A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors

This is a first in human, single arm, open label, Phase 1a/1b study to determine the safety, feasibility, and efficacy of a single dose of NeoTCR-P1 T cells in participants with solid tumors.

Start Date03 Jul 2019

Sponsor / Collaborator

PACT Pharma, Inc.Startup

100 Clinical Results associated with PACT Pharma, Inc.

0 Patents (Medical) associated with PACT Pharma, Inc.

Literatures (Medical) associated with PACT Pharma, Inc.

10 Nov 2023·Neuro-Oncology

EPCO-19. TUMOR-WIDE NEOANTIGEN-SPECIFIC T-CELLS INFILTRATING MUTANT IDH1 LOW-GRADE GLIOMAS AND PERSISTING IN PERIPHERAL BLOOD ALLOW FOR PERSONALIZED TCR-BASED IMMUNOTHERAPIES

Author: Borrman, Tyler ; Shai, Anny ; Wang, Cliff ; Hong, Chibo ; Phillips, Joanna ; Nguyen, Diana ; Kwok, Darwin ; Bush, Nancy Ann Oberheim ; Hervey-Jumper, Shawn ; Yuen, Benjamin ; Okada, Hideho ; Costello, Joseph ; Hilz, Stephanie ; Peng, Songming ; McDermott, Michael ; Mandl, Stefanie ; Pan, Zheng ; Zhang, Michael ; Stevers, Nicholas ; Martin, Michael

AbstractBACKGROUNDThe low mutational burden and immunologically “cold” microenvironment of mutant IDH1 low-grade gliomas (LGG) are considerable challenges in immunotherapy for these tumor types. However, we hypothesize that LGG-targeting T-cells may exist at low frequency and with limited regional infiltration within the tumor. Through multi-region tumor sampling coupled with high-throughput T-cell receptor (TCR) profiling, we identified tumor-wide neoantigens and corresponding neoantigen-specific T-cells regionally infiltrating the tumor and persisting in peripheral blood.METHODSMaximally-distanced anatomical sampling of at least 10 distinct tumor regions was performed at the initial resection for three WHO Grade II diffuse astrocytoma patients for exome-based prediction of clonally and subclonally expressed neoantigens, RNAseq analysis of regional immune cell composition, and TCR beta deep sequencing. We used these predictions to generate a barcoded library of patient-specific peptide-HLA multimers loaded with predicted neoepitopes. With this library, neoantigen-specific CD8+ T-cells were captured and isolated from patients’ peripheral blood. Single-cell TCR sequencing allowed us to identify the neoantigen-reactive TCR clonotypes which were transduced subsequently into Jurkat76 cell lines for functional validation.RESULTSWe screened patient-derived peripheral blood drawn two years after initial resection in 3 mutant IDH1 LGG patients and detected a total of 20 TCR clonotypes recognizing neoepitopes derived from truncal, tumor-wide mutations in CNTNAP1 (n=8), TP53 (n=3), and MRPL46 (n=2) as well as subclonal mutations in PRMT5 (n=1) and ZDHHC5 (n=6). Jurkat76 cells transduced with the mutant-PRMT5-specific TCR demonstrated dose-dependent neoantigen-specific immune responses when co-cultured with mutant-PRMT5 pulsed-antigen presenting cells expressing HLA-A*0201.CONCLUSIONOur study demonstrates the existence and persistence of neoantigen-targeting T-cells within the blood and tumor of mutant IDH1 LGG patients. We identified a TCR clonotype that successfully recognizes and induces an immune response against mutant-PRMT5. These findings suggest a feasible methodology to develop personalized T-cell-based immunotherapies for patients with mutant IDH1 LGGs.

