1stOncology™: Cancer Intelligence Service – Page 9985 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Arcus Biosciences to Present Preliminary Data from Phase 1 Portion of ARC-8 Study for AB680 in Metastatic Pancreatic Cancer at ASCO-GI Symposium

On January 11, 2021 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported that preliminary data from the ongoing dose-escalation portion of its ARC-8 Phase 1/1b study, evaluating the safety and tolerability of AB680, the first small-molecule CD73 inhibitor to enter the clinic, in combination with zimberelimab (anti-PD-1) and nab-paclitaxel plus gemcitabine (chemotherapy) in front-line metastatic pancreatic cancer will be presented in a poster session at the ASCO (Free ASCO Whitepaper) 2021 Virtual Gastrointestinal Cancers Symposium (ASCO GI) being held January 15th – 17th, 2021 (Press release, Arcus Biosciences, JAN 11, 2021, View Source [SID1234573853]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

"While recent cancer breakthrough therapies, most notably anti-PD-1 antibodies, have led to dramatic improvements in outcomes in many cancer settings, this is not the case for pancreatic cancer, which remains a devastating diagnosis for patients. We are highly encouraged by the preliminary data from our Phase 1 trial for AB680 in combination with anti-PD-1 therapy and chemotherapy, in which we have seen promising clinical activity in these difficult to treat patients. Importantly, this experimental regimen has been well tolerated, and early safety data indicate that this AB680 combination regimen appears to have a side effect profile similar to that of anti-PD-1 therapy and chemotherapy," said Bill Grossman, M.D., the Chief Medical Officer of Arcus. "We look forward to presenting updated data from the Phase 1 portion of this trial at ASCO (Free ASCO Whitepaper) GI on January 15th, wherein we will report more mature safety and clinical response data, including those from the 100mg dose cohort."

The clinical activity and safety profile observed to date with AB680 in combination with zimberelimab (anti-PD-1 antibody) and chemotherapy support its recent advancement into the ongoing Phase 1b expansion portion of the study, as well as plans to open a randomized control arm for the Phase 1b expansion. Dosing of AB680 100mg I.V. every two weeks has been selected for this portion of the study.

Full details of the presentation are as follows:

Abstract/Poster Title: ARC-8: Phase I/Ib study to evaluate safety and tolerability of AB680 + chemotherapy + zimberelimab (AB122) in patients with treatment-naive metastatic pancreatic adenocarcinoma (mPDAC)
Abstract No: 404
Poster Session: Pancreatic Cancer
Available Date: January 15, 2021
Time: 5:00 a.m. PT

In addition to the presentation on AB680, Arcus will also highlight the design of the recently initiated ARC-9 randomized Phase 2 study to advance etrumadenant in late-line colorectal cancer:

Abstract/Poster Title: ARC-9: Phase Ib/II study to evaluate etrumadenant (AB928)-based treatment combinations in patients with metastatic colorectal cancer (mCRC)
Abstract No: TPS150
Trials in Progress Poster Session: Colorectal Cancer
Available Date: January 15, 2021
Time: 5:00 a.m. PT

Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer-related deaths in Europe and the United States1 and the seventh leading cause of cancer-related deaths worldwide2.

Pancreatic ductal adenocarcinoma (PDAC) is the most prevalent neoplastic disease of the pancreas, with high metastatic potential, accounting for more than 90% of all pancreatic malignancies and is a highly devastating disease with poor prognosis and rising incidence.3,4

Few treatment options exist for metastatic pancreatic cancer, and response rates to the standard of care therapy of gemcitabine/nab-paclitaxel remain very low. Based on the FDA approved label for nab-paclitaxel in combination with gemcitabine, the phase 3 registrational trial demonstrated overall and complete response rates in patients with metastatic pancreatic cancer that were 23% and <1%, respectively. 1,5

To date, addition of anti-PD-1 antibodies to gemcitabine/nab-paclitaxel in controlled clinical trials in this setting has shown no added benefit when compared to that obtained with the chemotherapy alone.6,7

About ARC-8 Study

ARC-8 is a Phase 1/1b study to evaluate safety and tolerability of AB680 + zimberelimab (AB122) + chemotherapy in patients with treatment-naive metastatic pancreatic adenocarcinoma.

For additional information on this trial (NCT04104672), please visit www.clinicaltrials.gov.

