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.

On November 13, 2018 Onconova Therapeutics, Inc. (Nasdaq: ONTX), a Phase 3 stage biopharmaceutical company focused on developing rigosertib, a novel small molecule drug candidate to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported financial results for the third quarter of 2018, ended September 30, 2018 (Press release, Onconova, NOV 13, 2018, View Sourcenews-releases/news-release-details/onconova-therapeutics-announces-business-highlights-and" target="_blank" title="View Sourcenews-releases/news-release-details/onconova-therapeutics-announces-business-highlights-and" rel="nofollow">View Source [SID1234531245]).

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"During the third quarter, we strengthened our intellectual property for rigosertib by expanding the geographical coverage of our patents and extending patent protection to 2037. We also completed a 1-for-15 reverse split of our common stock in order to regain compliance with Nasdaq’s requirements," stated Dr. Ramesh Kumar, Chief Executive Officer. "These accomplishments, combined with the $28.75 million financing completed in May, position us to drive toward many near-term value-inflection points and business development opportunities."

Steven M. Fruchtman, M.D., President of Onconova, said, "As we continue enrollment toward our target of 360 randomized patients in our Phase 3 INSPIRE trial with intravenous rigosertib, the safety and efficacy data from an expanded Phase 2 trial of oral rigosertib in combination with azacitidine will be presented at an oral session on MDS at the 2018 ASH (Free ASH Whitepaper) conference. We are advancing this combination for HMA naïve higher-risk MDS patients toward a Phase 3 trial protocol under the Special Protocol Assessment (SPA) process in the fourth quarter of 2018."

Third Quarter and Recent Highlights

Richard Woodman, M.D., most recently Senior Vice President and Head of U.S. Oncology Clinical Development and Medical Affairs for Novartis, joined Onconova on November 5, 2018, as Chief Medical Officer and Senior Vice President of Research & Development. In this role, Ric’s expertise will help optimize the development of rigosertib for patients with unmet medical needs in MDS and cancer.

A new composition of matter patent, No. 10,098,862, covering oral and IV formulations of rigosertib, was issued by the United States Patent and Trademark Office in October. This new patent extends protection for the Company’s lead product candidate, rigosertib, to 2037. Foreign equivalent patents are in process, and once issued, will expand the geographical coverage for rigosertib.

In September, Onconova effected a 1-for-15 reverse split of its common stock aimed at continued compliance with Nasdaq’s requirements. The reverse split also enhances the investment opportunity in Onconova among a broader group of investors.

Four abstracts relating to the Company’s lead product candidate, rigosertib, were accepted for presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in San Diego, California, taking place December 1-4, 2018. On Saturday, December 1, Dr. Shyamala Navada, Assistant Professor, Medicine, Hematology and Medical Oncology at the Icahn School of Medicine at Mount Sinai in New York, on behalf of her co-investigators, will present data from the expanded Phase 2 trial of rigosertib plus azacitidine combination. Two additional presentations will highlight the PK/PD and safety clinical data from patients treated with this combination therapy, and the fourth will demonstrate a biomarker to predict a response to rigosertib.

Onconova’s novel CDK4/6+ARK5 inhibitor ON 123300 is now in an advanced pre-IND stage with expected IND filing in the first half of 2019. This program is partnered in Greater China with the Company’s development partner HanX Biopharmaceuticals.
Upcoming Milestones

Based on end-of-Phase 2 meetings with the FDA and updated data from the expanded trial, Onconova expects to file a Phase 3 protocol under the Special Protocol Assessment (SPA) process. This filing will be followed by similar submissions in Europe and Japan (the latter by Onconova’s Japan/Korea partner, SymBio). After the SPA process is completed, the pivotal trial for the combination product for front-line (HMA naïve) higher-risk MDS patients is ready to be initiated, with additional funding from financing and/or business development activities.

For the pivotal Phase 3 INSPIRE study, target enrollment is 360 randomized patients and the Company continues to project completion in the second half of 2019. Top-line data will be available after 288 death events.

The RASopathies program is advancing under a CRADA with the National Cancer Institute. The NCI is carrying out PK/PD and dose escalation studies in preclinical models to prepare for dosing of pediatric patients with single agent rigosertib. A clinical trial protocol concept has been developed and is under review. Based on NCI guidance, the Company expects the first patient to be treated in the first half of 2019.

Rigosertib studies alone or in combination with immuno-oncology agents in solid tumors driven by RAS mutations are in development.

IND filing for Dual CDK 4/6 + ARK5 inhibitor ON 123300 (IND studies funded by HanX Biopharmaceuticals) is expected to be submitted in the first half of 2019.
Third Quarter 2018 Financial Results

Cash and cash equivalents at September 30, 2018, totaled $22.4 million, compared to $4.0 million at December 31, 2017.

Net loss was $5.3 million for the third quarter ended September 30, 2018, compared to a net loss of $7.0 million for the third quarter ended September 30, 2017. Research and development expenses were $4.0 million for the third quarter ended September 30, 2018, and $5.1 million for the comparable period in 2017. General and administrative expenses were $1.7 million for the third quarter ended September 30, 2018, and $1.7 million for comparable period in 2017.

Net loss was $14.8 million for the nine months ended September 30, 2018, compared to a net loss of $17.9 million for the nine months ended September 30, 2017.

The Company will host a conference call today at 9:00 a.m. Eastern Time to provide a corporate update and discuss third quarter 2018 financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the U.S., or (210) 229-8823 internationally, and using conference ID: 3355668. The call will also be webcast live. Please visit the Investor Relations page of the Company’s website at View Source to access the webcast. A replay will be available for 90 days.