On February 17, 2021 Theragnostics, which is developing molecular radiotherapy for imaging and treating a broad range of cancers, reported a research collaboration with Essen University Hospital to examine Theragnostics’ investigational agent THG-008 for PET imaging in a range of cancers (Press release, Theragnostics, FEB 17, 2021, View Source;utm_medium=rss&utm_campaign=theragnostics-announces-a-research-collaboration-with-essen-university-hospital-to-study-thg-008-for-oncology-pet-imaging [SID1234575169]).

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The research is due to start in February 2021 and will be led by Dr. Michael Nader, head of radiochemistry and part of the Clinic for Nuclear Medicine at Universitätsklinikum Essen (University Hospital Essen), in Germany.

THG-008 is a novel fluorine-18 radiolabelled PARP inhibitor (18F-PARPi) which has a number of applications relevant to imaging cancer. A Phase 1 clinical study for THG-008 in head and neck squamous cell carcinoma (HNSCC) completed recruitment in May 2019. Data published in a peer-reviewed publication confirmed imaging of head and neck cancer with 18F-PARPi was feasible and had an acceptable safety profile.1 The study also confirmed that 18F-PARPi can detect primary and metastatic HNSCC lesions, and that retention in cancer deposits was longer than in healthy tissues.

Commenting on the collaboration, Greg Mullen, Chief Executive Officer of Theragnostics, said: "We are excited to collaborate with Professor Dr Ken Herrmann, who has extensive experience in Nuclear Medicine and is an important researcher in the field. Radiolabelled PARP inhibitors have the potential to improve patient survival in a number of cancers. There are several approved conventional pharmaceutical PARP inhibitors on the market with new indications being approved in recent months further expanding an existing multibillion dollar market."

Professor Dr. Ken Herrmann added: "Universitätsklinikum Essen specialises in the diagnosis and treatment of cancer using nuclear medicine techniques which puts us in a privileged position to assess and evaluate the potential of THG-008 as a PET imaging agent. With this study we hope to advance our understanding of the applicability of PARP inhibitor imaging oncology."

On February 17, 2021 Molecular Templates, Inc. (Nasdaq: MTEM) (the "Company" or "Molecular"), a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer and other serious diseases, reported that it has commenced an underwritten public offering of its common stock (Press release, Molecular Templates, FEB 17, 2021, View Source [SID1234575187]). Molecular also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering on the same terms and conditions. All of the shares in the offering are to be sold by Molecular.

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Molecular intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to fund: its Phase II clinical studies for MT-3724 and/or development of other CD20-targeted molecules; its ongoing Phase I clinical study of MT-5111; its share of development expenses in its CD38 collaboration with Takeda; its PD-L1 program (including its anticipated upcoming Phase I clinical study for MT-6402); further preclinical development and drug discovery activities in its other programs; and for working capital and general corporate purposes. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

BofA Securities, Cowen, Evercore ISI and Barclays are acting as joint book-running managers for the offering.

The securities are being offered by Molecular pursuant to a shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC. A preliminary prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may be obtained from BofA Securities, Inc., c/o BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or via e-mail at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or via telephone at (833) 297-2926; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, via telephone at (888) 474-0200, or via e-mail at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, via telephone at (888) 603-5847, or via e-mail at [email protected][email protected]. You may also obtain these documents free of charge by visiting the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 17, 2021 United Therapeutics Corporation (Nasdaq: UTHR) reported that it will report its fourth quarter and full year 2020 financial results before the market opens on Wednesday, February 24, 2021 (Press release, United Therapeutics, FEB 17, 2021, View Source [SID1234575204]).

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United Therapeutics will host a teleconference on Wednesday, February 24, 2021, at 9:00 a.m. Eastern Time. The teleconference is accessible by dialing (866) 393-4306 in the United States, with international callers dialing +1 (763) 488-9145. A rebroadcast of the teleconference will be available for one week and can be accessed by dialing (855) 859-2056 in the United States, with international callers dialing +1 (404) 537-3406, and using access code: 8999095.

On February 17, 2021 Nektar Therapeutics (NASDAQ: NKTR) reported that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada) for a Phase 2/3 study of bempegaldesleukin (NKTR-214, BEMPEG), Nektar’s investigational IL-2 pathway agent, in combination with Merck’s KEYTRUDA (pembrolizumab) for first-line treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck (SCCHN) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) (Press release, Nektar Therapeutics, FEB 17, 2021, View Source [SID1234575223]). The study is planned to start in the second half of 2021.

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"We are excited to advance the combination of BEMPEG plus KEYTRUDA to a Phase 2/3 study in first-line squamous cell carcinoma of the head and neck," said Jonathan Zalevsky, PhD, Chief R&D Officer at Nektar. "Earlier studies of BEMPEG in combination with immune checkpoint inhibitors, also known as ICIs, evaluated in patients with immune-sensitive cancers have shown the potential to increase and deepen treatment responses as compared to historical rates for ICIs alone. This collaboration with Merck will enable us to further explore the combination of BEMPEG with the leading checkpoint inhibitor therapy in the setting of advanced head and neck cancer."

Under the terms of the agreement, Nektar will conduct the Phase 2/3 study, which is expected to enroll 500 patients with metastatic or recurrent SCCHN with PD-L1 expressing tumors. Patients will be randomized to receive either the combination of BEMPEG plus pembrolizumab or pembrolizumab alone. The Phase 2 portion of the study will include an interim analysis of overall response rate (ORR) after the first 200 patients enrolled have a minimum follow up of 4 months. If the ORR passes a prespecified futility boundary, the study will continue, and the remaining 300 patients will be enrolled to the Phase 3 portion of the study. The primary endpoints of the trial are ORR and overall survival (OS); progression free survival (PFS) is a secondary endpoint.

On February 17, 2021 An international multidisciplinary consortium, co-led by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI), reported that has been convened to generate recommendations to standardize the use, analysis, and interpretation of patient reported outcome (PRO) data in cancer clinical trials (Press release, EORTC, FEB 17, 2021, View Source [SID1234575348]).

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SISAQOL-IMI (Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials – IMI) will establish guidance on how to use patient-reported outcomes in cancer clinical trials so that they can be used in a methodologically sound way, analysed in a statistically adequate manner, and intelligibly presented to ensure a high study quality and a better comparability of results across clinical trials.

SISAQOL-IMI is a public-private collaborative research project under the Innovative Medicines Initiative (IMI). Forty-one stakeholder groups are involved in the partnership, including researchers from the pharmaceutical industry, academia, non-profit associations, cancer institutes, regulators, and patient advocacy organisations. The project aims to improve the interpretability of cancer clinical trials and thereby (in the long run) also provide a more solid and reliable basis for shared decision making between patients and physicians to improve outcomes, treatment satisfaction, and care treatment decisions in clinical practice.

Andrew Bottomley, Assistant Director and Head of the Quality of Life Department at the EORTC and SISAQOL-IMI project coordinator said,

"Outcomes from this project will help us understand more about the impact of treatment on the lives of patients. We are looking forward to working with our project partners to generate recommendations that will be useful to so many different stakeholders "

Kathy Oliver, Chair and Co-Director of the International Brain Tumour Alliance also commented,

"The SISAQOL-IMI initiative is a ground-breaking project which will set much-needed international standards for PRO data analysis in cancer clinical trials. We look forward to WECAN’s involvement with this exciting initiative"

Dr Ingolf Griebsch Head of Corporate Market Access Oncology at Boehringer Ingelheim and SISAQOL-IMI project leader said,

"SISAQOL-IMI is a great example of how researchers from academia and industry can truly partner with regulators and patient organisations to develop useful recommendations for interpreting PRO data in the future"

SISAQOL-IMI kicked off at the beginning of January and will run for four years.