On April 9, 2019 Foundation Medicine and Flatiron Health reported the publication of study results in the Journal of the American Medical Association validating that real-world clinico-genomic data obtained during the course of routine patient care can yield scientifically and clinically meaningful insights (Press release, Foundation Medicine, APR 9, 2019, View Source [SID1234535090]). These insights can serve as real-world evidence to advance research and discovery in oncology, and may also ultimately inform clinical guidelines. The continuously-updated, de-identified clinico-genomic database includes patient outcomes data processed from patients in Flatiron Health’s network of oncology clinics, linked with comprehensive genomic profiling (CGP) results from Foundation Medicine’s FoundationCORE database.

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The findings demonstrate the feasibility of creating a de-identified clinico-genomic database (CGDB) and validate the potential of such real-world data for understanding and optimizing personalized cancer care, including, for example, biomarkers of response to immunotherapy treatment. The study linked clinical data from the electronic health records (EHRs) of 28,998 patients from 275 oncology practices in Flatiron Health’s network across the United States with genomic data from Foundation Medicine CGP testing. Among 4,064 patients with non-small cell lung cancer (NSCLC), exploratory analyses recapitulated previously described associations between clinical and genomic characteristics, between driver mutations and response to targeted therapy, and between tumor mutation burden (TMB) and response to immunotherapy.

"The publication of our validation study in a high-profile journal not only validates the ability of a real-world clinico-genomic database to yield scientifically and clinically-relevant findings, but also the potential for this novel approach to significantly impact our understanding of personalized medicine. This represents a major milestone in our mission to leverage regulatory-grade, real-world data to advance cancer care," stated Gaurav Singal, MD, chief data officer at Foundation Medicine. "As the dataset continues to grow, we expect it will advance therapeutics development, optimize clinical trial design and execution, and ultimately even support clinical decision making, enabling a more efficient way to evaluate new medicines and accelerate their availability for patients who need them."

In addition to demonstrating the scientific validity of the database for rigorous research, the study findings confirmed and extended several biomarker hypotheses in oncology. Corroborating recent clinical trial data, high TMB was shown to be associated with both longer duration on anti-PD-1/PD-L1 therapy and improved overall survival (OS) from treatment initiation. In addition, this retrospective real-world analysis re-demonstrated the importance of genomic biomarker-guided targeted treatment in NSCLC: among patients with genomic alterations known to drive tumor growth, treatment with agents targeted to these mutations was associated with prolonged survival. These findings may be extended in the future to identify additional factors associated with response to targeted therapies and immunotherapies.

"Our proof-of-principle study validated the importance of marrying tumor genomic data with clinical outcomes recorded during routine care, which represents a huge stream of data that is being generated and recorded every day, but has not yet been used meaningfully outside of patient care," said Vineeta Agarwala, MD, PhD, director of product management at Flatiron Health. "These data can inform treatment guidelines, clinical trial design, and precision drug development."

Since launching in November 2016, the CGDB now includes linked, de-identified data for more than 50,000 patients (over 6,000 with non-small cell lung cancer) and helps researchers and biopharmaceutical partners accelerate the development of targeted therapeutics and immunotherapies to treat cancer. The CGDB includes de-identified clinical data (demographic data, medication history, laboratory testing, and outcomes including survival) from Flatiron Health linked to genomic data (comprehensive genomic profiling of tumors, including genomic findings, variant annotations, and computational biomarkers such as tumor mutational burden [TMB], microsatellite instability [MSI], and loss of heterozygosity [LOH]) from Foundation Medicine across a variety of tumor types, allowing for a continuously updated, longitudinal view of a patient’s clinical, diagnostic and therapeutic journey.

On April 9, 2019 Illumina, Inc. (NASDAQ:ILMN) reported that it will issue results for first quarter 2019 following the close of market on Thursday, April 25, 2019 (Press release, Illumina, APR 9, 2019, View Source [SID1234535085]).

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On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time) Francis deSouza, President and Chief Executive Officer, and Sam Samad, Senior Vice President and 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, April 25, 2019. Interested parties may access the live teleconference through the Investor Relations section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (844) 647-5490 or 1 (615) 247-0295 outside North America, both with conference ID 9153579.

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.

On April 9, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported the closing of its previously announced concurrent underwritten public offerings of (i) 8,667,333 shares of its common stock and accompanying Class A warrants to purchase up to 1,951,844 shares of its common stock, at a combined price to the public of $7.50 per common share and accompanying Class A warrant and (ii) 666 shares of its Series A convertible preferred stock, which are convertible into 666,000 shares of its common stock, and accompanying Class A warrants to purchase up to 166,500 shares of its common stock, at a combined price to the public of $7,500 per Series A share and accompanying Class A warrant (Press release, Syros Pharmaceuticals, APR 9, 2019, View Source [SID1234535084]). Each Class A warrant has an exercise price of $8.625 per share and expires 3.5 years from the date of issuance. Gross proceeds from the offerings, before deducting underwriting discounts and commissions and offering expenses, were approximately $70 million.

