Ouro Medicines Launches to Define the Future of Treatment for People with Immune-Mediated Diseases

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 https://www.ouromedicines.com/ or follow us on LinkedIn @ouromedicines.

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SOURCE Ouro Medicines