Industry updates from the field of stem cell research and regenerative medicine in September 2023

Business Development

Co-development agreement: JURA Bio & Syena

JURA Bio, a biotechnology company developing immune-based therapeutics using machine learning and synthetic biology (MA, USA; www.jurabio.com), has announced a research collaboration with Syena, a cell therapy product company and subsidiary of Replay (CA, USA; https://replay.bio), a genome writing company, to develop T cell receptor (TCR)-based therapies [1]. 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 (TX, USA; www.mdanderson.org) in February 2023.

Collaboration agreement: Kyverna & Elevate Bio

Kyverna Therapeutics (CA, USA; https://kyvernatx.com), a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases, and ElevateBio (MA, USA; https://elevate.bio), a technology-driven company focused on powering transformative cell and gene therapies, have announced a partnership to advance process development and manufacturing to produce industry-leading Ingenui-T-derived chimeric antigen receptor (CAR) T-cell therapies [2]. Ingenui-T is an optimized autologous manufacturing platform developed by Kyverna to specifically address the needs of patients with autoimmune diseases, enabling a lower cost of goods and an improved patient experience.

ElevateBio and Kyverna will implement Kyverna's Ingenui-T platform into their process development and cell product manufacturing efforts at ElevateBio BaseCamp^®. BaseCamp is ElevateBio's end-to-end genetic medicine current Good Manufacturing Practice (cGMP) manufacturing and process development business with capabilities for research, clinical and commercial cell and gene therapies.

License agreement: Beam Therapeutics & Eli Lilly

Beam Therapeutics (MA, USA; https://beamtx.com), a biotechnology company developing precision genetic medicines through base editing, has announced that Eli Lilly and Company (IN, USA; www.lilly.com) has agreed to acquire certain rights under Beam's amended collaboration and license agreement with Verve Therapeutics (MA, USA; www.vervetx.com), including Beam's opt-in rights to co-develop and co-commercialize Verve's base editing programs for cardiovascular disease, which includes programs targeting PCSK9, ANGPTL3 and an undisclosed liver-mediated, cardiovascular target [3]. Under the terms of the agreement, Beam will receive a US $200 million upfront payment and US $50 million equity investment. Beam is also eligible to receive up to US $350 million in potential future development-stage payments upon the completion of certain clinical, regulatory and alliance events for a total of up to US $600 million in potential total deal consideration.

License & supply agreement: Kyverna & Oxford Biomedica

Kyverna Therapeutics (CA, USA; https://kyvernatx.com), a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases, has announced a non-exclusive, multi-year license and supply agreement with Oxford Biomedica (UK; www.oxb.com), a quality and innovation-led viral vector Contract and Development Manufacturing Organization (CDMO), enabling the use of LentiVector^® with any Kyverna product [4]. The LentiVector platform is the first commercially approved lentiviral-based gene-delivery system.

Partnership agreement: Colossal Bioscience & BioRescue

Colossal Biosciences (TX, USA; https://colossal.com), the world's first de-extinction company, and BioRescue (Germany; http://www.biorescue.org), a consortium initiating and leading the scientific rescue mission of the northern white rhino employing advanced assisted reproduction technologies and stem cell associated techniques, have teamed up to save the northern white rhino from extinction [5]. The partnership will also develop a roadmap for future rescue missions of endangered species using the world leading expertise of both organizations. Together they will work to improve, develop and implement strategies in the fields of wildlife conservation research and wildlife veterinary medicine, providing approaches to reduce the sixth mass extinction.

Achievements, launches…

Abu Dhabi Stem Cell Center

Abu Dhabi Stem Cells Center (ADSCC; Abu Dhabi; https://adscc.ae), a PureHealth (Abu Dhabi; https://purehealth.ae) subsidiary and the largest healthcare platform in the Middle East, has successfully manufactured the UAE's first CAR-T cells and treated an 11-year-old boy with leukemia [6].

