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Trillium Therapeutics Reports Third Quarter 2017 Financial and Operating Results

On November 10, 2017 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial results for the nine months ended September 30, 2017 (Press release, , NOV 10, 2017, View Source [SID1234521942]).

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"Our strategy of running intravenous and intratumoral signal-seeking Phase 1 trials of TTI-621 in multiple indications gives us the best opportunity to identify malignancies where we can further focus our clinical efforts," said Dr. Niclas Stiernholm, Trillium’s Chief Executive Officer. "We are on track to provide additional clinical updates by year end."

Upcoming Clinical Events in the Fourth Quarter of 2017:

Preliminary data from the TTI-621 Phase 1a intratumoral dose escalation trial in solid tumors to be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 59th Annual Meeting
Additional clinical data from the TTI-621 Phase 1b intravenous trial to be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 59th Annual Meeting
IND submission for TTI-622
Third Quarter 2017 Financial Results

As of September 30, 2017, Trillium had cash and marketable securities of $64.3 million compared to $50.5 million at December 31, 2016. The increase in cash and marketable securities was due mainly to receiving net proceeds of $39.0 million from the June 2017 financing, partially offset by cash used in operations of $20.4 million and an unrealized foreign exchange loss of $4.5 million.

Net loss for the nine months ended September 30, 2017 of $34.4 million was higher than the loss of $22.7 million for the nine months ended September 30, 2016. The net loss was higher due mainly to higher research and development expenses of $6.8 million with two active Phase 1 trials for TTI-621 and manufacturing expenses for TTI-622 in 2017, the recognition of a deferred tax recovery in the nine months ended September 30, 2016 related to the acquisition of Fluorinov of $3.7 million, and a higher net foreign currency loss of $1.8 million.

Five Prime Therapeutics Presents Poster on FGFR2b Expression and Immune Signature in Urothelial Cancer at the Society for Immunotherapy of Cancer 32nd Annual Meeting

On November 10, 2017 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that analyses of FGFR2b expression and baseline immune signature in urothelial cancer (UC) samples were featured in a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting, being held November 8-12, 2017 in National Harbor, Maryland (Press release, Five Prime Therapeutics, NOV 10, 2017, View Source [SID1234521937]). A PDF of the poster, "FGFR2b Expression and Baseline Immune Signature to Guide FPA144 Development in Urothelial Cancer," will be made available on the Publications page of the Five Prime website. Five Prime is developing FPA144, an isoform-selective antibody, as a targeted immunotherapy for tumors that overexpress FGFR2b. Five Prime continues to enroll patients in the Phase 1 trial cohort evaluating FPA144 as a treatment for patients with bladder cancer whose tumors overexpress FGFR2b.

"Profiling FGFR2b expression and baseline tumor-associated immune cells could help guide our clinical development strategy for FPA144 in bladder cancer," said Kevin Baker, Ph.D., Senior Vice President, Development Sciences at Five Prime. "Previously we showed in a pre-clinical model with moderate FGFR2b expression, that FPA144 can reprogram the tumor microenvironment making it more inflammatory. In the same studies, we also showed that FPA144 and PD-1 blockade have additive anti-tumor effects."

Five Prime evaluated FGFR2b expression in 387 archival primary early stage UC samples and previously reported that > 10% had overexpression of FGFR2b by immunohistochemistry (IHC) with intensity level of at least 1+. The research team selected 32 archival UC cases with a range of FGFR2b expression (62% were FGFR2b positive) and characterized baseline immune composition in the tumor microenvironment and the relationship with FGFR2b expression to potentially guide FPA144 development in combination with other therapies.

The results from the selected cases suggest that FGFR2b is expressed in all immune subtypes of UCs, but the expression level varies. The highest level of expression is in inflamed and more proliferative UCs. The Company plans to evaluate additional archival UC tissues from patients with more advanced metastatic disease to determine if there is an association of FGFR2b expression with baseline immune signature in late-stage patient tumors.

Halozyme To Present Nonclinical Data At SITC 2017 Supporting Combination Of PEGPH20 With Checkpoint Inhibitors

On November 10, 2017 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that it will present nonclinical data at the 32nd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) which demonstrate the potential for PEGPH20, Halozyme’s pegylated recombinant human hyaluronidase, to increase the infiltration of immune cells into the tumor microenvironment and enhance the efficacy of immuno-oncology drugs in an HA-accumulating murine colon tumor model (Press release, Halozyme, NOV 10, 2017, View Source [SID1234521938]).

The study shows that degradation of hyaluronan (HA) in a tumor by PEGPH20 can facilitate an anti-tumor immune response induced by checkpoint blockade by promoting effector cell infiltration and skewing the immune microenvironment toward a more anti-tumor composition. The data support Halozyme’s ongoing clinical evaluation of PEGPH20 in combination with checkpoint inhibitors.

The poster, entitled "Degradation of hyaluronan by PEGPH20 promotes anti-tumor immunity and enhances the effect of checkpoint blockade in an HA-accumulating mouse syngeneic tumor model," will be presented as part of a series of posters focusing on the tumor microenvironment from 12:30 p.m. to 2 p.m. EST on Saturday, November 11.

Northern Presents Phase 1 Trial Poster at SITC Conference

On November 10, 2017 Northern Presented Phase 1 Trial Poster at SITC (Free SITC Whitepaper) Conference.(Presentation, Northern Biologics, NOV 10, 2017, View Source [SID1234521940])

ZIOPHARM to Present at the Stifel 2017 Healthcare Conference

On November 10, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) reported that David Mauney, M.D., CBO and interim COO, will present at the Stifel 2017 Healthcare Conference in New York on Tuesday, November 14, 2017 at 11:00 a.m. ET (Press release, Ziopharm, NOV 10, 2017, View Source [SID1234521941]).

To access a live audio webcast of the presentation, please visit the Investor Relations section at www.ziopharm.com. The webcast will be archived for 90 days.