BETHESDA, Md., Oct. 13, 2023 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, provided an update today about its progress toward submission of a Marketing Authorization Application (MAA) to the Medicines and Healthcare Products Regulatory Agency (MHRA)(the equivalent of the U.S. FDA) in the U.K. for commercial approval of the Company's DCVax-L treatment for glioblastoma.
The Company reported that the majority of the MAA has been completed, and all but one of the key sections of the MAA have been delivered to the publisher. The publisher is an independent party who does the final step of the preparation for the submission: formatting, checking references and the like.
The Company and its consultants are working intensively to finalize this last key section of the MAA, after overcoming an unexpected delay in that regard. The Company strongly believes that after so many years of work on the DCVax-L program, taking some additional time to help ensure that the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators.
An additional factor in the timeline is that certain expert consultants who are key to this remaining section will be temporarily unavailable during the next two-week period, returning the week of October 30. The Company anticipates that the remaining section of the MAA package will be delivered to the publisher within about two weeks after the consultants return.
The Company further anticipates that once this last section of the MAA is delivered to the publisher, they will need about two to three weeks to complete their work on both the last portion and the integrated whole. With this timeline, the submission of the MAA to the MHRA would take place between mid and late November. The Company plans to provide updates when the delivery is made to the publisher and when the MAA is submitted.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company's lead program involves DCVax-L treatment for glioblastoma (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." The Company has completed a 331-patient Phase III trial of of DCVax-L for GBM, and the results have been presented in scientific meetings and published in JAMA Oncology. The Company has also developed DCVax-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
馬里蘭州貝塞斯達,2023年10月13日 /PRNewswire/ — 開發DCVax實體瘤個性化免疫療法的生物技術公司西北生物治療公司(OTCQB:NWBO)(“NW Bio”)今天提供了其向美國藥品和保健產品監管局(MHRA)(相當於美國食品藥品管理局)提交上市許可申請(MAA)的最新進展 K. 申請該公司的膠質母細胞瘤dcVax-L治療藥物獲得商業批准。
該公司報告說,MAA的大部分內容已經完成,MAA的關鍵部分除一個以外的所有部分都已交付給出版商。出版商是一個獨立方,負責準備提交的最後一步:格式化、查看參考文獻等。
在克服了這方面的意外延誤之後,公司及其顧問正在加緊努力,以最終確定MAA的最後一個關鍵部分。該公司堅信,在DCVax-L計劃上進行了這麼多年的工作之後,再花一些時間來幫助確保完整的MAA一攬子計劃儘可能強大尤其重要,因爲該公司計劃向多個監管機構提交申請。
時間表中的另一個因素是,在接下來的兩週內,某些對剩餘部分至關重要的專家顧問將在10月30日這一週內暫時無法工作。該公司預計,MAA套餐的其餘部分將在顧問返回後約兩週內交付給出版商。
該公司還預計,一旦MAA的最後一部分交付給出版商,他們將需要大約兩到三週的時間才能完成最後一部分和整體的工作。按照這個時間表,MAA將在11月中旬至下旬提交給MHRA。公司計劃在向出版商交付和提交MAA時提供更新。
關於西北生物治療公司
Northwest Biotherapeutics是一家生物技術公司,致力於在北美和歐洲開發個性化免疫療法產品,這些產品旨在比目前的治療方法更有效地治療癌症,不存在與化療相關的毒性,並且具有成本效益。該公司擁有基於dcVax樹突狀細胞的疫苗的廣泛平台技術。該公司的主要項目涉及膠質母細胞瘤(GBM)的dcVax-L治療。GBM是最具侵略性和致命性的腦癌形式,是一種 “孤兒病”。該公司已經完成了一項針對GBM的dcVax-L的331名患者的III期試驗,結果已在科學會議上公佈並發表在《JAMA Oncology》上。該公司還開發了用於無法手術的實體瘤癌的DCVax-Direct。它已經完成了一項40名患者的一期試驗,並在資源允許的情況下計劃進行II期試驗。該公司此前曾與賓夕法尼亞大學一起使用dcVax-L進行了一項針對晚期卵巢癌的I/II期試驗。