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Adaptimmune Therapeutics plc (NASDAQ: ADAP) is a clinical-stage biopharmaceutical company focused on the design, development, and delivery of T-cell therapies to treat cancer. Established in 2008, Adaptimmune has grown from a private entity to one of the top biopharmaceutical IPOs in 2015, and its U.S. operations are headquartered in Philadelphia, PA. Using its proprietary T-cell receptor (TCR) platform, Adaptimmune engineers T-cells to target and destroy cancer cells. This innovative approach has led to the development of a robust pipeline of immuno-oncology product candidates primarily aimed at solid tumors.
The company’s leading programs include afami-cel and lete-cel, both engineered T-cell therapies targeting specific cancer antigens. Afami-cel, targeting MAGE-A4, has shown promising results in treating advanced synovial sarcoma, with the U.S. FDA accepting its Biologics License Application (BLA) for priority review. The anticipated approval and commercial launch of afami-cel in 2024 will mark a significant milestone for Adaptimmune, potentially making it the first engineered T-cell therapy for solid tumors available to patients. Lete-cel, targeting NY-ESO-1, is being evaluated for synovial sarcoma and myxoid round cell liposarcoma (MRCLS) in the pivotal IGNYTE-ESO trial. Preliminary results indicate a 40% response rate, meeting the primary efficacy endpoint.
Adaptimmune has formed strategic partnerships to advance its pipeline and enhance its manufacturing capabilities. Recent collaborations include agreements with Galapagos to develop next-generation TCR therapies and a $125 million debt financing deal with Hercules Capital, strengthening its financial position.
In addition to its lead programs, Adaptimmune is advancing a broad clinical and preclinical pipeline, including ADP-A2M4CD8 (uza-cel), targeting a range of solid tumors, and several other next-generation and allogeneic T-cell therapies. The company continues to invest in research and development, with plans to expand its platform and address additional cancer indications.
The company’s commitment to transforming cancer treatment is underpinned by a strategy of bringing novel therapies to market efficiently. With over $300 million in funding and strategic plans extending into 2026, Adaptimmune is well-positioned to achieve significant milestones and make substantial impacts in the field of oncology.
Adaptimmune Therapeutics (NASDAQ: ADAP) presented interim analysis data from its pivotal IGNYTE-ESO trial at ASCO. The study focuses on lete-cel, an engineered cell therapy targeting NY-ESO-1, in synovial sarcoma (SyS) and myxoid/round cell liposarcoma (MRCLS). The trial achieved a 40% overall response rate (ORR) across both cancer types and a median duration of response (mDOR) of approximately 11 months. These findings reinforce the potential of lete-cel to address unmet medical needs in these sarcoma indications. Full results are expected in late 2024, with a Biologics License Application (BLA) submission planned for 2025. Adaptimmune aims to commercialize afami-cel later this year and lete-cel in 2026.
Adaptimmune and Galapagos have entered a clinical collaboration to evaluate Adaptimmune's TCR T-cell therapy candidate, uza-cel, in head & neck cancer. The trial aims to leverage Galapagos' decentralized manufacturing platform to improve efficacy and durability. Initial trials showed an 80% response rate with partial responses in four out of five patients. Adaptimmune will receive $70M upfront, $30M in R&D funding, and potentially up to $465M in milestone payments, with additional tiered royalties. Galapagos has an option to license uza-cel for global development and commercialization.
Adaptimmune Therapeutics (NASDAQ: ADAP) reported Q1 2024 results, highlighting a cash runway through late 2025. Revenue fell to $5.7M from $47.6M YoY due to the termination of the Astellas collaboration. Net loss was $48.5M, compared to a $1.0M profit in Q1 2023. R&D expenses rose to $35.2M, driven by increased employee costs and lease properties from the TCR2 acquisition. G&A expenses decreased to $19.7M due to restructuring and lower corporate costs. The FDA is reviewing afami-cel for advanced synovial sarcoma with a PDUFA date of August 4, 2024. The company plans to launch afami-cel upon approval and lete-cel for synovial sarcoma and MRCLS in 2026, targeting peak U.S. sales of $400M. A $125M debt facility with Hercules Capital was secured.
Adaptimmune has secured a $125 million debt financing deal with Hercules Capital. The agreement includes an initial $25 million tranche available upon closing and an additional $25 million contingent on the approval of afami-cel. The remaining $75 million will be available subject to certain conditions. This financing aims to bolster the company's balance sheet as it prepares for the commercial launch of afami-cel later this year and lete-cel in 2026. Adaptimmune's CFO, Gavin Wood, expressed confidence in the potential impact of afami-cel on sarcoma treatment. A live webcast will provide further Q1 financial and business updates.
Adaptimmune Therapeutics plc (NASDAQ: ADAP) will report Q1 2024 financial results and business updates on May 15, 2024. The company specializes in solid tumor cancer treatment using cell therapy. A live webcast will follow the announcement at 8:00 a.m. EDT (1:00 p.m. BST) on the same day.
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