Market Data 
Markets
Replies to post #207760 on Biotech Values
01/09/17 11:38 AM
01/09/17 2:45 PM
02/27/17 11:42 AM
Advaxis, Inc. and SELLAS Life Sciences Group…today announced that Advaxis has granted SELLAS a license to develop a novel cancer immunotherapy agent using Advaxis' proprietary Lm-based antigen delivery technology with SELLAS' patented WT1 targeted heteroclitic peptide antigen mixture (galinpepimut-S).
…Galinpepimut-S has demonstrated positive phase 2 clinical results in acute myeloid leukemia and malignant pleural mesothelioma and positive early clinical data in multiple myeloma. It has been shown to induce strong immune responses (CD4+/CD8+) against the WT1 antigen and to access a broad range of HLA types. Advaxis' Lm-based antigen delivery technology has demonstrated the potential to induce an enhanced innate immune stimulation and generate specific T cells while reducing immune tolerance in the tumor microenvironment.
Under the terms of the collaboration, Advaxis will conduct all pre-clinical activities required for an IND filing. Thereafter, SELLAS will be responsible for all clinical development and commercial activities. Advaxis will receive future payments of up to $358 million from SELLAS if certain development, regulatory, and commercial milestones are met.
Following any regulatory approval of the product candidate emanating from this particular program, SELLAS has agreed to pay Advaxis single-digit to low double-digit royalties based on worldwide net sales upon commercialization.
03/23/17 11:01 AM
03/27/17 10:36 AM
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 [a/k/a AXAL] was well-tolerated across two dose levels. The study also established a recommended phase 2 dose of 1×10^10 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.
…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 5×10^9 CFU. Across all doses, eight of nine patients experienced a grade 1-2 TRAE, including chills, nausea and hypotension.
AI
