Updates
May, 2020

CSIR-Centre for Cellular and Molecular Biology (CCMB), Hyderabad & Eyestem Research Private Limited, Bangalore announce a unique public-private collaboration in the fight against Covid-19

Under this agreement, CCMB will use Eyestem’s human lung epithelial cell culture system provided as part of its Anti-Covid screening (ACS) platform to understand the molecular and pathological characteristics of the COVID-19 virus with a view to establishing a rational basis for testing potential drugs in vitro.

Commenting on the development, Dr. Rakesh Mishra, Director of CCMB, said “Culturing the virus outside the human host is a technological challenge that needs to be overcome. Eyestem’s cell culture system expresses the ACE2 receptor and other genes that are key determinants of viral entry and replication. We hope that employing this system will allow the CCMB team led by Dr. Krishnan Harshan to grow the virus predictably and thereby open up the potential for drug screening and vaccine development strategies”

Dr. Jogin Desai, CEO of Eyestem agreed and remarked “We are honoured to enter into this research collaboration with one of the premier scientific institutes in India. The ACS platform has been developed by Dr. Rajarshi Pal and his team and is a testament to our depth and expertise in cell therapy and disease modelling. We remain hopeful that CCMB will be able to leverage this platform and advance Covid research that will help humanity in India and abroad”

About CCMB
The Centre for Cellular & Molecular Biology (CCMB), a premier research organization in frontier areas of modern biology is an autonmous laboratory under the Council for Scientific and Industrial Research.(CSIR) CCMB has responded to the current crisis and was the first academic laboratory outside ICMR to initiate COVID19 testing and kit validation. In addition, CCMB has intiated a variety of new research projects on SARS-CoV2.

About Eyestem
Eyestem Research Private Limited is a cell therapy start-up incubated at the Centre for Cellular and Molecular Platforms, Bangalore. Its vision is to democratize access to cell therapy as well as disease modeling platforms and bring their benefit to a large section of humanity.

April, 2020

Eyestem Research announces immediate availability of its Anti-Covid Screening (ACS) platform using iPSC derived lung progenitors

Eyestem has been selected to be part of the Centre for Cellular and Molecular Platforms (C-CAMP) Covid Innovation Deployment Accelerator (C-CIDA) and announces immediate availability of its Anti-Covid screening (ACS) platform using iPSC-derived lung progenitors. While any treatment modality including vaccines are 12-18 months away and the validity of antibody test are under debate, the shortest path to normalcy for the world is re-purposing of pre-approved drugs . The ACS platform, developed at Eyestem, provides the research community with a unique resource to determine efficacy of drugs/vaccines using the closest human host cell population.

Dr. Rajarshi Pal, Chief Scientist of Eyestem, commented “The ACS platform has been built upon lung stem cell work that has been done in our lab over the last 3 years. The launch of the platform is a credit to the depth of expertise of our scientists and their passion to contribute in solving this crisis”

Below is a list of frequently asked questions about our ACS platform.

1) What does the Anti-COVID Screening (ACS) platform consist of?

This ACS platform consists of three parts.

i) Cell lines: Frozen vials of airway (proximal lung) epithelial cells derived through a unique protocol that has been published and is patent pending.

ii) Expertise: We will work with our collaboration partners to help them thaw out and culture the frozen cells effectively and finally use them for screening purposes.

iii) Data sharing: We will share relevant characterization data with our collaboration partners which will help them in experimental design.

2) What is the genesis of the ACS platform?

The original genesis of the platform is based on a DBT- Stem Cells and Regenerative Medicine Task Force grant titled “Generation of airway progenitors from pluripotent stem cells by simulating milestones of in vivo lung development and their applicability for treatment of experimental pulmonary fibrosis” that I received in 2017 as Visiting Faculty, The University of Transdisciplinary Health Sciences and Technology, Bangalore. Owing to the immense translational potential of this project, over the last one year Eyestem invested into this area, thus expanding the scope of our lung research and resulted in a collaboration agreement with the Institute of Stem Cell and Regenerative Medicine (InStem, Bangalore) to study whether exogenously added lineage-traced lung progenitor cells will contribute toward the repair of the fibrotic lung in mouse models. When the COVID outbreak hit, we already had a small but very capable team working with hiPSCs (human Induced pluripotent stem cells) and lung cells and hence we decided to step-up and repurpose our efforts. Our goal is to get the relevant information out to the community and to share data as soon as possible, so that we can help accelerate ongoing efforts in the scientific and medical communities to fight the current COVID-19 crisis.

