On November 14, 2018 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development and commercialization of female-specific oncology products, reported the acceptance of three posters for presentation at the 2018 San Antonio Breast Cancer Symposium (SABCS) (Press release, Sermonix Pharmaceuticals, NOV 14, 2018, View Source [SID1234532257]). The accepted presentations demonstrate Sermonix’s continued momentum toward realizing the potential of its lead investigational drug, lasofoxifene, as an oral targeted treatment for women with ESR1 mutations in metastatic breast cancer.

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The Dec. 4-8 meeting at the Henry B. Gonzalez Convention Center in San Antonio will include the following posters:

An open-label, randomized, multi-center Phase 2 study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic ER+/HER2 – breast cancer (MBC) with an ESR1 mutation
Presenting author Matthew Goetz, M.D., Mayo Clinic
Poster Session OT (OT1-01-02); Wed., Dec. 5, 5pm-7pm
A preliminary assessment of knowledge, attitudes, and awareness surrounding ESR1 mutations and biomarker testing amongst medical oncologists
Presenting author Shari Goldfarb, M.D., Memorial Sloan Kettering Cancer Center
Poster Session 5 (PD5-11-11); Fri. Dec. 7, 5pm-7pm

Spotlight Session

Lasofoxifene decreases breast cancer lung and liver metastasis in a mammary intraductal (MIND) xenograft model of mutant ER-alpha+ breast cancer
Presenting author Muriel Lainé, Ph.D., University of Chicago
Poster Session 7 (PD7-09); Fri., Dec. 7, 7am-9am
One poster introduces a Phase 2 trial of oral lasofoxifene, evaluating its activity versus intramuscular fulvestrant for the treatment of postmenopausal women who have locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 (estrogen receptor gene) mutation. Another poster, selected for a spotlight session on endocrine resistance, is Sermonix-sponsored research from the University of Chicago Ben May Department for Cancer Research in a MIND xenograft model of mutant ER+ breast cancer. The third poster will share results of a study on medical oncologists’ knowledge, awareness and perceptions of precision medicine and liquid biopsy biomarker testing specific to breast cancer and ESR1 mutations.

"Lasofoxifene’s potency and newly discovered activity in ESR1 mutations may hold promise for patients who have acquired resistance in an area of significant unmet medical need," said David Portman, M.D., Sermonix founder and chief executive officer. "We look forward to presenting exciting data at this year’s San Antonio Breast Cancer Symposium as we move lasofoxifene forward as a targeted therapy for women with advanced breast cancer."

"Clinical data have shown a significant reduction in the incidence of ER+ breast cancer in postmenopausal women with osteoporosis who were treated with lasofoxifene," said Paul Plourde, M.D., Sermonix vice president of clinical development. "Further non-clinical and clinical study results provide a strong rationale for pursuing a Phase 2 clinical trial comparing lasofoxifene to fulvestrant, a current widely used injectable medication for advanced breast cancer."

"Lasofoxifene’s ability to reduce primary tumor weights and inhibit metastasis of ER-mutated breast cancer xenografts in a mouse mammary intraductal (MIND) model was reported at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June this year," said Geoffrey Greene, Ph.D., chair of the Ben May Department for Cancer Research and co-director of the Ludwig Center for Metastasis Research at the University of Chicago. "We look forward to sharing new data on lasofoxifene’s impact on lung and liver metastases in breast cancer xenografts that express mutant ER."

Muriel Lainé, a senior research professional in Greene’s lab, will serve as presenting author for the Spotlight Session in San Antonio.

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 women worldwide.

Lasofoxifene’s binding affinity and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered and Sermonix has exclusive rights to develop and commercialize it in this area. A potent, well-characterized and bioavailable SERM, lasofoxifene, if approved, could play a critical role in the personalized treatment of advanced ER+ breast cancer.

On November 14, 2018 Blue Earth Diagnostics, a molecular imaging diagnostics company, reported that a presentation related to the clinical use of 18F-fluciclovine in adults with glioma will be occurring at the upcoming Society for Neuro-Oncology (SNO) Annual Scientific Meeting, being held November 15 – 18, 2018 in New Orleans, La (Press release, Blue Earth Diagnostics, NOV 14, 2018, View Source [SID1234531313]). Blue Earth Diagnostics is investigating the potential use of 18F-fluciclovine in adults for the detection and continuing assessment of glioma.