04 Apr 2023·Cancer Research

Abstract 901: Monitoring of neoantigens and adoptively transferred personalized neoTCR T cell populations in the tumor and PBMCs of patients with solid tumors

Author: Hoover, Jonathan ; Hunter, Theresa ; Stawiski, Eric ; Pan, Zheng ; Lu, Yue ; Nayak, Saparya ; Heath, James ; Borrman, Tyler ; Smith, Chad ; Foy, Susan ; Ng, Alphonsus H. C. ; Said, Sara ; Wang, Cliff ; Yuen, Benjamin ; Quach, Boi ; Mandl, Stefanie

AbstractBackground: NeoTCR-P1 is a personalized autologous T cell therapy for treatment of patients with solid tumors. Neoantigen-specific T cell receptors (neoTCRs) were isolated from the patients’ circulating CD8 T cells followed by non-viral precision genome engineering into autologous apheresis-derived T cells for infusion back into the patient. We present comprehensive immune monitoring data for 2 patients treated in a first-in-human Phase 1 clinical trial (NCT03970382). Each patient was infused with their own personalized cell therapy product consisting of 3 unique neoTCRs targeting neoantigens identified as truncal in screening biopsies.Methods: We identified infused neoTCR specific T cells in the blood by using patient-specific peptide HLA reagents with single cell RNA seq and in the tumor using RNA scope probes or bulk transcriptome analysis.Results: Patient 0503, a patient with MSS colorectal cancer, was treated with 3 unique neoTCRs (1.3x109 neoTCR+ cells) which targeted 2 distinct neoantigens presented by HLA-B*39:01 or HLA-C*12:02. Analysis of longitudinal biopsies confirmed that targeted mutations were truncal, with both neoantigens present pre- and post-dosing. NeoTCR+ T cells were identified in the tumor by RNA seq and imaging, with neoTCR+ T cells also expressing Granzyme B. Furthermore, single cell RNA seq of neoTCR+ T cells from the pre-infusion product as compared neoTCR T cells isolated from the patients’ blood 2 months post-infusion demonstrated evidence of antigen engagement in 1 out of 3 neoTCR T cell products, with a shift from a predominantly Tcm/Tem-like phenotype pre-infusion to a Teff-like state post-infusion. This neoTCR T cell product also increased slightly in the blood from 1.1 to 3.4% between month 1 and 2, while the other 2 T cell products remained predominantly in the Tcm-like phenotype and remained stable in the blood between month 1 and 2. Patient 0612, a patient with melanoma, was treated with 3 unique neoTCRs (4.0x109 neoTCR+ cells) which targeted 3 distinct neoantigens presented by HLA-B*08:01 or HLA-C*07:02. Longitudinal biopsies support the assessment that 2/3 mutations were truncal and 1 targeted mutation was sub-clonal based on their presence in each biopsy. Retrospective analysis showed HLA loss of heterozygosity at HLA-C07:02 in all 3 biopsies, affecting 2/3 infused TCR products. The remaining TCR showed evidence of a shift from a predominantly Tcm-like phenotype pre-infusion to more differentiated Teff/Tcm-em phenotypes post-infusion compared to the 2 TCRs targeting mutations expressed by the lost HLA allele.Conclusion: These case studies illustrate for the first time tracking of 3 unique personalized T cell products within a single patient. Shifts in the T cell phenotype of the neoTCR T cell products post-infusion for some, but not all, of the products suggest early signs of T cell engagement with the target.Citation Format: Susan Foy, Cliff Wang, Benjamin Yuen, Sara Said, Boi Quach, Jonathan Hoover, Saparya Nayak, Theresa Hunter, Zheng Pan, Chad Smith, Tyler Borrman, Eric Stawiski, Alphonsus H. C. Ng, Yue Lu, James Heath, Stefanie Mandl. Monitoring of neoantigens and adoptively transferred personalized neoTCR T cell populations in the tumor and PBMCs of patients with solid tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 901.

04 Apr 2023·Cancer Research

Abstract 895: Tumor-wide neoantigen-specific T-cells infiltrating mutant IDH1 low-grade gliomas and persisting in peripheral blood allow for personalized TCR-based immunotherapies

Author: Phillips, Joanna ; Hong, Chibo ; Mandl, Stefanie ; Wang, Cliff ; Pan, Zheng ; Martin, Michael ; Borrman, Tyler ; Bush, Nancy Ann Oberheim ; Stevers, Nicholas ; Costello, Joseph ; Hilz, Stephanie ; Kwok, Darwin W. ; Zhang, Michael Y. ; Hervey-Jumper, Shawn ; Okada, Hideho ; Nguyen, Diana ; Yuen, Benjamin ; Peng, Songming ; McDermott, Michael ; Shai, Anny

