Celldex Therapeutics, Inc. CLDX announced the commencement of a phase I/II safety pilot and expansion study to evaluate Celldex's varlilumab in combination with Bristol-Myers Squibb Company’s BMY melanoma drug, Yervoy. Yervoy is approved for the treatment of unresectable or metastatic melanoma. The company intends to study the combination in patients suffering from stage III or IV metastatic melanoma.
While the phase I portion of the study will evaluate the safety and tolerability of varlilumab (0.3 and 3.0 mg/kg) when administered with Yervoy (3 mg/kg) once over a period of three weeks, the phase II part will include two groups of patients (NY-ESO-1 positive and NY-ESO-1 negative). NY-ESO-1 positive patients will be administered with Celldex's off-the-shelf cancer vaccine candidate, CDX-1401, in addition to the above combination.
We note that Celldex is also evaluating varlilumab in combination with another Bristol-Myers’ drug – Opdivo – in adult patients with advanced non-small cell lung cancer, metastatic melanoma, colorectal cancer, ovarian cancer and head and neck squamous cell carcinoma.
Celldex is evaluating varlilumab in combination with several other candidates and approved cancer drugs. Last month, the company entered into an agreement with Roche RHHBY to evaluate varlilumab in combination with Roche’s cancer immunotherapy candidate, MPDL3280A (anti-PDL1), in a phase I/II study for renal cell carcinoma.
Cancer immunotherapy has been in the spotlight since quite some time now. Several companies are looking to bring immuno-oncology drugs to market. Some of the candidates currently under development include elotuzumab (multiple myeloma) and Prostvac (asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer).
We are positive on Celldex’s plans to evaluate varlilumab in combination with other treatments and across multiple types of cancer.
Celldex carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Cambrex Corporation CBM, sporting a Zacks Rank #1 (Strong Buy).
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