About AB680

AB680 is an extremely potent and selective small-molecule CD73 inhibitor designed to provide differential benefits relative to monoclonal antibodies, such as greater inhibition of CD73 enzymatic activity (both soluble and cell-bound) and deeper tumor penetration. CD73 is the primary enzymatic producer of immunosuppressive adenosine in the tumor microenvironment, and high CD73 expression is associated with significantly poorer prognosis in several tumor types, including pancreatic cancer. 8 By effectively eliminating CD73-derived adenosine, AB680 may improve the efficacy of treatment approaches expected to elicit anti-cancer immune responses (e.g., platinum-based chemotherapy with/without anti-PD-1 therapy). AB680 was the first small-molecule CD73 inhibitor to enter the clinic and demonstrated a favorable safety profile with a long half-life in a healthy volunteer study. AB680 is currently in a Phase 1/1b study for the treatment of first-line metastatic pancreatic cancer.

Omeros to Present at the 39th Annual J.P. Morgan Healthcare Conference

On January 11, 2021 Omeros Corporation (Nasdaq: OMER) reported that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the 39th Annual J.P. Morgan Healthcare Conference this week (Press release, Omeros, JAN 11, 2021, View Source [SID1234573852]). This conference is being held as a virtual conference this year. The presentation is scheduled for Wednesday, January 13, 2021 at 10:50 a.m. EST.

The presentation will be webcast. The live and archived webcasts can be accessed on the investor relations section of the company’s website at www.omeros.com under "Events." The archived webcast will be available for 30 days.

BeiGene Announces Collaboration with Novartis to Develop and Commercialize Anti-PD-1 Antibody Tislelizumab

On January 11, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported a collaboration and license agreement with Novartis Pharma AG to develop, manufacture and commercialize BeiGene’s anti-PD-1 antibody tislelizumab in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan (Press release, BeiGene, JAN 11, 2021, View Source [SID1234573851]). The Companies have agreed to jointly develop tislelizumab in these licensed countries, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals. In addition, both companies may conduct clinical trials globally to explore combinations of tislelizumab with other cancer treatments, and BeiGene has an option to co-detail the product in North America, funded in part by Novartis.

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It is approved and marketed by BeiGene in China in two indications, classical Hodgkin’s lymphoma (cHL) following at least two prior therapies and locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression. In addition, three supplemental new drug applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) and are under review. These indications are first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and previously treated unresectable hepatocellular carcinoma.

"We are excited to collaborate with Novartis to further explore the potential of tislelizumab in multiple combinations and indications. Novartis is a well-recognized leader in oncology with a unique portfolio of cancer treatments and pipeline agents," said John V. Oyler, Co-Founder, CEO, and Chairman of BeiGene. "This important collaboration stands on a strong foundation of tislelizumab’s broad global development program, which has delivered two approvals in China, currently spans 15 potentially registration-enabling clinical trials, and has enrolled over 7,700 patients to date, including approximately 2,500 patients in more than 20 countries and regions outside of mainland China. We look forward to working with Novartis to fulfill the global opportunity of this potentially differentiated anti-PD-1 antibody."

Under the agreement BeiGene will receive an upfront cash payment of $650 million from Novartis. BeiGene is eligible to receive up to $1.3 billion upon the achievement of regulatory milestones, $250 million upon the achievement of sales milestones, and royalties on future sales of tislelizumab in the licensed territory. Under the terms of the agreement, BeiGene will be responsible for funding ongoing clinical trials of tislelizumab, Novartis has agreed to fund new registrational, bridging, or post-marketing studies in its territory, and each party will be responsible for funding clinical trials evaluating tislelizumab in combination with its own or third party products. Each party retains the worldwide right to commercialize its propriety products in combination with tislelizumab.

Closing of the transaction is subject to the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

BeiGene Presentation at J.P. Morgan Healthcare Conference

The Company will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14 at 5:20 p.m. ET.

A live webcast of the conference call can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available after the event for 90 days.

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed globally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab received conditional approval from the China NMPA as a treatment for patients with cHL who received at least two prior therapies and for patients with locally advanced or metastatic UC with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Complete approval for these indications may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, three sNDAs for tislelizumab have been accepted by the CDE of the NMPA and are under review, for first-line treatment of patients with advanced squamous NSCLC in combination with chemotherapy, for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for previously treated unresectable HCC.

Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 13 Phase 3 trials and two pivotal Phase 2 trials.

Tislelizumab is not approved for use outside of China.

About Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 3 trial comparing tislelizumab to salvage chemotherapy in patients with relapsed/refractory classical Hodgkin Lymphoma (NCT04486391);
Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).

