Research Desk Line-up: Abeona Therapeutics Post Earnings Coverage

LONDON, UK / ACCESSWIRE / November 22, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Celldex Therapeutics, Inc. (NASDAQ: CLDX) ("Celldex"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=CLDX. The Company announced on November 17, 2017, that it has started the enrollment for its open-label Phase-2 study of CDX-3379 in combination with Cetuximab in patients with Cetuximab-refractory, advanced head and neck squamous cell carcinoma (HNSCC). Celldex works towards developing targeted therapeutics for devastating diseases. For immediate access to our complimentary reports, including today's coverage, register for free now at:

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Discover more of our free reports coverage from other companies within the Biotechnology industry. Pro-TD has currently selected Abeona Therapeutics Inc. (NASDAQ: ABEO) for due-diligence and potential coverage as the Company announced on November 15, 2017, its financial results for Q3 2017 and also its recent business highlights. Tune in to our site to register for a free membership, and be among the early birds that get our report on Abeona Therapeutics when we publish it.

At Pro-TD, we make it our mission to bring you news that matter about the stock you follow. Today, our research desk covers a blog story on CLDX; also brushing on ABEO. Go directly to your stock of interest and access today's free coverage at:

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About CDX-3379

  • CDX-3379 is a human immunoglobulin G1 lambda (IgG1?) monoclonal antibody that binds and inhibits the activity of ErbB3, which is the main receptor that regulates cancer cell growth, survival, and resistance to targeted therapies.
  • ErbB3 is a dominant element in many cancers, such as head and neck, thyroid, breast, lung, and gastric cancers, as well as melanoma.
  • The action mechanism of CDX-3379 differentiates it from other drugs under development in this class. This is because CDX-3379 has the capability to block both ligand-independent and ligand-dependent ErbB3 signaling by binding to a unique epitope.
  • Moreover, CDX-3379 is capable of enhancing anti-tumor activity and/or overcoming resistance in combination with other targeted and cytotoxic therapies to directly sabotage tumor cells.
  • Besides, it also has a favorable pharmacologic profile. It has a longer half-life and slower clearance compared to other drug candidates in this class.

About Cetuximab

Cetuximab is marketed under the brand name Erbitux®, which is a registered trademark of Eli Lilly & Co. (NYSE: LLY). It is a monoclonal antibody that specifically binds EGFR and inhibits its signaling pathway.

Phase-2 Study Design

  • This Phase-2 study of CDX-3379 in combination with Cetuximab is a multicenter, open-label study that would enroll around 30 patients who have Cetuximab-resistant, advanced HNSCC. The patients enrolled must have been previously treated with an anti-PD1 checkpoint inhibitor. This group represents a population with limited options and a particularly poor prognosis.
  • As part of the study, CDX-3379 (12 mg/kg) will be administered once every three weeks, and Cetuximab (initial dose of 400 mg/m2, then 250 mg/m2) will be administered every week.
  • This treatment would continue until the disease progresses or in case of any intolerance. The assessments would be done every six weeks.
  • The study is divided into two stages, using the Simon two-stage design. The first stage would enroll 13 patients, and if at least one patient achieves a partial response, or complete response, enrollment would progress to the second stage.

Study Checkpoints

  • The primary objective of the Phase-2 study is to investigate the anti-tumor efficacy of CDX-3379 in combination with Cetuximab, as measured by objective response rate.
  • Secondary objectives cover analyses of safety, pharmacokinetics, immunogenicity, and further assessment of anti-tumor activity across a broad range of endpoints, such as clinical benefit rate, duration of response, progression-free survival, and overall survival for the combination.
  • An investigator would conduct the tumor response assessments on the basis of standardized, objective response criteria (RECIST 1.1).

Comments from Vice President

Christopher Turner, M.D. and Vice President at Clinical Science, Celldex, stated that ErbB3 is the main enabler for most oncogenic drivers, including EGFR, which is a validated target with approved targeted therapeutics like Cetuximab. A number of times, patients develop resistance to targeted treatments over a period of time. CDX-3379 plays an important role in cases like these. CDX-3379 precisely blocks ErbB3 with potent binding affinity and locks it into a deactivated state. This blocks ErbB3 mechanisms for interacting with its ligand and other oncogenic drivers.

Turner also shared some information about the Phase-1b study of CDX-3379. The Phase-1b study validated the antitumor activity of CDX-3379 among the nine patients with HNSCC who were treated with CDX-3379 in combination with Cetuximab. In the Phase-1b study, a patient, who had previously progressed on single-agent Cetuximab, reported a durable complete response.

Last Close Stock Review

Celldex Therapeutics' share price finished yesterday's trading session at $2.82, dropping 1.40%. A total volume of 734.44 thousand shares have exchanged hands. The Company's stock price surged 1.08% in the past one month and 21.55% in the last three months. The stock currently has a market cap of $375.62 million.

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