On April 16, 2018 SELLAS Life Sciences Group Inc. (Nasdaq: SLS) ("SELLAS"), a clinical-stage biopharmaceutical company focused on novel cancer immunotherapies for a broad range of cancer indications, reported financial results for the year ended December 31, 2017 and provided a business update (Press release, Galena Biopharma, APR 16, 2018, View Source [SID1234525344]).

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"In recent months, we have made meaningful progress advancing our business objectives, maturing SELLAS Life Sciences Group Ltd. into a publicly-traded company following the business combination and progressing our pipeline of cancer immunotherapies for patients with limited treatment options," said Angelos Stergiou, MD, ScD h.c., President & Chief Executive Officer of SELLAS. "We are particularly excited about our recent financing and the positive interim results from the Phase 2b NeuVax + Herceptin study announced earlier this month which we believe help position SELLAS for continued success throughout the remainder of 2018. We also look forward to commencing the Phase 1/2 clinical trial of galinpepimut-S in combination with Keytruda under our collaboration and supply agreement with Merck and our planned Phase 3 Acute Myeloid Leukemia program."
Recent Corporate and Pipeline Highlights

In April 2018, SELLAS announced positive interim data from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial (IST) of trastuzumab (Herceptin) +/-nelipepimut-S (NeuVax) in HER 1+/2+ breast cancer patients in the adjuvant setting to prevent recurrences.

In March 2018, open label Phase 2 clinical and immunological data for SELLAS’ lead product candidate, galinpepimut-S (GPS) in patients with multiple myeloma (MM) was presented at the 2018 European Society for Blood and Marrow Transplantation (EBMT) 44th Annual Meeting in Lisbon, Portugal. Median progression-free survival (PFS) of 23.6 months was reported in the high-risk disease setting, compared to historically inferior outcomes while on an immunomodulatory drug (IMID) or proteasome inhibitor post-autologous stem cell transplant maintenance.

In March 2018, SELLAS appointed Barbara Wood as Executive Vice President, General Counsel and Corporate Secretary.

In March 2018, SELLAS entered into a definitive securities purchase agreement to issue up to 10,700 shares of its Series A convertible preferred stock and warrants to purchase 1,363,631 shares of its common stock in a private placement transaction to a select group of institutional investors, in Europe and the United States, for aggregate gross proceeds of $10.7 million. The closing of the first tranche for approximately $6.0 million took place on March 9, 2018. The closing of the second tranche for approximately $4.7 million is expected to occur by the end of April 2018 following stockholder approval.

In December 2017, SELLAS Life Sciences Group Ltd. ("SELLAS Ltd."), a privately-held Bermuda exempted company, completed a business combination (the "Merger") with Galena Biopharma, Inc. ("Galena"). Upon completion of the Merger, Galena was renamed "SELLAS Life Sciences Group, Inc.," began trading under a new ticker symbol "SLS" and the combined company now includes the late-stage pipelines of novel cancer immunotherapies for both hematologic and solid malignancies of SELLAS Ltd. and Galena.

In October 2017, SELLAS Ltd. entered into a clinical trial collaboration and supply agreement with Merck & Co. for a combination clinical trial targeting multiple cancer types, in which GPS will be administered in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a Phase 1/2 trial in five cancer indications, including both hematologic malignancies and solid tumors.

