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News Article | May 30, 2017
Site: www.marketwired.com

SAN CARLOS, CA--(Marketwired - May 30, 2017) - Lion Biotechnologies, Inc. ( : LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, today announced that President and Chief Executive Officer, Dr. Maria Fardis will present an overview of Lion's recent progress and 2017 plans at the upcoming Jefferies 2017 Healthcare Conference on Tuesday, June 6, 2017 at 8:30 a.m. E.T. in New York, NY. A live webcast of the presentation will be available by visiting the Investors section of Lion Biotechnologies' website at http://ir.lbio.com/. A replay of the webcast will be archived on Lion Biotechnologies' website for 30 days following the presentation. 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 lymphocyte (TIL) technology being investigated for the treatment of patients with refractory metastatic melanoma, metastatic squamous cell carcinoma of the head and neck, and metastatic cervical carcinoma. For more information, please visit http://www.lionbio.com.


SAN CARLOS, CA--(Marketwired - June 01, 2017) - Lion Biotechnologies, Inc. ( : LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, today announced that the first patient was dosed in its Phase 2 trial of LN-145 for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. "We are pleased to have dosed our first patient in this trial evaluating LN-145 for the treatment of head and neck cancer. While some patients benefit from the few options available for the treatment of metastatic squamous cell carcinoma of the head and neck, there remains an unmet medical need for those who progress through such therapies," said Dr. Maria Fardis, PhD, MBA, Chief Executive Officer of Lion Biotechnologies. "With this important milestone, patient dosing is now ongoing in two of our three Lion sponsored Phase 2 programs. We look forward to reporting data from these trials." LN-145 is an adoptive cell transfer (ACT) therapy that utilizes an autologous TIL manufacturing process as originally developed by the National Cancer Institute. This Phase 2, multicenter, single-arm, open-label interventional study will enroll up to 47 patients and will assess the safety and efficacy of LN-145 for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The cell transfer therapy used in this study involves patients receiving a non-myeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2. Additional information on this study is available at www.clinicaltrials.gov. 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 lymphocyte (TIL) technology being investigated for the treatment of patients with refractory metastatic melanoma, recurrent and/or metastatic squamous cell carcinoma of the head and neck and metastatic cervical carcinoma. For more information, please visit http://www.lionbio.com. Forward-Looking Statements This press release contains "forward-looking statements" regarding, among other things, the Company's clinical plans. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate, or if known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections. A further list and description of Lion Biotechnologies risks, uncertainties and other factors can be found in Lion Biotechnologies, Inc. most recent Annual Report on Form 10-K and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or www.lionbio.com. Any forward-looking statement made in this release speaks only as of the date of this release. Lion Biotechnologies, Inc. does not undertake to update any forward-looking statements as a result of new information or future events or developments.


SAN CARLOS, CA--(Marketwired - February 28, 2017) - Lion Biotechnologies, Inc. ( : LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, today announced that it will report its fourth quarter and full year 2016 financial and operating results after the close of the U.S. financial markets on Tuesday, March 7, 2017. Management will host a conference call and live audio webcast to discuss these results and provide a business update at 4:30 p.m. ET. In order to participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The live webcast can be accessed under "News / Events" in the "Investors" section of the Company's website at http://ir.lbio.com/ or you may use the link: http://edge.media-server.com/m/p/zbgfaa8j. A replay of the call will be available one hour after the end of the call on March 7, 2017 until 4:30 p.m. ET on March 17, 2017. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and reference the access code 75631507. The archived webcast will be available for thirty days in the Investors section of Lion Biotechnologies' website at http://www.lbio.com. 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.


