share_log

FibroGen Enters Into Exclusive License for FOR46 With Fortis Therapeutics

FibroGen Enters Into Exclusive License for FOR46 With Fortis Therapeutics

FibroGen 與 Fortis Therapeutics 簽署 FOR46 的獨家
GlobeNewswire ·  2023/05/09 04:06
  • FOR46, an ADC targeting CD46, is in Phase 1 development with potential applications in mCRPC and other CD46-expressing cancers
  • Collaboration expands FibroGen's clinical pipeline with potential first-in-class product candidate
  • FOR46 是一種靶向 CD46 的 ADC,目前正處於 1 期開發階段,可能應用於 mcRPC 和其他表達 CD46 的癌症
  • 合作擴大了FibroGen的臨床產品線,開發了潛在的同類首創候選產品

SAN FRANCISCO and LA JOLLA, Calif., May 08, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq: FGEN) and Fortis Therapeutics announced that FibroGen has entered into an exclusive license with Fortis Therapeutics for FOR46, a potential first-in-class Phase 1 antibody-drug conjugate (ADC) targeting a novel epitope on CD46. FOR46 is being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and is being explored for use in other CD46 expressing cancers. As part of the clinical development strategy, FibroGen will continue Fortis Therapeutics' work to develop a PET-based biomarker utilizing a radiolabeled version of the targeting antibody (PET46) for patient selection.

舊金山和加利福尼亞州拉霍亞,2023年5月8日(GLOBE NEWSWIRE)——FibroGen, Inc.(納斯達克股票代碼:FGEN)和富通療法宣佈,FibroGen 已與 Fortis Therapeutics 簽訂了 FOR46 的獨家許可,這是一種潛在的同類首創 1 期抗體藥物偶聯物 (ADC),靶向 CD46 上的新表位。FOR46 正在開發用於治療轉移性去勢抵抗性前列腺癌 (mcRPC),並正在探索用於其他表達 CD46 的癌症。作爲臨床開發戰略的一部分,FibroGen將繼續努力開發基於PET的生物標誌物,利用靶向抗體(PET46)的放射性標記版本進行患者選擇。

"The agreement with Fortis Therapeutics bolsters FibroGen's clinical pipeline in a capital-efficient manner, providing a product candidate with the potential to address a significant unmet medical need in oncology," said Enrique Conterno, Chief Executive Officer, FibroGen. "FOR46 is a natural fit with our R&D capabilities and expertise. The flexibility of the agreement gives us the opportunity to clinically develop FOR46, and ultimately acquire it as a Phase 3-ready asset, potentially delivering a therapy that may transform the treatment of patients with mCRPC and other CD46 expressing cancers."

FibroGen首席執行官恩裏克·康特爾諾表示:“與Fortis Therapeutics的協議以資本效率的方式加強了FibroGen的臨床產品線,爲有可能解決腫瘤學中未得到滿足的重大醫療需求提供了候選產品。”“FOR46 自然符合我們的研發能力和專業知識。該協議的靈活性使我們有機會在臨床上開發 FOR46,並最終將其作爲3期就緒資產收購,從而有可能提供一種可能改變mcRPC和其他表達CD46的癌症患者的治療方法的療法。”

"We are pleased to partner with the team at FibroGen, who are experienced in advancing novel drug candidates in the clinic for life-threatening diseases," said Jay Lichter, Ph.D., President and CEO of Fortis and Managing Partner of Avalon Bioventures. "We believe that FOR46 is a novel and unique antibody drug conjugate therapy that could help patients with prostate cancer and other cancers, where currently approved treatments have failed."

富通總裁兼首席執行官兼Avalon Bioventures管理合夥人傑伊·利希特博士說:“我們很高興與FibroGen的團隊合作,他們在爲危及生命的疾病的臨床開發新候選藥物方面經驗豐富。“我們認爲,FOR46 是一種新穎而獨特的抗體藥物偶聯療法,可以幫助前列腺癌和其他癌症的患者,而目前批准的治療已經失敗。”

Under the terms of the agreement, there is no upfront consideration. FibroGen will conduct and fund future research, development, and manufacturing of FOR46 and PET46. During the four-year evaluation period, FibroGen has the option to acquire Fortis Therapeutics for $80 million. In addition, Fortis is eligible to receive up to a total of $200 million based on various regulatory approvals.

根據協議條款,沒有預先對價。FibroGen 將進行 FOR46 和 PET46 的未來研究、開發和製造併爲其提供資金。在四年的評估期內,FibroGen可以選擇以8000萬美元的價格收購Fortis Therapeutics。此外,根據各種監管部門的批准,富通有資格獲得高達2億美元的總額。

About FOR46

關於 FOR46

FOR46 is an antibody drug conjugate that binds a specific conformational epitope of CD46 that is highly expressed in various cancer types, including multiple myeloma and prostate and colorectal tumors, with limited reactivity against normal tissues. FOR46 is a fully human antibody conjugated to MMAE, a potent cytotoxic payload utilized in a variety of approved ADCs. Early clinical data show FOR46 to be generally well tolerated with demonstrated monotherapy activity in multiple myeloma and mCRPC.

FOR46 是一種抗體藥物偶聯物,可結合 CD46 的特定構象表位,該表位在各種癌症類型中高度表達,包括多發性骨髓瘤以及前列腺和結直腸腫瘤,對正常組織的反應性有限。FOR46 是一種與 MMAE 偶聯的全人類抗體,MMAE 是一種有效的細胞毒性有效載荷,用於各種經批准的 ADC。早期臨床數據顯示,FOR46 的耐受性總體良好,在多發性骨髓瘤和 mcRPC 中表現出單一療法活性。

About FibroGen
FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in connective tissue growth factor (CTGF) biology and hypoxia-inducible factor (HIF) to advance innovative medicines for the treatment of unmet needs. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), metastatic pancreatic cancer, and Duchenne muscular dystrophy (DMD). Roxadustat (爱瑞卓, EVRENZO) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on dialysis and not on dialysis. Roxadustat is in clinical development for anemia of chronic kidney disease (CKD) and anemia associated with myelodysplastic syndromes (MDS), and for chemotherapy-induced anemia (CIA). FibroGen recently expanded its research and development portfolio to include product candidates in the immuno-oncology space. For more information, please visit .

關於纖維根
FibroGen, Inc. 是一家生物製藥公司,致力於發現、開發和商業化一系列一流的療法。該公司運用其在結締組織生長因子(CTGF)生物學和缺氧誘導因子(HIF)方面的開創性專業知識來推進用於治療未滿足需求的創新藥物。Pamrevlumab是一種抗ctGF人類單克隆抗體,正在臨床開發中,用於治療特發性肺纖維化(IPF)、局部晚期不可切除的胰腺癌(LAPC)、轉移性胰腺癌和杜興氏肌營養不良症(DMD)。Roxadustat (Roxadustat,EVRENZO)目前已在中國、歐洲、日本和許多其他國家獲准用於治療接受透析和未接受透析的 CKD 患者的貧血。Roxadustat正在臨床開發中,用於慢性腎臟病(CKD)貧血、與骨髓增生異常綜合徵(MDS)相關的貧血,以及化療誘發的貧血(CIA)。FibroGen最近擴大了其研發產品組合,將免疫腫瘤學領域的候選產品包括在內。欲瞭解更多信息,請訪問。

About Fortis Therapeutics

關於富通療法

Fortis Therapeutics is an immuno-oncology biotech developing a novel antibody-drug conjugate for late-stage multiple myeloma and metastatic castration-resistant prostate cancer. Fortis was founded based on technology exclusively licensed from UCSF and developed in the laboratory of Bin Liu, Ph.D. Fortis is located in Avalon Bioventures's Community of Innovation, in San Diego. FOR46 is Fortis' sole pharmaceutical asset. For more information, please visit .

Fortis Therapeutics是一家免疫腫瘤生物技術公司,正在開發一種用於晚期多發性骨髓瘤和轉移性去勢抵抗性前列腺癌的新型抗體藥物偶聯物。富通基於加州大學舊金山分校獨家許可的技術成立,由劉斌博士的實驗室開發。富通位於聖地亞哥的Avalon Bioventures創新社區。FOR46 是 Fortis 唯一的製藥資產。欲瞭解更多信息,請訪問。

Forward-Looking Statements
This release contains forward-looking statements regarding FibroGen's strategy, future plans and prospects, and the timing of potential events, including statements regarding the development and commercialization of the company's product candidates, the potential safety and efficacy profile of its product candidates, and timelines for our clinical programs. These forward-looking statements include, but are not limited to, statements about FibroGen's plans and objectives and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. FibroGen's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen's Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the Securities and Exchange Commission (SEC) on February 27, 2023, including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

前瞻性陳述
本新聞稿包含有關FibroGen戰略、未來計劃和前景以及潛在事件發生時間的前瞻性陳述,包括有關公司候選產品的開發和商業化、其候選產品的潛在安全性和有效性特徵以及我們的臨床項目時間表的陳述。這些前瞻性陳述包括但不限於關於FibroGen計劃和目標的陳述,通常使用諸如 “可能”、“將”、“應該”、“步入正軌”、“可能”、“期望”、“計劃”、“預期”、“相信”、“估計”、“預測”、“潛在”、“繼續” 等術語來識別,儘管一些前瞻性陳述的表達方式有所不同。FibroGen的實際業績可能與這些前瞻性陳述中顯示的結果存在重大差異,這是由於與其各項計劃的持續進展和時間安排相關的風險和不確定性,包括正在進行的和可能的未來臨床試驗的註冊人數和結果,以及FibroGen於2023年2月27日向美國證券交易委員會(SEC)提交的截至2022年12月31日財年的10-K表年度報告中描述的其他事項,包括列出的風險因素在其中。提醒投資者不要過分依賴這些前瞻性陳述,這些陳述僅代表截至本新聞稿發佈之日,除非法律要求,否則FibroGen沒有義務更新本新聞稿中的任何前瞻性陳述。

Contacts:
FibroGen, Inc.

聯繫人:
FibroGen, Inc.

Investors:
Michael Tung, M.D.
Corporate Strategy / Investor Relations
415.978.1434
mtung@fibrogen.com

投資者:
邁克爾·東,醫學博士
企業戰略/投資者關係
415.978.1434
mtung@fibrogen.com

Media:
Meichiel Jennifer Keenan
Investor Relations/Corporate Communications
mkeenan@fibrogen.com

媒體:
梅希爾·詹妮弗·基南
投資者關係/企業傳播
mkeenan@fibrogen.com

Fortis Therapeutics
Media:
Jessica Yingling
858.344.8091
jessica@litldog.com

富通療法
媒體:
傑西卡英林
858.344.8091
jessica@litldog.com


譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
    搶先評論