On September 16, 2020 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported it has published a presentation that Joseph C. Papa, chairman and CEO, and Paul S. Herendeen, executive vice president and chief financial officer, are scheduled to present at the virtual 18th Annual Morgan Stanley Global Healthcare Conference today, Sept. 16, 2020, at 1:15 p.m. ET (Press release, Bausch Health, SEP 16, 2020, View Source [SID1234565263]).

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The presentation provides an update on Bausch Health’s current business recovery in the wake of the COVID-19 pandemic, as well as an update and progress report regarding the Company’s previously disclosed intention to spin off its eye health business.

The presentation is available on the Investor Relations page of the Bausch Health Companies Inc. web site at: View Source A live webcast and audio archive of the event will be also be available for 90 days.

On September 16, 2020 Genelux Corporation, a privately-held biopharmaceutical company, reported that data from the Phase 2 VIRO-15 study evaluating its lead oncolytic virus, Olvi-Vec-primed immunochemotherapy in platinum-resistant/refractory ovarian cancer (PRROC) (NCT02759588), will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, being held September 19-21 (Press release, Genelux, SEP 16, 2020, View Source [SID1234565262]).

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"The Phase 2 data in PRROC patients demonstrated remarkable overall survival in combination with a platinum-based regimen, especially in the difficult-to-treat platinum-refractory disease population, considering these patients were heavily pretreated and largely at pre-hospice stage," said Robert Holloway, MD, principal investigator for VIRO-15 and Chair of Genelux’s Clinical Advisory Board on gynecologic cancers.

"Genelux is pleased with the promising data out of the Phase 2 VIRO-15 study, and we are optimistic about the potential of Olvi-Vec-primed immunochemotherapy to extend the life expectancy and improve the quality of life of patients who currently lack effective treatment options," said Thomas Zindrick, J.D., President and CEO of Genelux. "A registration trial of Olvi-Vec-primed immunochemotherapy is being planned."

Data from the Phase 2 VIRO-15 trial are outlined below.

Abstract Number: 2982

Abstract Title: Phase 2 Trial of Oncolytic Vaccinia Virus Olvi-Vec-Primed Immunochemotherapy in Heavily Treated Platinum-Resistant/Refractory Ovarian Cancer (PRROC)

Abstract Authors: Robert W. Hollowaya, Alberto A. Mendivilb, James E. Kendricka, Lisa N. Abaidb, John V. Brownb, Christine K. Fitzsimmonsa, Jessica A. Kennarda, Monica Kingb, Jane LeBlanca, Katrina Lopezb, Madhavi Manyama, Nathalie D. McKenziea, Kristina M. Morib, Amanda J. Stephensa, Sarfraz Ahmada. aAdventHealth Cancer Institute, Orlando, FL 32804, USA, bGynecologic Oncology Associates, Newport Beach, CA 92663, USA

Session Title/Date: ESMO (Free ESMO Whitepaper) Virtual Congress 2020, Science Weekend, September 19-21, 2020

Abstract Highlights:

Background: Intraperitoneal infusion of Olvi-Vec virus followed by IV carboplatin-doublet (CD) ± bevacizumab (Bev) in heavily pretreated patients with PRROC was evaluated. Primary objectives were RECIST overall response rate (ORR) and progression-free survival (PFS). Secondary objectives included overall survival (OS), CA-125 response, safety and translational studies.

Methods: Patients who progressed on most recent therapies received 2 consecutive days of Olvi-Vec followed by CD ± Bev, and then maintenance single agent ± Bev. Pre- & post-virotherapy tumor biopsies and blood were obtained for analyses.

Key results: 27 patients (median 4 prior lines, 52% platinum-refractory, 48% platinum-resistant) enrolled. Median OS was 15.7 mos (95% CI: 12.3 – 23.5) for all patients. 9/27 (33.3%) patients have survival > 18 months, with 4 of these patients still alive beyond 3-4 years. In patients with platinum-refractory disease, median OS was 15.2 months (95% CI: 10.8 – 33.6).

Conclusions: Despite having PRROC and documented disease progression at enrollment, most patients responded to CD therapies after oncolytic virotherapy, with OS exceeding historical comparisons in heavily pretreated PRROC patients. Virus-induced changes in the tumor microenvironment may explain the apparent reversal of platinum resistance.

About Olvimulogene Nanivacirepvec (Olvi-Vec)
Olvi-Vec is a proprietary, non-pathogenic oncolytic vaccinia virus, modified to increase its safety, tumor selectivity and anti-tumor activity. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer. Clinical results in more than 150 subjects have shown Olvi-Vec is well tolerated with documented clinical benefits.

