I spoke Dan at the June Investor Conference and ask him directly about the PETX project delays. He said they had been working through a disagreement with PETX on the correct process to administer AT-014. PETX was insisting on a (freeze) dried approach.
There are clear indications that freeze drying is not or was not viewed as an optimal way to store vaccines as it could impact effectiveness. Perhaps PETX feels they’ve overcome the drawbacks associated with a freeze dried product. PETX has referred to refrigerating AT-014 being a problem for Veterinary offices. ADXS was clearly working on a dry room temperature application of Lm as early as 2010 which obviously would have simplified the portability, storage and application of the product. Especially important in 3rd world settings.
June 3, 2010 - Advaxis Annual Meeting notes
“A dry, room temperature, stable dose of Advaxis lead immunotherapeutic candidate ADXS11-001 is currently being developed.”
August 11, 2010 IR
“NORTH BRUNSWICK, N.J.-- Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company and Vibalogics GmbH, a German biologics manufacturing company, have agreed to co-develop a room temperature stable, processing technology for live vaccines originally engineered for Advaxis.
Most live vaccines are stored via freeze drying called lyophilization. This drying method may not be suitable for all products, as it frequently kills most of the microorganism; depending upon the organism type and related recovery and stability issues. Based on Vibalogics' drying experience, a new method has been found that allows for a room temperature, storage-stable form of Advaxis' live Listeria vaccines with a very high recovery.”
October 18, 2011 IR
“PRINCETON, N.J.-- Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, today announced that the United States Patent and Trademark Office has issued a Notice of Allowance for a US Patent titled “Compositions and Methods for Treatment of Cervical Cancer.” This patent specifically protects the use of the Advaxis HPV construct for the treatment of late stage cervical cancer, an unmet medical need for which this agent is currently being evaluated in 2 Phase II clinical trials, two of which are in recurrent metastatic cervical cancer, one in India and one in collaboration with the Gynecologic Oncology Group of the National Cancer Institute in the US.
Once issued, this patent will provide a new 17+ year patent cycle for Advaxis’ lead compound.
This patent establishes ADXS-HPV as a method of treatment for late stage cervical cancer in human patients using a recombinant Listeria strain comprised of a fusion of HPV E7 antigen and an N-terminal fragment of an LLO protein.
This patent also protects ADXS-HPV in various physical formulations, including a dried formulation that is stable at room temperature.”
Has Advaxis perfected a stable room temperature version of Lm and if so, why the pissing contest with PETX. A little transparency from ADXS leadership around questions the PETX statements have raised would be nice.
G.B.
AI
