AMA Webinar: FDA Review Process for COVID-19 Vaccine Candidates (Episode 1 of a series)

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UBI/聯亞集團提出高精準設計COVID-19新冠疫苗UB-612第二期臨床試驗申請

發佈日期:中華民國109年11月12日

聯亞生技於11月9日向台灣食品藥物管理署(TFDA)提出高精準設計COVID-19新冠疫苗UB-612第二期人體臨床試驗申請,預計於今年年底前可以開始進行試驗。

聯亞生技表示,UB-612第一期臨床試驗受試者施打疫苗,安全狀況均呈現良好。第二期臨床試驗將採多中心、安慰劑對照、隨機分派、觀察者盲性之設計,於青少年及成人受試者進一步探討UB-612疫苗之免疫原性、安全性及耐受性,預計將招募約4,000名受試者。同時,TFDA已指派技術查核人員蒞廠監督UB-612疫苗成分與製劑之生產,使公司於明年第三季達成COVID-19 疫苗於台灣取得緊急使用授權(EUA)之商業規模量產要求。

UB-612疫苗係UBI/聯亞集團利用其獨有之專利平台技術,針對SARS-CoV-2病毒高精準設計(high precision design),為全球首創之COVID-19多重表位次單位疫苗(Multitope Protein/Peptide-based Vaccine;MPV)。UB-612除了含有精準設計之S1-RBD病毒抗原外,更加入了獨創之CTL及Th抗原決定位胜肽,這些胜肽選自於可與人類MHC I和II結合且具免疫優勢之M、S2和N部位。此經過精準設計之Th/CTL混合胜肽可以活化T細胞,並引發T細胞之記憶反應和效用功能。在動物試驗中,注射UB-612疫苗除了使動物產生大於10,000倍稀釋之高度特異性中和抗體(遠高於目前國際間任何COVID-19疫苗),亦可產生Th1型之T細胞免疫反應。預期具多重成分之UB-612疫苗於人體將能引起均衡之B細胞活化並擴大T細胞免疫反應,以達到良好保護效果。此外,UB-612不需以超低溫冷鏈運送及儲存,比輝瑞/BNT等公司所開發之RNA疫苗更具競爭優勢。

UB-612疫苗第一期臨床試驗於健康成人受試者施打兩劑UB-612疫苗,受試者分低、中、高三個劑量組,每組20位,共收60位,主要目的為探索本疫苗之安全性、耐受性及免疫原性。試驗醫院為中國醫藥大學附設醫院,由黃高彬副院長擔任試驗主持人。

關於UBI集團

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全人單株抗體UB-621用於復發性生殖器皰疹病患2期臨床試驗獲中國NMPA核准執行

聯合生物製藥(股)公司(聯生藥)今日宣佈,其候選抗體新藥UB-621應用於治療復發性生殖器皰疹(recurrent genital herpes) 之2期臨床試驗已獲中國國家藥品監督管理局(National Medical Products Administration,NMPA)核准執行。

生殖器皰疹是肛周、生殖器區域感染HSV-2病毒所引起,是生殖器潰瘍之主因,也是常見的性傳播感染病之一。生殖器皰疹患者可能會反復發作症狀,已被視為一個重大的全球性公共衛生問題,因為它也會加劇愛滋病毒HIV-1的傳播。

目前市場上尚無針對復發性生殖器皰疹的有效疫苗,治療藥物主要為抑制病毒DNA合成的小分子核苷類藥物,例如acyclovir、valacyclovir和famciclovir等。這些藥物僅能達到病症減緩作用,無法清除潛伏體內的HSV病毒,患者可能因免疫力低下而復發生殖器皰疹。儘管已有幾種藥物可用於治療生殖器皰疹發作和做為抑制性治療,但這些抗病毒藥並不一定有效;有超過半數的患者即使接受了長期抑制療法,仍會經歷生殖器皰疹的復發,並且約有0.1〜0.6%免疫力正常的患者可能產生抗藥性,在免疫功能低下患者中的抗藥性更高達3.5〜10%。因此,部分復發性生殖器皰疹患者仍需要更有效的治療或症狀緩解藥物。

UB-621是一支新型的全人源單克隆抗體,透過專一性、高親和力結合HSV病毒表面醣蛋白gD來干擾HSV感染細胞,體外試驗顯示UB-621可以抑制野生型與多重抗藥的HSV感染宿主細胞,且可抑制HSV在細胞間的傳播(cell-to-cell spread)。我們的臨床前和一期臨床數據表明,UB-621具有應用於抑制生殖器皰疹復發的潛力。

關於UB-621

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United BioPharma Received IND Approval from China NMPA for UB-621 Phase 2 Trial in Patients with Recurrent Genital Herpes

Taipei, Taiwan – November 10th, 2020 –United BioPharma (UBP) announced today that they have received Investigational New Drug (IND) approval from China National Medical Products Administration (NMPA) to conduct a Phase 2 clinical trial with UB-621, an anti-HSV (Herpes Simplex Virus) monoclonal antibody, to evaluate its safety and efficacy in adults with recurrent genital herpes.

Earlier in an open label, dose-escalation Phase 1 study, UB-621 was demonstrated to be safe and well-tolerated in 15 healthy volunteers receiving a single subcutaneous (SC) injection of UB-621 at doses ranging from 0.1 mg/kg to 5 mg/kg. In particular, UB-621 was found to have a remarkably long half-life of approximately 25 days. The current Phase 2 study is a randomized, single-blinded, placebo-controlled study to investigate the efficacy and safety of single dose UB-621 treatment for recurrent genital herpes.

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UBI/聯亞集團所研發之高精準設計COVID-19疫苗UB-612第一期臨床試驗計畫獲台灣衛福部同意施打受試者

發佈日期:中華民國109年9月25日

新聞聯絡人:戴源宏副總經理

聯絡電話:(03) 598-4151分機6651

 

聯亞生技今日宣佈,在補齊第一期臨床試驗技術性資料後,UBI/聯亞集團所研發之高精準設計COVID-19疫苗UB-612獲台灣衛福部同意施打受試者,第一批6位合格受試者已接受UB-612疫苗注射。

聯亞生技表示,第一期臨床試驗將於健康成人受試者施打兩劑UB-612疫苗,受試者分低、中、高三個劑量組,每組20位,預計共收60位,主要目的為探索本疫苗之安全性、耐受性及免疫原性。試驗醫院為中國醫藥大學附設醫院,由黃高彬副院長擔任試驗主持人。

關於UB-621疫苗

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COVAXX Initiates Phase 1 Clinical Trial of COVID-19 Vaccine UB-612 in Taiwan

  • First Patients Safely Dosed with UB-612
  • Clinical Trial Currently Enrolling up to 60 Healthy Volunteers
  • Taiwan’s Ministry of Health and Wellness Approves Up to $15M (USD) Grant to Support Phase 1 and 2 of Human Trials
  • Clinical Trial Expands on Existing International Collaborations with Brazil and U.S.

HAUPPAUGE, NY and HSINCHU, TAIWAN (September 28th, 2020) –COVAXX announced today that the first patients were safely dosed in the company’s Phase 1, open-label, dose-escalation study of the UB-612 vaccine candidate for COVID-19 in Taiwan. The study is partly supported by a grant from the Ministry of Health and Welfare in Taiwan of up to 430M (NTD) or approximately $15M (USD). This clinical trial expands the international collaborations of COVAXX after the recently announced agreements with Dasa, the largest diagnostic medicine company in Brazil and Latin America, and with The University of Nebraska Medical Center to conduct large scale human efficacy clinical trials in Brazil and the United States, respectively.

“Administering the initial dose of our vaccine candidate to the first participants not only marks the start of this Phase 1 clinical trial but also represents a significant step forward in the global fight against COVID-19,” said Mei Mei Hu, co-Chief Executive Officer of COVAXX.

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Beyond the Spike: The COVAXX Approach to a COVID-19 Vaccine

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Peter H. Diamandis, PhD, calls himself a “data-driven optimist,” which is a necessary quality for an entrepreneur who relishes tackling grand challenges.

His XPRIZE Foundation has created $10-million incentive competitions focused on the life sciences and other areas, while his venture capital fund, BOLD Capital Partners, has invested $250 million in innovative or “exponential” technologies. His Abundance 360 summits have brought together entrepreneurs, executives, and investors to apply those technologies toward transforming their businesses. His Singularity University focuses on solving global problems through educational programs, partnerships, and a startup accelerator. Diamandis’ companies also specialize in cellular therapeutics (Celularity), personalized machine learning (Futureloop), and longevity health (Fountain Life and Human Longevity).

Another Diamandis company, United Neuroscience, combats animal and human diseases by discovering, developing, and commercializing vaccines and monoclonal antibody treatments. Earlier this year, United Biomedical created a subsidiary called COVAXX focused on tackling COVID-19 through a vaccine as well as through antibody diagnostics deployed in China, Taiwan, and several U.S. states. The company’s serology test is designed to complement RT-PCR testing by helping identify asymptomatic COVID-19 patients and those who were infected and have recovered.

COVAXX’s UB-612 program focuses on developing its Multitope Peptide-based Vaccine against SARS-CoV-2, constructed from a peptide-based platform first deployed by United Biomedical. The vaccine platform has been commercialized successfully in more than 500 million doses annually and 5 billion doses cumulatively in animal health indications for infectious disease.

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UBI/聯亞集團所研發之高精準設計COVID-19疫苗UB-612獲台灣衛福部有條件核准進行第一期臨床試驗

發佈日期:中華民國109年8月28日

新聞聯絡人:戴源宏 副總經理

聯絡電話:(03) 598-4151分機6651

聯亞生技今日宣佈,台灣衛生福利部食品藥物管理署(TFDA)有條件核准UBI/聯亞集團所研發之高精準設計COVID-19疫苗UB-612進行第一期臨床試驗聯亞生技將開始篩選合格受試者待於九月初完成補件並取得正式核准後,開始施打疫苗。本試驗將於健康成人受試者施打兩劑UB-612疫苗,受試者分低、中、高三個劑量組每組20位預計共收60位,主要目的為探索本疫苗之安全性、耐受性及免疫原性。試驗醫院為中國醫藥大學附設醫院黃高彬主任擔任試驗主持人。

聯亞生技表示,UB-612疫苗係UBI/聯亞集團利用其獨有之專利平台技術,針對SARS-CoV-2病毒開發之高精準設計疫苗(high precision designer vaccine)。UB-612除了含有精準設計之S1-RBD病毒抗原外,更加入了全球首創之CTL及Th抗原決定位胜肽這些胜肽選自於可與人類MHC I和II結合且具免疫優勢之M、S2和N部位。此經過精準設計之Th/CTL混合胜肽可以活化T細胞,並引發T細胞之記憶反應和效用功能。在動物試驗中,注射UB-612疫苗除了使動物產生大於10,000倍稀釋之高度特異性中和抗體(遠高於目前國際間任何COVID-19疫苗),亦可產生Th1型之T細胞免疫反應。預期具多重成分之UB-612疫苗於人體將能引起均衡之B細胞活化並擴大T細胞免疫反應,以達到良好保護效果

基於以上非臨床試驗結果,UB-612疫苗已有條件獲准於台灣進行第一期臨床試驗並規劃於台灣美國及巴西等國進行第二/三期多國多中心臨床試驗,以證實疫苗之療效與安全性UBI/聯亞集團已在台灣建立TFDA及美國FDA核准之生產設施,並計劃在2020年12月至2021年第一季間於集團內公司生產5,000萬至1億劑疫苗,2021年則可在無需委外之情況下生產5至10億劑,使得未來定價極具成本效益之競爭性

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聯生藥抗體新藥UB-421用於多重抗藥性愛滋病患3期臨床試驗獲中國NMPA核准執行

聯合生物製藥(股)公司(聯生藥)今日宣佈,其抗體新藥UB-421應用於治療多重抗藥性(multi-drug resistant (MDR)HIV感染病患之3期臨床試驗今日獲中國國家藥品監督管理局(National Medical Products Administration,NMPA)核准執行。這項研究是一個多國臨床試驗,包括台灣、中國等。相同的臨床試驗方案先前已獲台灣衛生福利部食品藥物管理署核准。

大多數HIV感染者可以通過聯合抗逆轉錄病毒療法(combined antiretroviral therapy,ART) 獲得良好治療效果,亦即可以將血中HIV RNA壓抑至檢測不到之水平;然而,一小部分患者會對多種藥物或多種類型的藥物產生抗藥性,臨床醫師已無法建構有效的ART方案藥物壓抑該群患者血中之HIV-RNA含量至無法檢測之水平。這群病患由於治療選擇非常有限,故處於容易產生HIV相關併發症和發展為愛滋病 (AIDS)的高風險。因此這群患者迫切需要一種相對安全、新類型藥物且無藥物相互作用或交叉耐藥性(cross-resistance)的新療法。

在這項3期臨床試驗中,將招募共50名對多種抗逆轉錄病毒藥物具有耐藥性,已經有高度治療歷史的 HIV感染患者。本臨床試驗方案是根據美國FDA指南設計,先於2週內評估主要藥效終點(HIV RNA含量降低至少0.5 log),然後在24週的維持期間(maintenance phase)評估次要藥效和安全終點。

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United BioPharma Received IND Approval from China NMPA for a Phase 3 Trial with UB-421 in Patients with Multi-Drug Resistance (MDR) HIV-1 infection

Taipei, Taiwan –Aug. 21, 2020 –United BioPharma (UBP) announced today that they have received Investigational New Drug (IND) approval from the China National Medical Products Administration (NMPA) to conduct a Phase 3 clinical trial with UB-421, an anti-CD4 monoclonal antibody, in patients with multi-drug resistant (MDR) HIV-1 infection. The study is a multi-nation trial which will include Taiwan and China; the same protocol was approved earlier this year by TFDA.

A majority of people living with HIV can be successfully treated with combined antiretroviral therapy (ART); however, a subset of patients develop resistance to multi-drugs or multi-drug classes, and are unable to tolerate a regimen that could suppress HIV-RNA to undetectable levels. With very limited treatment options, these patients are at a higher risk of HIV-related complications and progression to AIDS. The MDR patients are in vital need of a new treatment that is relatively safe, and without drug-drug interactions or cross-resistance.

In this multi-nation Phase 3 trial, a total of 50 HIV-infected patients who are highly treatment- experienced with resistance to multi-classes of antiretroviral agents will be enrolled. The protocol is designed according to US FDA guidance to evaluate the primary efficacy endpoint (at least 0.5 log reduction of HIV RNA achieved) within 2 weeks, followed by a maintenance phase of 24-weeks to assess the secondary efficacy and safety endpoints. The dosing regimen of UB-421 is 25 mg/Kg bi-weekly via intravenous (iv) administration.

About UB-421

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聯生藥抗體新藥UB-421皮下注射(SC)劑型 獲台灣衛福部核准進行臨床I期試驗

聯合生物製藥(股)公司(聯生藥)今日宣佈,台灣衛生福利部食品藥物管理署(TFDA)已核准其開發中抗體新藥UB-421之皮下注射(SC)劑型在HIV-1感染、但尚未接受任何藥物治療 (treatment naive)的患者上進行I 期臨床試驗。

本次臨床試驗是一項開放標示、多劑量、評估UB-421的安全性、藥物動力學和抗病毒活性的研究。受試者條件為先前未接受抗逆轉錄病毒藥物(Anti-Retroviral drugs)治療的HIV-1陽性、無症狀成年人,試驗方案為每週皮下注射UB-421持續4週,分三個不同劑量組(250 mg 、500 mg和700 mg),4週後再給予標準ART療法(Anti-Retroviral Therapy)。本次試驗預計招募18名受試者,每個劑量組有6名。

UB-421 的皮下注射劑型開發可提供一種比靜脈輸液(IV)途徑更方便的給藥方法,從而使患者可以在家中自行施打UB-421,進而改善患者的治療依從性。 UB-421 皮下注射劑型乃是由更高產量的細胞株生產,並製成冷凍乾燥形式。凍乾劑型UB-421在使用前以注射用水(Water For Injection)回溶後形成可皮下注射的藥劑。在前臨床動物實驗結果顯示,UB-421 皮下注射與靜脈輸注劑型對於中和HIV與抑制病毒載量具有相等的藥效。

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新冠肺炎病毒疫苗發展瓶頸及解決之道座談會

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聯亞集團董事長特助彭文君博士向社會大眾報告UBI /聯亞生技集團新冠肺炎研發進度。

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Total confirmed COVID-19 cases

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騰訊新聞:新型冠狀病毒肺炎疫情實時追蹤

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Coronavirus Dashboard

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60 個傳福音最常遇見的問題與解答

C. Caroline Wang
Professor of Business Practice
School of Business and Management
Hong Kong University of Science and Technology

序  言

在我们探索真理的过程中,一定会有很多提问(questions),这些提问会不会成为我们的问题(problems)呢,就看我们在寻找什么?

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《@老謝看世界》2020.11. 28 半導體重磅出招 蘋果M1鬼滅晶片戰 曲建仲、鄭清文

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BEFORE YOU STEP OUT OF THE WILL OF GOD

In this message, Dr. Stanley conveys an essential challenge from Scripture—will we choose our way, or God’s? A closer look at the lives of Old and New Testament saints reveals the painful consequences of choosing less than His best. Disobedience carries a high price, but the blessings of obedience are without number.

Also this week: The Great Deception

This sermon was recorded before COVID-19. For the protection of our staff members and the community, we are currently following safety guidelines by practicing social distancing. We appreciate your understanding.


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聖經鳥瞰33 加拉太書(四)(王生台弟兄)

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數字台灣HD332 解構美中台的變與不變 謝金河 魏啟林 方恩格

發表於 政治觀察, 社會經濟 | 發表迴響

《#老謝看世界》2020.11.21 台積包下沃旭綠電 離岸風電供應鏈大進擊 王雲怡、許乃文

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HOW TO BE SURE OF GOD’S WILL

Every day of our lives is to be lived for God’s purpose, according to His plan, and in obedience to His desires. But how can we be certain we are walking in His will, especially in times of difficulty, suffering, or pain?

Each day is filled with decisions, and every choice is an opportunity to ask the Lord what He would have us do. In this message, Dr. Stanley shares principles from Scripture to help us evaluate our circumstances and decisions through the lens of God’s will.

God assures us that whatever we experience, even our difficulties, can be redeemed for our ultimate good. We can know His will even in times of heartache and hardship, and we can thank Him for His empowering presence and unwavering love.

Also this week: Be Careful When All Is Well

This sermon was recorded before COVID-19. For the protection of our staff members and the community, we are currently following safety guidelines by practicing social distancing. We appreciate your understanding.


發表於 歷史軼聞, 社會經濟 | 發表迴響

聖經鳥瞰33 加拉太書(三)(王生台弟兄)

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《#老謝看世界》2020.11.14 低利率炒房歪風再起 央行傳出打房前奏?張建一、顏炳立

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LIVING A SURRENDERED LIFE

Is there something God is asking you to relinquish to Him? In military terms, surrender means defeat. But as followers of Jesus, it means victory over whatever is hindering our Christian life. In this message, Dr. Stanley explores what it means to ask the Lord for His will to be done in our lives. And he encourages us to let go of anything that God says is not for our best. We lose nothing when we yield everything to the Lord.

Also this week: Impression Or Impact?

This sermon was recorded before COVID-19. For the protection of our staff members and the community, we are currently following safety guidelines by practicing social distancing. We appreciate your understanding.

發表於 歷史軼聞, 社會經濟 | 發表迴響

聖經鳥瞰33 加拉太書(二)(王生台弟兄)

發表於 社會經濟 | 發表迴響