PURPOSE OF REVIEWCompared with the current standard of implanting bone anabolics for fracture repair, bone fracture-targeted anabolics would be more effective, less invasive, and less toxic and would allow for control over what phase of fracture healing is being affected. We therefore sought to identify the optimal bone-targeting molecule to allow for systemic administration of therapeutics to bone fractures.RECENT FINDINGSWe found that many bone-targeting molecules exist, but most have been developed for the treatment of bone cancers, osteomyelitis, or osteoporosis. There are a few examples of bone-targeting ligands that have been developed for bone fractures that are selective for the bone fracture over the body and skeleton. Acidic oligopeptides have the ideal half-life, toxicity profile, and selectivity for a bone fracture-targeting ligand and are the most developed and promising of these bone fracture-targeting ligands. However, many other promising ligands have been developed that could be used for bone fractures.

Biomedicines

Targeted Delivery of Abaloparatide to Spinal Fusion Site Accelerates Fusion Process in Rats

Article

作者: Trigg, Lina ; Tremby, Madeline ; Low, Philip S ; Li, Xinlan ; Chen, Christopher ; Mbachu, Ephraim ; Hadap, Rahul ; Sun, Siyuan ; Nielsen, Jeffery J ; Low, Stewart A

Spinal fusions are performed to treat congenital skeletal malformations, spondylosis, degenerative disk diseases, and other pathologies of the vertebrae that can be resolved by reducing motion between neighboring vertebrae. Unfortunately, up to 100,000 fusion procedures fail per year in the United States, suggesting that efforts to develop new approaches to improve spinal fusions are justified. We have explored whether the use of an osteotropic oligopeptide to target an attached bone anabolic agent to the fusion site might be exploited to both accelerate the mineralization process and improve the overall success rate of spinal fusions. The data presented below demonstrate that subcutaneous administration of a modified abaloparatide conjugated to 20 mer of D-glutamic acid not only localizes at the spinal fusion site but also outperforms the standard of care (topically applied BMP2) in both speed of mineralization (p < 0.05) and overall fusion success rate (p < 0.05) in a posterior lateral spinal fusion model in male and female rats, with no accompanying ectopic mineralization. Because the bone-localizing conjugate can be administered ad libitum post-surgery, and since the procedure appears to improve on standard of care, we conclude that administration of a bone-homing anabolic agent for improvement of spinal fusion surgeries warrants further exploration.

项与 Novosteo, Inc. 相关的新闻（医药）

2023-04-06

·FierceBiotech

UPDATED: Quince adopts 'poison pill' to fend off buyout bid as investor builds stake

Quince has adopted a "poison pill" plan days after an investor disclosed a 9.98% stake. Quince Therapeutics is trying to make itself a less appetizing bite for potential buyers to fend off an unsolicited buyout bid from Echo Lake Capital. The “poison pill” is intended to deter investors from accumulating stock on the open market and will kick in once they buy a set percentage of the shares. Last month, Echo Lake offered $1.60 a share in cash to buy Quince. The stock was trading at 84 cents before the buyout bid, reflecting the fact that Quince, formerly known as Cortexyme, has struggled to regain ground after its Alzheimer’s disease plans unraveled early in 2022. Management responded by buying Novosteo and changing its name, only to later seek to outlicense the recently acquired assets. Quince wants to rebuild by using the $94 million it had at the end of last year to pick up new clinical-stage assets. Echo Lake has another plan, arguing that the uncertainty created by Quince’s lack of a pipeline is causing investors to undervalue its cash, Novosteo asset and federal net operating loss carryforwards. After receiving the Echo Lake offer, Quince said it would “carefully review and evaluate the proposal to determine the course of action it believes is in the best interests of the company and its stockholders.” Now, Quince is erecting barriers to a deal. The biotech, which takes its name from a hard, tart and astringent fruit that is rarely eaten raw, has put a stockholder rights plan in place for one year. While the plan is active, the acquisition of 10% or more of Quince’s stock, or 15% under certain circumstances, will trigger certain changes that could put a buyer off hoovering up shares on the open market. Quince adopted the plan days after another investor, Tang Capital Partners, said it had built up a 9.98% stake in the company. Tang, a life science-focused investment group, has a history of taking positions in struggling biotechs, with recent financial disclosures revealing stakes in Jounce Therapeutics, Elevation Oncology and Tcr2 Therapeutics. A day after announcing the corporate defense mechanism, Quince said it had hired MTS Health Partners to review and explore strategic alternatives. The priority, Quince says, will be to focus on in-licensing and acquisition opportunities, in addition to "alternative options and proposals." Editor's note: This story was updated after Quince announced it had hired MTS Health Partners to help review strategic alternatives.

