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Exelixis (EXEL) Initiates Early Stage Study of Lymphoma
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Exelixis, Inc. (EXEL - Free Report) recently announced that it has initiated the dose-escalation stage of the first-in-human phase I study of investigational candidate XL114.
XL114 is a novel anti-cancer compound that inhibits the CARD11-BCL10-MALT1 complex, a key component of signaling downstream of B- and T-cell receptors, promoting B- and T-cell lymphoma survival and proliferation.
The study will evaluate the candidate as a monotherapy in patients with non-Hodgkin’s lymphoma (NHL) who have received prior standard therapies.
The study’s objectives are to determine the recommended dose and/or the maximum tolerated dose of XL114 and evaluate the safety and preliminary efficacy of XL114 in patients with NHL.
The safety and preliminary efficacy of XL114 will be further evaluated in B-cell NHL-specific expansion cohorts. These include patients with activated B-cell-like diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma. The primary endpoint of the expansion stage will be an objective response rate based on lymphoma-specific response criteria as assessed by the investigator.
We remind investors that Exelixis in-licensed XL114 from Aurigene Discovery Technologies Limited in October 2021 under the companies’ 2019 collaboration, option and license agreement.
Exelixis assumed responsibility for the future clinical development, commercialization and global manufacturing of XL114.
Exelixis’ shares have gained 24.6% in the year so far against the industry’s decline of 13.4%.
Image Source: Zacks Investment Research
It is also looking to develop its portfolio beyond lead drug Cabometyx and has a strong pipeline.
In December 2021, Exelixis announced the initiation of the dose-escalation stage of STELLAR-002, a phase Ib trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors.
The successful development of these candidates will broaden its portfolio and reduce its dependence on EXEL.
Meanwhile, the company to looking to expand Cabometyx’s label further. Cabometyx tablets are approved for the treatment of patients with advanced renal cell carcinoma (RCC) and for patients with HCC who have been previously treated with Nexavar.
It is also approved for patients with advanced RCC as a first-line treatment in combination with Bristol Myers’ (BMY - Free Report) Opdivo (nivolumab) and for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible. The drug’s sales have shown a strong uptake following the approval of the drug in combination with Opdivo in 2021.
Bristol-Myers’ Opdivo is one of the leading revenue generators of the company and is approved for various oncology indications.
Loss estimates for VYGR have narrowed to $1.35 from $2.20 for 2022 in the past 60 days. Earnings of Voyager surpassed estimates in three of the trailing four quarters and missed the same once, the average surprise being 41%.
Loss estimates for KLDO have narrowed to $1.09 from $2.13 for 2022 in the past 90 days. Earnings of Kaleido Biosciences surpassed estimates in three of the trailing four quarters and missed the same once.
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Exelixis (EXEL) Initiates Early Stage Study of Lymphoma
Exelixis, Inc. (EXEL - Free Report) recently announced that it has initiated the dose-escalation stage of the first-in-human phase I study of investigational candidate XL114.
XL114 is a novel anti-cancer compound that inhibits the CARD11-BCL10-MALT1 complex, a key component of signaling downstream of B- and T-cell receptors, promoting B- and T-cell lymphoma survival and proliferation.
The study will evaluate the candidate as a monotherapy in patients with non-Hodgkin’s lymphoma (NHL) who have received prior standard therapies.
The study’s objectives are to determine the recommended dose and/or the maximum tolerated dose of XL114 and evaluate the safety and preliminary efficacy of XL114 in patients with NHL.
The safety and preliminary efficacy of XL114 will be further evaluated in B-cell NHL-specific expansion cohorts. These include patients with activated B-cell-like diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma. The primary endpoint of the expansion stage will be an objective response rate based on lymphoma-specific response criteria as assessed by the investigator.
We remind investors that Exelixis in-licensed XL114 from Aurigene Discovery Technologies Limited in October 2021 under the companies’ 2019 collaboration, option and license agreement.
Exelixis assumed responsibility for the future clinical development, commercialization and global manufacturing of XL114.
Exelixis’ shares have gained 24.6% in the year so far against the industry’s decline of 13.4%.
Image Source: Zacks Investment Research
It is also looking to develop its portfolio beyond lead drug Cabometyx and has a strong pipeline.
In December 2021, Exelixis announced the initiation of the dose-escalation stage of STELLAR-002, a phase Ib trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors.
The successful development of these candidates will broaden its portfolio and reduce its dependence on EXEL.
Meanwhile, the company to looking to expand Cabometyx’s label further. Cabometyx tablets are approved for the treatment of patients with advanced renal cell carcinoma (RCC) and for patients with HCC who have been previously treated with Nexavar.
It is also approved for patients with advanced RCC as a first-line treatment in combination with Bristol Myers’ (BMY - Free Report) Opdivo (nivolumab) and for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible. The drug’s sales have shown a strong uptake following the approval of the drug in combination with Opdivo in 2021.
Bristol-Myers’ Opdivo is one of the leading revenue generators of the company and is approved for various oncology indications.
EXEL currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Voyager Therapeutics (VYGR - Free Report) and Kaleido Biosciences , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for VYGR have narrowed to $1.35 from $2.20 for 2022 in the past 60 days. Earnings of Voyager surpassed estimates in three of the trailing four quarters and missed the same once, the average surprise being 41%.
Loss estimates for KLDO have narrowed to $1.09 from $2.13 for 2022 in the past 90 days. Earnings of Kaleido Biosciences surpassed estimates in three of the trailing four quarters and missed the same once.