• Abecma in the U.S. The Company reported collaborative arrangement revenue of approximately $1100萬 related to the collaboration with BMS for the three months ended September 30, 2024.
SELECt THIRD QUARTER FINANCIAL RESULTS
•Total revenues were $1350萬 for the three months ended September 30, 2024, compared to $1200萬 for the three months ended September 30, 2023. Total revenues were $3490萬 for the nine months ended September 30, 2024, compared to $8970萬 for the nine months ended September 30, 2023.
•Research and development expenses were $830萬 for the three months ended September 30, 2024, compared to $5130萬 for the three months ended September 30, 2023. Research and development expenses were $6830萬 for the nine months ended September 30, 2024, compared to $17950萬 for the nine months ended September 30, 2023.
•Selling, general and administrative expenses were $1290萬 for the three months ended September 30, 2024, compared to $1300萬 for the three months ended September 30, 2023. Selling, general and administrative expenses were $3540萬 for the nine months ended September 30, 2024, compared to $5320萬 for the nine months ended September 30, 2023.
•Net loss was $990萬 for the three months ended September 30, 2024, compared to $7160萬 for the three months ended September 30, 2023. Net loss was $3770萬 for the nine months ended September 30, 2024, compared to $16070萬 for the nine months ended September 30, 2023.
•The Company reiterates its net cash spend range of $4000-6000萬 for 2024.
在臨床試驗中接受ABECMA治療的349名患者中,有226名(65%)患者接受了tocilizumab;39%(135/349)患者只接受了一劑,而26%(91/349)患者接受了多於1劑的tocilizumab。整體上,24%(82/349)的患者至少接受過1劑皮質類固醇治療CRS。幾乎所有接受皮質類固醇治療CRS的患者也接受了tocilizumab。對於在460至510 x 10區間內接受治療的患者6 CAR陽性T細胞患者中,76%(54/71)患者接受了tocilizumab,35%(25/71)患者至少接受過1劑皮質類固醇治療CRS。對於在300至460 x 10 區間內接受治療的患者6 CAR陽性T細胞患者中,63%(152/241)患者接受了tocilizumab,20%(49/241)患者至少接受過1劑皮質類固醇治療CRS。
在KarMMa和KarMMa-3研究中接受ABECMA治療的患者中,有40%(139/349)發生了CAR T細胞相關神經毒性,其中有4%(14/349)的患者出現3級,而有0.6%(2/349)的患者出現4級。神經毒性的發作中位時間為2天(範圍:1至148天)。所有患者中包括存在神經事件的患者在死亡或數據截止時的中位CAR T細胞相關神經毒性持續時間為8天(範圍:1至720天)。 139名患者中有123名(88%)的CAR T細胞相關神經毒性得以解決,中位解決時間為5天(範圍:1至245天)。 349名有神經毒性的患者中有134名(38%)患者出現了CRS。在CRS期間出現的神經毒性有93名患者,12名患者在CRS發作之前出現,29名患者在CRS事件後出現。在460至510 x 10區間內治療的患者中,3級或4級CAR T細胞相關神經毒性的比率分別為5.6%(4/71)和3.7%(9/241)6 CAR陽性T細胞為300至460 x 10的劑量範圍內。6 CAR T 電芯相關的神經毒性最常見的(大於或等於5%)症狀包括腦病(21%)、頭痛(15%)、頭暈(8%)、譫妄(6%)和顫抖(6%)。
持久性輕微或重度細胞减少症: 在KarMMa和KarMMa-3研究中接受ABECMA治療的患者中,有40%的患者(139/349)出現持久性3級或4級中性粒細胞减少,42%(145/349)出現持久性3級或4級血小板减少,並且在接受ABECMA輸注後第1個月仍未解除。在恢復自3級或4級中性粒細胞减少的139名患者中,89%(123/139)的患者從ABECMA輸注後恢復的中位時間為1.9個月。在恢復自3級或4級血小板减少的145名患者中,76%(110/145)的患者恢復的中位時間為1.9個月。由於持久性細胞减少,五名患者接受幹細胞治療進行造血重建。接受劑量在460至510 x 10區間內的患者中,3級或4級血小板减少率分別為62%(44/71)和56%(135/241)。6 CAR陽性T細胞為300至460 x 10的劑量範圍內。6 CAR陽性T細胞。
Abecma is being jointly developed and commercialized in the U.S. as part of a Co-Development, Co-Promotion, and Profit Share Agreement between Bristol Myers Squibb and 2seventy bio. Bristol Myers Squibb assumes sole responsibility for Abecma drug product manufacturing and commercialization outside of the U.S. The companies’ clinical development program for Abecma includes ongoing clinical studies (KarMMa-2, KarMMa-3) in earlier lines of treatment for patients with multiple myeloma. For more information visit clinicaltrials.gov.
關於2seventy bio
Our name, 2seventy bio, reflects why we do what we do - TIME. Cancer rips time away, and our goal is to work at the maximum speed of translating human thought into action – 270 miles per hour – to give the people we serve more time. With a deep understanding of the human body’s immune response to tumor cells and how to translate cell therapies into practice, we’re applying this knowledge to deliver the first FDA-approved CAR t cell therapy for multiple myeloma to as many patients as possible. Importantly, we remain focused on accomplishing our mission by staying genuine and authentic to our “why” and keeping our people and culture top of mind every day. For more information, visit www.2seventybio.com.
Follow 2seventy bio on social media: X (Twitter) and LinkedIn.
2seventy bio是2seventy bio, Inc.的商標。
關於前瞻性陳述的注意事項
This release contains “forward-looking statements” within the meaning of applicable laws and regulations. These statements include, but are not limited to: statements regarding expected ABECMA
(ide-cel) U.S. revenue, including potential demand; statements regarding expected benefits from our strategic collaboration with BMS; statements about the discontinuation of the ongoing Phase 3 KarMMa-9 study, including the potential cost savings; statements about the efficacy and perceived therapeutic benefits of ABECMA;有關我們戰略重組和預期節省成本的聲明;有關我們的財務狀況、支出、營運結果、對資本使用的期望、現金途程、達到盈虧平衡的途徑、淨現金支出和其他未來的財務結果的聲明;有關我們的業務計劃和策略的聲明;以及有關我們能否執行戰略重點的聲明。本新聞稿中的任何前瞻性聲明均基於管理層目前的期望和信念,並受到一系列風險、不確定因素和重要因素的影響,這些因素可能導致本新聞稿中包含的任何前瞻性聲明與實際事件或結果有重大差異,包括但不限於,我們有限的獨立運營歷史和我們的會計和其他管理系統可能無法準備滿足作為獨立上市公司的財務報告和其他要求的風險;風險 Abecma 將不會像我們預期的那樣取得商業上的成功;我們戰略重組以專注於...的發展和商業化。 Abecma 可能不如預期成功,可能無法實現預期的成本節省,可能導致對我們業務的干擾,這可能使我們難以實現我們的戰略目標;以及我們無法管理我們的營業費用或現金用於營運。有關其他風險和不確定性的討論,以及其他重要因素,這些因素中的任何一項都可能導致我們的實際結果與前瞻性聲明中包含的結果不符,請參閱我們“風險因素”一節」,該節在我們的 於2024年3月7日提交的10-k表格, 及我們不時向證券交易委員會提交的其他申報。本新聞稿中的所有信息截至本新聞稿發布日期,除非法律要求,我們無需更新此信息。所有本新聞稿中的信息均截至本稿日期,我們不承擔更新此信息的義務,除非法律要求。