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6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On March 15, 2016 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) reported that safety and immune monitoring data from an investigator-led clinical trial in melanoma using IMP321 as an adjuvant to a therapeutic vaccine has been published in the March 15 edition of the Clinical Cancer Research journal (Filing, 6-K, Prima Biomed, MAR 15, 2016, View Source [SID:1234509754]). The paper is titled "Vaccination with sLAG-3-Ig (IMP321) and peptides induces specific CD4 and CD8 T-cell responses in metastatic melanoma patients: report of a phase I/IIa clinical trial" and is the result of a long-standing academic collaboration between Dr. Frédéric Triebel, Prima’s Chief Scientific Officer and Chief Medical Officer and scientists at the Ludwig Centre for Cancer Research at the University of Lausanne, Switzerland.

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Professor Daniel Speiser, the lead investigator in the study and a key opinion leader in the research of peptide vaccines stated: "It is remarkable that serial vaccinations induced antigen specific T cell responses in all 16 vaccinated melanoma patients. We are very encouraged by the results from this second collaborative study using IMP321 as an adjuvant to boost our peptide vaccine effectiveness, which support the further development of peptide vaccines as part of a combination approach to treating cancer."

Dr. Triebel, a coauthor on the publication commented from Prima’s research laboratory in Paris: "We are very pleased to have demonstrated additional safety and immune monitoring data on IMP321 in this vaccine adjuvant setting. This is another clear demonstration of the potency of IMP321 as an antigen presenting cell (APC) activator able to boost tumor-specific T cells. The fact that the article featured in the highlights section both online and in the print publication is a great honour and recognition of the data’s scientific contribution."

OPKO 4Kscore® Recommended in 2016 European Association of Urology Prostate Cancer Guidelines

On March 15, 2016 OPKO Health, Inc. (NYSE:OPK) reported the decision of the European Association of Urology (EAU) Prostate Cancer Guidelines Panel to include the 4Kscore Test in the 2016 EAU Guidelines for Prostate Cancer (Press release, Opko Health, MAR 15, 2016, View Source [SID:1234509564]). The panel concluded that the 4Kscore, as a blood test with greater specificity over the PSA test, is indicated for use prior to a first prostate biopsy or after a negative biopsy to assist patients and physicians in further defining the probability of high-grade cancer.

"The EAU Prostate Cancer Guidelines Panel is an international, multi-disciplinary group of specialists in prostate cancer diagnosis and treatment," said Dr. Alberto Briganti, Department of Urology, San Raffaele Scientific Institute, Milan, Italy. "The decision to include the 4Kscore in the guidelines indicates that the Panel views the 4Kscore Test as having achieved an appropriate level of clinical evidence to recommend its use for both assessment of asymptomatic men prior to a first prostate biopsy and as an additional investigational test to be done after a negative prostate biopsy."

The 4Kscore test has been studied on over 22,000 patients with results published in 12 peer-reviewed scientific publications. The 4Kscore test is the only blood test that accurately identifies an individual patient’s risk for high-grade, aggressive cancer.

About the 4Kscore Test

The 4Kscore, a laboratory developed test, is the only blood test that accurately identifies an individual patient’s risk for aggressive prostate cancer, the lethal form of prostate cancer. The 4Kscore test uses a proprietary algorithm that incorporates the blood levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and Human Kallikrein-2 (hK2), plus the patient’s age, and other clinical information to calculate the percentage risk (probability) of finding a Gleason Score 7 or higher grade of prostate cancer. The four kallikrein panel of biomarkers utilized in the 4Kscore Test is based on over a decade of research conducted by scientists at Memorial Sloan-Kettering Cancer Center and leading European institutions and is included as a standard of care in both the 2016 NCCN Early Detection Guidelines and the 2016 EAU Guidelines for prostate cancer. The 4Kscore test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the shared decision making discussion between the Urologist and the patient.

Loxo Oncology Reports Fourth Quarter and Year-End 2015 Financial Results and Provides Program Updates

On March 15, 2016 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported fourth quarter and year-end 2015 financial results and provided an update on its drug development programs (Press release, Loxo Oncology, MAR 15, 2016, View Source [SID:1234509558]). Loxo Oncology will not be conducting a conference call in conjunction with this earnings release.

"We ended 2015 with great momentum behind LOXO-101 and our pipeline programs," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "We are excited to announce that updated LOXO-101 adult Phase 1 data have been selected for an oral plenary session at AACR (Free AACR Whitepaper) in April. This presentation will provide further follow-up on the first three enrolled patients with TRK fusions that responded to LOXO-101, and will provide initial response assessment and follow-up on the next three enrolled patients with TRK fusions. We are also pleased to announce that we have developed a next-generation selective TRK inhibitor, LOXO-195, in collaboration with our partner Array BioPharma. Last year, we supported academic research to anticipate potential mechanisms of acquired resistance to TRK inhibition and we have continued to follow published literature reports that corroborate and add to those results. Should a patient progress on LOXO-101 or another compound, we hope LOXO-195 will be able to induce a new response in the patient and functionally extend time on therapy."

Dr. Bilenker continued, "We are fortunate that our financing in November allows us to fund operations well into 2018, which we believe will provide ample runway for potentially meaningful clinical data events for LOXO-101, LOXO-195, our RET program and other possible Array collaboration projects."

New Announcements

Updated LOXO-101 Phase 1 Data at AACR (Free AACR Whitepaper): Loxo Oncology announced today that updated clinical data from the ongoing LOXO-101 Phase 1 trial were accepted for oral plenary session presentation at the 2016 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans, taking place April 16-20, 2016. This presentation will be an update to data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting in November 2015, with a focus on enrolled patients with TRK fusions. The abstract title will be posted online at 4:30 p.m. ET on Wednesday, March 16.
Next-Generation Selective TRK Inhibitor: Acquired resistance to targeted therapies has proven to be an important component of long-term cancer care and targeted therapy drug development. In anticipation of potential resistance to LOXO-101, and in light of recent published literature regarding emerging mechanisms of resistance to TRK inhibition, Loxo Oncology today unveiled its next-generation selective TRK inhibitor, LOXO-195, which is capable of addressing potential mechanisms of acquired resistance that may emerge in patients receiving LOXO-101 or multikinase inhibitors with anti-TRK activity. With the LOXO-195 program, Loxo Oncology has an opportunity to strengthen its leadership position in the field of TRK inhibition and clinically extend the duration of disease control for patients with TRK-driven cancers. Loxo Oncology will begin IND-enabling activities in 2016 that should enable initiation of a LOXO-195 Phase 1 study in 2017.
2015 Financial Results and 2016 Cash Guidance. As of December 31, 2015, Loxo Oncology had cash, cash equivalents and investments of $153.9 million. The company expects a cash burn of $48 to $52 million in 2016. The company believes that based upon its current operating plan, its existing capital resources will be sufficient to fund its anticipated operations well into 2018.

Recent Highlights

LOXO-101 Program

LOXO-101 Phase 1 Pediatric Trial Initiated: In December, Loxo Oncology enrolled the first patient in the LOXO-101 pediatric Phase 1 trial, a multicenter, open-label trial in pediatric patients with advanced solid or primary CNS tumors.
LOXO-101 Phase 1 Data Presented at AACR (Free AACR Whitepaper)-NCI-EORTC: Results from the Phase 1 study of LOXO-101 were reported in a late-breaking oral presentation at the 27th AACR (Free AACR Whitepaper)-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics in November. As of the October 20, 2015 cutoff date, six patients with cancers harboring TRK fusions had been enrolled and treated. Three of the six patients with TRK fusion cancers had been on study long enough for their first efficacy assessment, and all three had achieved an objective response at the first response assessment, as defined by standard RECIST criteria. See the full data here.
LOXO-101 Phase 2 Basket Trial Initiated: In October, Loxo Oncology enrolled the first patient in the LOXO-101 Phase 2 trial, a global, multi-center, single-arm, open-label basket trial in adult patients with solid tumors that harbor a TRK fusion.
LOXO-101 Selected for NCI-MATCH Trial: In October, the independent committee of the National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) clinical trial chose LOXO-101 as the sole, dedicated treatment arm for patients with TRK gene fusions. Loxo Oncology anticipates that the NCI will activate the TRK fusion arm of this study later in 2016.

Pipeline: RET and FGFR Pre-clinical Programs

Data on RET and FGFR Programs Presented at AACR (Free AACR Whitepaper)-NCI-EORTC: Loxo Oncology presented two preclinical posters at AACR (Free AACR Whitepaper)-NCI-EORTC containing the first publicly disclosed data for its Rearranged during Transfection (RET) and Fibroblast Growth Factor Receptor (FGFR) programs showing potential best-in-class selectivity and target coverage.
RET Clinical Trial Initiation: Consistent with prior guidance, the company plans to initiate a Phase 1 study of its RET inhibitor in late 2016 or early 2017.

