In June, the U.S. Food & Drug Administration (FDA) issued a ‘safe to proceed’ for the Investigational New Drug (IND) application for NY-ESO-1 TCR/IL-15 NK, an engineered T-Cell Receptor Natural Killer (TCR-NK) cell therapy for advanced synovial sarcoma and myxoid/round cell liposarcoma, being developed by Syena, the oncology-focused product company launched by Replay and MD Anderson.

Replay’s Chief Medical Officer provides further insights into the first clinical trial of NY-ESO-1 TCR/IL-15 NK.

__1. Can you explain why you have chosen sarcoma for trials of your investigational TCR-NK cell therapy?__

The answer is really two-fold. We focus on the science with everything we do at Replay. Our choice of sarcoma is based on our understanding of science and its potential for patients. NY-ESO-1, the first cancer neoantigen that our therapy is targeting, is an extensively validated tumor-associated antigen expressed on a variety of tumor types, including synovial sarcomas and myxoid/round cell liposarcomas, the subtypes of sarcoma that Replay is focusing on in this trial. Its highly immunogenic nature and its association with these sarcomas give us a strong reason to believe in its promising potential as a target for our novel immunotherapy.

Alongside that, there is the patient need. Synovial sarcoma and myxoid/round cell liposarcoma are amongst the rarest forms of cancers, with a high unmet need, that poses a significant burden on the lives of patients, including a late or incorrect diagnosis and difficulties for patients in accessing appropriate treatment. We need newer, more advanced therapies for these patients which offer greater potential for prolonged survival, reduced risk of side effects and, ultimately, a better quality of life. 

![Arun Balakumaran](//images.ctfassets.net/g16a9pxiy3in/7hAfSzn1tKxApFOHJlXYMZ/4dc393b0d45add59fd077588409d2428/Arun.jpg)

__2. What is the current treatment pathway for sarcoma patients?__

While new treatment options are being introduced and approaches are evolving, the backbone of sarcoma treatment continues to be older, more traditional therapies, such as chemotherapy and radiation therapy, as well as surgery. Historically sarcomas have been difficult to treat, for several reasons. Firstly, there are multiple subtypes of the cancer which have impeded our ability to build a greater knowledge datasets around the disease, then there is its rarity, and finally it is a highly aggressive cancer. Sarcoma is notorious for its  ability to spread fast despite initial treatment. 

In many cases sarcoma can be present with no specific symptoms, so it’s difficult to catch it and intervene in the initial stages. Overall, this makes treatment of  sarcoma extremely challenging. Sarcomas diagnosed in an advanced stage, can unfortunately relapse, with little hope of any viable options. This is why we need to think beyond the current treatment paradigm. We need to develop novel therapies that can break the barriers currently limiting treatment options for sarcoma patients, whilst always ensuring the patient achieves an optimum quality of life. This is what we believe our cell therapy has the potential to achieve. 

__3. Can you explain a little more about the TCR-NK approach?__

This is a novel cell therapy with the potential to transform the current treatment landscape for synovial and myxoid/round cell liposarcoma. We anticipate it will achieve compelling efficacy alongside a reduced treatment burden and a significantly reduced risk to the patient. It is the lead clinical program of Syena, the first-in-class engineered T-Cell Receptor Natural Killer (TCR-NK) cell therapy company that we formed earlier this year with The University of Texas MD Anderson Cancer Center, building on the pioneering science of Professor Katy Rezvani, M.D., Ph.D. The vision behind Syena is really to disrupt the existing cell therapy paradigm with a next generation agent that can bring new options for patients in need. We’ve seen the transformative effect from the likes of engineered CAR T or TCR T-cell therapies that have brought to cancer care, but the field is still plagued by limitations. The inability to treat large patient populations or solid tumors, complex manufacturing remains prohibitively expensive, and with safety challenges. Syena is leveraging the power of NK cells to democratize engineered cell therapy for the treatment of these sarcomas and other cancers. The TCR-NK cell therapy platform combines the advantages of an engineered TCR cancer therapy with the killing power of NK cells. Our therapy  offers the possibility of both improved efficacy and safety. These attributes of our therapy are critical for these patients, particularly those who have undergone earlier rounds of treatment resulting in weakened immunity.

