Study Shows Biocept’s Assays are Viable and Sensitive for Detecting Tumor Cells and Biomarkers in the Cerebrospinal Fluid of Patients with Breast and Lung Cancer that has Metastasized to the Central Nervous System

On November 20, 2020 Biocept, Inc. (Nasdaq: BIOC), a leading commercial provider of molecular diagnostic assays, products and services designed to provide physicians with clinically actionable information to improve patient outcomes, reported the results of a study analyzing cerebrospinal fluid (CSF) samples in patients with primary lung or breast cancer with either brain or leptomeningeal disease (Press release, Biocept, NOV 20, 2020, View Source [SID1234571492]). The findings indicate that Target Selector CSF assays are a viable and sensitive platform for circulating tumor cell (CTC) detection and molecular analysis compared to the current standard of care, CSF cytology, which is typically used to establish or confirm leptomeningeal disease when imaging findings are suspicious or equivocal. CSF cytology has limited sensitivity and provides no additional information needed for target therapy choice.

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The results were discussed yesterday in a poster presentation by Santosh Kesari, MD, PhD, Chair and Professor, Department of Translational Neurosciences, Director of Neuro-oncology at the Pacific Neuroscience Institute and John Wayne Cancer Institute, at the Society for Neuro-Oncology’s SNO2020 Virtual Conference on November 19, 2020.

"Once a tumor has metastasized to the brain, CTCs and circulating tumor DNA (ctDNA) can be found in the cerebrospinal fluid," said Dr. Kesari. "This prospective study compared the sensitivity of CTC detection and molecular analysis of Biocept’s Target Selector CSF assays to cytology (microscopic examination of conventional CSF cytology slide preps). This study highlights the potential of CSF-based diagnostics for longitudinal monitoring cancers in the central nervous system."

"Our Target Selector testing is a minimally invasive, cost-effective strategy to simultaneously confirm metastasis to the brain, while also assessing cancer biomarkers in order to qualify a patient for potential targeted therapy options," said Michael Nall, President and CEO of Biocept. "Identifying CTCs and actionable biomarkers with Target Selector can help to confirm and monitor central nervous system involvement when clinically suspected, without the risk of complications associated with surgical biopsies, which are often impossible in these cases.

"This the second major scientific conference in less than two months to accept study results from Target Selector testing in cerebrospinal fluid for presentation," added Mr. Nall. "We view neuro-oncology as an area where our technology is uniquely suited to answer questions posed by treating physicians, and we are appreciative of the Society of Neuro-Oncology’s recognition of our Target Selector testing."

About the SNO2020 Virtual Conference

The Society for Neuro-Oncology exists to advance multi-disciplinary brain tumor research, education, and collaboration to drive discovery and improve patient care. Over 2,600 neuro-oncology professionals are expected to register for the SNO2020 Virtual Conference being held November 19-21, 2020. More information can be found at soc-neuro-onc.org.

Seres Therapeutics, Inc. Corporate Slide Presentation as of November 20, 2020

On November 20, 2020 Seres Therapeutics Presented the Corporate Presentation (Press release, Seres Therapeutics, NOV 20, 2020, View Source [SID1234575087]).

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Clovis Oncology to Present at the Piper Sandler 32nd Annual Healthcare Conference

On November 20, 2020 Clovis Oncology, Inc. (Nasdaq: CLVS) reported that a pre-recorded fireside chat with President and Chief Executive Officer Patrick J. Mahaffy will be available next week for replay as part of the Piper Sandler 32nd Annual Healthcare Conference (Press release, Clovis Oncology, NOV 20, 2020, View Source [SID1234571471]). The virtual conference, which takes place November 30 to December 3, 2020, incorporates a library of pre-recorded fireside chat presentations with presenting companies available on Monday, November 23, 2020 at 10:00 a.m. Eastern time.

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This conference is virtual and the pre-recorded presentation can be accessed through the investor relations section of the Company’s website at www.clovisoncology.com. The replay of the webcast will be available on the Company’s website for 30 days. The presentation was recorded on November 18, 2020, and statements made in the presentation speak only as of such date. Clovis Oncology does not undertake to update or revise any statements made therein.

Glycostem initiates phase I/IIa (pivotal) trial to evaluate the safety and efficacy of oNKord® in patients with Acute Myeloid Leukemia (AML)

On November 20, 2020 Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic off-the-shelf Natural Killer (NK) cells, reported the opening of a phase I/IIa trial for its lead product oNKord for the treatment of AML patients (Press release, Glycostem Therapeutics, NOV 20, 2020, View Source [SID1234571493]). The WiNK trial will enroll 33 AML patients at eight clinical sites based in five European countries. oNKord is the company’s first-generation off-the-shelf allogeneic NK cellular immunotherapy product. Glycostem is furthermore developing a range of second (CAR-NK) and third generation (TCR-NK) NK products in-house.

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"During our phase I safety study, in which ten elderly AML patients were treated, we verified our lead product oNKord to be a safe therapeutic agent in the field of cellular immunotherapy. Interestingly, year 1 survival data showed promising efficacy outcome (80%) compared to historical cohort data (40%)," tells Troels Jordansen, CEO at Glycostem. "The opening of this phase I/IIa / pivotal trial is an important step and we are looking forward to the data from this study, which will allow us to draw conclusions regarding oNKord safety and tolerability and most importantly its efficacy for treatment of AML patients."

