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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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February 3, 2016
08:11 EDTADXSAdvaxis' Axalimogene Filolisbac to be developed in Latin America with Stendhal
Advaxis announced that it has entered into a co-development and commercialization agreement with Especificos Stendhal SA de CV, for Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, in HPV-associated cancers. Stendhal is a privately held Latin American specialty pharmaceutical company that partners with leading drug companies to deliver effective solutions for life-threatening diseases in Latin American markets. Under the terms of the Agreement, Stendhal will pay $10M toward the expenses of AIM2CERV, a planned global Phase 3 clinical trial in women with high-risk, locally advanced cervical cancer. This payment covers a significant portion of the total planned study costs. Stendhal will also work with Advaxis to complete the clinical trial of axalimogene filolisbac in Mexico, Brazil, Colombia, and other investigational sites in Latin American countries. Additionally, Stendhal will manage the regulatory approval process, promotion, commercialization and market access for axalimogene filolisbac in these markets. Advaxis and Stendhal will share profits on a pre-determined basis.

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