A Double Blind, Randomized, Placebo Controlled, Single Dose, Phase I Study of the Safety and Tolerability of Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects With Cystic Fibrosis

Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.

开始日期2011-04-01

申办/合作机构

CSL Behring LLC

100 项与 CR-002(CuraGen Corp.) 相关的临床结果

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100 项与 CR-002(CuraGen Corp.) 相关的转化医学

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100 项与 CR-002(CuraGen Corp.) 相关的专利（医药）

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项与 CR-002(CuraGen Corp.) 相关的文献（医药）

2018-02-01·European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology3区 · 医学

Evaluation of colistin stability in agar and comparison of four methods for MIC testing of colistin

3区 · 医学

Article

作者: Xavier, Basil Britto ; Janssens, Lore ; Lammens, Christine ; Goossens, Herman ; Turlej-Rogacka, Agata ; Zarkotou, Olympia ; Malhotra-Kumar, Surbhi ; Pournaras, Spyros

Susceptibility testing for colistin remains challenging primarily due to its inherent properties. We evaluated colistin stability in agar and reproducibility of colistin MICs obtained by agar dilution, broth macro- and micro-dilution and MIC gradient strips on 3-7 iterations of each method using clinical Klebsiella pneumoniae (susceptible-CS, and resistant-CR, n = 2 each), mcr-harboring Escherichia coli (n = 2), and reference strains E. coli ATCC25922 and Pseudomonas aeruginosa ATCC27853. MICs for reference strains were not in the given range using Etest and broth microdilution (ATCC25922, 0.125 and 4 μg/ml, respectively). MICs of CR-1 and CR-2, and of the mcr-harboring E. coli showed high concordance between agar and broth dilution varying up to one 2-fold dilution. However, remarkable variations were observed on broth dilution with CS-1 and CS-2 (MIC range 0.25-32 and 0.5-64 μg/ml, respectively); whereas for agar dilution the MIC for both CS strains was 0.5 μg/ml in all the runs. MICs obtained by MIC gradient strips were lower than those obtained by dilution methods (1-2 dilutions for CS and mcr strains, and up to five dilutions for CR strains). To confirm uniform distribution of colistin in agar, a single strain was spotted in five different regions of the same plate. All spots showed concordant growth with maximum one dilution difference. No effect on MIC was found due to storage of colistin-containing agar plates for 7 days at 4 °C. In our hands, agar dilution was superior in terms of reproducibility and robustness, compared to broth dilution methods, for colistin MIC determination.

2015-11-22·Toxicology mechanisms and methods4区 · 医学

Safety and efficacy of a novel Prunus domestica extract (Sitoprin, CR002) on testosterone-induced benign prostatic hyperplasia (BPH) in male Wistar rats

4区 · 医学

Article

作者: Preuss, Harry G. ; Bagchi, Debasis ; Bagchi, Manashi ; Kumar, Pawan ; Swaroop, Anand

The efficacy of a novel Prunus domestica bark extract (Sitoprin, CR002) was investigated on testosterone propionate (TP)-induced benign prostatic hyperplasia (BPH) in male Wistar rats. BPH was induced by daily subcutaneous administration of TP (3.0 mg/kg) over a period of 15 days (interim sacrifice group) and for an additional 21 days (terminal sacrifice group). We evaluated the dose-dependent efficacy (0, 50, 100 and 200 mg/kg body weight/day) of CR002 and a control group against BPH, and compared with a reference standard Prunus africana extract (CR001). Extensive clinical examinations were carried out on days 1, 7, 14, 21, 28 and 35 of treatment period to determine the onset, duration and severity of clinical signs. Clinical pathology, hematology, biochemistry and histopathology were performed on days 15 and 35, prior to necropsy. Animals were fasted overnight prior to blood collection. Prostate glands and tissues were examined. On day 36, histopathology of ventral prostrate of control rats demonstrates single layer of columnar mucin secreting epithelial cells along with a lumen occupied with eosinophilic secretion. In contrast, CR002 and CR001 groups (100 and 200 mg/kg/day) exhibited no hyperplasia and proliferation of epithelial cells. Prostate histopathology of these treated groups was comparable with control rats. The hyperplasia and hypertrophy of prostrate was reduced to single-layered cell indicating the efficacy of CR002 and CR001. Overall, results demonstrate that CR002 exhibits therapeutic efficacy/activity in TP-induced BPH in rats, which is comparable to CR001.

2008-05-01·International journal of clinical pharmacology and therapeutics4区 · 医学

A Phase I study of CR002, a fully-human monoclonal antibody against platelet-derived growth factor-D

4区 · 医学

Article

作者: Mansfield, T. ; Giot, L. ; Hawthorne, T. ; Gerwien, R. ; Blake, L. ; Pochart, P. ; Hahne, W. ; Smithson, G. ; Starling, G. C. ; Kuang, B. ; Hoelscher, D. ; Halvorsen, Y.-D.

