­Nevro to Participate in Citi Bank Head Shoulders Knees and Toes Conference Call Series on November 30th

On November 24, 2020 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported that D. Keith Grossman, Nevro’s Chairman, CEO and President will participate in Citi Bank’s Head Shoulders Knees and Toes Conference Call Series on November 30, 2020 at 2pm ET (Press release, Nevro, NOV 24, 2020, View Source [SID1234571693]).

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Investors interested in listening to the call may do so by dialing (856) 344-9142 in the U.S., using Conference ID: 3168278. This dial-in information is available on the "Investors" section of the Company’s website at: www.nevro.com.

Sutro Biopharma to Host a Virtual KOL Event to Provide Clinical Update on Antibody-Drug Conjugate STRO-002 in Ovarian Cancer

On November 24, 2020 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported that it will host a live webcast event to provide a clinical update from the company’s ongoing dose escalation Phase 1 study of STRO-002, a folate receptor alpha (FolRα) targeting antibody-drug conjugate (ADC), for patients with ovarian cancer (Press release, Sutro Biopharma, NOV 24, 2020, View Source [SID1234571692]). The results presented will follow-up on previously presented data, based on a new data cut-off date of Oct. 30, 2020. The company will also give an update on the program expansion cohorts in ovarian and endometrial cancer. The virtual KOL Discussion of STRO-002 Data will be held on Thursday, Dec. 3, 2020, at 5pm ET / 2pm PT.

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The data will be presented and discussed by Principal Investigators from two STRO-002 clinical trial sites:

Lainie P. Martin, M.D. – Leader, Gynecology/Oncology Program and Associate Professor of Medicine at Hospital of the University of Pennsylvania; Dr. Martin is also a member of Sutro’s Clinical Advisory Board
R. Wendel Naumann, M.D. – Professor & Director of Gynecologic Oncology Research and Associate Medical Director of Clinical Trials at Levine Cancer Institute – Atrium Health in Charlotte, North Carolina; Dr. Naumann is also a member of Sutro’s Clinical Advisory Board
To register and access the Zoom link for this event click here or email Annie Chang at [email protected].

An archived recording of the event will be available through the Company Presentation page of the Investor section of the company’s website at View Source for approximately 30 days.

About the Phase 1 Trial of STRO-002 in Ovarian Cancer
STRO-002-GM1, the Phase 1 open-label, multicenter, dose escalation trial with dose expansion of STRO-002, has completed enrollment. Follow-up is ongoing and will continue to evaluate the safety, tolerability, and preliminary anti-tumor activity of STRO-002 in adults with advanced epithelial ovarian cancer, including fallopian and primary peritoneal cancer. The trial is registered with clinicaltrials.gov identifier NCT03748186. Sutro discovered, developed and manufactures STRO-002 using its proprietary XpressCF cell-free protein synthesis and XpressCF+ site-specific conjugation technologies.

Arena Pharmaceuticals to Present at the Evercore ISI HealthCONx Conference on December 1

On November 24, 2020 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that Amit D. Munshi, the Company’s President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat at the 3rd Annual Evercore ISI HealthCONx Conference on Tuesday, December 1, at 4:20 PM ET (Press release, Arena Pharmaceuticals, NOV 24, 2020, https://www.prnewswire.com/news-releases/arena-pharmaceuticals-to-present-at-the-evercore-isi-healthconx-conference-on-december-1-301179350.html [SID1234571690]).

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A live webcast of the presentation will be posted under the investor relations section of Arena’s website at www.arenapharm.com. A replay of the presentation will be available for 30 days following the event.

Celularity Announces Dosing of First Patient in Phase I Study of Human Placental Hematopoietic Stem Cell-Derived Natural Killer Cells (CYNK-001) in Adults with Recurrent Glioblastoma Multiforme (GBM) and E-Poster Presentation at the Society for Neuro-Oncology (SNO) 2020 Virtual Meeting

On November 24, 2020 Celularity, Inc., a clinical-stage cell therapeutics company focused on the development of innovative allogeneic placenta-derived cellular therapies, reported that the first patient was dosed in its Phase 1 clinical study of human placental hematopoietic stem cell-derived natural killer cells (CYNK-001) in adults with recurrent glioblastoma multiforme (Press release, Celularity, NOV 24, 2020, View Source [SID1234571688]).

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"Celularity is committed to the development of innovative therapeutic tools to treat serious diseases, particularly targeting diseases with unmet medical needs that have a devastating impact on patients and families. As testimony to this commitment, we are extremely excited to announce the dosing of our first patient in our first clinical trial for, glioblastoma multiforme (GBM). Through the study team’s diligent efforts, we were able to rapidly complete the start-up activities and to accelerate the commencement of patient screening, enrollment, and first dosing in this important study," said Robert J. Hariri, M.D., Ph.D., Celularity’s Founder, Chairman and Chief Executive Officer.

This study (ClinicalTrials.gov Identifier: NCT04489420) will determine the maximum safe dose (MSD) of CYNK-001 which are culture-expanded NK cells derived from human placental CD34+ cells. The intravenous (IV) cohort will receive repeat administration of CYNK-001 cells after lymphodepleting chemotherapy. The intratumoral (IT) cohort will not receive lymphodepletion. The safety of this treatment will be evaluated, as researchers investigate the role of NK cells in the treatment of recurrent glioblastoma.

"Glioblastoma patients have poor survival and novel treatments are urgently needed for this patient population," said Nazanin Majd, M.D., Ph.D., assistant professor of Neuro-Oncology at The University of Texas MD Anderson Cancer Center and principal investigator of the study. "Placental-derived NK cells are a promising approach in treatment of GBM patients as these cells have been shown to kill GBM tumor cells in pre-clinical animal studies. This trial offers an innovative immunotherapy approach where exogenously manufactured NK cells will be administered to GBM patients with the goal of shrinking the tumor and improving outcomes."

In a related development, the Company also announced that its abstract highlighting the details of this Phase 1 study was accepted for a poster presentation at the 25th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO) which will occur November 19-21, 2020.

Presentation Details

Poster #:

RTID-07

Title:

HUMAN PLACENTAL HEMATOPOIETIC STEM CELL DERIVED NATURAL KILLER CELLS (CYNK-001) FOR TREATMENT OF RECURRENT GLIOBLASTOMA

Session:

Randomized Trials in Development

Authors:

Nazanin Majd, Maha Rizk, Solveig Ericson, Kris Grzegorzewski, Sharmila Koppisetti, Junhong Zhu, Lin Kang, Shawn He, Tanel Mahlakoiv, William van Der Touw, Xiaokui Zhang, Nassir Habboubi, Robert Hariri, Kathy Hunter, Kristin Alfaro-Munoz, Amy Heimberger, John de Groot, Linda Chi, Samer Srour

Dates:

Available November 19-21, 2020

Link:

View Source

About CYNK-001
CYNK-001 is an investigational cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM).

Phoenix Molecular Designs Announces First Patient Dosed in Phase 1b Clinical Trial of PMD-026 Taking Aim at Triple Negative Breast Cancer

On November 24, 2020 Phoenix Molecular Designs (PhoenixMD), an industry leader in the development of precise cancer therapeutics focusing on first-in-class RSK kinase inhibitors, reported that the first patient has been dosed in their Phase 1b clinical trial of PMD-026 (Press release, PhoenixMD, NOV 24, 2020, View Source [SID1234571687]). This RSK targeting trial is a first of its kind in the battle to combat the most aggressive subtype of breast cancer, known as Triple Negative Breast Cancer (TNBC), which claims the lives of thousands of patients each year. This patented small molecule, PMD-026, positions PhoenixMD in the lead to fill an unmet medical need as an effective treatment for this serious medical condition.

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This new trial comes at a critical time as, to date, durable treatment options for TNBC have been extremely limited. PhoenixMD’s lead asset, PMD-026, is the first purpose-built investigational drug specifically designed for TNBC. The company’s goal is to develop a therapy to treat TNBC that offers advantages over current approaches by taking aim at RSK, which is an entirely new drug target. PMD-026 is different from other therapies in that it is an oral capsule that can be taken at home rather than requiring an in-clinic or in-hospital administration. In addition, based on the data obtained in their Phase 1 clinical trial, PMD-026 was well-tolerated without hair loss or peripheral neuropathy, which are side effects of a number of other chemotherapy drugs. This data from their Phase 1 clinical trial of PMD-026 in metastatic cancer will be presented at the San Antonio Breast Cancer Conference Dec 8-12, 2020.

"Our mission is to improve the outcome for TNBC patients. This is a pivotal time for PhoenixMD; our extensive research to finding a path forward has reached the next important clinical milestone. PhoenixMD continues to aggressively pursue the clinical development of PMD-026 in an accelerated timeline while always ensuring that patient care is first and foremost in every decision that we make. As we begin our Phase 1b clinical trial, I am excited about the opportunity to bring this therapy, that uniquely targets the RSK pathway, to women with TNBC who participate in our clinical trial and who so desperately need help not provided by existing treatment options," said Sandra Dunn, Ph.D., Chief Executive Officer, PhoenixMD."

Initially, 20 TNBC patients will be enrolled in this Phase 1b expansion trial. As with the Phase 1 trial, this new trial will be conducted at leading medical centers across the United States.

"As a TNBC survivor, who was diagnosed at 34 years old, and patient advocate in the breast cancer community, I cannot emphasize enough how important this trial could be in the lives of so many. For a long time, there has been an utter lack of treatment options for this vulnerable breast cancer population," said Tara Coleman, Licensed Occupational Therapist, and Lymphedema Therapist. "Trials like this are urgently needed, and it is my hope that this trial proves to be a game-changer for the TNBC community. It has been my honor to work with Sandra and her team; the strides they have made coupled with their enthusiasm and commitment to patient advocate involvement and patient care has been truly incredible."

"Today’s announcement builds on PhoenixMD’s success with our Phase 1 clinical trial in metastatic cancer patients, which PhoenixMD completed in September of 2020," said F. Andrew Dorr, M.D., Chief Medical Officer, PhoenixMD. "At this pivotal time, I would like to recognize the PhoenixMD and SciQuus Oncology teams who have worked so diligently throughout the COVID-19 pandemic and the Phase 1 clinical trial. We are ready to meet the challenges and successes ahead in this next phase. I firmly believe that every step we take is a step closer towards finding a successful treatment for TNBC."

For more information about the Company’s Phase 1b clinical trial of PMD-026 in metastatic triple negative breast cancer, please visit www.clinicaltrials.gov (identifier NCT04115306).