Synthetic Genomics and Advaxis have developed a current good manufacturing practice (cGMP) synthetic biology suite to produce synthetic DNA constructs. The cGMP facility meets U.S. Food and Drug Administration (FDA) requirements to begin a Phase 1 clinical trial testing ADXS-NEO — a potential immunotherapy made by Advaxis to treat a variety of cancers, including cervical cancer. ADXS-NEO activates immune system responses against the unique mutations in each patient’s tumor, says Advaxis. The therapy primarily identifies neoepitopes – proteins that arise from mutations on t ..read more

Adding S-1 to Platinol (cisplatin) chemotherapy improved cervical cancer patients’ response to treatment and lengthened the time it took for their disease to progress, according to a Phase 3 clinical trial. Taiho Pharmaceutical, which developed S-1, presented the results at the American Society of Clinical Oncology annual meeting in Chicago, June 2-6. The poster-session presentation was titled “A randomized phase III trial of cisplatin with or without S-1 in patients with FIGO IVB, recurrent, or persistent cervical cancer: An Asian study.” S-1, also known as TS-1, is an oral fl ..read more

Preliminary data from a Phase 1/2 trial, presented at the American Society of Clinical Oncology Annual 2017 Annual Meeting, shows that Opdivo (nivolumab) monotherapy was effective in more than 26 percent of patients with cervical cancer, regardless of their PD-L1 or HPV status, or number of prior systemic therapies. The study, “An open-label, multicohort, phase I/II study of nivolumab in patients with virus-associated tumors (CheckMate 358): Efficacy and safety in recurrent or metastatic (R/M) cervical, vaginal, and vulvar cancers,” was presented June 2 by Antoine Hollebecque, the study ..read more

A new device developed at Duke University aims to improve cervical cancer screening by replacing uncomfortable speculum exams and high-cost colposcopes with a device that would allow for at home self-screening. Initial results obtained with the device were published in the study, “Design and preliminary analysis of a vaginal inserter for speculum-free cervical cancer screening,“ in the online journal PLOS One. The device, referred to as a “pocket colposcope,” is a miniature pen sized-colposcope which can connect to many home devices including cellphones and laptop computers. Healthcare p ..read more

Cervical cancer patients are being recruited for a Phase 2 clinical trial of a combination of Keytruda (pembrolizumab) and chemoradiation therapy. The randomized trial (NCT02635360) is expected to include about 88 adults with locally advanced cervical cancer, or LACC. Keytruda’s developer, Merck, is sponsoring the trial, with University of Virginia researchers conducting  it. Researchers will discuss the trial at the American Society of Clinical Oncology annual meeting in Chicago, June 2-6. The title of the poster presentation is “A randomized phase II ..read more

Advaxis and Bristol-Myers Squibb have entered a clinical collaboration to evaluate the second generation of axalimogene filolisbac, called ADXS-DUAL, in combination with Opdivo (nivolumab) in women with metastatic cervical cancer. In particular, the study will assess the combination in patients with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix who failed at least one prior line of chemotherapy. The trial, expected to start by the end of 2017, will be sponsored by Advaxis. “Combining immunotherapy agents is at the core of Bristol-Myers Squibb ..read more

Merck’s Keytruda (pembrolizumab) shows promise as a treatment for advanced, previously treated cervical squamous cell cancer, according to a preliminary analysis of a Phase 2 trial. The data, which will be presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, June 2-6, indicated response rates increased with longer follow-up. The ongoing trial — which is still recruiting participants — is expected to conclude in May 2019. The poster presentation, “Pembrolizumab for previously treated advanced cervical squamous cell cancer: Preliminary results from the phase 2 KEYN ..read more

Locally advanced cervical cancer (LACC) may be treated with a combination of neoadjuvant chemotherapy (administered before surgery) and p53 gene therapy, according to a new clinical trial. The trial results, titled “Efficacy of recombinant human adenovirus-p53 combined with chemotherapy for locally advanced cervical cancer: A clinical trial,” were published in the journal Oncology Letters. LACC refers to a group of high risk cervical cancers with poor prognosis. According to researchers, young patients with LACC prefer neoadjuvant chemotherapy rather than radical surgery, but the effectivenes ..read more

A new diagnostic system by Mel-Mont Medical that allows women to collect cervical cell samples at home could help boost cervical cancer screening in areas where women lack access to health services. This could help prevent unnecessary deaths caused by this preventable disease, the company said. The system, called Mía by XytoTest, includes a medical device that allows women to self-collect cervical cells. The cells are then analyzed to identify human papillomavirus (HPV) using a molecular system of real-time polymerase chain reaction (PCR). If a woman’s cells are ..read more

One of nine cervical cancer patients treated with AXAL achieved a long-lasting partial response to the therapy, according to a Phase 1 study. The treatment’s maker, Advaxis, presented the results in a poster session at a National Cancer Research Institute conference in Liverpool, England. The trial covered patients with persistent or recurrent metastatic carcinoma of the cervix (PRmCC). You can find the presentation, titled “High-dose treatment with ADXS11-001, a Listeria monocytogenes-listeriolysin O (Lm-LLO) immunotherapy, in women with cervical cancer: a ..read more