September 2021

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Overview

GentiBio is an early stage, privately held biotech company, founded in 2020. The company is focused on developing new therapies to regulate aberrantly functioning immune responses. Because the company is at an early stage, its pipeline remains undisclosed, however, GentiBio has disclosed its technology  to be based on regulatory T cells (Tregs)[1].

On August 11th, GentiBio announced the closing of a $157 million Series A financing round with the lead investor being Matrix Capital Management. Previously, the company secured $20 million in seed funding from investors such as Novartis Venture Fund, Orbimed and RA Capital Management. Collectively, these investments have secured GentiBio $177 million to further their research into treating autoimmune and autoinflammatory diseases[2].

GentiBio is based out of Boston, Massachusetts USA. This area is known for its pivotal role in developing novel technologies in many areas, including biotech, in affiliation with some of the most highly acknowledged universities in the world. Additionally, the Boston area has developed into the epicenter of biotech, and this puts GentiBio in a very favorable spot for securing future financing.

Technology

Tregs mediate essential regulatory functions of the immune system's response to harmful invaders such as bacteria and viruses, as well as cancerous cells. Tregs suppress activation, proliferation and cytokine production of CD4+ T cells and CD8+ T cells, and thus, act as a "brake" for the immune response. At GentiBio, the aim is to leverage Tregs using the company’s engineered Tregs or EngTregs, thus seeking to address the underlying causes of autoimmune diseases.

Currently, Treg cell therapies are being investigated in clinical trials for the treatment of autoimmune diseases, graft vs. host, and transplant rejections due to the strong regulatory capabilities of Tregs[3]. Treg cells comprise about 5-7% of the human CD4+ T cell population. They develop when regular CD4+ T cells are exposed to high levels of transforming growth factor β (TGFβ) and/or retinoic acid in the local environment of peripheral tissues outside the ordinary thymus maturation[3]. But even though these cells are low in numbers compared to other CD4+ T cell populations, they play an important role in regulating the immune system, as exemplified earlier by their role in addressing hypersensitivity.

GentiBio’s unique approach to engineered Tregs is focused on repurposing more abundant immune cells, as described by the company itself: “Rather than isolating Tregs – a very rare population in the blood, we zero in on more abundant effector T cells to generate our EngTregs. Our technology stably converts the effector T cells into EngTregs and ensures our ability to scale manufacturing at very efficient costs”[1].

Engineered Tregs, like GentiBio is developing with their EngTreg technology platform, is not a new concept, but they can undeniably represent a unique opportunity for regulation of the immune system’s response to allergens or grafts. However, how the company plans to execute their technology remains to be seen, as they are yet to disclose their actual mode of action and pipeline.

As GentiBio is still in stealth mode, the company is still not disclosing results in studies using their Treg platform; it is not possible to discuss any potential results achieved by the company.

Partnerships

GentiBio has attracted funding from many high profile investment companies and funds. Novartis Venture Fund and Matrix Capital management are great investors to have on the hook, especially when looking at future investment potential.

Aside from promising investors, GentiBio has a long-running affiliation with Seattle Children’s Research Institute and Benaroya Research Institute at Virginia Mason. Both of these institutes have also assisted in the launch of GentiBio.

GentiBio has licensed its technology from both Seattle Children’s and Benaroya, but additionally, it has also licensed from Israel based MIGAL Galilee Research Institute[4]. 

On the 19th of June 2021, it was announced that GentiBio had entered into a viral vector contract development and GMP manufacturing partnership with Forge Biologics [5]. Forge Biologics is a dedicated contract development manufacturing organization focused on using their cGMP facilities for the development of new cell- and gene therapies and adeno associated virus viral vector manufacturing[6].

This partnership between Forge and GentiBio will employ Forge’s Blaze Vector™ production platform and HEK 293 Suspension Ignition Cells™ to help scale GentiBio’s operations. With this partnership, GentiBio is well positioned to scale their programs and enter into the clinic.

Team and Leadership

GentiBio is made up of 11 different members with expertise within biotechnology. GentiBio’s chief executive officer is Adel Nada, a proven medical doctor with years of experience in other biotech companies. Previous to co-founding GentiBio, Nada worked as chief medical officer in Casebia Therapeutics, and have resided in the role of vice president in the highly profiled gene therapy company Intellia Therapeutics. Aside from strong leadership from the company CEO, GentiBio also employs several PhD’s in key roles, related to both business operations, platform development and R&D[1]. 

Market Insight

The Treg cell therapy market is a growing entity in the biotherapy industry. The allergy market, which Treg based therapies may target, is valued at $18 billion, and is expected to grow by 6% by 2026 with a future valuation of $26.2 billion[7]. Organ transplant rejection medication (OTRM) market was valued at $4.7 billion in 2018. By 2026 the OTRM market is estimated to have grown by 3% to a valuation of $4.84 billion[8]. These two markets alone will constitute a possible market size of $30 billion, leaving a lot of room for growth for GentiBio.

Some big pharma companies like Gilead are involved in development of Tregs, however, most regulatory T-cell companies are early stage and privately held. Other Treg companies like Sangamo Therapeutics and Sonoma Biotherapeutics are also working on developing engineered regulatory T cells, and likely serves as direct competitors to GentiBio.

Comparing competition between Treg companies with other sectors of biotech, the competition is much smaller than for example mRNA therapeutics or targeted protein degradation. This allows GentiBio to establish a high market share if the company plays its cards right, and with the high amount of cash on hand generated by its Series A funding, the company is well positioned to enter into clinical trials. With all of these factors in mind, it will be exciting to follow the future development of GentiBio.

At Stargazing Bio Research we have created a database containing every company working within the specific niche of Treg cell therapies. To learn more about the Treg company database click the link here.

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