On May 13, 2016 Trillium Therapeutics Inc. (NASDAQ:TRIL; TSX: TR) a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported a corporate update and reported financial results for the three months ended March 31, 2016 (Press release, Trillium Therapeutics, MAY 13, 2016, View Source [SID:1234512367]).

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"We made significant progress during the first quarter of 2016, positioning our oncology pipeline for long-term growth. Firstly, we advanced our lead CD47 clinical program on schedule, and secondly, we acquired Fluorinov, a preclinical company with a proprietary fluorine-based chemistry platform," said Dr. Niclas Stiernholm, president and chief executive officer of Trillium. "We are intensifying our internal research efforts on the biology of the CD47 pathway in order to understand how to best combine CD47 blockade with other therapies, and to elucidate the potential advantages of using a SIRPaFc fusion protein compared to a CD47-specific antibody. Additionally, key development activities related to the Fluorinov acquisition, involving several of its preclinical programs, are now underway."

Corporate Update

The Phase I dose escalation clinical trial treating patients with advanced hematologic malignancies with TTI-621, an IgG1 SIRPaFc fusion protein targeting CD47, is progressing according to established timelines and an update on the trial is planned for the end of the year.
At the AACR (Free AACR Whitepaper) 2016 Annual Meeting in April, Trillium presented data showing that TTI-621 promotes phagocytosis of lymphoma cells by diverse types of macrophages, including M2 macrophages, which are often implicated in tumor progression.
Following the acquisition of Fluorinov Pharma in January 2016, the company has quickly integrated its staff and operations. Preclinical development plans are currently being finalized.
Trillium has completed its relocation to a larger research and development facility and continues to grow key staff, with specific emphasis on the clinical and regulatory areas. The company has also added external resources in the form of additional legal and intellectual property support, as well as assistance with investor relations and corporate communications.
First Quarter 2016 Financial Results

(Amounts in Canadian dollars)

As of March 31, 2016, Trillium had cash of $65.8 million. During the first quarter, the company used $9.5 million of cash for the acquisition of Fluorinov; $6.0 million for operations; recorded a net foreign exchange loss on cash of $3.6 million; and used $1.8 million for capital purchases related to its new office and laboratory facility.

Net loss for the three months ended March 31, 2016 of $7.2 million compared to a loss of $4.7 million for the three months ended March 31, 2015. The net loss was higher due mainly to a net foreign currency loss of $3.6 million from holding US denominated cash with a weakening US dollar, amortization of $0.7 million on Fluorinov intangible assets and higher research and development spending. This was partially offset by the recognition of a deferred tax recovery in relation to the acquisition of Fluorinov of $3.7 million.

XBiotech has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, XBiotech, 2017, MAY 13, 2016, View Source [SID1234521614]).

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On May 12, 2016 Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, reported that data from four abstracts from the Company’s clinical development program in support of tazemetostat for use in non-Hodgkin lymphoma (NHL) will be presented during the American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting on Lymphoma Biology, to be held in Colorado Springs, CO, from June 18 to June 21, 2016 (Press release, Epizyme, MAY 12, 2016, View Source [SID:1234512293]).

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Tazemetostat is a first-in-class EZH2 inhibitor currently in phase 2 studies in advanced B-cell non-Hodgkin lymphoma (NHL) and certain genetically defined solid tumors. Among the data to be presented is the first interim report from the Company’s ongoing phase 2 study in patients with NHL.

Planned Presentations:

Oral Presentation: EZH2 as a target for non-Hodgkin lymphoma and beyond: tazemetostat experience; from bench to bedside and back to the bench
Speaker: Vincent Ribrag, MD, Institut Gustave-Roussy, Paris, France
Session Title: Exciting New Mechanisms-Targeted Therapies and Clinical Trials
Date: June 21, 2016
Time: 10:20 a.m. – 10:50 a.m. Mountain Time

Poster: Tazemetostat treatment drives wild-type and mutant EZH2 DLBCL cell lines to a cell fate decision between apoptosis or differentiation (Poster #39)
Author: Michael Thomenius, Ph.D., Epizyme
Date: June 19, 2016
Time: 3:45 p.m. – 5:15 p.m. Mountain Time

Poster: Initial report from a phase 2 multi-center study of tazemetostat (EPZ-6438), an inhibitor of enhancer of zeste-homolog 2 (EZH2), in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (Poster #98)
Author: Franck Morschhauser, MD, PhD, Centre Hospitalier Régional Universitaire de Lille, Lille, France
Date: June 20, 2016
Time: 3:45 p.m. – 5:15 p.m. Mountain Time

Poster: Chromatin flow cytometry based assessment of H3K27me3 pharmacodynamics in blood from diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) patients following exposure to the EZH2 inhibitor tazemetostat reveals disparate response profiles in specific PMBC subpopulations (Poster #38)
Author: Christopher Plescia, Epizyme
Date: June 20, 2016
Time: 3:45 p.m. – 5:15 p.m. Mountain Time

About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing phase 2 programs in both non-Hodgkin lymphoma and certain genetically defined solid tumors, including INI1-negative and SMARCA4-negative tumors and synovial sarcoma.

The Company has announced plans to initiate additional clinical evaluations of tazemetostat in 2016, including both a combination study with R-CHOP and a combination study with an immune checkpoint inhibitor in patients with NHL, as well as a monotherapy study in patients with mesothelioma.

