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November 8, 2016
By Mark Terry, BioSpace.com Breaking News Staff



Hampton, NJ-based Celldex (CLDX) announced recently that it planned to acquire Kolltan Pharmaceuticals. In addition to the news from its third-quarter financial report, the company indicated it had $203.2 million in cash, cash equivalents and marketable securities at the end of the third quarter. Is this a hint the company will do more acquisitions?

Maybe. But the real focus appears to be on its pipeline.

The Kolltan acquisition is a stock-for-stock deal with an upfront equity value of about $62.5 million. What’s most interesting is the pipeline products it picked up in the deal. KTN-158 is a humanized monoclonal antibody that inhibits KIT activation and receptor dimerization in tumor cells and mast cells. It’s currently in a Phase I study in refractory gastrointestinal stromal tumors (GIST). KTN3379 is a monoclonal antibody that blocks the activity of ErbB3 (HER3). It just finished a Phase Ib trial with combination cohorts in cetuximab (Erbitux) refractory patients in head and neck squamous cell carcinoma and in BRAF-mutant non-small cell lung cancer (NSCLC).

It also picked up a multi-faceted TAM program, which it describes as “a broad antibody discovery effort underway to generate antibodies that modulate the TAM family of RTKs, comprised of Tyro3, AXL and MerTK, which are expressed on tumor-infiltrating macrophages, dendritic cells and some tumors.” It’s believed to have broad potential in immuno-oncology and inflammatory diseases.

Keith Speights, writing for The Motley Fool, says, “The Kolltan acquisition adds a new twist for investors to watch. However, the main catalysts for Celldex should continue to be clinical results for glemba and varlilumab. How the biotech’s stock performs will depend primarily on its pipeline progress.”

In a statement, Anthony Marcucci, Celldex’s co-founder, president and chief executive officer, said, “In the third quarter, we presented important data from our Phase II study of glembatumumab vedotin in checkpoint-refractory metastatic melanoma at ESMO, meeting the primary overall response endpoint and demonstrating clinically meaningful duration of response in this difficult-to-treat setting. Building on these promising signals, we are now enrolling a combination arm with our CD27 agonist, varlilumab, and are in the process of finalizing an additional arm to explore a glembatumumab vedotin and checkpoint inhibitor combination.”

Likely of even more interest is that the company continues to enroll patients in a Phase IIb trial of glemba in metastatic triple-negative breast cancer. Celldex hopes that the results of the trial will give it enough positive data to file for regulatory approval.

The company also has an ongoing Phase II trial of varlilumab with Bristol-Myers Squibb (BMS)’s Opdivo for several different types of cancer. It’s also studying varlilumab in combination with glemba in a Phase II trial for metastatic melanoma.

Speights writes, “Investigator-sponsored trials are in progress for a couple of other pipeline candidates. The National Cancer Institute is sponsoring a Phase II study of CDX-1401 and CDX-301. Roswell Park Cancer Center is conducting an early stage study of CDX-1401 in combination with Hiltonol and epacadostat targeting treatment of patients in remission with ovarian, fallopian tube, or primary peritoneal cancer.”

Although the company is staying mum about more acquisitions, it has hinted that it might make a secondary offering of public stock.

Celldex stock is currently trading for $3.47.



Source: BioSpace