On November 13, 2020 Agilent Technologies Inc. (NYSE: A) reported it has received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as an aid in identifying patients with triple-negative breast cancer (TNBC) for treatment with KEYTRUDA (pembrolizumab) (Press release, Agilent Technologies, NOV 13, 2020, View Source [SID1234571069]).

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"With the expanded FDA approval of PD-L1 IHC 22C3 pharmDx in TNBC, physicians will be able to access critical information to qualify even more patients who could benefit from these treatments. This new approval reinforces Agilent’s role as a worldwide leader in developing companion diagnostics for targeted therapies."

PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as KEYTRUDA. The expanded use of PD-L1 IHC 22C3 pharmDx strengthens the ability of pathologists to identify patients who may be eligible for treatment with KEYTRUDA. KEYTRUDA, in combination with chemotherapy, is approved for patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 10] as determined by an FDA-approved test.

PD-L1 IHC 22C3 pharmDx is the only companion diagnostic that is FDA-approved to aid in the identification of TNBC patients for treatment with KEYTRUDA in combination with chemotherapy. With TNBC marking the seventh cancer type for which PD-L1 IHC 22C3 pharmDx has gained FDA approval, Agilent is further solidifying its position as a go-to partner for drug/diagnostic co-development. PD-L1 IHC 22C3 pharmDx also helps physicians identify non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction (GEJ) adenocarcinoma, esophageal squamous cell carcinoma (ESCC), cervical cancer, urothelial carcinoma, and head and neck squamous cell carcinoma (HNSCC) patients for treatment with KEYTRUDA.

"Anti-PD-1 therapies, including KEYTRUDA, continue to offer new treatment options for a growing population of cancer patients," said Nina Green, vice president and general manager of Companion Diagnostics at Agilent. "With the expanded FDA approval of PD-L1 IHC 22C3 pharmDx in TNBC, physicians will be able to access critical information to qualify even more patients who could benefit from these treatments. This new approval reinforces Agilent’s role as a worldwide leader in developing companion diagnostics for targeted therapies."

Breast cancer is the most common type of cancer among women, with 276,480 new cases estimated to be diagnosed in the United States in 2020.1 Approximately 10% of breast cancer diagnoses are TNBC.2

KEYTRUDA is a humanized monoclonal antibody that enhances the ability of the immune system to detect and fight tumor cells. KEYTRUDA blocks the PD-1 pathway, thereby activating T lymphocytes that may affect both tumor cells and healthy cells. KEYTRUDA and other targeted immunotherapies are changing cancer treatment, and their therapeutic value is being realized across a growing list of cancer types. PD-L1 IHC 22C3 pharmDx was developed by Agilent as a companion diagnostic for KEYTRUDA in partnership with Merck (known as MSD outside the United States and Canada).

On November 13, 2020 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported Chairman, Chief Executive Officer and President, Kevin Hrusovsky will participate in a virtual fireside chat discussion at the Canaccord Medical Technologies and Diagnostics Forum on November 19 at 10:30 a.m., EST (Press release, Quanterix, NOV 13, 2020, View Source [SID1234571068]). Hrusovsky will also host virtual one-on-one and group meetings with institutional investors that day.

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A live webcast of the conversation will be available on the investor section of the Quanterix website at View Source Replays of the webcast will be available on the Quanterix website for 90 days following the conference.

On November 13, 2020 Lantheus Holdings, Inc. (the "Company") (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, reported the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the use of Lantheus’ artificial intelligence enabled automated bone scan index (aBSI) product on GE Healthcare’s Xeleris platform (Press release, Lantheus Medical Imaging, NOV 13, 2020, View Source [SID1234571067]).

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"Lantheus is delighted by the U.S. approval of our digital AI solution for prostate cancer, aBSI, on GE Healthcare’s platform. As a leading multinational medical technology company with deep experience in medical imaging and diagnostics, GE Healthcare presents the ideal attributes to provide global access to this unique digital solution," said Etienne Montagut, Sr. Vice President of Corporate Development. "aBSI has demonstrated clinical value in quantifying and managing disease progression in advanced prostate cancer patients with the potential to support critical clinical decisions. Lantheus will continue to develop AI solutions to augment and expand the utility of imaging diagnostics for precision medicine in oncology," Mr. Montagut added.

In October 2019, the Company entered into a global software licensing agreement with GE Healthcare for the rights to aBSI, a vendor neutral stand-alone platform that is enabled with artificial intelligence, which has been trained to automate the detection of hotspots in bone indicative of metastatic disease and calculate the aBSI. The platform offers a fast and reliable alternative to manual interpretation of bone scan images of metastatic prostate cancer. Recent investigations have demonstrated the clinical utility of aBSI as a prognostic and a response imaging biomarker in patients with metastatic prostate cancer.1,2

"The pandemic has proven that data, analytics, AI and connectivity will only become more central to delivering care," said Erez Levy, General Manager, Nuclear Medicine, GE Healthcare. "For GE Healthcare, that means continuing to advance intelligent and innovative technologies, like aBSI, and deliver precision health to promote better patient outcomes around the world."

Under the terms of the non-exclusive agreement, GE Healthcare acquired from Lantheus the software license for aBSI for integration into GE Healthcare’s Xeleris platform, excluding the use of aBSI in Japan. Under the agreement with GE Healthcare, Lantheus will receive tiered licensing fees per license sold.

On November 13, 2020 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) reported that the company’s senior management will participate in the following virtual investor conferences (Press release, Aldeyra Therapeutics, NOV 13, 2020, View Source [SID1234571066]):

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Jefferies Virtual London Healthcare Conference: Aldeyra President and CEO Todd C. Brady, M.D., Ph.D., is scheduled to participate in a fireside chat at 1:10 p.m. ET on Wednesday, November 18, 2020. The fireside chat will be broadcast live and archived for 90 days on the company’s website at View Source the "Events & Presentations" page. In addition, company executives are scheduled to host virtual one-on-one meetings with institutional investors.
A.G.P./Alliance Global Partners Virtual Healthcare Symposium: Aldeyra executives are scheduled to host virtual one-on-one meetings with institutional investors on November 19, 2020.

On November 13, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, reported that the Company will host a key opinion leader (KOL) webcast on the treatment options in ovarian cancer and competitive landscape within the disease state on Thursday, December 3, 2020 at 8.00am Eastern Time (Press release, IMV, NOV 13, 2020, View Source [SID1234571064]).

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The webcast will feature presentations by KOLs Oliver Dorigo, MD, PhD and Jeannine Villella, DO, FACOG, FACS who will discuss the treatment options in ovarian cancer and competitive landscape within the disease state. The KOLs will also provide an update on the ongoing Phase 2 trial with IMV’s novel T cell therapy in patients with advanced ovarian cancer, along with insights about the patients’ experience. Drs. Dorigo and Villella will be available to answer questions from financial analysts following the formal presentation.

IMV management will discuss trial results and their significance to DPX, the company’s delivery platform, as well its outlook on next steps.

To register for the webcast, please click here. A webcast of the presentation will be available under "Events, Webcasts and Presentations" in the investors section of IMV’s website and a replay will be available approximately one hour after the presentation. Afterwards, the replay will be available for approximately 30 days. Financial analysts are welcome to ask questions during the live Q&A and are invited to submit their request via email.

About the KOLs

Dr. Oliver Dorigo is the director and associate professor of the division of gynecologic oncology and the director of the gynecologic clinical care program at the Women’s Cancer Center at Stanford University. He is also director of the Mary Lake Polan Gynecologic Oncology Research Laboratory. Dr. Dorigo received his MD from the University of Heidelberg Medical School in Germany. He did a residency in obstetrics and gynecology at the University of Munich, followed by a research fellowship in cancer gene therapy at the Sidney Kimmel Cancer Center in San Diego. He completed his PhD in molecular biology at University of California, Los Angeles, and a clinical fellowship in gynecologic oncology at UCLA/Cedars Sinai Medical Center. Dr. Dorigo was an assistant professor at UCLA until he joined the Stanford faculty in 2013.

Dr. Jeannine Villella obtained her medical degree from New York College of Osteopathic Medicine in Old Westbury, New York and completed her residency training in Obstetrics and Gynecology at Winthrop University Hospital. Thereafter, Dr. Villella was granted a 2-year Henrietta Milstein Fellowship at Columbia University College of Physicians & Surgeons. As part of the division of gynecologic oncology, she performed research in the role of angiogenesis in ovarian cancer and was involved in the care of gynecologic oncology patients. She then completed a 3-year subspecialty fellowship in Gynecologic Oncology at Roswell Park Cancer Institute, where she expanded her research interests into immune response to malignancy and cancer immunotherapy. She has been granted a Winthrop University Hospital Pilot Grant to pursue her research interests in genetic polymorphisms in indoleamine 2, 3- dioxygenase and the effect on ovarian cancer outcomes. Her future goals include having ovarian cancer vaccine clinical trials available at Winthrop University Hospital. She also serves on the Society of Gynecologic Oncologists Clinical Practice Committee and the Gynecologic Oncology Group Vaccine Committee. Dr. Villella is board certified in Obstetrics & Gynecology and Gynecologic Oncology. She currently holds the title Associate Director of Gynecologic Oncology at Winthrop University Hospital and Assistant Professor of Stony Brook School of Medicine. She is the Principal Investigator for the Gynecologic Oncology Group Clinical Trials at Winthrop University Hospital. She also serves on the Society of Gynecologic Oncologists Clinical Practice Committee. She is also an active member of the research organization Society of Gynecologic Investigation.

About the DeCidE Study

"DeCidE" is a Phase 2 multicenter, randomized, open-label study to evaluate the safety and effectiveness of DPX-Survivac with intermittent low dose cyclophosphamide (CPA). This phase 2 arm enrolled 22 patients with recurrent, advanced platinum-sensitive and –resistant ovarian cancer. The trial is active but not recruiting. Patients received 2 subcutaneous injections of DPX-Survivac 3 weeks apart and every eight weeks thereafter, and intermittent low dose CPA one week on and one week off for up to 1 year. Paired tumor biopsies were performed prior to treatment and on treatment.

Primary endpoints of this study are overall response rate, disease control rate and safety. Secondary endpoints include cell mediated immunity, immune cell infiltration in paired biopsy samples, duration of response, time to progression, overall survival and biomarker analyses.

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of immunotherapy that generates targeted and sustained cancer cell killing capabilities in vivo. Treatments with the DPX-Survivac T cell therapy have demonstrated a favorable safety profile across all clinical studies.

IMV’s T cell therapy, DPX-Survivac, consists of survivin-based peptides formulated in IMV’s proprietary delivery platform (DPX). IMV’s lead compound is designed to generate a sustained cytotoxic T cell response against cancer cells presenting survivin peptides on their surface.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as Orphan Drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.