Corporate Activities

Strengthened Balance Sheet: Loxo Oncology raised $76.2 million in gross proceeds in an equity financing in November 2015. Loxo Oncology’s cash, cash equivalents and marketable securities are expected to be sufficient to fund operations well into 2018.

Fourth Quarter and Year-End 2015 Financial Results

Cash, cash equivalents and investments totaled $153.9 million as of December 31, 2015, compared to $112.9 million as of December 31, 2014. The increase was attributable to $71.3 million in net proceeds from our November 2015 equity financing offset by $30.3 million in cash burn.

Research and development expenses were $9.8 million for the fourth quarter of 2015 compared to $4.6 million in the fourth quarter of 2014. The increase was primarily attributable to expanded Phase 1 and Phase 2 clinical development activities for LOXO-101 and additional full-time equivalents and other support dedicated to discovery, preclinical, and manufacturing activities at Array BioPharma or third-party vendors.

Research and development expenses were $25.6 million for the year ended December 31, 2015, compared to $14.5 million for the year ended December 31, 2014. The increase was primarily due to expanded Phase 1 and Phase 2 clinical development activities for LOXO-101 and additional full-time equivalents and other support dedicated to discovery, preclinical, and manufacturing activities at Array BioPharma or third-party vendors. The company also recognized R&D-related stock-based compensation expense of $3.3 million during the year ended December 31, 2015 compared to $2.0 million for the year ended December 31, 2014.

General and administrative expenses were $3.2 million for the fourth quarter of 2015 compared to $2.6 million in the fourth quarter of 2014. The increase was primarily due to additional full-time equivalents, increased compensation costs and increased costs associated with operating as a public company.

General and administrative expenses were $10.5 million for the year ended December 31, 2015, compared to $6.2 million for the year ended December 31, 2014. The increase was primarily due to additional full-time equivalents, increased compensation costs and increased costs associated with operating as a public company. The company also recognized G&A-related stock-based compensation expense of $2.8 million during the year ended December 31, 2015 compared to $1.0 million for the year ended December 31, 2014.

Net loss attributable to common stockholders was $12.9 million for the fourth quarter of 2015, compared to $7.1 million for the fourth quarter of 2014. Net loss attributable to common stockholders was $35.9 million for the year ended December 31, 2015, compared to $20.7 million for the year ended December 31, 2014.

About LOXO-101

LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in a global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions, and a Phase 1 dose escalation trial in pediatric cancer patients. For additional information about both the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123.

Diffusion Pharmaceuticals Announces Publication of RES-529 Review Article in Anti-Cancer Drugs

On March 15, 2016 Diffusion Pharmaceuticals Inc. (OTCQX: DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer, reported the online publication of a reviewed article on RES-529 ahead of print in Anti-Cancer Drugs (Press release, Diffusion Pharmaceuticals, MAR 15, 2016, View Source [SID:1234509556]).

Diffusion Pharmaceuticals recently acquired RES-529, a novel PI3K/AKT/mTOR pathway inhibitor that targets both mTORC1 and mTORC2 through mTOR complex dissociation, from RestorGenex Corporation at the closing of its reverse merger on January 8, 2016. RES-529 is being developed for oncology and ophthalmology with a primary focus in the treatment of glioblastoma multiforme (GBM). Orphan drug designation has been granted by the FDA for this indication.

The article entitled "RES-529: a PI3K/AKT/mTOR pathway inhibitor that dissociates the mTORC1 and mTORC2 complexes," reviews the potential of RES-529 to inhibit tumorigenesis in glioblastoma, prostate cancer, and breast cancer. RES-529 treatment has been shown to be effective in preclinical models of glioblastoma as well as synergistic with radiation therapy in these models. In preclinical models of prostate cancer, RES-529 has been shown to be synergistic with all three common modalities of treatment: radiation therapy, chemotherapy, and hormonal therapy. The article was authored by Mark Weinberg, MD, MBA, who was previously Senior VP of Clinical Development at RestorGenex.

David Kalergis, Chairman and Chief Executive Officer of Diffusion Pharmaceuticals, said, "The acquisition of RES-529 has strengthened our oncology pipeline. Concurrent with our primary focus of advancing our lead candidate, trans sodium crocetinate (TSC), into a Phase III clinical program in GBM and a Phase II/III trial in pancreatic cancer, we are also assessing the future opportunities and plans for RES-529."

Calithera Biosciences Reports Fourth Quarter and Full Year 2015 Financial Results and Recent Highlights

On March 15, 2016 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported its financial results for the fiscal fourth quarter and year ended December 31, 2015 (Press release, Calithera Biosciences, MAR 15, 2016, View Source;p=RssLanding&cat=news&id=2148507 [SID:1234509553]). As of December 31, 2015, cash, cash equivalents and investments totaled $71.9 million.

"In 2015, we made significant progress executing on our clinical development plan for CB-839, enrolling several monotherapy cohorts on our Phase 1 trials, while remaining on track with our IND-enabling studies for our immunotherapy arginase inhibitor, CB-1158, all while advancing internal preclinical programs," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "Looking forward to 2016, we expect to highlight new clinical data and scientific progress at oncology meetings, including CB-839 Phase 1b updates from our ongoing trials, dosing CB-839 in combination with other therapies. This is expected to occur initially in the second quarter of 2016, with further updates in the second half of the year. In addition, we plan on initiating a clinical trial of CB-839 in combination with a checkpoint inhibitor by mid-year. Our arginase inhibitor, CB-1158, is progressing towards the clinic with an IND filing expected mid-year."

Fourth Quarter 2015 and Recent Highlights

CB-839 clinical date presented at major medical meetings. The three phase I clinical trials with CB-839 in solid tumors and hematological malignancies continued to enroll throughout 2015, with 184 patients enrolled as of January 2016, across the three trials. New data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting in November demonstrate stable disease across a variety of tumor types, as well as a single agent partial response in a renal cell carcinoma (RCC) patient. This patient showed a 32% reduction in target lesions by RECIST with generalized shrinkage of lymph node metastases. Among the fifteen evaluable patients with RCC, nine (60%) had stable disease or better, with stable disease lasting three cycles (63 days). Among efficacy-evaluable patients across a range of tumor types treated on the current dosing schedule of twice-daily, 22 of 50 patients (44%) experienced stable disease or better. Five stable disease patients currently on study have been treated with CB-839 for over 8 months without progression (2 triple negative breast cancer, 1 RCC, 1 mesothelioma and 1 IDH1 mutant chondrosarcoma). In addition, the first results of CB-839 dosed in combination therapy were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.

Arginase inhibitor CB-1158 preclinical data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Meeting. CB-1158, a highly selective, orally bioavailable, small molecule inhibitor of human arginase with nanomolar potency, demonstrated single agent efficacy in animal models. Inhibition of tumor growth was accompanied by a rapid increase in the local concentration of arginine, and the induction of multiple pro-inflammatory changes in the tumor microenvironment. CB-1158, when administered with anti-CTLA-4, increased CD8+ T-cell infiltrates in the tumor. The addition of CB-1158 to anti-CTLA-4 and anti-PD-1, significantly inhibited tumor growth in a mouse model that was resistant to dual checkpoint inhibitor therapy. CB-1158 was well tolerated as a single agent and in combination with checkpoint inhibitors in animal studies.

Selected Fourth Quarter and Year-end 2015 Financial Results

Cash, cash equivalents and investments totaled $71.9 million at December 31, 2015 compared with $102.0 million at December 31, 2014.

Research and development expenses for the full year 2015 were $23.7 million, compared with $16.4 million in the prior year. The increase of $7.4 million in 2015 was primarily attributed to higher expenses associated with Calithera’s arginase inhibitor program, including the selection of CB-1158 and its advancement through preclinical development, and continued enrollment of CB-839, Calithera’s first-in-class glutaminase inhibitor, in phase 1 clinical trials. Calithera expects to file an IND for the arginase inhibitor program mid-2016. Research and development expenses for the fourth quarter of 2015 were $5.8 million, compared to $5.0 million for the same period last year.

General and administrative expenses for the full year 2015 were $9.1 million, compared with $5.4 million in the prior year. The increase of $3.7 million in 2015 was primarily due to higher employment related expenses, including stock based compensation expense, and professional service fees relating to Calithera’s costs associated with operating as a publicly traded company. General and administrative expenses for the fourth quarter of 2015 were $2.3 million, compared to $1.9 million for the same period last year.

Loss from operations for the three months and year end ended December 31, 2015 was $8.1 million and $32.6 million, respectively.

Financial Guidance for 2016

Calithera expects that its cash, cash equivalents and investments will be at least $35 million at the end of 2016, exclusive of any funds arising from new collaborations or partnerships, equity financings or other new sources.