并购

2023-01-31

·Endpoints

After pivoting from Alzheimer's to bone conditions, biotech pivots again — and halves its headcount

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform. Less than a year later, Quince is pivoting again. The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release . As a result, Quince will let go of about 47% of its staff, the company quietly disclosed in an SEC filing . The revamp is expected to save about $9.5 million in 2023; excluding the impact of corporate restructuring and any business development that takes place, the company is budgeting about $11 million in spending for the year. Just a few days ago, Quince put out word about its sale of Cortexyme’s legacy small molecule protease inhibitor portfolio. Lighthouse Pharmaceuticals, a company co-founded by a former Cortexyme CEO, bought the compounds to continue testing an out-of-the-box hypothesis that you can slow the cognitive decline in Alzheimer’s patients by blocking a bacteria known as P. gingivalis . With $94 million in cash, equivalents and marketable securities in the bank, Quince noted in its press release that it has enough cash runway to fund pipeline expansion deals as well as other expenditures into at least 2028. Dirk Thye, the Novosteo chief who took over as Quince CEO, said he believes directing capital, drug development and corporate resources toward clinical-stage assets constitutes the “optimal growth plan.” While the company had previously worked on rare skeletal diseases, bone cancer and injury, his team is now looking for “commercially viable” programs across a broad range of therapeutic areas, primarily targeting “debilitating and rare disease therapeutic areas.” “Potential asset targets must have compelling data, a well-defined commercial opportunity, and efficient clinical and regulatory development pathway,” Quince wrote. As for its former lead drug, it emphasized that NOV004, while still preclinical, has completed all IND-enabling studies. The company has also held a pre-IND meeting with the FDA.

并购

2022-08-10

·药时代

2022年会是生物医药企业并购大年吗？

2022年上半年生物医药企业并购情况今年上半年，生物医药指数（XBI）延续了2021年的跌势，跌幅达34.28%，不少生物医药企业的市值出现50%以上的下跌，而医药行业的并购却远比二级市场表现要好，上半年共有21起并购事件：从并购的领域看，肿瘤和中枢神经系统是热门领域，分别有8起和4起并购事件，其中上半年规模最大的并购事件也出现在中枢神经系统领域。从被并购的对象看，上市药企（11家）和非上市药企（10家）平分秋色，而并购的主体则是以上市公司为主（16家），其中辉瑞和葛兰素史克各进行了两次并购。本文对上半年重要并购事件进行解析，下一篇文章将对下半年的潜在并购机会展开分析。1、规模最大的并购：Biohaven5月10日，辉瑞宣布以116亿美元现金收购Biohaven(NYSE:BHVN)，这是截至目前，今年规模最大的医药行业并购事件，也是辉瑞自2016年以140亿美元收购Medivation以来的最大一笔交易。Biohaven是一家中枢神经系统药物公司，是偏头痛（CGRP）领域的领导企业，其重磅药物Rimegepant在2021年卖出了4.625亿美元。辉瑞和Biohaven于去年11月达成战略合作，辉瑞向后者支付5亿美元首付款获得Rimegepant以及在研药物小分子CGRP受体拮抗剂Zavegepant的部分商业化权益，总交易高达12.4亿美元。Biohaven的被并购，可能会激发其他药企进入偏头痛赛道的兴趣，而 Impel(NASDAQ:IMPL)的潜力较大：公司治疗偏头痛的药物Trudhesa已于去年获批；公司的CEO Adrian Adams履历丰富，先后在多家公司担任CEO，其中有三家公司在其任职期间被收购；公司第一大股东是华尔街老牌机构KKR（持股17.85%），此外还有vivo、venbio、5AM等知名机构，资本运作的可能性较大。2、首家被中国药企并购的美国上市医药公司：F-star6月23日，中国生物制药(HK:01177)发布公告，将以每股7.12美元的价格收购F-star Therapeutics(NASDAQ:FSTX)，总收购对价为1.61亿美元(约合10.8亿人民币)，FSTX将成为第一家被中国药企收购的纳斯达克上市医药公司。FSTX由奥地利科学家Florian Ruker于2006年创办，是一家专注于双抗的生物医药公司。2020年7月，FSTX与Spring Bank（NASDAQ:SBPH）完成反向并购上市。公司有3款双抗候选药物，分别针对LAG-3/PD-L1、OX40/CD137以及CD137/ PD-L1。FSTX拥有双抗平台Fcab与mAb2，在双抗领域耕耘颇深，几乎与所有的一线大药企有着合作：目前，中国生物制药和FSTX的董事会均已批准该项并购，但仍需包括美国反垄断部门在内的监管审批。如果最终顺利完成并购，中国生物制药将获得国际前沿的双抗技术平台，且成本仅为10亿人民币，性价比远超国内大部分技术逊色且估值更贵的同类药企。3、溢价率最高的并购：Checkmate4月19日，再生元(NASDAQ:REGN)宣布以2.5亿美元的价格收购Checkmate Pharmaceuticals(NASDAQ:CMPI)，这是再生元自1988年成立以来，第一次对外并购，也是上半年溢价最高的并购，溢价率达335%（其余较高的还有溢价率122%的TPTX，以及溢价率均为79%的FSTX和BHVN）。Checkmate成立于2015年，由遗传医学领域著名科学家Art Krieg创立，专注于肿瘤免疫治疗领域。公司主打管线vidutolimod是一款CpG-A寡脱氧核苷酸Toll样受体9（TLR9）激动剂，以病毒样颗粒的形式输送到患者身体，患者免疫系统会因受到病毒样颗粒的刺激而产生抗体，抗体则进一步将药物扩散到全身免疫系统，进而帮助药物找到TLR9，同时刺激受体释放更大量的免疫细胞激活剂，产生抗肿瘤免疫细胞反应。Vidutolimod正在进行与Opdivo、Keytruda、Bavencio等其他治疗方法联合治疗黑色素瘤、非黑色素瘤皮肤癌和头颈癌等各种类型肿瘤的临床研究，最快的进度处于临床二期。本次收购金额虽然不大，但对于一直坚持自主研发的再生元而言，可能会由此开启这家医药巨头的并购之路。4、最有潜力的并购：Affinivax5月31日，葛兰素史克宣布将以33亿美元的价格收购Affinivax，以加强其疫苗管线。本次收购Affinivax是葛兰素史克自2015年收购诺华疫苗业务以来最大的疫苗交易。Affinivax是一家疫苗研发公司，拥有名为多抗原呈递系统（MAPS）的新型技术平台。