On November 4, 2019 RhoVac AB ("RhoVac") reported that the first patient has been screened for the company’s clinical phase IIb study in prostate cancer, a study entitled RhoVac-002 ("BRaVac") (Press release, RhoVac, NOV 4, 2019, View Source [SID1234550259]). The screening took place at the Odense University Hospital.

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BRaVac is a randomized, placebo-controlled and double-blinded study in prostate cancer, with the primary end-point of evaluating if and to what extent treatment with the drug candidate RV001 can prevent or limit the development of cancer measured as a more limited development of PSA (prostate specific antigen) in treated patients compared to the control group (placebo group). The clinical phase IIb study is an international, multicenter study, which is expected to recruit over 175 patients in six European countries (Denmark, Finland, Sweden, United Kingdom, Belgium and Germany), as well as the United States. The first patient is now screened for the study and the ambition is that all patients will be recruited in Q3 2020. The study results on the primary end-points are expected to be reported in 2021.

Anders Ljungqvist, COO: "It has been a challenge to start this large clinical phase IIb study in the summer holiday period, and it is therefore particularly gratifying that the first patient is now screened at Odense University Hospital. Other clinical sites in Denmark are ready to screen patients and Finland is the next country to open up for screening."

Anders Månsson, CEO: "The last few months have been very intense at RhoVac – we have received approval from the Danish authorities to start the clinical phase IIb study, and FDA has also stated, in a pre-IND, a positive opinion on starting the clinical phase IIb trial in the United States. We have also received approval to start the study in Finland. In addition, only a few months ago we completed a new rights issue that will fund the current clinical study, and we applied for and also received a grant of EUR 2.5 million from the EU Research and Innovation Fund Horizon2020. In July 2019, we presented the 12-month follow-up study from the clinical phase I/II-study showing good and stable results over time. The fact that we now have screened our first patient for the clinical phase IIb trial is an extremely important milestone for RhoVac! I would also like to extend my gratitude to all employees and consultants who have worked tirelessly to take the project to the point where it is today. Phase IIb is extremely well prepared, and with this, RhoVac is entering its last development phase, and as a result of this the partnering discussions will advance further."

On November 4, 2019 Genoscience Pharma is reported a new data from in vivo study of GNS561 alone or in combination with a PD-1 inhibitor in a transgenic mouse model of hepatocarcinoma (HCC) (Press release, GenoScience, NOV 4, 2019, View Source [SID1234550467]). In addition to good tolerance, GNS561 in combination with a PD-1 inhibitor showed significant antitumoral activity, with a 77% decrease in the macronodule counts compared to control group. This new data shows GNS561 allows PD-1 inhibitor to recover its antitumoral efficacy.

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Genoscience Pharma, a clinical-stage biotechnology company dedicated to discovering and developing anticancer treatment drugs, today announces that its poster demonstrating promising results from a combination study with a PD-1 inhibitor in a transgenic mouse model of hepatocarcinoma (HCC) was selected for presentation at the American Association for the Study of Liver Diseases (AALSD) Liver Meeting 2019 being held November 8-12, 2019 in Boston, MA.

The in vivo study was performed in a transgenic immunocompetent mouse model of HCC (ASV-B). Animals were treated by vehicle, GNS561 or PD-1 inhibitor as monotherapy or GNS561 in combination with PD-1 inhibitor. Results showed an outstanding anticancer response, with a 77% decrease of the macronodule count in the combination group compared to controls.

"We are delighted to be presenting this positive in vivo study at the AASLD Liver Meeting 2019. These results may open a new horizon in the area of immuno-oncology by enlarging indication of the use of immune checkpoint inhibitors in tumor types that are marginally sensitive to immunotherapy or for patients developing resistance to checkpoint inhibitors. We believe our results provide a strong rationale for combining our drug to a PD-1 inhibitor antibody in clinical trials with HCC patients" said Pr Eric Raymond, Chief Medical Officer at Genoscience Pharma.

"We are looking forward to assessing this combination in HCC patients, for which immunotherapy hasn’t answered the current medical need" commented Pr Philippe Halfon, president and founder of Genoscience Pharma.

Genoscience Pharma will be also presenting three additional posters at the conference. Data on the primary results of the ongoing Phase 1b assessing GNS561 in patients with primary or secondary liver cancers will be presented as well as efficacy preclinical data against intra-hepatic cholangiocarcinoma and liver fibrosis.

The details for the Company’s poster presentation are as follows:

Presenting Author: Philippe Halfon, MD, PhD.
Abstract title: GNS561, a New Oral Clinical-Stage Small Molecule Combined with a PD-1 Inhibitor Showed Remarkable Anti-Tumor Effects in a Transgenic Immunocompetent Hepatocellular Carcinoma Mouse Model (ASV-B). Poster 1993.
Presentation date and time: November 11, 2019 (presentation from 12.30 pm to 1.30 pm)

On November 4, 2019 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the third quarter ended September 30, 2019 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, NOV 4, 2019, View Source [SID1234550227]).

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"Strong and swift is the pace of our progress as we eagerly anticipate topline data from our Phase III pivotal ADVOCATE trial of avacopan in ANCA vasculitis," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "At our recent R&D Day in New York the stage was set for the upcoming data, as our schedule featured two pre-eminent nephrologists as well as an ANCA vasculitis patient who highlighted the patient journey, the disease burden and the noxious consequences of chronic steroid use as part of the current standard-of-care. We provided a comprehensive overview of ANCA disease assessment and therapeutic improvement—ranging from the primary endpoints, BVAS remission at 26 and 52 weeks, to key secondary endpoints in the trial, as we aim to demonstrate a new way to treat this deadly disease."

"Furthermore, topline data from ADVOCATE is just the first in a cadence of five data readouts expected between now and the end of 2020. These readouts include those from the LUMINA-1 and LUMINA-2 trials of our CCR2 inhibitor, CCX140, in Focal Segmental Glomerulosclerosis (FSGS), the ACCOLADE trial of avacopan in C3 Glomerulopathy (C3G) and the AURORA trial of avacopan in Hidradenitis Suppurativa (HS). Our financial position is strong, enabling this historic period of data readouts. We look forward to a time soon where our innovations can be brought to the real service of our patients, to the aid of clinicians and to the benefit of those who have invested in this inventive enterprise."

Recent Highlights

Remained on track for mid-to-late Q4 topline data from the ADVOCATE global Phase III trial of avacopan in 331 patients with ANCA-associated vasculitis.

Completed enrollment in the Company’s LUMINA-1 Phase II randomized clinical trial of CCX140, an inhibitor of the chemokine receptor known as CCR2, in patients with sub-nephrotic primary Focal Segmental Glomerulosclerosis (FSGS), another rare kidney disease. Topline data is

anticipated in the first half of 2020. The single-arm, open label LUMINA-2 study continues to enroll, evaluating CCX140 in primary FSGS patients with the more severe nephrotic levels of proteinuria.

Awarded a two-year $1 million grant from the orphan drug office of the FDA to support advancement in the Company’s ACCOLADE Phase II clinical trial of avacopan in patients with the rare kidney disease C3 Glomerulopathy, a disease with no effective approved treatment. Approaching 60 percent enrollment in the ACCOLADE trial.

Attended Symposium on Hidradenitis Suppurativa Advances (SHSA), held November 1-3 in Detroit, Michigan. The Company’s AURORA Phase IIb clinical trial of avacopan for the treatment of the chronic disabling skin disease Hidradenitis Suppurativa (HS) is progressing well, with almost 80 percent of sites now activated and over 55 percent of patients enrolled to date.

Third Quarter 2019 Financial Results

Revenue was $10.6 million for the third quarter of 2019, compared to $9.0 million for the same period in 2018. Revenue is recognized based on the proportionate amount of costs incurred as a percentage of total budgeted costs to fulfill the performance obligations under the Company’s avacopan and CCX140 commercialization agreements with Vifor Pharma.

Research and development expenses were $18.1 million for the third quarter of 2019, compared to $15.1 million for the same period in 2018. The increase from 2018 to 2019 was primarily attributable to patient enrollment of the avacopan AURORA Phase II clinical trial in patients with HS and the two CCX140 LUMINA Phase II clinical trials in patients with FSGS, partially offset by decreases in research and drug discovery expenses.

General and administrative expenses were $6.1 million for the third quarter of 2019, compared to $5.4 million for the same period in 2018. The increase from 2018 to 2019 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, and higher professional fees.

Net loss for the third quarter of 2019 was $12.9 million, compared to $10.9 million for the same period in 2018.

Total shares outstanding at September 30, 2019 were approximately 58.3 million shares.

Cash, cash equivalents and investments totaled $205.8 million at September 30, 2019. The Company expects to close 2019 with cash and investments in excess of $185 million.

Conference Call and Webcast

The Company will host a conference call and webcast today, November 4, 2019 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 5867903. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.

On November 4, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 10:55 a.m. MST (9:55 a.m. PST, 12:55 p.m. EST) on Tuesday, November 12, at the Credit Suisse 28th Annual Healthcare Conference (Press release, Puma Biotechnology, NOV 4, 2019, View Source [SID1234550243]). The conference will be held at The Phoenician Resort in Scottsdale, Arizona.

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A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days.

On November 4, 2019 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for translational research and molecular diagnostic products, reported the availability of its new GeoMx Cancer Transcriptome Atlas through the Technology Access Program (TAP) for the GeoMx Digital Spatial Profiler (DSP) (Press release, NanoString Technologies, NOV 4, 2019, View Source [SID1234550260]).

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This new high-plex RNA expression profiling panel provides the most informed view of the cancer transcriptome based on evidence from the Cancer Genome Atlas Program as well as important immuno-oncology biology. The assay is compatible with both fresh frozen (FF) and Formalin-Fixed Paraffin-Embedded tissue (FFPE) enabling researchers to access more samples to power their studies. NanoString’s GeoMx DSP is used to prepare the sample for spatial analysis using a read-out chemistry designed to be compatible with Illumina’s next-generation sequencing instruments.

"Over the last year we’ve generated strong demand for our GeoMx Digital Spatial Profiler in the translational medicine market," said Brad Gray, president and CEO of NanoString. "The launch of this high-plex RNA assay marks the next phase of our market development activities in which we plan to expand into the large market for discovery applications by leveraging next-generation sequencing read-out to achieve an unprecedented level of multiplex profiling with spatial context."

The GeoMx Cancer Transcriptome Atlas expands on the nCounter PanCancer series of gene expression panels by combining the content from the PanCancer Pathways, PanCancer Immune Profiling and the IO 360 panels with additional gene content. Under the program, a TAP partner can submit FFPE tissue sections to NanoString and NanoString will run the GeoMx Cancer Transcriptome Atlas and provide the analysis report back to the partner.

Researchers interested in participating in NanoString’s technology access program should contact us at [email protected].