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RhoVac receives FDA approval in the US for the start of its Phase IIb clinical trial

On February 28, 2020 RhoVac AB ("RhoVac") reported that the US Food and Drug Administration (FDA) has approved RhoVac to initiate its clinical phase IIb study in prostate cancer in the United States, and the FDA has thus accepted the company’s Investigational New Drug (IND) application (Press release, RhoVac, FEB 28, 2020, View Source [SID1234555924]). The study, titled RhoVac-002 ("BRaVac") is an international multicenter study, which is expected to recruit at least 175 patients in the EU as well as in the United States. RhoVac has previously received approval for the start of the clinical phase IIb trial in Denmark, Finland, Germany and Belgium.

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The FDA has approved RhoVac to initiate its clinical study in prostate cancer and the FDA has thus accepted the company’s IND application. BRaVac is a randomized, placebo-controlled and double-blind study, with the primary objective of evaluating if treatment with the drug candidate RV001 can prevent or limit the development of advanced prostate cancer after curative treatment. The Phase IIb study is an international multicenter study, which is expected to recruit at least 175 patients in the EU and the US. The ambition is to recruit all patients by the end of Q3 2020. The results report on active treatment part of the study is expected in H2 2021. RhoVac has already received approval in Denmark, Finland, Germany and Belgium. Rhovac is also awaiting final approval from the ethics committees in Sweden and the UK.

RhoVac’s CEO Anders Månsson comments: "The FDA’s approval for the start the clinical trial in prostate cancer in the United States is an important milestone for RhoVac. The purpose of the development of RV001 is to eventually be able to offer patients with prostate cancer a drug that minimizes the risk of the cancer returning in metastatic form after curative intent treatment of the primary tumor."

Multivariate RNA Modeling Techniques Predicts Immune Checkpoint Responders

On February 28, 2020 Cofactor Genomics reported that a retrospective study among head and neck cancer patients found that a multivariate RNA biomarker test performed equally as standard PD-L1 immunohistochemistry (IHC) testing for predicting responses to anti-PD1-based immune checkpoint inhibitors (Press release, Cofactor Genomics, FEB 28, 2020, View Source [SID1234555270]). In the study, the Predictive Immune Modeling technique from Cofactor Genomics detected an equal number of predicted responders to anti-PD-L1 therapies compared with IHC, or 80 percent. The PIM test resulted in fewer false positives comparatively from 68 percent to 52 percent, respectively. The study was conducted in collaboration with the Washington University School of Medicine in St. Louis and presented at the 2020 Multidisciplinary Head and Neck Cancers Symposium.

The study assessed the predictive response of 107 patients with recurrent or metastatic squamous cell carcinoma of the head and neck previously treated with PD-L1 therapies—either pembrolizumab, nivolumab, or both therapies. Pre-treatment solid tumor tissues were analyzed using PIM compared with an open-label PD-L1 IHC assay.

Source: National Cancer Institute
Head and neck cancer is one of many cancers approved by the FDA for immune checkpoint inhibitors. "The challenge for these immune checkpoint inhibitors is that when they work, they work really well. But they only work, on average, for about 25 percent of the affected population," says Jarrett Glasscock, CEO of Cofactor Genomics. Predicting who will respond to PD-L1 therapy in advance would spare patients from the harm of pursuing therapies likely to fail.

While the two techniques responded equally in terms of sensitivity, the PIM test reduced the false positive rate by 16 percent. But half of the samples still led to a false positive test.

"Better tools are needed to provide clinicians and patients with a more accurate understanding of tumor response ahead of treatment decisions," explained Douglas Adkins, M.D., who led the study. "The use of multidimensional biomarkers rather than single analyte biomarkers represents a promising new approach."

Using an RNA sequencing approach, Cofactor Genomics’ focus is on modeling the RNA or transcriptome of each individual immune cells, including T- and B-cells, macrophages, monocytes, Tregs, and natural killer cells. "These are all immune cells that when in the tumor microenvironment they can be predictive of whether a patient is going to respond to an immunotherapy, or more specifically, an immune checkpoint inhibitor," says Glasscock.

The ImmunoPrism assay is the result of the company’s current state of modeling the RNA of the immune system. "Because of those models we are able to understand the composition of the tumor microenvironment with respect to the immune system," he says. "The underlying thesis is if you have a more comprehensive biomarker — more than just one analyte like PD-L1 —one hopes to do a better job of predicting who the responders are going to be."

The company’s method relies on applying machine learning to train results to identify RNA biomarkers in responders and non-responders to immunotherapy.

RNA sequencing results are translated into immune cell percentages that are in the tumor microenvironment.

