June 1, 2015
By Alex Keown, BioSpace.com Breaking News Staff
CHICAGO – Patients undergoing treatment for glioblastoma, an aggressive form of brain cancer, can live longer using an experimental vaccine currently in mid-stage trials, New Jersey-based Celldex Therapeutics, Inc. announced at the 2015 American Society of Clinical Oncology (ASCO) meeting in Chicago.
The company announced data from the clinical the Phase II ReACT study of Rintega (rindopepimut), showed the patients with recurrent glioblastoma who were taking Rintega, were experiencing six months of progression free survival as well as a reduction of need for additional steroids.
“We were extremely pleased to see that even in patients with bulky, growing tumors, RINTEGA generated remarkably frequent and robust anti-EGFRvIII immune responses, which strongly correlated with meaningful clinical activity,” Thomas Davis, chief medical officer at Celldex, said in a statement.
David Reardon, director of the Center for Neuro-Oncology, said patients diagnosed with glioblastoma are in “dire need” of better treatment options.
“I believe Rintega could become a critical therapy for patients with EGFRvIII-positive glioblastoma. Above all, I think these results offer much needed hope to patients, their families and the physicians who treat them that progress is being made in treating this devastating disease,” said Reardon, who presented the Celldex trial data at ASCO.
Although the company’s news was positive, it did not spark a spike in morning trading. Celldex Therapeutics was trading at $28.44 per share, down from the previous close of $28.87 per share.
The company said if data remains consistent during later trials, it will begin the process of discussing approval with regulatory agencies. 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.
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. 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.
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.
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.
“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.
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?
