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Stock Market & Financial Investment News

News Breaks
February 11, 2014
07:37 EDTADXSAdvaxis engages SynCo Bio Partners for maufacturing of ADXS-HPV
Advaxis and SynCo Bio Partners B.V. announced that they have signed an agreement for SynCo to manufacture Advaxis' novel drug candidate, ADXS-HPV. Under the agreement, SynCo will assist Advaxis in developing scale-up and commercial manufacturing processes for ADXS-HPV bulk drug substance and drug product. Advaxis plans to initiate registrational trials this year with ADXS-HPV for the treatment of cervical cancer. ADXS-HPV has demonstrated improved survival and objective tumor responses in a Phase 2 trial in 110 patients with recurrent cervical cancer. Advaxis is now planning the registrational program for ADXS-HPV. ADXS-HPV is also being evaluated in other HPV-associated cancers including a Phase 2 in advanced cervical cancer, a Phase 1/2 in head and neck cancer, and a Phase 1/2 in anal cancer. ADXS-HPV has been granted orphan drug designation for both anal and head and neck cancers.
News For ADXS From The Last 14 Days
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June 25, 2015
07:34 EDTADXSAdvaxis provides milestones outlook for 2015 and 2016
The company anticipates the following milestones through the remainder of 2015 and into 2016 for ADXS-HPV: Commence enrollment in the Phase 3, registration quality trial, AIM2CERV; Complete enrollment in Stage 2 of the ongoing GOG-0265 Phase 2 trial of ADXS-HPV in persistent or recurrent cervical cancer being conducted by the Gynecologic Oncology Group, anticipating up to 38 patients enrolled by June 30, 2016 with Final Stage 1 safety and efficacy data to be presented at an upcoming major medical meeting in 2015. Final study data to be available in the first half of 2017; Enroll the first patient this summer in a collaborative Phase 1/2 study of ADXS-HPV in combination with AstraZeneca/MedImmune's MEDI4736 in cervical cancer and HPV-associated head and neck cancer in second half of 2015 with data available in the first half of 2016; Complete enrollment in Part A of our Phase 1 study evaluating higher doses of ADXS-HPV immunotherapy and repeat cycles of treatment with data available from Part A in 2016. Complete enrollment of the Mount Sinai investigator-sponsored Phase 1/2 study of ADXS-HPV in patients with HPV-associated head and neck cancer. Data to be available in the first half of 2016; Commence enrollment in a Phase 2 study in patients with HPV-associated metastatic anal cancer by year's end with data available in the second half of 2016; Commence enrollment in the second half of 2015 on the Phase 1/2 combination study with Incyte Corporation's IDO-1 inhibitor. Expects to complete enrollment in Part A in the first half of 2016 in the Phase 1/2 study of ADXS-PSA as a monotherapy or in combination with Merck's anti-PD-1 therapy, Keytruda, in metastatic, castration-resistant prostate cancer. Data to be available in second half of 2016. Expects to enroll the first patient in a Phase 1 first-in-human trial of ADXS-HER2 in metastatic HER2 expressing solid tumors in the second half of 2015 with data to be available in the second half of 2016; Initiate a clinical study of ADXS-HER2 in pediatric osteosarcoma in partnership with the Children's Oncology Group in 2016; Secure conditional license for ADXS-HER2 for the treatment of canine osteosarcoma from the U.S. Department of Agriculture in 2016.
June 24, 2015
11:19 EDTADXSAdvaxis management to meet with Jefferies
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June 19, 2015
10:42 EDTADXSAdvaxis to host business news update conference call
Conference call to be held on June 25 at 8:30 am. Webcast Link

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