Year End 2017 Financial Results
For accounting purposes, SELLAS Ltd. is considered to have acquired Galena in the Merger; therefore, the financial statements of Galena became those of SELLAS Ltd. and the results reported are those of SELLAS Ltd.
Cash Position: As of December 31, 2017, cash and cash equivalents were $2.3 million, compared to $6.0 million as of December 31, 2016. Net cash used in operating activities was $11.0 million for the year ended December 31, 2017, compared to $11.9 million for the year ended December 31, 2016.
R&D Expenses: Research and development expenses were $6.1 million for the year ended December 31, 2017, as compared to $11.4 million for the year ended December 31, 2016. The $5.3 million decrease was primarily attributable to a decrease of $2.5 million in fees due under licensing and collaboration agreements, a decrease of $1.7 million in clinical trial expense, a $1.3 million decrease in manufacturing expenses, a $1.2 million decrease in consulting fees, and $0.2 million decrease in regulatory expenses. These decreases were partially offset by a $0.7 million increase in stock-based compensation and a $0.9 million increase in personnel related expenses. Overall, research and development expenses were reduced in 2017 as SELLAS Ltd. explored various strategic options.
G&A Expenses: General and administrative expenses were $15.1 million for the year ended December 31, 2017, as compared to $4.6 million for the year ended December 31, 2016. The $10.5 million increase was primarily due to $5.7 million of transaction costs related to the Merger and a $2.1 million increase in stock-based compensation from the acceleration of restricted stock units, and a $1.5 million increase in personnel related expenses due to an increase in headcount, $0.6 million increase in accounting and audit fees, and $0.6 million in outside consulting services. The $5.7 million of transactions costs consist of $2.9 million of banking fees, $1.6 million in legal fees, $1.0 million incentive fee payable through approximately $0.1 million in cash and the issuance of 119,672 shares of our common stock upon consummation, and $0.2 million in accounting and audit fees. The transaction costs incurred related to the Merger are non-recurring expenses for the year 2017.
Non-recurring Severance Costs: Severance costs incurred during the year ended December 31, 2017 include employee-related costs for severance of former Galena employees of $1.9 million.
Net Loss: Net loss was $23.8 million and loss attributable to common stockholders was $24.4 million for the year ended December 31, 2017, or a basic and diluted loss per share to common stockholders of $10.44, as compared to a net loss and loss attributable to common stockholders of $17.7 million for the year ended December 31, 2016, or a basic and diluted loss per share to common stock holders of $18.66.

On April 16, 2018 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the Company is presenting new preclinical data on FT819, its off-the-shelf CAR T-cell product candidate, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held from April 14-18, 2018 in Chicago, Illinois (Press release, Fate Therapeutics, APR 16, 2018, View Source [SID1234525343]).

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The presentation of FT819 was accepted by AACR (Free AACR Whitepaper) as a late-breaking abstract, and was subsequently selected by AACR (Free AACR Whitepaper) to be featured at the AACR (Free AACR Whitepaper) Annual Meeting press program being held today at 8:30 a.m. CT.
FT819 is an off-the-shelf CAR T-cell product candidate produced from a master induced pluripotent stem cell (iPSC) line. FT819 has two targeting receptors, a chimeric antigen receptor (CAR) targeting CD19-positive tumor cells and a CD16 Fc receptor that can engage other proven cancer therapies, such as tumor antigen-targeting monoclonal antibody (mAb)-based treatments, to overcome antigen escape. Fate Therapeutics is developing FT819 as part of a research collaboration being led by Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center.

In preclinical studies, FT819 exhibited an efficient cytotoxic T-cell response in vitro when challenged with CD19-positive tumor cells, displaying robust production of effector cytokines, including INF-gamma and TNF-alpha, and cytolytic proteins, including perforin and granzyme B. The product candidate’s activity was also found to be target-specific in vitro, attacking only CD19-positive tumor cells and sparing CD19-negative tumor cells. Additionally, when combined with a mAb-based treatment targeting CD20, FT819 was shown to elicit antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro against CD19-negative, CD20-positive tumor cells through CD16 engagement.
The master iPSC line used for the production of FT819 is engineered in a one-time event to insert CAR19 into the T-cell receptor α constant (TRAC) locus for enhanced safety and potency and to completely eliminate T-cell receptor (TCR) expression. The line serves as a renewable source for consistently and repeatedly manufacturing homogeneous cell products in quantities that support the treatment of many thousands of patients in an off-the-shelf manner. This approach eliminates the need to create a personalized therapy from a patient’s own cells, enables mass production at scale and significantly reduces the cost of, and time to, patient treatment.
The data is also being presented by the Company in a poster session.

