
- 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.


synHLA 1/2

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


- First-in-human Phase 1 study of NY-ESO-1 TCR/IL-15 NK for advanced synovial sarcoma and myxoid/round cell liposarcoma anticipated to commence Q3 2023
- NY-ESO-1 TCR/IL-15 NK is the lead clinical program of Syena, Replay and MD Anderson’s first-in-class engineered TCR-NK cell therapy company. The Company’s scientific founder is Professor Katy Rezvani, M.D., Ph.D.
- NY-ESO-1 is an extensively validated tumor-associated antigen that has been successfully targeted by TCR therapies in a range of oncology indications

__San Diego, California, London, UK, and Houston, Texas, June 20, 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, an engineered T-Cell Receptor Natural Killer (TCR-NK) cell therapy for advanced synovial sarcoma and myxoid/round cell liposarcoma. 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. This first-in-class engineered cell therapy is comprised of cord blood-derived natural killer cells that express an affinity-enhanced T-cell receptor (TCR) targeted against the NY-ESO-1 cancer-associated antigen, which is highly immunogenic and expressed on numerous cancer cell types. The ability of NY-ESO-1 to elicit humoral and cellular immune responses, along with its restricted tissue expression, establishes it as a compelling target for cancer immunotherapy. 

The Phase 1/1b study will assess the safety and efficacy of NY-ESO-1 TCR/IL-15 NK in patients with synovial sarcoma and myxoid/round cell liposarcoma. It will be administered following lymphodepletion with standard doses of fludarabine/cyclophosphamide (Flu/Cy). Approximately 44 patients will be enrolled into the study, anticipated to commence in Q3 2023.

"Syena is leveraging the scalability and allogeneic nature of engineered cord blood-derived NK cells to democratize cell therapy for cancer treatment. The recent FDA IND clearance of the first-in-human TCR-NK protocol is a significant milestone for Syena," said __Adrian Woolfson, Executive Chairman, President, and Co-Founder of Replay__. “Syena is now one step closer to bringing its first-in-class, ‘off-the-shelf’ engineered TCR-NK therapy to patients with solid tumors.”

__Lachlan MacKinnon, CEO and Co-Founder of Replay__, commented: “Following the FDA IND acceptance, Syena is Replay’s first product company to enter the clinic. The ability to secure rapid FDA IND clearance for our first-in-class TCR-NK program is a testament to the caliber of our team and quality of our science, and continues to validate our business model.”

“Synovial and myxoid/round cell liposarcomas express NY-ESO-1 at high levels and in a high frequency of cells, making them excellent tumor types for establishing proof of concept for the TCR-NK platform,” said __Dr. Katy Rezvani__. “I am delighted with the team's progress and look forward to initiating the Phase 1/1b study 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, 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 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 Synovial Sarcoma__

Synovial Sarcoma is an aggressive and rare human malignancy that accounts for approximately 5-10% of all soft-tissue sarcomas. The peak incidence is in the third decade of life. It typically presents at extremities, but any serosal surface may be involved. The 5-year overall survival is 50-60% in adult patients. Most patients with localized synovial sarcoma can be cured using multimodality treatment, but in the case of patients with advanced disease, the treatment options are more limited, and the prognosis poor. Liposarcomas (LPS) are the commonest subtype of adult soft tissue sarcomas. There are multiple histological subtypes of LPS with different natural histories, treatment, and prognosis. Myxoid/round cell liposarcoma (MRCLS) accounts for ~40% of liposarcomas. MRCLS typically arises at the extremity of young adults but may also present in the retroperitoneum. The prognosis for patients with metastatic MRCLS is poor.

__Contacts:__

__Replay__

Dr Adrian Woolfson/Lachlan MacKinnon

info@replay.bio

__Consilium Strategic Communications – Media relations__

Amber Fennell/David Daley /Melissa Gardiner

replay@consilium-comms.com 

__MD Anderson__

Clayton Boldt, Ph.D.

CRBoldt@MDAnderson.org


31 Katy Rezvani light green

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

- Cristian Massacesi, M.D., Chief Medical Officer of AstraZeneca and Alexion and Oncology Chief Development Officer of AstraZeneca, to support Replay in advancing genomic medicine and cell therapy pipeline
- Dr. Massacesi brings over 20 years of research and medicines development experience to the Replay Board

__San Diego, California and London, UK, May 25, 2023__ – Replay, a genome writing company reprogramming biology by writing and delivering big DNA, today announced the appointment of Cristian Massacesi, M.D., as a member of its Board of Directors, with immediate effect.

Dr. Massacesi is a leading expert in medical oncology, with over 20 years of research and drug development experience in the pharmaceutical industry. Dr. Massacesi is the Chief Medical Officer of AstraZeneca and Alexion, where he oversees patient safety and quality assurance activities for the entire company portfolio – from investigational drugs to established products. He is also the Oncology Chief Development Officer at AstraZeneca, where he leads the global development and operations of its late-stage Oncology portfolio of innovative medicines and immunotherapies, comprising more than 160 studies spanning multiple indications. His role and responsibilities at AstraZeneca continue unchanged.

Prior to AstraZeneca, Dr. Massacesi held several other senior leadership roles. He was Vice President, and Medicine Team Leader Immuno-Oncology at Pfizer, where he led multiple development programs in lung cancer, head and neck cancer, and hematological malignancies, and supported the oncology business development and pipeline strategy.

Dr. Massacesi was also Vice President, and Senior Global Clinical Program Head for the Immunotherapy Centre of Excellence at Novartis, and the Oncology Global Development and Global Medical Affairs Paris Site Head. Prior to that, as Global Clinical Program Head, he led the company’s PI3K-inhibitors portfolio through clinical development, including registrational studies and submissions.

Dr. Massacesi began his Academic career at Marche Polytechnic University in Italy, where he worked in the Department of Medical Oncology and Radiotherapy. He holds postgraduate degrees from the School of Oncology and School of Forensic Medicine at Marche Polytechnic University and received his medical oncology training at the Royal Marsden Hospital in London, UK, the Kaplan Comprehensive Cancer Center, NY, USA, and the European Institute of Oncology, Italy.

Dr. Massacesi has authored over 50 peer-reviewed papers and 100 conference abstracts on a wide range of cancer topics and lectured on subjects that include immunotherapy clinical trials, breast cancer, and the clinical development of PI3K-inhibitors. Dr. Massacesi has authored multiple patents on cancer treatment combinations and regimens.

__Adrian Woolfson, Executive Chairman, President, and Co-founder of Replay__, commented: “Cristian has an exceptional reputation within the life sciences community and his extensive experience and expertise in leading oncology clinical development programs is a significant addition to Replay’s board. His breadth of industry knowledge, especially in the field of immuno-oncology, will be invaluable to Replay’s continued growth, as we build out our first-in-class portfolio of TCR-NK cell therapies and HSV-based gene therapies to address some of the most significant challenges in cell therapy and genomic medicine. On behalf of the Board of Directors, I am delighted to welcome Cristian to the company and look forward to working with him as we continue to build an enduring enterprise with the potential to shape the future of the industry.”

__Lachlan MacKinnon, CEO and Co-Founder of Replay__, added, “Replay’s genomic medicine toolkit encompasses a broad portfolio of disruptive platform technologies to write and deliver big DNA that we are advancing within our distinct hub-and-spoke business model. Our Board brings together unrivalled expertise across a wide range of specialties that support this, and Cristian’s unique knowledge and skill set, especially within the immuno-oncology space, will be invaluable as we continue to drive the strategy forward.”

__Kugan Sathiyanandarajah, Managing Director at KKR and Board Member at Replay__, stated, “We are thrilled to have Cristian joining the Board. His extensive experience in oncology drug development within the pharmaceutical industry will be of immense value as Replay transitions into a clinical-stage company with the potential to significantly impact the healthcare sector.”

Commenting on his appointment, __Cristian Massacesi__ said, “Replay has the potential to transform the future of cell therapy and genomic medicine in general through its unique portfolio of technology platforms and innovative approach to product development. I am excited to be joining as a board member and to be supporting such a strong and dynamic team. It’s a pivotal moment in the company’s development as it progresses its first-in-class, engineered TCR-NK cell therapies and HSV-based gene therapies into the clinic, and I’m pleased to be able to bring my knowledge and experience to help Replay’s mission.”

__Ends__

__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 full 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 Professor Katy Rezvani at the 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.

__Contacts:__

__Replay__

Dr Adrian Woolfson/Lachlan MacKinnon

info@replay.bio

__Consilium Strategic Communications – Media relations__

Amber Fennell/David Daley /Melissa Gardiner

replay@consilium-comms.com


Cristian Massacesi

Cristian Massacesi, M.D., Appointed to Replay Board of Directors

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Writing Genes

- Rapid and cost-effective gene synthesis 
- Synthetic gene library generation 
- Rewrite and optimise gene sequences


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- Write and deliver big genes, genomic genes, and multiple genes 
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Latest news

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”?

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

Cristian Massacesi, M.D., Appointed to Replay Board of Directors