On May 21, 2019 RhoVac reported that a summary of the collaboration with Lund University has been published prior to the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting (American Society of Clinical Oncology) held in Chicago on May 31-June 4 (Press release, RhoVac, MAY 21, 2019, View Source [SID1234555930]).

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The primary objective of the study was to investigate whether RhoC is expressed to a greater extent in cancer stem cells in prostate cancer induced metastases in radiation exposed mice. The metastasis tissues were harvested, sectioned and analyzed by immunohistochemical methods, comparing the presence of different biomarkers. The biomarkers analyzed were for RhoC, Adenoreceptor (AR), CD 166 (cancer stem cell) and Ki67 (proliferation). The results showed, that RhoC is expressed to a greater extent in the metastatic tissue and, and that there is a subpopulation of RhoC-positive cells in the metastases, which are double-labeled with CD166 to the cancer stem cells.

Anders Ljungqvist, CEO: – It was satisfying to see that these results confirmed that RhoC was expressed to a greater extent in the metastasis tissue than in the tumor, and that a subpopulation of the RhoC-positive cells also has cancer stem cell character.

On May 21, 2019 Nordic Nanovector ASA (OSE: NANO) reported that following a safety review of the first patients in the ongoing Archer-1 (LYMRIT 37-07) trial investigating Betalutin (177Lu-satetraxetan-lilotomab) in combination with rituximab (RTX) in second-line follicular lymphoma (2L FL), the Betalutin dose has been escalated to 15 MBq/kg for the next cohort of patients (Press release, Nordic Nanovector, MAY 21, 2019, https://www.nordicnanovector.com/investors-and-media/press-releases?page=/en/pressreleases/nordic-nanovector%253A-archer-1-phase-1b-betalutin%2528r%2529-rituximab-combination-trial-advances-to-next-cohort-1692267 [SID1234553451]).

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Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial to assess the safety and preliminary activity of combining CD37-targeted Betalutin with CD20-targeted RTX in 20-25 patients with relapsed/refractory FL who have received one or more prior therapies. Starting doses of Betalutin and lilotomab are 10MBq/kg and 40mg, respectively, with the option for dose escalation.

Following Betalutin dosing, patients will receive 375 mg/m2 RTX once per week for four weeks. The primary endpoint is safety, and secondary endpoints include overall response rate, duration of response, progression free survival and overall survival. Data read-out is expected during the second half of 2020.

Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, commented: "We are pleased to be moving ahead with the next group of patients in the study, which will enable us to recommend a dose for further evaluation of safety and preliminary efficacy in additional patients."

Rituximab is a CD20-targeting monoclonal antibody that is administered to patients with newly-diagnosed or relapsed FL as a single agent or in combination with chemotherapy. Over time, patients may develop resistance to RTX, thus alternative targets and new treatments are important. The combination of anti-CD37 and anti-CD20 modalities could therefore represent a novel dual immunotherapy approach for the treatment of 2L FL patients, and potentially avoid or delay the use of chemotherapy.

On May 21, 2019 Inhibrx, Inc. ("Inhibrx"), a clinical-stage biotechnology company developing a broad pipeline of novel biologic therapeutic candidates, reported that it has entered into an agreement with Viking Global Investors LP ("Viking") for the offering and sale of convertible promissory notes in a private placement transaction in the aggregate principal amount of $40 million (Press release, Inhibrx, MAY 21, 2019, View Source [SID1234536939]). Inhibrx has received approximately $205 million since inception, including raising $135 million in investor equity and debt and receiving $70 million in licensing and grant payments.

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Viking joins existing Inhibrx investors RA Capital, Lilly Asia Ventures, ArrowMark Partners, WuXi Biologics and Alexandria.

"We are pleased to welcome Viking Global to our supportive investor syndicate," said Mark Lappe, Chief Executive Officer of Inhibrx. "This new investment, coupled with our current investor support, provides us with additional capital to advance our pipeline, including our three clinical-stage programs with two additional programs expected to enter the clinic this year, and our proprietary sdAb platform."

Evercore served as sole financial advisor to Inhibrx in connection with this issuance.

About the Inhibrx sdAb Platform
Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary sdAb platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform enables the construction of molecules that contain multiple binding units with defined valency or multiple specificities. These novel antibodies can be combined to create therapeutic candidates with the potential to achieve enhanced cell signaling or conditional activation. Importantly, these optimized, multi-functional entities can be manufactured using the established processes that are common in the production of therapeutic proteins.

