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Blue Earth Diagnostics Announces Fluciclovine F 18 Research Presentations at Upcoming ASTRO Annual Meeting

On October 17, 2018 Blue Earth Diagnostics, a molecular imaging diagnostics company, reported that oral and poster presentations related to the clinical use of fluciclovine F 18 injection will be occurring at the 2018 American Society for Radiation Oncology (ASTRO) Annual Meeting, from October 21 – 24, 2018 in San Antonio, Texas (Press release, Blue Earth Diagnostics, OCT 17, 2018, View Source [SID1234529951]).

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Some of the oral and poster presentations listed below highlight investigational uses of fluciclovine F 18. 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. Presentations noted by "*" describe investigational uses of fluciclovine F 18 for which the safety and efficacy have not been established.

Sunday, October 21, 2018

ePoster Discussions

Session Title: GU 1 – ePoster Discussion – New Data on PET, MRI and Protons for Treating Prostate Cancer
Presentation Title:
Positive Findings on 18F-fluciclovine PET/CT in Patients with Suspected Recurrent Prostate Cancer and PSA levels ≤0.5 and ≤0.3 ng/ml

Presenter: Petra Lovec, MD, Loyola University Medical Center
Presentation Number: 1001
Presentation Time: 1:21 – 1:27 p.m. CT
Location: Room 217 A/B

Session Title: GU 1 – ePoster Discussion – New Data on PET, MRI and Protons for Treating Prostate Cancer
Presentation Title:
The Impact of 18F-Fluciclovine Positron Emission Tomography on Salvage Radiation Therapy Decisions for Patients with Post-Radical Prostatectomy Recurrence of Prostate Cancer: Results from LOCATE

Presenter: Abhishek Solanki, MD, MS, Loyola University Medical Center
Presentation Number: 1000
Presentation Time: 1:15 – 1:21 p.m. CT
Location: Room 217 A/B

Poster Viewings

Session Title: Poster Viewing Q&A 1
Presentation Title:
Application of 18-F Fluciclovine PET/CT in Guiding Salvage Radiation Therapy for Recurrent Prostate Cancer*

Presenter: Jalal Ahmed, MD, PhD, BS, Icahn School of Medicine at Mt Sinai
Session Time: 1:15 – 2:45 p.m. CT
Location: Innovation Hub, Exhibit Hall 3
Presentation No.: SU_22_2227

Tuesday, October 23, 2018

Poster Viewings

Session Title: Poster Viewing Q&A 3
Title:
Design and Evaluation of a Semi-Automated Algorithm for Segmentation of Anti-[18F]FACBC (Fluciclovine F18] PET Images for Post-Prostatectomy Radiation Therapy*

Presenter: Eduard Schreibmann, PhD, DABR, Emory University
Presentation Time: 1:00 – 2:30 p.m. CT
Location: Innovation Hub, Exhibit Hall 3
Presentation No.: TU_20_3312

Blue Earth Diagnostics invites participants at the 2018 ASTRO Annual Meeting to visit the company at Exhibit Booth 2163. The company is also hosting an Industry-Expert Theater event, "Detecting and Localizing Recurrent Prostate Cancer with Axumin (Fluciclovine F 18) Injection," with invited speaker Dr. Rodney Ellis, MD FACRO, Vice Chairman, Strategic Affairs, Radiation Oncology, University Hospital Cleveland Medical Center, Associate Professor, Radiation Oncology and Urology, Case Western Reserve University School of Medicine, Cleveland, Ohio, which will be held on Sunday, October 21, 2018, from 12:15 – 1:15 p.m. CT, in Theater 1, Innovation Hub.

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 Axumin (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 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. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications, such as glioma.

Foundation Medicine Announces Strategic Collaboration with Major Pharmaceutical Company

On October 17, 2018 Foundation Medicine, Inc. reported a strategic collaboration with Novartis allowing the development of companion diagnostic (CDx) tests for the Novartis portfolio of targeted oncology and immuno-oncology therapeutics (Press release, Foundation Medicine, OCT 17, 2018, View Source [SID1234529950]). The collaboration structure allows for multiple therapy programs and includes development, regulatory support and commercialization of CDx tests for inclusion on FoundationOne CDx. FoundationOne CDx is Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors that incorporates multiple companion diagnostics.

"It is imperative that we collaborate with all of the key stakeholders in oncology to accelerate patient access to personalized medicine," said Melanie Nallicheri, chief business officer and head of biopharma at Foundation Medicine. "Novartis shares this mission and we look forward to working with them to develop companion diagnostics across multiple therapies. This collaboration reaffirms our commitment to expedite biomarker-driven development and ultimately bring more personalized treatment options to patients."

