On June 1, 2017 Lion Biotechnologies, Inc. (NASDAQ: LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported 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 (Press release, Lion Biotechnologies, JUN 1, 2017, View Source;p=irol-newsArticle&ID=2278256 [SID1234519425]).

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"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.

On June 1, 2017 OBI Pharma, Inc., a Taiwan biopharma company (TPex: 4174), reported an agreement with Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) to acquire TH-3424, a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1c3 (AKR1C3) (Press release, OBI Pharma, JUN 1, 2017, View Source [SID1234525559]). The product will be renamed OBI-3424 effective immediately.

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OBI-3424 is a first-in-class prodrug that selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme. This selective mode of activation distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are non-selective.

AKR1C3 overexpression has been documented in a number of treatment-resistant and difficult to treat cancers. For example, hepatocellular carcinomas (HCC), which highly overexpress AKR1C3 in the majority of patients. OBI-3424 has demonstrated potent activities in preclinical models of HCC, including a model resistant to the standard of care treatment, sorafenib. AKR1C3 is adaptively upregulated in response to castration; therefore, castrate-resistant prostate cancer is another logical unmet need population where OBI-3424 will be tested. In addition, the US National Cancer Institute is performing preclinical evaluations of OBI-3424 for the potential treatment of T-cell acute lymphoblastic leukemia (T-ALL).

Furthermore, individualized patient selection by staining for AKR1C3 overexpression by immunohistochemistry can be performed to identify patients with other tumor types most likely to respond to treatment with OBI-3424, thereby offering the possibility for a streamlined clinical development strategy.

Under the terms of the agreement, Threshold will transfer to OBI Pharma its ownership rights as well as preclinical and manufacturing data for OBI-3424 in exchange for an undisclosed, upfront one-time payment. No further payments or future royalties are required. OBI Pharma will obtain Threshold’s global intellectual property as well as the commercial, developmental, and manufacturing rights to OBI-3424, except in certain specified countries in Asia (see footnote 1).

"OBI-3424 is an innovative anticancer drug that can preferentially deliver its payload to cancers that overexpress the activating enzyme, AKR1C3. AKR1C3 is highly overexpressed in a number of cancers that represent unmet medical needs, including hepatocellular carcinoma, castrate-resistant prostate cancer, and T-cell acute lymphoblastic leukemia. OBI-3424 offers the possibility of early efficacy read outs based on objective response rates in well-defined resistant patient populations," said Tillman Pearce, M.D., Threshold’s Chief Medical Officer.

"We will continue the pre-clinical work and hope that OBI-3424 develops into a solid treatment option for patients with cancers that express AKR1C3," said Amy Huang, General Manager of OBI Pharma, Inc. "This novel cancer therapeutic enhances our pipeline and moves us another step towards becoming a global cancer biopharma company. "

OBI Pharma plans to accelerate the development of OBI-3424, with an Investigational New Drug (IND) application filing with the U.S. Food and Drug Administration (FDA) planned for early 2018.

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(1) OBI obtains worldwide rights with the exception of the following countries: China, Hong Kong, Macao, Taiwan, Japan, South Korea, Singapore, Malaysia, Thailand, Turkey and India.

On June 1, 2017 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported that Tito Serafini, Ph.D., President, Chief Executive Officer, and Co-Founder, will present at the Jefferies 2017 Global Healthcare Conference on Thursday, June 8, 2017 at 8:00 a.m. Eastern Time in New York, NY (Press release, Atreca, JUN 1, 2017, View Source [SID1234522952]). Dr. Serafini will provide an overview of Atreca’s technologies, programs and progress.

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On May 31, 2017 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, and the Dana-­Farber Cancer Institute reported that they have entered into a collaborative research agreement to focus Atreca’s IRC technology on the active immune responses of cancer patients whose disease is responding well to immunotherapy and other treatments (Press release, Atreca, MAY 31, 2017, View Source [SID1234522953]). The research will apply Atreca’s Immune Repertoire Capture (IRC) technology, which identifies and generates sequences of functional, native antibodies and T cell receptors (TCRs) from active human immune responses.

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A team of scientists led by F. Stephen Hodi, M.D., Director of the Melanoma Center and Center for Immuno-­Oncology at Dana-­Farber Cancer Institute/Brigham and Women’s Cancer Center and Professor of Medicine at Harvard Medical School, will collaborate with Atreca to study how different immunotherapies generate an active immune response, to understand why only a subset of patients benefit from therapy, and to identify anti-­tumor antibodies generated in these responses. The study will focus on patients with melanoma, non-­small cell lung cancer (NSCLC), and renal cell cancer, with the potential to expand into other cancer types.

"We are excited to collaborate with the accomplished team at Atreca. Through this unique collaboration, we believe we can work together to accelerate the discovery and development of novel therapeutic agents and treatment paradigms with the potential to improve patient outcomes in diverse cancer indications," stated Dr. Hodi.

