Celldex Therapeutics, Inc. (NASDAQ:CLDX) presented data on new product candidate CDX-1140, a fully human antibody targeted to CD40 that has demonstrated potent agonist and anti-lymphoma activity. Found on antigen presenting cells, such as dendritic cells, macrophages and B cells, CD40 is a key activator of the immune response and is expressed on many cancer cells, in particular B cell lymphomas. The data were presented at the American Society of Hematology (ASH) Annual Meeting on Saturday, December 3 in a poster titled “CDX-1140, A Novel Agonist CD40 Antibody with Potent Anti-lymphoma Activity” (Abstract #1848). CDX-1140 is expected to be ready to enter clinical studies in patients with advanced cancers, including lymphoma, in 2017.
“We have previously characterized CDX-1140 as possessing a needed balance between its agonist activity and its safety profile to allow for systemic dosing at levels that provide good tissue and tumor penetration, which we believe to be important in order to fully capture the benefit of CD40 immunotherapy,” said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. “With this study in preclinical lymphoma tumor models, we show both direct and indirect anti-lymphoma activity as well as synergistic anti-lymphoma activity with our CD27 agonist varlilumab, supporting potential combination treatment in this setting.”
The poster features detailed analyses of the anti-lymphoma efficacy of CDX-1140 both as a single-agent and in combination with varlilumab, Celldex’s agonist antibody that binds and activates CD27, or with human immune cells. It is available on the “Publications” page of the “Science” section of the Celldex website. Key findings include:
- CDX-1140 elicits direct anti-tumor activity against CD40-positive lymphomas in preclinical tumor models.
- The addition of human peripheral blood mononuclear cells (PBMCs) to the tumor models enhances the anti-tumor activity of CDX-1140 compared to the administration of either human PBMC or CDX-1140 alone, indicating an activated anti-tumor immune response by CDX-1140 in addition to direct anti-tumor activity.
- The combination of CDX-1140 and varlilumab, elicited greater anti-tumor activity than either antibody alone.
Celldex is currently performing manufacturing and IND-enabling studies to support Phase 1 dose-escalation studies of CDX-1140. The Company believes that the potential for CDX-1140 will be best defined in combination studies with other immunotherapies or conventional cancer treatments.
Additionally, data from investigator sponsored research with varlilumab, CDX-301 and CDX-1401 were/will be presented by Celldex’s collaborating investigators during the ASH Annual Meeting.
- Varlilumab: “Anti-CD27 Enhances Lymphoma Immunotherapy through Profound Myeloid Cell Recruitment” was presented in a poster session on Sunday, December 4 (Abstract #3024). This poster was selected for discussion in a Special-Interest Session called, “Novel Approaches to Immunotherapy — Not Just Checkpoint” to be held on Monday, December 5, 2016 from 12:15-1:15 pm PST.
- CDX-301: “Combining In Situ Vaccination with Immune Checkpoint Blockade Induces Long-Term Regression of Lymphoma Tumors” was presented in an oral session on Sunday, December 4 (Abstract #465).
- CDX-1401: “Vaccination with NY-ESO-1 in Combination with Decitabine for Patients with MDS” will be presented in a poster session on Monday, December 5 (Abstract #4326). (Original Source)
Shares of Celldex closed last Friday at $3.55, down $0.02 or -0.56%. CLDX has a 1-year high of $17.30 and a 1-year low of $2.85. The stock’s 50-day moving average is $3.38 and its 200-day moving average is $4.18.
On the ratings front, CLDX stock has been the subject of a number of recent research reports. In a report issued on December 1, Cantor analyst Mara Goldstein reiterated a Buy rating on CLDX, with a price target of $9.00, which implies an upside of 154% from current levels. Separately, on November 7, Roth Capital’s Joseph Pantginis reiterated a Buy rating on the stock and has a price target of $7.00.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Mara Goldstein and Joseph Pantginis have a yearly average return of 1.4% and a loss of 14.7% respectively. Goldstein has a success rate of 42% and is ranked #1505 out of 4240 analysts, while Pantginis has a success rate of 32% and is ranked #4146.
Sentiment on the street is mostly bullish on CLDX stock. Out of 5 analysts who cover the stock, 4 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $16.00, which represents a potential upside of 351% from where the stock is currently trading.
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.