Presentation: Generation of off-the-shelf TCR-less CAR-targeted cytotoxic T cells from renewable pluripotent cells for cancer immunotherapy

Session: Late-Breaking Poster Session – Immunology
Time and Date:8:00 a.m. – 12:00 p.m. CT, Monday, April 16, 2018
Location:McCormick Place South (Level 3), Exhibit Hall A, Section 45, Poster LB-108 / 5
Following presentation at the meeting, the AACR (Free AACR Whitepaper) press program and poster presentations will be available on the Company’s website at www.fatetherapeutics.com.

On April 16, 2018 Exicure, Inc., the pioneer in gene regulatory and immunotherapeutic drugs utilizing three-dimensional, spherical nucleic acid (SNA) constructs, reported that it will present preclinical data in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting in Chicago, Illinois from April 14-18, 2018 (Press release, Exicure, APR 16, 2018, View Source;p=RssLanding&cat=news&id=2342684 [SID1234525342]). The poster titled "TLR9 agonist SNA-induced innate and adaptive immune responses in tumor microenvironment enhance checkpoint inhibitor antitumor activity in mouse tumor models" supports the ongoing clinical development of the company’s proprietary SNA technology and highlights its potential impact in the tumor microenvironment in potentiating antitumor effects of anti-PD-1.

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The data presented in the poster, in combination with many other preclinical studies, provided the basis for advancing Exicure’s drug candidate, AST-008, into its Phase 1 clinical trial. We began subject dosing in our Phase 1 clinical trial for AST-008 in the fourth quarter of 2017 and expect this trial to be completed in mid-2018.

AST-008 utilizes Exicure’s proprietary spherical nucleic acid (SNA) technology designed in this case to agonize toll-like receptor 9, or TLR9, for application in immuno-oncology. Exicure has observed that administration of AST-008 as a monotherapy can have anti-tumor activity in colon cancer, breast cancer, lymphoma and melanoma mouse models. The company has also observed that, in preclinical studies in a variety of tumor models, AST-008 applied in combination with certain checkpoint inhibitors exhibited anti-tumor responses and survival rates that were greater than those demonstrated by checkpoint inhibitors alone.

Details on the poster presentation are as follows:

Title: TLR9 agonist SNA-induced innate and adaptive immune responses in tumor micro-environment enhance checkpoint inhibitor antitumor activity in mouse tumor models
Abstract No: 3758
Session Title: Immunomodulatory Agents and Interventions 1
Date/Time: April 17, 2018; 8:00 AM – 12:00 PM CT
Location: McCormick Place South, Exhibit Hall A, Poster Section 32

Full abstracts are available on the AACR (Free AACR Whitepaper) conference website at View Source

On April 16, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported in a late-breaking poster session the presentation of new research from Endocyte’s chimeric antigen receptor T-cell (CAR T) adaptor molecule (CAM) platform at the AACR (Free AACR Whitepaper) Annual Meeting 2018 in Chicago, IL (Press release, Endocyte, APR 16, 2018, View Source [SID1234525341]).

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"We are pleased to present data that support the utility of our unique CAR T platform, which potentially enables us to control cytokine release syndrome (CRS), manage T-cell exhaustion and address heterogeneity in both solid and liquid tumors through the administration of multiple CAMs," said Chris Leamon, vice president, research and development of Endocyte. "These findings are critical towards identifying the dosing regimen and confirming the anti-tumor activity of EC17/CAR T, our folate-targeted CAM-based therapy, as we look to initiate a phase 1 trial in osteosarcoma later this year."

Endocyte’s CAM-based therapies consist of a single universal autologous CAR T-cell, designed to bind with high affinity to FITC. This universal CAR T-cell can be specifically directed to cancer cells through the administration of a bi-specific adaptor molecule targeted to both FITC and a tumor target, which acts to bridge the universal CAR T-cell with the cancer cells. This allows for control of the antigen target through the administration of the CAM, in contrast to current CAR T-cell therapies, in which the antigen targets are not controlled.

The data presented at AACR (Free AACR Whitepaper) show that EC17 penetrates solid tumors within minutes and is retained due to high affinity for the folate receptor (FR), while unbound EC17 rapidly clears from the blood and receptor-negative tissues. When tested against human xenografts, EC17/CAR T-cell therapy has shown consistent antitumor activity with low or no adverse reactions. For translation into first-in-human testing, clinically relevant dosing regimens were evaluated using tumor-free and tumor-bearing mice to study CAR T-cell proliferation, cytokine production and the onset/mitigation of CRS. Preclinically, EC17/CAR T-cell therapy has demonstrated meaningful efficacy against some of the more aggressive and chemo-resistant FR+ tumors of various histology.