SAN CARLOS, CA--(Marketwired - December 20, 2016) - Lion Biotechnologies, Inc. ( : LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, announced today that it has entered into a new three-year Sponsored Research Agreement with the H. Lee Moffitt Cancer Center and Research Institute. At the same time, Lion Biotechnologies also announced that it has entered into a Clinical Grant Agreement with the H. Lee Moffitt Cancer Center and Research Institute Hospital (collectively, with the H. Lee Moffitt Cancer Center and Research Institute, "Moffitt") to support an ongoing clinical trial at Moffitt that combines TIL therapy with nivolumab for the treatment of patients with metastatic melanoma. Maria Fardis, PhD, MBA, Lion Biotechnologies' President and Chief Executive Officer said, "We are very pleased to continue our research collaboration with Moffitt. The first year of research at Moffitt will focus on evaluation of CD4+ T cells as well as NK cells within the TIL cultures in multiple indications under various ex vivo growth conditions. We are also excited to announce today that we will be supporting Moffitt in conducting a melanoma combination trial investigating TIL therapy in conjunction with nivolumab. This is the third study combining TIL plus a checkpoint inhibitor that Lion will have supported." "Moffitt is a leader in the development and translation of novel therapies for the treatment of melanoma," said James J. Mulé, PhD, Associate Center Director of Translational Science at Moffitt. "This partnership with Lion Biotechnologies will further our institution's efforts to lead the way in providing cutting-edge immunotherapies to cancer patients in Florida and beyond." The Sponsored Research Agreement will have a three-year term. Areas of research will include an evaluation of the role of individual effector cells in the expansion of TIL from primary solid tumors; the use of toll-like receptor (TLR) ligands in the expansion of TIL from solid tumors; optimal expansion of TIL from various solid tumors and phenotype and function analysis of patient blood and tumor samples from clinical trials. 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. 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 the ability of Lion Biotechnologies ("the Company") and/or Moffitt Cancer Center to complete the clinical trials, the results from such clinical trials, and the other risks described in the Company's filings with the Securities and Exchange Commission, including without limitation in its most recently filed quarterly report on Form 10-Q and annual report on Form 10-K. Any forward-looking statements that the Company makes 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.


SAN CARLOS, CA --(Marketwired - November 08, 2016) - Lion Biotechnologies, Inc. ( : LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte technology (TIL), today reported encouraging data in four poster presentations at the Society for Immunotherapy of Cancer (SITC) 31st Annual Meeting & Associated Programs in National Harbor, Maryland taking place November 9-13, 2016. "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" Poster Presentation: "Bioluminescent Redirected Lysis Assay (BRLA) as an Efficient Potency Assay to Assess Tumor-Infiltrating Lymphocytes (TILs) for Immunotherapy" 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. 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.


SAN CARLOS, CA--(Marketwired - October 28, 2016) - Lion Biotechnologies, Inc. ( : LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte technology (TIL), today announced that it will report its third quarter 2016 financial and operating results before the open of the U.S. financial markets on Friday, November 4, 2016. Management will host a conference call and live audio webcast to discuss these results and provide a business update at 8:30 a.m. ET. In order to participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The live webcast can be accessed under "Events and Presentation" in the "Investors" section of the Company's website at http://www.lbio.com/ or you may use the link: http://edge.media-server.com/m/p/usbgqbbo. A replay of the call will be available one hour after the end of the call on November 4, 2016 until 8:30 a.m. ET on November 11, 2016. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and reference the access code 3946579. The archived webcast will be available for thirty days in the Investors section of Lion Biotechnologies' website at http://www.lbio.com. 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 lymphocyte technology (TIL) for the treatment of patients with refractory metastatic melanoma. TIL therapy is also being evaluated in clinical trials at the National Cancer Institute, MD Anderson Cancer Center and Moffitt Cancer Center. For more information, please visit http://www.lionbio.com.


News Article | February 15, 2017
Site: www.businesswire.com

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "T-Cell Immunotherapy Market (2nd Edition), 2017-2030" report to their offering. The "T-Cell Immunotherapy Market, 2017-2030 (2nd edition)" report features an extensive study of the current market landscape and the future potential of T-cell immunotherapies. Immuno-oncology has been gradually nurtured by researchers over the last several years and is now considered as the fourth major pillar of cancer therapy, after surgery, chemotherapy and radiotherapy. As indicated earlier, the T-cell therapy market has evolved significantly over the last few years, offering promising opportunities for a variety of stakeholders. The domain is characterized by a robust and opportunistic pipeline of product candidates focused on targeting hematological cancers and solid tumors. However, with no marketed products, this emerging field is still in its infancy. The report provides a comprehensive overview of the market, focusing particularly on CAR-T therapies, TCR therapies and TIL therapies. The role of academic players/research institutes has been critical in this domain. Post the establishment of initial proof-of-concept, several industry players have entered into collaboration with non-industry participants to fund the clinical and commercial development of potential product candidates. Some late stage products that have emerged out of such collaborations include CTL-019 (Novartis/University of Pennsylvania), KTE-C19 and HPV-16 E6 TCR (Kite Pharma/National Cancer Institute), and LN-144 (Lion Biotechnologies/National Cancer Institute). As mentioned before, encouraging clinical results have significantly accelerated the progress of these therapies. Several technology providers, especially those with capabilities in genome editing, and viral and non-viral gene transfer, are also actively involved in this emerging market. Many of these players have entered into partnerships with therapy developers in order to assist in designing novel features to enhance the efficacy and potency of existing T-cell therapies. A prominent example of such a technology is safety switches; these are innovative molecular tools designed to manage known side effects, such as cytokine release syndrome and B-cell aplasia, by allowing control over the expression of certain genes in the engineered cell population. One of the key objectives of the study was to review and quantify the future opportunities associated with the ongoing programs of both small and big pharmaceutical firms in this domain. It is worth mentioning that there is a lot of hope pinned on multiple start-ups, which have received significant backing by several strategic investors and venture capital firms. For more information about this report visit http://www.researchandmarkets.com/research/fkgnpz/tcell


News Article | November 23, 2016
Site: www.marketwired.com

SAN CARLOS, CA--(Marketwired - November 23, 2016) - Lion Biotechnologies, Inc. ( : LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte technology (TIL), today announced that its President and Chief Executive Officer, Dr. Maria Fardis, and Chief Financial Officer, Greg Schiffman, will participate in a fireside chat at the upcoming 28th Annual Piper Jaffray Healthcare Conference on Wednesday, November 30, 2016 at 2:30 p.m. E.T. in New York, NY. A live webcast of the presentation will be available by visiting the Investors section of Lion Biotechnologies' website at http://ir.lbio.com/. A replay of the webcast will be archived on Lion Biotechnologies' website for 30 days following the presentation. 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.


News Article | February 27, 2017
Site: www.marketwired.com

SAN CARLOS, CA--(Marketwired - February 27, 2017) - Lion Biotechnologies, Inc. ( : LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, announced today that company management will present a corporate update at two investor conferences in March: Live webcasts of the presentations will be available by visiting the Investors section of Lion Biotechnologies' website at http://ir.lbio.com/. Replays of the webcasts will be archived on Lion Biotechnologies' website for 30 days following the presentations. 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 lymphocyte (TIL) technology 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.


Lion Biotechnologies, Inc. ( : LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte technology (TIL), today reported its third quarter 2016 financial results and provided a corporate update. "Lion continues building momentum in broadening the utility of our TIL technology in new indications through internal R&D as well as with our collaborators. We recently announced our collaboration with the Karolinska Institute which expands the utility of TIL into two new indications, glioblastoma and pancreatic cancer. We also extended our Cooperative Research and Development Agreement (CRADA) with Professor Rosenberg at the National Cancer Institute (NCI) for an additional 5 years. We continue our process development work in optimizing the process of manufacturing TIL. Some of our preliminary work on developing a more robust and lower cost processes for growth of TIL will be presented at the upcoming 2016 SITC meeting. We are building our team to become a fully integrated immuno-oncology company with new members with extensive expertise in cell-based therapy as evident by our recent hire of our CFO, Greg Schiffman. We have now doubled the number of our employees since June 2016 and moved to our San Carlos headquarters," said Dr. Maria Fardis, Chief Executive Officer of Lion Biotechnologies. Third Quarter and Year-to-Date 2016 Financial Results As of September 30, 2016 the Company held $179.3 million in cash and cash equivalents and short-term investments, compared to $103.7 million as of December 31, 2015. GAAP net loss attributable to common stockholders, which included a one-time deemed dividend charge of $49.5 million incurred as a result of the conversion feature of the Series B convertible preferred stock, for the quarter ended September 30, 2016 was $68.2 million, or ($1.15) per share, compared to GAAP net loss attributable to common stockholders of $7.6 million or ($0.16) per share for the quarter ended September 30, 2015. The deemed dividend did not have any monetary impact for the Company. Non-GAAP net loss attributable to common stockholders, which excludes amounts related to stock-based compensation and the non-cash deemed dividend, for the quarter ended September 30, 2016 was $10.1 million, or ($0.17) per share, compared to non-GAAP net loss attributable to common stockholders of $5.2 million, or ($0.11) per share for the quarter ended September 30, 2015. The non-GAAP net loss attributable to common stockholders for the three months ended September 30, 2016 excludes $8.6 million of non-cash stock-based compensation and a non-cash deemed dividend of $49.5 million. The stock compensation increase year-over-year of $6.3 million is primarily driven by the departure of the Company's former CFO. The deemed dividend will only impact the current quarter's financial statements. GAAP net loss attributable to common stockholders for the nine months ended September 30, 2016, which includes a one-time deemed dividend related to a charge of $49.5 million incurred as a result of the conversion feature of the Series B convertible preferred stock was $86.7 million, or ($1.64) per share, compared to GAAP net loss attributable to common stockholders of $19.3 million or ($0.44) per share for the nine months ended September 30, 2015. Non-GAAP net loss, which excludes amounts related to stock-based compensation and the non-cash deemed dividend for the nine months ended September 30, 2016 was $21.4 million, or ($0.40) per share, compared to non-GAAP net loss of $13.5 million or ($0.31) per share for the nine months ended September 30, 2015. The Company believes that it is important for investors to understand these