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."

Anixa Biosciences Releases Data Presented at AACR Artificial Intelligence Conference

On October 17, 2018 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, presented the results from its ongoing study utilizing Cchek, its artificial intelligence (AI) driven early cancer detection technology, at the 30th Anniversary AACR (Free AACR Whitepaper) Special Conference – Convergence: Artificial Intelligence, Big Data and Prediction in Cancer (Press release, Anixa Biosciences, OCT 17, 2018, View Source [SID1234530497]). This AACR (Free AACR Whitepaper) special conference covered the state of research in understanding cancer from incident to early diagnosis, prevention, and treatment using big data and machine learning. The meeting was held October 14–17, 2018 in Newport, Rhode Island and was attended by global leaders in the intersection of cancer research and artificial intelligence.

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Anixa, for the first time, presented data demonstrating the ability of Cchek to distinguish, among patients scheduled for biopsy, those who have high risk prostate cancer and those who have benign conditions or low grade cancer, for whom surgery is not required and a biopsy is unnecessary. In addition, Anixa’s Cchek data showed the ability to distinguish healthy males from high risk prostate cancer patients with a sensitivity of 89% and a specificity of 100%. This study further demonstrated the potential for Cchek to reduce the number of unnecessary prostate biopsies by up to 56%, while still retaining 89% sensitivity for detecting prostate cancers.

Dr. Amit Kumar, Anixa President and CEO stated, "We are pleased with the results of our ongoing study presented at the AACR (Free AACR Whitepaper) AI conference, and we are excited about the potential for us to dramatically reduce the number of unnecessary prostate biopsies. The ability to distinguish between high risk prostate cancer patients and those with a benign condition or low grade, non-surgically treated cancer is significant, and is a distinct differentiator between Cchek and many other liquid biopsy tests being developed today."

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

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).

Acorda Third Quarter 2018 Update: Webcast/Conference Call Scheduled for October 31, 2018

On October 17, 2018 Acorda Therapeutics, Inc. (Nasdaq:ACOR) reported that it will host a conference call and webcast to report its third quarter 2018 update and financial results on Wednesday, October 31 at 8:30 a.m. ET (Press release, Acorda Therapeutics, OCT 17, 2018, View Source [SID1234530263]).

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To participate in the conference call, please dial (833) 236-2756 (domestic) or (647) 689-4181 (international) and reference the access code 4468928. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 11:30 a.m. ET on October 31, 2018 until 11:59 p.m. ET on November 30, 2018. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 4468928. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.