Although CRS could be triggered in this study, it could also be mitigated, or even prevented, using intermittent dosing and/or dose titration of the EC17 CAM. Under extreme conditions where dose cessation failed, intravenous sodium fluorescein (NaFl) could be used as a fast-acting rescue agent to temporarily displace CAR T-cells from their targets and reverse the CRS.

Website Information
Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

On April 16, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported the presentation of updated data from its ongoing Phase 1 clinical trial of DCC-2618, the Company’s broad spectrum KIT and PDGFRα inhibitor, in patients with gastrointestinal stromal tumors (GIST) (Press release, Deciphera Pharmaceuticals, APR 16, 2018, View Source [SID1234525340]). Filip Janku, M.D., Ph.D., Assistant Professor, The University of Texas MD Anderson Cancer Center presented the poster titled "Pharmacokinetic (PK), safety, and tolerability profile of DCC-2618 in a phase 1 trial supports 150 mg QD (once daily) selected for a pivotal phase 3 trial in gastrointestinal stromal tumors (GIST)" at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, IL. The poster includes an assessment of the safety and tolerability profile of DCC-2618 in 100 GIST patients treated at the recommended Phase 2 dose (RP2D) of 150 mg QD, which supports the selection of this dose for the ongoing pivotal, randomized Phase 3 INVICTUS study (NCT03353753).

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"The data presented at AACR (Free AACR Whitepaper) provides a robust assessment of the safety and tolerability profile of DCC-2618 in GIST patients at the 150 mg QD dose selected for the INVICTUS pivotal Phase 3 study in fourth-line and fourth line plus GIST, which we initiated in January 2018," said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. "If successful, the INVICTUS study could serve as the basis for a New Drug Application (NDA), providing a much-needed therapeutic option for these patients for whom there are no approved treatment options. We also plan to initiate a second Phase 3 registration study later this year, evaluating DCC-2618 in second-line GIST patients who have progressed, or are intolerant to front-line therapy with imatinib."

The poster presentation includes the following highlights:
Safety and tolerability of DCC-2618 on 100 GIST patients treated at the 150 mg QD dose out of the total of 169 patients treated with DCC-2618, as of the cut-off date of January 18, 2018.
As of March 19, 2018, 81 of 137 GIST patients enrolled at the cut-off date and treated at 100 mg or more per day, remained on study treatment. In addition, 46 patients were treated for more than 6 months, including 10 patients who were treated for more than 12 months.
Employing a population pharmacokinetic (PK) model based on steady state exposure to DCC-2618 and the active metabolite, DP-5439, increasing doses of DCC-2618 resulted in dose proportional increases in the combined exposure.

Preliminary data from the 12 GIST patients dose escalated from 150 mg QD to 150 mg BID following progression by RECIST (Response Evaluation Criteria in Solid Tumors) are immature and do not currently support a conclusion regarding a benefit from intra-patient dose escalation.
Based on the 100 GIST patients treated at the RP2D dose of 150 mg QD, DCC-2618 was well-tolerated, supporting the use of this dose in the pivotal, randomized Phase 3 trial, INVICTUS (NCT03353753).

About DCC-2618
DCC-2618 is a KIT and PDGFRα kinase switch control inhibitor in clinical development for the treatment of KIT and/or PDGFRα-driven cancers, including gastrointestinal stromal tumors, systemic mastocytosis and glioblastoma multiforme. DCC-2618 was specifically designed to improve the treatment of GIST patients by inhibiting a broad spectrum of mutations in KIT and PDGFRα. DCC-2618 is a KIT and PDGFRα inhibitor that blocks initiating KIT mutations in exons 9, 11, 13, 14, 17, and 18, involved in GIST as well as the primary D816V exon 17 mutation involved in SM. DCC-2618 also inhibits primary PDGFRα mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST.