA approval and establish this technology as the standard of care for patients with diabetes and autoimmune diseases.


We have been approved to conduct phase 2 clinical trials treating type 1 diabetes and alopecia areata with Stem Cell Educator® Therapy. These are monumental and critical steps to secure US FDA approval. Although we’ve gathered some phase I/II data from the Spain, China, and the US, we must meet the US FDA requirements by completing a full phase 2 US clinical trial. Due to the amount of data we’ve gathered in previous trials, we are confident that our FDA phase 2 trials will replicate the previous efficacy data which gives us confidence for FDA approval in the future. 


Per conversations with the FDA, we believe that the clinical data produced from these studies will be critical in fast-tracking this technology to market through special regulatory pathways (RMAT and Compassion Use).


We believe our accomplished team of scientists, doctors, and industry professionals will ensure the clinical success of FDA approval and commercial success in market adoption. Our team has held senior leadership roles among institutions including Yale University, University of Chicago, Hackensack Meridian Health, and Johnson and Johnson. 


PLATFORM TECHNOLOGY


Throne Biotechnologies has significant potential beyond just type 1 diabetes and alopecia. The approval of the technology for either disease will make it significantly easier to acquire FDA approvals for additional diseases in a direct-to-phase-2 pathway. Studies have demonstrated the therapeutic potential of Stem Cell Educator® Therapy to potentially treat other diseases, including Type 2 diabetes.


When diagnosed with an autoimmune disease, an individual’s identity and prospects change instantly. It’s a severe life sentence, but we believe Throne Biotechnologies can reverse it — one immune re-education at a time. 


Let’s give 8.6 million people their lives back. Join us!

Choose Link

Offering Summary


Company

:

Throne Biotechnologies Inc.

Corporate Address

:

10 Forest Avenue, Suite 110, Paramus, NJ 07652

Offering Minimum

:

$9,996.03

Offering Maximum

:

$1,006,995.66

Minimum Investment Amount

(per investor)

:

$349.14











Terms


Offering Type

:

Equity

Security Name

:

Common Stock

Minimum Number of Shares Offered

:

1,317

Maximum Number of Shares Offered

:

132,674

Price per Share

:

$7.59

Pre-Money Valuation

:

$119,922,000.00











*Maximum Number of Shares Offered subject to adjustment for bonus shares. See Bonus info below.

Voting Rights of Securities Sold in this Offering

Voting Proxy. Each Subscriber shall appoint the Chief Executive Officer of the Company (the “CEO”), or his or her successor, as the Subscriber’s true and lawful proxy and attorney, with the power to act alone and with full power of substitution, to, consistent with this instrument and on behalf of the Subscriber, (i) vote all Securities, (ii) give and receive notices and communications, (iii) execute any instrument or document that the CEO determines is necessary or appropriate in the exercise of its authority under this instrument, and (iv) take all actions necessary or appropriate in the judgment of the CEO for the accomplishment of the foregoing. The proxy and power granted by the Subscriber pursuant to this Section are coupled with an interest. Such proxy and power will be irrevocable. The proxy and power, so long as the Subscriber is an individual, will survive the death, incompetency and disability of the Subscriber and, so long as the Subscriber is an entity, will survive the merger or reorganization of the Subscriber or any other entity holding the Securities. However, the Proxy will terminate upon the closing of a firm-commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933 covering the offer and sale of Common Stock or the effectiveness of a registration statement under the Securities Exchange Act of 1934 covering the Common Stock.

Investment Incentives and Bonuses*

Invest $1,000 and receive an additional 10% bonus shares

Invest $2,500 and receive an additional 11% bonus shares

Invest $5,000 and receive an additional 12% bonus shares

+ A patient of your choice will secure 'Tier 5 Priority' on the treatment waiting list for receiving the Stem Cell Educator Therapy upon commercialization in the US*

Invest $10,000 and receive an additional 13% bonus shares

+ A patient of your choice will secure 'Tier 4 Preferential Priority' on the treatment waiting list for receiving the Stem Cell Educator Therapy upon commercialization in the US*

Invest $25,000 and receive an additional 14% bonus shares

+ A patient of your choice will secure 'Tier 3 Premium Priority' on the treatment waiting list for receiving the Stem Cell Educator Therapy upon commercialization in the US* 

+ $1,000 off of commercial treatment price (if paid for out of pocket)

