Celldex/Bristol-Myers Initiate Phase I/II Solid Tumor Study - Analyst Blog

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Celldex Therapeutics, Inc. (CLDX) and Bristol-Myers Squibb Company (BMY) announced the commencement of a phase I/II dose escalation and cohort expansion study to evaluate Celldex's varlilumab (a monoclonal investigational antibody targeting CD27) in combination with Bristol-Myers’ Opdivo (human programmed death receptor-1 blocking antibody).

The companies intend to study the combination in adult patients suffering from advanced non-small cell lung cancer (NSCLC), metastatic melanoma (MEL), colorectal cancer (CRC), ovarian cancer and head and neck squamous cell carcinoma (SCCHN).

While the dose-escalation portion of the phase I study will evaluate the safety and tolerability of varlilumab (doses ranging from 0.1 to 10 mg/kg) when administered with Opdivo (3mg/kg), the phase II portion of the study will include 5 disease-specific cohorts either with 18 (CRC, SCCHN, ovarian) or 35 (NSCLC and MEL) patients in each cohort. The primary objective of the phase II study is the assessment of the overall response rate.

We remind investors that in May 2014, Celldex and Bristol-Myers had entered into an agreement to evaluate the safety, tolerability and preliminary efficacy of varlilumab in combination with Opdivo for multiple cancer types. As per the agreement terms, Celldex is responsible for conducting the study while development costs will be shared by the companies.

Currently, varlilumab is being evaluated in two phase I/II combination studies and several additional combination studies for various types of cancer are expected to begin shortly.

Meanwhile, Celldex continues to progress with its pipeline. The company completed patient enrolment in a phase III ACT IV study on one of its lead pipeline candidates, rindopepimut, for EGFRvIII positive glioblastoma multiforme. Another key candidate in Celldex’s pipeline, glembatumumab vedotin (triple negative breast cancer and advanced melanoma), is presently in phase II development.

We expect investor focus to remain on pipeline updates from the company.

Celldex currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Celgene Corp. (CELG) and Regado Biosciences, Inc. (RGDO). Both carry a Zacks Rank #1 (Strong Buy).


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