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.

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.

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.

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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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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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.

On October 9, 2018 Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported that it has raised $40 million in a Series C financing in support of further development of the company’s clinical and pre-clinical oncology programs and for general corporate purposes (Press release, Rgenix, OCT 9, 2018, View Source [SID1234529827]).

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The Series C financing was led by Lepu Medical, a publicly traded global healthcare firm, and includes Oceanpine Capital and WuXi AppTec’s Corporate Venture Fund. Existing investors also participated in the financing round, including Novo Holdings A/S, Sofinnova Partners, Alexandria Venture Investments, LLC, and the Partnership Fund for New York City’s Innovate NY Fund and associated entities.

The financing will support Phase 1b/2 clinical trials of the lead program RGX-104 in multiple cancer indications, including in checkpoint inhibitor refractory patients. It will also support early clinical development of RGX-202, a first-in-class cancer metabolism program, as well as discovery stage programs arising from the Rgenix target discovery platform.

"Lepu Medical is very pleased to make this investment in Rgenix. We truly appreciate Rgenix’s unique RNA target discovery approach in identifying various first-in-class cancer targets. We also believe RGX-104 has great potential with checkpoint inhibitors across many important cancer types," said Dr. Zhongjie Pu, PhD, Chairman and CEO of Lepu Medical. "As Lepu Medical has PD-1, PD-L1 checkpoint inhibitors and an oncolytic virus in clinical trials, we also look forward to exploring possible collaborative opportunities with Rgenix as part of our goal to develop further in the oncology market together."

"The addition of new investors to our already strong investor base is a testament to the power of our approach to develop first-in-class cancer therapeutics using the innovative Rgenix RNA target discovery platform to identify novel cancer targets," said Masoud Tavazoie, MD, PhD, and Chief Executive Officer and co-founder of Rgenix. "We are delighted to have the support of these investors and to know that they share our excitement for the work we are doing to develop these new therapies for patients who suffer from cancers of high unmet need."

RGX-104 is a first-in-class small-molecule immunotherapy that targets the Liver X Receptor (LXR) and modulates innate immunity by activating the ApoE gene. Data from a Phase 1a dose escalation of RGX-104 in advanced cancer patients demonstrated both immune-stimulatory and anti-tumor activity. Rgenix is currently enrolling patients in the Phase 1b stage of the trial in multiple cancer indications, including in combination with the checkpoint inhibitor nivolumab.

RGX-202 is a small molecule compound that suppresses gastrointestinal cancer progression by inhibiting a novel cancer metabolism pathway involved in supplying energy to cancer cells. Pre-clinical research shows the compound is active as a monotherapy and in combination with chemotherapy considered to be the standard of care. Rgenix expects to launch a Phase 1 trial of RGX-202 in 2018.

Rgenix was advised by Jefferies LLC in this Series C financing.