The agreement also allows for global expansion in ex-US markets including Japan, where in partnership with Chugai, Foundation Medicine has submitted FoundationOne CDx for regulatory approval from the Ministry of Health, Labour and Welfare (MHLW). If approved in Japan, FoundationOne CDx would enable access to MHLW-approved targeted therapies and immunotherapies, as well as clinical trials, for patients with cancer in Japan.

Iovance Biotherapeutics, Inc. Announces Closing of $252 Million Common Stock Public Offering

On October 17, 2018 Iovance Biotherapeutics, Inc. (Nasdaq:IOVA) ("Iovance" or "Company"), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported the closing of an underwritten public offering of 25,300,000 shares of its common stock at a public offering price of $9.97 per share (Press release, Iovance Biotherapeutics, OCT 17, 2018, View Source;p=irol-newsArticle&ID=2372014 [SID1234529946]). The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance, are approximately $252.2 million. The shares of common stock issued and sold in the offering include 3,300,000 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price, less the underwriting discounts and commissions.

Iovance intends to use the proceeds from this offering to fund the expansion of its organization to support the potential commercial launch of lifileucel, to fund its commercial manufacturing capabilities and facilities, to fund its ongoing clinical trials for its current product candidates, including its on-going Phase 2 clinical trials of LN-144, TIL for the treatment of metastatic melanoma, and LN-145, TIL for the treatment of cervical and head and neck cancers, to fund its planned clinical trials for its current product candidates, including its ongoing Phase 2 clinical trial of LN-145 for the treatment of non-small cell lung cancer, or NSCLC, in collaboration with MedImmune, and its ongoing Phase 2 clinical trials of Iovance TIL as an early-line therapy alone or in combination with pembrolizumab in melanoma, head and neck cancer, and NSCLC, and for other general corporate purposes. Additional indications may be explored with the use of proceeds.

Jefferies LLC acted as sole book-running manager for the offering.

The shares of common stock described above were offered by Iovance pursuant to its shelf registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (the "SEC"). The offering has been made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at View Source A final prospectus supplement and accompanying prospectus was filed with the SEC, copies of which may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor New York, New York, 10022, by telephone at (877) 821-7388, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

ArQule to Report Third Quarter 2018 Financial Results on October 31, 2018

On October 17, 2018 ArQule, Inc. (Nasdaq: ARQL) reported it will report financial results for the third quarter of 2018 before the market opens on Wednesday, October 31, 2018 (Press release, ArQule, OCT 17, 2018, View Source [SID1234529945]). The Company will hold a conference call and webcast on the same day at 9:00 a.m. ET to discuss these results and provide a general business update.

The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events & Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events and Presentations."

Onconova Therapeutics Announces Issuance Of A New U.S. Patent For Rigosertib

On October 17, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported that the United States Patent and Trademark Office issued a new patent protecting the company’s lead product candidate, Rigosertib (Press release, Onconova, OCT 17, 2018, View Source [SID1234529944]). U.S. patent 10,098,862 "Formulations with enhanced stability and bioavailability for administration of (E)-2, 6-Dialkoxystyryl 4-Substituted Benzyl Sulfones" describes novel compositions directed towards improving stability and enhancing bioavailability of Rigosertib. The issued patent claims novel formulations for oral and parenteral administration and oral dosing regimens of Rigosertib for the treatment of cancer and proliferative disorders.

"Rigosertib is well protected by issued US and foreign patents as well as by Orphan Designation in the U.S., Europe, and Japan. We remain focused on our broader IP strategy that provides additional barriers to entry and expanded geographical coverage for our lead product candidate, which is in advanced clinical trials for unmet medical needs of patients with Myelodysplastic Syndromes," commented, Ramesh Kumar, Chief Executive Officer of Onconova. "Ensuring multi-faceted intellectual property protection around Rigosertib helps enhance the potential value of this innovative program."

U.S. patent 10,098,862 complements and adds to coverage provided by previously issued Composition of Matter patent U.S. 7,598,232 and its international counterpart patents and patent applications, including Rigosertib drug combination patents. While previous patents cover compositions, methods, formulations and other aspects of utility, the new patent provides additional coverage related to an oral dosing regimen of Rigosertib. The novel formulation patent was filed in 2017 as a PCT application globally and as National Phase applications in the U.S. and in Non-PCT countries including Taiwan and various countries in Latin America.

The named inventor of the patented technology is Dr. Manoj Maniar, Senior Vice President of Product Development for Onconova. The patent was filed by and is assigned to the Company.