"It is a thrilling opportunity for us to partner with one of the world’s leading institutions advancing cancer treatment," said Tito A. Serafini, Ph.D., Atreca’s President, Chief Executive Officer, and Co-­Founder. "Previous peer-­reviewed findings have demonstrated that our IRC technology delivers valuable data from the active immune responses of patients. We believe the collaboration with Dana-­Farber, focused on generating such actionable data, will make an important contribution to our immuno-­ oncology therapeutics programs."

Atreca applies IRC to generate sequences of native antibodies and TCRs from cancer patients, patients with autoimmune disease, vaccinated subjects, and patients who resolve infections. Analyses of the resulting essentially unbiased and error-­free repertoires yield valuable insights, as well as potent antibodies targeting tumors, pathogens, and autoimmune epitopes.

On May 31, 2017 GlycoMimetics, Inc. (NASDAQ:GLYC) reported that the second of two patient cohorts in the Phase 2 portion of its ongoing Phase 1/2 clinical trial of GMI-1271 in patients with acute myeloid leukemia (AML) has completed enrollment (Press release, GlycoMimetics, MAY 31, 2017, View Source [SID1234519338]). This second cohort is comprised of 66 participants with relapsed/refractory AML. The study is designed to evaluate the potential of GMI-1271, an E-selectin antagonist drug candidate, in combination with chemotherapy, as a treatment for individuals with either newly diagnosed or relapsed/refractory AML. Enrollment in the study’s first arm in newly diagnosed elderly AML patients was completed in the first quarter of this year. GlycoMimetics expects to submit interim study data for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2017.

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"Across the two cohorts of this Phase 1/2 clinical trial, we have a strong sample size of 91 patients and experienced brisk enrollment, which we feel is indicative of the strong interest that our clinical investigators have for this novel agent," said Helen Thackray, M.D., Chief Medical Officer of GlycoMimetics. "We are further encouraged by GMI-1271’s achievement of European Orphan Designation as well as the recent granting of Breakthrough Therapy designation by the U.S. Food & Drug Administration (FDA) for the treatment of adults with relapsed/refractory AML. We believe GMI-1271, when combined with chemotherapy, has the potential to address an unmet therapeutic need for individuals living with AML, and we are encouraged by both our clinical results to date and the acknowledgement of the U.S. and European regulatory agencies."

Interim clinical data from the ongoing trial of GMI-1271 will be presented at the 2017 meetings of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Hematology Association (EHA) (Free EHA Whitepaper). To date, GMI-1271 has been consistently well tolerated, with no obvious incremental toxicity when added to chemotherapy. In addition, patients with AML treated with GMI-1271 have experienced higher than expected remission rates and lower than expected 30- and 60-day mortality rates.

"The consistency of our data readouts is great news in and of itself, and the emerging biomarker data is especially encouraging," said Rachel King, CEO of GlycoMimetics. "AML has long been a difficult indication for the developers of new therapeutics, and we continue to feel more confident that our investigational drug, GMI-1271, may play a role in addressing key unmet needs in this deadly cancer."

In addition to the ongoing Phase 1/2 trial, clinical investigators are currently evaluating GMI-1271 in an ongoing Phase 1 clinical trial in multiple myeloma. Preclinical data supporting the multiple myeloma study was recently published in an online preview of the journal Leukemia on April 25, 2017. Specifically, the newly published preclinical results indicate that myeloma with higher levels of E-selectin ligands is a more aggressive disease that is more likely to be resistant to bortezomib, which is currently the front-line standard of care The publication reported that in preclinical studies, the combination treatment of GMI-1271 to bortezomib was able to break this chemoresistance and restore sensitivity to bortezomib which led to significant improvement in survival. This preclinical multiple myeloma conclusion supports the clinical findings on the potential biomarker that the Company is presenting at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) next month.

About AML

AML is a cancer of the blood and bone marrow. AML is the most common type of acute leukemia in adults. The National Cancer Institute estimates that there will be over 21,000 new cases of AML diagnosed in 2017 in the United States, and over 10,000 people will die from all forms of the disease in 2017. AML is more commonly present in elderly patients. Unlike other cancers that start in an organ and spread to the bone marrow, AML is known for rapid growth of abnormal white blood cells that gather in the bone marrow, getting in the way of normal blood cell production. The lack of normal blood cells can cause some of the symptoms of AML, including anemia (shortage of red blood cells resulting in tiredness and weakness), neutropenia (shortage of white blood cells that may lead to increased infections), and thrombocytopenia (shortage of platelets in the blood that may lead to excessive bleeding). Current treatment options for AML consist of reducing and eliminating cancer cells mainly through chemotherapy, radiation therapy, and stem cell transplantation.