2seventy bio, Inc (NASDAQ:TSVT) and its partner Bristol Myers Squibb & Co (NYSE:BMY), will discontinue enrollment in its ongoing Phase 3 KarMMa-9 study of Abecma (idecabtagene vicleucel; ide-cel) with lenalidomide maintenance versus lenalidomide maintenance alone for newly diagnosed multiple myeloma (NDMM) who have suboptimal response to autologous stem cell transplant.
"Consistent with our focus on capital allocation and creating value for all stakeholders, we anticipate this decision will conserve over $80 million in near-term expenditures and accelerate our path to breakeven in 2025," said Chip Baird, CEO of 2seventy bio.
Also Read: FDA Approves Bristol-Myers/2seventy Bio's Abecma For Earlier Use In Pretreated Blood Cancer Patients With Updated Boxed Warning On Secondary Cancer.
2seventy also reported continued positive momentum in Abecma's expected return to growth in the earlier line setting following the FDA's approval in April 2024.
The company expects third-quarter Abecma U.S. revenue growth of approximately 30% from second-quarter revenue of $54 million. Demand, as measured by new patients undergoing apheresis in the third quarter, is also expected to reflect double-digit growth compared to the second quarter of 2024.
William Blair says while expectations for Abecma are generally low for investors at this point, the ability to maximize the opportunity in the current label would offset concerns about the fixed costs of the cell therapy franchise.
2seventy bio and BMS share equally in all profits and losses related to the development, manufacturing, and commercialization of Abecma in the U.S.
Overall, the announcement suggests moving CAR-T therapies into the earliest lines of treatment may have headwinds given the strong current standard of care. Therefore, we think thoughtful trial designs that reflect the changing standard of care will have the greatest potential of maximizing the CAR-T total addressable market."
Recently, Novo Nordisk A/S (NYSE:NVO) acquired the Hemophilia A program and rights to 2seventy's in vivo gene editing technology outside of oncology and gene editing for autologous or allogeneic cell therapies of immune cells for autoimmune disease.
2seventy bio will focus exclusively on the commercialization and continued development of Abecma.
Price Action: TSVT stock is down 7.65% at $4.41, and BMY stock is down 2.90% at $49.47 at last check Wednesday.
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2seventy bio, Inc（納斯達克股票代碼：TSVT）及其合作伙伴百時美施貴寶公司（紐約證券交易所代碼：BMY）將停止註冊正在進行的針對Abecma（idecabtagene vicleucel；ide-cel）的3期Karmma-9研究，該研究對自體反應不佳的新診斷多發性骨髓瘤（NDMM）採用來那度胺維持對比單獨維持的Abecma（idecabtagene vicleucel；ide-cel）幹細胞移植。
2seventy bio首席執行官奇普·貝爾德表示：「根據我們對資本配置和爲所有利益相關者創造價值的關注，我們預計這一決定將節省超過8000萬美元的短期支出，並加快我們在2025年實現盈虧平衡的道路。」
另請閱讀：美國食品藥品管理局批准Bristol-Myers/2Seventy Bio的Abecma更早地用於預先治療的血液癌患者，並更新了有關繼發性癌症的方框警告。
2seventy還報告稱，繼美國食品藥品管理局於2024年4月批准後，Abecma的預期恢復增長勢頭持續良好。
該公司預計，第三季度Abecma美國收入將從第二季度的5400萬美元收入增長約30％。以第三季度接受血液分離術的新患者來衡量，與2024年第二季度相比，需求預計也將反映出兩位數的增長。
威廉·布萊爾說，儘管目前投資者對Abecma的期望普遍較低，但最大限度地利用當前標籤的機會將抵消對細胞療法特許經營權固定成本的擔憂。
2seventy bio和BMS平均分攤與Abecma在美國的開發、製造和商業化相關的所有利潤和虧損。
總體而言，該公告表明，鑑於目前強大的護理標準，將CAR-T療法納入最早的治療方案可能會帶來不利因素。因此，我們認爲，反映護理標準變化的深思熟慮的試驗設計將最有可能最大限度地提高CAR-t的總體潛在市場。”
最近，Novo Nordisk A/S（紐約證券交易所代碼：NVO）收購了Hemophilia A項目以及除腫瘤學和基因編輯之外的2seventy體內基因編輯技術的版權，用於自身免疫性疾病免疫細胞的自體或異基因細胞療法。
2seventy bio將專門專注於Abecma的商業化和持續發展。
價格走勢：在週三的最後一次檢查中，tSVT股價下跌7.65％，至4.41美元，BMY股價下跌2.90％，至49.47美元。
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