Illumina Announces New and Expanded Oncology Partnerships with Bristol Myers Squibb, Kura Oncology, Myriad Genetics, and Merck to Advance Comprehensive Genomic Profiling

On January 11, 2021 With genetic sequencing at the forefront of precision medicine, Illumina (NASDAQ: ILMN) reported a portfolio of new and expanded oncology partnerships that further the company’s commitment to develop standardized, globally distributable tools for precision oncology (Press release, Illumina, JAN 11, 2021, View Source [SID1234573850]).

Speaking today at the 39th Annual J.P. Morgan Healthcare Conference in San Francisco, California, Illumina CEO, Francis deSouza, announced a series of oncology partnerships that aim to expand the reach of its powerhouse comprehensive genomic profiling family of products, TruSight Oncology.

TruSight Oncology 500 (TSO 500) is a Research Use Only comprehensive pan-cancer assay designed to identify 523 known and emerging tumor biomarkers. TSO 500 utilizes both DNA and RNA from tumor samples to identify key somatic variants critical for cancer development and progression, such as small DNA variants, fusions, and splice variants. Based on the content of TSO 500, Illumina will be adding an in vitro diagnostic (IVD) test to the TruSight Oncology product family. This comprehensive tumor profiling assay will have similar chemistry and analytics to TSO 500 and is currently undergoing review with regulatory authorities. It is expected to be launched in both the U.S. and Europe later this year.

"Cancer is a disease of the genome and treatment will increasingly leverage NGS-based tests, from early detection and diagnoses, to therapy selection and monitoring," said deSouza. "The continued expansion of our TruSight Oncology pipeline complements our planned acquisition of multi-cancer early detection company GRAIL."

Illumina is leveraging the content of its TSO 500 assay to develop companion diagnostics (CDx). The following partnerships demonstrate Illumina’s commitment to collaborating with industry leaders on cancer diagnostics and the advancement of precision oncology:

BRISTOL MYERS SQUIBB: Expanding on a collaboration that began in 2018, Bristol Myers Squibb will develop a microsatellite instability CDx, as well as develop a diagnostic based on the content of TruSight Oncology 500 ctDNA, Illumina’s first liquid biopsy assay. Both program expansions are planned for global use by Bristol Myers Squibb’s portfolio of cancer therapeutics.
KURA ONCOLOGY: Our partnership with Kura Oncology is focused on building a CDx claim for HRAS mutations in Head and Neck Squamous Cell Carcinomas.
Responding to the growing clinical use of PARP inhibitor drugs beyond BRCA-mutant cancers, and toward broader populations of patients with homologous recombination repair deficiency (HRD), Illumina is partnering to further expand the clinical utility of the TruSight Oncology portfolio.

MYRIAD GENETICS: Illumina is partnering with Myriad, with time-limited exclusivity in certain markets, to develop and commercialize distributed kits for the assessment of HRD and for Myriad to expand its HRD service offerings, through a combination of TruSight Oncology content and Myriad’s myChoice CDx test.
"The agreement between Myriad and Illumina combines clinically validated companion diagnostics and next-generation sequencing to advance comprehensive genomic profiling of tumor samples and drive improved outcomes for oncology patients," said Paul J. Diaz, President and CEO, Myriad Genetics. "We are pleased to collaborate with a high-caliber healthcare leader like Illumina to expand international access to the proprietary technology in Myriad’s myChoice CDx test and together bring innovative solutions to the oncology market."

MERCK: Additionally, Illumina and Merck are conducting a study focused on the expanded TruSight Oncology HRD offering.
"Illumina remains committed to innovating and diversifying our oncology product portfolio and partnerships. Together we can help rapidly deliver actionable insights to patients and physicians, by removing the empiric nature of therapy selection," said Joydeep Goswami, Senior Vice President of Corporate Business Development at Illumina. "With sequencing at the forefront of precision medicine, we are inspired by the opportunity that lies ahead with not just these partnerships, but others to come."

Agendia to Participate in the 39th Annual J.P. Morgan Healthcare Conference

On January 11, 2021 Agendia, Inc., a world leader in precision oncology for breast cancer, reported its participation in the 39th Annual J.P. Morgan Healthcare Conference, which will take place from Monday, January 11 through Thursday, January 14, 2021 (Press release, Agendia, JAN 11, 2021, View Source [SID1234573849]). Agendia Chief Executive Mark Straley will give a virtual presentation on Thursday, January 14 at 2:35 PM EST.

A link to the live audio webcast of Mr. Straley’s presentation will be available by visiting the News & Updates section of Agendia’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.