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Entera Bio Appoints Dr. Rachel B Wagman as Key Clinical Advisor and Scientific Advisory Board Member

Entera Bio Appoints Dr. Rachel B Wagman as Key Clinical Advisor and Scientific Advisory Board Member

Entera Bio 任命 Rachel B Wagman 博士爲主要臨床顧問和科學顧問委員會成員
GlobeNewswire ·  05/15 20:00

JERUSALEM, May 15, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company"), a leader in the development of orally delivered peptides and small therapeutic proteins, today announced the appointment of Rachel B Wagman, MD, FACE, FACP, as Key Clinical Advisor and Member of its Scientific Advisory Board. Dr. Wagman brings more than 20 years of metabolic bone disease and women's health research and drug development experience to Entera. She has successfully advanced the development of five molecules, including the osteoporosis products teriparatide (Forteo), denosumab (Prolia) and romosozumab (Evenity) through clinical development, registration, and lifecycle management.

耶路撒冷,2024年5月15日(環球通訊社)——口服肽和小型治療蛋白開發領域的領導者Entera Bio Ltd.(納斯達克股票代碼:ENTX)(“Entera” 或 “公司”)今天宣佈任命FACP醫學博士雷切爾·瓦格曼爲主要臨床顧問兼科學顧問委員會成員。瓦格曼博士爲Entera帶來了20多年的代謝性骨病和女性健康研究和藥物開發經驗。她通過臨床開發、註冊和生命週期管理,成功推進了五種分子的開發,包括骨質疏鬆症產品特立帕肽(Forteo)、denosumab(Prolia)和romosozumab(Evenity)。

"Rachel's patient-focused approach and track record advancing multiple blockbuster treatments through clinical development to registration, coupled with her therapeutic specializations in the specific areas Entera is focused on, is a significant advantage in the continued build out of our oral peptide pipeline. We are extremely excited to welcome Rachel to Entera," said Miranda Toledano, CEO of Entera.

“Rachel以患者爲中心的方法和從臨床開發到註冊推進多種重磅療法的往績,再加上她在Entera專注的特定領域的治療專長,是我們持續擴大口服肽產品線的顯著優勢。我們非常高興歡迎瑞秋加入Entera。” Entera首席執行官米蘭達·託萊達諾說。

"I have been committed to bring innovative medicines to patients whose needs are not met with current treatment options. In osteoporosis, complacency is the largest barrier to help patients reduce the risk for fracture. Identification of new options to address their needs remains an important enterprise," said Dr. Wagman. "Entera's unique oral peptide delivery technology platform offers the prospect to address several chronic metabolic disorders. I am delighted to have the opportunity to work with the talented Entera team and support their work, which has the potential to significantly improve patient care."

“我一直致力於爲當前治療方案無法滿足需求的患者提供創新藥物。在骨質疏鬆症中,自滿情緒是幫助患者降低骨折風險的最大障礙。尋找滿足他們需求的新選擇仍然是一項重要的任務,” 瓦格曼博士說。“Entera獨特的口服肽輸送技術平台爲解決多種慢性代謝疾病提供了前景。我很高興有機會與才華橫溢的Entera團隊合作並支持他們的工作,這有可能顯著改善患者護理。”

Dr. Wagman's clinical leadership experiences include progressive roles at Eli Lilly, Amgen, and Myovant Sciences, where, as Senior Vice President, Clinical Development, she integrated Myovant's development portfolio into the newly-established Sumitomo Pharma America. She completed her BA at the University of Pennsylvania, MD at Jefferson Medical College, Internal Medicine residency at Thomas Jefferson University Hospital, and postdoctoral fellowship in Endocrinology, Gerontology, and Metabolism at Stanford University School of Medicine. She is a Fellow of both the American College of Endocrinology and the American College of Physicians and holds dual board certifications in Internal Medicine and Endocrinology, Diabetes, and Metabolism.

瓦格曼博士的臨床領導經歷包括在禮來、安進和Myovant Sciences擔任的漸進職務,作爲臨床開發高級副總裁,她將Myovant的開發組合整合到新成立的美國住友製藥公司。她在賓夕法尼亞大學完成了學士學位,在傑斐遜醫學院完成了醫學博士,在托馬斯·傑斐遜大學醫院完成了內科住院醫師學位,在斯坦福大學醫學院完成了內分泌、老年學和新陳代謝博士後獎學金。她是美國內分泌學會和美國內科醫師學會的會員,並擁有內科和內分泌學、糖尿病和新陳代謝方面的雙委員會認證。

About Entera Bio

關於 Entera Bio

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company's most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA's qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit or follow us on LinkedIn, Twitter, Facebook, Instagram.

