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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.

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"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.

Symposium and Panel Discussion on Nymox’s Fexapotide To Be Held at American Urological Association North Central Section Annual Meeting in Scottsdale AZ November 15

On November 10, 2017 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported that a Symposium on Fexapotide Triflutate studies will be held at the Annual Meeting of the American Urological Association North Central Section, in Scottsdale AZ next week (Press release, Nymox, NOV 10, 2017, View Source;fvtc=4&fvtv=6907 [SID1234521932]). The symposium, "Fexapotide Triflutate: Long-Term BPH Studies 2009-2017" will be chaired by Mohamed Bidair MD of San Diego CA. The other panel members at the Symposium will be Alan Hay MD FACS of Salem OR, Stephen Richardson MD of Salt Lake City UT, and Barton Wachs MD of Long Beach CA.

Nymox’s lead drug Fexapotide has been in development for over 10 years and has been tested by expert clinical trial investigative teams in over 70 distinguished clinical trial centers throughout the US, and has been found after 7 years of prospective placebo controlled double blind studies of treatment of 995 U.S. men with prostate enlargement to not only show clinically meaningful and durable relief of BPH symptoms, but also to show a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease. The same clinical program has also shown in a long-term blinded placebo crossover group study an 82-95% reduction in the number of these patients who required surgery after they received crossover Fexapotide in the trial, as compared to patients who did not receive Fexapotide but instead received crossover conventional approved BPH treatments (p<.0001).

The Symposium will present detailed clinical data on the Phase 3 clinical trials that have been completed for Fexapotide and that have shown excellent safety and significant efficacy for the treatment of BPH. In addition, scientific data supporting the safety and efficacy from non-clinical and laboratory testing and analysis will be demonstrated. The main presentation will be followed by a panel discussion and by an interactive question and answer session with the specialist doctors in attendance.

For more information please contact [email protected] or 800-936-9669.

Forward Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH and prostate cancer, the potential of Fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for Fexapotide. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Nymox’s regulatory filings, Nymox’s substantial dependence on Fexapotide, Nymox’s commercialization plans and efforts and other matters that could affect the availability or commercial potential of Fexapotide. Nymox undertakes no obligation to update or revise any forward looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Nymox in general, see Nymox’s current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F for the year ended December 31, 2016, and its Quarterly Reports.