On September 24, 2018 Foundation Medicine, Inc. reported that FoundationOneLiquid, its next-generation liquid biopsy test for solid tumors, is commercially available in the United States (Press release, Foundation Medicine, SEP 24, 2018, View Source [SID1234530052]). Using a blood sample, FoundationOne Liquid analyzes 70 genes known to drive cancer growth, including homologous recombination deficiency (HRD) genes, and reports the genomic biomarker for microsatellite instability (MSI),1 to help inform the use of checkpoint inhibitor immunotherapies and multiple targeted therapies, including poly (ADP-ribose) polymerase (PARP) inhibitors, as well as clinical trials for patients with advanced cancer.

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"With the commercial launch of FoundationOne Liquid, we are further expanding access to important genomic information that has the potential to match more patients to targeted therapies," said Tom Civik, Chief Commercial Officer at Foundation Medicine. "For many cancer patients, traditional tissue testing is not feasible, and there is a pressing need for minimally invasive solutions to help inform personalized treatment decisions. FoundationOne Liquid meets our highest standards for sensitivity and analytical validation and offers providers additional insights to help guide treatment options, including immunotherapies and PARP inhibitors. In addition to the clinical advancements this test provides, it will also help our biopharma partners improve trial design and accelerate drug development."

FoundationOne Liquid is a hybrid capture-based, next-generation sequencing in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations (indels), copy number alterations (CNAs) and select gene rearrangements using circulating cell-free DNA (cfDNA) isolated from plasma derived from peripheral whole blood. The FoundationOne Liquid test expands upon the previous version of the Company’s liquid biopsy test, FoundationACT, which has been analytically validated across the four main classes of genomic alterations. Evaluation of the platform using multiple validation methods across a broad range of tumor types demonstrated high sensitivity2 and positive predictive value3, even at the low allele frequencies often observed in clinical samples.4

"This is an important new option for metastatic cancer patients with insufficient tumor tissue specimens or for those at risk for invasive biopsy," said Tianhong (Tina) Li, MD, PhD, University of California Davis Comprehensive Cancer Center. "FoundationOne Liquid expands the ability of clinicians to select the most appropriate cancer therapy based on individual patients’ molecular and immune biomarker profile at initial diagnosis and as the disease progresses."

FoundationOne Liquid represents the latest advance in Foundation Medicine’s long-standing commitment to develop innovative liquid biopsy technologies. In April 2018, the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation for the Company’s liquid biopsy assay currently in development that includes the genomic biomarker blood tumor mutational burden (bTMB). If approved, this forthcoming test could be the first FDA-approved liquid biopsy test to incorporate multiple companion diagnostics (CDx) and multiple biomarkers to inform the use of targeted oncology therapies, including immunotherapies.

FoundationOne Liquid can also be used to complement prior tissue-based testing methods, providing results with longitudinal comparisons to previous Foundation Medicine test results. Foundation Medicine offers an option to automatically reflex to FoundationOne Liquid if tissue is insufficient for tissue-based testing. Healthcare providers can order a FoundationOne Liquid kit online at www.foundationmedicine.com/genomic-testing/foundation-one-liquid/order-kit, or visit www.foundationmedicine.com/genomic-testing/foundation-one-liquid to learn more.

On September 24, 2018 CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that management will participate in upcoming investor conferences, including the 2018 Cantor Global Healthcare Conference, the LEERINK Partners Roundtable Series: Rare Disease & Oncology, and the ROTH Battle of the NASH Thrones Investor Conference (Press release, CymaBay Therapeutics, SEP 24, 2018, View Source [SID1234529535]).

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2018 Cantor Global Healthcare Conference
Date: Monday, October 1
Time: 8:55am Eastern Time
Location: Intercontinental Barclay New York Hotel
Webcast: View Source

LEERINK Partners Roundtable Series: Rare Disease & Oncology
Date: Tuesday, October 2
Time: 8:30am Eastern Time
Location: Lotte New York Palace Hotel
Webcast: View Source

ROTH Battle of the NASH Thrones Investor Conference
Date: Wednesday, October 17
Time: Panel discussions and 1-on-1 meetings
Location: Park Hyatt New York Hotel

On September 24, 2018 Sangamo Therapeutics, Inc. (Nasdaq: SGMO) reported that management will participate in the following healthcare investor and industry conferences in September and October (Press release, Sangamo Therapeutics, SEP 24, 2018, View Source [SID1234529552]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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2018 Jefferies Gene Therapy Summit, New York, NY, September 27, 2018
Sangamo’s presentation is scheduled for 2:05 p.m. ET on Thursday.

Cantor Fitzgerald 2018 Global Healthcare Conference, New York, NY, October 1-3, 2018
Sangamo’s presentation is scheduled for 12:15 p.m. ET on Tuesday, October 2nd.

ARM Cell & Gene Meeting on the Mesa, La Jolla, CA, October 3-5, 2018
Sangamo’s presentation is scheduled for 3:15 p.m. PT on Wednesday, October 3rd. Earlier that day, Sandy Macrae, CEO of Sangamo, is also scheduled to participate in a panel discussion titled, "Spotlight: Commercializing Gene Therapies for Hemophilia" at 10:45 a.m. PT.

2018 Chardan Genetic Medicines Conference, New York, NY, October 9, 2018
Sangamo’s presentation is scheduled for 3:15 p.m. ET on Tuesday.

The presentations will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The presentations will be archived on the Sangamo website for two weeks after the events.

On September 24, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported results from the Phase III IMpower132 study of Tecentriq (atezolizumab) plus pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) for the initial (first-line) treatment of people with non-squamous, non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, SEP 24, 2018, View Source [SID1234529662]). This interim analysis showed that Tecentriq and chemotherapy reduced the risk of disease worsening or death (progression-free survival, PFS) by 40% compared with chemotherapy alone (PFS=7.6 versus 5.2 months; hazard ratio [HR]=0.60, 95% CI: 0.49-0.72; p<0.0001).1 While a numerical improvement of 4.5 months for the co-primary endpoint of overall survival (OS) was observed, at this interim analysis statistical significance has not yet been met (median OS=18.1 versus 13.6 months; HR=0.81, 95% CI: 0.64-1.03; p=0.0797). The study will continue as planned, with final OS results expected next year. Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination.

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"This is our third Phase III trial in non-squamous non-small cell lung cancer demonstrating that a Tecentriq -based regimen can help reduce the risk of disease progression for people living with this disease," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We will discuss these results with health authorities globally."

Data will be presented at the International Association for the Study of Lung Cancer (IASLC) 2018 World Conference on Lung Cancer (WCLC) on Monday 24 September at 14:35-14:45 EDT (Abstract OA05.07 Oral) and featured in the official WCLC press conference at 09:45-10:30 EDT.

About the IMpower132 study
IMpower132 is a Phase III, open-label, randomised study evaluating the efficacy and safety of Tecentriq plus chemotherapy (cisplatin or carboplatin and pemetrexed) versus chemotherapy alone in chemotherapy-naïve patients with NSCLC. The study enrolled 578 people who were randomised equally (1:1) to receive:

Tecentriq in combination with cisplatin or carboplatin and pemetrexed (Arm A),
or Cisplatin or carboplatin and pemetrexed (Arm B, control arm)
During the treatment-induction phase, people received Tecentriq, pemetrexed and investigator’s choice of either cisplatin or carboplatin on Day 1 of every three weeks for a dosing period of four or six cycles. People who experienced clinical benefit during the induction phase began maintenance therapy until disease progression.

The co-primary endpoints were:

PFS as determined by the investigator using RECIST v1.1
OS
IMpower132 met its PFS co-primary endpoint as per the study protocol. A summary of the results are included below:

Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. Grade 3-4 treatment-related adverse events (AEs) were reported in 53.6 percent of people receiving Tecentriq plus chemotherapy compared to 39.1 percent of people receiving chemotherapy alone.

About NSCLC
Lung cancer is the leading cause of cancer death globally.2 Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.2 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.3 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.3

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies evaluating Tecentriq alone or in combination with other medicines.

Tecentriq is already approved in the European Union, United States and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).

On September 24, 2018 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported it has entered into purchase agreements with several institutional investors for the purchase in a registered direct offering of 286,633 shares of its common stock at a public offering price of $17.02 per share, for expected gross proceeds of approximately $4.9 million before placement agent fees and other offering expenses payable by Altimmune (Press release, Altimmune, SEP 24, 2018, View Source [SID1234529902]). The offering is expected to close on or about September 26, 2018, subject to customary closing conditions.

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Altimmune intends to use the net proceeds from this offering for the continued advancement of development activities for our clinical-stage product pipeline, general corporate purposes, and strategic growth opportunities.

Roth Capital Partners acted as sole placement agent for the offering.

The securities described above are being offered by Altimmune pursuant to a registration statement on Form S-3 (File No. 333-217034) that was declared effective by the Securities and Exchange Commission (SEC) on April 6, 2017. A final prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting Roth Capital Partners, LLC, Attention: Equity Capital Markets, 888 San Clemente Drive, Suite 400, Newport Beach, California 92660, by telephone at (800) 678-9147 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a 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.