Greenwich LifeSciences to Present at 2022 BIO CEO & Investor Conference

On February 3, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that Snehal Patel, CEO of Greenwich LifeSciences, will present in-person at 2:30 pm ET on February 14, 2022 at the 2022 BIO CEO & Investor Conference and will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference (Press release, Greenwich LifeSciences, FEB 3, 2022, View Source [SID1234607693]).

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BIO CEO & Investor Conference

The 2022 BIO CEO & Investor Conference will be held from February 14-17, 2022. For more than 20 years, the BIO CEO & Investor Conference has fueled biotech industry networking with premier investor and banking communities, focused on established and emerging publicly traded and select private biotech companies. In addition, there will be four days of in-person and virtual meetings with institutional investors, industry analysts, and senior business development executives seeking potential investments and deal partners. For more information please visit: View Source

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

Zymeworks Announces Participation in Upcoming Investor Conferences

On February 3, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will participate in upcoming investor conferences (Press release, Zymeworks, FEB 3, 2022, View Source [SID1234607692]).

Guggenheim Oncology Conference 2022. Zymeworks will participate virtually in one-on-one meetings and a fireside chat on February 9th at 1:00 p.m. ET.

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11th Annual SVB Leerink Global Healthcare Conference. Zymeworks will participate virtually in one-on-one meetings and a fireside chat on February 17th at 3:40 p.m. ET.

Fireside chats will be webcast live with dial-in details and webcast replays available on Zymeworks’ website at View Source

Arvinas to Present at Upcoming Investor Conferences

On February 3, 2022 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that it will participate in two upcoming virtual investor conferences (Press release, Arvinas, FEB 3, 2022, View Source [SID1234607691]):

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Guggenheim Oncology Conference on Thursday, February 10. Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat. A live audio webcast of the presentation will be available here and on the Events + Presentations section of the Company’s website.

2022 SVB Leerink Global Healthcare Conference on Friday, February 18. John Houston, Ph.D., President and Chief Executive Officer, will participate in a fireside chat. A live audio webcast of the presentation will be available here and on the Events + Presentations section of the Company’s website.

Results of Single Center Study on Delcath’s CHEMOSAT® Hepatic Delivery System Published in Melanoma Research

On February 3, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that results from a single-institution retrospective study, conducted by University Hospital Southampton NHS Foundation Trust (UHS) in England on the use of the Delcath CHEMOSAT Hepatic Delivery System for the treatment of patients with liver dominant metastatic uveal melanoma (mUM), were published in the journal Melanoma Research (Press release, Delcath Systems, FEB 3, 2022, View Source [SID1234607690]).

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The study, Chemosaturation with percutaneous hepatic perfusion of melphalan for metastatic uveal melanoma, by Dr. Sachin Modi, et al, evaluated the safety and efficacy of the CHEMOSAT Hepatic Delivery System in 81 patients with liver dominant metastatic uveal melanoma treated with CHEMOSAT between August 2012 and September 2020. Forty-one (50.6%) patients had received other treatments, either systemic or liver-directed, before PHP treatment. The median time to treatment from diagnosis of stage IV disease was 158 days. Tumor response was evaluated following each PHP treatment using Response Evaluation Criteria in Solid Tumors (RECIST), and serious adverse events (SAEs) were evaluated using Common Terminology Criteria for Adverse Events (CTCAE).

250 PHP procedures were performed in 81 patients (median of three per patient). The analysis demonstrated a hepatic disease control rate of 88.9% (72/81), a hepatic response rate of 66.7% (54/81), and an overall response rate of 60.5% (49/81). After a median follow-up of 12.9 months, median overall progression-free survival (PFS) and median overall survival (OS) were 8.4 and 14.9 months, respectively.

Treatment-emergent adverse events of Grade 3 or 4 occurred in 23 patients (27.7%) The most common Grade 3 or 4 hematological toxicities were anemia observed in 11 patients (13.3%) and thrombocytopenia observed in 10 patients (12%). There were no fatal treatment-related adverse events.

Investigators concluded that PHP provides excellent response rates and progression free survival compared with other available treatments, with a decreasing side effect profile with experience. Combination therapy with systemic agents may be viable to further advance overall survival.

"This study adds to the growing body of published research of the efficacy of our CHEMOSAT system in the European commercial setting," said Gerard Michel, CEO of Delcath. "The improved safety profile of the Gen2 device is consistent with our recently released phase 3 FOCUS trial data as well as the progression-free-survival efficacy results."

A PDF of the open access article can be viewed in its entirety, via immediate download link, by clicking here.

Silverback Therapeutics to Participate in the SVB Leerink 11th Annual Global Healthcare Conference

On February 3, 2022 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported that Silverback management will participate in the SVB Leerink 11th Annual Global Healthcare Conference from February 14-18, 2022 (Press release, Silverback Therapeutics, FEB 3, 2022, View Source [SID1234607689]).

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Laura Shawver, Ph.D., Silverback’s Chief Executive Officer, and Valerie Odegard, Ph.D., Silverback’s President and Chief Scientific Officer, will participate in a fireside chat on Wednesday, February 16th, 2022, at 1:00 PM ET (10:00 AM PT). The live webcast of the event will be available on Silverback’s Investor Relations website and a replay will be available for 30 days following the event. Members of the Silverback management team will also host investor meetings during the conference.