Invest $50,000 and receive an additional 15% bonus shares

+ A patient of your choice will secure 'Tier 2 Top Priority' on the treatment waiting list for receiving the Stem Cell Educator Therapy upon commercialization in the US* 

+ $3,000 off of commercial treatment price (if paid for out of pocket)

Invest $100,000 and receive an additional 15% bonus shares

+ A patient of your choice will secure 'Tier 1 Super Priority' on the treatment waiting list for receiving the Stem Cell Educator Therapy upon commercialization in the US** 

+ $5,000 off of commercial treatment price (if paid for out of pocket)

+ In person lunch with Throne Executives for you and 2 guests in NJ (travel and lodging not included) - [First 3 investors, only 3 available]

------------

*All perks occur when the offering is completed.

**There is no guarantee commercialization in the US will occur. All patients are subject to enrollment requirements and other treatment criteria set forth by the doctor, the clinical site, FDA, Throne, or another factor. There may be factors that would disqualify a patient from receiving the treatment and therefore securing a place on the waiting list does not guarantee treatment. To claim this perk, please email your name, patient name, and 'Tier' status to connect@thronebio.com within 90 days of investment.

The 10% StartEngine OWNer's Bonus

Throne Biotechnologies Inc. will offer 10% additional bonus shares for all investments that are committed by investors that are eligible for the StartEngine Crowdfunding Inc. OWNer's bonus.

This means eligible StartEngine shareholders will receive a 10% bonus for any shares they purchase in this offering. For example, if you buy 100 shares of Common Stock at $7.59 / share, you will receive 110 shares of Common Stock, meaning you'll own 110 shares for $759. Fractional shares will not be distributed and share bonuses will be determined by rounding down to the nearest whole share.

This 10% Bonus is only valid during the investor's eligibility period. Investors eligible for this bonus will also have priority if they are on a waitlist to invest and the company surpasses its maximum funding goal. They will have the first opportunity to invest should room in the offering become available if prior investments are canceled or fail.

Investors will only receive a single bonus, which will be the highest bonus rate they are eligible for.

Insider Investment Notice

Officers, directors, executives, and existing owners with a controlling stake in the company (or their immediate family members) may make investments in this offering. Any such investments will be included in the raised amount reflected on the campaign page.

 

Irregular Use of Proceeds

The Company might incur Irregular Use of Proceeds that may include but are not limited to the following over $10,000: Vendor payments.

Show More
Most recent fiscal year-end:
Prior fiscal year-end:
Total Assets
$2,201,526.00 USD
$2,619,727.00 USD
Cash And Cash Equivalents
$59,519.00 USD
$208,101.00 USD
Accounts Receivable
$0.00 USD
$0.00 USD
Short Term Debt
$360,000.00 USD
$360,000.00 USD
Long Term Debt
$409,055.00 USD
$383,699.00 USD
Revenues And Sales
$0.00 USD
$0.00 USD
Costs Of Goods Sold
$0.00 USD
$0.00 USD
Taxes Paid
$0.00 USD
$0.00 USD
Net Income
-$482,168.00 USD
-$496,520.00 USD

Risks

A crowdfunding investment involves risk. You should not invest any funds in this offering unless you can afford to lose your entire investment. In making an investment decision, investors must rely on their own examination of the issuer and the terms of the offering, including the merits and risks involved. These securities have not been recommended or approved by any federal or state securities commission or regulatory authority. Furthermore, these authorities have not passed upon the accuracy or adequacy of this document. The U.S. Securities and Exchange Commission does not pass upon the merits of any securities offered or the terms of the offering, nor does it pass upon the accuracy or completeness of any offering document or literature. These securities are offered under an exemption from registration; however, the U.S. Securities and Exchange Commission has not made an independent determination that these securities are exempt from registration.


Updates

Final Hours Left to Invest at the Throne’s Equity Crowdfunding Campaign

about 2 months ago

We sincerely appreciate all our investors who kindly care and support the Throne’s Crowdfunding Campaign at StartEngine, leading to the initiation of our clinical trials of Stem Cell Educator therapy. This campaign is going to be closed today. We will focus on the preparation and starting our clinical trials. We are looking forward to collaborating with you and crossing the finish line. Visit our page at https://www.startengine.com/throne-biotechnologies to invest.