On May 21, 2019 Bio-Techne Corporation (NASDAQ:TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the Jefferies 2019 Global Healthcare Conference on Wednesday, June 5th, 2019, at 9:30 a.m. EDT (Press release, Bio-Techne, MAY 21, 2019, View Sourcenews/detail/139/bio-techne-to-present-at-the-jefferies-2019-global-healthcare-conference" target="_blank" title="View Sourcenews/detail/139/bio-techne-to-present-at-the-jefferies-2019-global-healthcare-conference" rel="nofollow">View Source [SID1234536926]). The conference will be held at the Grand Hyatt Hotel in New York City.

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A live webcast of the presentation can be accessed via Bio-Techne’s Investor Relations website at View Source or through the following link View Source

On May 21, 2019 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported its results from the Company’s R&D Validation study at the American Thoracic Society (ATS) 2019 International Conference, which is being held May 17 to May 22 in Dallas (Press release, BioTime, MAY 21, 2019, View Source;p=RssLanding&cat=news&id=2399321 [SID1234536544]). The poster details the compelling results from the Company’s successful R&D Validation study of DetermaVu, OncoCyte’s liquid biopsy test for the early detection of lung cancer.

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The R&D Validation study demonstrated a sensitivity of 90% (95% confidence interval from 82%-95%) and specificity of 75% (95% confidence interval from 68%-81%) of DetermaVu on a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators.

"We are very pleased to present for the first time the strong findings from our R&D Validation study of DetermaVu at this year’s ATS meeting. We believe these results are poised to redefine the paradigm in lung cancer detection," said Lyndal Hesterberg, Chief Scientific Officer of OncoCyte. "Most notably, we were able to achieve these results using gene-expression biomarkers alone and without the use of clinical parameters such as nodule size that are solely employed by the Mayo model and other algorithm models currently used to estimate the probability of cancer in patients with pulmonary nodules. Our unique Immune System Interrogation approach can potentially detect lung cancer in earlier stages of the disease when more favorable patient outcomes are feasible. We are excited about the potential of this novel test to positively impact the lives of patients globally, and are rapidly advancing through remaining development studies as we work to make DetermaVu commercially available in the second half of this year."

Summary results:

A multivariate gene expression classifier was used to identify benign from malignant nodules between 5-30mm with a high degree of accuracy in a diverse population of current and former smokers

Using only gene-expression biomarkers from whole blood, and with no clinical parameters, the DetermaVu test yielded an overall Area Under the Curve (AUC) of 0.89 with Sensitivity ~90% (95% confidence interval of 82%-95%) and Specificity ~75% (95% confidence interval of 68%-81%)

This classifier significantly outperformed the Mayo algorithm model for cancer risk that utilizes only clinical factors such as nodule size
Poster details:

Session: 110 – THE FUTURE OF LUNG CANCER BIOMARKERS: WHERE SHOULD WE LOOK?
RAPiD: Rapid Abstract Poster Discussion Session
Day and time: Tuesday, May 21, 2019 – 2:15 – 4:15 PM CDT
Location: Arena (Level 2), KBHCCD
Poster Title: Blinded Prospective Validation Study of a Whole Blood Gene-Expression Classifier
for the Diagnosis of Benign Versus Malignant Pulmonary Nodules
Poster #: 421
Viewing Time: 2:15-2:45 PM CDT
Discussion Time: 2:45-4:15 PM CDT
The poster can be viewed here.

About ATS

The American Thoracic Society improves global health by advancing research, patient care, and public health in pulmonary disease, critical illness, and sleep disorders. Founded in 1905 to combat tuberculosis (TB), the ATS has grown to tackle asthma, COPD, lung cancer, sepsis, acute respiratory distress, and sleep apnea, among other diseases.

About DetermaVu

DetermaVu is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant. OncoCyte estimates that a $2 billion to $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on the scope of physician utilization, market penetration and reimbursable pricing.

DetermaVu has the potential to dramatically reduce U.S. healthcare costs by billions of dollars each year by eliminating unnecessary biopsies, which, according to a study of Medicare data by an independent health economics firm, cost on average $14,634 each. In addition, DetermaVu can provide great benefit to patients by avoiding invasive biopsies and the complications that arise in up to 24% of those procedures, and deaths that occur in up to 1% of cases.

DetermaVu is a trademark of OncoCyte Corporation