On May 12, 2016 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported financial results for the first quarter ended March 31, 2016 and provided an update on the Company’s clinical programs (Press release, Argos Therapeutics, MAY 12, 2016, View Source [SID:1234512326]).

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"We have gotten off to a strong start in 2016. In the first quarter, we were able to accomplish a number of critical activities," said Jeff Abbey, president and chief executive officer. "The most significant of these was securing a financing agreement for up to $60 million. This financing, if fully funded, would provide us with funding for our operations into the second quarter of 2017, which is when we anticipate having a sufficient number of events to permit the primary analysis and assessment of overall survival to occur from the Phase 3 ADAPT trial of our lead product, AGS-003, in metastatic renal cell carcinoma. We look forward to the upcoming review of ADAPT trial data at the meeting of the Independent Data Monitoring Committee (IDMC) in June."

"Also, during the quarter, Dr. Lee Allen joined Argos as our chief medical officer. His experience and guidance have already made an impact on the development of AGS-003, including, in particular, with our preparation for the submission of our Biologics License Application (BLA) that would follow completion of the ADAPT trial, in addition to helping facilitate investigator-initiated trials of AGS-003," Mr. Abbey continued. "Lastly, and to that end, we announced that an investigator-initiated trial of AGS-003 in non-small cell lung cancer opened for enrollment during the quarter. We are excited for this first trial of AGS-003 outside of kidney cancer as we explore the potential activity of this novel immunotherapy in other solid tumors. These developments are all meaningful stepping stones as we continue on the pathway to achieving our goal of becoming a fully-integrated commercial biotechnology company."

First Quarter 2016 Operational Highlights:

In January 2016, Dr. Lee F. Allen joined the Company as chief medical officer
In March 2016, the Company entered into an equity financing agreement for up to $60 million
Will take place in up to three tranches: approximately $20 million in March 2016, approximately $30 million subject to and following the June 2016 IDMC meeting and a company controlled option for up to an additional $10 million subject to and following the late 2016 IDMC meeting
In March 2016, investigator-initiated Phase 2 study of AGS-003 in non-small cell lung cancer opened for enrollment at the Cancer Research Network of Nebraska (CRNN)
Selected First Quarter 2016 Financial Results

Net loss for the three months ended March 31, 2016 was $12.8 million, or $0.57 per share, compared to a net loss of $17.5 million, or $0.89 per share, for the same period in 2015.

Revenue for the three months ended March 31, 2016 totaled $0.1 million compared to $0.2 million for the same period in 2015.

Research and development expenses for the three months ended March 31, 2016 totaled $9.5 million compared to $14.8 million for the same period in 2015. General and administrative expenses for the three months ended March 31, 2016 totaled $3.0 million compared to $2.4 million for the same period in 2015.

As of March 31, 2016, Argos’ cash, cash equivalents and short-term investments totaled $13.8 million compared to $7.2 million as of December 31, 2015.

Conference Call and Webcast Details

Argos executive management will host a conference call beginning at 4:30 p.m. Eastern Time today to discuss these results and to answer questions.

To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 7392695. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.argostherapeutics.com. The archived webcast will remain available on the Company’s website for twelve (12) months following the call.

About the Arcelis Technology Platform
Arcelis is a precision immunotherapy technology that captures mutated and variant antigens that are specific to each patient’s disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma and administered via intradermal injection.

On May 12, 2016 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported financial results for the first quarter of 2016 (Press release, ImmunoCellular Therapeutics, MAY 12, 2016, View Source [SID:1234512328]).

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Andrew Gengos, ImmunoCellular Chief Executive Officer, commented: "We continue to make progress in all aspects of implementing our ICT-107 registration trial in patients with newly diagnosed glioblastoma. Over half of the targeted clinical sites in the US have been activated and are screening patients. We anticipate that all sites in the US can be activated by the middle of 2016. In Europe, the process of gaining regulatory approval for the trial and bringing clinical trial sites online is going very well. Clinical trial applications have been approved by the regulatory authorities in the Netherlands and the UK, and we are involved in interactions with the six other country authorities where the trial will be conducted. We also have received regulatory approval to start the trial in Canada. We expect to manufacture clinical supplies for the first qualifying patients in Canada and Europe in the third quarter. As the competitive landscape in newly diagnosed glioblastoma evolves, we continue to think that our phase 3 registration program, with the strong foundational support of placebo-controlled phase 2 data, is the best designed program underway in this indication. We are pleased with the progress we made in the first quarter, and believe that 2016 will be a year of accomplishment and value creation for our company."

For the quarter ended March 31, 2016, ImmunoCellular incurred a net loss of $5.6 million, or $0.06 per basic and diluted share, compared to a net loss of $1.4 million, or $0.02 per basic and diluted share, for the quarter ended March 31, 2015.

During the first quarter 2016, the Company incurred $4.7 million of research and development expenses compared to $2.1 million in the prior year quarter while general and administrative expenses remained relatively constant between periods. The $2.6 million increase in research and development expenses primarily reflects the additional expenses associated with the phase 3 trial of ICT-107. During the first quarter of 2016, the Company recorded a credit to other income of $500,000 related to reflect a write-down of the Company’s warrant liability, compared to a credit to other income of $1.8 million during the same period in 2015.

The Company also reported that cash used in operations in the first quarter of 2016 was $5.4 million compared to $3.0 million in the prior year quarter. The increase primarily reflects that additional research and development expenditures in the current year. As of March 31, 2016, the Company had $17.5 million in cash.