GentiBio, Inc.

Ouro will leverage $120 million in funding to develop novel T cell engagers with potential to reset the immune system in patients with chronic immune-mediated diseases Company launches with a promising clinical-stage asset and robust discovery pipeline Company founded by Monograph Capital in partnership with GSK; Series A co-led by TPG, NEA, and Norwest SAN FRANCISCO, Jan. 10, 2025 /PRNewswire/ -- Ouro Medicines, a biotechnology company developing immune reset therapeutics for people living with chronic immune-mediated diseases, today announced its launch with $120 million in funding. The company was founded by Monograph Capital in partnership with GSK plc. The Series A was co-led by TPG Life Sciences Innovations, NEA, and Norwest Venture Partners, with participation from Monograph Capital, GSK, UPMC Enterprises, Boyu/Zoo Capital, LongRiver Investments, and other unnamed investors. Chronic immune-mediated diseases encompass an array of conditions where the body's own immune cells play a driving role. This category includes B cell mediated diseases, which make up the company's immediate focus. Current treatments for such diseases generally require ongoing immunosuppressive therapy and may be minimally effective with high levels of toxicity. Due to their high potency, specificity, and relative ease of administration and manufacture, T cell engager antibodies (TCEs) have emerged as a promising off-the-shelf therapeutic modality for targeting and depleting specific pathogenic cell populations that drive immune-mediated diseases. By depleting target cell populations, TCEs might be used to reset the immune system to a state before those cells became pathogenic. This approach has potential to create long periods of remission where immunosuppression is unnecessary. "We see a tremendous opportunity to define the future of treatment for people with immune-mediated diseases because the standard of care today leaves a lot to be desired," said Jaideep Dudani, CEO, Ouro Medicines and Portfolio Principal, Monograph Capital. "As a class, we believe TCEs have properties that make it possible to unlock immune system resets with periods of durable remission and without the need for ongoing immunosuppression. Being able to precisely target cell populations with a high-potency therapeutic is crucial to depleting whole lineages of pathogenic cell populations so that we can achieve immune reset." Ouro's most advanced product candidate is OM336, a BCMA-directed, bispecific T cell engager recently licensed from Keymed Biosciences (2162.HK). BCMA is highly expressed across several B cell subtypes that play a role in driving multiple indications where high specificity and potency are needed to achieve near-complete B cell depletion. Keymed Biosciences is currently studying OM336 (CM336) in an ongoing Phase 2 expansion study in multiple myeloma in China. Ouro holds exclusive rights outside of Greater China and intends to start its first Phase 1 study in 2025. Examples of B cell mediated diseases include systemic lupus erythematosus, scleroderma, rheumatoid arthritis, Sjögren's, and myositis. Supportive proof of concept data has been generated from the off-label use of BCMA-directed TCEs in these indications. "TPG has been following the theme of deep B cell depletion since initial data came from CAR-T cell therapies," said Shinichiro Fuse, PhD, Business Unit Partner with TPG Life Sciences Innovations. "In Ouro, we found a leadership team and a group of advisors who bring deep knowledge of immune-mediated diseases and the key modalities being investigated for these indications, as well as a wealth of experience in both drug discovery and clinical development. We are thrilled to support the company as it works to develop immune reset therapeutics that address serious unmet needs for patients." Behind its lead program, Ouro intends to advance a broad set of discovery programs targeting additional dimensions of B cell biology. These programs probe unique subsets of B cells compared to existing therapies in the clinic. Additionally, Ouro's protein engineering expertise is being applied to next-generation versions of novel TCEs to continue to drive innovative treatments for chronic immune-mediated diseases. "Monograph has high conviction that immune reset has the potential to change the course of many autoimmune diseases," said Tim Funnell, DPhil, Member, Ouro Medicines Board of Directors and Partner, Monograph Capital. "We started Ouro with an intention of building a discovery platform to unlock immune reset therapeutics, and we have been excited to accelerate the company's development by bringing in OM336, which we believe has great promise based on the preclinical profile and clinical data we've seen in oncology. The combination of learnings from the OM336 clinical program and Ouro's discovery activities will give us a strong foundation as we aim to build the leading immune reset therapeutics company." Ouro has assembled a leadership team with expertise in a range of relevant diseases and modalities, including: Jaideep Dudani, PhD, Chief Executive Officer. Dudani was most recently part of the founding team of Human Immunology Biosciences (HI-Bio), where he led portfolio development and strategy prior to the acquisition by Biogen, and has played cross-functional roles across R&D, strategy, and business development throughout his career. Dudani is also a Portfolio Principal at Monograph Capital. Neely Mozaffarian, MD, PhD, Chief Medical Officer. Mozaffarian was previously Chief Medical Officer at GentiBio and Atomwise, with large pharma experience at Johnson & Johnson, Gilead, Eli Lilly, and AbbVie, leading drug development of biologics and small molecules. Christina Carlson, JD, Chief Administrative Officer. Carlson most recently served as General Counsel of Human Immunology Biosciences (HI-Bio) and brings nearly 20 years of pharmaceutical and legal experience to her role at Ouro. Kevin P. Baker, PhD, Chief Development Officer. Baker was previously Chief Development Officer at Pionyr Immunotherapeutics, where he led a team developing monoclonal antibodies and proteins to modulate the tumor microenvironment, and has deep experience across research programs in immune-oncology and immunology. Ouro's Board of Directors includes Shinichiro Fuse, PhD (TPG), Matt McAviney, MD (NEA), Brian Matesic, MD (Norwest), Tim Funnell, DPhil (Monograph), and Bo Chen, PhD (Keymed). Supporting the Ouro leadership team are several deeply experienced clinical advisors, including John Davis, MD, MPH, President, Norte Health Consulting and former scientific advisory board member of HI-Bio; Matthew Baker, MD, MS, Clinical Chief in the Division of Immunology and Rheumatology at Stanford University and the Co-Director of the Stanford Multidisciplinary Sarcoidosis Program; and Stanford Peng, MD, PhD, most recently President and Head of Research & Development at Alpine Immune Sciences. About Ouro Medicines Ouro Medicines is a biotechnology company dedicated to developing immune reset therapeutics for people living with chronic immune-mediated diseases. Ouro's approach is focused on leveraging T cell engagers in B cell mediated diseases to achieve immune resets that create durable remissions without ongoing immunosuppression. Based in San Francisco and launched in 2025, Ouro was founded by Monograph Capital in partnership with GSK. Ouro is also backed by leading investors TPG, NEA, and Norwest. For more information visit or follow us on LinkedIn @ouromedicines. Media Contact Morgan Warners FGS Global [email protected] SOURCE Ouro Medicines WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

T cell engagers are having a moment, much like antibody-drug conjugates have for the past two years. The cell-depleting medicines, known simply as TCEs, are being adopted from the oncology field as a new class of autoimmune drugs , mimicking the way many cell therapy drug developers are moving into immune-mediated diseases. And now there’s another biotech in the mix. Ouro Medicines broke cover on Friday morning with $120 million in funding. It marks the sixth nine-figure funding round of the week for the biopharma industry, continuing the megaround-heavy environment of 2024. Pitching into the launch is GSK, a large pharma that’s bagged multiple TCE deals in recent memory, including a $300 million upfront deal for an antibody from Chimagen Biosciences . Ouro’s TCE OM336 derives from Chengdu, China-based Keymed Biosciences. Ouro paid $16 million upfront and could dish out up to $610 million in biobucks, Endpoints News reported in November. The startup joins a growing chorus of biopharmas that have in-licensed or acquired TCEs from China-based companies. The most prolific dealmaker, though, has been Ken Song’s Candid Therapeutics , which has inked multiple deals with Chinese drug developers since unveiling $370 million in September. Monograph Capital founded Ouro “in partnership with GSK,” the San Francisco startup said. It’s led by CEO Jaideep Dudani, who is also a portfolio principal at Ouro. He said GSK is “helping shape the strategy” and guiding the buildout of Ouro. “In 2024, Monograph Capital and GSK got together and said, ‘Hey, this is a space that we really think is going to be really important, and started building the bones of the company,” Dudani said. He was previously part of the founding team of Human Immunology Biosciences, which Biogen bought for $1.15 billion last year. Co-leading Ouro’s Series A are investors TPG Life Sciences Innovations, NEA and Norwest Venture Partners. Additional investors include Boyu/Zoo Capital, LongRiver Investments, UPMC Enterprises and other undisclosed shops. The 10-employee biotech plans to double in size this year, the CEO said. Its chief medical officer is Neely Mozaffarian, who held the same posts at GentiBio and Atomwise. Kevin Baker is chief development officer, having held the same role at Pionyr Immunotherapeutics, and former HI-Bio general counsel Christina Carlson is its chief administrative officer. Keymed is testing OM336/CM336, a BCMA-directed bispecific TCE, in patients with multiple myeloma in a Phase 2 study in China. Ouro was originally formed around discovery-stage programs and the company then “decided to accelerate” that mission by in-licensing the candidate from Keymed. It’s still advancing an internal preclinical pipeline as well, but declined to disclose further details. Ouro holds the ex-China rights to OM336 and plans to start a Phase 1 this year for B cell-mediated diseases, which the company said could include systemic lupus erythematosus, scleroderma, rheumatoid arthritis, Sjögren’s syndrome and myositis. The goal is to rid the need for immunosuppressive treatments, which are typically needed for current drugs in B cell-mediated diseases. The biotech’s name derives from Ouroboros, an ancient symbol of a serpent eating itself. “It’s supposed to represent an eternal recycle, rebirth, renewal. That’s the vision of the company,” Dudani said. “It’s achieving this immune reset for patients and giving them this opportunity to not be a patient anymore, if that’s possible, no longer needing to take their daily dose of steroids.”

Treg Cell-based Therapies refer to therapeutic approaches that utilize regulatory T cells (Tregs) to modulate the immune system. Innovations in cell expansion and engineering techniques have greatly enhanced the ability to isolate, expand, and deliver functional Tregs. Ex vivo expansion technologies and genetic engineering (such as CAR-Tregs) have opened up new possibilities for enhancing the stability, specificity, and effectiveness of Treg therapies. LAS VEGAS, Oct. 28, 2024 /PRNewswire/ -- DelveInsight's ' Treg Cell-based Therapies Pipeline Insight 2024 ' report provides comprehensive global coverage of available, marketed, and pipeline Treg cell-based therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Treg cell-based therapies pipeline domain. Key Takeaways from the Treg Cell-based Therapies Pipeline Report DelveInsight's Treg cell-based therapies pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for various indications. Key Treg cell-based therapies companies such as Orca Bio, Nektar Therapeutics, Quell Therapeutics, Cugene, Sangamo Therapeutics, Abata Therapeutics, HCW Biologics, GentiBio, Tr1X, PolTREG, Cellenkos, VT BIO, Miltenyi Biotec GmbH, KSQ Therapeutics, TeraImmune, Tract Therapeutics, and others are evaluating new Treg cell-based therapies to improve the treatment landscape. Promising Treg cell-based therapies in the pipeline in various stages of development include Orca-T, NKTR-358, QEL-001, CUG-252, TX200, ABA-101, HCW9302, GNTI-122, TRX-103, PTG-020, CK-0804, VT-301, TR-004, KSQ 001, TI-620, TRK 001, and others. In October 2024, Quell Therapeutics hired eXmoor Pharma to make supplies of its pipeline of novel immunosuppressive cell therapies—called CAR-Tregs—at its new cell and gene therapy facility. Quell recently teamed with fellow U.K.-based eXmoor in a strategic partnership that will see the contractor make its candidate autoimmune disease cell therapies for early-phase clinical studies. In September 2024, Abata Therapeutics announced that ABA-101, an autologous regulatory T-cell (Treg) therapy for the treatment of patients with progressive multiple sclerosis (MS), has received fast-track designation from the US FDA. In September 2024, PolTREG S.A. announced that China's National Intellectual Property Administration, PRC (CNIPA) had issued a notification to grant a patent for the intrathecal administration of the company's cellular therapies in patients with multiple sclerosis (MS). The intrathecal administration is an established method used to deliver therapy across the blood-brain barrier via injection into the subarachnoid space. In June 2024, Orca Bio announced that it had completed enrollment in the pivotal Precision-T Phase III clinical study. The primary endpoint of the Precision-T study is the rate of survival free from moderate-to-severe chronic graft versus host disease (GvHD). In March 2024, PolTREG announced that the company is planning to launch Phase II trials testing its Tregs therapy — the T-cell-based treatment PTG-007 in people with multiple sclerosis (MS). In February 2024, Cellenkos announced encouraging safety data from its innovative CK0803 neurotrophic T regulatory (Treg) cell therapy, being developed to help treat individuals with Amyotrophic Lateral Sclerosis (ALS). The company was given the green light to move ahead following a review of safety data by the Data Safety Monitoring Board (DSMB). In August 2023, BlueRock Therapeutics LP, a wholly owned, independently operated subsidiary of Bayer AG, and bit.bio, the company coding human cells for novel cures announced a collaboration and option agreement for the discovery and manufacture of iPSC-derived regulatory T cells (Tregs) for use in creating therapeutics. Request a sample and discover the recent advances in Treg cell-based therapies @ Treg Cell-based Therapies Pipeline Outlook The Treg cell-based therapies pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage Treg cell-based therapies, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the Treg cell-based therapies pipeline landscape. Treg Cell-based Therapies Overview Treg cell-based therapies represent a promising frontier in immunotherapy, focusing on harnessing regulatory T cells (Tregs) to modulate the immune response in various clinical settings. Tregs play a crucial role in maintaining immune homeostasis and preventing autoimmune reactions by suppressing excessive immune responses. In the context of autoimmune diseases, these therapies aim to restore balance by expanding or enhancing Tregs to dampen inappropriate immune activity. For instance, in diseases like type 1 diabetes or multiple sclerosis, Treg cell-based treatments seek to prevent or slow disease progression by reestablishing immune tolerance. Beyond autoimmune disorders, Treg cell-based therapies are also being explored in cancer treatment. Tumors often exploit Tregs to evade immune detection, and by manipulating these cells, it's possible to enhance the anti-tumor immune response. Strategies include expanding Tregs ex vivo and reinfusing them to boost their numbers or modifying them to more effectively target tumor-associated antigens. These approaches hold the potential to improve the efficacy of existing immunotherapies and offer new avenues for treating cancers that are currently resistant to conventional treatments. Find out more about Treg cell-based therapies @ Treg Cell-based Therapies in Development A snapshot of the Treg Cell-based Therapies Pipeline Drugs mentioned in the report: Learn more about the emerging Treg cell-based therapies @ Treg Cell-based Therapies Clinical Trials Treg Cell-based Therapies Therapeutics Assessment The Treg cell-based therapies pipeline report proffers an integral view of the emerging Treg cell-based therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Treg Cell-based Therapies Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intravenous, Subcutaneous, Oral, Intramuscular Therapeutics Assessment By Molecule Type: Monoclonal antibody, Small molecule, Peptide Therapeutics Assessment By Mechanism of Action: Immunologic cytotoxicity, T lymphocyte replacements, Interleukin 2 replacements, Cell replacements Key Treg Cell-based Therapies Companies: Orca Bio, Nektar Therapeutics, Quell Therapeutics, Cugene, Sangamo Therapeutics, Abata Therapeutics, HCW Biologics, GentiBio, Tr1X, PolTREG, Cellenkos, VT BIO, Miltenyi Biotec GmbH, KSQ Therapeutics, TeraImmune, Tract Therapeutics, and others. Key Treg Cell-based Therapies in Pipeline: Orca-T, NKTR-358, QEL-001, CUG-252, TX200, ABA-101, HCW9302, GNTI-122, TRX-103, PTG-020, CK-0804, VT-301, TR-004, KSQ 001, TI-620, TRK 001, and others. Dive deep into rich insights for Treg cell-based therapies assessment, visit @ Treg Cell-based Therapies Therapeutics Assessment Table of Contents For further information on the Treg cell-based therapies pipeline therapeutics, reach out @ Treg Cell-based Therapies Pipeline Landscape Related Reports Type 1 Diabetes Market Type 1 Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key type 1 diabetes companies, including Histogen , Novo Nordisk, Prevention Bio, among others. 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LTD, BioVie Inc., Prothena Corporation plc, Coya Therapeutics, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED