Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced that it has initiated an open-label Phase 1/2 safety and tolerability study of glembatumumab vedotin in patients with unresectable stage IIIB or IV, gpNMB-expressing, advanced or metastatic squamous cell carcinoma (SCC) of the lung, who have progressed on prior platinum-based chemotherapy. Glembatumumab vedotin is a fully human monoclonal antibody-drug conjugate (ADC) that targets gpNMB, a protein overexpressed by multiple tumor types, including SCC of the lung, where approximately 85 percent of patients overexpress the marker. Overexpression of gpNMB has been shown to promote the invasion and metastasis of cancer and has been associated with poor clinical outcome. Celldex has entered into a collaborative relationship with PrECOG, LLC, which represents a research network established by the Eastern Cooperative Oncology Group (ECOG), and PrECOG, LLC will conduct the study.

“While checkpoint inhibitor therapy has been an important development for patients with squamous cell lung cancer, the majority of patients still require new, effective treatment options—especially targeted therapies,” said Thomas Davis, M.D., Executive Vice President and Chief Medical Officer of Celldex Therapeutics. “gpNMB, the target of glembatumumab vedotin, is strongly expressed in the vast majority of squamous cell lung cancers. Glembatumumab vedotin has consistently induced notable response rates in other difficult to treat cancers that overexpress gpNMB. We hope to elicit similar activity in squamous cell carcinoma and look forward to completing this study.”

Glembatumumab vedotin is currently being evaluated in patients with metastatic triple negative breast cancers that overexpress gpNMB in the registrational METRIC study, as well as in a Phase 2 study in patients with advanced melanoma who have progressed after at least one checkpoint inhibitor therapy and, if applicable, BRAF- or MEK-targeted therapy. It has been previously evaluated in a Phase 2 study in advanced breast cancer (the EMERGE study), a Phase 1/2 study in advanced breast cancer and a Phase 1/2 study in patients with unresectable stage III or IV melanoma. Also, Celldex and the National Cancer Institute (NCI) have entered into a Cooperative Research and Development Agreement (CRADA) under which the NCI is sponsoring two studies of glembatumumab vedotin—one in uveal melanoma and one in pediatric osteosarcoma. Both studies are currently open to enrollment.

Study Design
This Phase 1/2 study will enroll patients with gpNMB-positive stage IIIB or IV non-small cell lung cancer (NSCLC) of squamous histology who have previously been treated with platinum-based chemotherapy. gpNMB positivity will be determined by a greater than, or equal to, five percent gpNMB expression in tumor epithelial cells. Glembatumumab vedotin will be administered once every three weeks until disease progression or intolerance. The study is expected to include 10 sites in the United States.

The study will include a dose-escalation phase followed by a two-stage Phase 2 portion (Simon two-stage design). The Phase 1, dose-escalation portion of the study will assess the safety and tolerability of glembatumumab vedotin at the current dose of 1.9 mg/kg and then 2.2 mg/kg in order to determine whether higher dosing is feasible in this population. The first stage of the Phase 2 portion will enroll approximately 20 patients, and if at least two patients achieve a partial response or complete response, a second stage may enroll an additional 15 patients. The primary objective of the Phase 2 portion of the study is to assess the anti-tumor efficacy of glembatumumab vedotin in squamous cell lung cancer as measured by objective response rate (ORR). Secondary objectives of the study include analyses of safety and tolerability and further assessment of anti-tumor activity across a broad range of endpoints.(Original Source)

Shares of Celldex closed yesterday at $3.96, down $0.07 or -1.74%. CLDX has a 1-year high of $29.94 and a 1-year low of $2.96. The stock’s 50-day moving average is $3.95 and its 200-day moving average is $10.18.

On the ratings front, Celldex has been the subject of a number of recent research reports. In a report issued on April 19, Cowen analyst Boris Peaker reiterated a Buy rating on CLDX, with a price target of $12, which implies an upside of 203.0% from current levels. Separately, on March 8, Brean Murray Carret’s Jonathan Aschoff reiterated a Buy rating on the stock and has a price target of $24.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Boris Peaker and Jonathan Aschoff have a total average return of 15.2% and -8.4% respectively. Peaker has a success rate of 48.5% and is ranked #148 out of 3829 analysts, while Aschoff has a success rate of 39.6% and is ranked #3780.

Overall, 4 research analysts have assigned a Hold rating and 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $6.20 which is 56.6% above where the stock closed yesterday.

Celldex Therapeutics, Inc. engages in the research, development, and manufacture of biopharmaceutical products. Its portfolio includes therapeutic antibodies, antibody drug conjugates, vaccines, and immune system modulators. Its drug candidates include Glembatumumab vedotin, Varlilumab, CDX-1401, CDX-301, and Rintega. The company was founded by Anthony S. Marucci and Tibor Keler in 1983 and is headquartered in Hampton, NJ.