Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced three poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2016 in New Orleans. The Company previously reported on four poster presentations at AACR, which included Phase 1 safety and immune response data from the ongoing study evaluating varlilumab and nivolumab in patients with advanced cancers. New presentations included data enhancing the understanding of glembatumumab vedotin’s mechanism of action and further validation of the overexpression of its target, gpNMB, in a wide range of tumor types. Additionally, the Company also presented research with lead agonist antibodies targeting the CD40 receptor, a promising target for immunotherapy, in a poster titled “Development and characterization of novel CD40 antibody agonists for cancer immunotherapy.”
Found on antigen presenting cells, such as dendritic cells, macrophages and B cells, CD40 is a key activator of immune responses. The Company has characterized two fully human antibodies that demonstrated potent agonist activity, such as activating human dendritic cells and B cells and indirectly inducing T cell proliferation. Importantly, Fc receptor interaction, which could cause signal amplification and is required for some CD40 agonist antibodies in development, was not required for agonist ability, enabling controlled, sensitive activation of CD40. Additionally, the drug candidates were shown to upregulate CD95/Fas, a receptor involved in apoptosis, on B cell lymphoma cell lines and to mediate potent anti-tumor activity against the lymphomas in vivo.
“The CD40 pathway has a unique and powerful role in bridging the innate and adaptive immune response, and if properly modulated, it could become a very important part of cancer immunotherapy. We have identified some promising and differentiated antibodies, from which we will select a lead clinical candidate to complement our growing immunotherapy pipeline,” said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. “In addition, we are enthusiastic about new research demonstrating gpNMB overexpression in a broad set of tumor types, further reinforcing the wide potential clinical applicability of glembatumumab vedotin.”
The CD40 poster is available on the “Publications” page of the “Science” section of the Celldex website.
Celldex and its collaborating investigators also presented two additional posters supporting the clinical development of glembatumumab vedotin:
Title: Glycoprotein NMB (gpNMB) overexpression is prevalent in human cancers: pancreatic cancer, non-small cell lung cancer, head and neck cancer, and osteosarcoma
gpNMB is the target of Celldex’s antibody-drug conjugate glembatumumab vedotin. Using a validated immunohistochemistry (IHC) assay to detect the expression of gpNMB, the Company examined tissues from multiple types of solid tumors and normal tissue. Overexpression of gpNMB in samples of tumor tissue versus normal tissue was found in squamous cell carcinoma of the lung (85%), osteosarcoma (62%), pancreatic cancer (55%), lung adenocarcinoma (45%) and squamous cell carcinoma of the head and neck (40%). These results support the potential broad applicability of gpNMB as a therapeutic target across a wide range of tumor types. Celldex is currently investigating glembatumumab vedotin in the pivotal METRIC study in triple-negative breast cancer and in a Phase 2 study in metastatic melanoma. Independent investigators are also studying glembatumumab vedotin in uveal melanoma and osteosarcoma. A Phase 1/2 study in squamous cell carcinoma of the lung is expected to commence in the second quarter of 2016.
The poster is available on the “Publications” page of the “Science” section of the Celldex website.
Title: Targeting gpNMB with 89Zr-CR011 for PET imaging of triple negative breast cancer
Collaborating investigators used a radio-labeled form of the glembatumumab antibody to study uptake by tumor cells in vitro and in vivo. Using positron emission tomography (PET) imaging with xenograft models of triple-negative breast cancer (TNBC), the investigators detected specific localization of glembatumumab in the tumor and plan to perform similar studies with patient derived tumor samples. These studies contribute to understanding the mechanisms of action for glembatumumab vedotin, Celldex’s antibody-drug conjugate targeting gpNMB, and may provide a diagnostic approach for selecting patients with the greatest likelihood of clinical benefit. (Original Source)
Shares of Celldex Therapeutics closed yesterday at $4.00, down $0.40 or -9.09%. CLDX has a 1-year high of $30.28 and a 1-year low of $2.96. The stock’s 50-day moving average is $4.41 and its 200-day moving average is $10.47.
On the ratings front, Celldex has been the subject of a number of recent research reports. In a report released yesterday, Cowen analyst Boris Peaker reiterated a Buy rating on CLDX, with a price target of $12, which represents a potential upside of 200.0% from where the stock is currently trading. 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 14.5% and -8.7% respectively. Peaker has a success rate of 47.7% and is ranked #164 out of 3812 analysts, while Aschoff has a success rate of 38.8% and is ranked #3765.
The street is mostly Bullish on CLDX stock. Out of 9 analysts who cover the stock, 5 suggest a Buy rating and 4 recommend to Hold the stock. The 12-month average price target assigned to the stock is $6.00, which represents a potential upside of 50.0% 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. The company was founded by Anthony S. Marucci and Tibor Keler in 1983 and is headquartered in Hampton, NJ.