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Aduro Starts Phase II Combo Study with CRS-207 & Keytruda
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Aduro Biotech, Inc. has announced initiation of a phase II study to evaluate a combination therapy of its lead LADD (live, attenuated double-deleted) based candidate, CRS-207, in combination with Merck & Co., Inc.’s (MRK - Free Report) anti-PD-1 therapy, Keytruda (pembrolizumab), for treatment of patients previously nursed for malignant pleural mesothelioma (MPM). Note that, this combination therapy is also being evaluated for treatment of gastric cancer.
Aduro is developing the LADD platform for treating multiple cancer indications, including pancreatic, ovarian, lung and prostate cancers, mesothelioma and glioblastoma. In addition, a personalized form of LADD is being developed utilizing tumor neoantigens, specific to an individual patient’s tumor.
We remind investors that in Oct 2016, the FDA had placed a partial clinical hold on studies evaluating Aduro’s LADD-based agents, thus bringing patient enrollment to a halt. The decision came after a blood culture sample taken from an indwelling port of a metastatic pancreatic cancer patient tested positive for Listeria, a serious infection usually caused by eating contaminated food. Subsequently in Nov 2016, the FDA had lifted the partial clinical hold on studies.
However, the company had to revise and implement study protocols in accordance with the FDA’s guideline in order to recommence enrollment.
Shares of Aduro increased almost 2% after the company announced initiation of the combination trial. Moreover, the company’s shares have outperformed the Zacks classified Medical-Biomed/Genetics industry in the last three months. The stock rose 2.8% compared with the broader industry’s advance of 2.2%.
The phase II study is designed to evaluate the safety and efficacy of the combination of CRS-207 with Keytruda in adult patients (n=35), previously treated for MPM. The primary efficacy endpoint of the study is objective response rate, to be based on the proportion of patients with either complete or partial responses.
It is important to remind investors that in June last year, Aduro had presented data from a phase Ib study, evaluating CRS-207 alone and in combination with standard chemotherapy in patients with newly-diagnosed MPM at the American Society of Clinical Oncology. Data from the study has demonstrated encouraging anti-tumor responses.
Note that, several studies utilizing this platform are being conducted, including a phase I/II study on CRS-207 in combination with Incyte Corporation’s (INCY - Free Report) selective IDO1 inhibitor epacadostat, for healing ovarian cancer; and a phase I lung cancer study on ADU-214 in collaboration with Johnson & Johnson’s (JNJ - Free Report) Janssen Biotech, among others.
Aduro continues to progress with its other two platform technologies – the STING pathway activator and the B-select antibody programs.
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And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation. See Them Free>>
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Aduro Starts Phase II Combo Study with CRS-207 & Keytruda
Aduro Biotech, Inc. has announced initiation of a phase II study to evaluate a combination therapy of its lead LADD (live, attenuated double-deleted) based candidate, CRS-207, in combination with Merck & Co., Inc.’s (MRK - Free Report) anti-PD-1 therapy, Keytruda (pembrolizumab), for treatment of patients previously nursed for malignant pleural mesothelioma (MPM). Note that, this combination therapy is also being evaluated for treatment of gastric cancer.
Aduro is developing the LADD platform for treating multiple cancer indications, including pancreatic, ovarian, lung and prostate cancers, mesothelioma and glioblastoma. In addition, a personalized form of LADD is being developed utilizing tumor neoantigens, specific to an individual patient’s tumor.
We remind investors that in Oct 2016, the FDA had placed a partial clinical hold on studies evaluating Aduro’s LADD-based agents, thus bringing patient enrollment to a halt. The decision came after a blood culture sample taken from an indwelling port of a metastatic pancreatic cancer patient tested positive for Listeria, a serious infection usually caused by eating contaminated food. Subsequently in Nov 2016, the FDA had lifted the partial clinical hold on studies.
However, the company had to revise and implement study protocols in accordance with the FDA’s guideline in order to recommence enrollment.
Shares of Aduro increased almost 2% after the company announced initiation of the combination trial. Moreover, the company’s shares have outperformed the Zacks classified Medical-Biomed/Genetics industry in the last three months. The stock rose 2.8% compared with the broader industry’s advance of 2.2%.
The phase II study is designed to evaluate the safety and efficacy of the combination of CRS-207 with Keytruda in adult patients (n=35), previously treated for MPM. The primary efficacy endpoint of the study is objective response rate, to be based on the proportion of patients with either complete or partial responses.
It is important to remind investors that in June last year, Aduro had presented data from a phase Ib study, evaluating CRS-207 alone and in combination with standard chemotherapy in patients with newly-diagnosed MPM at the American Society of Clinical Oncology. Data from the study has demonstrated encouraging anti-tumor responses.
Note that, several studies utilizing this platform are being conducted, including a phase I/II study on CRS-207 in combination with Incyte Corporation’s (INCY - Free Report) selective IDO1 inhibitor epacadostat, for healing ovarian cancer; and a phase I lung cancer study on ADU-214 in collaboration with Johnson & Johnson’s (JNJ - Free Report) Janssen Biotech, among others.
Aduro continues to progress with its other two platform technologies – the STING pathway activator and the B-select antibody programs.
Aduro Biotech, Inc. Price
Aduro Biotech, Inc. Price | Aduro Biotech, Inc. Quote
Zacks Rank
Aduro currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +18.8% from 2016 - Q1 2017, our top stock-picking screens have returned +157.0%, +128.0%, +97.8%, +94.7%, and +90.2% respectively.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation. See Them Free>>