New Publication Validates Performance of Natera’s Signatera™ MRD Test in Ovarian Cancer

On October 6, 2022 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported the publication of a manuscript in Gynecologic Oncology, found here, validating the performance of its personalized molecular residual disease (MRD) test, Signatera, in epithelial ovarian cancer (EOC) (Press release, Natera, OCT 6, 2022, View Source [SID1234621804]). This study adds to the growing library of over 30 published clinical studies incorporating Signatera technology.

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The blinded, multi-site study analyzed 163 plasma samples from 69 patients with Stage I-IV disease across a range of histologies, including high-grade serous (54%), endometrioid (13%), clear cell (13%) and other (20%). Test performance was evaluated at multiple time points: pre-surgery, post-surgery prior to adjuvant treatment, and longitudinally every 3 months for up to 40 months after the completion of definitive therapy. With longitudinal testing, recurrence was detected with 100% sensitivity, 100% specificity, and an average lead time of 10 months ahead of imaging compared to 1 month for CA-125.

"Ovarian cancer is an aggressive disease with poor survival, especially in advanced stages. This study suggests that ctDNA analysis can provide clinicians with invaluable information regarding an individual patient’s prognosis," said Dr. Minetta C. Liu, Natera’s chief medical officer of oncology. "Furthermore, high sensitivity and a significant lead time in detecting recurrence before both CA-125 and surveillance imaging could elicit a meaningful impact on patient outcomes by informing timely treatment decisions for personalized disease management."

EOC is the most lethal gynecologic cancer worldwide.1 In the U.S., it is the fifth most common cancer type in women.2 The 5-year survival rate decreases significantly as stage increases3 and the majority of patients will recur, even when achieving complete remission with primary treatment.4

About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and assess how much cancer is left in the body, to identify recurrence earlier and to help optimize treatment decisions.

AIkido Share Repurchase Continues

On October 6, 2022 AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") reported an update on the Company’s share repurchase program (the "Share Repurchase Program") authorized by the Company’s Board of Directors on January 21, 2022 (Press release, AIkido Pharma, OCT 6, 2022, View Source [SID1234621803]).

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The Company reported that on October 5, 2022, the Company purchased 10,500 shares of common stock at $7.0679 per share.

Additional shares may be repurchased from time to time in open market transactions, or other means in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Rule 10b -18 of the Exchange Act. The timing, number of shares repurchased, and prices paid for the stock under this program will depend on general business and market conditions as well as corporate and regulatory limitations, including blackout period restrictions.

Illumina to Announce Third Quarter 2022 Financial Results on Thursday, November 3, 2022

On October 6, 2022 Illumina, Inc. (NASDAQ: ILMN) reported that it will issue results for the third quarter 2022 following the close of market on Thursday, November 3, 2022 (Press release, Illumina, OCT 6, 2022, View Source [SID1234621802]).

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On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time) Francis deSouza, Chief Executive Officer, and Joydeep Goswami, Chief Strategy and Corporate Development Officer and Interim Chief Financial Officer, will host a conference call with analysts, investors, and other interested parties to discuss financial and operating results.

Conference Call Details

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Thursday, November 3, 2022. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website at investor.illumina.com. Alternatively, individuals can access the call by dialing 866.409.1555 or +1.313.209.4906 outside North America, both with Conference ID 7679670. To ensure timely connection, please dial in at least ten minutes before the scheduled start of the call.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

Citius Pharmaceuticals to Present at Dawson James Securities Small Cap Growth Conference on October 12, 2022

On October 6, 2022 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, reported that Chairman and CEO Leonard Mazur will be presenting at the Dawson James Securities Small Cap Growth Conference on October 12, 2022 (Press release, Citius Pharmaceuticals, OCT 6, 2022, View Source [SID1234621801]).

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Tempus Announces Companion Diagnostic Collaboration with Kartos Therapeutics

On October 6, 2022 Tempus, a leader in artificial intelligence and precision medicine, reported a new collaboration to develop a companion diagnostic (CDx) test with Kartos Therapeutics, a clinical stage biopharmaceutical company, in support of its ongoing Phase II study of navtemadlin (KRT-232) (Press release, Tempus, OCT 6, 2022, View Source [SID1234621800]). Tempus’ CDx test, which will be developed on Tempus’ xT platform, will be used to identify patients with TP53 wild-type (TP53WT) Merkel cell carcinoma (MCC) who may be eligible for treatment with navtemadlin. Navtemadlin is a potent, selective, orally available MDM2 inhibitor that overcomes MDM2 dysregulation by restoring p53 activity and inducing apoptosis of TP53WT tumor cells.

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Although rare, MCC is one of the most aggressive and lethal types of skin cancer, associated with a high risk of recurrence and metastasis, making it very difficult to treat. While anti-PD-1/L-1 antibodies have become standard of care for advanced or metastatic MCC, there remains an urgent need for effective therapies for patients who fail to respond, relapse or are intolerant to immunotherapy. Kartos is collaborating with Tempus to use the xT assay, a 648-gene panel, to identify patients with advanced or metastatic MCC who have retained functional (wild-type) TP53 and who have failed or are intolerant to anti-PD-1/L-1 immunotherapy.

"We are pleased to be collaborating with the Tempus team to progress our goal of developing innovative therapies that meaningfully improve the lives of patients," said Jesse McGreivy, MD, Chief Executive Officer and Chief Medical Officer at Kartos Therapeutics. "This partnership will allow us to develop a test to identify cancer patients who may benefit from treatment with navtemadlin; a therapy which offers a unique mechanism to restore the function of p53, one of the most critical tumor suppressor proteins, resulting in apoptosis of malignant cells in TP53WT MCC and other tumor types."

"Our proprietary platform provides a comprehensive suite of solutions for novel drug development programs while also giving physicians the data needed to make informed treatment decisions for their patients," said Michael Yasiejko, Executive Vice President at Tempus. "We look forward to supporting Kartos’ diagnostic efforts in identifying cancer patients who could benefit from a more personalized approach to their treatment using a widely-available assay and clinician-friendly tools."