OBJECTIVE:

To investigate the safety, pharmacokinetics (PK), binding activity and immunogenicity of CR002, a human monoclonal antibody (mAb) directed against platelet-derived growth factor-D (PDGF-D), administered as a single intravenous (i.v.) infusion over a range of doses.

SUBJECTS:

40 healthy male subjects received increasing doses of CR002 at 0.3, 1, 3, 10, 30 mg/kg or placebo.

METHOD:

This was a randomized, double-blind, placebo-controlled, dose-escalation Phase I study. The trial had a duration of 90 days, with dosing on Day 1 and follow-up visits on Days 2, 4, 7, 14, 21, 30, 45 and 90. Serum was collected for PK, binding activity and immunogenicity analysis at screening and up to Day 90. Safety was recorded throughout the study by performing laboratory tests, recording vital signs and electrocardiograms (ECGs), by monitoring the occurrence of adverse events (AEs). The use of concomitant medications was also recorded.

RESULTS:

All 40 subjects received CR002 or placebo, and completed the trial. No dose-limiting toxicities (DLTs) occurred, the maximum tolerated dose (MTD) was not reached and was estimated as > 30 mg/kg. There were no deaths during this study and no SAEs or other significant AEs reported. The most frequent drug-related treatment-emergent AE (TEAE) was headache in 4 of 30 subjects (13.3%) in the CR002 group vs. 0 of 10 subjects in the placebo group. CR002 exhibited linear PK parameters, had a long half-life (t1/2 in the range 15.5 â 48.1 days) and a volume of distribution at steady state in the range 4.7 â 6.5. Free PDGF-D in the serum bound to CR002 in a reversible manner, as shown in the lowest dose cohort. However, levels of total circulating PDGF-D remained constant throughout the study. There were no anti-CR002 antibodies detected in subjects dosed with CR002.

CONCLUSIONS:

CR002 was safe and well-tolerated at all doses tested as a single i.v. administration. The MTD was estimated to be above 30 mg/kg, the highest dose tested. CR002 had a long half-life, low clearance and a limited tissue distribution. Although total levels of PDGF-D at all dose levels remained relatively constant, there was no detectable circulating free PDGF-D after CR002 administration. At the lowest CR002 dose tested (0.3 mg/kg), PDGF-D was detectable again by Day 21 and the levels increased near to pre-infusion levels by Day 90. In this study, CR002 was not immunogenic during the 90-day study period.

项与 CR-002(CuraGen Corp.) 相关的新闻（医药）

2024-11-11

·PRNewswire

Crescent Biopharma Appoints Susan Moran, MD, MSCE, and Alexandra Balcom, MBA, CPA, to Board of Directors