![Katy Rezvani ](//images.ctfassets.net/g16a9pxiy3in/3LVR3NzSM9l94c9AbaNYy1/5843dac61db6795fd78472abb3420f62/31_Katy_Rezvani_light_green.jpg)

__4. Will this trial be expanded to other types of cancer?__

There will be further updates as we expand to other cancer types. But given what we know about NY-ESO-1 as a target, which is expressed at high levels and in a high frequency in a number of different cancers, we do plan to instigate further trials – the next one will be in relapsed or refractory multiple myeloma. We received approval from the US regulator in July 2023 to begin that trial so plans are well underway.

__5. What are the next steps and when can we expect to hear more?__

We expect this sarcoma study to begin in the coming months. The team at MD Anderson is close to screening patients. Up to 44 patients will be enrolled, which will generate the critical data set, required to support its continued development. Our priority is identifying the right patients for this study. Firstly, this is a rare cancer. Secondly, this trial is focused on enrolling patients who possess the HLA-A*02 allele HLA haplotype. Haplotypes can be thought of as unique genetic fingerprints that are inherited from the mother and father. HLA haplotypes encode for proteins called human leukocyte antigens (HLA), which, in conjunction with additional antigen processing components within the cell, capture and present fragments of intracellular proteins on the cell's surface. In cancer cells, these HLA molecules display aberrant protein fragments, serving as signals or markers that prompt immune cells to identify and eliminate the malignant cell. In a cancerous cell, the HLA proteins display abnormal fragments which act as a trigger or call-sign for immune cells to destroy that cell. 

The HLA-A*02 allele along with NY ESO-1 expression are strong biomarkers for the potential effectiveness of our therapy. Our priority is to develop strategies to find the right patients, considering this is a rare cancer with only a subset of patients who are eligible to take part. You’ll hear details when the trial starts later this year as we expand the program into other cancer types.


Chief Medical Officer, Arun Balakumaran explores the potential of TCR-NK cell therapy for sarcoma 

Arun

In discussion with Chief Medical Officer, Arun Balakumaran: Exploring the potential of a TCR-NK cell therapy for sarcoma 

 - Collaboration leverages JURA Bio’s T cell receptor (TCR) discovery platform to discover and develop innovative therapies by applying AI/machine learning

__San Diego, California, London, UK, and Newport Beach, California, September 21, 2023__ – Replay, a genome writing company reprogramming biology by writing and delivering big DNA, announced today a research collaboration between JURA Bio, a biotechnology company developing immune-based therapeutics using machine learning and synthetic biology, and Syena, a cell therapy product company and subsidiary of Replay, to develop T cell receptor (TCR) based therapies. 

“JURA Bio’s highly differentiated TCR discovery platform has transformative potential and combines the power of synthetic biology with that of machine learning. We look forward to working with them to identify high performing TCRs recognizing challenging but therapeutically important targets such as KRAS G12D,” __said Adrian Woolfson, Executive Chairman, President, and Co-Founder of Replay.__ “JURA Bio’s unique AI tools and expertise in synthetic libraries offer a differentiated approach for discovering TCRs. This will be invaluable in helping Replay’s cell therapy product company Syena to advance novel TCR-NK therapies into the clinic.”

“We’re thrilled to announce our first partnership with Replay and its product company Syena. This partnership validates our approach of using synthesized human T cell repertoires to generate safe and effective libraries to discover antigen specific TCRs at scale,” __said Elizabeth Wood, Ph.D., Founder & CEO, JURA Bio__. “The human immune system is a powerful source of safe and effective immune receptors, and while one patient might lack a TCR necessary to fight cancer, it may be present in another. By leveraging machine learning to rewrite the gene synthesis process from the ground up, we can produce extraordinarily high-quality immune receptors libraries to discover and train probabilistic machine learning models to ensure a faster development process that identifies TCRs recognizing the most challenging therapeutic targets.” 

__Lachlan MacKinnon, CEO and Co-Founder of Replay, said:__ “We are delighted to be partnering with JURA Bio and their innovative team of synthetic and computational biologists to develop highly differentiated TCR-NK cell therapies. This new partnership is an exciting opportunity for Replay’s cell therapy product company Syena to leverage JURA Bio’s powerful toolkit of machine learning and synthetic protein design, coupled with their extensive expertise, and to use this to advance the development of our engineered TCR-NK cell therapy programs.” 
JURA Bio will receive an upfront payment as well as research funding for the period of the partnership. The details of the financial terms of the agreement were not disclosed. If the option is exercised, Replay and its cell therapy product company Syena will be responsible for global development and hold exclusive worldwide commercialization rights on all TCR-NK therapies resulting from the partnership.

JURA Bio will be eligible to receive development, regulatory, and commercial milestone payments in addition to tiered deferred option payments on global net sales for products based on TCRs arising from the collaboration, as well as royalties on products utilizing at least one of the licensed technologies. 

Replay launched Syena, an oncology-focused product company, with The University of Texas MD Anderson Cancer Center in February 2023. The engineered TCR-NK technology in Syena is based on the scientific discoveries of Katy Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation & Cellular Therapy at MD Anderson.

“In areas where conventional methods are insufficient, machine learning emerges as the catalyst that unlocks the full potential of cell-based therapy and personalized medicine,” __said Julie Norville, Founder and Chief Technical Officer, JURA Bio__. “We founded the company in 2017 as a synthetic biology and probabilistic machine learning entity. Our team has built all the tools necessary to define machine-learning driven candidates at an incredible scale, and has been able to test and develop these with incredible speed. We look forward to working with Replay and its cell therapy product company Syena to develop new treatments to address cancers with high unmet medical need.”

Most existing generative machine learning workflows face a fundamental bottleneck in their ability to synthesize and test their candidates of choice. JURA has built an ML-first workflow that incorporates the relevant underlying chemistry, physics, and biology, as well as developing a statistical framework for evaluating model quality that allows them to build and train flexible and reliable models from huge amounts of data. JURA Bio can propose, build, and physically assay candidates at a scale previously unimaginable.

JURA Bio’s ML-improved gene synthesis technology has generated an off-the-shelf library of 100 billion potential human and improved TCR candidates that are ready for antigen-specific TCR discovery and development. The company has already discovered high-value TCRs for prostate cancer and other key neoantigen targets that have never been before recorded in key HLA-types. 

In another example, JURA Bio has generated a polyclonal candidate pool for six melanoma patients that were refractory to MART-1 specific adoptive cell therapy. These six patients failed to respond to adoptive transfer of autologous cells from healthy donors. Using an off-the-shelf HLA-matched variational synthesis library of TCR candidates, JURA Bio identified 10 candidates for expansion and engineering to create a truly personalized therapeutic polyclonal candidate pool for each individual. The company has also manufactured peptidome and virodome-scale libraries of antigens to help determine the underlying mechanisms of autoimmunity.

“It is remarkable how little we know about the cell identities underlying and driving autoimmune disease. We are not able to reliably say how many are restricted to specific individuals or shared by common mechanisms population wide. In having the ability to screen at the scale of human peptidomes, we will not only learn a lot about potential therapeutics, but also better understand the underlying heterogeneity of autoimmune disease,” __said Everett Meyer, Associate Professor of Medicine, Blood and Marrow Transplantation and Cellular Therapy, Director Stanford Cellular Immune Tolerance Program__. 

"AI-ML and multiplex libraries are useful tools individually, but when combined together they can generate remarkable synergy, known as ML-ML variational synthesis. This has the potential to generate billions to trillions-fold of potential candidates. The mastery of this strategy for TCR, MHC, and T-cell engineering at JURA is without competition and in huge demand," __said George Church, Ph.D., Founder & Scientific Advisory Board Chair, JURA Bio__.  

Additional members of JURA Bio’s scientific advisory board include Debora Marks, PhD (Harvard), David Hafler, MD (Yale), Jay Fishman, MD (Harvard/MGH), Melina Fan, PhD (Addgene), Kevan Herold (Yale), Lester Mackey (Microsoft Research/Stanford), and Everett Meyer, MD/PhD (Stanford).  

