Biothera Pharmaceuticals Presents Translational Data from Ongoing Clinical Trials Showing Imprime PGG in Combination with Merck’s KEYTRUDA® (pembrolizumab) Drives Innate and Adaptive Immune Responses in Tumors

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EAGAN, Minn., April 16, 2018 (GLOBE NEWSWIRE) -- Biothera Pharmaceuticals, Inc. today announced the presentation of new translational data from ongoing phase 2 clinical trials combining Biothera’s Imprime PGG with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck (known as MSD outside the United States and Canada).  These data provide the first evidence in human clinical trials that Imprime PGG-based therapy can activate the immune system at the tumor site in cancer patients.  Pre- and on-treatment tumor biopsy data supporting this activity were presented in a late-breaking poster at the ongoing American Association for Cancer Research (AACR) annual meeting taking place in Chicago, IL, April 14-18, 2018.

The therapeutic combination of Imprime PGG and KEYTRUDA is being evaluated in Phase 2 clinical studies for Triple Negative Breast Cancer (TNBC) patients who have failed chemotherapy but are checkpoint inhibitor (CPI) therapy naïve, and for metastatic melanoma patients who have failed CPI therapy ( Identifier: ).  As part of this phase 2 program, Biothera has obtained paired tumor biopsy samples from patients taken immediately prior to treatment and at 6 weeks “on treatment.”  Biothera’s AACR poster is based on the multispectral imaging analyses performed on seven paired biopsies (five melanoma and two TNBC), which assessed the character and quality of the immune response at the tumor site.  When compared to the pre-treatment biopsies, the “on treatment” samples consistently showed enhanced infiltration of the tumor bed by activated myeloid cells (i.e., innate immune cells), as well as CD8 and CD4 T cells.

“For the first time, we are seeing the changes in human tumors that we have routinely seen in preclinical cancer models—increased activation of both the innate and adaptive arms of the immune system following Imprime-based therapy,” said Jeremy Graff, Ph.D., Chief Scientific Officer and Senior Vice President of Research for Biothera Pharmaceuticals.  “There is a consistent repolarization of the immunosuppressive tumor microenvironment and increased T cell infiltration and activation in these on treatment biopsies.  We look forward to gaining further insights into how Imprime PGG may enhance the efficacy of KEYTRUDA and other checkpoint inhibitor therapies.”

The late-breaking poster presentation at AACR is titled, “.”  Abstract LB-129/Poster 26.

Two additional poster presentations at AACR highlighted preclinical data that expand knowledge of Imprime PGG’s mechanism of action and potential therapeutic combinations. 

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

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Globe Newswire: 14:00 GMT Monday 16th April 2018

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