Nicox Third Quarter 2018 Business Update and Financial Highlights

On October 17, 2018 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported its upcoming milestones and operational highlights, as well as revenue and cash position for Nicox and its subsidiaries (the "Nicox Group") as of September 30, 2018 (Press release, NicOx, OCT 17, 2018, View Source [SID1234530253]).

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Key Upcoming Milestones
Q1 2019: Planned Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) for NCX 4251 to enable a Phase 2 clinical study1 in patients with acute exacerbations of blepharitis.
Q1 2019: Expected delivery of ZERVIATETM (cetirizine ophthalmic solution), 0.24% commercial product to partner Eyevance Pharmaceuticals LLC, followed by a commercial launch in the U.S. planned for the spring 2019 allergy season.
H2 2019: Expected top-line data from the NCX 470 Phase 2 clinical study for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Third Quarter 2018 and Recent Operational Highlights
In September 2018, Nicox and Fera Pharmaceuticals amended their 2015 agreement granting Fera exclusive rights to develop and commercialize naproxcinod for the U.S. market. The development of naproxcinod will focus on an undisclosed rare disease for which Fera expects to apply for an Orphan Drug Designation from the FDA. Nicox will be eligible to potentially receive a single $40 million sales-based milestone if naproxcinod reaches $1 billion yearly sales (for any indication) in the U.S. Royalties remain at 7% of net sales of naproxcinod in the U.S. Fera remains responsible for all clinical development, manufacturing, regulatory, and commercialization activities.
In Q3 2018, our lead product candidate NCX 470, a novel second generation nitric oxide (NO)-donating prostaglandin analog entered Phase 2 clinical study to evaluate its efficacy and safety compared to latanoprost 0.005% for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension and to select the optimal Phase 3 dose. The study is expected to randomize 420 patients in clinical sites across the U.S. Top-line data are expected in the second half of 2019.
Third Quarter 2018 Financial Highlights
As of September 30, 2018, the Nicox Group had cash and cash equivalents of €25.7 million as compared with €32.7 million at June 30, 2018 and €41.4 million at December 31, 2017. Net revenue2 for the third quarter of 2018 was $0.438 million, comprised exclusively of royalties on third quarter 2018 sales of VYZULTATM by global partner Bausch + Lomb, after deduction of royalty payments due by Nicox. This represents an increase of 66% in net revenue3 received by Nicox compared to the second quarter of 2018. The Nicox Group recorded no revenues for the third quarter of 2017.

Intensity Therapeutics to Present Preliminary Data from Clinical Study of INT230-6 at Upcoming Medical Conferences

On October 17, 2018 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary immune cell-activating cancer treatments, reported that preliminary data from a Phase 1/2 clinical study of INT230-6 will be presented in poster sessions at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, which is being held October 19-23 in Munich, Germany, and the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, which is being held November 7-11 in Washington, DC (Press release, Intensity Therapeutics, OCT 17, 2018, View Source [SID1234530320]).
Details of the posters are below.

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ESMO 2018 Congress

Title: Phase 1/2 trial evaluation of intratumoral INT230-6 for the treatment of solid tumors

Abstract Number: 4458

Presentation Number: 1160P

Session: Poster Display Session – Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)

Date/Time: October 20, 2018, 12:30 p.m. CEST

Location: Hall A3; Poster Area Networking Hub, ICM München

Presenter: Anthony El-Khoueiry, MD (University of Southern California, USA)

For more information about the ESMO (Free ESMO Whitepaper) 2018 Congress, please visit View Source

SITC Annual Meeting

Title: Phase 1/2 evaluation of intratumoral INT230-6 for the treatment of solid tumors

Poster Number: P622

Poster Hall Hours: November 9, 8 a.m.-8 p.m.; November 10, 8 a.m.-8:30 p.m. EST

Poster Presentation Hours: November 10, 12:20-1:50 p.m. and 7-8:30 p.m. EST

Poster Hall Location: Hall E; Walter E. Washington Convention Center

Presenter: Anthony Olszanski, MD, RPh (Fox Chase Cancer Center)

For more information about the SITC (Free SITC Whitepaper) Annual Meeting, please visit View Source

About INT230-6

INT230-6, Intensity’s lead product candidate designed for direct intratumoral injection, is comprised of two proven, potent anti-cancer agents and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers. In mouse models, INT230-6 has shown strong synergy with checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was discovered from Intensity’s DfuseRxSM platform.

About the Phase 1/2 Clinical Study

INT230-6 is being evaluated in a Phase 1/2 clinical study in patients with different types of advanced solid tumor malignancies. The study’s primary objective is to assess the safety and tolerability of multiple intratumoral doses of INT230-6. Secondary assessments are the measurement of injected and bystander tumor responses, and determination of the systemic pharmacokinetic profile of multiple doses of INT230-6’s drug substances after single and then multiple intratumoral injections. Exploratory analysis will characterize patient outcome, as well as evaluate various tumor and anti-tumor immune response biomarkers that may correlate with response. The study includes several adaptive components that will allow for adjustments in patient groups, dosing schedule and dose volumes administered. Data will be used to assess the progression free and overall survival in patients receiving INT230-6. For more information, please visit www.clinicaltrials.gov (NCT03058289).

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.

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"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.

