Recent extensive investment in oncology—particularly immuno-oncology—has driven scientific and medical breakthroughs delivering life-changing outcomes for many patients living with cancer.
Scientific advances in understanding the immune system are driving renewed interest in autoimmune diseases, with insights now being applied to autoimmune disorders like systemic lupus erythematosus (SLE) and rheumatoid arthritis, where current therapies routinely fail to achieve treatment-free remission.1,2 Subsequently, many patients with these chronic diseases require lifelong immune suppression for symptom management, often without achieving long-term disease control.3,4
The biotech industry, pursuing ideas holding the greatest potential impact on patient lives, is positioned to act quickly on emerging science—accelerating development of new standards of care. Companies like Cullinan Therapeutics are helping lead this groundswell in autoimmune diseases with a unique, modality-agnostic approach and collaboration with external experts, reflective of its innovation-without-borders philosophy—seeking to bring forward only the most promising therapies.
Strategy grounded in patient impact
However, not all biotechs have the resources, teams, or agility to make quick, strategic decisions in an ever-adapting scientific landscape. For those that can, success hinges on addressing unmet needs as quickly as possible in diseases with significant potential for improved patient outcomes.
This shift is already happening in autoimmune diseases. Strategies centered on B cell depletion have long been validated in both oncology and autoimmune disorders, given B cells’ role in immune system dysregulation.5,6 While TCE therapies have achieved lasting remissions in B cell malignancies, only recently has research suggested their disease-modifying potential in autoimmune diseases.7.8
This watershed moment renewed energy and investment in immunology. While many companies focused on advancing CAR T cell therapies, teams at Cullinan identified the broader utility of a different modality—their novel, highly potent CD19-specific TCE. With off-the-shelf convenience and subcutaneous delivery allowing flexible, repeat dosing (as needed), CLN-978 emerged as a differentiated, patient-friendly option being studied in clinical trials.9
“As new research surfaced, our scientific teams quickly evaluated whether we could make a meaningful difference for patients in this growing area of unmet need,” said Jeff Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “Our modality-agnostic model gives us the agility to recalibrate based on scientific breakthroughs and ensure we’re focusing our pipeline on areas with the greatest need and potential for impact.”
Just six months after its strategic expansion into autoimmune diseases, Cullinan progressed its global development plan for CLN-978 to be studied in multiple clinical trials.10,11 In October, the U.S. Food and Drug Administration cleared Cullinan’s Investigational New Drug application to proceed with its global Phase 1 clinical trial of CLN-978 in moderate to severe SLE, representing the first development-stage CD19-specific TCE to receive U.S. clearance in autoimmune disease.12 This followed approval from a Human Research Ethics Committee in Australia in September—which marked the launch of the global trial.13 A second Phase 1 study in refractory rheumatoid arthritis is in development.
Innovation without borders to progress new opportunities
Advancing new ideas offering the greatest potential patient benefit is only possible through cross-industry collaboration, including with institutional and advocacy partners worldwide.
“Lupus is a complex and heterogeneous disease. The disease can impact everyone differently and symptoms can change over time. Many patients try existing therapies, sometimes in combination, to achieve short periods of remission. Treatment solutions capable of delivering long-term remission would be very impactful,” said Stacie Bell, Executive Vice President and lead of Lupus Therapeutics, the clinical affiliate of the Lupus Research Alliance. “Success in treatment development requires collaboration with industry, especially in early clinical research, which drives life-changing innovations and potential curative therapies that those living with lupus are waiting for.”
Dr. Jones, a former academic physician, emphasizes that the best results come from engaging experts passionate about advancing science and improving lives through development of groundbreaking, investigational assets. Cullinan’s global clinical strategy reflects its innovation-without-borders ethos, enabling teams to secure alignment, validation, and support from leading institutions and patient advocacy and research groups as they work to progress CLN-978.
“The potential of anti-CD19 T cell engagers, including CLN-978, is incredibly exciting—it’s an exhilarating time as a rheumatologist,” said Anca Askanase, MD, MPH, Founder and Director of Columbia University’s Lupus Center and the Director of Rheumatology Clinical Trials. “These industry collaborations are likely to bring forward treatments that make a real difference for patients with autoimmune diseases.”
This moment presents an exciting convergence—decades of scientific progress intersecting with established clinical experience in practice-changing modalities. Companies with agile, multidisciplinary strategies that embrace emerging science are well-positioned to deliver transformational medicines in autoimmune diseases.
References:
1. Lupus Foundation of America. Lupus remission. 2022
2. Arthritis Foundation. Your RA is in Remission! Now What?
3. Cleveland Clinic. Autoimmune Diseases. 2021
4. Lopez-Millan B et al. Nature. 2017
5. Zhang Z et al. Front Immunol. 2023
6. Mackensen A et al. Nat Med. 2022
7. Michaelson J & Baeuerle P J. Exp. Med. 2024
8. Müller F et al. N Engl J Med. 2024
9. Cullinan Therapeutics. Targeting CD19 With T Cell Engagers. 2024
10. Cullinan Therapeutics. Cullinan Therapeutics Announces Strategic Expansion into Autoimmune Diseases. Press release. 2024
11. Cullinan Therapeutics. Cullinan Therapeutics Announces Submission of Investigational New Drug Application to U.S. Food and Drug Administration for CLN-978 to Treat Systemic Lupus Erythematosus. Press Release. 2024
12. Cullinan Therapeutics. Cullinan Therapeutics Receives U.S. FDA Clearance of Investigational New Drug Application for CLN-978 Administered Subcutaneously in Patients with Moderate to Severe Systemic Lupus Erythematosus. Press Release. 2024
13. Cullinan Therapeutics. Cullinan Therapeutics Receives Approval to Initiate its Global Phase 1 Clinical Trial of CLN-978 for the Treatment of Systemic Lupus Erythematosus. Press Release. 2024
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- Source: https://www.biopharmadive.com/spons/fueling-accelerated-drug-development-in-autoimmune-diseases-with-a-modality/732069/