"The assay includes a combination of immune cell percentages paired with RNA expression of genes — these are typically the immune escape genes that are so important in immune oncology," says Glasscock. The test also collects information on expression of co-stimulators and co-inhibitors. "It is really a comprehensive view of not only RNA expression but immune cell composition."

While the false positive rate is still high, specificity is likely to improve over time. "We have taken a very conservative approach in this study, "adds Glasscock. "As the technique becomes more precise, we hope to match on the diagnostic side the excitement we have seen on the treatment side with immunotherapy in the last five years especially."

Nanobiotix 2019 Q4 and Annual Revenues

On February 28, 2020 NANOBIOTIX (Paris:NANO) (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its unaudited annual revenues for Q4 and the unaudited revenues for the year ended December 31, 2019 (Press release, Nanobiotix, FEB 28, 2020, View Source [SID1234555004]).

Activity and results

Nanobiotix’s revenue for the fourth quarter amounted to approximatively €20k.

Most of the revenues generated by the Company during this period result from the recharge of costs related to our license and collaboration agreement with PharmaEngine.

Overall, Nanobiotix’s annual revenue in 2019 amounted to approximatively €68k.

The amount of cash and cash equivalent as of December 31st, 2019 amounted to €35 094k. This amount does not include the research tax credit related to 2018, normally expected in Q4 which was received in February 2020.

In November 2019, Nanobiotix announced promising results from a pre-clinical immuno-oncology study of NBTXR3 at the 2019 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). In the study, conducted at The University of Texas MD Anderson Cancer Center, researchers studied NBTXR3 activated by radiation therapy in combination with anti-PD-1 treatment in immunocompetent mice. Combination treatment that included NBTXR3 and anti-PD-1 increased local control of the irradiated tumor, generated a marked abscopal effect, decreased the number of spontaneous lung metastases, and significantly increased survival when compared to other treatments in the study, including anti-PD-1 combined with radiation therapy alone. The results indicated that the combination treatment has the potential to achieve an equivalent abscopal effect at a lower dose of radiation.

The study also included an in vivo RadScopal model in which a second tumor received a low dose of radiation while the first tumor received a full dose. In this model, researchers evaluated NBTXR3 activated by radiation therapy combined with anti-PD-1 and anti-CTLA-4 treatment. In the study, combination treatment triggered better local control, along with significant increases in abscopal effect and survival, when compared to all other tested combinations. Several complete responses were observed in the second tumor of the group that received the NBTXR3 combination, while none were observed in the other groups. Nanobiotix believes these results could pave the way for the use of NBTXR3 to improve treatment outcomes for immunooncology patients, including checkpoint inhibitor non-responders.

On December 16th 2019, Nanobiotix received the French 2019 Prix Galien award for Most Innovative MedTech. This award recognizes outstanding biomedical and medical technology product achievements that improve the human condition.

2020 Financial agenda

Nanobiotix plans to announce its financial and operating results as follows:

March 13, 2020 – 2019 Annual results
April 28, 2020 – Annual General Meeting, Paris, France
April 30, 2020 – Revenue for Q1
July 17, 2020 – Revenue for Q2
September 4, 2020 – Half year results
October 23, 2020 – Revenue for Q3

Puma Biotechnology to Present at Cowen’s Annual Health Care Conference

On February 28, 2020 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 9:20 a.m. EST on Wednesday, March 4 at the Cowen and Company 40th Annual Health Care Conference (Press release, Puma Biotechnology, FEB 28, 2020, View Source [SID1234555003]). The conference will be held at the Boston Marriott Copley Place.

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.

Harbour BioMed Announces U.S. FDA Approval of IND for Its Next Generation anti-CTLA-4 Antibody, HBM4003, to Treat Cancer

On February 28, 2020 Harbour BioMed (HBM) reported U.S. Food and Drug Administration (FDA) approval of its Investigational New Drug (IND) application to begin clinical studies with HBM4003, its next generation anti-CTLA-4 antibody for the treatment of cancer (Press release, Harbour BioMed, FEB 28, 2020, View Source [SID1234555002]). The U.S. study builds on an initial ongoing trial in Australia. The trial will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM4003 as a single agent in subjects with advanced solid tumors.

"The IND approval is an important next step in our global program to develop this exciting molecule," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "In preclinical studies, HBM4003 demonstrated potent anti-tumor activity based on a differentiated mechanism of action and a favorable safety profile. HBM4003 is the first in a portfolio of mono- and bi-specific antibodies based on our patented, heavy chain only (HCAb) technology against various immuno-oncology and immunology targets that are advancing toward clinical trials."

About HBM4003
HBM4003 is the fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice. HBM4003 shows enhanced antibody-dependent cell cytotoxicity (ADCC) killing activity and is extremely specific to CTLA-4High Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug.