Celldex's Brain Cancer Drug Rintega Will Take Center Stage at ASCO
May 29, 2015
By Alex Keown, BioSpace.com Breaking News Staff
BOSTON – New Jersey-based Celldex Therapeutics, Inc. could announce a breakthrough in treatments for glioblastoma, an aggressive form of brain cancer, at the 2015 American Society of Clinical Oncology (ASCO) meeting in Chicago.
The company announced it will present data from multiple clinical programs, including the Phase II ReACT study of Rintega (rindopepimut) in patients with recurrent glioblastoma at the annual meeting, which begins Sunday. The ReACT presentation will include final analysis of progression-free survival at six months and current data on overall survival and other endpoints, the company said. In addition to the ReAct Study, there have been three other Phase II trials—ACTIVATE, ACT II, and ACT III. The trials showed consistent improvements in both overall survival and median progression-free survival. The most common adverse events for Rintega include injection site reactions, fatigue, rash, nausea and pruritus.
Anthony Marucci, president and chief executive officer of Celldex Therapeutics, said patients diagnosed with glioblastoma have “extremely limited treatment options, with only three new drugs approved” in the past 20 years.
Gliomas, one of the most common types of brain tumors, can affect your brain function and be life-threatening depending on their location and rate of growth, according to the Mayo Clinic. Glioblastoma tumors are often called “grow-and-go tumors”due to their rapid growth and propensity to rapidly spread to other areas. There are about 23,000 cases of glioblastoma diagnosed in the United States each year.
In February the U.S. Food and Drug Administration (FDA) granted Rintega (rindopepimut) Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma.
“Emerging clinical data suggests that rindopepimut may offer an improvement over existing standard of care for EGFRvIII-positive patients. With continued positive data, we look forward to working closely with the FDA to support potential approval of rindopepimut as expeditiously as possible,” Marucci said in a statement after the FDA’s action.
The breakthrough designation was awarded following early stage clinical trial showed Rintega, combined with Genentech ’s Avastin, helped patients survive 36 percent longer than Avastin alone, extending the lives of patients from an average of less than nine months to a full year.
Rintega is an investigational immunotherapy that targets the tumor specific oncogene EGFRvIII. Patients with EGFRvIII-positive glioblastoma typically have a worse prognosis than the overall glioblastoma population, including poor long term survival.
Rintega works “by stimulating a major immune response in the body, spurring the body to produce more of the antibodies that help destroy tumor cells,” Celldex’s Chief Medical Officer Thomas Davis told the Journal. The drug is able to reach the tumor in large part due to a porous blood-brain barrier that is found in patients with glioblastoma. That compromised blood-brain barrier allows the drug molecules to work, Davis said.
Celldex stock was trading up with a morning with a high of $29.86 per share. If the presentations at ASCO are as positive as expected, the stock will most likely see a positive boost in next week’s training. Analysts have estimated Rintega is a billion-dollar-plus drug, if it receives approval in the United States and Europe.
Last month Celldex reported total revenue for the first quarter of 2015 was $500,000, up $100,000 over the same quarter in 2015. Research and development expenses were $25.1 million in the first quarter of 2015 compared to $27.1 million for the comparable period in 2014.
Will PfizerKline Become the Next Pharma Player?
The speculation surrounding a possible bid from Pfizer Inc. for struggling GlaxoSmithKline is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.”
Gregg Gilbert, a biotech analyst at Deutsche Bank, wrote in a note to investors “Introducing PfizerKline” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer’s earnings per share by 10 percent to 16 percent beginning in 2016.
“We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.”
We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history?