Entera是一家臨床階段的公司,專注於開發口服肽或蛋白質替代療法,以滿足尚未滿足的重大醫療需求,在這些需求中,口服片劑有可能改變護理標準。該公司利用顛覆性的專有技術平台(N-Tab),其產品線包括五個差異化的、同類首創的口服肽項目,預計將在2025年進入臨床(第一階段至第三階段)。該公司最先進的候選產品 EB613(口服 PTH(1-34))正在開發中,它是首款口服、整骨代謝(造骨)片劑治療藥物,適用於骨密度低和高風險骨質疏鬆症的絕經後女性,此前沒有骨折。一項針對 EB613 片劑(n= 161)的安慰劑對照、劑量範圍的 2 期研究符合主要終點(PD/骨週轉生物標誌物)和次要終點(BMD)。根據美國食品藥品管理局對骨髓病定量終點的認證,Entera正準備啓動 EB613 的3期註冊研究,該研究預計將於2025年1月進行。EB612 計劃是作爲第一種口服 PTH(1-34)片劑肽替代療法開發的,用於甲狀旁腺功能減退症。Entera 還在開發第一款口服 oxyntomodulin,一種雙靶向 GLP1/Glucagon 肽,以片劑形式治療肥胖;並與 OPKO Health 合作開發了第一款口服 GLP-2 肽片劑,作爲針對患有罕見吸收不良疾病(例如短腸綜合徵)的患者的免注射替代品。有關Entera Bio的更多信息,請在領英、推特、臉書、Instagram上訪問或關注我們。

Cautionary Statement Regarding Forward Looking Statements

關於前瞻性陳述的警示聲明

Various statements in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

本新聞稿中的各種聲明均爲1995年《私人證券訴訟改革法》所指的 “前瞻性陳述”。本新聞稿中有關我們的前景、計劃、財務狀況、業務戰略以及預期財務和經營業績的所有陳述(歷史事實陳述除外)均可能構成前瞻性陳述。但不限於 “預測”、“相信”、“可以”、“可以”、“期望”、“估計”、“設計”、“目標”、“打算”、“可能”、“目標”、“計劃”、“預測”、“項目”、“目標”、“可能”、“可能”、“應該”、“將” 和 “會” 等詞語,或其中的否定詞術語和類似的表達方式或詞語,標識前瞻性陳述。前瞻性陳述基於當前的預期,涉及風險、情況變化、假設和不確定性。前瞻性陳述不應被視爲對未來業績或業績的保證,也可能無法準確表明何時實現此類業績或成果。

Important factors that could cause actual results to differ materially from those reflected in Entera's forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's expectations regarding licensing, business transactions and strategic collaborations; Entera's operation as a development stage company with limited operating history; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the "Cautionary Statements Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's most recent Annual Report on Form 10-K filed with the SEC, as well as the company's subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

可能導致實際結果與Entera前瞻性陳述中反映的結果存在重大差異的重要因素包括:臨床數據解釋的變化;我們的臨床試驗結果;美國食品藥品管理局對我們臨床試驗結果的解釋和審查;我們正在和計劃中的臨床前開發和臨床試驗的意外變化、監管申報以及獲得和維持候選產品的監管批准的時間和能力;潛在的製造供應鏈的中斷和延遲;Entera或其合作和實驗室合作伙伴的可用勞動力資源的流失;對Entera可能有合同義務提供的研發或臨床活動的影響;總體監管時間表;候選產品潛在市場的規模和增長;開發Entera候選產品的範圍、進展和成本;Entera對第三方進行臨床試驗的依賴;Entera對第三方進行臨床試驗的預期許可,商業交易和戰略合作;Entera作爲一家處於發展階段的公司的運營,運營歷史有限;Entera在沒有流動性來源的情況下繼續作爲持續經營企業的能力;Entera獲得和維持監管部門對其任何候選產品的批准的能力;Entera遵守納斯達克最低上市標準以及與遵守美國上市公司要求相關的其他事項的能力;Entera的知識產權狀況及其能力保護其智力財產;以及Entera最近向美國證券交易委員會提交的10-K表年度報告以及該公司隨後提交的10-Q表季度報告和8-K表最新報告中 “關於前瞻性陳述的警示性陳述”、“風險因素” 和 “管理層對財務狀況和經營業績的討論和分析” 部分中描述的其他因素。無法保證Entera預期的實際結果或發展能夠實現,即使已基本實現,也無法保證它們會對Entera產生預期的後果或影響。因此,無法保證此類前瞻性陳述和估計中陳述或暗示的結果將實現。Entera提醒投資者不要依賴Entera在本新聞稿中發表的前瞻性陳述。本新聞稿中的信息僅在本新聞稿發佈之日提供,除非法律要求,否則Entera沒有義務公開更新或修改任何前瞻性陳述,無論是由於新信息、未來事件還是其他原因。

CONTACT: Contact:  Entera Bio: Ms. Miranda Toledano Chief Executive Officer Entera Bio Email: miranda@enterabio.com
聯繫人:聯繫人:Entera Bio:Miranda Toledano 女士首席執行官 Entera Bio 電子郵件:miranda@enterabio.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。
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