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03/06/17 9:07 AM

#209640 RE: DewDiligence #209446

ADXS, AMGN > Advaxis Announces FDA Acceptance of IND for Groundbreaking Personalized Neoepitope Immunotherapy, ADXS-NEO

https://finance.yahoo.com/news/advaxis-announces-fda-acceptance-ind-110000608.html

This ground-breaking IND paves the way for bringing a new precision immunotherapy for the treatment of cancers into the clinic this year. ADXS-NEO employs Advaxis’ proprietary Listeria monocytogenes (Lm)-based antigen delivery technology, its Lm Technology™, to target multiple patient-specific neoantigens in each individual patient’s tumor that are not present in normal cells. ADXS-NEO is designed to stimulate both the innate and adaptive arms of the immune system.

Advaxis bioengineers ADXS-NEO constructs by programming its Lm-based antigen delivery technology to present the unique protein fragments or neoantigens associated with mutations found in a patient’s own cancer cells. These cancer-specific mutations are identified by comparing the DNA sequences of cancer cells with normal cells. ADXS-NEO works by presenting a large payload of neoantigens directly into dendritic cells within the patient’s immune system to generate new cancer-fighting white blood cells. These T cells hunt down cancer cells bearing these neoantigens while at the same time broadly stimulating the immune system and reducing the ability of the cancer to resist.

ADXS-NEO constructs can present multiple neoantigens that can be targeted by a patient’s immune system simultaneously. Tumors may accumulate up to 100 or more mutations that can generate neoantigens, and each patient has a set of mutations that are unique to his or her own tumors. ADXS-NEO is designed to hit multiple targets at once to improve the likelihood of a benefit.

ADXS-NEO will be manufactured in Advaxis’ newly constructed facility in Princeton, N.J., utilizing a process that minimizes the time required to develop the patient-specific immunotherapy. A single manufacturing run can provide sufficient product to treat each patient repeatedly for more than one year.

ADXS-NEO is under development through a collaboration between Amgen and Advaxis, bringing together Amgen’s expertise in immuno-oncology development and commercialization and Advaxis’ proprietary Lm-based antigen delivery technology and it’s My Immunotherapy Neo-Epitopes or MINE™ platform. Advaxis plans to initiate a phase 1 trial evaluating ADXS-NEO in multiple tumor types later this year.

DewDiligence

08/08/17 11:52 AM

#212975 RE: DewDiligence #209446

Sellas Life Sciences reverse merges into GALE:

https://finance.yahoo.com/news/galena-biopharma-enters-merger-agreement-100000305.html

Galena Biopharma, Inc. (GALE) and SELLAS Life Sciences Group Ltd, a privately-held, oncology-focused, clinical stage biopharmaceutical company, today jointly announced they have entered into an all stock definitive merger agreement under which SELLAS will merge into and become an indirect, wholly-owned subsidiary of Galena. The combined company will be renamed SELLAS Life Science Group, Inc. The merger will result in a combined company focused on the development of novel treatments for cancer.

…On a pro forma basis…Galena stock and warrant holders are expected to own approximately 32.5%, and SELLAS shareholders will own approximately 67.5% of the combined company.

…Upon closing of the transaction, the name of the combined company will become SELLAS Life Sciences Group, Inc. and shares of the combined are expected to continue trading on the NASDAQ Capital Market under a new ticker symbol, SLS.

Sellas has a partnership with ADXS announced in Feb 2017 (#msg-129039283).

DewDiligence

03/20/18 7:42 PM

#218016 RE: DewDiligence #209446

(ADXS)—SLS expects to file IND for Lm-WT1 vaccine in 2018, according to today’s Oppenheimer webcast:

https://www.veracast.com/webcasts/opco/healthcare2018/59111401745.cfm