3) What are the details of the ACS platform?

a) What are the lacunae in existing screening strategies?

Since there is no effective way to address the threats of emerging mutant strains of COVID-19, the current de novo drug discovery and development pipeline is ineffective in dealing quickly with such a sudden viral outbreak. Repurposing existing drugs that may have unanticipated activities or rapidly developing newer vaccines as potential countermeasures against viral infections are two strategies being explored globally. Although several efforts are currently ongoing to study the repurposing potential of some pre-approved drugs, most studies are being carried out either in animal models or transformed cell lines wherein viral pathogenesis in human species is not faithfully mimicked. In addition, while a patient’s cell can directly model the effects of a drug on humans, their availability and capacity for expansion are limited compared to transformed or immortalized cells or tumour derived cell lines. The latter, however, may contain genetic and metabolic abnormalities due to their derivation, and thus would not represent a suitable drug screening model for human patients. These limitations present a significant obstacle that warrants the need for better models for studying drug efficacy, toxicity, and other host-targeted therapies.

b) What are the existing features of the ACS platform that can help fill the gap?

The entry of coronaviruses into the host lungs depends on the binding of the viral spike (S) proteins to cellular receptors and its priming by host cell proteases. This S protein mediates host cell invasion by SARS-CoV-2 via binding to a receptor protein called angiotensin-converting enzyme 2 (ACE2) located on the surface membrane of host cells. This invasion process requires S protein priming by the host cell-produced serine protease TMPRSS2. Notably we have shown upregulation of both ACE2 and TMPRSS2 in our iPSC-derived airway and alveolar epithelial cells grown in 2D cultures. If not naturally/endogenously expressed, one has to overexpress/engineer these crucial proteins on certain cell lines to facilitate COVID-19 infection (viral titer) which is not only complicated but also time consuming. Therefore, our in vitro model system is better suited for anti-viral screening and drug repurposing efforts.

c) What have we done so far?

Primary human lung alveolar epithelial cells are challenging to obtain and maintain in culture. We have successfully generated lung progenitors (Nkx2.1+) via definitive endoderm induction followed by anteriorized foregut endoderm formation. These proximal and distal lung progenitors have been shown to differentiate into airway epithelial and alveolar epithelial cells that can undergo freeze-thaw in 2D culture. Our published protocol recapitulates in vivo lung morphogenesis as demonstrated by the spatiotemporal expression of key transcription factors (SOX2, SOX9, FOXJ1) and protein markers (SFTPC, MUC5AC, CC10). The differentiation method is not very difficult to reproduce, easily scalable and is rapid (21-24 days).

d) What are we doing now?

Currently, this 2D protocol is being further expanded to culture these alveolar and airway cells at air-liquid interface (ALI). ALI culture will permit the exposure of SARS-CoV-2 to the apical surface of the cells. In parallel, we are working towards developing a three‐dimensional lung (bud) organoid model in collaboration with international labs.

4) What should interested parties do to set up a collaboration?

Please write to us at info@eyestem.com with a brief description of the collaboration you seek. Do ensure that you mention “COVID-19 collaboration” in the subject line of the email.

5) How much would it cost for us to use the platform?

Given the current crisis, Eyestem is willing to deploy this platform at research centres of repute who have access to the virus and the requisite BSL3 infrastructure at minimal cost.

Any private entity that would like to deploy the platform should get in touch with us for further discussions.

6) Can you provide us some references for the work done?

1. Surendran HS, Mohanapriya R, Pal R. Differentiating induced pluripotent stem cells into lung epithelial cells. 2019. Curr Protoc Stem Cell Biol 49(1):e86.

2. Banerjee P, Surendran H, Bharti K, Morishita K, Varshney A, Pal R. Long non-coding RNA RP11-380D23.2 drives distal-proximal patterning of the lung by regulating PITX2 expression. 2018. STEM CELLS. 36(2): 218-229.

3. May-Simera HL, Wan Q, Jha BS, Hartford J, Khristov V, Dejene R, Chang J, Patnaik S, Lu Q, Banerjee P, Silver J, Insinna-Kettenhofen C, Patel D, Lotfi M, Malicdan M, Hotaling N, Maminishkis A, Sridharan R, Brooks B, Miyagishima K, Gunay-Aygun M, Pal R, Westlake C, Miller S, Sharma R, Bharti K. Primary Cilium Mediated Retinal Pigment Epithelium Maturation is Disrupted in Ciliopathy Patient Cells. 2018. Cell Reports 22(1): 189-205.

February, 2020

Eyestem Research, India’s premier cell therapy company, announces successful completion of pre-IND meeting with FDA

The company aims to remedy hitherto incurable dry Age-Related Macular Degeneration (AMD) - the leading cause of blindness, affecting about 170 million people worldwide.

Bengaluru, 20th February 2020 : In its endeavour to create first-in-class advanced therapies in India with global benchmarks, Eyestem Research is delighted to announce successful completion of a pre-IND (Investigational New Drug) meeting with the FDA regarding regulatory roadmaps for its flagship product.

Eyecyte-RPE, a patent-pending suspension of Retinal Pigment Epithelium cells, is designed to arrest and reverse symptoms of dry Age-Related Macular Degeneration (AMD) – an incurable cause of blindness that affects about 170 million people globally. Eyestem is among the very few companies worldwide which are racing to find a cure for this debilitating condition. Once the IND application is filed this year, the start-up plans to commence the clinical trials by next year.

Commenting on the positive development, Dr. Jogin Desai, Founder and CEO, Eyestem said, “We are on a mission to democratize access to cell therapy and make it available to a large section of humanity. The pre-IND meeting is aimed at creating a validated regulatory roadmap and we are delighted to obtain encouraging feedback from the FDA on our intended development path. As the only Indian company in this segment, we are determined to make the most of our exceptional pre-clinical animal results in order to find a cure for Dry AMD. We are fortunate to have a superb partner in Ora clinical, the world’s leading ophthalmology research organization for creation of the regulatory roadmap. We now look forward to starting clinical trials on the product by next year”

Last year, the company had raised an undisclosed amount in funding from global investors in Switzerland and South Africa. It is also ably supported through grants by BIRAC, the investment arm of the Department of Biotechnology, India and by Centre for Cellular and Molecular Platforms. The company will use this momentum to raise the next round of funds to get to the end of phase one trials.

Jeanne Hecht, CEO, Ora Clinical said, “As one of the top ophthalmic contract research organisations (CROs) in the world, we recognise the need to nurture ideas that can change the world. Eyestem’s pioneering work can halt the progression of dry AMD by using a unique composition of retinal cells to restore the health of the retina and we are incredibly excited to be partners in their journey”

Eyestem’s vision is to create a global and scalable cell therapy platform that produces consistent and quality products to treat incurable diseases. The company, founded by a top-class management team consisting of clinical trial, cell therapy and ophthalmology experts, boasts of a world-class advisory board and collaborations with pioneers and global industry leaders.

BOX: What’s dry AMD?

• The eye’s macula, located near the center of the retina, is responsible for sharp, clear, straight-ahead vision. Dry Age-related macular degeneration (AMD) occurs when macula degenerates with increasing age. It starts with loss of central vision and ultimately leads to blindness.
• Wet AMD, a variant of AMD, is treatable and the global market of drugs for wet AMD is expected to reach USD 8.9 billion by 2022.
• The incidence of dry AMD incidence is nine times that of wet AMD. Yet, there is no cure for dry AMD.

FOR ANY FURTHER MEDIA INFORMATION, PLEASE CONTACT

Trisha Sirur | Lokesh Kumar | Sudhakar Rao

atrisha@lateralthinkers.co.in | lokesh@lateralthinkers.co.in | sudhakar@lateralthinkers.co.in

MbL: 90359 00388 | 91641 64788 | 99161 38037

Lateral Thinkers, PR, Bangalore

July, 2019

Eyestem, India’s pioneering cell therapy company, secures global funding

Bengaluru-based start-up to take its flagship product, Eyecyte-RPE, to human clinical trials in 18 months. If successful, it will be among the first few companies globally to find a treatment for Dry AMD, the largest cause of incurable blindness that affects nearly 170 million people worldwide

Bengaluru, July 2019: Eyestem, India’s leading cell therapy company, has raised an undisclosed amount in funding from global investors in Switzerland and South Africa. The investment will boost the Bengaluru-based start-up’s efforts to find a treatment for Dry Age-related Macular Degeneration (Dry AMD), the leading cause of incurable blindness affecting almost 170 million people – mostly above 50 years of age – across the globe.

Founded by a top-class management team consisting of clinical trial, cell therapy and ophthalmology experts, Eyestem has created a platform for allogeneic, scalable cell therapy. Eyecyte-RPE, the company’s flagship product, holds the promise of finding a treatment for Dry AMD. The recent funding will help the company to complete all the pre-clinical work to file for an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) and be ready for phase one clinical trials by end of next year.