该平台大大简化了疫苗设计，同时加强了对许多最具挑战性的感染和其他疾病的保护深度和广度，有潜力实现在更短时间内开发更为有效的疫苗。Affinivax的在研疫苗（AFX3772）包括24种肺炎球菌多糖加上两种保守的肺炎球菌蛋白，已经获得FDA的突破性疗法认定。其30多价肺炎球菌候选疫苗目前处于临床前开发阶段，适应症囊括了肺炎、脑膜炎、血液感染和鼻窦炎等。5、转型并购一般情况下，医药行业的并购以补强既有药物管线，或者开拓新的业务线为主，也有一些并购主体则是研发失败或销售不好的药企，此类药企的并购目的主要是寻求业务转型。上半年有两起以转型为目的并购事件：Cortexyme(NASDAQ:CRTX)：一家治疗阿尔海默兹为主的医药公司，主要管线COR388在去年10月宣布了2/3期临床实验失败，又在今年1月被FDA暂停试验，导致股价分别下跌了76%和31%。由于原有管线的希望不大，公司于今年5月宣布收购罕见骨科疾病药物公司Novosteo，并计划更名为Quince Therapeutics，上市交易代码变更为“QNCX”，以反映公司在研管线的扩展。Galapagos(NASDAQ:GLPG)：公司在与吉利德的合作中获得了不少资金支持，目前仍有40多亿欧元的现金（高于市值），但销售与研发一直没有起色，上半年，公司邀请前强生的首席科学家Paul Stoffels担任CEO，随后宣布并购CellPoint和AboundBio两家公司，进军CAR-T疗法领域。下半年医药行业有哪些并购机会？上半年，生物医药领域出现了21起并购事件，其中发生于二季度的并购事件（15件）是一季度的近三倍，而在7月，生物医药领域又出现了5起并购事件，整体上有加速趋势。随着美联储加息预期逐渐走低，以及中小市值医药股估值仍处于历史低位，结合上半年生物医药领域的并购情况（详见2022年上半年生物医药企业并购情况），我们认为以下医药公司或技术领域值得关注：1、Seagen(NASDAQ:SGEN)6月中旬，传出默克准备收购ADC药物巨头Seagen(NASDAQ:SGEN)，据称并购金额达400亿美元，如果最终完成，将会刷新今年医药领域的并购规模记录。Seagen成立于1998年，是ADC药物研发领域的领头羊，截至目前，公司已有4款ADC新药获批上市，另有多款ADC新药在研，2021年销售收入达15.74亿美元。对于默克而言，这是一项比较稳健的收购：双方已有合作：默克与Seagen于2020年达成合作，共同开发LIV-1 ADC药物 ladiratuzumab vedotin，并就该药物与Keytruda的联合用药开展临床研究；Seagen的ADC技术平台已经得到验证，且每年仍有一定的收入；对于PD-1专利将到期的默克而言，仅就Seagen目前体量，难以解决专利悬崖带来的问题，且400亿的并购金额过于昂贵。不过对于ADC赛道而言，Seagen的成功并购，将会再次让ADC行业成为市场热点，其他ADC药物公司会借此上涨。2、基因编辑领域在近期上涨的医药股中，基因编辑是领涨板块。7月20日，Vertex宣布与基因编辑公司Verve Therapeutics(NASDAQ:VERV)就肝病领域进行合作，合作金额高达4.46亿美元。除了近期的合作事件，基因编辑板块在下半年仍有较多重磅事件：CRISPR Therapeutics(NASDAQ:CRSP)：公司药物CTX001计划在今年递交治疗镰状细胞贫血症和β-地中海贫血症的NDA；Intellia(NASDAQ:NTLA)：公司药物NTLA-2001治疗ATTR的数据一直不错，下半年仍有更新数据；如果上述事件有利好消息，基因编辑板块还是有较大概率出现并购事件，潜在标的信息，可以详见文末的知识星球介绍。3、中枢神经系统领域上半年，中枢神经系统领域出现了4起并购事件，属于热门赛道，以下公司值得关注：Intra-cellular(NASDAQ:ITCI)：在医药板块长达一年半的回调中，公司的股价上涨了70%，股价走势似乎已经透露出有潜在并购的可能性。公司治疗精神分裂和抑郁症的药物Caplyta在2021年录得8380万美元的收入，且增速迅猛，其他在研管线储备也较为丰富。Xenon(NASDAQ:XENE)：公司是一家以治疗癫痫为主的中枢神经系统药物研发公司，去年10月，主要管线XEN1101宣布治疗成人局部癫痫的临床二期成功，FDA要求公司再做一个三期即可申报上市申请。另外一个治疗婴儿癫痫的XEN496也处于临床三期，也要较大的成功概率。Amylyx(NASDAQ:AMLX)：药物AMX0035是治疗肌萎缩侧索硬化（ALS），也就是大家所知的渐冻症。