New NCCN Breast Cancer Guidelines Elevate Oncotype DX Breast Recurrence Score® as the Only Preferred Multi-gene Test to Predict Chemotherapy Treatment

On October 9, 2018 Genomic Health, Inc. (NASDAQ: GHDX) reported that its Oncotype DX Breast Recurrence Score test has been categorized as the only "preferred" test for chemotherapy treatment decision-making for patients with node-negative early-stage breast cancer by the National Comprehensive Cancer Network (NCCN) in its 2018 guidelines for invasive breast cancer chemotherapy treatment (Press release, Genomic Health, OCT 9, 2018, View Source [SID1234529844]). The only test elevated to "strongly consider" guideline inclusion with level 1 evidence, Oncotype DX continues to be distinguished as the only genomic test predictive of chemotherapy benefit.

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NCCN’s guidelines update follows the recent publication of results of Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, led by ECOG-ACRIN Research Group. The largest adjuvant treatment breast cancer trial to date, TAILORx involved 10,273 women across 1,100 trial sites in six participating countries. The study results, published in The New England Journal of Medicine, demonstrated that the Oncotype DX Breast Recurrence Score test definitively identifies the vast majority of women with early-stage breast cancer who receive no benefit from chemotherapy, and the important minority of women for whom chemotherapy benefit can be life-saving.

Additionally, the NCCN guidelines elevated Oncotype DX into the algorithm for chemotherapy treatment of patients with micrometastases and one to three positive lymph nodes.

"We are pleased NCCN continues to clearly distinguish Oncotype DX from other genomic tests based on clinical evidence and the critical importance of predicting chemotherapy benefit," said Steven Shak, M.D., chief scientific and medical officer, Genomic Health. "This new strengthened NCCN guidelines, combined with the recent inclusion of Oncotype DX in international guidelines, demonstrates global support for Oncotype DX as the only ‘preferred’ test to guide optimal treatment based on its unique ability to predict chemotherapy benefit."

NCCN is an alliance of 21 world-leading cancer centers dedicated to improving the quality and effectiveness of care provided to patients with cancer. The 2018 guidelines were published online this week.

About Oncotype DX

The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX Breast Recurrence Score test, is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention. With more than 900,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatement.org.

BerGenBio to present interim phase II clinical, preclinical and biomarker data with selective AXL inhibitor bemcentinib at ESMO

On October 9, 2018 BerGenBio ASA (OSE:BGBIO) reported that the company and its collaborators will present interim clinical and biomarker data from its Phase II clinical programme with bemcentinib (BGB324), a first-in-class highly selective oral AXL inhibitor at the ESMO (Free ESMO Whitepaper) 2018 Congress in Munich (19 – 23 October 2018) (Press release, BerGenBio, OCT 9, 2018, View Source [SID1234529835]).

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Pre-clinical data on the role of AXL inhibition in Myelodysplastic Syndrome (MDS) will also be presented. Details of the presentations are below.

The posters will be made available at www.bergenbio.com in the Investors / Presentations section at the time of presentation and full abstracts will be made available online according to ESMO (Free ESMO Whitepaper)’s embargo schedule: View Source

Poster presentations at ESMO (Free ESMO Whitepaper):
Sunday 21 October, 11:15 – 12:15, Hall B3 – Room 21

Predictive and Pharmacodynamic Biomarkers Associated with Phase II, selective and orally bioavailable AXL Inhibitor Bemcentinib Across Multiple Clinical Trials
Robert Holt, PhD et al
Poster Discussion session – Translational research 2
Invited discussant: 11:15 – 11:45
Presentation number: 63PD
Sunday 21 October, 12:45 – 13:45, Hall A3 – Poster Area

Update on the randomised Phase Ib/II study of the selective small molecule AXL inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib or pembrolizumab in patients with metastatic melanoma
Cornelia Schuster, MD, PhD et al
Poster display session – Melanoma and other skin tumours
Presentation number: 1266P
Sunday 21 October, 16:30 – 17:45, Hall B3 – Room 21

The identification of the AXL/Gas6 signalling axis as a key player of myelodysplastic syndrome (MDS) and the potential of the oral selective AXL inhibitor bemcentinib in the treatment of MDS
Hind Medyouf, PhD et al
Poster Discussion session – Haematological malignancies
Invited discussant: 16:30 – 16:55
Presentation number: 1009PD
END

About the ESMO (Free ESMO Whitepaper) Congress
The ESMO (Free ESMO Whitepaper) Congress is the leading European meeting for medical oncology convening over 20,000 international delegates from the field. ESMO (Free ESMO Whitepaper) 2018 will be held in Munich, Germany 19-23 October 2018.

Oblique Therapeutics Present Tumor Growth Inhibition and Treg-lowering Data for OT-1096 in Humanized Mouse TNBC Model at Oncology Congress ESMO

On October 9, 2018 Oblique Therapeutics, a biotech focused on new medicines for severe diseases with large unmet medical needs, reported that it will present new promising preclinical data for the drug candidate OT-1096 in triple-negative breast cancer (TNBC) at the largest oncology congress in Europe, the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), held 19-23 October in Munich, Germany (Press release, Oblique Therapeutics, OCT 9, 2018, View Source [SID1234529831]).