7 Days Left to Invest at the Throne’s Campaign

2 months ago

We are so thankful for all of our investors so far and sincerely appreciate all your generosities to support the clinical trials of Stem Cell Educator therapy to treat type 1 diabetes and alopecia areata through this campaign at StartEngine. We are happy to announce that we are going to start these clinical trials in June, about two months away from nowThrone’s equity crowdfunding campaign will be closed soon on April 30th. We look forward to the growth that would not be possible without your investment. Visit our page at https://www.startengine.com/throne-biotechnologies to invest.

Can Stem Cell Educator therapy help the long-standing type 1 diabetics to improve or restore their islet beta cell function?

2 months ago

The answer is Yes. Dr. Yong Zhao and his colleagues have demonstrated this through a clinical trial in long-standing type 1 diabetic (T1D) patients who had no or a little residual islet beta-cell function before receiving Stem Cell Educator therapy (see following Figure 1, and the manuscript Zhao Y, et al. BMC Medicine 2012 for more information).

        Due to human islet β-cell replication usually occurs during the fetal and neonatal stages and then declines after these stages, it will be necessary to provide alternative resources for the restoration of b-cell function in those longstanding severe T1D subjects. Recently, functional insulin-producing cells have been generated from embryonic stem cells (ESC) and induced pluripotent stem cells (iPSCs). This has led to clinical trials for the treatment of T1D subjects including ViaCyte studies with VC-01 and VC-02 products (NCT04678557 and NCT03163511, respectively) and a Vertex study with VX-880 (NCT04786262). Clinical applications of these stem cell-derived insulin-producing cells may have ethical and safety concerns including potential tumor formation and immune rejection. Our previous studies demonstrated peripheral blood-insulin-producing cells (PB-IPC) naturally circulate in human peripheral blood. In comparison with the generation of insulin-producing cells from ES and iPS cells, this technology can efficiently isolate insulin-producing cells PB-IPC from patients’ own blood, without any ethical issues and the hazards of immune rejection. Currently, the newly developed technology through the mitochondrial reprogramming of PB-IPC may provide a novel approach for the generation of a large amount of autologous insulin-producing cells from patients themselves to potentially treat T1D patients in clinics in combination of Stem Cell Educator therapy.

We need your support to facilitate the clinical transition of Stem Cell Educator therapy into a practical care. Please visit the Throne campaign page to learn more and invest on StartEngine: https://www.startengine.com/throne-biotechnologies

Practical Cure for Patients with Alopecia Areata by the Stem Cell Educator Therapy

3 months ago

Alopecia areata (AA) is one of the most common autoimmune diseases that results in loss of body hair such as alopecia totalis (AT, total loss of scalp hair) and alopecia universalis (AU, complete loss of body hair). AA is a serious condition with physical, emotional and social impacts, having an unmet need. To date, there are no FDA-approved drugs for AA. Notably, Dr. Zhao and his team demonstrated the clinical efficacy of Stem Cell Educator therapy for the treatment of alopecia patients (see the following image, for more information see the publication Li Y, et al. BMC Medicine 2015). 

Currently, Throne has received the FDA approval for phase 2 clinical trial of Educator therapy to treat AA subjects through the collaboration with the renowned dermatologist Dr. Brett King at Yale University. It is highly expected that Stem Cell Educator therapy will achieve an expedited FDA approval under the designation of Regenerative Medicine Advanced Therapy (RMAT) due to an unmet medical need for AA. We need your support to facilitate the clinical transition of Stem Cell Educator therapy into a practical care. Please visit the Throne campaign page to learn more and invest on StartEngine: https://www.startengine.com/throne-biotechnologies

The Procedure of Stem Cell Educator Therapy and Patients' Testimony

3 months ago


Throne Biotechnologies Receive Award: One of the "5 Best BioTech Companies To Watch" by The Silicon Review

3 months ago

We are honored to announce that Throne Biotechnologies (Throne) is one of the awardees of the “5 Best BioTech Companies To Watch“ by The Silicon Review.

Why Can Stem Cell Educator Therapy Be Utilized to Treat Type 2 Diabetes?

3 months ago

Type 2 diabetes (T2D) is the most common type of diabetes, with prevalence increasing worldwide due to the popularization of a Western lifestyle characterized by overnutrition and limited exercise. According to the International Diabetes Federation (IDF) Diabetes Atlas Tenth edition 2021(https://idf.org/aboutdiabetes/what-is-diabetes/facts-figures.html), approximately 537 million adults (20-79 years) are living with diabetes. The total number of people living with diabetes is projected to rise to 643 million by 2030 and 783 million by 2045. Diabetes-associated complications (e.g., cardiovascular diseases, stroke, blindness, kidney failure, and emotional stress) markedly decrease quality of life of T2D patients, limiting the productivity of individuals with the disease and creating significant economic and social burdens. Thus, finding a cure for T2D is a top priority. 

     Insulin resistance is the key issue causing T2D. Mounting clinical evidence and animal studies point to the involvement of monocytes/macrophage-associated immune dysfunctions as crucial issues in insulin resistance in T2D, suggesting that immune modulation may be a useful tool in treating the disease. The failures of using conventional approaches to controlling inflammation and immune dysfunction of type 1 diabetes (T1D) should enlighten the development and testing of novel approaches in T2D. Currently, insulin therapy and  FDA-approved medications for T2D patients only treat the symptoms and can not fully address these fundamental issues causing insulin resistance.  

    To determine the clinical efficacy of Stem Cell Educator therapy in T2D, Dr. Zhao and colleagues found that about 70% of T2D patients achieved the improved metabolic control, with marked reduction of median glycated hemoglobin (HbA1 C) values from 8.61% ± 1.12 at baseline to 7.9% ± 1.22 at 4 weeks post-treatment (P = 0.026), and to 7.25% ± 0.58 at 12 weeks post-treatment with Educator therapy (P = 2.62E-06) in long-standing T2D subjects. Homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) revealed that insulin sensitivity was improved, as well as significantly reduced inflammation markers after receiving Stem Cell Educator therapy. Notably, the islet b-cell function in long-standing severe T2D subjects (15 ~24 years) was markedly recovered, as established by the restoration of C-peptide levels at both fasting and post glucose challenging. This clinical efficacy could be retained over four years after receiving one treatment with Stem Cell Educator therapy. Therefore, Stem Cell Educator therapy holds great promise for improving diabetic treatment and finding a cure for diabetes.

Monocytes/macrophages are important front line of immune cells in humans. Based on the phenotypic differences, macrophages are simply characterized with type 1 macrophages (M1, inflammatory) and type 2 macrophages (M2, inflammatory). Mechanistic studies have shown that the percentage of monocytes expressing an M1 macrophage marker was markedly decreased in T2D patients four weeks after Stem Cell Educator therapy and that co-culture of activated monocytes with stem cells CB-SC significantly down-regulated numbers of inflammation-related genes, including chemokines and cytokines. To further explore the molecular mechanisms underlying the immune modulation of Educator therapy on monocytes/macrophages, our recent study demonstrated that CB-SC could release exosomes (designated cbExosomes, see following Figure) that promoted the M2 differentiation of monocytes. Exosomes belong to a family of nanoparticles with diameters ranging 30‒150 nm. Thus, Stem Cell Educator therapy through the action of CB-SC counteract the chronic inflammation by releasing cbExosomes, which promote monocyte differentiation into anti-inflammatory M2 macrophages, contributing to the control of inflammation and producing the long-lasting clinical outcomes in metabolic control for individuals with moderate or severe T2D who receive a single treatment.

Collectively, Stem Cell Educator therapy has the great therapeutic potential to revolutionize the treatment of both type 1 and type 2 diabetes and eliminate the need for lifelong insulin therapy, without the safety and ethical concerns associated with conventional immune and/or stem cell-based approaches.

    We appreciate your financial support to facilitate the clinical transition of Stem Cell Educator therapy into a practical care. Please visit the Throne campaign page to learn more and invest on StartEngine: https://www.startengine.com/throne-biotechnologies

Stem Cell Educator Therapy: New Hope for Patients with Alopecia Areata and Other Autoimmune Diseases

4 months ago

    Alopecia areata (AA) is a common autoimmune disease that results in loss of body hair in varying degrees. The condition is estimated to affect more than 6.8 million people in the United States (naaf.org), with a worldwide prevalence of 0.1% to 0.2%. AA and its variants such as alopecia totalis (AT, total loss of scalp hair) and alopecia universalis (AU, complete loss of body hair) can have devastating effects on patients’ quality of life and social functioning. 

