Spherix Provides Video Demonstration of CBM Drug Reversing Paralysis in Preclinical Study

On October 17, 2018 Spherix Incorporated (Nasdaq: SPEX) today provided shareholders with a video demonstration on its website of the potential effectiveness of CBM BioPharma, Inc.’s ("CBM) innovative drug platform (Press release, Spherix, OCT 17, 2018, View Source [SID1234538989]). As previously disclosed on October 11, 2018, Spherix entered into a merger agreement with CBM, a privately held innovative pharmaceutical company focused on the development of drugs in the multibillion-dollar oncology therapeutics market . The notable video, which was recorded at Wake Forest University, visually demonstrates the potential effectiveness of one of CBM’s primary drug candidates known as KPC34. Researchers at Wake Forest have been testing whether KPC34 can be used on mouse subjects to treat Acute Lymphoblastic Leukemia (ALL) that has spread to the nervous system. Once recurrent ALL spreads to the nervous system, patients often experience paralysis.

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In the video, a mouse which suffers from hind leg paralysis as a result of recurrent late staged ALL is shown to improve dramatically from the paralysis within forty-eight hours of being treated with KPC34. Within just twenty-four hours of the first injection of KPC34, the mouse could walk. Forty-eight hours later a second injection was administered and the mouse was able to move about without challenges.

Anthony Hayes, CEO of Spherix, stated, "This remarkable video demonstrates the tremendous potential for this drug to treat ALL. The video was part of a written submission on KPC34 to PLOS OneTM a peer reviewed medical journal. We are collecting additional information to continually provide our shareholders with updates to help better educate them on these compounds and the biotechnology space generally. We anticipate further updates in the future."

Invenra Secures $7M in Series B Growth Round to Accelerate Bispecific Antibody Development

On October 17, 2018 Invenra, an antibody drug discovery and development company with novel multispecific platforms and product candidates, reported the close of a $7M Series B financing round (Press release, Invenra, OCT 17, 2018, View Source [SID1234570587]). The financing will be used to expand the company to meet growing demand for partnerships using its’ B-Body multispecific technology as well as continuing development of its internal pipeline.

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Venture Investors led the round with participation from existing investors including Series A leader Wisconsin Investment Partners. The State of Wisconsin Investment Board (SWIB) also joined as a new investor. Additionally, Paul Weiss, Managing Director at Venture Investors, will join Invenra’s Board of Directors.

"Invenra’s discovery and development platform for bispecific antibodies has the potential to make meaningful contributions to the advancement of immuno-oncology", said Paul Weiss. "We already knew the capability of the team from our experience in backing Roland Green and members of the Board at NimbleGen Systems. We look forward to the opportunity to work together again on the important mission of Invenra."

Roland Green, CEO of Invenra, says "Invenra is excited to have Venture Investors and SWIB as part of our team. We look forward to working with Paul on our board as we develop our pipeline and partnerships. The additional funding will allow us to further leverage the B-Body platform for the high-throughput assessment of multispecific antibodies. This throughput and performance unlocks new and important therapeutic targets and mechanisms of action that were previously impractical through traditional methods. This funding along with milestones from partnerships will allow us to advance the preclinical development of our lead product candidates, namely our Biparatopic OX40 Agonist B-Body program and our tumor-specific Treg depleter SNIPER program."

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.