Xencor to Present at Upcoming Investor Conferences

On November 12, 2020 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, reported that company management will participate at three upcoming conferences (Press release, Xencor, NOV 12, 2020, View Source [SID1234570835]):

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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

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Jefferies Virtual London Healthcare Conference
Conference Dates: November 17-19, 2020
Presentation Date: Thursday, November 19, 2020
Presentation Time: 5:00 p.m. GMT / 9:00 a.m. PST
SVB Leerink Oncology Day
Conference Date: Thursday, November 19, 2020
Piper Sandler 32nd Annual Virtual Healthcare Conference
Conference Dates: November 30 – December 3, 2020
Presentation Available: Monday, November 23, 2020
Webcasts of the Jefferies and Piper Sandler presentations will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. A replay of the live Jefferies presentation will be posted on the Xencor website approximately one hour after the live event. Both presentations will be available for at least 30 days.

CG Oncology Announces First Patient Dosed in Phase 1b Study of Oncolytic Immunotherapy CG0070 in Combination with OPDIVO® (nivolumab) in Muscle-Invasive Bladder Cancer

On November 12, 2020 CG Oncology, Inc. reported that the first patient has been treated in an investigator-initiated Phase 1b study evaluating the safety and efficacy of CG0070 in combination with OPDIVO (nivolumab), as a neoadjuvant immunotherapy for Muscle-Invasive Bladder Cancer (MIBC) in cisplatin-ineligible patients (Press release, CG Oncology, NOV 12, 2020, View Source [SID1234570834]). CG0070, the company’s lead product candidate, is a selective oncolytic immunotherapy.

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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

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The multi-center trial is being led by Roger Li, M.D. of Moffitt Cancer Center in Tampa, Florida. "We are excited to offer this novel combination to patients without any alternatives for systemic treatment prior to radical cystectomy," said Li. "Additionally, this study will also enable us to investigate whether CG0070 can be used as the match to ignite the anti-bladder cancer immune response and to further our understanding of the mechanisms underpinning successful immunotherapy."

"CG0070 dosing of the first patient in our Phase 1b combination study with anti-PD1 antibody OPDIVO represents a key milestone for our oncolytic immunotherapy clinical program," said Arthur Kuan, Chief Executive Officer at CG Oncology. "The combination regimen of CG0070 and OPDIVO may provide improved outcomes for patients, based on extensive preclinical and clinical research of both these candidates to date. We are excited to advance our investigational oncolytic immunotherapy CG0070 to improve the lives of patients with MIBC."

The Phase 1b study will evaluate CG0070 combined with nivolumab in cisplatin-ineligible patients with MIBC. The single-arm, multi-center trial will enroll up to 30 patients with or without pelvic lymphadenopathy and who show no evidence of distant metastases prior to radical cystectomy. Primary endpoints of the trial will be safety and pathological complete response rate. For additional information about the clinical trial, visit www.clinicaltrials.gov (NCT04610671).

About CG0070

CG0070, a selective oncolytic immunotherapy based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroys bladder tumor cells through their defective retinoblastoma (Rb) pathway. CG0070 was designed to replicate inside tumor cells with dysfunctional Rb pathways, causing tumor cell lysis and immunogenic cell death. The rupture of cancer cells releases tumor-derived antigens and GM-CSF, which stimulates a systemic anti-tumor immune response. In advanced clinical trials, CG0070 is a safe and efficacious agent in Non-Muscle-Invasive Bladder Cancer (NMIBC) following BCG failure. CG0070 is currently in late-stage clinical trials across a variety of solid cancers, as a monotherapy or in combination with immune checkpoint inhibitors.

Greenwich LifeSciences, Inc. Announces Partnership with Baylor College of Medicine for its Planned Phase III Clinical Trial

On November 12, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the formation of a partnership with Baylor College of Medicine in Houston, Texas to act as the lead clinical site for the Company’s upcoming Phase III clinical trial (Press release, Greenwich LifeSciences, NOV 12, 2020, View Source [SID1234570833]). Professor Mothaffar F. Rimawi has agreed to serve as the Global Principal Investigator of the Phase III clinical trial, and Professor C. Kent Osborne and Professor Rimawi are expected to serve as the first members of the Company’s Clinical Advisory Board for the development of GP2 immunotherapy across all indications and HER2 expressing cancers.

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Snehal Patel, CEO of Greenwich LifeSciences, commented, "We are pleased to have entered into this collaboration with such prominent key opinion leaders who are truly committed to evaluating the potential of GP2 immunotherapy. Due to GP2’s safety profile, GP2 immunotherapy may provide clinicians with an option to deescalate treatment of patients by reducing the use of other, more toxic and expensive standard of care treatments. Both Professors Rimawi and Osborne have already introduced us to other breast cancer clinical sites and clinical leaders who have provided input into the design of the upcoming Phase III trial and who have expressed an interest in participating in the Phase III trial as high enrollment sites. In addition, we have also been jointly exploring the addition of both US and European breast cancer cooperative groups to more rapidly expand the clinical team."

Professor Rimawi added, "We are excited to jointly evaluate the potential of GP2 immunotherapy. We believe that our patients will seek to participate in the upcoming trial as the GP2 Phase IIb clinical trial data suggests that GP2 could be both safe and effective and could be easily administered during standard of care follow-up visits. Our patients are seeking safe preventative treatments that allow them to transition away from the trauma of surgery, trastuzumab-based therapies, other HER2 targeted therapies, chemotherapy, and radiation as they seek to return to normal and healthy lives."

Professor Osborne commented, "Bringing new alternatives to chemotherapy and improving quality of life for patients undergoing treatment for breast cancer are primary focuses of the Breast Cancer Program. GP2 immunotherapy may represent one such opportunity, and we look forward to collaborating with Greenwich LifeSciences and supporting the planned clinical trial with the resources of both the Dan L Duncan Comprehensive Cancer Center and the Baylor College of Medicine."

Professor Mothaffar F. Rimawi is board certified in internal medicine, hematology and medical oncology, and serves as both Executive Medical Director and Co-Leader of the Breast Cancer Program at the Dan L Duncan Comprehensive Cancer Center.

Professor C. Kent Osborne is board certified in internal medicine, hematology and medical oncology, and serves as both the Tina and Dudley Sharp Chair in Oncology and the founding Director of the Dan L Duncan Comprehensive Cancer Center. Professor Osborne is also Professor of Medicine and Molecular and Cellular Biology at Baylor College of Medicine.

About Dan L Duncan Comprehensive Cancer Center

The Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine has grown and matured over the 13 years since its original designation as a Cancer Center by the National Cancer Institute, which was followed by an NCI Comprehensive Cancer Center designation in 2015. The clinical operations have expanded with new faculty and programs, and the center moved into new clinical space on the McNair campus in January 2019. The research portfolio has grown dramatically to more than $180 million in annual cancer relevant research funding today from less than $100 million in 2007. These amazing accomplishments were made possible by the transformational gift in 2006 from Dan L Duncan and his family.

Xilio Therapeutics Presents Promising Preclinical Tumor-Selective Efficacy and Safety Data for XTX201 (IL-2) and XTX101 (anti-CTLA-4) at SITC

On November 12, 2020 Xilio Therapeutics, a biotechnology company developing potent, tumor-selective immunotherapies for patients with cancer, reported the presentation of preclinical data of its lead investigational therapies: XTX201, a tumor-selective IL-2, and XTX101, a tumor-selective anti-CTLA-4 antibody (Press release, Xilio Therapeutics, NOV 12, 2020, View Source [SID1234570832]). The findings were presented at the 35th Annual Meeting of The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2020).

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"This is a transformational moment for the company. These positive preclinical data showing tumor-selective activity with our most advanced therapeutic candidates, XTX201 and XTX101, support the evaluation of both molecules in clinical studies, bringing us one step closer to delivering transformative cancer treatments for patients. Based on these findings, we hope to submit Investigational New Drug applications for both molecules in 2021," said Rene Russo, Chief Executive Officer of Xilio Therapeutics.

XTX201 is a protein-engineered IL-2 agonist, and XTX101 is an Fc-engineered anti-CTLA4 monoclonal antibody. Both are novel molecules designed to bind their targets preferentially in tumors while minimizing activity in healthy non-tumor tissues. The new data demonstrate preclinical proof-of-concept for these molecules with significant anti-tumor effects and minimal peripheral effects in animal models, significantly widening the potential therapeutic index for these therapies vs. currently available treatments.

Abstracts and presentations at SITC (Free SITC Whitepaper) 2020

XTX201, a protein-engineered IL-2, exhibits tumor-selective activity in mice without peripheral toxicities in non-human primates (Poster Presentation, Abstract #568)
Tumor-activated Fc-engineered anti-CTLA-4 monoclonal antibody, XTX101, demonstrates tumor-selective PD and efficacy in preclinical models (Oral Presentation, Abstract #587)

Scholar Rock to Present at Upcoming Healthcare Conferences

On November 12, 2020 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that management will participate in the following upcoming virtual investor conferences (Press release, Scholar Rock, NOV 12, 2020, View Source [SID1234570831]):

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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

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Jefferies Virtual London Healthcare Conference on Thursday, November 19, 2020 at 1:45 pm ET.
A live webcast of this presentation may be accessed by visiting the Investors & Media section of the Scholar Rock website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the presentation.
Piper Sandler 32nd Annual Virtual Healthcare Conference being held November 30- December 3, 2020.