On September 4, 2019 Sysmex Inostics’ novel SafeSEQ next-generation sequencing cell-free DNA technology, investigators from the Biomedical Research Institute of Malaga [(IBIMA)-CIMES-UMA, Malaga Spain] and collaborators reported have published the first pilot study to examine the use of a non-invasive liquid biopsy in early diagnosis of breast cancer (Press release, Sysmex Inostics, SEP 4, 2019, View Source [SID1234539286]). This study was unique in that the ctDNA analyses was performed before any invasive diagnostic procedure or treatment.

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The SafeSEQ liquid biopsy technology has shown sensitivity down to five mutant molecules in a background of ten thousand normal ones (or 0.05% mutant allele frequency also known as MAF). Utilizing the genes TP53 and PIK3CA, which are commonly mutated in breast cancer, investigators compared the results of traditional standard-of-care tissue biopsy with those of liquid biopsy to determine the degree to which a highly sensitive assay might complement clinical assessment of disease. Of the 13 mutations detected in 10 of the primary breast cancer patients (out of a total of 29 samples) 8 mutations had a variant allele frequency less than 0.39%.

Comparing tissue to liquid biopsy, eight patients had detectable mutations in ctDNA with concordant results between tissue and plasma. Liquid biopsy testing with SafeSEQ detected an additional three patients with ctDNA mutations that were not present in the tissue. The breast cancer samples with detected ctDNA biomarkers were significantly associated with a lower patient age, a higher tumor size, and higher imaging score (indicating higher likelihood of neoplastic disease).

"We have shown in this study how important a sensitive technology is for early detection of breast cancer, as trace amounts of circulating tumor DNA may be lost by the detection method leading to false-negative results", said Dr. Emilio Alba, senior author of the Biomedical Research Institute of Malaga. "Studies of this kind have not been attempted before due to limitations of the technology, and it is great to see Sysmex Inostics leading the path forward for early detection."

The publication "Detection of TP53 and PIK3CA mutations in circulating tumor DNA using Next-Generation Sequencing in the screening process for early breast cancer diagnosis", was published online in the Journal of Clinical Medicine in August of 2019. View Source

On September 4, 2019 Nordic Nanovector ASA (OSE: NANO) reported that its CEO, Eduardo Bravo, will participate and present at the following upcoming investor conferences during September (Press release, Nordic Nanovector, SEP 4, 2019, View Source [SID1234539285]):

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Citi 14th Annual Biotech Conference in Boston on 4-5 September
BioCentury 26th Annual NewsMakers in the Biotech Industry 2019 in New York on 6 September
HC Wainwright & Co. 21st Global Investment Conference in New York on 9-10 September
The company presentation will be available on the 5 September on the investors and media page.

For further information, please contact:

IR enquiries
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44-7561-431-762
Email: [email protected]

Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44-207-638-9571
Email: [email protected]

On September 4, 2019 Amgen (NASDAQ:AMGN) reported that it will host a webcast call for the investment community at the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer (WCLC) on Sunday, Sept. 8, at 8 a.m. PT. David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team, will participate to discuss Amgen’s oncology program, including data being presented at WCLC for the Company’s KRASG12C inhibitor AMG 510 (Press release, Amgen, SEP 4, 2019, View Source [SID1234539284]).

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Live audio of the investor call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On September 4, 2019 Adastra Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of proprietary medicines for the treatment of cancer, reported that Scott Megaffin, Chief Executive Officer, will present at the 2019 Janney Healthcare Conference being held September 9-10, 2019, at The Union League Club in New York City (Press release, Adastra Pharmaceuticals, SEP 4, 2019, View Source [SID1234539283]).

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Mr. Megaffin will present Adastra’s corporate growth strategy and clinical plans for its lead candidate, Zotiraciclib, which is designed to treat cancers characterized by Myc overexpression. Adastra is currently evaluating Zotiraciclib in two Phase 1b trials in glioblastoma multiforme (GBM) and a separate Phase 1b study in pediatric diffuse intrinsic pontine glioma (DIPG).

Event:

2019 Janney Healthcare Conference

Date:

Monday, September 9, 2019

Time:

11:50 AM (Eastern Time)

Location:

The Union League Club, New York, NY

Webcast Link:

View Source;eom

The presentation’s audio and slides will be webcast live and available for up to 90 days via the webcast link above and on Adastra’s website at www.adastrarx.com.

On September 4, 2019 Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, reported publication of results from its PROCEED registry, which evaluated real-world use of PROVENGE (sipuleucel-T) in men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC) (Press release, Dendreon, SEP 4, 2019, View Source [SID1234539280]). The findings, published in Cancer1, showed that men with mCRPC who were treated with PROVENGE when their PSA was <5.27 ng/mL had a median survival of nearly four years.

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"The median survival of four years following treatment with PROVENGE is meaningful," said Celestia S. Higano, M.D., FACP, lead author of the PROCEED analysis, and professor, Division of Medical Oncology, Department of Medicine, University of Washington School of Medicine and Fred Hutchinson Cancer Research Center. "PROCEED provides a real-world portrait of the expected OS after sipuleucel-T in mCRPC patients in the modern era of five additional life-prolonging agents."

Notably, 44% of patients with a PSA of <5.27 ng/mL did not receive any additional cancer treatments for at least one year. Of those, 95% were treated with PROVENGE as first-line therapy for mCRPC as recommended by the National Comprehensive Cancer Network (NCCN).

"Median baseline PSA levels at mCRPC diagnosis have declined steadily since the approval of PROVENGE in 2010," said Bruce A. Brown, M.D., chief medical officer at Dendreon. "Of the nearly 2,000 patients enrolled in PROCEED between 2011-2014 a quarter had a PSA of <5.27 ng/mL, and these men lived much longer than those in the higher quartiles. It’s worth noting that the median baseline PSA levels observed in PROCEED are lower than those in the pivotal IMPACT trial and would likely be lower if PROCEED was enrolling today."

PROCEED Registry – Baseline PSA and Median Survival

<5.27 ng/mL – 47.7 months
>5.27 to ≤15.08 ng/mL – 33.2 months
>15.08 to ≤ 46 ng/mL – 27.2 months
>46 ng/mL – 18.4 months
Findings from the PROCEED registry are consistent with a previous post-hoc analysis of the pivotal Phase 3 IMPACT trial of sipuleucel-T published in Urology in 2013. In that analysis, a lower baseline PSA level was associated with improved overall survival (OS). Among patients with a baseline PSA ≤22.1 ng/mL, the median OS was 41.3 months (3.4 years) for those treated with sipuleucel-T vs. 28.3 months for those in the control arm – an improvement of 13 months.2

About the PROCEED Registry

PROCEED (NCT01306890) was a multicenter, open-label, observational registry conducted at urology and medical oncology clinics in private practice and academic sites. PROCEED enrolled 1,976 patients with mCRPC who received PROVENGE between 2011 and 2014 in everyday treatment settings. Patients were followed for a median of 46.6 months. Their median age was 72 years and their median baseline PSA was 15.0 ng/mL.

About PROVENGE (sipuleucel-T)

PROVENGE is the only FDA-approved immunotherapy made from a patient’s own immune cells for the treatment of prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for certain men in advanced stages of the disease.

INDICATION

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

For full Prescribing Information, please visit www.dendreon.com/Products.