    The quality of life in AA patients has been significantly affected by the disappointing outcomes, side effects, and relapses with current conventional therapies, including topical and systematic applications of immunosuppressive regimens (such as corticosteroids and cyclosporine). To date, curative therapy for AA does not exist. There are no FDA-approved treatments for AA. Recently, Janus kinase (JAK) inhibitors are effective treatment for severe AA. However, for all those patients who do respond, relapses are common after discontinuation of treatment, due to the existing of autoimmune memory T cells. Additionally, the side effects of JAK inhibitors make patients vulnerable to potential infections and tumor formation. Therefore, AA is a serious condition with physical, emotional and social impacts, having an unmet need.

    To date, there are more than eighty autoimmune diseases that have been characterized in clinics with either systematic or organ-specific damage. Importantly, T cell dysfunction was associated with the chronic pathogenesis of most autoimmune diseases. Therefore, it is essential to find a cure for AA and other autoimmune diseases through targeting the T cells and correcting their functional defects. Notably, Dr. Zhao and his team demonstrated the clinical efficacy of Stem Cell Educator therapy in ten autoimmune/inflammatory diseases. Why is the Educator therapy so powerful? The key molecular mechanism underlying the Educator therapy is the expression of autoimmune regulator (AIRE) in the stem cells CB-SC (see following Figure, Note: BTLA, B and T lymphocyte attenuator; PD1, programmed death 1; PD-L1, programmed death ligand-1), which AIRE is a master transcription factor that has key roles in governing T-cell development and immune tolerance in humans. Thus, Educator therapy can be utilized to treat multiple autoimmune diseases and offer a practical cure.  

         Currently, Throne has received the FDA approval for phase 2 clinical trial of Educator therapy to treat AA subjects. It is highly expected that Stem Cell Educator therapy will achieve an expedited FDA approval under the designation of Regenerative Medicine Advanced Therapy (RMAT) due to an unmet medical need for AA. We need your support to facilitate the clinical transition of Stem Cell Educator therapy into a practical care. Please visit the Throne campaign page to learn more and invest on StartEngine: https://www.startengine.com/throne-biotechnologies

New hope for type 1 diabetes (T1D): Phase 2 clinical trial of Stem Cell Educator therapy is ready to start once funding available

4 months ago

The hallmark of T1D is the autoimmune destruction of islet beta cells, leading to the shortage of insulin production. Over the last 40 years, the failures of most clinical trials have highlighted the limits of conventional immunotherapy in T1D and underscore the need for novel treatments that overcome multiple immune dysfunctions and help restore islet beta-cell function. To address these two key issues (autoimmunity and shortage of islet beta cells) in T1D, Throne has developed a unique and novel procedure designated the Stem Cell EducatorÔ therapy, based on the immune education by cord-blood-derived multipotent stem cells (CB-SC). Notably, our Stem Cell Educator technology has been evaluated through international multi-center clinical studies, which have demonstrated its clinical safety and efficacy in T1D and other autoimmune diseases. Now, everything is ready to start the FDA-approved phase 2 clinical trial, except the only hurdle of funding

  1. Throne has received the FDA approval for the phase 2 clinical trial in T1D. This is a big milestone for a biotech company. 
  2. Throne has received the IRB (Institutional Review Board) approval on this clinical trial. 
  3. Throne has a certified GMP facility for producing Stem Cell Educators and processing the treatment of patient’s immune cells (see the image of GMP facility). 

As a global-leading technology in the field of T1D treatment (JDCA, 2021, New York), it is highly expected that Stem Cell Educator therapy will achieve an expedited FDA approval under the designation of Regenerative Medicine Advanced Therapy (RMAT) due to an unmet medical need for T1D. Those interested in facilitating the clinical transition of Stem Cell Educator therapy can visit the Throne campaign page to learn more and invest on StartEngine: https://www.startengine.com/throne-biotechnologies


Our equity crowdfunding campaign is live

4 months ago

NOW LIVE: We are very excited that our equity crowdfunding campaign is live on StartEngine! The Press Release of this campaign has been widely published in major social media such as Time, Entrepreneur, US Weekly, Newsday, Washington Times, The Hill, Chicago Tribune, Daily Press, Reader’s Digest, Life and Style Magazine, Wall Street Business News, NBC-2, ABC-7, and etc. 

Throne Biotechnologies (Throne), one of the global-leading biotech companies aiming to achieve the FDA approval on the Stem Cell Educator therapy and find a cure for type 1 diabetes, alopecia areata and other autoimmune diseases. Those interested in facilitating the clinical transition of Stem Cell Educator therapy can visit the Throne campaign page to learn more and invest on StartEngine: https://www.startengine.com/throne-biotechnologies

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