On March 1, 2021 Window Therapeutics reported that in March, 2020, the company in conjunction with the Johnson Lab at The Massachusetts Institute of Technology was awarded the prestigious Assay Cascade Grant, for its Window-Bortezomib program for Multiple Myeloma, from the Nanotechnology Characterization Laboratory (NCL), a division of the National Cancer Institute and the Frederick National Laboratory for Cancer Research (Press release, Window Therapeutics, MAR 1, 2021, View Source [SID1234609535]). The NCL accepts the most promising cancer nanomedicine candidates into its Assay Cascade characterization and testing program.
Nanomedicines accepted into the program undergo a rigorous evaluation ranging from sterility and endotoxin testing, physicochemical characterization, in vitro hemato- and immunotoxicity, and in vivo studies to evaluate safety, efficacy and pharmacokinetics. The studies are tailored to each individual nanomedicine and are designed to promote the clinical translation of these novel therapies. All studies are conducted free of charge for Awardees. Initiation of the evaluation of the Window-Bortezomib program began in the first half of 2021 with developmental research currently in progress.

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On March 1, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the patient’s body, reported that it will present at the Cowen 41st Annual Health Care Conference being held virtually from March 1-4, 2021 (Press release, Cue Biopharma, MAR 1, 2021, https://cuebiopharma.gcs-web.com/news-releases/news-release-details/cue-biopharma-present-cowen-41st-annual-health-care-conference [SID1234608285]).

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At the conference, Cue Biopharma will provide an overview highlighting recent developments of the Immuno-STAT (Selective Targeting and Alteration of T cells) platform, its expanding pipeline and anticipated milestones. The presentation will also include an update on the Company’s ongoing Phase 1 monotherapy dose escalation trial of CUE-101 as well as its combination trial of CUE-101 with KEYTRUDA (pembrolizumab) as first-line treatment for HPV+ recurrent/metastatic head and neck cancer.

Presentation Details

Date and Time: Thursday, March 4, 2021 at 9:10 a.m. EST
Webcast Link: https://wsw.com/webcast/cowen81/cue/1782129
A live and archived webcast of the presentation will be available in the Investors & Media section of the Company’s website at www.cuebiopharma.com. The presentation will be archived for 30 days.

On March 1, 2021 Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) reported that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of their biosimilar Bevacizumab, co-developed with Viatris, to be marketed as Abevmy (injection bevacizumab 100mg and 400mg) (Press release, Biocon, MAR 1, 2021, View Source [SID1234594757]). Abevmy is a biosimilar to Roche’s Avastin, prescribed for all indications including metastatic colorectal carcinoma, metastatic breast cancer, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer as part of a specific regimen.

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The decision of the European Commission (EC) is expected in May 2021, which, when approved, will grant marketing authorization in the 27 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. For the U.K., the Medicines and Healthcare Products Regulatory Agency’s "reliance procedure" will be followed, and the U.K. marketing authorization can be expected shortly after the EC decision.

Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Biologics, said: "CHMP’s decision to recommend approval of our biosimilar Bevacizumab brings us a step closer to enable affordable access to this biologic therapy for cancer patients in the EU along with our partner Viatris. It is an outcome of our commitment to expand access for patients leveraging our science and global scale manufacturing for a range of biosimilars. Through bTrastuzumab and bPegfilgrastim we are already making a difference to the lives of cancer patients in several EU countries. We look forward to a final decision from the European Commission approving biosimilar Bevacizumab, which will add to our efforts in cancer care."

Abevmy, bBevacizumab, is a recombinant "humanized" monoclonal antibody that selectively binds to human vascular endothelial growth factor (VEGF) and neutralizes its biologic activity. Bevacizumab inhibits the formation of tumor vasculature, thereby inhibiting tumor growth.

On March 1, 2021 EXACT THERAPEUTICS AS ("EXACT-Tx" or the "Company"), a clinical stage precision medicine company reported that its proprietary Acoustic Cluster Therapy (ACT) platform technology for targeted therapeutic enhancement will be the subject of a presentation at the forthcoming ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies (TAT) Virtual Congress 2021 (Press release, Exact Therapeutics, MAR 1, 2021, View Source [SID1234578278]).

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The ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies Virtual Congress 2021 is set to offer participants a glimpse of the future of targeted anticancer therapies and is the premier international meeting focusing on promising new anticancer targets and agents, with a particular focus on those in early phase clinical development.

The presentation will take place on March 1st 2021 and will focus on the background and rationale of ACT, preclinical study data and the ongoing Phase I evaluation. The Phase I ACTIVATE study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ACT when co-administered with standard of care chemotherapy in patients with metastatic colorectal cancer.

Title: Acoustic cluster therapy (ACT) as a mechanism of increasing drug delivery: Phase I experience (ID50)

Presenting Author: Prof Udai Banerji, NIHR Professor of Molecular Cancer Pharmacology at The Institute of Cancer Research, London, and Honorary Consultant in Medical Oncology, Royal Marsden Hospital NHS Foundation Trust.

Session: (Educational) Nothing is undruggable! (ID19)

Date/Time: Monday 1st March 2021/ 13.00-13.15

The Targeted Anticancer Therapies 2021 Virtual Congress 2021 will bring together experts in anticancer drug discovery and clinical development, translational scientists, and regulators in a unique forum to highlight recent advances and new data, whilst promoting collaboration and knowledge-sharing in a bench-to-bedside approach.The TAT meeting is a meeting focused on early clinical trials and has been described as ‘The home of phase I in oncology’. This meeting will be entirely dedicated to improving the conduct of early anti-cancer clinical trials, with presentations, discussions and educational reviews and workshops highlighting emerging pre-clinical and clinical data, as well as defining optimal methodologies for early clinical trials

About ACT

• ACT is a proprietary formulation consisting of microbubbles and microdroplets that are activated through the application of ultrasound with the consequent increase in targeted delivery of a co-administered therapeutic agent.

• ACT is supported by a strong and broad preclinical package demonstrating therapeutic enhancement in multiple oncology models (pancreatic, breast, colon, prostate) as well as blood-brain barrier penetration.

• Initial focus of the company is oncology, however the ACT platform has potential across therapeutic areas (infectious diseases, CNS, immunotherapy) and product classes.

On March 1, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, MAR 1, 2021, View Source [SID1234577315]). This programme is part of the overall share repurchase programme of up to DKK 17 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 3 February 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.0 billion in the period from 3 February 2021 to 3 May 2021.

Since the announcement as of 22 February 2021, the following transactions have been made:

Transactions related to Novo Nordisk’s incentive programmes have resulted in a net transfer from Novo Nordisk of 9,261 B shares in the period from 22 February 2021 to 26 February 2021. The shares in these transactions were not part of the Safe Harbour repurchase programme.

With the transactions stated above, Novo Nordisk owns a total of 40,877,947 B shares of DKK 0.20 as treasury shares, corresponding to 1.7% of the share capital. The total amount of A and B shares in the company is 2,350,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 17 billion during a 12- month period beginning 3 February 2021. As of 26 February 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 1,974,017 B shares at an average share price of DKK 448.81 per B share equal to a transaction value of DKK 885,959,577.