BlueWhale

BlueWhale Bio (PA, USA; https://bluewhale.bio/), a new company spun out of the University of Pennsylvania (PA, USA; www.upenn.edu) to overcome key bottlenecks in cell and gene therapy manufacturing, has raised US $18 million in Seed financing [7].

CARsgen

CARsgen Therapeutics Holdings Limited (China; www.carsgen.com), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced the publication of two cases of the treatment of metastatic pancreatic cancer with CARsgen's CT041, an innovative CLDN18.2 CAR T-cell therapy [8,9].

For case 1, a 58-year-old woman was diagnosed with pancreatic cancer with lung and lymph nodes metastasis. First-line nab-paclitaxel plus gemcitabine and second-line irinotecan-liposome plus 5-flurouracil were failed before she was enrolled in CT041 clinical trial, after confirming CLDN18.2 expression as 2+/70%. After lymphodepletion consisting of fludarabine, cyclophosphamide and nab-paclitaxel, a CT041 dose of 250 × 10 cells was administered to the patient in September 2021. Grade 2 cytokine-release syndrome (CRS) occurred, which was later controlled by tocilizumab. Partial response (PR) was achieved according to RECIST v1.1, with great shrinkage of lung metastasis.

For case 2, a 75-year-old woman was diagnosed as pT2N0 pancreatic cancer after she underwent surgery in May 2019. Lung metastasis was found after 5 months during routine post-surgery follow-up. S-1 monotherapy was given as the first-line chemotherapy starting from December 2019. During the surgical area palliative radiation, tumor progression was observed in the lung. Since the CLDN18.2 expression was determined as 3+/60%, the patient was enrolled in CT041 clinical trial. After receiving lymphodepletion consisting of fludarabine, cyclophosphamide and nab-paclitaxel, the patient was infused with a CT041 dose of 250 × 10 cells in July 2021. Patient experienced grade 2 CRS, which was further controlled with tocilizumab. PR was reached since the first evaluation 4 weeks after infusion. Target lesions of lung metastasis subsequently disappeared and achieved complete response. The tumor was still under well control until the last follow-up in July 2023. The peripheral blood CLDN18.2 CAR copy number in both patients exhibited a rapid post-infusion increase, peaking within 2 weeks. Concurrently, fluorescence-activated cell sorting results indicated an increase in peripheral blood CD8 T cells and Treg cells, alongside a reduction in CD4 T cells and B cells. These shifts in immune cell phenotypes demonstrated greater persistence compared with alterations in cytokine levels.

CT041 targets the treatment of CLDN18.2-positive solid tumors with a primary focus on gastric (GC), gastroesophageal junction (GEJ) and pancreatic cancers. CT041 was granted Regenerative Medicine Advanced Therapy (RMAT) Designation by US FDA for the treatment of advanced GC/GEJ with CLDN18.2-positive tumors in January 2022 and was granted PRIME eligibility by the EMA for the treatment of advanced GC in November 2021. CT041 received Orphan Drug designation from the US FDA in 2020 for the treatment of GC/GEJ and Orphan Medicinal Product designation from the EMA in 2021 for the treatment of advanced GC. CT041 is currently tested in several ongoing clinical trials.

Catapult

The Cell and Gene Therapy Catapult (UK; https://ct.catapult.org.uk), with support from Scottish Enterprise, Scotland's national economic development agency, has launched a new cooperative network to foster collaboration and boost the sharing of knowledge and expertise within the advanced therapies industry across the north of the UK [10].