TAPIMMUNE AND MARKER THERAPEUTICS ANNOUNCE SUCCESSFUL CLOSING OF
PREVIOUSLY ANNOUNCED MERGER AND FINANCING

On October 17, 2018 TapImmune Inc. (NASDAQ: TPIV), reported the closing of the previously announced merger with privately-held Marker Therapeutics, Inc. In connection with the merger, TapImmune Inc. changed its name to Marker Therapeutics, Inc., and reincorporated from Nevada into Delaware (Press release, TapImmune, OCT 17, 2018, View Source [SID1234530399]). The combined company will focus on the continued development and commercialization of T cell therapies. Beginning Thursday, October 18, 2018, the Company’s stock will begin trading under the new ticker symbol "MRKR" on the Nasdaq Capital Market and will have a new CUSIP number, 57055L 107.

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"The closing of this merger marks a significant milestone, since the combined company is well-positioned to become a leader in cancer immunotherapy, with potentially transformative therapies," said Peter L. Hoang, CEO of Marker Therapeutics, Inc. "The combined company will have exponentially superior capabilities and resources than either company had alone. With the transaction completed, we can now push our clinical trials forward more efficiently with the full resources available to the combined company. We are confident that our therapies can fundamentally improve therapeutic outcomes for patients with life-threatening diseases, and drive life-changing results for patients suffering from a variety of terrible cancers."

Mr. Hoang continued, "In connection with the merger, we welcome to our Board of Directors, John Wilson, Dr. Juan Vera and David Eansor, whose participation and future contributions will enhance the future prospects of the combined company."

"This merger provides Marker’s unique and highly promising T cell therapies with an excellent combination of financial support, management capacity, and scientific expertise that is expected to expedite a fundamental change in the lives of cancer patients," said John Wilson, CEO of the former Marker Therapeutics, Inc., which changed its name to Marker Cell Therapy, Inc. in connection with the merger. "Our belief that this merger provides the best path forward has been reinforced by events surrounding the transaction, including the significant capital contribution made by highly discerning healthcare investors, led by New Enterprise Associates, the exclusive license with Baylor College of Medicine that will allow us to leverage the vast capabilities of their Center for Cell and Gene Therapy going forward, and by the willingness of Dr. James Allison (2018 Nobel Prize of Medicine recipient) and Dr. Padmanee Sharma (2018 Coley Award in Tumor Immunology recipient) to join our internationally acclaimed founders (Drs. Malcolm Brenner, Cliona Rooney, and Helen Heslop) on Marker’s Scientific Advisory Board."

As a result of the merger, 13,914,255 shares of common stock of the Company, and warrants to purchase 5,046,003 shares of common stock at an exercise price of $2.99 per share with a five-year term, were issued to the prior stockholders of the former Marker Therapeutics, Inc., which will become a subsidiary of the combined company and renamed Marker Cell Therapy, Inc.

Concurrent with the merger, the Company closed on the previously announced private placement financing (the "Financing"). The aggregate offering size, before deducting the placement agent fees and other offering expenses, was $70 million. The Company issued 17,500,000 shares of its common stock and issued warrants to purchase 13,125,000 shares of common stock at an exercise price of $5.00 per share that will be exercisable for a period of five years. The closing of the merger and the Financing were subject to the approval of TapImmune’s stockholders as required by NASDAQ Stock Market Rules. TapImmune’s stockholders approved the issuance of the merger and Financing shares and warrants at TapImmune’s annual meeting which occurred on October 16, 2018.

The Financing proceeds will be used to advance the combined company’s novel T cell therapies into multiple Phase 2 clinical studies, build out infrastructure to support clinical and manufacturing capabilities, and other corporate and general purposes.

Piper Jaffray & Co. served as sole lead placement agent for the private placement, and Nomura Securities International, Inc. served as co-placement agent and exclusive financial advisor in conjunction with the merger.

The securities issued in the merger and sold in the Financing (together the "Securities") have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the Securities and Exchange Commission covering the resale of the Securities, including the shares of common stock issuable upon exercise of the warrants. If any of the Securities are unable to be included on the initial registration statement, the Company has agreed to file subsequent registration statements until all the Securities have been registered.

As a result of the closing of the merger and the Financing, the former Marker stockholders, after taking into account the issuance of shares in the Financing occurring concurrently with the merger, now own, on a fully-diluted basis (assuming the exercise of all outstanding warrants and options), approximately 27.5%, and TapImmune’s current stockholders now own approximately 27.5%, of the Company’s common stock.

Frederick Wasserman, who was appointed Chairman of Marker’s Board upon closing of the merger said, "The completion of the merger and financing provide a strong foundation for Marker’s future growth initiatives. We are now better positioned to develop new therapies for patients and create value for our shareholders." Mr. Wasserman continued and noted, "We look forward to working with our three new directors who are joining our Board. We also wish to recognize our former board members who left the Board in connection with the merger (Glynn Wilson, Sherry Grisewood, Mark Reddish and Joshua Silverman) for their many contributions in helping the Company reach this milestone event."

The Company will be relocating its corporate headquarters to Houston, Texas to facilitate its collaboration with the research team at the Baylor College of Medicine. In conjunction with its move, the Company plans to open a facility in Houston to conduct its operations and oversee its clinical trials.

President & Chief Executive Officer Peter L. Hoang, accompanied by the senior management team and Board of Directors, will ring the Nasdaq Closing Bell to mark the end of trading for today, October 17th.

The ceremony, which will take place between 3:45 p.m. and 4:15 p.m. Eastern Time, will stream live online at View Source

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.