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强生与Halozyme联手开发单抗药物daratumumab

来源:生物谷 2015-03-13 09:28

2015年3月12日讯 /生物谷BIOON/--生物医药巨头强生旗下的杨森公司最近和著名生物医药公司Halozyme达成了合作研发协议,双方将联手开发治疗多发性骨髓瘤抗体药物daratumumab。而就在一个月之前,杨森公司和其合作伙伴Genmab公司刚刚公布了这一药物研发的中期临床研究数据。

Daratumumab是强生公司大力开发的肿瘤单抗药物,这种药物属于CD38单克隆抗体。在此次有124名患者参与的临床研究显示,接受daratumumab治疗患者的总反应率达到了29.2%。值得注意的是这些患者此前都已经接受过数种不同的临床治疗方案。这一积极研究数据也使得美国FDA对这一单抗要去青睐有加,并将其加入到加速审批渠道中。该药物于2013年获得了FDA授予的突破性药物疗法认证。

根据计划,强生公司希望在2016年上半年将这一药物推上市场。而未来强生公司在这一领域并未能一家独大。Celgene的Revlimid和Takeda 公司的Velcade都将成为其强有力的竞争者。

Halozyme公司则借此机会凭借其先进的皮下输送技术Enhanze成功进入到这一合作中分得一杯羹。双方协议规定,Halozyme公司将会开展一次临床一期研究以确定Halozyme公司的Enhanze技术是否能为daratumumab的研发带来惊喜。

对于杨森公司来说,这已经不是第一次与Halozyme公司合作。双方曾在去年12月签订了一份总额超过5亿美元的研究协议。对于Halozyme公司来说,与强生公司的合作也只是公司发展的一个缩影。凭借公司独特的药物输送技术,Halozyme公司已经先后和辉瑞、罗氏和百特医疗等生物医药巨头达成了合作研究协议。(生物谷Bioon.com)

详细英文报道:

A month after Genmab and Johnson & Johnson's ($JNJ) Janssenreleased successful mid-stage data for its multiple myeloma antibody daratumumab, Halozyme ($HALO) has jumped on board, planning a Phase I trial with its subcutaneous delivery technology.

The candidate marks San Diego-based Halozyme's first in its collaboration with Janssen, inked in December last year. That agreement--worth an initial $15 million for Halozyme and up to $566 million in milestones--gave Janssen access to the delivery company's Enhanze technology, which uses a human enzyme found in the extracellular matrix to aid in the dispersion and absorption of injected drugs.

In early February this year, Genmab and J&J had analysts humming about a fast-track approval down the road for daratumumab, the CD38 monoclonal antibody the companies hope to bring to market in the first half of 2016. The 124-patient Phase II trial from Janssen achieved an overall response rate of 29.2% for a median of 7.4 months in 124 patients who had already received at least three different lines of treatment.

The antibody is the first of up to 5 targets Janssen can develop using Enhanze under the current agreement. And for Halozyme, this is just one of several Big Pharma partnerships with Enhanze as the main focal point. Roche ($RHHBY), Pfizer ($PFE) and Baxter ($BAX) are also looking to make use of the subcutaneous biologics and small molecule enhancer. Baxter's Halozyme-partnered immunodeficiency treatment HyQvia won FDA approval last year.

Halozyme is, however, coming off an unexpected flop from 2013, in which ViroPharma cut short its Cinryze trial mid-stage, leaving partner Halozyme flapping in the wind. But the other products in the works then figured more heavily into analysts' expectations than Cinryze ever did, Halozyme's then-CEO Gregory Frost said at the time. Helen Torley has since stepped into the CEO role.

Daratumumab picked up an FDA breakthrough designation in 2013, and while the current results limit it to a salvage therapy, Janssen is hoping to expand upon its label. Late-phase trials as a first-line treatment in combination with other multiple myeloma drugs such as Celgene's ($CELG) Revlimid and Takeda's Velcade are underway.

 

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