On March 07, 2016 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported that the independent Data Safety and Monitoring Board (DSMB) has determined, based on a preplanned interim analysis, that continuation of the Phase 3 ACT IV study of RINTEGA (rindopepimut) in patients with newly diagnosed EGFRvIII-positive glioblastoma will not reach statistical significance for overall survival in patients with minimal residual disease, the primary endpoint of the study, as both the RINTEGA arm and the control arm are performing on par with each other (Press release, Celldex Therapeutics, MAR 7, 2016, View Source [SID:1234509385]).

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In the ACT IV study, RINTEGA has performed consistently with prior Phase 2 studies but the control arm has significantly outperformed expectations (Hazard ratio = 0.99; median OS: RINTEGA 20.4 months vs. control 21.1 months). Based on this recommendation, Celldex is discontinuing the study and does not anticipate incurring substantial additional costs related to RINTEGA at this time. All patients on the RINTEGA arm of the ACT IV study, prior Phase 2 studies and existing compassionate use recipients will be offered ongoing access to RINTEGA on a compassionate use basis. Celldex first received the data after market close on Friday, March 4th and is in the process of reviewing the results.

"We are extremely disappointed for patients that the ACT IV study was not successful," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "On behalf of Celldex, I want to express our gratitude to the ACT IV investigators, patients and families who participated in this trial. While this is certainly not the desired outcome, we remain steadfast believers in the power of immunotherapy to transform the future of cancer treatment."

Celldex currently has seven company-led clinical trials across five product candidates ongoing. The Company expects to report data from a number of these studies over the next three to 18 months, including a registration study in triple negative breast cancer and a number of Phase 1 and 2 cancer immunotherapy combination trials.

On March 07, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported dose administration for the first patient in the expansion phase of an ongoing Phase 2 clinical trial of its lead Lm immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) (Press release, Advaxis, MAR 7, 2016, View Source [SID:1234509384]).

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The interventional, open-label, non-randomized dose-escalation study is designed to evaluate the safety, efficacy and immunological effect of AXAL administered at doses up to 1 x 1010 colony forming units (CFU) in repeat cycles of treatment in approximately 25 women with cervical cancer whose disease recurred after receiving one prior cytotoxic treatment regimen. The study is being led by principal investigator Sharad Ghamande, M.D., Director of Gynecology Oncology at GRU Cancer Center, Augusta University in Augusta, Ga.

Launch of the expansion phase follows a poster presentation of preliminary data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2015 Annual Meeting, where data from 9 patients showed that AXAL could be safely administered with prophylactic antibiotics up to 1 x1010 CFU, a tenfold increase from prior dosing regimens at 1 x 109. Adverse events at this high dose were consistent with previous experience with predominately grade 1 or grade 2, transient events that self-resolved or were resolved with anti-inflammatory agents (NSAIDS) and antiemetics. The high dose expansion phase will include 15 patients.

"The launch of the expansion phase of this clinical study is an important next step in AXAL’s development program. This study will further explore what our research has shown to date – that a higher dose drives an increase in protein expression in the cytosol and results in greater generation of T cells to the HPV target," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "AXAL holds the potential to fill an unmet treatment gap for women with recurrent cervical cancer."

About Cervical Cancer

Cervical cancer is the fourth most common cancer in women worldwide. In the United States, nearly 13,000 new cases are diagnosed and approximately 4,100 deaths are reported because of cervical cancer. According to the WHO/ICO Information Centre on HPV and Cervical Cancer, about 3.9 percent of women in the U.S. are estimated to harbor high-risk cervical HPV infection at a given time, and 71.7 percent of invasive cervical cancers are attributed to high-risk HPV strains.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis’ lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology. Axalimogene filolisbac has Orphan Drug Designation in the U.S. for the treatment of invasive cervical cancer, head and neck, and anal cancer.