SAN CARLOS, CA --(Marketwired - November 08, 2016) - Lion Biotechnologies, Inc. (
"The data to be presented at SITC is reflective of our progress in two main directions at Lion; process optimization and expansion of utilization of the TIL technology in new indications. In one abstract, data is provided demonstrating successful culturing of TIL cells from non-melanoma solid tumors, potentially expanding application of the Lion TIL technology in new indications. Additionally, we show progress in process optimization including development of cryopreservation methodology and a more efficient assay to assess potency of TIL cells," said Maria Fardis, PhD, MBA, Lion Biotechnologies President and Chief Executive Officer.
Poster Presentation: "Successful Expansion and Characterization of Tumor Infiltrating Lymphocytes (TILs) from Non-melanoma Tumors"
- This study demonstrated the feasibility of culturing and expanding TILs isolated from non-melanoma tumors including bladder, cervical, head and neck, lung and triple negative breast cancer (TNBC).
- TILs were harvested to assess cell count and viability, followed by immunophenotyping and cryopreservation for future studies.
- Phenotypic characterization of TIL from bladder, cervical and lung cancer were > 60-70% CD8+ T cells whereas TILs from head and neck demonstrated variable distribution of CD8+ and CD4+ T cells. TIL propagated from TNBC were > 80% CD4+ T cells. Regardless of the tumors, most cultures had < 20% CD56+ NK cells.
- Based on the successful culturing of TILs, clinical feasibility of adoptive cellular therapy for patients with non-melanoma solid tumors will be investigated.
Poster Presentation: "Artificial Antigen Presenting Cells Promote Expansion of Tumor Infiltrating Lymphocytes (TILs)"
- The study evaluated artificial antigen presenting cells (aAPC) as a potential substitute for allogeneic peripheral blood mononuclear cells (PBMC) which are currently required for the expansion of TIL. The benefit of using aAPC is to reduce the price of the manufacturing process as well to turn the process into a more reproducible and scalable one.
- A novel aAPC was developed from the CD64+ MOLM-14 human leukemia cell line, genetically engineered to express recombinant CD86 (B7-2) and CD137-L (41BBL) (MOLM14-86/137).
- The study showed that co-culture of TILs with MOLM-14-86/137 aAPC resulted in expansion, metabolic activity and cytotoxicity that were sufficiently similar to that obtained with PBMC.
- TIL differentiation, cellular respiration (OXPHOS) and redirected cytotoxicity were also within the range expected via co-culture with PBMC.
- This data suggests that the expansion protocol using the novel MOLM14-86/137 aAPC can be tested in a clinical setting.
Poster Presentation: "Bioluminescent Redirected Lysis Assay (BRLA) as an Efficient Potency Assay to Assess Tumor-Infiltrating Lymphocytes (TILs) for Immunotherapy"
- TIL therapy involves culturing and expanding T cells isolated from a patient's tumor and then reinfusing them into the patient. TIL antitumor activity is commonly measured using tumor cells from the patient's tumor, when available.
- In order to test the potency of TILs, a BRLA assay was developed using an engineered P815 cell line. It requires no radionuclides and is more efficient than traditional cytotoxicity assays.
- The assay was shown to measure TIL cytotoxicity in a highly sensitive dose dependent manner.
Poster Presentation: "Stable Tumor-Infiltrating Lymphocytes (TIL) Phenotype Following Cryopreservation"
- Cryopreservation is a beneficial process which allows cell products to be shipped in a safe manner with less time constraints. In this study, the data show that cryopreservation did not affect the measured phenotypic characteristics of TIL, enabling Lion to further investigate the possibility of using cryopreserved TIL in a clinical setting.
- Clinical studies using cryopreserved TIL have not been conducted so far.
- In this study, fresh versus frozen/thawed TIL samples were tested to evaluate the expression of phenotypic markers.
- Cryopreservation did not affect the measured phenotypic characteristics of TIL, with the exception of some regulatory molecules. Lion will further investigate the possibility of using cryopreserved TIL in a clinical setting.
About Lion Biotechnologies, Inc.
Lion Biotechnologies, Inc. is a clinical-stage biotechnology company focused on the development of cancer immunotherapy products for the treatment of various cancers. The Company's lead product candidate is an adoptive cell therapy using tumor-infiltrating lymphocytes (TIL) for the treatment of patients with refractory metastatic melanoma. TIL therapy is also being evaluated in clinical trials at the National Cancer Institute and Moffitt Cancer Center. For more information, please visit http://www.lionbio.com .
Forward-Looking Statements
This press release contains certain forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that are subject to a number of risks and uncertainties, including those described in the Company's most recently filed quarterly report on Form 10-Q and annual report on Form 10-K. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact: Sarah McCabe Stern Investor Relations, Inc. 212-362-1200 sarah@sternir.com Media Relations Contact: Alex Ferrara inVentivHealth Public Relations 212-849-9487 Alexandra.Ferrara@inventivhealth.com
