Genetron Approved to Launch 8-Gene Lung Cancer Assay in China

On February 13, 2020 Genetron Holdings of Beijing reported that it received NMPA approval to launch its 8-gene Lung Cancer Assay along with a high-throughput NGS platform, the GENETRON S2000 (Press release, ChinaBio, FEB 13, 2020, View Source [SID1234554358]). Genetron, a precision oncology diagnostics company, said the new assay is fast and easy-to-use with a One-Step Seq technology suited for high-throughput clinical testing centers such as large hospitals and regional medical testing centers. Genetron’s services include risk assessment, early screening, molecular pathology diagnosis, medication guidance and prognosis monitoring. The company has raised $132 million in C and D rounds over the last two years.

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MacroGenics Announces Date of Fourth Quarter and Full Year 2019 Financial Results Conference Call

On February 13, 2020 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company will release its financial results for the fourth quarter and full year 2019 after the market closes on Tuesday, February 25, 2020 (Press release, MacroGenics, FEB 13, 2020, View Source [SID1234554270]). MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Tuesday, February 25, 2020 at 4:30 p.m. ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID 5581596.

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The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

Phio Pharmaceuticals Announces Closing of $8.0 Million Underwritten Public Offering

On February 13, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported the closing of its previously announced underwritten public offering of 993,633 units at a public price of $4.00 per unit and 1,006,367 pre-funded units at a public price of $3.999 per pre-funded unit, raising gross proceeds of approximately $8.0 million, prior to deducting underwriting discounts and commissions and estimated offering expenses (Press release, Phio Pharmaceuticals, FEB 13, 2020, View Source [SID1234554294]).

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H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

Phio intends to use the net proceeds from this offering to fund the development of its immuno-oncology programs, for other research and development activities and for general working capital needs.

The Company has also granted the underwriter a 30-day option to purchase up to an additional 300,000 shares of common stock and/or warrants to purchase up to 300,000 shares of common stock, which option to purchase warrants was exercised by the underwriter.

Each unit sold in this offering contains one share of common stock and one warrant to purchase one share of common stock. Each pre-funded unit sold in this offering contains one pre-funded warrant to purchase one share of common stock at an exercise price of $0.001 per share and one warrant to purchase one share of common stock. Each warrant included in the units has an exercise price of $4.00 per share, is immediately exercisable and will expire five years from the date of issuance. The shares of common stock (or the pre-funded warrants, as the case may be) and the accompanying warrants included in the units or pre-funded units were purchased together in this offering, but were issued separately.

The securities described above were offered by Phio pursuant to a registration statement on Form S-1 (File No. 333-234032) declared effective by the Securities and Exchange Commission (the "SEC") on February 11, 2020. The offering was made only by means of a prospectus forming a part of the effective registration statement. Electronic copies of the final prospectus may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by e-mailing [email protected] or via telephone at (646) 975-6996 or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Genetron Health Announces NMPA Approval of its 8-gene Lung Cancer Assay and NGS Platform GENETRON S2000

On February 13, 2020 Genetron Holdings Limited ("Genetron Health"), a China-based precision oncology company that covers full-cycle cancer care, reported that the National Medical Products Administration (NMPA) has approved its 8-gene Lung Cancer Assay and high-throughput NGS platform GENETRON S2000 to empower comprehensive panel genomic testing for more patients (Press release, Genetron Health Technologies, FEB 13, 2020, View Source [SID1234554310]).

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The 8-gene Lung Cancer Assay is the first lung cancer clinical testing assay based on Genetron One-Step Seq Method approved by NMPA, offering fast and easy-to-use testing procedures, that is suitable for independent operation within hospitals. With the Genetron One-Step Seq technology, the library construction process is finished in one step of reaction, minimizing manual operation to one mixture of reagents with DNA/cDNA. The chance of contamination in the process is minimal with the "sample in library out" workflow. The assay is compatible with both the Genetron S5 sequencing platform and the Genetron Chef System. The 8-gene Lung Cancer Assay covers EGFR, ALK, ROS1, BRAF, KRAS, HER2, MET, PIK3CA, and 7 genes of them are recommended biomarkers by the 2018 NCCN guideline for Non-Small Cell Lung Cancer (NSCLC) patients.

GENETRON S2000 enables comprehensive genomic testing for high-throughput clinical testing centers such as large hospitals and regional medical testing centers. GENETRON S2000 adopts an innovative Flow Cell system that provides two types of Flow Cells to support various sequencing modes, and an optimized optical and biochemical system which enables the whole sequencing process to complete within a short period of time, offering a simplified and streamlined sequencing experience with a highly-automated process and friendly operating system. The data output could range from 55G to 1440G. With the approved platform, Genetron Health is developing testing solutions covering multi-application scenarios.

Based on patented technologies including the One-Step Seq Method, Genetron Health has developed seven NMPA approved clinical molecular testing equipment or assays on NGS, digital PCR and qPCR platforms, and has now realized full-range sequencing capabilities with the medium-throughput NGS system Genetron S5, featuring 8-gene Lung Cancer Assay, and the high-throughput NGS platform GENETRON S2000, featuring 825-gene Testing Assay.

