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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]).

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.

Rgenix Raises $40M in Series C Funding To Support Clinical Stage Oncology Programs

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]).

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.

REVOLUTION Medicines Announces First Patient Dosed with RMC-4630 in Phase 1 Clinical Study in Patients with Advanced Solid Tumors

On October 9, 2018 REVOLUTION Medicines, Inc. reported dosing of the first patient in a Phase 1, open-label, monotherapy dose-escalation and expansion study of RMC-4630, the company’s lead investigational drug candidate targeting the enzyme SHP2 (Press release, Revolution Medicines, OCT 9, 2018, View Source [SID1234529826]). REVOLUTION Medicines holds the IND for RMC-4630, and this trial is being conducted under the recently announced global partnership on SHP2 between REVOLUTION Medicines and Sanofi. Initiation of this clinical trial represents an important step in the company’s mission to translate frontier oncology targets on behalf of cancer patients.

"REVOLUTION Medicines is proud to advance RMC-4630 into clinical development on behalf of patients with advanced cancers who have limited treatment options," said Stephen Kelsey, M.D., FRCP, FRCPath, president of R&D of REVOLUTION Medicines. "Our discovery of optimal inhibitors of SHP2 and elucidation of the critical role of SHP2 in the growth of certain cancers has, for the first time, suggested the potential to render these drivers of cancer clinically actionable. We are eager to advance this program by working with patients, experienced clinical investigators and our development partners at Sanofi."

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of RMC-4630 in people with relapsed, refractory solid tumors including non-small cell lung cancer and other tumor types carrying certain mutations that cause hyperactivation of the RAS-MAP kinase cell growth signaling cascade. Despite notable recent therapeutic advances in the management of lung cancer and melanoma, there remain large unmet medical needs as no targeted therapies have been approved for treating patients with solid tumors carrying these specific mutations. The study will comprise two parallel components: (1) a dose escalation study for patients with solid tumors, and (2) an expansion study for patients with tumors harboring specific mutations.

Original research led by scientists at REVOLUTION Medicines, and conducted in collaboration with researchers at the University of California, San Francisco School of Medicine, discovered that cancers caused by these oncogenic signaling proteins rely on the normal biochemical actions of SHP2. These data were first disclosed in preliminary form in 2017 via BioRxiv, and have now been published in a full peer-reviewed paper in Nature Cell Biology. They demonstrated that cancers with such "semi-autonomous" mutations may be susceptible to treatment with an inhibitor of SHP2. The trial of RMC-4630 will explore precision oncology hypotheses based on these findings at several clinical centers, including the University of California, Irvine, Chao Family Comprehensive Cancer Center.

The Role of SHP2 in Cancer

SHP2 (PTPN11), a cellular enzyme in the protein tyrosine phosphatase family, plays an important role in multiple forms of cancer and in anticancer immunity. Recently REVOLUTION Medicines reported discoveries about the regulation by SHP2 of a cell growth signaling pathway, known as the RAS-MAP kinase pathway, that frequently is hyperactive in human cancers. The research showed that some mutated forms of proteins in the RAS-MAP kinase pathway depend on SHP2 for their oncogenic activity, and that small molecule inhibitors of SHP2 designed by the company may reduce their tumorigenic effects.

About RMC-4630

RMC-4630 is a potent, selective and orally administered small molecule inhibitor of SHP2. RMC-4630 acts by stabilizing the SHP2 protein in an inactive conformation that is unable to transmit cell growth signals. RMC-4630 as a single agent was found to attenuate signal transduction through the RAS-MAP kinase cascade, reduce tumor growth and cause tumor cell death in preclinical xenograft studies of human tumors carrying select mutations in the RAS-MAP kinase pathway.

AVEO Oncology to Present Updated Interim Results from the Phase 2 Portion of the TiNivo Study of Tivozanib and Nivolumab (OPDIVO®) in RCC at the ESMO 2018 Annual Congress

On October 9, 2018 AVEO Oncology (NASDAQ:AVEO) reported that updated interim data from the Phase 2 portion of the TiNivo trial of tivozanib and nivolumab (OPDIVO) in advanced renal cell carcinoma will be presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Annual Congress being held October 19-23, 2018 in Munich, Germany (Press release, AVEO, OCT 9, 2018, View Source [SID1234529825]). The TiNivo study is a Phase 1b/2 multicenter trial of oral tivozanib (FOTIVDA) in combination with intravenous nivolumab (OPDIVO, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, for the treatment of metastatic renal cell carcinoma (mRCC).

The accepted abstract, which includes results from a poster presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January, is available via the ESMO (Free ESMO Whitepaper) 2018 Annual Congress website. Updated data will be presented at the ESMO (Free ESMO Whitepaper) conference.

Presentation Details

Title: TiNivo: Tivozanib combined with nivolumab: safety and efficacy in patients with metastatic renal cell carcinoma (mRCC)
Presenter: Philippe Barthelemy, Medical Oncology Department, Hôpitaux Universitaires de Strasbourg, Strasbourg, FR
Presentation Number: 878P
Date and Time: October 22, 2018, 1:05 p.m. CEST
Location: Hall A3 – Poster Area