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NuCana to Present New Data from its ProTide Portfolio at the European Society for Medical Oncology (ESMO) 2018 Congress

On October 9, 2018 NuCana plc (NASDAQ:NCNA), a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer, reported that investigators will present new data from the Acelarin (NUC-1031) and NUC-3373 programs at the ESMO (Free ESMO Whitepaper) 2018 Congress to be held October 19-23, 2018, in Munich, Germany (Press release, Nucana BioPharmaceuticals, OCT 9, 2018, View Source [SID1234529859]). These data include the latest results from the ABC-08 Phase Ib front-line study of Acelarin plus cisplatin in advanced biliary tract cancer, as well as a recruitment update from the Acelarate Phase III front-line study of Acelarin in pancreatic cancer. In addition, results from the NuTide:301 Phase I study of NUC-3373 in advanced solid tumors will be presented.

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Hugh S. Griffith, NuCana’s Chief Executive Officer, said: "We are excited about sharing these latest data at ESMO (Free ESMO Whitepaper) and the potential of our pipeline of innovative ProTides to transform the treatment of patients with cancer."

Details of NuCana’s poster presentations are as follows:

Poster Presentation Session Date & Time: October 21, 2018, 12:45pm CEST

Title: A new ProTide, NUC-1031, combined with cisplatin for the first-line treatment of advanced biliary tract cancer (ABC-08)

Presentation Number: 758P

Session Title: Basic science, Endocrine tumours, Gastrointestinal tumours – colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Location: Hall A3, Poster Area Networking Hub

Presenter: Dr. Mairead McNamara

Poster Presentation Session Date & Time: October 21, 2018, 12:45pm CEST

Title: ACELARATE – A randomised Phase III, open label, clinical study comparing NUC-1031 with gemcitabine in patients with metastatic pancreatic carcinoma

Presentation Number: 788TiP

Location: Hall A3 – Poster Area Networking Hub

Presenter: Professor Daniel Palmer

Poster Presentation Session Date & Time: October 22, 2018, 12:45pm CEST

Title: A Phase I first-in-human, dose-escalation and expansion study to evaluate the safety and tolerability of NUC-3373 in patients with locally advanced, unresectable or metastatic solid malignancies

Presentation Number: 442TiP

Session Title: Breast cancer – early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours—prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Location: Hall A3 – Poster Area Networking Hub

Presenter: Professor Sarah Blagden

TESARO Announces Data Presentations at the ESMO 2018 Congress

On October 9, 2018 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, reported that data from six abstracts will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress from October 19-23, 2018 in Munich, Germany (Press release, TESARO, OCT 9, 2018, View Source [SID1234529855]).

"At this year’s ESMO (Free ESMO Whitepaper) Congress, blinded, pooled interim safety data from PRIMA will be presented, which demonstrated that an individualized starting dose of ZEJULA resulted in a favorable tolerability profile compared to a fixed starting dose of 300 milligrams. PRIMA is a fully-enrolled Phase 3 trial for patients with first-line ovarian cancer regardless of biomarker status and we expect top-line results to be available in late 2019," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "TESARO is also advancing a robust immuno-oncology portfolio. Data will be presented in a poster discussion from the MSI-H endometrial cohort of the GARNET trial of TSR-042, our anti-PD-1 antibody, for which we are planning to submit a biologic license application (BLA) next year."

Please plan to visit TESARO at Booth #212 for information about ZEJULA and our pipeline.

Details of TESARO’s poster presentations are as follows (all times local):
All posters will be on display beginning Saturday, October 20, 7:30 AM.

ZEJULA (niraparib)

Saturday, October 20, 2018, 9:15 AM – 10:45 AM; Lecture time: 9:59 AM
A prospective evaluation of tolerability of niraparib dosing based upon baseline body weight (wt) and platelet (plt) count: Blinded pooled interim safety data from the PRIMA Study
Poster Discussion, Abstract: 941PD, Location: ICM – Room 13, Poster Displayed: Hall B4

Saturday, October 20, 2018, 12:30 PM – 1:30 PM
QUADRA: A phase 2, open-label, single-arm study to evaluate niraparib in patients with relapsed ovarian cancer in 4th or later line of therapy: results from the tBRCAmut subset
Poster Session, Abstract: 944P, Location: Hall A3

Saturday, October 20, 2018, 12:30 PM – 1:30 PM
OVARIO: A single-arm, open-label phase 2 study of maintenance therapy with niraparib + bevacizumab in patients with advanced ovarian cancer after response to frontline platinum-based chemotherapy
Poster Session, Abstract: 999TiP, Location: Hall A3

Saturday, October 20, 2018, 12:30 PM – 1:30 PM
Real world occurrence of top three clinical-trial reported adverse events of PARP inhibitor niraparib maintenance therapy in platinum-sensitive recurrent ovarian cancer, a national retrospective observational study of a 200 mg/day starting-dose cohort
Poster Session, Abstract: 986P, Location: Hall A3

Saturday, October 20, 2018, 12:30 PM – 1:30 PM
Brain metastases in primary ovarian cancer: real-world data
Poster Session, Abstract: 946P, Location: Hall A3

TSR-042 (anti-PD-1)

Saturday, October 20, 2018, 9:15 – 10:45 AM; Lecture time: 9:15 AM
Preliminary safety, efficacy, and PK/PD characterization from GARNET, a phase 1 clinical trial of the anti–PD-1 monoclonal antibody, TSR-042, in patients with recurrent or advanced MSI-H endometrial cancer
Poster Discussion, Abstract: 935PD, Location: ICM – Room 13, Poster displayed: Hall B4

Niraparib is marketed in the United States and Europe under trade name ZEJULA.

About ZEJULA (Niraparib)
ZEJULA (niraparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. ZEJULA can cause fetal harm and females of reproductive potential should use effective contraception. Please see full U.S. prescribing information, including additional important safety information, available at www.zejula.com.

About TSR-042
TSR-042 is a monoclonal antibody targeting PD-1 and was developed as part of the collaboration between TESARO and AnaptysBio, Inc. This collaboration was initiated in March of 2014, and is focused on the development of monospecific antibody drugs targeting PD-1, TIM-3 (TSR-022), and LAG-3 (TSR-033), in addition to a bi-specific antibody drug candidate targeting PD-1/LAG-3 (TSR-075).

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.

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]).

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]).

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.