The current round was led by Zurich based Jacesa investments, South Africa based Church Street Trustees and Gillian Corken. India based Impres Health also participated in the round.

Commenting on the positive developments, Dr. Jogin Desai, Founder and CEO, Eyestem, said, “Cell-based therapy is the transplantation of human cells grown in a laboratory to replace or repair damaged cells in the body. We have received excellent pre-clinical animal results for Eyecyte-RPE, our product to treat macular degeneration, from our partners at the Oregon Health and Science University, USA. We now intend to take the product forward and aim to be in human clinical trials in 18 months. It is encouraging to know that experienced and senior healthcare professionals from around the world have faith in our vision and have invested in us. We will be deploying these funds to manufacture the product, do confirmatory efficacy and toxicology and file an IND application.”

Global investors are seeing a huge potential in the hitherto untapped market, which players like Eyestem are well-positioned to disrupt. “Eyestem has the ambition of creating a cell therapy platform which is scalable. It has the potential to disrupt the global cell therapy ecosystem, which is currently facing scale and pricing challenges,” agreed Gert Hoogland, (Jacesa Investments).

According to the other investors, Prof.Oppel Greeff (Church Street Trustees) and Gillian Corken, “Eyestem is among a handful of companies globally who are leading the charge to treat macular degeneration and retinitis pigmentosa, both incurable diseases of the eye.”

“What made us invest in Eyestem is its global ambition, driven by its unique management team, which has a deep understanding of cellular biology, regulatory roadmaps and retinal degeneration,” they remarked.

As global investors and seasoned healthcare professionals exhibit growing interest in Indian start-ups, the Indian ecosystem is also taking note of home-grown businesses that have the potential to revolutionise the industry.

Ashok Vohra, Managing Director, Impres Health, is confident that investing in Eyestem will pave the way for a healthier future. “Eyestem has significant potential to be a global player in the new frontiers of cell therapy and we are proud to be associated with them,” he maintained.

Eyestem, which boasts of a world-class advisory board and collaborations with pioneers and global industry leaders, aims to create multiple cell-based products over the next few years to help treat intractable and incurable diseases through its scalable cell therapy platform.

For any further information, please contact

Dhanusha Sasidharan | Lokesh Kumar

dhanusha@lateralthinkers.co.in | lokesh@lateralthinkers.co.in

MbL: Lateral Thinkers, PR, Bangalore

March, 2019

Eyestem announces a significant milestone against an incurable form of blindness which affects over 150 million people globally ( About Dry AMD )

We are delighted to share positive animal efficacy results from Dr. Trevor McGill ( About Dr. Trevor McGill) at the Oregon Health and Science University for EyecyteRPE: our lead product for treatment of Dry AMD (macular degeneration)

As per Dr.McGill "EyecyteRPE provided significant beneficial effects on the degenerating retina in RCS ratswithout any significant safety concerns suggesting this cell type may have significant therapeutic value in human retinal degenerative disease".

Dr. Jogin Desai, Founder and CEO, Eyestem Research said " The POC results have shown significant preservation of photoreceptors and functional rescue of vision and the results are at par or better than most published data globally. We will be using this momentum to now aggressively move forward into GLP toxicology, larger efficacy and GMP production for our product for Dry AMD."

February 2019

Eyestem wins the BIPP grant from BIRAC

Eyestem was awarded a multi-crore grant under the Biotechnology Industry Partnership Programme.(BIPP) by the Department of Biotechnology, India. The grant will advance EyecyteRPE through GMP manufacturing and GLP toxicology studies. It is one of the largest ever grants accorded to a start-up in the medical biotech space.

January 2019

Eyestem among top start-ups at #LevelNXT

Eyestem is among the top 30 startups selected by #LevelNXT, India’s most comprehensive scaleup programme to recognize and nurture high-growth scaleups, hosted by PwC and FICCI. The program is meant to unearth the brightest entrepreneurs and offer them a collaborative ecosystem and easier access to growth networks.

June 2018

Eyestem featured in Economic Times

From an Economic Times report: Jogin Desai brings the global regulatory experience that can help scientists look ahead. His strategy is to be based in Bengaluru but leverage specialised skills from around the world. So, Eyestem has a set of advisors and collaborators in the country and in some of the best labs in the world. The company has started growing retinal cells in its lab through a unified protocol that can be used by technicians and hopes to begin clinical trials by 2020.