Exelixis, Inc. ( EXEL Quick Quote EXEL - Free Report) announced a clinical trial collaboration and supply agreement with biotech bigwig Bristol Myers Squibb Company ( BMY Quick Quote BMY - Free Report) for combination studies on its novel next-generation tyrosine kinase inhibitor (TKI), XL092.
The companies have collaborated for a new phase Ib study, STELLAR-002, evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors.
The objective of the study is to evaluate the safety, tolerability and efficacy of XL092 in combination with Bristol Myers’ Opdivo (nivolumab); Opdivo and Yervoy (ipilimumab); and Opdivo and bempegaldesleukin (an investigational CD122-preferential IL-2–pathway agonist). The study will begin with a dose-escalation phase to determine the recommended dose for each of the XL092 combination therapies.
Thereafter, depending on the dose-escalation results, the study may enroll patients with certain genitourinary cancers (those that affect the urinary tract, prostate, testicles or penis — parts of the body involved in reproduction, urine production and excretion — and include renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC) and urothelial carcinomas).
During the cohort-expansion stage, patients in each cohort will be randomized to multiple treatment arms, which will include XL092 monotherapy, XL092 combined with Opdivo, and XL092 combined with Opdivo and Yervoy or Opdivo and bempegaldesleukin.
The study is being sponsored by Exelixis, while Bristol Myers Squibb will provide Opdivo, Yervoy and bempegaldesleukin for use in the study.
We note that Bristol Myers has an existing global development and commercialization agreement with
Nektar Therapeutics ( NKTR Quick Quote NKTR - Free Report) , which is evaluating Opdivo in combination with bempegaldesleukin. Nektar will supply bempegaldesleukin to Bristol Myers through this collaboration.
Exelixis’ shares have gained 13.3% in the year so far compared with the
industry’s growth of 0.8%. Image Source: Zacks Investment Research
The company’s pipeline progress has been encouraging in the year so far and the successful development and commercialization of the drug should diversify the revenue base.
Lead drug, Cabometyx (cabozantinib tablets), is approved for advanced RCC and hepatocellular carcinoma (HCC).
In January 2021, Exelixis obtained FDA approval for its supplemental new drug application (sNDA) for Cabometyx in combination with Opdivo as a first-line treatment of patients with advanced RCC. The approval of Cabometyx in combination with immuno-oncology drug, Opdivo, for advanced RCC should boost sales, given the market potential.
Exelixis currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is
Repligen Corporation ( RGEN Quick Quote RGEN - Free Report) , which carries a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Repligen’s earnings estimates for 2021 have increased to $2.26 from $1.91 in the past 60 days.
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