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The presentation listed below highlights the investigational use of 18F-fluciclovine, as an adjunct to magnetic resonance imaging (MRI), in adults with glioma.

Friday, November 16, 2018

Session Type: Poster Session
Session Title:

A Blinded Image Evaluation Study to Determine the Diagnostic Efficacy of 18F- fluciclovine PET, as an Adjunct to MRI Imaging, in Adults with Glioma

Presenter: Matthew P. Miller, PhD, Blue Earth Diagnostics
Poster Number: NIMG-01
Abstract ID: 506064
Presentation Time: 7:30 – 9:30 p.m. CT

Axumin (fluciclovine F 18) injection is FDA-approved for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. The safety and efficacy of 18F-fluciclovine PET imaging in glioma have not been established.

U.S. Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at www.axumin.com.

About 18F-fluciclovine PET in Glioma

18F-fluciclovine PET is a diagnostic imaging radiopharmaceutical for PET imaging that consists of a synthetic amino acid labeled with the radioisotope F 18, enabling the visualization of the increased amino acid transport that occurs in malignant tumors. 18F-fluciclovine, under the trade name Axumin, is approved by the U.S. Food and Drug Administration (FDA) for PET imaging in men with biochemically recurrent prostate cancer. It is also under investigation by Blue Earth Diagnostics for use in adults for the detection and continuing assessment of glioma. 18F-fluciclovine has been granted Orphan Drug status by both the FDA and the European Medicines Agency for the diagnosis of glioma. The compound was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences.

About Glioma

Glioma, the most commonly occurring type of primary brain tumor, is a serious and life-threatening condition. Cancer of the brain and central nervous system (CNS) is the twelfth most common cause of cancer death worldwide. Glioma accounts for about 25% of all brain tumors, and 80% of all malignant brain tumors. The most aggressive form of glioma, glioblastoma multiforme, is associated with significant morbidity and mortality with relatively low 5-year survival estimates after diagnosis. Current treatment options for patients with glioma include surgery, radiation and chemotherapy. Accurate evaluation of the location and extent of a glioma tumor is essential before or during surgery and radiotherapy and in assessing the continuing status of the disease. The detection and assessment of gliomas typically involves magnetic resonance imaging (MRI), which may be complemented by metabolic imaging using an appropriate amino acid-based PET radiopharmaceutical, as recommended in the Response Assessment in Neuro-Oncology (RANO) working group and European Association for Neuro-Oncology (EANO) guidelines.1

On November 14, 2018 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the third quarter ended September 30, 2018 (Press release, Cleveland BioLabs, NOV 14, 2018, View Source [SID1234531430]).

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Cleveland BioLabs reported a net loss of $(1.1) million, excluding minority interests, for the third quarter of 2018, or $(0.10) per share, compared to a net loss, excluding minority interests, of $(1.26) million, or $(0.11) per share, for the same period in 2017. The decrease in net loss was primarily due to a decrease in the non-cash adjustment to our warrant liabilities, reduced operating costs aligned with our streamlined focus primarily on pursuing a pre Emergency Use Authorization with the U.S. Food and Drug Administration ("FDA") for entolimod as a medical radiation countermeasure partially offset by an increase in General and Administrative costs related to the corporate formation of Genome Protection, Inc. (GPI), our joint venture with Everon Biosciences, Inc. focused on developing anti-aging medications.

As of September 30, 2018, the Company had $5.3 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund operations for at least one year beyond the filing date of our Form 10-Q.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The development, pursuit of regulatory approval and commercialization for entolimod as a medical radiation countermeasure remains our top priority."

Further Financial Results

Revenue for the third quarter of 2018 decreased to $0.28 million compared to $0.3 million for the third quarter of 2017. The net decrease was primarily attributable to decreased revenue from our Joint Warfighter Medical Research Program ("JWMRP") contract from the Department of Defense ("DoD") for the continued development of the entolimod as a medical radiation countermeasure and decreased revenue from our service contract with Incuron.

Research and development costs for the third quarter of 2018 decreased to $0.8 million compared to $0.9 million for the third quarter of 2017. The reduction in research and development costs is due to a $0.2 million reduction in spending for biodefense applications of entolimod and a $0.1 million reduction in spending on Panacela’s product candidates partially offset by a $0.2 million increase in expenses related to the oncology applications of the entolimod family of compounds.

