A doctor innovates cell therapy in India; Seeks to make vision restoration 80% cheaper

For Dr Jogin Desai, CEO and co-founder of Eyestem, India’s leading cell therapy company, a 2015 meeting with ophthalmologist Dr Rajani Battu for a medical appointment changed everything. Following the appointment, she introduced him to patients diagnosed with degenerative eye diseases and the terrible suffering they must endure.

It was a revelation for Desai, a native of Ahmedabad and an expert in the field of drug development. Desai, at the time, was CEO of Cenduit, an industry leader in the IRT (Interactive Response Technology) market and eClinical domain.

“From schoolchildren who can’t see their blackboards to families with children who are blind from genetic disorders and elderly people who have lost all agency due to their inability to read, the conversation has opened up eyes on a world I never knew existed.. During the same week, I met Prof. S. Ramaswamy at the Instem (Institute of Stem Cells and Regenerative Medicine), again to something completely independent, and we discussed the evolution possibilities of the next two or three decades with the maturation of cells and gene therapy products in the world”, recalls Desai, during a conversation with The best India.

Following the meeting, it dawned on Desai that the world is on the cusp of a fundamental shift in the healthcare landscape that will evolve over the coming decades.

Today, Dr. Rajani Battu is Eyestem’s chief medical officer.

“Diseases that were once incurable will begin to become curable. Going deeper, I realized that most of these Western-developed therapies would cost upwards of $450,000 (about Rs 3.5 Crore) per injection. This, I believe, has presented a unique opportunity for a platform that can help disrupt this paradigm and create incredible impact in the lives of patients. I made the decision to create Eyestem within two days of those meetings at the end of 2015,” adds Desai.

Eyestem’s vision is to create a scalable cell therapy platform to treat incurable diseases and democratize access to these new technologies.

Incorporated at the end of 2015, Eyestem started its activities at the beginning of 2017.

“As cell and gene therapies become available worldwide, they will only be accessible to the top 0.01% of the world’s population. Our goal is simple: we aim to democratize access by creating therapy accessible to much of the bottom 99.99% of the world’s population. To our knowledge, we are the only company in the world to have such a mission. Although it is difficult to predict the price of the therapy at this point, we expect the therapy to cost 80-90% less than these comparable therapies in the West. The sole purpose of starting Eyestem was to make sure the therapy reaches the people who need it most,” Desai says.

With its lead product Eyecyte-RPE, the company replaces lost retinal pigment epithelial cells. It is designed to restore sight to patients in the early stages of Age-Related Macular Degeneration (AMD) and stop loss for those in the later stages.

“There is no cure for dry age-related macular degeneration in the world. It is the leading cause of blindness in people over the age of 50. It is estimated that more than 170 million people (including 40 million in India) suffer from this disease. Eyestem is seeking to qualify Eyecyte-RPE for dry AMD in clinical trials and is one of six companies worldwide to pursue this treatment,” he said. declared.

Vision in macular degeneration (Image courtesy Eyestem)

This type of treatment is based on products based on induced pluripotent stem cells (iPSC). An iPSC is a cell that can grow into any cell in the body. Currently, no iPSC-based products are approved worldwide.

Over the next ten years, Desai explains, many of these products will begin to become available on the market and diseases such as hereditary blindness/pulmonary fibrosis/diabetes, which until now were considered incurable, will begin to become curable.

“Thereafter, an explosion of iPSC-based therapies combined with genetic engineering will be the next wave of pharmaceutical innovation. Many diseases arise when our body’s cells die prematurely or malfunction. In its most basic details, we can create tissues of any type (whether brain, heart, lungs, eyes, liver, kidneys) through iPSC and replace lost/damaged body cells For example, in AMD dry, the RPE layer degenerates and our treatment would be to inject that layer (from a healthy donor) back into the body part to treat the disease,” he explains.

Dr Jogin Desai, Founder of a company specializing in cell therapy
Dr. Jogin Desai, CEO and co-founder of Eyestem, a leading cell therapy company (Image courtesy of Eyestem)

Cure incurable blindness and other diseases

So how does Eyestem’s flagship product, Eyecte-RPE, work as a mode of treatment?