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The new data of the first-in-class anti-cancer agent OT-1096 shows promising preliminary results with improved tumor growth inhibition compared to pembrolizumab, one of the blockbuster drugs within immunooncology. The humanized TNBC PDX mouse-model, used in this study, allows for the growth of a breast cancer derived from a patient, in the presence of a human immune system. The results suggest that OT-1096 reduces tumor growth by two associated mechanisms; direct cancer cell killing activity by redox system modulation that, in turn, results in a beneficial immunomodulatory action through lowering of regulatory T-cells within the TIL* population as compared to controls. The results warrant further investigations of OT-1096 in TNBC and other aggressive cancers. Treatment with OT-1096 shows no safety or tolerability concerns.

"First of all, it is an honor to be recognized by ESMO (Free ESMO Whitepaper), and we are thrilled to exhibit our promising results for OT-1096 for the first time. Even more so, being part of changing the treatment landscape for cancer at this time is exciting for us: the 2018 Nobel Prize in Medicine was awarded for pioneering work in immunooncology and we see more and more traction and exciting results from novel immunomodulatory small molecules, such as ours, with the capacity to favorably change the immune system inside tumors ," said Prof. Owe Orwar, CEO at Oblique Therapeutics.

TNBC is an aggressive subtype of breast cancer associated with poor prognosis and limited treatment options, and new effective medicines are needed. Globally, two million people are diagnosed with breast cancer every year; of which 10-13 percent has TNBC.

Prof. Owe Orwar, CEO at Oblique Therapeutics, will present a poster (441P) with the title: "OT-1096, a first-in-class immunoactivating small molecule that targets the thioredoxin reductase/thioredoxin axis causes strong tumor growth inhibition by downregulating intratumoral Tregs in a humanized TNBC-PDX model" on Monday 22 October 2018 at 12:45-13:45. The abstract is available through esmo.org: View Source (search: 441P)

For more information, please contact:

Prof. Owe Orwar
CEO
Email: [email protected]

About OT-1096

OT-1096 is a next-generation first-in-class small molecule immunomodulator with anti-cancer activity. The initial clinical focus is on targeting advanced triple-negative breast cancer (TNBC) but the program will be extended to include other forms of metastatic and advanced cancer that fits to the mechanism of action of OT-1096.

Illumina to Announce Third Quarter 2018 Financial Results on Tuesday, October 23, 2018

On October 9, 2018 Illumina, Inc. (NASDAQ:ILMN) reported that it will issue results for third quarter 2018 following the close of market on Tuesday, October 23, 2018 (Press release, Illumina, OCT 9, 2018, View Source [SID1234529829]).

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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 Tuesday, October 23, 2018. Interested parties may access the live teleconference through the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1-800-708-4540, or 1-847-619-6397 outside North America, both with passcode 47554920.

A replay of the conference call will be available from 4:30 pm Pacific Time (7:30 pm Eastern Time) on October 23, 2018 through October 30, 2018 by dialing 1-888-843-7419, or 1-630-652-3042 outside North America, both with passcode 47554920.

Sensei Biotherapeutics to Present Clinical Data at Upcoming Oncology Medical Conferences

On October 9, 2018 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company discovering and developing precision immuno-oncology therapies, reported that it will present clinical data for SNS-301, its first-in-class cancer immunotherapy candidate, at two upcoming oncology medical meetings (Press release, Sensei Biotherapeutics, OCT 9, 2018, View Source [SID1234529828]).

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The company will present results from its Phase 1 study of SNS-301 in antigen-positive patients targeting human aspartate β-hydroxylase (ASPH), a novel tumor-specific embryonic antigen, at a Poster Discussion session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, taking place October 19-23 in Munich. Sensei will also present additional data on the antigen-specific immune responses achieved using SNS-301 in this clinical study, at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), taking place November 9-11 in Washington DC.

Details of the presentations on SNS-301 are as follows:

European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress


Title: Final Results from a Phase 1 Clinical Trial Evaluating the Safety, Immunogenicity, and Anti-Tumor Activity of SNS-301 in Men with Biochemically Relapsed Pro state Cancer

Session Type:

Poster Discussion session – Development therapeutics / investigational immunotherapy

Date & Time:

October 20, 2018, 3:00 – 4:15 p.m. CET

Location:

Hall B3 – Room 22

Presentation #:

416PD

Poster Display:

In designated Poster Discussion area, displayed for the duration of the Congress

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting


Title: Characterization of antigen specific immune responses from a first-in-human study evaluating the anti-ASPH cancer vaccine SNS-301 in biochemically relapsed prostate cancer patients

Session Type:

Poster session

Date & Time:

Friday, November 9, 2018, from 8 a.m. – 8 p.m. ET

Saturday, November 10, 2018, from 8 a.m. – 8:30 p.m. ET

Location:

Hall E

Poster #:

P167

About SNS-301

SNS-301 is a first-in-class cancer immunotherapy targeting human aspartate β-hydroxylase (ASPH), a cell surface enzyme that is normally expressed during fetal development. Following fetal development, the protein is no longer expressed. Expression of ASPH is uniquely upregulated in more than 20 different types of cancer and is related to cancer cell growth, cell motility and invasiveness. ASPH expression levels in various tumors are inversely correlated with disease prognosis. Through enhanced antigen presentation and other engineered immunotherapeutic features, SNS-301 is designed to overcome self-tolerance and induce robust and durable ASPH-specific humoral and cellular immune responses that are specific to ASPH. SNS-301 is paired with a companion diagnostic to select antigen-positive patients and is delivered through intradermal injection to facilitate administration and aid in generating robust immune response.