AMX0035在3月底的FDA AdCom会议上，以4：6的投票未能获得专家委员会的支持，但FDA在6月初宣布了延期3个月审批，随即AMX0035在加拿大获批，7月，FDA计划在9月初就AMX0035重新召开专家委员会。此外，FDA设定了促进包括ALS在内的罕见神经退行性疾病治疗创新的五年计划，Medicare等医保也表示支持ALS治疗。一旦药物获批，AMLX被收购的概率还是比较大。Impel(NASDAQ:IMPL)：随着Biohaven的被并购，可能会激发其他药企进入偏头痛赛道的兴趣，而IMPL的潜力较大：公司治疗偏头痛的药物Trudhesa已于去年获批；CEO Adrian Adams履历丰富，先后在多家公司担任CEO，其中有三家公司在其任职期间被收购；公司第一大股东是华尔街老牌机构KKR（持股17.85%），此外还有Vivo、Venbio、5AM等知名机构，资本运作的可能性较大。此外，老牌的中枢神经系统药物公司Bioxcel Therapeutics、Axsome Therapeutics、Sage Therapeutics等也都有被并购的机会。4、Mereo Biopharma(NASDAQ:MREO)6月17日，有消息传称阿斯利康正在考虑收购Mereo (NASDAQ:MREO)，后者主要在研管线包括中性粒细胞弹性蛋白酶抑制剂AZD9668、TIGIT单抗etigilimab和硬化蛋白单抗Setrusumab。早在2017年，阿斯利康就与Mereo建立了合作伙伴关系，当时阿斯利康为削减研发管线，将治疗alpha-1抗胰蛋白酶缺乏症的药物AZD9668出售给了Mereo。更为行业所知的是，MREO是一家拥有TIGIT靶点的公司，该靶点一度被视作是下一个PD-1，各大药企也是纷纷出手布局，累计投入了60亿美元。随着罗氏的TIGIT药物tiragolumab于今年上半年宣布第二个临床三期实验失败，给TIGIT药物赛道蒙上了阴影。如果下半年吉利德与ARCUS合作的药物数据不错，则有望进一步推动行业并购。5、其他领域在经过长达一年半的下跌之后，医药板块中不少优质标的的股价已经有较大回撤，一些已经被验证过的技术平台公司仍有较大被并购的潜力，比如RNAi公司Alnylam、Arrowhead，长效药物公司Ascendis，以递送技术见长的Halozyme，差异化抗体药物公司Argenx等。此外，一些市场空间相对较大的罕见病公司也有机会获得大药企的并购青睐，比如肝病领域的Mirum和Albireo，治疗杜氏肌营养不良症的Sarepta、治疗遗传性血管水肿的BioCryst等。附：虽然收购不可预测，但上半年我们在生物医药领域的收购预测准确率较高：1、5月10日，辉瑞收购Biohaven(NYSE:BHVN)，溢价70%+。2、6月3日，百时美施贵宝收购Turning Point(NASDAQ:TPTX)，溢价100%+。3、6月23日，中国生物制药收购F-star Therapeutics(NASDAQ:FSTX)，溢价60%+。4、7月21日，亚马逊收购了1Life (NASDAQ:ONEM)，溢价70%+。版权声明/免责声明本文为授权转载文章，版权归拥有者。仅供感兴趣的个人谨慎参考，非商用，非医用、非投资用。欢迎朋友们批评指正！衷心感谢！文中图片、视频为授权正版作品，或来自微信公共图片库，或取自公司官网/网络根据CC0协议使用，版权归拥有者。任何问题，请与我们联系（电话：13651980212。微信：27674131。邮箱：contact@drugtimes.cn）。衷心感谢！推荐阅读54亿美金，买！歇了不到3个月的辉瑞，又开始溢价收购了...104家中国新药企业扬帆出海！ADC赛道喜讯频传！科伦博泰势头赶超老大哥石药 | 药时代出海系列对话RNA靶向新兴企业施能康（SynerK）：从Alnylam公司APOLLO-B的成功看RNAi药物的研发提前4个月！FDA批准ADC药物Enhertu（DS-8201）用于治疗「HER2低表达」乳腺癌患者，市场有望扩大5倍！接连7款药物试验失败！新药研发既要有毅力，更要有「及时止损」的智慧万字长文：从理论到生产，一文读懂mRNA-LNP制剂技术药时代第111期直播笔记 | 欧美儿童药物开发相关的法规和指导原则2022上半年成绩单出炉！勃林格殷格翰保持稳健增长，夯实研发管线！重磅 | Nature Medicine发文，邦耀生物BRL-101基因治疗地中海贫血症患儿脱离输血依赖已超过2年吉利德2022H1业绩：总营收128.5亿美元，肿瘤业务大涨71%，瑞德西韦神奇不再，肝病领域全面下滑...点击这里，欢聚药时代！

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