Core Insights - Cullinan Therapeutics is presenting new preclinical data for CLN-978, a bispecific T cell engager targeting autoimmune diseases, at the ACR Convergence 2025 [1][5] - CLN-978 has shown robust B cell depletion and T cell activation in patients with autoimmune diseases [2] - The drug demonstrated dose-dependent B cell depletion in nonhuman primates, indicating potential for significant clinical efficacy [3] - In murine models, CLN-978 treatment resulted in reduced circulating B cells and disease-modifying effects in systemic lupus erythematosus [4] Company Overview - Cullinan Therapeutics is focused on developing first- or best-in-class therapies for autoimmune diseases and cancer, leveraging expertise in T cell engagers [7] - The company is advancing global clinical programs for CLN-978 in rheumatoid arthritis, Sjögren's disease, and systemic lupus erythematosus, with active trials in multiple countries [5][6] - CLN-978 is designed for high affinity binding to CD19, allowing it to target B cells effectively, including those with low CD19 levels [6]

Group 1 - Cullinan Therapeutics, Inc. (NASDAQ: CGEM) shares have declined approximately 70% since May 2024 due to a lack of data regarding its off-the-shelf CD19xCD3 T cell engager CLN-978 [2] - The company is focused on autoimmune and oncology therapies, with the CLN-978 therapy being particularly anticipated by investors [2] - The Biotech Forum offers a model portfolio featuring 12-20 high upside biotech stocks, along with live discussions and weekly updates [2] Group 2 - The article emphasizes the importance of market commentary and portfolio updates provided by The Biotech Forum on a weekly basis [2] - Analyst disclosures indicate a beneficial long position in shares of AMGN and CGEM, highlighting the analyst's personal investment interests [3] - Seeking Alpha clarifies that past performance does not guarantee future results and that the views expressed may not reflect the platform's overall stance [4]

Taiho Oncology Inc. and Cullinan Therapeutics Inc. (NASDAQ:CGEM) shared new data on Sunday from the central nervous system (CNS) involvement cohort of the REZILIENT2 study of zipalertinib for advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations (ex20ins) or uncommon non-ex20ins EGFR mutations.Data will be presented at the European Society for Medical Oncology (ESMO) Congress 2025.The mini oral presentation will highlight preliminary efficacy and safety data fr ...

, /PRNewswire/ -- Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., today announced new data from the central nervous system (CNS) involvement cohort of the REZILIENT2 study of zipalertinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in patients with advanced or metastatic non- small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations (ex20ins) or uncommon non- ex20ins EGFR mutations and CNS involvement. Data will be presented at the European Society fo ...

Key Takeaways BDTX is advancing silevertinib in phase II for EGFRm NSCLC, with initial frontline results due late 2025.Cullinan's zipalertinib met its phase IIb endpoint in EGFR ex20ins NSCLC, with Taiho planning a 2025 filingBDTX shares have surged 59.8% YTD versus a 48.4% drop for Cullinan, while trading at a cheaper valuation.Black Diamond Therapeutics, Inc. ((BDTX) is a clinical-stage oncology company developing therapies that target families of oncogenic mutations in patients with cancer.Cullinan Thera ...

Summary of Cullinan Therapeutics Conference Call Company Overview - **Company**: Cullinan Therapeutics (NasdaqGS:CGEM) - **Focus**: Development of best-in-class molecules for oncology and autoimmune diseases, with a portfolio centered around high-priority programs including CLN-978 for autoimmune diseases and zipalertinib for oncology [2][4] Key Programs and Developments - **Lead Program**: CLN-978, a CD19 x CD3 bispecific T cell engager, is currently in phase 1 clinical studies for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjogren's disease, with initial clinical data expected in the first half of 2026 [3][4] - **Oncology Program**: Zipalertinib TKI for EGFR exon 20 non-small cell lung cancer is planned for regulatory filing by the end of 2025 [4] Clinical Data and Study Design - **SLE and RA Studies**: Initial clinical data for SLE and RA has been shifted to the first half of 2026, with ongoing patient enrollment in global sites [3][25] - **Study Design**: The SLE study includes a modified single ascending dose study to identify a deeply B cell depleting dose while maintaining a therapeutic index [14][15] - **Eligibility Criteria Update**: Adjustments made to broaden patient eligibility, allowing those who have only received small molecule immune suppressants to participate [20][22] Therapeutic Benefits and Differentiation - **T Cell Engagers**: The potential for T cell engagers to provide therapeutic benefits without ongoing immune suppression is highlighted, with a focus on achieving durable responses [6][10] - **Differentiation of CLN-978**: High affinity binding to CD19 and a favorable cytokine window are key differentiators from other CD19 T cell engagers [8][9] Evidence and Market Potential - **RA Evidence**: Previous studies indicate that T cell engagers can provide clinical benefits through B cell depletion in RA, supporting the rationale for further development [28][30] - **Sjogren's Disease**: While evidence for T cell engagers in Sjogren's is limited, the disease's B cell-centric nature suggests potential therapeutic benefits from B cell-targeting therapies [32][33] Financial Position - **Cash Reserves**: As of the end of Q2, the company reported over $500 million in cash reserves, providing a runway into 2028 [39][41] Regulatory Pathway - **Collaboration with Genrex Bio**: Ongoing studies in China are expected to facilitate regulatory ambitions outside of China, with data generation in autoimmune disease patients aiding in the development of Cullinan's own studies [36][38] Conclusion - Cullinan Therapeutics is positioned to advance its innovative therapies in both oncology and autoimmune diseases, with a strong financial foundation and promising clinical programs aimed at addressing significant unmet medical needs in these areas [41]

