On May 15, 2017 Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing cancer immunotherapies, reported online a poster previously presented at the National Cancer Research Institute (NCRI) Cancer Conference in Liverpool that showed axalimogene filolisbac achieved durable response in a patient with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) (Press release, Advaxis, MAY 15, 2017, View Source [SID1234519112]).

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Sharad Ghamande, MD, principal investigator and Professor and Director of Gynecologic Oncology at the Georgia Cancer Center at Augusta University, discussed cervical cancer and axalimogene filolisbac in detail recently on the JENNIE Show on the News Channel ABC 6, WJBF in Augusta, GA. Also, one patient in this phase 1 study experienced an ongoing and durable partial response, and this patient was recently featured in the Augusta Chronicle, as she is being treated by Dr. Ghamande at the Georgia Cancer Center at Augusta University. Read the full Augusta Chronicle article here.

Overall, nine patients who had documented disease progression after they had received curative treatments of chemotherapy and/or radiation with or without bevacizumab were enrolled in this phase 1, open-label, dose-determining study. Axalimogene filolisbac was well-tolerated across two dose levels. The study also established a recommended phase 2 dose of 1×1010 CFU and demonstrated antitumor activity at that dose. Axalimogene filolisbac was safely administered at 5 and 10 times the dose levels previously studied, without significant toxicity.

"The best overall tumor response in eight of the nine enrolled patients is encouraging in evaluating the potential of axalimogene filolisbac," said Dr. Ghamande. "We were pleased to see a sustained and durable partial response in one patient, which is very rare for this kind of tumor that is unresponsive to chemotherapy, and survival in these patients is often less than 10 months. In addition, we could safely administer the drug at 5 and 10 times the dose levels previously studied, without any significant toxicity."

There was only one instance of dose-limiting toxicity, with that patient experiencing a grade 3 treatment related adverse event (TRAE) of hypotension at a dose of 5×109 CFU. Across all doses, eight of nine patients experienced a grade 1-2 TRAE, including chills, nausea and hypotension.

The poster on the phase 1 data, "High-dose treatment with ADXS11-001, a Listeria monocytogenes-listeriolysin O (Lm-LLO) immunotherapy, in women with cervical cancer: a phase I, dose-escalation study" (no. 58) is available at www.advaxis.com. The company is preparing to initiate a phase 3 trial in PRmCC later this year.

About Axalimogene Filolisbac

Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack. In a phase 2 trial evaluating axalimogene filolisbac for the treatment of persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), the drug candidate showed a 12-month overall survival rate of 38 percent observed in 50 patients in the trial. This is a 52 percent improvement over the 12-month overall survival rate that was expected in the trial’s patient population based on prognostic factors.

Axalimogene filolisbac has received Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. The immunotherapy has also received orphan drug designation in three clinical indications.

On March 27, 2017 Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing cancer immunotherapies, reported that it has published online a poster previously presented at the National Cancer Research Institute (NCRI) Cancer Conference in Liverpool that showed axalimogene filolisbac achieved durable response in a patient with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) (Press release, Advaxis, MAR 27, 2017, View Source [SID1234518271]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Nine patients who had documented disease progression after they had received curative treatments of chemotherapy and/or radiation with or without bevacizumab were enrolled in this phase 1, open-label, dose-determining study. Axalimogene filolisbac was well-tolerated across two dose levels. The study also established a recommended phase 2 dose of 1×1010 CFU and demonstrated antitumor activity at that dose. Axalimogene filolisbac was safely administered at 5 and 10 times the dose levels previously studied, without any significant toxicity. One patient experienced an ongoing and durable partial response. This patient was recently featured in the Augusta Chronicle, as she is being treated at the Georgia Cancer Center at Augusta University. Read the full Augusta Chronicle article here.

"The best overall tumor response in eight of the nine enrolled patients is encouraging in evaluating the potential of axalimogene filolisbac," said Sharad Ghamande, principal investigator and Professor and Director of Gynecologic Oncology at the Georgia Cancer Center at Augusta University. "We were pleased to see a sustained and durable partial response in one patient, which is very rare for this kind of tumor that is unresponsive to chemotherapy, and survival in these patients is often less than 10 months. In addition, we could safely administer the drug at 5 and 10 times the dose levels previously studied, without any significant toxicity."

There was only one instance of dose-limiting toxicity, with that patient experiencing a grade 3 treatment related adverse event (TRAE) of hypotension at a dose of 5×109 CFU. Across all doses, eight of nine patients experienced a grade 1-2 TRAE, including chills, nausea and hypotension.

The poster on the phase 1 data, "High-dose treatment with ADXS11-001, a Listeria monocytogenes-listeriolysin O (Lm-LLO) immunotherapy, in women with cervical cancer: a phase I, dose-escalation study" (no. 58) is available at www.advaxis.com. The company is preparing to initiate a phase 3 trial in PRmCC later this year.

About Axalimogene Filolisbac

Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack. In a phase 2 trial evaluating axalimogene filolisbac for the treatment of persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), the drug candidate showed a 12-month overall survival rate of 38 percent observed in 50 patients in the trial. This is a 52 percent improvement over the 12-month overall survival rate that was expected in the trial’s patient population based on prognostic factors.

Axalimogene filolisbac has received Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. The immunotherapy has also received orphan drug designation in three clinical indications.