Chan Zuckerberg Initiative

Chan Zuckerberg Initiative (CA, USA; https://chanzuckerberg.com) announced the funding and building of one of the largest computing systems dedicated to nonprofit life science research in the world [11]. This new effort will provide the scientific community with access to predictive models of healthy and diseased cells, which will lead to ground-breaking new discoveries that could help cure, prevent, or manage all diseases by the end of this century. The high-performance computing cluster, which is planned to comprise 1,000+ graphics processing units (GPUs), will enable AI and large language models for biomedicine at scale. These predictive models will be trained on datasets such as those integrated into the Chan Zuckerberg CELL by GENE (https://cellxgene.cziscience.com) software tool, which comprises the largest corpus of standardized single-cell datasets, with more than 50 million cells. Other data sources include resources generated by CZ Science research institutes, such as the protein location and interaction atlas OpenCell (https://opencell.czbiohub.org) and the cell atlas Tabula Sapiens (https://tabula-sapiens-portal.ds.czbiohub.org), built by the Chan Zuckerberg Biohub San Francisco (https://www.czbiohub.org/sf/). Large imaging datasets from the Chan Zuckerberg Institute for Advanced Biological Imaging (CZ Imaging Institute; www.czimaginginstitute.org) will also be included, as well as publicly available datasets.

MaaT & Skyepharma

MaaT Pharma (France; www.maatpharma.com), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, and Skyepharma (France; www.skyepharma.com), an independent CDMO, expert in providing innovative solutions for bioproduction as well as complex drugs development and manufacturing, have announced that a significant development milestone has been reached with the completion of the facility and the transfer of MaaT Pharma's Production and Development teams to the new site [12]. The companies had entered a partnership in February 2022 to build the largest cGMP facility, to date, for full ecosystem microbiome therapies in Europe.

Novo Nordisk Foundation

The Novo Nordisk Foundation (Denmark; https://novonordiskfonden.dk/en/) has committed up to US $136 M (DKK 950 M) to establish a world-class facility for the final development steps and upscaling of cell therapies for testing in humans [13]. The Novo Nordisk Foundation Cellerator will fill a critical gap in the Danish cell therapy ecosystem, helping to translate breakthroughs in cell therapy research into real-world treatments for people with diseases such as chronic heart failure, Parkinson's, kidney disease, Type 1 diabetes and several forms of cancer.

The facility will be located at the Technical University of Denmark (DTU) in Lyngby. It will serve public and private, national, and international clients from academia, biotech and the pharmaceutical industry and is expected to be operational in 2027.

Singleron

Singleron (Germany; https://singleron.bio) has announced the launch of its AccuraCode^® TCR library construction kit for high-throughput T-cell receptor (TCR) profiling [14]. It enables simultaneous analysis of hundreds of samples for T cell clonotypes, gene usage, V(D)J recombination patterns, and diversity, all supported by compatible bioinformatics pipelines.

The product is built upon Singleron's molecular barcoding technology, enabling multiplexing of 96 or 384 samples in a single library construction reaction. This new product significantly reduces the cost and time needed for large-scale TCR profiling.

Clinical trials

Immune cells

Beam Therapeutics

Beam Therapeutics (MA, USA; https://beamtx.com), a biotechnology company developing precision genetic medicines through base editing, has announced that the first patient was treated with BEAM-201, a quadruplex-edited allogeneic CAR-T cell investigational therapy [15,16]. Multiplexed base editing was designed to eliminate expression of the CD7, TRAC, PDCD1 and CD52 genes. This approach has the potential to reduce fratricide, graft-versus-host disease and CAR-T cell exhaustion and to enable BEAM-201 cells to evade anti-CD52 lymphodepleting agents and enable use of an allogeneic cell source. BEAM-201 is being evaluated in a phase I/II clinical study for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma (T-ALL/T-LL), a severe disease affecting children and adults.

ImmPACT Bio

ImmPACT Bio USA (CA, USA; https://immpact-bio.com), a clinical-stage company developing transformative logic-gate-based CAR T-cell therapies for treating cancer and autoimmune diseases announced that the first patient has been dosed in the phase I/II trial evaluating IMPT-314 CAR T-cell therapy for the treatment of relapsed or refractory (R/R) aggressive B-cell lymphoma [17,18]. IMPT-314 has received Fast Track Designation from the US FDA for the treatment of R/R aggressive B-cell lymphoma. IMPT-314 is a CD19/CD20-targeting CAR T-cell therapy that utilizes a potent bispecific CAR and a 4-1BB costimulatory domain. It is the same CAR construct as ImmPACT Bio's IMPT-514, which is under development for systemic lupus erythematosus and lupus nephritis.

Kite

Kite (CA, USA; www.kitepharma.com), a Gilead Company (CA, USA; www.gilead.com), has announced results from the Phase 2 ALYCANTE study, led and sponsored by the French collaborative group LYSA/LYSARC, for use of its CAR T-cell therapy Yescarta^® (axicabtagene ciloleucel) in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) after one prior line of therapy who were deemed ineligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) [19,20].

The ALYCANTE study, a multicenter, open-label phase 2 LYSA study, evaluated for the first time the efficacy and safety of Yescarta as a second-line therapy in 62 patients with R/R LBCL who were deemed ineligible for HDCT and ASCT. The study met its primary end point, with a complete metabolic response (CMR) of 71% (n = 44, 95% confidence interval [CI], 58.1%–81.8%) at 3 months versus 12% expected with standard of care (based on historical controls). At 6 months, 59.7% of patients (n = 37) remained in CMR. CMR is defined as negative findings on a positron emission tomography (PET) during or following antitumor therapy. The full findings from the study were also published [21,22].

Myeloid Therapeutics

Myeloid Therapeutics (MA, USA; https://myeloidtx.com), a clinical stage oncology company, has dosed the first patient with MT-302 in a phase 1 study for advanced or metastatic epithelial tumors [23,24]. Dosing with MT-302 represents a significant advance in the development of new therapies for solid tumors, particularly those arising from epithelial tissues. Unlike traditional CAR-T cell therapies, Myeloid's approach focuses on in vivo programming of immune cells with an off-the-shelf mRNA encoded CAR technology. MT-302, the Company's lead development candidate for in vivo immune cell programming, delivers TROP2-targeting RNA chimeric antigen receptors that express selectively within myeloid cells.

PeproMene

PeproMene Bio (CA, USA; https://pepromenebio.com) a clinical-stage biotech company developing novel therapies to treat cancers and immune disorders, has announced that the first dose cohort of its phase 1 relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) clinical trial of PMB-CT01 (BAFFR-CAR T Cells) has been completed. No dose-limiting toxicity (DLT) was observed, and the study has been cleared to proceed with the next cohort [25,26].

PMB-CT01 is a first-in-class BAFFR-targeted, autologous CAR T cell therapy. BAFFR, a TNF receptor superfamily member, is the main receptor for BAFF expressing almost exclusively on B cells. Since BAFFR signaling promotes normal B-cell proliferation and appears to be required for B-cell survival, it is unlikely tumor cells could escape immune responses via loss of BAFFR antigen. This unique characteristic makes BAFFR CAR T therapy a great potential treatment of B cell malignancies. BAFFR CAR-T was constructed using the anti-BAFFR single-chain fragment variable (scFv) antibodies with the 2nd generation signaling domains containing CD3ζ and 4-1BB.

Verismo

Verismo Therapeutics (PA, USA; https://verismotherapeutics.com), a clinical-stage CAR-T company developing novel KIR-CAR platform technology invented at and licensed from the University of Pennsylvania (PA, USA; www.upenn.edu), has announced that a first patient has been dosed in their STAR-101 clinical trial to study the SynKIR-110 product in individuals with advanced ovarian cancer, mesothelioma, and cholangiocarcinoma [27,28]. SynKIR-110 product is comprised of autologous T cells transduced with a mesothelin-targeted KIR-CAR. The KIR-CAR platform is a dual-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging solid tumor environments. DAP12 acts as a novel costimulatory molecule for T cells using additional T cell-stimulating pathways, further sustaining chimeric receptor expression, and improving KIR-CAR T cell functional persistence. This continued T cell function and persistence can lead to ongoing regression of solid tumors in preclinical models, including those resistant to traditional CAR T cell therapies. The KIR-CAR platform is being investigated in combination with many additional emerging technologies, such as in vivo gene engineering, advanced cell manufacturing and reprogramming, combinational therapies, and even allogeneic cellular therapies to potentially provide the next-generation multimodal targeted immunotherapy for patients in need.

Mesenchymal stromal/stem cells

Creative Medical

Creative Medical Technology Holdings (AZ, USA; www.creativemedicaltechnology.com), a biotechnology company focused on a regenerative approach to immunotherapy, endocrinology, urology, gynecology, and orthopedics, has announced that the US FDA has cleared the Company to proceed with a phase I/II clinical trial of StemSpine^® using AlloStem™ (‘CELZ-201-DDT’) [29,30].

The study is designed to evaluate the safety, efficacy, and tolerability of CELZ-201-DDT. The study will enroll 30 individuals suffering from chronic lower back pain. CELZ-201-DDT is a patented procedure that utilizes an “off the shelf, ready-to-use” allogenic cell line developed by the Company and trademarked as AlloStem. Using an ultrasound guided, non-surgical procedure AlloStem will be injected in areas surrounding the diseased disc(s), thereby potentially repairing, remodeling, and improving the blood supply around the disc and lower back area.

Regulations, approvals, acquisitions…

Green light

BioLineRx

BioLineRx (Israel; www.biolinrx.com), a commercial stage biopharmaceutical company focused on certain cancers and rare diseases, has announced that the US FDA has approved APHEXDA™ (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma [31]. APHEXDA is administered by injection, for subcutaneous use. APHEXDA (motixafortide) is a CXCR4 antagonist with long receptor occupancy (>72 h) that, in combination with filgrastim (G-CSF), enables mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplantation in patients with multiple myeloma.

Biosyngen

Biosyngen (Singapore; www.biosyngen.com) has announced that the US FDA has cleared the Investigational New Drug (IND) application for phase I/II clinical trial of BRL03, an engineered T cell therapy, for the treatment of lung cancer, gastric cancer and other advanced solid tumors [32].

Leucid Bio

Leucid Bio (UK; www.leucid.com), a privately-held biotechnology company pursuing the development of innovative chimeric antigen receptor T-cell (CAR-T) therapies using the Company's proprietary Lateral CAR platform, has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted clinical trial authorisation (CTA) to commence the phase I/II AERIAL clinical trial evaluating the safety and tolerability of LEU011 for the treatment of adults with relapsed or refractory solid tumours [33].

LEU011 is an autologous, lateral CAR T cell therapy targeting NKG2D ligands. The NKG2D receptor enables immune recognition of one or more of the eight human NKG2D ligands expressed on transformed, infected or damaged cells. LEU011 has the potential for the treatment of multiple cancer indications as NKG2D ligands are reported to be expressed on more than 80% of human tumours.

The phase I/II AERIAL trial will evaluate the safety and clinical activity of LEU011 in patients with relapsed or refractory solid tumours following preconditioning chemotherapy. The phase I/II trial consists of an open-label, single-ascending dose design which will identify the maximum tolerated dose for LEU011. Following the dose-escalation portion of the trial, LEU011 will further be evaluated in a dose expansion open-label segment with enrolment of patients with solid tumours expressing one or more NKG2D ligands.

MaaT

MaaT Pharma (France; www.maatpharma.com), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, announced that the European Medicines Agency (EMA) has granted MaaT033 orphan drug designation [34]. MaaT033, a donor-derived, high-richness, high-diversity oral MET containing anti-inflammatory ButycoreTM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting.

Neuralink

Neuralink (CA, USA; https://neuralink.com/), the brain–computer interface (BCI) company, has received approval from the reviewing independent institutional review board and our first hospital site to begin recruitment for their first-in-human clinical trial [35]. The PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface) – a ground-breaking investigational medical device trial for the fully-implantable, wireless BCI – aims to evaluate the safety of the implant (N1) and surgical robot (R1) and assess the initial functionality of the BCI for enabling people with paralysis to control external devices with their thoughts. During the study, the R1 robot will be used to surgically place the N1 implant's ultra-fine and flexible threads in a region of the brain that controls movement intention. Once in place, the N1 implant is cosmetically invisible and is intended to record and transmit brain signals wirelessly to an app that decodes movement intention. The initial goal of our BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone. The PRIME Study is being conducted under the investigational device exemption (IDE) awarded by the FDA in May 2023 and represents an important step in the Company's mission to create a generalized brain interface to restore autonomy to those with unmet medical needs. Those who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify.

Capital market & finances

Calidi

Calidi Biotherapeutics (CA, USA; www.calidibio.com), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, has completed its business combination with First Light Acquisition Group (FLAG; CA, USA; https://firstlightacquisition.com), a special purpose acquisition company [36]. The common stock and warrants of Calidi commenced trading on the New York Stock Exchange American under the ticker symbols “CLDI” and “CLDI WS”, on September 13, 2023. The stockholders of FLAG approved the transaction on August 28, 2023, following approval by Calidi shareholders. Calidi's existing management team will lead the combined company.

ResVita Bio

ResVita Bio (CA, USA; www.resvitabio.com), a synthetic biology start-up, has been awarded a US $250,000 phase 1 Small Business Innovation Research (SBIR) grant by the National Institute of Allergy and Infectious Disease (NIAID). This grant will be used to develop RVB-101, a new type of treatment for severe atopic dermatitis, consisting of genetically engineered cells within a moisturizer formulation [37]. Topically applied, the cells temporarily colonize the skin and continuously release proteins that rebuild the epidermal barrier and alleviate inflammation.

However, in a separate press release earlier this year, the company stated that RVB-001 is a genetically engineered probiotic that is topically applied to temporarily colonize the skin and continuously release LEKTI, thereby inhibiting proteolysis and restoring the integrity of the epidermal barrier in patients with Netherton syndrome [38].

Qihan

Qihan Biotech (China; www.qihanbio.com), a company applying multiplexable genome editing technology to cell therapies and organ transplantation, has announced the successful completion of a pre-Series B financing exceeding US$16 M [39]. The combined funds from this financing round and the company's reserves will support the rapid product development in the next four years. With a vision to create a world in which cell and organ therapies are universally available to patients, Qihan Biotech has raised several financing rounds. It has multiple products at different stages of development, including QN-019a, which had already received IND approval from China NMPA to treat CD19-positive relapsed/refractory aggressive B-cell non-Hodgkin lymphoma.

Rejuvenation Technologies

Rejuvenation Technologies CA, USA; https://rejuvenationtech.com), a biotechnology company developing mRNA-based therapeutics to address mechanisms of aging, has announced a US $10.6 M seed financing round [40]. The company has also raised US$4.6 M in grant funding, bringing the total amount raised to US$15.2 M. The funding will be used to advance its programs to IND approval in fibrotic disease, such as pulmonary fibrosis and liver cirrhosis, as well as early research targeting the immune system. Rejuvenation's lead candidate targets a key aging mechanism, telomere shortening. The company's products include optimized telomerase mRNA encapsulated in custom tissue-targeted lipid nanoparticles (LNP). The company plans to expand its operations and bring on additional team members to oversee scale-up manufacturing, clinical operations and R&D efforts to expand mRNA delivery capabilities to additional organ systems.

Thymmune

Thymmune Therapeutics (MA, USA; www.thymmune.com), a biotechnology company developing scalable thymic cell therapies to restore immune function in aging and disease, has announced that the US Department of Health and Human Services, through the Advanced Research Projects Agency for Health (ARPA-H; https://arpa-h.gov) has awarded up to US $37 million in funding to the Thymus Rejuvenation project [41]. This is the first industry project funded by the ARPA-H Open Broad Agency Announcement (https://arpa-h.gov/engage/baa/). The Thymus Rejuvenation project, led by Thymmune Therapeutics, aims to restore damaged or non-functional thymus tissue. Using laboratory methods, scientists can turn cells into different tissue types, eventually growing into functional thymus tissue for a patient, and allowing for a ‘reboot’ of immunity. ARPA-H funding will not only advance the treatment toward clinical development but also aim to effectively treat a broader range of clinical indications related to immune depletion as we age.