AbstractBACKGROUND: The low mutational burden and immunologically “cold” microenvironment of mutant IDH1 low-grade gliomas (LGG) are considerable challenges facing immunotherapy against these tumor types. However, we hypothesize that LGG-targeting T-cells may exist at low frequency and with limited regional infiltration within the tumor. Multi-region tumor sampling coupled with high-throughput T-cell receptor (TCR) profiling across the LGG landscape detected neoantigen-specific T-cells that persisted in peripheral blood. TCR-engineered T-cells transduced with these TCRs demonstrated neoantigen-specific immunogenicity.METHODS: Maximal-anatomical sampling of at least 10 distinct tumor regions were collected at the initial resection for three WHO Grade II diffuse astrocytoma patients for exome-based prediction of clonally and subclonally expressed neoantigens, RNAseq analysis of regional immune cell composition, and TCR beta deep sequencing. We used these predictions to generate a barcoded library of patient-specific peptide-HLA multimers loaded with predicted neoepitopes. With this library, neoantigen-specific CD8+ T-cells were captured and isolated from patient peripheral blood. Single cell TCR sequencing allowed us to identify the neoantigen-reactive TCR clonotypes which were transduced subsequently into Jurkat76 cell lines for functional validation.RESULTS: We screened patient-derived peripheral blood drawn two years after initial resection in 3 mutant IDH1 LGG patients and detected a total of 20 TCR clonotypes recognizing neoepitopes derived from truncal, tumor-wide mutations in CNTNAP1 (n=8), TP53 (n=3), and MRPL46 (n=2) as well as subclonal mutations in PRMT5 (n=1) and ZDHHC5 (n=6). Multi-sampling RNAseq analysis indicated varying degrees of interpatient and intratumoral immune infiltration as well as distally located populations of neoantigen-reactive T-cells within the tumor, suggesting widespread migration of neoantigen-specific T-cells across the glioma landscape. We proceeded with TCR functional analysis for one patient (P375) with 5 detected TCR clonotypes recognizing neoantigens derived from mutations in PRMT5, MRPL46, and TP53. Jurkat76 cells transduced with the mutant-PRMT5-specific TCR demonstrated a neoantigen-specific immune response when co-cultured with mutant-PRMT5 pulsed-antigen presenting cells expressing HLA-A*0201 (T2 cells).CONCLUSION: Our study demonstrates the existence and persistence of neoantigen-targeting T-cells within the blood and tumor of mutant IDH1 LGG patients. We identified a TCR clonotype that successfully recognizes and induces an immune response against mutant-PRMT5. These findings suggest a feasible methodology to develop personalized T-cell-based immunotherapies for patients with mutant IDH1 LGGs.Citation Format: Darwin W. Kwok, Michael Y. Zhang, Cliff Wang, Nicholas Stevers, Tyler Borrman, Zheng Pan, Benjamin Yuen, Songming Peng, Diana Nguyen, Michael Martin, Chibo Hong, Stephanie Hilz, Joanna Phillips, Anny Shai, Nancy Ann Oberheim Bush, Shawn Hervey-Jumper, Michael McDermott, Stefanie Mandl, Hideho Okada, Joseph Costello. Tumor-wide neoantigen-specific T-cells infiltrating mutant IDH1 low-grade gliomas and persisting in peripheral blood allow for personalized TCR-based immunotherapies [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 895.

News (Medical) associated with PACT Pharma, Inc.

21 Feb 2024

·www.biospace.com

Synthekine Appoints Geoff Nosrati, Ph.D., as Chief Business Officer and Announces Executive Leadership Changes

Martin Oft, M.D., assumes role of Chief Scientific Officer Greg Yedinak promoted to Chief Technical Officer MENLO PARK, Calif.--(BUSINESS WIRE)-- Synthekine Inc., an engineered cytokine therapeutics company, today announced the appointment of Geoff Nosrati, Ph.D., as chief business officer. The company also announced additional changes in the executive leadership team, with Martin Oft, M.D., assuming the role of chief scientific officer and Greg Yedinak promoted to chief technical officer. “Geoff is an accomplished biotechnology executive with extensive knowledge in corporate strategy and business development,” said Debanjan Ray, chief executive officer of Synthekine. “His experience in portfolio strategy and transactions will be an asset to Synthekine as we continue to advance our wholly owned pipeline and progress our partnering activities.” Ray continued, “We’re also delighted to recognize Martin and Greg’s contributions to Synthekine with their new roles. Martin’s deep insights into cytokine biology and immunology were instrumental to shaping the development of STK-012, our first-in-class alpha/beta biased IL-2. Its unique mechanism expands the therapeutic index of IL-2, one of the most important immuno-oncology targets, providing improved efficacy while avoiding IL-2 related vascular toxicities. Greg’s broad expertise in the development and manufacturing of biologics and cell therapies has allowed us to advance both STK-012 and STK-009 + SYNCAR-001, our novel combination therapy of orthogonal IL-2 and CD19 CAR-T with potential to overcome limitations of current CD19 directed cell therapies in both hematological malignancies and autoimmune disease, into clinical development. Their contributions over the years have been invaluable to Synthekine’s rapid progress.” Dr. Nosrati is an expert in corporate strategy and business development with more than 20 years of experience in the biotechnology industry. He has worked across multiple modalities and therapeutic areas, with an emphasis on oncology, autoimmune and rare disease. Prior to joining Synthekine, Dr. Nosrati was chief business officer at Nutcracker Therapeutics. In his previous experience, he also served as chief business officer of ImmunoScape and held multiple senior executive roles at Aduro Biotech. In these positions, he worked closely with research, development, and commercial teams to strategically position the companies in the market and establish them as preferred partners for leading pharmaceutical and biotechnology organizations. Early in his career, Dr. Nosrati advised pharmaceutical and biotechnology clients at McKinsey & Co., with a focus on corporate strategy, finance, due diligence, and mergers and acquisitions. Dr. Nosrati holds a Ph.D. in Biochemistry and Molecular Biology from the University of California, Los Angeles and graduated with a B.S. in Chemistry from Duke University. Dr. Oft joined Synthekine at its formation in 2019 and previously served as the chief development officer. He is an expert in immune therapies, with in-depth experience in preclinical, translational, and clinical research and development of cytokine therapeutics for cancer and inflammatory disease. Prior to Synthekine, Dr. Oft co-founded ARMO Biosciences, where he oversaw pipeline development including pegilodecakin (pegylated IL-10) from early-target discovery through phase 3 clinical studies. He identified integrated immune-modulating strategies for the treatment of cancer, including the invigoration of tumor-specific T-cell immunity concomitant with inhibition of tumor-promoting inflammation. Prior to ARMO, Dr. Oft developed immune therapies for the treatment of cancer at DNAX Research in Palo Alto, now Merck Research Labs, and held positions at Onyx Pharmaceuticals, the UCSF Cancer Center and Boehringer Ingelheim. Dr. Oft earned his M.D. and medical license from the University of Erlangen, Germany. He performed his postdoctoral research at the Institute of Molecular Pathology in Vienna, Austria. Mr. Yedinak previously served as senior vice president of technical operations after joining the company in 2020. He has more than 30 years of experience in pharmaceutical, biologics, and medical device process development, manufacturing and operations. Prior to joining Synthekine, Greg was senior vice president of manufacturing and supply chain operations at PACT Pharma, where he was responsible for building the internal and CMO manufacturing operations for the PACT Pharma cell therapy programs. Prior to PACT Pharma, he held various executive and leadership positions at Versatis, Zosano, Nuvelo, Abgenix/Amgen and Genentech, where he was integral to the strategic production planning, process development, and production of numerous clinical and commercial products and devices. Greg earned a B.S. in biological sciences from the University of California-Irvine. About Synthekine Synthekine is harnessing the potential of cytokine therapeutics to develop selective immunotherapies designed to improve the treatment paradigm of cancer and inflammatory disease. Using insights on cytokine structure and function, the company engineers therapeutics designed to unlock the full efficacy potential of cytokines while avoiding their associated toxicities. Synthekine is applying principles of cytokine partial agonism and immunological specificity across multiple protein engineering platforms to create a broad and deep pipeline of product candidates. These novel immunotherapies include modified cytokines, cytokine-enhanced cell therapies and surrogate cytokine agonists. For more information, visit , and follow us on Twitter @synthekine and LinkedIn. View source version on businesswire.com: Contacts Will Zasadny Inizio Evoke Comms 619-961-8848 will.zasadny@inizioevoke.com Source: Synthekine Inc. View this news release online at:

Executive ChangeImmunotherapyCell TherapyPhase 3

17 Oct 2023

·www.globenewswire.com

Olema Oncology Appoints Oncology Biotech Executive Scott Garland to Board of Directors

Mr. Garland brings significant industry expertise with a long track record of successful launchesSAN FRANCISCO, Oct. 17, 2023 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today announced the appointment of Scott Garland to the company’s Board of Directors. Mr. Garland brings more than 30 years of biopharmaceutical industry experience with deep commercial and executive leadership expertise. “We are delighted to have Scott join our Board of Directors at such an exciting time for Olema,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “His broad experience on the frontlines of the biopharmaceutical industry, leading the commercialization of groundbreaking therapies, will be crucial as we enter the late-stage development of palazestrant.” Mr. Garland most recently served as CEO of PACT Pharma, an immuno-oncology company that was focused on developing cell therapies for solid tumors. Prior to PACT, Mr. Garland was president and chief executive officer of Portola Pharmaceuticals where he led the company through the commercial launch of Andexxa® and a successful acquisition by Alexion. Before joining Portola, he served first as chief commercial officer of Relypsa and then as president of the U.S. organization after the company was acquired by Vifor Pharma. Mr. Garland has held numerous other commercial leadership roles at Exelixis (leading the launch of cabozantinib), Genentech, Amgen, and Merck, including leading the commercial franchises for two multi-billion-dollar therapies – Avastin® and Rituxan®. Mr. Garland currently serves as a board member for ALX Oncology and Day One Biopharmaceuticals. He received a B.S. from California Polytechnic State University-San Luis Obispo and an MBA from the Fuqua School of Business at Duke University. “Olema is well along the path of advancing their mission to transform the standard of care for women living with breast cancer, and I am excited to contribute as palazestrant moves into Phase 3 and new pipeline assets are announced,” said Mr. Garland. “As Olema continues to advance its pipeline, I believe that Olema’s science, the management team’s track record of success, and its strong financial foundation positions the company well to define the next generation of targeted therapies for women’s cancers.” “On behalf of Olema’s Board of Directors, I would like to welcome Scott to the Board, and we look forward to benefiting from his unique perspective and counsel as we navigate this pivotal moment in Olema’s history,” Ian Clark, Chairman of Olema’s Board of Directors. About Olema OncologyOlema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers. Olema’s lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). It is currently being evaluated both as a single agent in an ongoing Phase 2 clinical trial, and in combination with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib), in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Palazestrant has been granted FDA Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com, or follow us on Twitter and LinkedIn. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “expect,” “will,” “may,” “goal,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the potential beneficial characteristics of palazestrant (OP-1250), including the potential to become best-in-class or transform the standard of care for women living with ER+/HER2- metastatic breast cancers, the capabilities of Olema’s executive management team and board of directors, the clinical timeline and status for palazestrant, and Olema’s preclinical and clinical pipeline. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. Contact:Geoffrey Mogilner, Vice President, Investor Relations and Communicationsir@olema.com

Executive ChangePhase 2Fast TrackAcquisition

12 Sep 2023

·www.globenewswire.com

4DMT Appoints Uneek Mehra as Chief Financial and Business Officer

EMERYVILLE, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced the appointment of Uneek Mehra as Chief Financial & Business Officer of 4DMT. Mr. Mehra will succeed August J. Moretti, J.D., who is retiring, and has agreed to serve in an advisory capacity to support Mr. Mehra’s transition. Mr. Mehra will lead 4DMT’s finance, business development, and precommercial functions and will be a member of 4DMT’s Executive Team, reporting to David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. Mr. Mehra brings over 27 years of extensive leadership experience including financial, commercial, corporate strategy, and business development expertise supporting multi-billion dollar commercial-stage businesses, in addition to deep experience successfully growing and scaling emerging companies. He previously served as a senior executive at Novartis for 13 years and as CFO & CBO of publicly traded companies, including most recently Myovant Sciences Ltd., which was recently acquired (all remaining shares not already owned) by Sumitovant Biopharma for $1.7 billion. “We are thrilled to welcome Uneek to 4DMT at an important inflection point in our company progress towards pivotal trials across multiple programs,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “Uneek brings valuable skillsets to 4DMT with his extensive experience and track record in biopharmaceutical finance, strategy, and transactions. His appointment reflects our commitment to unlocking the full potential of our Therapeutic Vector Evolution platform, and he will play a major role in our goal to become a fully integrated large market genetic medicines company. We thank August Moretti for his many outstanding contributions to the company over the past five years. He has helped lead the Company through multiple private and public capital raises, including our IPO in 2020, raising a total of $600 million of capital, and has been a valued member of our Executive Team.” Mr. Mehra joins 4DMT from Myovant Sciences Ltd., a public biopharma company, where, as Chief Financial and Business Officer, he successfully built partnerships, and enabled significant commercial growth for its products in Oncology and Women’s Health. Prior to joining Myovant, Mr. Mehra was Chief Financial Officer and Corporate Treasurer at PACT Pharma, a personalized cell therapy company targeting solid cancers, where he successfully built partnerships and raised capital to scale the emerging company. Previously, Mr. Mehra was Chief Financial Officer at Proteus Digital Health, a digital medicines company, with responsibility for Finance, Tax, Treasury, IT, Facilities, and Human Resources. Mr. Mehra also spent more than 13 years at Novartis where he drove strategic investments and commercial financial performance for multi-billion-dollar businesses. He successfully led strategic portfolio prioritization and resource allocation across several business units and steered successful transactions across oncology and specialty pharma assets. As Chief Financial Officer of the US Integrated Care and Critical Care Business Units, Mr. Mehra supported commercial excellence across multiple products; notably, driving the launch and execution of Cosentyx® and Entresto®. Earlier in his career, Mr. Mehra held senior finance roles with International Business Machines (IBM) Corporation and Citibank. Mr. Mehra obtained his MBA in Strategy and Leadership from the International Institute for Management Development, Lausanne, Switzerland; MS in Finance from the University of Mumbai, India; and Bachelor of Engineering in Electronics from the Birla Institute of Technology and Science, Pilani, India. “I’m honored to join 4DMT at this pivotal stage of growth for the Company. I look forward to enabling the rapid acceleration of next generation genetic medicines which are differentiated and address multiple large-market opportunities,” said Mr. Mehra. “4DMT's pioneering technology platform with enhanced specificity, its culture of innovation and its experienced leadership team provide a unique opportunity to deliver potentially curative therapies to patients.” About 4DMT 4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases. 4DMT seeks to unlock the full potential of genetic medicines using its proprietary invention platform, Therapeutic Vector Evolution, which combines the power of the Nobel Prize-winning technology, directed evolution, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors for use in our product candidates. All of our vectors are proprietary to 4DMT and were invented at 4DMT, including the vectors utilized in our clinical-stage and preclinical pipeline product candidates: R100, A101, and C102. The Company is initially focused on five clinical-stage product candidates in three therapeutic areas for both rare and large market diseases: ophthalmology, pulmonology, and cardiology. The 4DMT customized and evolved vectors were invented with the goal of being delivered at relatively low doses through clinically routine, well-tolerated, and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. 4DMT is currently advancing five product candidates in clinical development: 4D-150 for wet AMD and DME, 4D-710 for cystic fibrosis lung disease, 4D-310 for Fabry disease cardiomyopathy, 4D-125 for XLRP, and 4D-110 for choroideremia. The 4D preclinical product candidates in development are: 4D-175 for geographic atrophy and 4D-725 for AATLD. 4D-150, 4D-710, 4D-310, 4D-125, and 4D-110 are our product candidates in clinical development and have not yet been approved for marketing by the US FDA or any other regulatory authority. No representation is made as to the safety or effectiveness of 4D-150, 4D-710, 4D-310, 4D-125, or 4D-110 for the therapeutic uses for which they are being studied. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT. Contacts: Media: Katherine SmithEvoke CanaleKatherine.Smith@evokegroup.com Investors: Julian PeiHead of Investor Relations and Corporate CommunicationsInvestor.Relations@4DMT.com267-644-5097

Executive ChangeIPOAcquisition

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NeoTCR P1 ( HLA )	Colorectal Cancer More	Phase 1
NeoTCR-P200	Solid tumor More	Preclinical
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