Core Insights - Cullinan Therapeutics, Inc. is participating in the Stifel 2025 Virtual Immunology and Inflammation Forum, highlighting its engagement in the biopharmaceutical sector [1] - The company focuses on developing targeted therapies for autoimmune diseases and cancer, aiming to create new standards of care [3] Company Overview - Cullinan Therapeutics is a biopharmaceutical company listed on Nasdaq under the ticker CGEM, dedicated to developing modality-agnostic targeted therapies [1][3] - The company has built a diversified portfolio of clinical-stage assets that target key disease drivers and utilize the immune system to combat diseased cells [3] - Cullinan's approach includes rigorous candidate selection and development processes to fast-track promising therapeutic molecules [3] Event Participation - Jeffrey Jones, M.D., M.B.A., the Chief Medical Officer of Cullinan, will participate in a fireside chat at the Stifel forum on September 16, 2025, at 9:30 a.m. ET [1] - A webcast of the event will be available on the company's investor relations website [2]

Group 1 - Morgan Stanley's Global Healthcare Conference features Cullinan Therapeutics with CEO Nadim Ahmed and CMO Jeff Jones presenting [2] - Sean Laaman, Head of U.S. Smid-Cap Biotech Equity Research, is leading the session [1] - The conference aims to discuss key developments and insights in the healthcare sector [1]

Summary of Cullinan Therapeutics FY Conference Call Company Overview - **Company**: Cullinan Therapeutics (NasdaqGS:CGEM) - **Focus**: Development of first-in-class or best-in-class molecules targeting autoimmune diseases and cancer [7][8] Key Points Pipeline and Clinical Development - **Catalysts**: The company is at an important inflection point with several upcoming catalysts [7] - **Lead Program**: CLN-978, a CD19 x CD3 bispecific T-cell engager, is prioritized for autoimmune diseases [8] - **IND Clearance**: First company to receive IND clearance from the FDA for a CD19 T-cell engager in autoimmune diseases [9] - **Ongoing Studies**: Three studies in high unmet need indications, including lupus, rheumatoid arthritis (RA), and Sjogren's disease [9][10] - **Data Timeline**: Initial data for lupus expected in the first half of 2026, delayed from Q4 2025 due to enrollment challenges [9][25] Clinical Insights - **Mechanism of Action**: T-cell engagers can achieve deeper B-cell depletion compared to traditional monoclonal antibodies, potentially leading to disease-modifying effects [19][20] - **Safety Profile**: CLN-978 has shown a favorable safety profile in initial studies, with no significant adverse events reported [22] Market Opportunities - **Autoimmune Diseases**: Significant unmet need in RA, with nearly 1 million moderate to severe patients in the U.S. [36] - **Sjogren's Disease**: Approximately 800,000 patients in the U.S., with potential overlap with other autoimmune diseases [40] - **Belanotamab**: A BCMA x CD3 T-cell engager licensed from Generex BioHope, complementing CLN-978 by targeting plasma cells [42] Financial Position - **Cash Reserves**: Over $500 million in cash as of June 2025, providing a strong financial position to support ongoing and future programs without immediate capital raises [13][54] Strategic Partnerships - **Taiho Oncology**: Partnering for the commercialization of zipolirenib, with a 50/50 profit share in the U.S. [12][49] - **China Market**: Licensing agreements to leverage innovation from China, with initial studies planned there [16][17] Upcoming Data and Expectations - **CLN-049**: Initial data for another T-cell engager expected in Q4 2025 [55] - **RA Study**: Ongoing dosing with initial data expected in the first half of 2026 [37] Additional Insights - **Enrollment Challenges**: Difficulty in enrolling patients for lupus studies due to restrictive eligibility criteria, which have since been amended to broaden participation [25][28] - **Tissue Penetration Studies**: Plans to incorporate tissue-level B-cell depletion assessments in RA studies, which may provide additional insights into the drug's efficacy [38] This summary encapsulates the key points discussed during the conference call, highlighting Cullinan Therapeutics' strategic focus, clinical developments, market opportunities, and financial health.

Accessibility StatementSkip Navigation "Uncommon non-exon 20 insertion EGFR mutations represent a significant clinical challenge, as they exhibit variable and often suboptimal responses to currently approved tyrosine kinase inhibitors," said Hibiki Udagawa, MD, PhD, thoracic medical oncologist, National Cancer Hospital East, Japan. Â "We are pleased to present the interim data from the uncommon non-ex20ins EGFR mutations cohort from the REZILIENT2 trial, potentially demonstrating the need for novel, targete ...