On September 16, 2020 Ashion Analytics LLC reported a partnership with Elevation Oncology, a clinical stage biopharmaceutical company, focused on the matching of patients with tumors harboring an NRG1 gene fusion identified using Ashion’s proprietary GEM ExTra test with CRESTONE, a registration-directed Phase 2 study sponsored by Elevation Oncology (Press release, Ashion Analytics, SEP 16, 2020, View Source [SID1234565261]).

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NRG1 gene fusions are a rare genomic alteration implicated as a driver of tumorigenesis and growth across many types of solid tumors, including lung, breast, pancreatic, ovarian, and colorectal cancers. CRESTONE — or Clinical study of REsponse to Seribantumab in TumOrs with NEuregulin 1 (NRG1) fusions — provides an investigational treatment opportunity for patients with any advanced solid tumor who have not responded or are no longer responding to standard cancer treatment, and whose tumor has tested positive for an NRG1 fusion.

This partnership creates a new dynamic in the way cancer patients can be matched to precision medicine therapeutics. By first identifying a genetic driver that has an available targeted therapy option, in this case an NRG1 fusion and the investigational therapy seribantumab, the diagnostic technology, data insights, and network reach at Ashion Analytics can be leveraged to efficiently identify and directly match eligible patients to the CRESTONE trial using test results that are already available today, while also maximizing the value of every additional test.

"The comprehensive nature of the GEM ExTra test means that its value grows directly with each new genomic driver that is identified and each new precision therapy under development," said Laurie Goodman, Ph.D., Ashion Analytics Director of Business Development and Medical Affairs. "Partnerships like this enable us to continuously facilitate the ability for our patients to receive the most up-to-date information about the emerging treatment opportunities available to them today."

Ashion Analytics recently announced that Medicare has approved coverage of its proprietary cancer profiling test, GEM ExTra, one of the nation’s most comprehensive genomic cancer analysis tests. Medicare coverage enables potentially 44 million more patients to afford this test, which aims to match patients with best available treatments for their disease.

GEM ExTra detects tumor-specific mutations in both DNA and RNA, allowing physicians to make the best-available treatment recommendations for patients with advanced solid tumors. An Ashion study poster presented at the 2020 annual meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) details the importance of using RNA as part of the analysis to give cancer physicians the best possible options for treating their patients: Employing RNA Sequencing to Enhance Treatment Options for Cancer Patients.

This leading-edge test provides treating physicians with vital interpreted information needed to understand changes to a patient’s genomic profile. It outlines a therapeutic treatment plan best suited for each patient. Conditions that may benefit from this approach include treatment of refractory, rare or aggressive cancers.

"We are partnering with Ashion Analytics because we recognize the sensitivity and continuing potential of their GEM ExTra cancer profiling test," said Shawn Leland, PharmD, RPh, Founder and Chief Business Officer of Elevation Oncology. "Elevation Oncology is committed to expanding the benefit of precision medicine to all patients with cancer by developing therapies that make results from tests like GEM ExTra clinically actionable, no matter how rare the finding. Close collaboration between diagnostic and therapeutic developers is critical to re-thinking our approach to clinical trial enrollment as an industry and finding more efficient ways to bring the right treatment opportunities to the patients that need them."

On September 16, 2020 Menarini Ricerche, the R&D division of the Menarini Group, reported that a first patient in Europe has been treated in the cohort expansion phase of the DIAMOND clinical trial -01 (CLI24-001; NCT03008187), investigating SEL24 / MEN1703, a first-in-class dual oral PIM / FLT3 inhibitor, as a monotherapy agent in acute myeloid leukemia (AML) (Press release, Menarini, SEP 16, 2020, View Source [SID1234565260]). The patient has received the assigned treatment in the expansion phase of the cohort, which has been initiated after the end of the dose escalation phase of the trial, the results of which have been presented at the 25th annual meeting of the European Hematology Association (EHA) (Free EHA Whitepaper). The aforementioned cohort expansion phase began previously in the United States, with a first patient treated on July 21, 2020.

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DIAMOND-01 is a phase I-II trial, first administration to humans, in a dose escalation and cohort expansion design, to evaluate SEL24 / MEN1703,, in patients with recurrent or refractory AML, as well as patients who do not have been previously treated because they are not candidates for standard chemotherapy The expansion of the cohort, which has been implemented in various centers of excellence in oncology in the United States and Europe (Italy, Spain and Poland), will recruit patients with recurrent AML or refractory, and will evaluate the monotherapy activity and the safety profile of SEL24 / MEN1703 at the recommended dose, determined according to the results of the dose escalation phase.

On September 16, 2020 Amgen (NASDAQ:AMGN) reported that data from its oncology pipeline in solid tumors will be presented during the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, Sept. 19-21, 2020 (Press release, Amgen, SEP 16, 2020, View Source [SID1234565259]).

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Amgen will present new data for AMG 510 (proposed INN: sotorasib) and AMG 160 during two oral presentations. Data from the study of sotorasib, Amgen’s investigational KRASG12C inhibitor, will showcase Phase 1 clinical results on durability of clinical benefit in patients with non-small cell lung cancer (NSCLC). Additionally, data from Amgen’s bispecific T cell engager (BiTE) platform will feature preliminary safety and efficacy findings from the ongoing Phase 1 study of AMG 160, an investigational half-life extended BiTE immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA). Abstracts will be released on Saturday, Sept. 19, and will be followed by oral presentations (sotorasib, Sunday Sept. 20 and AMG 160, Monday Sept. 21) that will highlight more recent data.

"During ESMO (Free ESMO Whitepaper), we will highlight our pioneering work in two key areas of oncology research – KRAS inhibition and BiTE therapies," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Clinicians will be presenting updated data from the first and largest Phase 1 human clinical study of an investigational KRASG12C inhibitor, sotorasib — now the first KRASG12C inhibitor to advance to a Phase 3 study. In addition, early and encouraging data from our BiTE platform in the solid tumor setting will be presented. Our data at ESMO (Free ESMO Whitepaper) underscore our unique approach to harnessing the human biology of cancer to alter the course of cancer care for patients who need it most."

Learn more about Amgen’s development of innovative medicines for novel targets in difficult-to-treat solid tumors at AmgenOncology.com.

Key Clinical Abstracts and Presentation Times (Pipeline):

Durability of Clinical Benefit and Biomarkers in Patients (pts) With Advanced Non-Small Cell Lung Cancer (NSCLC) Treated With AMG 510 (sotorasib)*
Presentation #1257O, Proffered Paper Session, Sunday, Sept. 20, 2020, from 2:25 p.m. – 2:37 p.m. CEST / 5:25 a.m. – 5:37 a.m. PDT
Results From a Phase 1 Study of AMG 160, a Half-Life Extended (HLE), PSMA-Targeted, Bispecific T Cell Engager (BiTE) Immune Therapy for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Presentation #609O, Proffered Paper Session, Monday, Sept. 21, 2020, from 2:25 p.m. – 2:37 p.m. CEST / 5:25 a.m. – 5:37 a.m. PDT
Amgen Webcast Investor Call
Amgen will host two webcast calls for the investment community in conjunction with the ESMO (Free ESMO Whitepaper) Virtual Congress 2020. On Sunday, Sept. 20, 2020, at 11:00 a.m. PDT, David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRASG12C inhibitor sotorasib (AMG 510). On Monday, Sept. 21, at 1:00 p.m. PDT, David M. Reese, M.D., along with members of Amgen’s clinical development team, will discuss the Phase 1 data being presented on the Company’s investigational half-life extended bispecific T-cell engager (BiTE) immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA). 

Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit www.AmgenOncology.com.

About CodeBreaK
The CodeBreaK clinical trial program for Amgen’s investigational drug sotorasib is designed to treat patients with multiple KRAS G12C-mutant solid tumors and address the longstanding unmet medical need for these cancers.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients were heavily pretreated with at least two or more prior lines of treatment, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 1 study is safety, and key secondary endpoints include objective response rate (assessed every six weeks), duration of response and progression-free survival. Patients were enrolled in four dose cohorts: 180 mg, 360 mg, 720 mg and 960 mg, taken orally once a day.

Amgen’s single-arm Phase 2 trials in both non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) (also part of CodeBreaK 100) are now fully enrolled. The potentially registrational Phase 2 trial in NSCLC is on track for data readout later in 2020 and a Phase 3 trial comparing sotorasib with docetaxel in NSCLC has begun recruiting. The Phase 2 CRC trial is expected to have a data readout in early 2021.

Amgen is currently enrolling six Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101). In addition, a randomized global Phase 3 confirmatory study in NSCLC (CodeBreaK 200) has been initiated. Additional information about CodeBreaK clinical trials can be found at View Source

About BiTE Technology
BiTE (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patient’s own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit www.AmgenBiTETechnology.com.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.