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

On May 18, 2016 Trillium Therapeutics Inc. (NASDAQ: TRIL; TSX: TR), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported it will present its TTI-621 (SIRPaFc) immune checkpoint inhibitor program at the Trials in Progress Session of the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held in Chicago from June 3-7 (Filing, 6-K, Trillium Therapeutics, MAY 18, 2016, View Source [SID:1234512630]).

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Details of Trillium’s ASCO (Free ASCO Whitepaper) presentation are as follows:

Presentation Type: Poster
Abstract #: TPS7585
Title: A phase 1 study of TTI-621, a novel immune checkpoint inhibitor targeting CD47, in subjects with relapsed or refractory hematologic malignancies
Presenter: Stephen Maxted Ansell, M.D., Ph.D., Division of Hematology, Mayo Clinic
Track: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia
Time/Location: Monday, June 6, 8-11:30 a.m. in Hall A, Poster Board #134b

Five Prime Therapeutics Announces Updated Clinical Data on FPA144 and FP-1039 to be Presented during 2016 ASCO Annual Meeting

On May 18, 2016 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that updated data from the ongoing clinical trials of FPA144 and FP-1039 will be presented during the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held June 3-6, 2016, in Chicago (Press release, Five Prime Therapeutics, MAY 18, 2016, View Source [SID:1234512537]). The presentation abstracts are now available online at the meeting website: View Source Information contained in the abstracts was as of the time of submission in February 2016. Five Prime intends to announce more detailed results at the time of the presentations at the ASCO (Free ASCO Whitepaper) Annual Meeting.

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Further data on safety and activity from the Phase 1 trial evaluating FPA144, an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced, FGFR2b isoform-selective monoclonal antibody, as a single agent in patients with FGFR2b+ gastric cancer and advanced solid tumors will be featured in an oral presentation:

ABSTRACT 2502
Antitumor activity and safety of FPA144, an ADCC-enhanced, FGFR2b isoform-selective monoclonal antibody, in patients with FGFR2b+ gastric cancer and advanced solid tumors
Oral Abstract Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Date/Time: Monday, June 6, 2016, 8:24 AM – 8:36 AM Central Time
Location: E354b

Preliminary dose escalation data from the FPA144 trial were presented during the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January 2016.

Additionally, data on the safety, response rate and duration of response of FP-1039, an FGF ligand trap, combined with standard of care chemotherapy to treat malignant pleural mesothelioma patients in GlaxoSmithKline’s Phase 1b trial will be highlighted in a poster presentation:

ABSTRACT 8557/POSTER BOARD #185
Multi-arm, open-label Phase 1b study of FP-1039/GSK3052230 with chemotherapy in malignant pleural mesothelioma (MPM)
Poster Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Date/Time: Saturday, June 4, 2016, 8:00 AM – 11:30 AM Central Time
Location: Hall A

Initial data from the Phase 1b trial of FP-1039 were released during the World Conference on Lung Cancer in September 2015, but the majority of mesothelioma patients enrolled at the time were not yet evaluable.

About FPA144

FPA144 is an anti-FGF receptor 2b (FGFR2b) humanized monoclonal antibody in clinical development as a targeted immune therapy for tumors that over-express FGFR2b, as determined by a proprietary immunohistochemistry (IHC) diagnostic assay. FGFR2 gene amplification (as identified by FISH) is found in a number of tumors, including in approximately 5% of gastric cancer patients, and is associated with poor prognosis.

FPA144 is designed to block tumor growth through two distinct mechanisms. First, it has been engineered to drive immune-based killing of tumor cells by antibody-dependent cell-mediated cytotoxicity (ADCC) and the recruitment of natural killer (NK) cells and T cells. Second, it binds specifically to FGFR2b and prevents the binding of certain fibroblast growth factors that promote tumor growth. When combined with PD-1 blockade, FPA144 has shown an additive effect in tumor growth inhibition in preclinical models. Five Prime retains global development and commercialization rights to FPA144.

About FP-1039

FP-1039 is a protein drug designed to intervene in FGF signaling. As a ligand trap, FP-1039 binds to FGF ligands circulating in the extracellular space (such as FGF2), preventing these signaling proteins from reaching FGFR1 on the surface of tumor cells where they would otherwise stimulate cancer cell division and/or angiogenesis. However, FP-1039 does not bind to certain "hormonal" FGFs, including FGF-23, which regulates phosphate levels in the blood. As a result, treatment with FP-1039 treatment has not been shown to cause hyperphosphatemia, a side effect seen with small molecule inhibitors of FGF receptors, which block the activity of both cancer-associated FGFs and FGF-23.

GlaxoSmithKline is completing the ongoing Phase 1b trial in malignant pleural mesothelioma and will transfer its development and commercialization rights for FP-1039 back to Five Prime during 2016. Five Prime will base decisions on further development of FP-1039 in mesothelioma on the quality and duration of responses from the trial, as well as considerations such as drug supply and manufacturing.

Foundation Medicine Receives Patent Covering Fundamental Methods in Comprehensive Genomic Analysis in Cancer

On May 17, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) reported that the U.S. Patent and Trademark Office has issued U.S. patent number 9,340,830, entitled, "Optimization of Multigene Analysis of Tumor Samples (Press release, Foundation Medicine, MAY 17, 2016, View Source [SID:1234512446])." The patent, which is assigned to Foundation Medicine, includes fundamental claims describing methods of analyzing a cancer patient’s tissue or blood specimen to detect multiple classes of genomic alterations. The patent carries a term extending to 2032. The company is also pursuing patent applications covering aspects of its genomic analysis platform with the European Patent Office and in other jurisdictions outside the United States.