New appointees, along with recently appointed Directors Peter Harwin and Interim CEO Jonathan Violin, PhD, provide a strong foundation for the company WALTHAM, Mass., Nov. 11, 2024 /PRNewswire/ -- Crescent Biopharma, Inc. ("Crescent"), a private biotechnology company dedicated to advancing novel precision engineered molecules targeting validated biology to advance care for patients with solid tumors, today announced it has appointed Susan Moran, MD, MSCA, former Chief Medical Officer of RayzeBio, Inc., and Alexandra Balcom, MBA, CPA, Chief Financial Officer of Nuvalent, Inc., to its Board of Directors. They join Jonathan Violin, PhD, Crescent's Interim Chief Executive Officer and Venture Partner at Fairmount, and Peter Harwin, Fairmount Co-founder, on the Board. "We are honored to have Dr. Moran and Ms. Balcom join the Board. Their appointments ensure we are well situated for rapid growth as we work to deliver potentially best-in-class therapies to patients with solid tumors," said Dr. Violin. "Dr. Moran brings deep experience in developing novel oncology therapeutics and Ms. Balcom offers a wealth of expertise in finance and operations, both at top-tier oncology companies. We are all extremely excited by the potential impact of Crescent's pipeline, led by CR-001, our tetravalent PD-1 x VEGF bispecific antibody. CR-001 was specifically designed to uniquely recapitulate the groundbreaking cooperative binding mechanism of action that recently demonstrated superiority to pembrolizumab in a large Phase 3 clinical trial." Dr. Moran brings to the Crescent Board more than 20 years of industry and academic experience. Most recently, she served as Chief Medical Officer for RayzeBio until its acquisition in 2024 by Bristol Myers Squibb. Dr. Moran currently serves on the Board of Directors of Tyra Biosciences, Inc., and BioAtla, Inc., both publicly traded clinical-stage biotechnology companies. She was previously Chief Medical Officer at QED Therapeutics and prior to that, led clinical development at Puma Biotechnology. Dr. Moran received her B.A. from the University of Virginia, her M.S. in Clinical Epidemiology from the University of Pennsylvania School of Medicine, and her M.D. from Duke University. Ms. Balcom is currently the Chief Financial Officer at Nuvalent. Prior to joining Nuvalent, she served as Vice President of Finance at SQZ Biotechnologies, where she helped raise more than $200 million in private and public equity financing, including the company's 2020 initial public offering. Previously, Ms. Balcom served as Corporate Controller at Agios Pharmaceuticals, supporting more than $700 million in equity financing. She earned her B.B.A. in Finance from the University of Massachusetts, Amherst, and her M.B.A. from Boston College. She is also a Certified Public Accountant in Massachusetts. The company is on track to close its previously announced acquisition by GlycoMimetics in the second quarter of 2025, after which the combined company will advance Crescent's pipeline and be renamed Crescent Biopharma. Having recently secured $200 million in financing through a private placement from a leading syndicate of biotechnology investors, Crescent is funded through 2027, including through initial clinical data for CR-001, which is expected in the second half of 2026. The company is also advancing CR-002 and CR-003, antibody-drug conjugates with topoisomerase inhibitor payloads for undisclosed targets. About CR-001 CR-001 is a tetravalent PD-1 x VEGF bispecific antibody in development for treating solid tumors. It was designed to recapitulate the targeting, geometry, and cooperativity of ivonescimab, another tetravalent PD-1 x VEGF bispecific antibody that demonstrated efficacy superior to market-leading pembrolizumab in a large Phase 3 clinical trial. CR-001 was specifically designed to avoid mechanistic risks that could perturb the balance of efficacy and safety that define this new class of immunotherapy. About Crescent Biopharma Crescent Biopharma is a biotechnology company dedicated to advancing novel precision engineered molecules targeting validated biology to advance care for patients with solid tumors. The company's pipeline of three programs harnesses proven biology to accelerate the path to market for potentially best in class therapeutics. The company's lead program is CR-001, a tetravalent PD-1 x VEGF bispecific antibody; it is also advancing CR-002 and CR-003, antibody-drug conjugates with topoisomerase inhibitor payloads for undisclosed targets. For more information, visit . Media Contact Deerfield Group Lia Dangelico 540-303-0180 [email protected] Investor Contact: Argot Partners Dawn Schottlandt 212-600-1902 [email protected] SOURCE Crescent Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

高管变更临床3期并购IPO

2024-10-30

·药研网

康方生物PD-1/VEGF双抗：海外又有2家初创锚定

10月28日，总部位于英国的Ottimo Pharma走出隐形模式。前Seagen公司的首席执行官David Epstein，在辉瑞以430亿美元收购Seagen后，现已加入一个新的生物技术公司Ottimo Pharma。 Ottimo Pharma还任命了前罗氏高管、现任BioMarin首席商务官James Sabry为副主席，以及勃林格殷格翰的资深人士Mehdi Shahidi为首席医学官。 Ottimo Pharma在过去三年中一直致力于Jankistomig的临床前开发，Jankistomig是一种双功能抗体，靶向PD1和VEGFR2，这两种受体参与帮助肿瘤生长和逃避免疫系统的分子途径。Ottimo Pharma一直在对该分子进行全面的临床前表征，并预计在2025年底提交IND。 10月29日，GlycoMimetics宣布已与Crescent Biopharma 公司达成收购协议。交易完成后，公司计划以Crescent Biopharma的名义运营，推进旨在治疗实体瘤的肿瘤疗法。Crescent Biopharma的主导项目CR-001是一款PD-1 x VEGF双特异性抗体。 Crescent是第五家利用 Paragon Therapeutics 发现和开发的资产上市的公司。Paragon此前孵化了Apogee Therapeutics、SPYRE THERAPEUTICS、ORUKA THERAPEUTICS和JADE BIOSCIENCES多个自免药物开发上市公司。 Crescent Biopharma 管线 Crescent Biopharma注与实体瘤药物的开发，目前管线中装入了三款药物: PD-1/VEGF双抗CR-001，另外两款为拓扑异构酶的ADC药物 CR-002 和 CR-003。 CR-001是一种四价PD-1 x VEGF双特异性抗体，其形式和药理学与康方生物的ivonescimab相匹配。与目前的市场领导者pembrolizumab相比，ivonescimib具有更优的疗效。该公司预计 CR-001 的 IND 将于 2025 年Q4或 2026 年Q1提交，患者的中期 1 期数据预计将于 2026 年下半年获得。除了 CR-001，Crescent还在开发 CR-002 和 CR-003，它们是使用拓扑异构酶抑制剂有效载荷针对未公开靶点的抗体-药物偶联物 (ADC)；与具有替代有效载荷的 ADC 相比，具有拓扑异构酶抑制剂有效载荷的 ADC 显示出更高的疗效和安全性。CR-002 是 Crescent 的首个 ADC 项目，旨在成为同类最佳项目，预计将于 2026 年启动第 1 阶段；Crescent计划在项目进入临床阶段时披露 CR-002 的目标。该交易预计将于 2025 年Q2完成。预计公司交割时的现金余额将为2027年的运营提供资金，包括推进公司的主要项目 CR-001，预计在 2026 年下半年通过对实体瘤患者的初步概念验证临床数据进行推进。 PD-1/VEGF潜力巨大。去年11月，BioNTech超10亿美元引进普米斯PD-L1/VEGF双抗，2024年9月，该双抗产品PM8002注射液的新药研究申请（IND）成功获得CDE的批准。目前，PM8002注射液已在国内针对TNBC、SCLC、非小细胞肺癌（NSCLC）等多个瘤种开展了多项临床试验研究，相关临床研究数据也陆续在重要的国际学术会议上发布，展示了其广阔的应用前景和潜在的巨大临床价值。超10亿美元，BioNTech引进普米斯PD-L1/VEGF双抗今年5月，康方生物宣布，全球首创PD-1/VEGF双抗依沃西单抗头对头对比Keytruda一线治疗PD-L1阳性NSCLC的三期临床HARMOIN-2（HARMONi-2或AK112-303）达到无进展生存期（PFS）的主要研究终点，显示强阳性结果。里程碑! 国产PD-1/VEGF双抗，头对头击败K药！ PD-1/VEGF双抗的大获成功再次引起了人们的关注。今年8月，宜明昂科将旗下PD-L1xVEGF双特异性抗体IMM2510大中华区以外的开发和商业化权利以5000万美元首付+20亿美元里程碑付款授予Instil Bio。由此可见，该领域的竞争激烈程度不言而喻。 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾 1 8月 | 高达22家药企裁员 2 国产首款四价HPV疫苗拟纳入优先审评 3 3. 7亿美元!今年规模最大的生物医药融资诞生

抗体药物偶联物临床申请并购免疫疗法临床1期

2024-10-29

·EndPoints

Paragon launches another company in hot PD-1xVEGF space that goes straight to reverse merger

Antibody maker Paragon Therapeutics has formed another company, this time in the bustling cancer space of PD-1xVEGF, and it will go straight onto the public markets. The new biotech, named Crescent Biopharma, will take the place of GlycoMimetics on the Nasdaq, the companies said Tuesday morning. GlycoMimetics has failed multiple mid- and late-stage trials in recent months, including one for acute myeloid leukemia . The PD-1xVEGF space has become quite popular in recent months thanks to Keytruda-beating data from Summit Therapeutics and its Chinese partner Akeso. Former Seagen CEO David Epstein also joined a preclinical biotech, named Ottimo Pharma , on Monday that hopes to get bought out after Phase 1 data. BioNTech is also in the race. Crescent’s program, codenamed CR-001, will have initial proof of concept data in the second half of 2026, the company said. It also has two antibody-drug conjugates, another en-vogue area for oncology R&D. “This transaction and financing enable a potentially rapid development path for CR-001, and for the antibody-drug conjugate programs CR-002 and CR-003,” Crescent interim CEO Jonathan Violin said in a statement. Violin is also a venture partner at Fairmount, which is one of the investors supporting a concurrent $200 million financing for the merger, which will keep the R&D engine humming “through 2027,” the company said. Paragon has formed multiple autoimmune-focused biotechs over the past two years. Apogee went public via a traditional IPO, whereas other startups from its universe have landed on the public markets by way of reverse mergers, including Oruka and Spyre . In August, Paragon debuted another offshoot, named Jade Biosciences , with just a chief scientific officer and $80 million. Crescent’s shareholders will own almost all of the combined company, at 96.9%. The deal is anticipated to close in the second quarter of 2025.

IPO抗体药物偶联物

100 项与 CR-002(CuraGen Corp.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB05139

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
免疫球蛋白a肾病	临床1期	美国	CuraGen Corp.	-
免疫球蛋白a肾病	临床1期	-	Amgen, Inc.	-
糖尿病肾病	临床前	美国	CuraGen Corp.	-
糖尿病肾病	临床前	-	Amgen, Inc.	-
系统性红斑狼疮	临床前	美国	CuraGen Corp.	-
系统性红斑狼疮	临床前	-	Amgen, Inc.	-