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Celldex Begins Phase I Trial on Cancer Candidate CDX-1140


Celldex Therapeutics, Inc. CLDX announced that it has started patient enrollment in a phase I study, evaluating its new candidate, CDX-1140, for treatment of patients with advanced solid tumors. Notably, CDX-1140 is a fully human antibody that targets CD40, an immune response activator.

Shares of Celldex have increased more than 1% following the news release. However, the stock has underperformed the industry so far this year. Shares have lost 15.2%, comparing unfavorably with industry’s 2.6% increase during the period.

The study is expected to enroll a total of 105 patients with recurrent, locally-advanced or metastatic solid tumors. It is designed to evaluate the safety and tolerability of CDX-1140 at different dose levels ranging from 0.01 mg/kg to 3.0 mg/kg once every four weeks until disease progression or intolerance.

Significantly, the company is also planning to evaluate the combination of CDX-1140 with other anti-tumor agents.

We remind investors that last November, Celldex presented positive pre-clinical data on CDX-1140 at the Society for Immunotherapy of Cancer Annual Meeting. The trial outcomes demonstrated that CDX-1140 binds to CD40 with high affinity and does not block CD40 ligand binding. It also showed direct anti-tumor activity in immune-deficient mice with human lymphomas.

Apart from CDX-1140, Celldex has another interesting candidate in its oncology pipeline called varlilumab. The candidate is being evaluated in combination with Bristol-Myers' BMY Opdivo in a phase II study including cohorts in five indications namely, colorectal cancer, ovarian cancer, head and neck squamous cell carcinoma, renal cell carcinoma and glioblastoma. Celldex plans to complete enrolment across all cohorts in the phase II portion of the study in the first quarter of 2018.

Other promising candidates are CDX-1401/CDX-301 (phase II — multiple solid tumors; in collaboration with CITN) and CDX-014 (phase I — advanced renal cell carcinoma) among others.

Importantly, Celldex expects CDX-1140 to add stimulus to the company’s growing immunotherapy pipeline.

Zacks Rank & Other Key Picks

Celldex carries a Zacks Rank #2 (Buy). Two other top-ranked stocks in the health care sector are Corcept Therapeutics Inc. CORT and Achillion Pharmaceuticals, Inc. ACHN, both carrying a Zacks Rank of 2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Corcept’s earnings per share estimates have moved up from 78 cents to 88 cents for 2018 over the last 30 days. The company delivered positive earnings surprises in two of the trailing four quarters, with an average beat of 14.32%. The share price of the company has increased 147.1% year to date.

Achillion’s loss per share estimates has narrowed from 65 cents to 63 cents for 2017 and from 74 cents to 67 cents for 2018 over the last 30 days. The company came up with positive earnings surprises in two of the trailing four quarters with an average beat of 4.51%.

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