The retinal pigment epithelium (RPE) is one of the ten layers of the retina and acts as a foundation on which the rest of the retina rests. In dry AMD, the RPE layer disintegrates and the retinal layers disintegrate much like a building collapses when the foundation collapses.

“We developed the RPE layer in our lab and it is Eyecyte-RPE, our flagship product. This product was injected into special models of blind rats. We have proven that rats injected with our product can retain their sight while those that are controlled rats go blind. This animal experiment was performed at Oregon Health and Science University, a global center of excellence for macular degeneration research. DCGI (Drugs Controller General of India) has approved manufacturing for clinical trials only and we have not yet applied for commercial manufacturing,” he explains.

Eyecyte-RPE under the microscope. It is the basis on which our light-sensitive retinal cells rest. (Image courtesy Eyestem)

In addition to this, Eyestem is also one of five companies globally advancing the treatment of Retinitis Pigmentosa (RP) in the market called Eyecyte-PRP. Eyecyte-PRP replaces the photoreceptor cells that are lost as a result of this disease. RP is a group of rare genetic disorders that involve the loss of light-sensitive photoreceptor cells in the retina. It affects children and causes total blindness when they reach their twenties and thirties. It is estimated to affect 4 million children worldwide, including 1.5 million in India. Human trials for Eyecyte-PRP in the treatment of retinitis pigmentosa are expected to begin in the second half of fiscal 2023.

Similarly, Eyestem is also looking to treat idiopathic pulmonary fibrosis (IPF), a serious chronic disease that affects the tissues surrounding the alveoli (small air sacs in your lungs), with a pluripotent stem cell approach.

“Our first-in-human trials for our Aircyte-AEC therapy to treat idiopathic pulmonary fibrosis will begin in the second half of fiscal year 2024. Aircyte-AEC is a suspension of lung alveolar epithelial cells lost to this disease. It should be noted that pulmonary fibrosis occurs end-stage in several other diseases like COVID-19, tuberculosis, and chronic obstructive pulmonary disease,” notes Desai.

Meanwhile, for the sake of clarity, we asked Desai if cell therapy necessarily means stem cell therapy? “Yes, it means the same thing from a layman’s point of view. The only difference is that there are clinics that advertise “Stem Cell Therapy” for patients in India as well as the United States. It is important to remember that none of these stem cell therapy products are approved by the DCGI in India or the FDA in the United States,” he notes.

State of Cell Therapy in India, Funding and Evolution

There are only a handful of companies in India pursuing cell therapy. According to Desai, the developed world, especially countries like Israel, Japan and the United States, are at least two decades ahead of India in this regard.

“As more and more incurable diseases become curable (think diabetes or cancer), it is absolutely imperative for India to develop a research base on the development of such products, otherwise we will find ourselves in a similar situation. to the HIV epidemic (and cell therapy is not easily reverse-engineered unlike anti-HIV drugs.) Our patients will be at the mercy of predatory pricing from the global pharmaceutical industry unless innovative products to globally are manufactured and made available locally. Our team of nine members at Eyestem, the majority of whom are cell biology scientists specializing in this area, are looking to address this issue in a meaningful way in advance,” says Desay.

Meanwhile, Desai says his company has been very selective in fundraising so far because its goal is not to raise “rounds with higher valuations, but to benefit end patients.” . They are focused on creating an affordable cell therapy, and so have set a goal of spending no more than $4 million between the idea and first-in-human trials. Most pharmaceutical companies, he claims, spend 10 times that amount to get to that point.

The Eyestem team is working on an affordable cell therapy
Team Eyestem (Image courtesy of Eyestem)

“Any drug development company needs smart money. We were fortunate to have the interest of a group of investors who have decades of experience in global drug development. Two institutional investors ( Endiya Partners and Kotak Private Equity) joined in a subsequent pre-Series A round. We are currently raising our Series A and are halfway through. Approximately 30% has been pledged by current shareholders and we have a soft pledge from a global venture capital fund for the remaining 20% ​​We expect to close this round in the next 8-12 weeks Investors are investing in companies like ours because of the promise of immense market potential for these therapies. As soon as you get human data, startups like us hit an inflection point and become extremely valuable,” Desai says.

Please note: The Better India does not verify the future effectiveness of any therapy or medical treatment mentioned in the article. Please consult your physician for informed medical advice.

(Edited by Vinayak Hegde)

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