On December 8, 2021 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 the Company will participate in the following interviews and conferences (Press release, Greenwich LifeSciences, DEC 8, 2021, View Source [SID1234596596]).

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Today at 5:00 pm, the Company’s management team will be presenting two posters at the 2021 San Antonio Breast Cancer Symposium (SABCS) in person. The Company anticipates making the SABCS Phase IIb poster available on its website by the morning of December 9, exactly one year after the 2020 SABCS poster was published showing that no metastatic breast cancer recurrences were observed over 5 years of follow-up in HER2 positive patients who were fully treated. On December 9 at 2:20 pm ET, Snehal Patel, CEO of Greenwich LifeSciences, will appear as a featured guest in a live interview on TD Ameritrade Network’s The Watch List with host Nicole Petallides to discuss the poster.

A second poster at SABCS will provide further design features of the Phase III clinical trial for discussion with attending clinicians. At this hybrid conference the Company will be meeting with clinicians participating in the Phase III trial and with members of the Data Safety Monitoring Board and the Clinical Advisory/Steering Committee, both of which will provide independent oversight of the Phase III trial and will advise the Company on the conduct of the trial. The Company also hosted a dinner to bring the Phase III clinical team together.

An exclusive interview with CEO Snehal Patel was aired a second time on The RedChip Money Report on Bloomberg TV this past Saturday, December 4. In the interview Mr. Patel discusses the Phase IIb clinical trial results, the next steps for the upcoming FLAMINGO-01 Phase III clinical trial, potential Phase IIb and Phase III clinical data publications in 2022, the impact of joining the Russell 2000, and examples of recent comparable strategic transactions in breast cancer and immunotherapy. To view a replay of the interview, please click here.

During the week of January 10, 2022, Mr. Patel will participate in the following three virtual/hybrid investor conferences:

H.C. Wainwright 2022 BioConnect Conference:

The Company will be participating in the H.C. Wainwright BioConnect Conference with a virtual presentation that will be available on demand.

Biotech Showcase 2022:

The Company will be participating in the Biotech Showcase partnering event with an on-demand presentation available to conference participants and potentially an in-person presentation should conditions permit.

BIO Partnering at JPM:

The Company will be participating in the BIO partnering event at the 2022 JP Morgan Healthcare Conference.

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 and the link and trial identifier will be published shortly. 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.

On December 8, 2021 SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, reported that it has entered into a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ., through its subsidiaries, to evaluate the combination of SOT101, SOTIO’s IL-15 superagonist, and MSD’s KEYTRUDA (pembrolizumab) in patients with selected advanced/refractory solid tumors in the phase 2 AURELIO-04 study (Press release, SOTIO, DEC 8, 2021, View Source [SID1234596595]).

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"SOT101 in combination with KEYTRUDA has shown promising clinical efficacy across multiple indications in our ongoing phase 1/1b AURELIO-03 study," said Radek Špíšek, Ph.D., Global CEO of SOTIO. "We are excited to collaborate with MSD, a global leader in oncology, to continue studying the combination as part of the AURELIO-04 study for the treatment of certain patients with solid tumors while exploring the full potential of SOT101. We look forward to advancing SOT101 to the benefit of patients globally."

Under the terms of the agreement, SOTIO will conduct a Phase 2 open-label, multicenter study of SOT101 in combination with KEYTRUDA to evaluate efficacy and safety in patients with selected advanced or refractory solid tumors. The study is expected to treat up to 300 patients with a combination of SOT101 and a standard dose of KEYTRUDA. The study will enroll patients in the U.S. and selected European countries across six different indications, including second line non-small cell lung cancer, first and second line cutaneous squamous cell carcinoma, first line microsatellite instability-high colorectal cancer, second line hepatocellular carcinoma, first line metastatic castration-resistant prostate cancer, and second line ovarian cancer. MSD will supply KEYTRUDA for the study.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About SOT101
SOT101 (SO-C101) is a subcutaneously-administered IL-15 superagonist that is fused to the sushi+ domain of the IL-15 receptor α chain. SOT101 has demonstrated strong preclinical in vivo efficacy in various tumor models showing increased long-term survival and tumor regression, as well as a favorable toxicology profile. SOT101 has been shown in pre-clinical models to synergize with checkpoint inhibitors and antibody therapies exerting ADCC.

On December 8, 2021 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that management will host a virtual event entitled "B -cell Lymphoma Franchise Update" on Tuesday, December 14, 2021 at 8:00 AM ET (Press release, Fate Therapeutics, DEC 8, 2021, View Source [SID1234596594]).

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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 event will highlight interim Phase 1 clinical data from the Company’s FT516 and FT596 programs for the treatment of relapsed / refractory B-cell lymphomas.

The live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

The event is not an official program of the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About FT516
FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. ADCC is dependent on NK cells maintaining stable and effective expression of CD16, which has been shown to undergo considerable down-regulation in cancer patients. In addition, CD16 occurs in two variants, 158V or 158F, that elicit high or low binding affinity, respectively, to the Fc domain of IgG1 antibodies. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the 158V variant, which is present in only about 15% of patients, have improved clinical outcomes. FT516 is being investigated in a multi-dose Phase 1 clinical trial as a monotherapy for the treatment of relapsed / refractory acute myeloid leukemia and in combination with CD20-targeted monoclonal antibodies for the treatment of relapsed / refractory B-cell lymphoma (NCT04023071).

About FT596
FT596 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology that targets B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that augments NK cell activity. In preclinical studies of FT596, the Company has demonstrated that dual activation of the CAR19 and hnCD16 targeting receptors enhances cytotoxic activity, indicating that multi-antigen engagement may elicit a deeper and more durable response. Additionally, in a humanized mouse model of lymphoma, FT596 in combination with the anti-CD20 monoclonal antibody rituximab showed enhanced killing of tumor cells in vivo as compared to rituximab alone. FT596 is being investigated in a multi-center Phase 1 clinical trial for the treatment of relapsed / refractory B-cell lymphoma as a monotherapy and in combination with rituximab, and for the treatment of relapsed / refractory chronic lymphocytic leukemia (CLL) as a monotherapy and in combination with obinutuzumab (NCT04245722).

On December 8, 2021 Hoffmann-La Roche reported that invite investors and analysts to participate in our virtual event on Wednesday, 15 December, 2021, highlighting Roche data presented at the virtual American Society of Hematology (ASH) (Free ASH Whitepaper) 63rd Annual Meeting, from 11-14th December (Press release, Hoffmann-La Roche, DEC 8, 2021, View Source [SID1234596593]).

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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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16:00 – 17:30 CET / 15:00 – 16:30 GMT
10:00 – 11:30 am EST / 7:00 – 8:30 am PST

The webinar will start with a presentation, followed by a Q&A session (live access to the speakers).

Agenda:

Welcome
Karl Mahler, Head of Investor Relations

Hematology franchise overview
Peter Ahnesorg, Franchise Head Hematology

Review of key clinical data presented at ASH (Free ASH Whitepaper): Hemlibra, mosun, glofit, cevostamab
Charles Fuchs, Senior Vice President – Global Head Of Oncology And Hematology Product Development

Presentation of POLARIX data
Franck Morschhauser, MD, PhD, Professor of Hematology, University of Lille; President of LYSA, LYSARC

Q&A

The slides will be available for download at 15:00 CET on the day of the event. > click here

Should you be unable to register for the webinar due to your company IT policy, please send an email to [email protected].

On December 8, 2021 Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, reported the presentation of new data at the 2021 San Antonio Breast Cancer Symposium (SABCS) supporting the clinical value of the Oncotype DX Breast Recurrence Score test (Press release, Exact Sciences, DEC 8, 2021, View Source [SID1234596592]). New analyses presented at the meeting include an oral presentation of updated data from the RxPONDER study led by the independent SWOG Cancer Research Network, and sponsored by the National Cancer Institute (NCI).

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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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Exact Sciences announced new data at the 2021 SABCS, supporting the clinical value of the Oncotype DX test.
"New findings presented at SABCS 2021 add to the wealth of data highlighting the role of the Oncotype DX test in providing critical information to personalize and improve the quality of breast cancer treatment decisions," said Rick Baehner, M.D., chief medical officer of Precision Oncology at Exact Sciences. "Additionally, we are encouraged by results from a study validating our new 16-gene genomic radiation therapy signature in development, showing promise in identifying women with early-stage breast cancer who may be able to forgo irradiation following breast conserving surgery. Like the critical chemotherapy answer we are providing women with the Oncotype DX test, being able to offer clear guidance to radiotherapy benefit enables patients to avoid over- or under-treatment and further personalize their treatment plans."

New data from RxPONDER confirm and strengthen previous findings
Following the recent publication of initial study results in The New England Journal of Medicine[i], updated data were presented in an oral session[ii] at SABCS by Dr. Kevin Kalinsky, study lead investigator. In an analysis with longer follow-up (median 6.1 years), the investigators reported that postmenopausal women with 1-3 positive nodes and Recurrence Score results 0-25 continue to not benefit from adjuvant chemotherapy. In addition, a new analysis of distant recurrence-free interval (defined as time to distant recurrence or death from breast cancer) showed that premenopausal women with Recurrence Score results 0-13 received a modest 2.3% absolute benefit at five years. For those with Recurrence Score results 14-25 the benefit was 2.8%.

Approximately one-third of patients diagnosed with hormone receptor (HR)-positive, HER2-negative early breast cancer have a tumor that has spread to their lymph nodes. The vast majority of these patients currently receive chemotherapy[iii] even though approximately 85% of them have Recurrence Score results 0 to 25.[iv] In addition, approximately two out of three early-stage breast cancer patients are postmenopausal.[v]

Use of a 16-gene radiation therapy signature to identify patients with HR-positive, HER2-negative early-stage breast cancer who may skip radiotherapy
The study, presented at SABCS in a poster session[vi], applied the 16-gene radiation therapy signature to 132 patients enrolled in the Princess Margaret Trial, which randomized patients ages 50 or older to radiotherapy and tamoxifen or tamoxifen alone after breast conserving surgery. The results, in a treatment cohort in line with the current standard of care, support previous validation study data[vii] suggesting that the 16-gene radiation therapy signature may be used to identify patients with a low risk of locoregional recurrence who will not experience significant benefit from adjuvant radiotherapy. The 16-gene radiation therapy signature was developed by PFS Genomics, a company acquired by Exact Sciences earlier this year.

Additional Oncotype DX data presented at SABCS 2021
Other data featured in Poster Sessions and Spotlight Poster Discussions at SABCS 2021 include the following:

Poster #P1-08-28: Real world use of Oncotype DX testing in the management of breast cancer. The North East England experience
Authors: Gault, A., et al.
Date/Time: Wednesday, December 8, 7:00-9:30 a.m. CT

Poster #P2-15-02: Using Oncotype DX Breast Recurrence Score (RS) assay to define the role of neoadjuvant endocrine therapy (NET) in early-stage hormone receptor positive (HR+) breast cancer (BC)
Authors: Taylor, C., et al.
Date/Time: Wednesday, December 8, 5:00-6:30 p.m. CT

Spotlight Poster #PD9-01: Expanding downstaging criteria in AJCC pathologic prognostic staging using Oncotype DX Recurrence Score assay in T1-2N0 hormone-receptor positive patients enrolled in the TAILORx Trial
Authors: Kantor, O., et al.
Date/Time: Thursday, December 9, 7:00-8:30 a.m. CT

Spotlight Poster #PD15-05: Assessment of estrogen receptor (ESR1) mRNA expression for prediction of extended aromatase inhibitor benefit in HR-positive breast cancer using NRG Oncology/NSABP B-42
Authors: Mamounas, E., et al.
Date/Time: Friday, December 10, 7:00-8:30 a.m. CT

About the Oncotype DX and Oncotype MAP Portfolio of Tests
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as risk of distant recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. For patients with advanced and metastatic cancer, the company offers the Oncotype MAP Pan-Cancer Tissue test, a rapid, comprehensive tumor profiling panel, which provides results in three to five business days[viii] and allows physicians to understand a patient’s tumor profile and recommend actionable targeted therapies or clinical trials. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about the Oncotype DX and Oncotype MAP tests, visit www.OncotypeIQ.com/