Decipher GRID Signature Predicts Benefit from Chemotherapy in Men Diagnosed with Metastatic Prostate Cancer

On February 13, 2019 Decipher Biosciences, a commercial-stage precision oncology company committed to improving patient care, initially focused on urologic cancers, reported that a Decipher GRID molecular subtyping signature, studied in patients from the phase III, randomized controlled trial, CHAARTED, successfully predicted which prostate cancer patients diagnosed with metastatic hormone sensitive prostate cancer (mHSPC) benefited from the addition of chemotherapy to androgen deprivation hormone therapy (Press release, Deciphera Pharmaceuticals, FEB 13, 2020, View Source [SID1234554326]).

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The standard of care treatment for patients with mHSPC is androgen deprivation hormone therapy with the option for additional systemic therapy, such as taxane chemotherapy. Optimal treatment selection for these patients, however, remains challenging without knowledge of how each patient will respond. The Decipher GRID signature has demonstrated that patients with specific molecular subtypes have varying responses to systemic therapies, and investigators from the practice-changing CHAARTED trial used the signature to profile tumor tissue from trial participants and to identify which patients would receive the most benefit from the addition of taxane chemotherapy.

The investigators found that patients with the luminal B molecular subtype derived the most benefit from the addition of taxane chemotherapy, with a 55% reduction in risk of death, adding 22 months of median survival. In the trial population tested, 48% of the patients were found to have the luminal B molecular subtype. Patients with the remaining molecular subtypes received no significant survival benefit from the addition of taxane chemotherapy.

"Identifying which patients will benefit from chemotherapy is one of the most important clinical questions in the management of metastatic prostate cancer," said Christopher Sweeney, MBBS, a medical oncologist and professor of medicine at Dana-Farber Cancer Institute. "The ability to identify these patients at diagnosis is a very important step towards improving patient outcomes and accelerating the inclusion of novel drugs into the standard of care."

Results will be presented February 13, 2020, at the Genitourinary Cancer Symposium Oral Abstract A session:

Hamid A, et al. Luminal B subtype as a predictive biomarker of docetaxel benefit for newly diagnosed metastatic hormone sensitive prostate cancer (mHSPC): A correlative study of E3805 CHAARTED. Abstract #162

Findings from nine other studies of Decipher tests will be presented at the Genitourinary Cancer Symposium:

Ganguly S, et al. Tumor cell intrinsic androgen biosynthesis by 3β-hydroxy steroid dehydrogenase (HSD3B1) to modulate radiosensitivity in prostate cancer cells. Abstract #349

Grist E, et al. Multiregion expression profiling of prostate cancer from men randomized in the STAMPEDE trial: Stage I results of a multistage biomarker analysis. Abstract #349

Gupta S et al. Results from BLASST-1 (Bladder Cancer Signal Seeking Trial) of nivolumab, gemcitabine, and cisplatin in muscle invasive bladder cancer (MIBC) undergoing cystectomy. Abstract #439

Feng FY, et al. Transcriptome profiling of NRG Oncology/RTOG 9601: Validation of a prognostic genomic classifier in salvage radiotherapy prostate cancer patients from a prospective randomized trial. Abstract #276

King M, et al. INTREPId (INTermediate Risk Erection Preservation Trial): A randomized trial of radiation therapy and darolutamide for prostate cancer. Abstract #TPS384

Muralidhar V, et al. Clinical-genomic sub-classification of high-risk prostate cancer: Implications for tailoring therapy and clinical trial design. Abstract #337

Necchi A, et al. Association of an immune-gene signature with pathologic response and outcome after neoadjuvant pembrolizumab (pembro), compared to neoadjuvant chemotherapy (NAC), in muscle-invasive bladder cancer (MIBC). Abstract #533

Necchi A, et al. Development of a composite biomarker-based calculator to predict the probability of pathologic complete response (pT0) after neoadjuvant pembrolizumab (pembro) in muscle invasive bladder cancer (MIBC). Abstract #539

Shahait M, et al. Head-to-head comparison between decipher and prolaris tests: Two commercially available post-prostatectomy genomic tests. Abstract #348
About Decipher Prostate RP and Decipher GRID

Our Decipher Prostate RP genomic tests are currently marketed and sold to physicians treating prostate cancer through the adjuvant therapy decision for patients who have received a radical prostatectomy and are being considered for additional therapy. The test reports the Decipher score which prognosticates a patient’s risk of metastasis within five years. The Decipher score is intended to improve clinical decision making by helping physicians identify patients who have high risk of metastasis and require more intensive therapy or who have low risk of metastasis and can reduce treatment intensity. We have obtained Medicare coverage for patients, including for those who have been diagnosed with adverse pathology following a radical prostatectomy and are being considered for additional therapy. Decipher Prostate RP can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

Decipher GRID is our Real-World Evidence genomic database containing over 75,000 urologic cancer transcriptomes matched to patient demographics and including clinical trial outcome data, which is one of the largest and well-annotated urologic cancer genomic databases in the world. Decipher GRID’s patient data is derived from decades of clinical trials and is continuously being expanded through a growing community of pharmaceutical and academic partners. The diversity of clinical sample inputs, ranging from global clinical trials to standard-of-care practices in urban, suburban and rural centers, help provide a comprehensive view of the future and current states of the practice of urologic cancer care. We leverage Decipher GRID outputs to partner with investigators and pharmaceutical companies to help identify patient populations that might benefit from earlier use of proprietary drugs or combination therapeutic strategies, or that are prime candidates for novel therapeutics. Decipher GRID is our proprietary engine that drives product development for us, and informs the product development efforts for our pharmaceutical partners.