General and administrative costs for the third quarter of 2018 increased to $0.7 million compared to $0.6 million for the third quarter of 2017. This increase was primarily attributable to one-time legal costs associated with the corporate formation of GPI and Norma Investments Limited’s investment in GPI, and expense related to a one-time settlement for the previously completed research contracts with the Russian Ministry of Trade.

On November 14, 2018 Agilent Technologies Inc. (NYSE: A) reported it has completed the acquisition of ACEA Biosciences Inc. (ACEA), a developer of cutting-edge cell analysis tools, for $250 million in cash (Press release, Agilent, NOV 14, 2018, View Source [SID1234531314]). This acquisition brings together two pioneers in cellular function and metabolism measurements focused on real-time, live cell analyses.

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ACEA has developed two ground-breaking platforms that are complementary to Agilent’s current portfolio. The ACEA xCELLigence RTCA technology is a unique impedance platform for label-free, real-time cellular function measurements used in immuno-oncology, pre-clinical drug discovery and development, as well as in basic academic research. This technology is complemented by the introduction in recent years of the NovoCyte and NovoCyte Quanteon portfolio of high performance bench top flow cytometry systems.

ACEA also markets a clinical configuration of the NovoCyte platform, currently commercialized in China. This provides a unique opportunity in combination with Agilent’s Reagent Partnership business within Agilent’s Diagnostics and Genomics Group which provides reagents for flow cytometry.

"The Agilent and ACEA teams are united by a common goal to provide the most innovative high-performance solutions for cell analysis," said Todd Christian, Vice President & General Manager of Agilent’s Cell Analysis Division. "We are excited for the opportunities we have as a newly combined team to provide the most advanced tools for scientists performing cell analysis workflows."

ACEA is Agilent’s second acquisition this year in the cell analysis space. In January, Agilent acquired Luxcel Biosciences, a developer of real-time fluorescence plate-reader based in vitro cell assay kits. Cell analysis is a key area of strategic focus for Agilent.

ACEA was founded in 2002 and has its headquarters in San Diego and a large manufacturing and R&D footprint in Hangzhou, China. More than 2,500 ACEA instruments have been placed globally and have been used in more than 1,800 peer-reviewed publications.

On November 14, 2018 Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage biopharmaceutical company developing innovative therapies to improve outcomes in cancers that are difficult to treat, reported that Douglas J. Swirsky, who has served as Rexahn’s president and chief financial officer since January 2018, has been named the company’s president and chief executive officer and appointed to the company’s board of directors effective immediately (Press release, Rexahn, NOV 14, 2018, View Source [SID1234531477]). Peter D. Suzdak, Ph.D., chief executive officer, has departed the company and resigned as a member of its board of directors.

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"On behalf of the board and everyone at Rexahn, I want to thank Peter Suzdak for his contributions to the company over the past six years," said Peter Brandt, chairman of the board of directors. "The board is confident that Doug has the experience and creativity to deliver on the promise of Rexahn’s innovative pipeline and lead the company forward through substantial value-creating milestones."

"I am excited about the future of Rexahn and believe significant opportunities exist to transform Rexahn into an industry-leading, cancer-focused company. I look forward to working with the board, the executive team and all stakeholders to achieve this goal," said Mr. Swirsky.

Prior to joining Rexahn, Mr. Swirsky was CEO and a director of GenVec, Inc., a publicly traded biotechnology company, a position he held from 2013 through the sale of the company in 2017. He also served as GenVec’s CFO from 2006 until he assumed the role of CEO in 2013. Prior to joining GenVec, Mr. Swirsky was a managing director and the head of life sciences investment banking at Stifel Nicolaus from 2005 to 2006 and held investment banking positions at Legg Mason from 2002 until Stifel Financial’s acquisition of the Legg Mason Capital Markets business in 2005. He has also previously held investment banking positions at UBS, PaineWebber and Morgan Stanley. Mr. Swirsky currently serves on the board of directors of Fibrocell Science, Inc., Cellectar Biosciences, Inc. and Pernix Therapeutics Holdings, Inc. He is a certified public accountant and a CFA charter holder. He received his B.S. in Business Administration from Boston University and his M.B.A. from the Kellogg School of Management at Northwestern University.

Mr. Swirsky will also continue to serve as the company’s principal financial officer.