On December 18, 2018 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) (formerly RXi Pharmaceuticals Corporation), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported that Dr. Gerrit Dispersyn, President and Chief Operating Officer, will present at Biotech Showcase 2019, to be held January 7 – 9, 2019 at the Hilton San Francisco Union Square (Press release, Phio Pharmaceuticals, DEC 18, 2018, View Source [SID1234532115]).

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Dr. Gerrit Dispersyn will present an overview of the Company’s novel self-delivering RNAi (sd-rxRNA) technology and the multiple business development and commercial opportunities available with this proprietary platform on:

Date: Monday, January 7, 2019
Time: 9:00 a.m. PST
Room: Yosemite C (Ballroom Level)

He will also be available for investor and executive meetings throughout the conference. The presentation will be webcast and available on the "Investors – Events and Presentations" section of the Company’s website, www.phiopharma.com.

About Biotech Showcase
Now in its eleventh year, Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and executives in one place during the course of one of the industry’s largest annual healthcare investor conferences, J.P. Morgan Annual Healthcare Conference.

On December 17, 2018 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported top line results from the Phase III NALA trial of the Company’s lead drug candidate PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease) in the setting of metastatic disease (Press release, Puma Biotechnology, DEC 17, 2018, View Source [SID1234532097]). The Phase III NALA trial is a randomized controlled trial of neratinib plus capecitabine versus Tykerb (lapatinib) plus capecitabine in patients with third-line HER2-positive metastatic breast cancer. The trial enrolled 621 patients who were randomized (1:1) to receive either neratinib plus capecitabine or lapatinib plus capecitabine. The trial was conducted globally at sites in North America, Europe, Asia-Pacific and South America. The co-primary endpoints of the trial are centrally confirmed progression free survival (PFS) and overall survival (OS). An alpha level of 1% was allocated to the PFS and 4% allocated to OS. The study was to be considered positive if either of the co-primary endpoints was positive. Puma reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design of the Phase III clinical trial and the European Medicines Agency (EMA) also provided follow-on scientific advice (SA) consistent with that of the FDA regarding the Company’s Phase III trial design and endpoints used in the trial.

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For the primary analysis of centrally confirmed PFS, treatment with neratinib plus capecitabine resulted in a statistically significant improvement in centrally confirmed PFS (p=0.0059) compared to treatment with lapatinib plus capecitabine. For the primary analyses of OS, neratinib plus capecitabine resulted in an improvement in OS that did not achieve statistical significance but trended positively in favor of the neratinib plus capecitabine arm of the study (p=0.21). For the secondary endpoint of time to intervention for symptomatic central nervous system disease (also referred to as brain metastases), the results of the trial showed that treatment with neratinib plus capecitabine led to an improvement over the combination of lapatinib plus capecitabine (p=0.043).

The safety profile of neratinib in the Phase III NALA study was consistent with previous clinical trials of neratinib.

Full results of the trial will be submitted to health authorities around the world, including the U.S. Food and Drug Administration and European Medicines Agency. Results of the trial will be submitted for presentation at a major medical conference in 2019.

Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, "We are highly encouraged by these results from the NALA trial with the combination of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments. We look forward to working with the regulatory authorities in the hope of bringing another potential treatment option to patients with HER2-positive metastatic breast cancer as soon as possible."

Conference Call

Puma Biotechnology will host a conference call at 1:30 p.m. PST/4:30 p.m. EST on Monday, December 17, 2018, to discuss the results of its NALA trial. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least ten minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 30 days.

On December 17, 2018 Bristol-Myers Squibb Company (NYSE:BMY), and Boston Medical Center, a private, not-for-profit, academic medical center, reported a multi-year joint research study to identify and analyze potential sensitivity and resistance markers in patients treated with standard-of-care checkpoint inhibitors (Press release, Bristol-Myers Squibb, DEC 17, 2018, View Source [SID1234532098]). The comprehensive, multi-dimensional study will place an emphasis on uncovering mechanisms associated with lack of response to Immuno-Oncology (I-O) therapies, with the ultimate goal of identifying prognostic and potentially predictive I-O biomarkers in a variety of cancers.

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"Our newly opened R&D site in Kendall Square is focused on better understanding, and ultimately overcoming, the challenge of I-O resistance. We are thrilled to establish our first partnership since the site opened with our new neighbor, Boston Medical Center, with the goal of uncovering new insights into the biology of cancer and how it evolves with exposure to I-O intervention," said Saurabh Saha, M.D., Ph.D., senior vice president and global head of translational medicine, Bristol-Myers Squibb. "The information we glean from this collaboration will ultimately inform the development of novel therapeutic strategies to improve response rates and outcomes for patients."

Through the study, researchers will explore the role of tissue and circulating biomarkers on treatment sensitivity and resistance. In addition, scientists will investigate the role of the microbiome as a potential predictive biomarker in patients receiving treatment with immune checkpoint inhibitors.

"Boston Medical Center serves a diverse patient population, with 70 percent of our patients coming from underserved communities," said Matthew Kulke, M.D., chief of hematology/oncology at Boston Medical Center. "These patients are sorely underrepresented in current research studies. We look forward to partnering with Bristol-Myers Squibb on this study to identify and assess biomarkers across a diverse patient population, providing us with a deeper and more comprehensive understanding of I-O resistance."

The two organizations will jointly conduct the research throughout the duration of the study, after which Bristol-Myers Squibb and Boston Medical Center may collaborate to publish results.

Bristol-Myers Squibb opened its Cambridge R&D site, located in Kendall Square, on November 26, 2018.

On December 17, 2018 Abbott (NYSE: ABT) reported that it will announce its fourth-quarter 2018 financial results on Wednesday, Jan. 23, 2019, before the market opens (Press release, Abbott, DEC 17, 2018, View Source [SID1234532099]).

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The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

On December 17, 2018 RhoVac AB ("RhoVac") reported that the first prostate cancer patient included in the clinical phase I / II study with RhoVac’s drug candidate RV001 has completed it’s 12-month follow-up and thus the entire clinical phase I / II- study (Press release, RhoVac, DEC 17, 2018, https://www.rhovac.com/rhovac-announces-that-the-first-patient-completed-the-follow-up-phase-of-the-clinical-phase-i-ii-study/ [SID1234532083]).

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Prior to the clinical phase I / II study, conducted between 2017 and 2018, 22 patients with diagnosed prostate cancer and prostatectomized. Blood samples were taken before, during and after the study to analyse the product mediated immune response to treatments. The results, reported earlier this year, showed a significant immune response in 86% of the patients. Patients have also participated in a 3-, 6-, 9- and 12-month follow-up phase of the study, to assess the duration of the immune response.

RhoVac announces that the first patient has completed his 12-month follow-up and thus also completed his participation in RhoVac’s phase I / II clinical study. The samples for immunological analysis have been sent to the University of Tübingen. The interim report on the duration of the immunological responses, from all participating patients’ 3- and 6-month follow-up will be published in January 2019.

The last patient is expected to complete his 12-month follow-up in March 2019. The final report on the duration of the immunological responses is expected in the second quarter of 2019.

The company’s drug candidate RV001 activates T cells of the immune system to identify and eliminate cancer cells expressing the protein RhoC. As RhoC is generally overexpressed in metastatic cancer cells, RV001 can potentially be used in the treatment of several different cancer indications. It is the company’s ambition that the product being developed shall be used as a preventive treatment against metastases, thus preventing, or limiting the spread and recurrence of cancer