Date: 2014-02-11
Type of information: Production agreement
Compound: ADXS-HPV bulk drug
Company: SynCo Bio Partners (The Netherlands) Advaxis (USA - NJ)
Therapeutic area: Cancer - Oncology
Type agreement: bioproduction
manufacturing
development
Action mechanism: ADXS-HPV is a therapeutic vaccine administered intravenously that is being evaluated for the treatment of HPV-associated cancers and is the leading candidate from Advaxis’ novel immunotherapeutic platform. it 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 orphan drug status for both anal and head and neck cancers.
Disease: cervical cancer, head and neck cancer, anal cancer
Details: * On February 11, 2014, SynCo Bio Partners., a services provider for GMP manufacturing of live microbial vaccines and biotherapeutics has announced that they have entered into a long term manufacturing collaboration with Advaxis, a biotechnology company developing the next generation of cancer immunotherapies. Under the agreement, SynCo will support Advaxis with scale-up for supply of ADXS-HPV bulk drug substance and drug product for pivotal clinical studies and licensure. The manufacturing collaboration with Advaxis means that SynCo now has experience with 16 different strains of microorganisms for multiple clients to produce biopharmaceuticals. Ten of these microorganisms are live or whole cell microbial products, with three of these products being parenterally administered hence requiring monoseptic bulk drug substance operations prior to completing the drug product.
Financial terms:
Latest news:
