Archive for the ‘monoclonal antibody’ Category
Mar
29
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In the hunt to develop targeted drugs against plaque psoriasis, Amgen ($AMGN) and Eli Lilly ($LLY) both said their experimental biologics met the main goals of their respective mid-stage studies. And the positive data from the studies, both reported in the prestigious New England Journal of Medicine, have helped propel Lilly's and Amgen's programs into Phase III territory.
Both companies' drugs are monoclonal antibodies that target interleukin-17, a culprit in the inflammation that occurs in diseases such as plaque psoriasis, which is a chronic skin ailment that triggers the formation of red, scaly patches on the body.
Indianapolis-based Lilly said its ixekizumab offering passed the main test of the 142-patient trial, with way more patients on the drug achieving at least a 75% improvement in their Psoriasis Area and Severity Index scores versus those in the placebo camp at week 12. The study showed that 82% of patients on the 150-mg dose, 83% on the 75-mg dose and 77% on the 25-mg dose had a 75% improvement, compared with 8% in the placebo group after 12 weeks.
Some of the most frequent adverse events in patients on Lilly's treatment included respiratory inflammation, respiratory infections, headaches and reactions at the injection site.
In Thousand Oaks, CA-based Amgen's mid-stage trial of brodalumab in 198 patients, the study met the top goal with the drug providing an improvement in disease score for patients on all doses versus placebo. There was an average improvement of 85.9% in those who took 140-mg dose, 86.3% in patients on 210-mg dose and 45% in people on a 70-mg dose compared with 16% in the placebo group.
The most common side effects among patients on Amgen's drug were common cold, respiratory infections and irritation around the injection site. Two cases of neutropenia were also reported in patients on the 210-mg dose of the drug.
Amgen, of course, already markets its blockbuster antibody drug Enbrel for treating psoriasis. Yet companies are pursuing more targeted treatments that could quell the side effects related to existing therapies. There's a large potential market. According to Amgen, 80% of the 125 million people who suffer from psoriasis have the plaque version of the disease.
"Treatment with antibodies targeting interleukin-17 or its receptor should be more specific and may be expected to result in fewer side effects and therefore holds promise for patients with psoriasis," wrote Ari Waisman of the Johannes-Gutenberg University of Mainz in Germany in his commentary for the NEJM, as quoted by MedPage Today.
- here's Amgen's release
- and Lilly's release
- read BusinessWeek's article
- and MedPage Today's report
​Related Articles:
Idera gets FDA green light for Phase II psoriasis drug test
Pfizer's tasocitinib for psoriasis shows Phase II promise
Experimental psoriasis drug beats Enbrel in study
Mar
06
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Bidding to up its game in the antibody business, the U.K.'s Abcam has snapped up California-based Epitomics for $155 million. Epitomics, which has a big presence in China, offers rabbit monoclonal antibody tech--RabMAbs--to developers looking for new mAb therapies.
For Abcam, the buyout brings in an organization of 250 employees, with 80 based in San Francisco and 170 in China. In addition to its antibody work, the life sciences company also does work in reagents and in vitro diagnostics. And the buyout is expected to pave the way to more global M&A deals on Abcam's part.
"These are exciting times for Abcam as we continue to source new products to add to our catalogue whilst also searching for M&A opportunities," said CEO Jonathan Milner. "We are delighted to have announced the agreement to acquire Epitomics International Inc., which marks a gigantic step towards our ambition of creating the world's leading life science reagents company."
The buyout is being carried out with a mix of cash and shares. Abcam lined up a credit facility to complete the transaction.
- here's the story from BusinessWeekly
- get the Reuters report
Jan
05
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XOMA 052 by Ryan McBride
Xoma ($XOMA) has rung in 2012 with major cutbacks and organizational changes. The Berkeley, CA-based biotech company aims to axe 84 jobs or 34% of its work force by the end of the first quarter with plans to use the savings from the cutbacks for planned clinical trials, including the late-stage study of its lead drug gevokizumab (XOMA 052) for treating non-infectious uveitis.
The layoff ax is falling on about 50 employees immediately, with the rest expected to get pink slips by the end of March, the company announced Thursday afternoon. Its job cuts are a result of a decision made with its partner Servier, the French drugmaker, to use a contract-manufacturing group for large-scale production of its lead drug, and the company will be letting its lease expire on a 31,000-square-foot plant in 2013. Xoma said it's also letting go researchers whose duties can be outsourced to contract labs.
Beyond the layoffs, the biotech named John Varian, who was previously the company's interim chief executive, as the company's CEO. And the firm plans to stay clear of seeking further biodefense contracts, keeping its focus on the development of gevokizumab and its antibody drug discovery work, according to the company. In total, the company's planned cutbacks are expected to result in $6 million in restructuring and severance costs and to shed $14 million in expenses this year.
"We are streamlining Xoma's operations in order to focus on our key near-term value driver, gevokizumab, and to drive our discovery science toward development of value-creating products and technologies," stated Varian, who stepped in as interim chief in late August after the resignation of previous CEO Steve Engle. "We anticipate our global gevokizumab Phase 3 program in non-infectious uveitis, including Behçet's uveitis, will begin in the second quarter of 2012. We also have begun enrolling patients in our Phase 2 proof-of-concept trial of gevokizumab in moderate to severe acne as part of our plan to pinpoint additional indications that can expand the commercial opportunities for our lead drug candidate. Our strategy is to maximize the potential of XOMA's flagship product, pursue discovery-based opportunities, and establish a U.S. commercial presence."
Xoma is keeping its faith in its anti-inflammation antibody gevokizumab, which stumbled in a Phase II trial in Type 2 diabetics after failing to significantly improve glycemic control in patients with the disorder after 6 months. That failed trial, announced in March, triggered a steep drop in the company's share price and a call for previous CEO Engle's ouster.
- here's the release
- check out Reuters' report
Related Articles:
Beleaguered Xoma CEO Engle turns in his walking papers
Xoma shares blitzed after lead drug flunks key diabetes study
Xoma snags $505 million pact on its top drug prospect