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Exelixis' (EXEL) IND for Oncology Candidate Accepted by FDA

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Zacks Equity Research
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Exelixis, Inc. EXEL announced that the FDA has accepted its Investigational New Drug (IND) Application to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with advanced solid tumors.

XB002 (formerly ICON-2) is an antibody-drug conjugate (ADC) composed of a human monoclonal antibody against tissue factor that is conjugated to a cytotoxic agent.

A phase I study is expected to begin in the second quarter of 2021. The preclinical data demonstrated that XB002 binds to tissue factor without affecting the coagulation cascade, in contrast with prior therapies in this class. Encouraging activity of XB002 in multiple solid tumor cancer models and improved tolerability compared with other tissue factor-targeting ADCs were also observed.

We remind investors that Exelixis entered into an exclusive option and license agreement with Iconic in May 2019 and obtained an exclusive option to license XB002, Iconic’s lead Tissue Factor ADC program, in exchange for an upfront payment to the latter of $7.5 million and a commitment for preclinical development funding. Exelixis exercised its exclusive option to license XB002 in December 2020 and assumed responsibility for all subsequent clinical development, manufacturing and commercialization of XB002 and the payment of a $20-million option exercise fee to Iconic.

Exelixis’ efforts to develop its pipeline is encouraging and the successful development of candidates like XB002 will strengthen its oncology portfolio and reduce dependence on lead drug, Cabometyx.

Cabometyx is approved for advanced renal cell carcinoma (RCC) and previously-treated hepatocellular carcinoma (HCC). The company got a significant boost when the FDA approved its supplemental New Drug Application (sNDA) for Cabometyx in combination with Bristol Myers’ BMY Opdivo as a first-line treatment of patients with advanced RCC, in January.

Exelixis’ shares have gained 16.4% in the year so far against the industry’s decline of 4.7%.

The company faces stiff competition from combination therapies. Merck’s MRK Keytruda in combination with Inlyta is also approved for the first-line treatment of patients with advanced RCC.

Exelixis currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech space is Repligen Corporation RGEN, which currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Earnings estimates for Repligen have moved up 25 cents for 2021 in the past 60 days.

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Merck & Co., Inc. (MRK) : Free Stock Analysis Report

Exelixis, Inc. (EXEL) : Free Stock Analysis Report

Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report

Repligen Corporation (RGEN) : Free Stock Analysis Report

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