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Cowen and Piper Jaffray & Co. acted as joint book-running managers for the offerings. JMP Securities acted as lead manager and Roth Capital Partners acted as co-manager.

The securities were offered by Syros pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on July 20, 2017 and declared effective by the SEC on July 31, 2017. Final prospectus supplements and accompanying prospectuses relating to, and describing the terms of, each offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the prospectus supplements and the accompanying prospectuses relating to each offering can be obtained from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (631) 274-2806; or Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone: 800-747-3924, or by email: [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, 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.

On April 9, 2019 Cytonus Therapeutics Inc., a biotechnology company developing new platforms for delivering biologics, reported that it will be presenting preclinical data for its Cargocyte technology platform at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting April 29 – May 2 in Washington, DC (Press release, Cytonus Therapeutics, APR 9, 2019, View Source [SID1234535083]).

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"We are excited to be presenting our preclinical data supporting Cargocytes, a first-of-its-kind, cell-based platform technology for delivery of an Oncolytic Virus into metastatic tumors," said Remo Moomiaie-Qajar, M.D., president and CEO of Cytonus. "Our technology unleashes the promise of using Oncolytic Viruses to treat solid tumors by addressing a number of critical problems they inherently have, mainly homing the viruses to specific tissue without the immune system destroying it and then delivering those viruses into tumor cells. In addition, we are proud of our growing immune-oncology work with our Cargocytes and look forward to sharing our data at this year’s ASGCT (Free ASGCT Whitepaper) meeting."

Cargocytes are engineered allogenic cell lines that can carry a variety of payloads like small molecule compounds, gene editing therapies, therapeutic RNAs, and powerful biologics such as immune modulating cytokines, antibodies and oncolytic viruses.

Details of the presentations:

Abstract Title: Cargocyte Biofactories: A New Versatile Cell Therapy Platform for Delivery of a Wide Range of Biologics

Session Date/Time: Monday Apr 29, 2019 5:00 PM – 6:00 PM
Session title: Cancer-Targeted Gene & Cell Therapy
Room: Columbia Hall
Final abstract number: 272

Abstract Title: Cargocyte Biofactories: A Novel Platform for Delivering Oncolytic Viruses to Treat Metastatic Cancer

Session Date/Time: Tuesday Apr 30, 2019 3:30 PM – 5:15 PM
Session title: Oncolytic Viruses II
Room: International Ballroom
Our Presentation Time: 4:00 PM – 4:15 PM
Final abstract number: 404

Abstract Title: Cargocytes: A Novel Cell Therapy Platform to Drive Anti-Tumor Immunity

Session Date/Time: Tuesday Apr 30, 2019 5:00 PM – 6:00 PM
Session title: Cancer-Immunotherapy, Cancer Vaccines
Room: Columbia Hall
Final abstract number: 578

Cytonus will also be presenting at the Bio International Convention, June 3-6, 2019 in Philadelphia.

On April 9, 2019 Peloton Therapeutics, Inc., a clinical-stage biopharmaceutical company advancing first-in-class oral medicines for cancer and other serious conditions, reported the completion of patient enrollment in a Phase 2 clinical trial evaluating the efficacy and safety of its lead drug candidate, PT2977, to treat von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) (Press release, Peloton Therapeutics, APR 9, 2019, View Source [SID1234535082]). The clinical trial, which has enrolled 61 patients at clinical trial centers in the United States and Europe, is ongoing and the company anticipates topline results in the first half of 2020.

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This open-label Phase 2 trial will evaluate the efficacy and safety of PT2977 in patients with VHL disease-associated RCC. Key inclusion criteria are the diagnosis of VHL disease based on a germline VHL alteration, the presence of at least one measurable solid RCC tumor, and no evidence of metastatic disease. PT2977 will be administered orally at a once-daily, 120 mg dose. The primary objective of the trial is to evaluate safety and efficacy as measured by overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). Secondary objectives include other measures of efficacy, such as duration of response and progression free survival. The potential impact of PT2977 on VHL disease-associated non-RCC tumors, as well as the tolerability and pharmacokinetics of PT2977, will also be evaluated in this trial.

Further information on the clinical trial of PT2977 can be found on clinicaltrials.gov (Study identifier: NCT03401788).

About PT2977

Peloton’s lead drug candidate, PT2977, is a once-daily, oral inhibitor of hypoxia-inducible factor-2α (HIF-2α). PT2977 has demonstrated anti-tumor activity with a favorable safety profile in an early-stage clinical study in patients with solid tumors. The company is initially focused on developing PT2977 for the treatment of kidney cancer, specifically metastatic clear cell RCC and VHL disease-associated RCC.

About Von Hippel-Lindau Disease ("VHL Disease")

VHL disease is a familial cancer syndrome that commonly gives rise to renal cell tumors. VHL disease affects about one in 36,000 live births, and it is estimated that there are approximately 20,000 VHL disease patients in the United States and the European Union. The main manifestations of VHL disease include RCC as well as retinal, cerebellar and spinal hemangioblastomas. There are no approved systemic therapies for VHL disease.