Professor Doctor Arnold Ganser, MD of Hannover Medical School in Germany and WiNK trial coordinating investigator said: "The preliminary efficacy data obtained with oNKord was very promising and NK-cells have proven to be highly capable of targeting cancer cells. Therefore, I am excited about participating and being able to enroll patients in the WiNK trial." He continues: "Currently there is a risk of relapse for 80% of the successfully treated patients. This new form of cellular treatment can change the lives and future prospects of many patients with AML worldwide who do not proceed to allogeneic hematopoietic stem cell transplantation, in particular elderly patients, who represent the majority of patients with AML."

WiNK is a prospective two-stage, open-label, single arm, multicenter phase I/IIa trial to evaluate the safety and efficacy of oNKord, an off-the-shelf, ex. vivo-cultured allogeneic NK cell preparation, in 33 adults with AML who are in complete morphologic remission with residual measurable disease and with no strong indication for hematopoietic stem cell transplantation.

AIkido Pharma Inc. Announces Results of 2020 Annual Stockholder Meeting

On November 20, 2020 AIkido Pharma Inc. (the "Company" or "AIkido") (NASDAQ: AIKI) reported the results from the virtual 2020 Annual Meeting of Stockholders (the "Meeting") held on November 17, 2020 (the "Meeting") (Press release, AIkido Pharma, NOV 20, 2020, View Source [SID1234571472]).

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All proposals that were presented to the stockholders were approved at the Meeting, except for the proposal to amend the Company’s Amended and Restated Certificate of Incorporation, as amended, to effect a reverse stock split of the Company’s common stock (the "Common Stock") at a ratio of up to one-for-ten (the "Amendment Proposal"). Accordingly, the Company adjourned the Meeting to allow more time for stockholders to consider the Amendment Proposal. The adjournment of the Meeting will preserve the September 24, 2020 record date for the determination of stockholders entitled to receive notice of and vote at the upcoming adjourned meeting to be held at 12:00 p.m. on December 4, 2020.

The detailed voting results for the Meeting are provided in the Company’s Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission (the "SEC") on November 20, 2020.

The Company urges all stockholders who have not yet voted to vote in favor of the Amendment Proposal. Approval of the Amendment Proposal and the resulting reverse stock split is critical. The primary objective of the reverse stock split is to raise the per share trading price of the Common Stock to comply with the Nasdaq minimum share price listing rule to allow the Company to continue to list on Nasdaq. The higher stock price resulting from the reverse stock split and the listing of the Common Stock on Nasdaq is important for the marketability of the Common Stock to the financial community and investing public. If the reverse stock split is not effectuated, it could limit the number of potential buyers of the Common Stock as many institutional investors have policies prohibiting them from holding lower-priced stocks in their portfolios. Also, brokerage houses frequently have internal practices and policies that discourage individual brokers from dealing in lower-priced stocks. Top proxy advisory firms ISS and Glass Lewis, who together provide voting recommendations on stockholder meetings to a majority of institutional stockholders, both recommend a "FOR" vote for this proposal in order to maintain listing on Nasdaq.

We urge you to please vote your shares of AIkido today. You may do so by contacting MacKenzie Partners at 1-800-322-2885 (toll-free in the U.S.) or 212-929-5500.

MacKenzie Partners can also take your vote via email. To vote by email, simply send an email with your voting instructions to [email protected] . A sample email is below:

To: [email protected]
Cc: [email protected]:
Re: AIkido Pharma Inc. Annual Meeting

Dear Mr. Jaegers;

Please vote my shares of AIkido Pharma Inc. Common Stock for the 2020 Annual Meeting of Stockholders as follows:

FOR the amendment to effect reverse stock split
Proposals 2, 3a,3b,3c,3d, 3e, 3f, 4, 5, and 6 will be voted FOR in order to complete the proxy. Please be advised that these proposals have already passed at the shareholder meeting on November 17, 2020.

The shares are registered in the name of ___________

Thank you

Your vote is very important, regardless of the number of shares you own. Please take a moment to vote your shares by contacting MacKenzie Partners today.

Thank you for your support.

Important Information and Where to Find It
This communication may be deemed to be solicitation material in respect to the Meeting and the Proposals. On October 5, 2020, the Company initially filed the Definitive Proxy Statement with the SEC. The Company gave notice and mailed the Definitive Proxy Statement to certain stockholders on or about October 5, 2020. The Company may file other documents with the SEC in connection with the Meeting. BEFORE MAKING ANY VOTING DECISION, STOCKHOLDERS ARE URGED TO READ THESE MATERIALS CAREFULLY AND, IN THEIR ENTIRETY, BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY. Stockholders may obtain, free of charge, copies of the Definitive Proxy Statement and any other documents filed by the Company with the SEC in connection with the Meeting at the SEC’s website (View Source) and on the investor relations section of the Company’s website at www.aikidopharma.com. Investors and stockholders are urged to read the Definitive Proxy Statement and the other relevant materials before making any voting decision with respect to the Meeting and the Proposals.

Non-Solicitation
This communication does not constitute an offer to sell or solicitation of an offer to buy any securities, nor will there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

Participants in the Solicitation
The Company and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of the Company in connection with the Meeting. Additional information regarding the directors and executive officers of the Company is included in the Company’s Definitive Proxy Statement relating to the Meeting, filed with the SEC on October 5, 2020. These documents are available free of charge from the sources indicated above.