non-cash charges as they are materially impacting the quarterly loss and EPS calculations. See "Use of Non-GAAP Financial Measures" below for a description of the Company's Non-GAAP Financial Measures. Reconciliation between certain GAAP and Non-GAAP measures is provided at the end of this press release. GAAP research and development (R&D) expenses of $8.5 million for the quarter ended September 30, 2016 increased by $3.5 million compared to the quarter ended September 30, 2015. The increase in R&D expense is due to increased spending on clinical activities for LN-144. In addition, R&D-associated stock option expenses were $0.6 million for the three months ended September 30, 2016 and $1.8 million for the nine months ended September 30, 2016. Non-GAAP R&D expenses of $7.8 million for the quarter ended September 30, 2016 increased by $3.7 million, compared to $4.1 million for the quarter ended September 30, 2015. GAAP general and administrative (G&A) expenses of $10.5 million increased by $7.8 million compared to the quarter ended September 30, 2015. Non-GAAP G&A expenses of $2.5 million for the quarter ended September 30, 2016 increased by $1.3 million, compared to $1.2 million for the quarter ended September 30, 2015. Reconciliation between certain GAAP and Non-GAAP measures is provided at the end of this press release. Use of Non-GAAP Financial Measures This press release contains non-GAAP financial measures, including expenses adjusted to exclude certain non-cash expenses. These measures are not in accordance with, or an alternative to, generally accepted accounting principles, or GAAP, and may be different from non-GAAP financial measures used by other companies. The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in this press release are: (i) the non-cash stock-based compensation expense which may fluctuate from period to period based on factors including the timing and accounting of grants for stock options and changes in the Company's stock price which impacts the fair value of options granted, and (ii) the one-time non-cash deemed dividend related to the conversion feature of the Series B Preferred Stock. The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding various financial and business trends relating to our financial condition and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures, investors are provided with a more meaningful understanding of our ongoing operating performance. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating operational performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. To the extent this release contains historical or future non-GAAP financial measures, the Company has also provided corresponding GAAP financial measures for comparative purposes. Reconciliation between certain GAAP and non-GAAP measures is provided at the end of this press release. Lion anticipates the ending cash, cash equivalents and short-term investments as of December 31, 2016, to be in excess of $164.0 million. Lion will host a conference call today at 8:30 a.m. ET to discuss these third quarter 2016 results. In order to participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The live webcast can be accessed under "Events and Presentation" in the "Investors" section of the Company's website at http://www.lbio.com/ or you may use the link: http://edge.media-server.com/m/p/usbgqbbo. A replay of the call will be available one hour after the end of the call on November 4, 2016 until 8:30 a.m. ET on November 11, 2016. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and reference the access code 3946579. The archived webcast will be available for thirty days in the Investors section of Lion Biotechnologies' website at http://www.lbio.com. 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. This press release contains "forward-looking statements" regarding, among other things, the company's future goals, its operating and financial performance, additional studies and product development, expansion of the company's research platform, and market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate, or if known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections. Risks and uncertainties include, but are not limited to, the company's ability to initiate a Phase 2 trial for LN-145 in 2017, its ability to continue to enroll patients in the Phase 2 trial for LN-144, the initiation in 2017 by the Karolinska University Hospital of two Phase 1 trials and the conduct thereafter of those trials, the further development of TIL under the CRADA, and the amount of Cash and cash equivalents it will have at the end of 2016. A further list and description of these and other risks, uncertainties and other factors can be found in Lion Biotechnologies, Inc. most recent Annual Report on Form 10-K and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or www.lionbio.com. Any forward-looking statement made in this release speaks only as of the date of this release. Lion Biotechnologies, Inc. does not undertake to update any forward-looking statements as a result of new information or future events or developments.

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