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"Foundation Medicine has been at the leading edge of innovation in genomic analysis of cancer since our inception six years ago," said Michael Pellini, M.D, chief executive officer for Foundation Medicine. "We believe this patent both acknowledges our pioneering efforts in research and development, and, importantly, it demonstrates our expertise in translating innovation into clinically validated, best-in-class assays that benefit cancer patients around the world. We are gratified that our contributions to the clinical and scientific communities are enabling new genomic analysis products in the fight against cancer."

Dr. Pellini continued, "We believe patients and their physicians should have access to the full complement of test offerings that, when used appropriately, can meaningfully guide and inform treatment plans. We plan to evaluate strategies to maximize the value of this patent and our other intellectual property. That said, in leveraging this asset, we do not intend to block the use of methods covered by the patent in patient testing that may be offered by others. We are pleased with the issuance of this patent to strengthen Foundation Medicine’s intellectual property position and reinforce our overall leadership in transforming cancer care."

Report and termination of the liquidity contract with Gilbert Dupont

On May 18, 2016 The company Innate Pharma and the brokerage firm Gilbert Dupont reported that they have ended the liquidity contract signed on July 27, 2012 (Press release, Innate Pharma, MAY 17, 2016, View Source [SID:1234512539]). The termination is effective from May 13, 2016 after market.

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As at May 13, 2016 after market, the following assets appeared on the liquidity account:

18,575 shares of Innate Pharma that will be kept in shares portfolio, and
372,807.10 euros in cash.
As a reminder, at December 31, 2015, the following assets appeared on the liquidity account:

22,128 shares of Innate Pharma, and
358,336.72 euros in cash.

Camurus Interim Report January-March 2016

On May 17, 2016 Camurus reported its interim report for the period of January – March 2016 (Press release, Camurus, MAY 17, 2016, View Source [SID:1234512495]).

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Business highlights first quarter 2016

Recruitment goals reached in two Phase 3 trials of CAM2038 for opioid dependence treatment.
Start of Phase 2 study of CAM2038 in patients with chronic pain.
Completion of Phase 2 study of CAM2029 in two patient groups with acromegaly or neuroendocrine tumors.
Completion of Phase 1 study of CAM4071 in healthy volunteers.
Clinical development supporting toxicology studies initiated for two new product candidates after completed formulation development and assessment
License agreement signed with Rhythm Inc. for long-acting FluidCrystal setmelanotide under development for rare genetic obesity disorders.
Significant events after the reporting period

Positive results from a Phase 2 study of the blockade of opioid effects by CAM2038 in patients with opioid dependence.
Financial summary first quarter 2016

Revenues MSEK 20.2 (58.6).
Operating result MSEK -24.9 (13.1).
Result after tax MSEK -19.4 (10.2).
Earnings per share SEK -0.52 (0.41).
Cash position MSEK 571.9 (116.4).
CEO comments
We have had strong start of the year with positive preclinical assessments of new promising drug candidates, initiation of the build-up of our commercial organization in Europe, and completed recruitment of more than 600 patients in two ongoing Phase 3 trials of our long-acting buprenorphine products for treatment of opioid dependence.

The development of CAM2038 is well-timed, as problems associated with opioid dependence continue to mount. In the US, opioid dependence has reached epidemic proportions. Its’ devastating consequences are getting high attention with daily news headlines and commentaries by leading politicians. The situation is serious and untenable from both humanitarian and socioeconomic perspectives. There is consensus about the need to reduce the stigma of opioid addiction and recognize this condition as a chronic disease that must be treated using evidence based approaches.

Our success in enrolling more than 600 patients in two Phase 3 trials in the US, Europe and Australia in just three months, speaks to the high unmet need in this underserved patient population. With this positive progress, we are looking forward to completing the ongoing trials and receiving Phase 3 efficacy results in Q4 2016. In this context, the recently announced positive results from our Phase 2 opioid challenge study and the continued successful collaboration with Braeburn Pharmaceuticals is noteworthy.

Besides opioid dependence, CAM2038 is also being developed for the treatment of chronic pain. During Q1, we initiated a Phase 2 study in patients with chronic pain, set to deliver results in Q4 2016. We are enthusiastic about the prospects of CAM2038 for treatment of chronic pain, with the potential for round-the-clock pain relief combined with minimal risks of misuse, abuse and diversion.

In our partnership with Novartis, we recently completed a Phase 2 trial of our long-acting octreotide product, CAM2029, in patients with acromegaly and neuroendocrine tumors. Results are expected late Q2 2016. The partnership with Novartis continues to develop well, with high activity in preparing the start of Phase 3 trials.

In the late stage pipeline, we have also recently completed a Phase 2 study of product candidate CAM2032 for treatment of prostate cancer. Top-line results from this trial are expected during the Q2 2016.

We are also progressing with promising new product developments and bridging toxicology studies with two promising candidates were recently initiated. Clinical development of a first prioritized product candidate is planned to start during Q4 2016.

Several collaborations projects are also ongoing with international pharmaceutical and biotech companies. As an example, a new license agreement was signed with the US biotech Rhythm Inc. in January for the development and commercialization of a once-weekly formulation of setmelanotide for treatment of genetic obesity disorders. Shortly after the agreement, Rhythm received a Breakthrough Therapy designation for setmelanotide by US FDA.