__Ends__

__About Replay__

Replay is a genome writing company, which aims to define the future of genomic medicine by designing, writing, and delivering big DNA. The Company has assembled a toolkit of disruptive platform technologies — including a high payload capacity HSV platform, a hypoimmunogenic cell therapy platform, and a genome writing platform — to address the challenges currently limiting clinical progress and preventing genomic medicine from realizing its potential. 

The Company’s hub-and-spoke business model separates technology development within Replay from therapeutic development in a portfolio of product companies that leverage its technology platforms. For example, the Company recently incorporated a first-in-class engineered TCR-NK cell therapy product company using technology developed by Katy Rezvani, M.D., Ph.D., at The University of Texas MD Anderson Cancer Center in Houston, Texas. Replay’s synHSV™ technology, a high payload capacity HSV vector capable of delivering up to 30 times the payload of AAV, is utilized by Replay’s four gene therapy product companies, bringing big DNA treatments to diseases affecting the skin, eye, brain, and muscle. Replay is led by a distinguished team of academics, entrepreneurs, and industry experts. 

The Company raised $55 million in seed financing in July 2022 and is supported by an international syndicate of investors including: KKR, OMX Ventures, ARTIS Ventures, and Lansdowne Partners. 

Replay is headquartered in San Diego, California. For further information please visit [www.replay.bio](https://replay.bio/) and follow us on [LinkedIn](https://www.linkedin.com/company/replay-bio/) and [X/Twitter](https://twitter.com/replaybio).  

__About JURA Bio__

Founded in 2017, Jura Bio has developed an end-to-end platform of computational and synthetic biology framework for the discovery and development of genetic medicines. Therapeutic success depends on the TCR-epitope-HLA synapse, and Jura is developing a map from any antigen+ HLA to any TCR candidate. A map would enable the development of TCRs that are effective and able to target the correct antigen, that is potentially safer with no off-target effects and tunable affinity. JURA Bio is based in Boston, MA. For more information, visit [www.jurabio.com](http://www.jurabio.com/). 

__Contacts:__

__Replay__

Dr Adrian Woolfson/Lachlan MacKinnon
info@replay.bio

__ICR Consilium – Media relations__

Amber Fennell/David Daley/Isabelle Abdou
replay@consilium-comms.com 


Replay Bio Construct Illustration

Replay announces partnership between product company Syena and JURA Bio to advance T cell receptor NK therapies in cancer  


- Phase 1 study of NY-ESO-1 TCR/IL-15 NK for relapsed or refractory multiple myeloma, first TCR-NK clinical study in hematological malignancies, anticipated to commence Q3 2023
- Follows earlier IND clearance for solid tumor study in synovial sarcoma and myxoid/ round cell liposarcoma received in June 2023

__San Diego, California, London, UK, and Houston, Texas, July 24, 2023__ – Replay, a genome writing company reprogramming biology by writing and delivering big DNA, and The University of Texas MD Anderson Cancer Center (“MD Anderson”), today announced that the U.S. Food & Drug Administration (FDA) has issued a ‘safe to proceed’ for the Investigational New Drug (IND) application for NY-ESO-1 TCR/IL-15 NK, a first-in-class engineered T-Cell Receptor Natural Killer (TCR-NK) cell therapy for relapsed or refractory multiple myeloma. MD Anderson is the IND sponsor. 

NY-ESO-1 TCR/IL-15 NK is being developed by Syena, an oncology-focused product company launched by Replay and MD Anderson based upon the scientific discoveries of Katy Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation & Cellular Therapy at MD Anderson. Syena has an exclusive licensing agreement for MD Anderson’s TCR-NK platform. 

A study in patients with synovial sarcoma and myxoid/round cell liposarcoma received IND clearance from the FDA in June 2023.  

"This IND clearance of Syena’s engineered TCR-NK cell technology in hematological malignancies swiftly follows the FDA’s clearance of our solid tumor study in sarcoma, signalling the rapid advancement of our TCR-NK program into the clinic and the breadth of our engineered TCR-NK cell therapy’s potential," said __Adrian Woolfson, Executive Chairman, President, and Co-Founder of Replay__. 

__Lachlan MacKinnon, CEO and Co-Founder of Replay__, commented: “With clinical studies in two indications, spanning solid tumors and hematological malignancies, we are excited for the potential of Syena's first-in-class 'off-the-shelf' engineered TCR-NK platform to address multiple unmet clinical needs.”

“NY-ESO-1 is highly expressed in certain patients with multiple myeloma and associated with a poor prognosis, so this clinical study will be key to further understanding the potential of our TCR-NK platform in hematological malignancies,” said __Dr Katy Rezvani__. “I look forward to the study beginning later this year.”

__Ends__

__Disclosure__

MD Anderson has an institutional conflict of interest with Replay and Syena, and MD Anderson will implement an Institutional Conflict of Interest Management and Monitoring Plan to manage these relationships.

__About Replay__

Replay is a genome writing company, which aims to define the future of genomic medicine through reprogramming biology by writing and delivering big DNA. The Company has assembled a toolkit of disruptive platform technologies — including a high payload capacity HSV platform, a hypoimmunogenic cell therapy platform, and a genome writing platform — to address the challenges currently limiting clinical progress and preventing genomic medicine from realizing its potential. 

The Company’s hub-and-spoke business model separates technology development within Replay from therapeutic development in a portfolio of product companies that leverage its technology platforms. For example, the Company recently incorporated a first-in-class engineered TCR-NK cell therapy product company using technology developed by Katy Rezvani, MD, PhD, at The University of Texas MD Anderson Cancer Center in Houston, Texas. Replay’s synHSV™ technology, a high payload capacity HSV vector capable of delivering up to 30 times the payload of AAV, is utilized by Replay’s four gene therapy product companies, bringing big DNA treatments to diseases affecting the skin, eye, brain, and muscle. Replay is led by a distinguished team of academics, entrepreneurs, and industry experts. 

The Company raised $55 million in seed financing in July 2022 and is supported by an international syndicate of investors including: KKR, OMX Ventures, ARTIS Ventures, and Lansdowne Partners. 

Replay is headquartered in San Diego, California. For further information please visit www.replay.bio and follow us on LinkedIn and Twitter.  

__About MD Anderson__

The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 53 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is No. 1 for cancer in U.S. News & World Report’s “Best Hospitals” rankings and has been named one of the nation’s top two hospitals for cancer since the rankings began in 1990. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

__About NY-ESO-1 TCR/IL-15 NK__

NY-ESO-1 TCR/IL-15 NKs are adoptive Natural Killer (NK) cells expressing an affinity-enhanced T-cell receptor (TCR) reactive directed against the NY-ESO-1-specific cord blood-derived NK cells. The cells are engineered to express the CD3 and TCR signalling complex and IL-15, and use the same manufacturing method as that used for the engineered CAR-NKs, which have demonstrated safety and efficacy in lymphoma (Liu et al, NEJM 2020). 
NY-ESO-1 (New York Esophageal Squamous cell carcinoma 1) is an established cancer-testis antigen with re-expression in multiple cancer types, and restricted expression in healthy tissues. This expression pattern and its ability to elicit humoral and cellular immune responses makes it a compelling target for TCR-T cell therapy. TCR-engineered NK cells retain their intrinsic capacity to target tumor cells through their native receptors. The fact that NK cells kill tumor cells that down-regulate or lack MHC through the ‘missing self’ mechanism, may make disease escape through the most common primary mechanism of acquired resistance, less likely. IND-enabling studies have confirmed that NY-ESO-1 TCR/IL-15 NK cells do not kill healthy human cell lines derived from organs including the heart, lungs, liver, and kidneys. 

__About multiple myeloma__

Multiple myeloma is a common hematological malignancy, with an estimated 34,920 new cases diagnosed in the United States in 2021, accounting for 1.8% of all new cases of cancer in the country.  There has been a steady increase in the available treatment options for these patients, including proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and monoclonal antibodies. More recently, two separate autologous chimeric antigen receptor T (CAR-T) cells, and bispecific targeting BCMA have also been approved for the treatment of multiple myeloma.  They have shown impressive response rates and duration of response but are associated with serious toxicity, including cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, pancytopenia, prolonged hypogammaglobulinemia, immunodeficiency and delayed-onset progressive movement disorders.  There are no approved therapies for patients who have failed the BCMA targeting therapies and the outcome of relapsed/refractory multiple myeloma, especially the triple-class refractory multiple myeloma patients, who are refractory to a PI, an IMiD, and an anti-CD38 monoclonal antibody has been poor.

__Contacts:__

__Replay__

Dr Adrian Woolfson/Lachlan MacKinnon

info@replay.bio

__Consilium Strategic Communications – Media relations__

Amber Fennell/David Daley /Isabelle Abdou

replay@consilium-comms.com 


Replay and MD Anderson announce FDA clearance of IND application for first-in-class T-Cell Receptor Natural Killer (TCR-NK) cell therapy for multiple myeloma

While significant progress has been made in the field of cell therapy to treat hematological malignancies, substantial hurdles remain with regard to the provision of widespread and affordable access to these treatments and achieving efficacy in patients with solid tumors.

There are currently 6 FDA-approved chimeric antigen receptor (CAR)-T therapies. These have demonstrated striking efficacy in sensitive individuals across several hematological malignancies. But 90% of cancers are solid tumors, and these continue to remain a significant challenge for cell therapy. 

One reason for this is that CAR-T therapies can only target antigens expressed at the tumor cell surface, representing just 10% of the proteome. T-cell receptors (TCRs), on the other hand, are able to access antigens derived from the entire tumor cell proteome by targeting intracellularly processed and subsequently externalized peptides presented in the context of major histocompatibility antigen class 1 (MHC class 1). There are several examples of T-cell therapies engineered to express tumor antigen-specific TCRs (TCR-Ts) that have shown clinical efficacy in solid tumors. The first of these is expected to achieve regulatory approval in the next year or so.

![](//images.ctfassets.net/g16a9pxiy3in/7yA6gVU6n4M97zQtzNQ0eU/5a5cd9cfc17d39fe130ef51d7da9c29e/CancerCell_4.png)

One disadvantage of currently approved CAR-T therapies and potentially soon-to-be-approved TCR-T therapy is that they are autologous, being manufactured from an individual patient’s cells. This results in a manufacturing delay – during which time the patient’s disease may progress – as well as potential manufacturing failure, high cost of goods, a limited ability to safely and efficiently introduce cellular edits, and product heterogeneity, as each manufacturing run is derived from an individual patient.

Natural killer (NK) cell therapy is an emerging therapeutic modality that has demonstrated efficacy, and a safety profile that may be more favorable than that of T-cell therapies. One advantage of NK cells is that they can be administered allogeneically (from a donor who is not the patient) and without the need for gene editing, as they do not express an endogenous TCR and consequently have no risk of graft-versus-host disease (GvHD) – a significant potential issue for allogeneic T cell therapies. This means that they can be manufactured from healthy donor cells to produce potentially hundreds of clinical doses from a single manufacturing run. This substantially lowers the cost of goods and allows for a more homogeneous product.

Replay has partnered with The University of Texas MD Anderson Cancer Center to incorporate Syena, a pioneering TCR-NK cell therapy product company. Led by Katy Rezvani, MD, PhD, the Company is initiating first-in-human TCR-NK cell clinical studies in sarcoma and myeloma that combine the advantages of TCRs with those of NK cells. These first-in-class engineered TCR-NK cell therapies have significant potential to address patients with high unmet medical needs in a safe, effective, scalable, and cost-effective manner.


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Ask the Experts with Anthony Conway: What are “TCR-NKs”?

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In discussion with Chief Medical Officer, Arun Balakumaran: Exploring the potential of a TCR-NK cell therapy for sarcoma

Replay announces partnership between product company Syena and JURA Bio to advance T cell receptor NK therapies in cancer

Replay and MD Anderson announce FDA clearance of IND application for first-in-class T-Cell Receptor Natural Killer (TCR-NK) cell therapy for multiple myeloma

Ask the Experts with Anthony Conway: What are “TCR-NKs”?