On April 9, 2021 MiNA Therapeutics, the pioneer in RNA activation (RNAa) therapeutics, reported translational data supporting the favourable immunological effects of MTL-CEBPA and its benefits in combination with other cancer therapies including anti-PD1 checkpoint inhibition (Press release, MiNA Therapeutics, APR 9, 2021, View Source [SID1234577800]). The studies combine pre-clinical research conducted at the Wistar Institute as well as biomarker analysis of the previously completed OUTREACH clinical trial. MTL-CEBPA is the first candidate from MiNA’s pipeline of small activating RNA therapeutics, a new class of medicines to restore normal cell function. The data will be presented during a poster session at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held virtually from April 10 – April 15, 2021.

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"These new translational findings confirm the important role of MTL-CEBPA in cancer immunology," said Robert Habib, CEO of MiNA Therapeutics. "We continue to deepen our understanding of the immunological effects of MTL-CEBPA for the treatment of patients with advanced cancer and other indications and will analyse its effects as part of our ongoing clinical studies. Collectively, the data further demonstrate how RNA activation can access a previously undruggable target for patient benefit."

In pre-clinical studies, MTL-CEBPA was shown to counteract a key cancer immune evasion pathway by inhibiting immune suppression by myeloid cells. MTL-CEBPA was also shown to potentiate the anti-tumour activity of immunotherapies including anti-PD1 in models of lung and colon cancer. In addition, samples were analysed from advanced liver cancer patients treated with MTL-CEBPA as part of the OUTREACH clinical trial. Analysis of mRNA, protein and cellular biomarkers in peripheral blood confirmed that MTL-CEBPA reduced markers associated with immunosuppressive myeloid cells. Analysis of cellular biomarkers in tumour biopsies showed that those patients who responded to MTL-CEBPA combination therapy had high tumour infiltrations of immunosuppressive macrophages prior to treatment, which were depleted with treatment.

The results validate and expand on previously presented pre-clinical research findings on MTL-CEBPA as an immunological combination treatment in liver cancer and colon cancer. MTL-CEBPA demonstrated signals of activity in a Phase 1b trial in advanced liver cancer, including durable and complete tumour responses as a combination treatment with a standard of care tyrosine kinase inhibitor. A Phase 2 study in advanced liver cancer is expected to commence later this year. MTL-CEBPA is currently being evaluated in a second study in patients with advanced solid tumours in the TIMEPOINT Phase 1/1b clinical trial in combination with a leading checkpoint inhibitor.

The poster will be made available on the Company’s website in the Publications section under "RNA Activation" at the start of the conference on April 10th, 2021.

Presentation information

Title: Up-regulation of C/EBPα inhibits suppressive activity of myeloid cells and potentiates antitumor response in mice and cancer patients
Abstract No: 1730
Session: Immunology – Immunomodulatory Agents and Interventions
Presenter: Mikael Sodergren

About MTL-CEBPA
MTL-CEBPA is the first therapy that specifically up-regulates CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of myeloid cell lineage determination and differentiation. Dysregulated myeloid cells have been implicated in several diseases and in solid tumour cancers have been identified as a critical barrier for many therapies to induce clinical responses. In pre-clinical studies MTL‑CEBPA has been shown to improve the anti-tumour activity of cancer therapies by targeting dysregulated myeloid cells and reducing their suppressive effect in the tumour micro-environment. MTL-CEBPA is currently in clinical development as a combination therapy for the treatment of advanced liver cancer and advanced solid tumour malignancies.

On April 9, 2021 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 abstract results of the final 5 year immune response data of the Phase IIb clinical trial at the 2021 AACR (Free AACR Whitepaper) Annual Meeting (Press release, Greenwich LifeSciences, APR 9, 2021, View Source [SID1234577784]). Immune response is the primary mechanism of action and is critical to developing dosing and booster treatment strategies that are designed to achieve and sustain peak immunity and to prevent metastatic breast cancer recurrences.

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The AACR (Free AACR Whitepaper) published the Phase IIb final 5 year immune response data abstract on Friday, April 9th and plans to publish the corresponding poster on Saturday, April 10th. The poster, the abstract, and an audio recording will be published by the Company on Saturday, April 10th in a joint press release.

Summary of Additional Upcoming Posters/Press Releases:

Week of April 12th – Press release of the second poster at AACR (Free AACR Whitepaper), co-sponsored by the Company and the Baylor College of Medicine, will provide more details behind the updated design of the planned Phase III clinical trial.

Week of June 4th – The Company will present two abstract/poster presentations at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference. The poster presentations will include the final 5 year safety data of the GP2 Phase IIb clinical trial and an introduction to the interim analysis and clinical strategy of the planned Phase III clinical trial.

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. 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 April 9, 2021 Novocure (NASDAQ: NVCR) reported 26 presentations on Tumor Treating Fields suggesting broad applicability of Tumor Treating Fields at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, held virtually from April 10 to April 15, 2021 (Press release, NovoCure, APR 9, 2021, View Source [SID1234577801]). Research spanning seven solid tumor types confirms the anti-mitotic effect of Tumor Treating Fields and further explores downstream effects to identify optimal use of Tumor Treating Fields, including the role of Tumor Treating Fields-induced immunogenic cell death.

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Presentation highlights include research showing the induction of robust anti-tumor immunity by Tumor Treating Fields in glioblastoma, the immunoregulatory role of Tumor Treating Fields on macrophage polarization, the effects of Tumor Treating Fields on DNA damage repair, and replication stress as a pathway to illuminate novel combination therapy options.

"Ongoing research at Novocure and throughout the global scientific community continues to build upon and deepen our understanding of Tumor Treating Fields as we strive to extend survival in some of the most aggressive forms of cancer," said Dr. Uri Weinberg, Novocure’s Chief Science Officer. "We are honored to be a part of the invaluable exchange of scientific information at the AACR (Free AACR Whitepaper) Annual Meeting and are particularly pleased to see an increasing focus on the effect of Tumor Treating Fields on the immune system’s response against cancer."

Presentations from Novocure-sponsored and partner programs include:

(Poster #: CT258) EF-32 (TRIDENT): A pivotal randomized trial of radiation therapy concomitant with temozolomide +/- Tumor Treating Fields (TTFields) in newly diagnosed glioblastoma. W. Shi (Clinical Trials)

(Poster #: LB064) Long-term application of TTFields in anaplastic astrocytoma – a case study. D. Markovic (Clinical Research)

(Poster #: 2635) Contemporary clinical practice guidelines for the management of glioblastoma: an international survey. A. Lawson McLean (Science and Health Policy)

(Poster #: 1065) Concomitant dexamethasone treatment and tumor treating fields induced cell death in glioblastoma. B. Linder (Combination Therapies)

(Poster #: 2634) French health utilities for patients with glioblastoma using TTFields. G. Chavez (Science and Health Policy)

(Poster #: 717) Rapid transformation of TTFields care-delivery during COVID-19 pandemic to optimize treatment of patients with glioblastoma (GBM). P. Frongillo (COVID-19 and Cancer)

(Poster #: 1435) The distribution of Tumor Treating Fields is effected by cell confluence and pores in the membrane. T. Marciano (Experimental and Molecular Therapeutics)

(Poster #: 3070) Lung cancer TTFields treatment planning sensitivity to errors in torso segmentation. H. Ben Atya (Tumor Biology)

(Poster #: 3071) A method for infratentorial structures segmentation for tumor treating fields treatment planning. Y. Glozman (Tumor Biology)

(Poster #: 1692) A novel immunoregulatory role of Tumor Treating Fields (TTFields) on macrophage polarization. B. Brant (Immunotherapy, Preclinical and Clinical)

(Poster #: 1063) Effectiveness of Tumor Treating Fields (TTFields) in combination with sorafenib for treatment of hepatocellular carcinoma in vitro and in vivo. A. S. Davidi (Experimental and Molecular Therapeutics)

(Poster #: 1317) Inovivo: a dedicated system for delivery of therapeutic level Tumor Treating Fields (TTFields) to mice. S. Davidi (Experimental and Molecular Therapeutics)

(Poster #: 1382) Targeting Akt signaling pathway potentiates the antitumor effect of Tumor Treating Fields (TTFields) in vitro. A. Klein-Goldberg (Experimental and Molecular Therapeutics)

(Poster #: 1186) Efficacy of Tumor Treating Fields (TTFields) in mesothelioma is associated with reduced capacity for DNA damage repair. H. Mumblat (Experimental and Molecular Therapeutics)

(Poster #: 279) Transient opening of the blood brain barrier by Tumor Treating Fields (TTFields). C. Tempel Brami (Cancer Chemistry)

(Poster #: 1064) Antiproliferative effects of Tumor Treating Fields (TTFields) in human mesothelioma cell lines. M. Lupi (Combination Therapies)

(Poster #: 1200) Long-duration term TTFields treatment of glioblastoma cells induces cell death. S. Castiglione (New Targets)

(Poster #: 1037) Valproic acid (VPA) combined with Tumor Treating Fields (TTFields) in vitro decreases cellular proliferation and increases clonogenic potential of glioblastoma (GBM) cells. S. Michelhaugh (Combination Therapies)

(Poster #: 1007) Patient-derived metastatic renal carcinoma cells are highly sensitive to Tumor Treating Fields (TTFields) in vitro. S. Michelhaugh (Cellular Responses to Anticancer Drugs)

(Poster #: 2011) Tumor Treating Fields Induce Cellular and Morphologic Changes that Include Disruption of Intercellular Communication Networks in Malignant Pleural Mesothelioma. A. Sarkari (Cell-cell Interactions)

(Poster #: 1678) Induction of Robust Anti-Tumor Immunity by Tumor Treating Fields in Glioblastoma. D. Chen (Immune Response to Therapies)

(Poster #: 3063) Prostaglandin e receptor 3 mediates resistance to Tumor Treating Fields in glioblastoma cells. D. Chen (Radiation Science)

(Poster #: 1051) Targeting replication stress pathway provides an avenue for novel combination therapy options including TTFields plus chemo agents which increase replication stress. N. Karanam (Combination Therapies)

(Poster #: 1975) Tumor Treating Fields Triggers Autophagy Pathway Activation at Primary Cilia to Promote Glioma Cell Survival. P. Shi (Cell Signaling)

(Poster #: 3049) Tumor treating fields induce DNA damage and apoptosis in medulloblastoma. R. Nitta (Pediatric Cancer: Basic Science)

(Poster #: LB023) Drug loaded nanoparticle targeting of pancreatic cancer using tumor treating fields (TTFields). P. Desai (Cancer Chemistry)

About Tumor Treating Fields
Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division.

When cancer develops, rapid and uncontrolled division of unhealthy cells occurs. Electrically charged proteins within the cell are critical for cell division, making the rapidly dividing cancer cells vulnerable to electrical interference. All cells are surrounded by a bilipid membrane, which separates the interior of the cell, or cytoplasm, from the space around it. This membrane prevents low frequency electric fields from entering the cell. TTFields, however, have a unique frequency range, between 100 to 500 kHz, enabling the electric fields to penetrate the cancer cell membrane. As healthy cells differ from cancer cells in their division rate, geometry and electric properties, the frequency of TTFields can be tuned to specifically affect the cancer cells while leaving healthy cells mostly unaffected.

Whether cells are healthy or cancerous, cell division, or mitosis, is the same. When mitosis starts, charged proteins within the cell, or microtubules, form the mitotic spindle. The spindle is built on electric interaction between its building blocks. During division, the mitotic spindle segregates the chromosomes, pulling them in opposite directions. As the daughter cells begin to form, electrically polarized molecules migrate towards the midline to make up the mitotic cleavage furrow. The furrow contracts and the two daughter cells separate. TTFields can interfere with these conditions. When TTFields are present in a dividing cancer cell, they cause the electrically charged proteins to align with the directional forces applied by the field, thus preventing the mitotic spindle from forming. Electrical forces also interrupt the migration of key proteins to the cell midline, disrupting the formation of the mitotic cleavage furrow. Interfering with these key processes disrupts mitosis and can lead to cell death.

TTFields is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.

Fundamental scientific research extends across two decades and, in all preclinical research to date, TTFields has demonstrated a consistent anti-mitotic effect. The TTFields global development program includes a broad range of clinical trials across all phases, included four phase 3 pivotal trials in a variety of tumor types. To date, more than 18,000 patients have been treated with TTFields.

On April 8, 2021 Organon Finance 1 LLC, a subsidiary of Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Organon Finance 1 LLC has priced its previously announced offering of €1,250,000,000 aggregate principal amount of 2.875% senior secured notes due 2028 (the "euro secured notes"), $2,100,000,000 aggregate principal amount of 4.125% senior secured notes due 2028 (the "U.S. dollar secured notes") and $2,000,000,000 aggregate principal amount of 5.125% senior unsecured notes due 2031 (the "unsecured notes" and together with the euro secured notes and U.S. dollar secured notes, the "notes"), in connection with the previously announced spinoff of Organon & Co. ("Organon") from Merck (Press release, Merck & Co, APR 8, 2021, View Source [SID1234577733]). As part of the spinoff, the notes will be assumed by Organon, and a Dutch private limited company and wholly owned subsidiary of Organon which will act as co-issuer of the notes.

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Organon intends to use the net proceeds from the notes offering, together with available cash on its balance sheet and borrowings under senior secured credit facilities which Organon anticipates entering into, to repay one or more intercompany loans or notes owed by Organon to a Merck affiliate and to pay fees and expenses related to the spinoff. The proceeds of the notes offering will be held in escrow until satisfaction of the conditions precedent to the spinoff and certain other escrow release conditions (the "Effective Date").

Each series of notes will be issued at an issue price of 100%. From and after the Effective Date, the euro secured notes and the U.S. dollar secured notes will be guaranteed on a senior secured basis, and the unsecured notes will be guaranteed on a senior unsecured basis, jointly and severally, by all of Organon’s existing or future subsidiaries that guarantee its proposed senior secured credit facilities. Prior to the Effective Date, each series of notes will be senior secured obligations solely of the Organon Finance 1 LLC, and will not be guaranteed by Organon or any of its subsidiaries.

The notes offering is expected to close on April 22, 2021, subject to customary closing conditions.

The notes have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), any state securities laws or the securities laws of any other jurisdiction, and may not be offered or sold in the United States absent registration or an applicable exemption from registration. Accordingly, the notes are being offered and sold only to persons reasonably believed to be qualified institutional buyers in accordance with Rule 144A under the Securities Act and to non-U.S. persons outside the United States in reliance on Regulation S under the Securities Act.

This announcement is an advertisement and is not a prospectus for the purposes of Regulation (EU) 2017/1129 (as amended, the "Prospectus Regulation") or Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 (the "UK Prospectus Regulation").

In member states of the European Economic Area, this announcement is directed only at persons who are "qualified investors" within the meaning of the Prospectus Regulation. In the United Kingdom, this announcement is directed only at persons who are "qualified investors" within the meaning of the UK Prospectus Regulation.

Manufacturer target market (MiFID II product governance / UK MiFIR product governance) is eligible counterparties and professional clients only (all distribution channels). No PRIIPs key information document has been prepared as not available to retail in the EEA. No UK PRIIPs key information document has been prepared as not available to retail in the UK.

In the United Kingdom, this announcement is directed only at persons (i) that have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"); (ii) falling within Article 49(2)(a) to (d) ("high net worth companies, unincorporated associations etc.") of the Order; or (iii) at whom this announcement may otherwise be directed without contravention of Section 21 of the Financial Services and Markets Act 2000, as amended (all such persons together being referred to as "relevant persons"). This announcement must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful.

On April 9, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that positive initial clinical data from an investigator-sponsored study at The University of Texas MD Anderson Cancer Center evaluating cord blood-derived natural killer (cbNK) cells pre-complexed with Affimed’s innate cell engager (ICE) AFM13 (CD16A/CD30) (Press release, Affimed, APR 9, 2021, View Source [SID1234577785]).

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This approach was developed in the laboratory of Katy Rezvani, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson, who is presenting the data as part of the Major Symposia and Advances sessions at the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The presentation is available for viewing by registered participants through June 21, 2021. Dr. Rezvani will take part in a live panel discussion as part of the presentation on April 13, 2021 at 1:30 p.m. EDT.

"We are encouraged by the initial safety and efficacy data from this groundbreaking first in-human study. The finding of an objective response rate of 100% amongst our first four patients enrolled is impressive," said Andreas Harstrick, M.D., Chief Medical Officer of Affimed. "These initial results indicate AFM13 may have the potential to help NK cells target and destroy cancer cells. We plan to continue to develop and customize approaches that leverage the unique and differentiating features of our ICE molecules in combination with adoptive NK cell transfer to provide options for treating a variety of hematologic and solid tumors."

The open-label, non-randomized, single-center, dose-escalation trial is evaluating the pre-complexing of AFM13 with cbNK cells followed by three weekly infusions of AFM13 monotherapy in adult patients with recurrent/refractory CD30-positive lymphomas. The trial is led by Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson.

"There remains a high unmet need for effective treatments in relapsed/refractory (R/R) CD30+ lymphomas. We are encouraged by the data generated from the first patients treated with cbNK cells pre-complexed with AFM13," said Dr. Rezvani. "The results suggest this combination is facilitating clinical responses with minimal toxicity, warranting further study as we continue to explore novel cell therapies for our patients."

LOGO

As of March 31, 2021, three patients have been dosed with two cycles of therapy in dose cohort 1 (1×106 AFM13-cbNK/kg) and one patient has received a single cycle of therapy in dose cohort 2 (1×107 AFM13-cbNK/kg). The study is currently enrolling patients in the second dose cohort of NK cells, and further updates are expected later in 2021. Results from the first cycle of the first dose cohort are being presented by Dr. Rezvani at AACR (Free AACR Whitepaper), and Affimed is supplementing the data with best responses as of March 31, 2021, as summarized below.

Patient

number
cbNK Cell
Dose

Patient

Cancer Type

Prior Treatment

CRS/

Neurotoxicity/

GVHD

Best Response

Cohort 1 – completed
#1 1×106 / kg 43-year-old-male Hodgkin lymphoma 4 lines of therapy (ABVD, ICE, brentuximab vedotin, nivolumab + ruxolitinib) None Partial response
#2 1×106 / kg 31-year-old-male Hodgkin lymphoma 14 lines of therapy (ABVD, brentuximab vedotin, HDACi/P13Ki, pembrolizumab, nivolumab, allo-HSCT, hypercytoxan, ibrutinib, niraparib, bendamustine, everolimus) None Partial response
#3 1×106 / kg 53-year-old-female Hodgkin lymphoma 5 lines of therapy (ABVD, ICE, brentuximab vedotin, nivolumab, GemOx) None Complete response after cycle 2
Cohort 2 – ongoing (1 of 3 patients enrolled)
#4 1×107 / kg 26-year-old-male Hodgkin lymphoma 9 lines of therapy (ABVD, ICE + brentuximab vedotin, radiation, nivolumab, CD30-CART, TTI-622, brentuximab vedotin + bendamustine, allo-HSCT, brentuximab vedotin + bendamustine with brentuximab vedotin maintenance) None Complete response
ABVD = Adriamycin (doxorubicin), Bleomycin, Vinblastine, Dacarbazine (DTIC)

ICE = chemotherapy combination includes the drugs: ifosfamide, carboplatin, & etoposide phosphate

GemOx= gemcitabine, oxaliplatin

There were no observed events of cytokine release syndrome, neurotoxicity syndrome or graft-versus-host disease.

Response evaluation followed the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). All four patients had relapsed/refractory Hodgkin Lymphoma and were heavily pretreated, with between 4 and 14 previous lines of therapy which in all cases included brentuximab vedotin (Adcetris) and anti-PD1 antibodies. Of note, patient #4 had also previously received a CD30-CAR-T.

Conference Call/Webcast Details

Affimed will host a conference call and webcast on April 14, 2021, at 4:05 p.m. EDT to discuss the initial study findings. The conference call will be available via phone and webcast. To access the call, please dial +1 (646) 741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference passcode 1788338 approximately 15 minutes prior to the call.

A live audio webcast of the conference call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source A replay of the webcast will be accessible at the same link for 30 days following the call.

About the Phase 1 Study

The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-sponsored Phase 1 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The study is a dose-escalation trial of pre-complexed NK cells, with patients receiving 1×106 NK cells/kg in Cohort 1; 1×107 NK cells/kg in Cohort 2; and, 1×108 NK cells/kg in Cohort 3. The trial is designed to explore safety and activity and determine the recommended Phase 2 dose. In each cohort, the dose of the pre-complexed NK cells with AFM13 is to be followed by weekly doses of 200 mg AFM13 monotherapy for three weeks, with each patient evaluated for dose-limiting toxicities and responses on day 28.

MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan.

Additional information about the study can be found at www.clinicaltrials.gov (NCT04074746).

About AFM13

AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimed’s most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). The study is actively recruiting, and additional details can be found at www.clinicaltrials.gov (NCT04101331).