On May 4, 2021 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that it has completed a Private Placement ("Placement") of new shares to new and existing institutional and sophisticated investors (Press release, Amplia Therapeutics, MAY 4, 2021, View Source;TE [SID1234579120]). The Placement will raise a total of approximately $3.8 million at an issue price of $0.23 per new, fully paid, ordinary share representing a 10.0% discount to the 15-day volume weighted price of shares traded up to 29 April 2021.

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A total of 16,585,000 new shares will be issued within the Company’s placement capacity under ASX Listing Rules 7.1 and 7.1A. The new shares are expected to be issued on 7 May 2021.

The placement was strongly supported by the Company’s largest shareholders, Platinum Investment Management Ltd. and Blueflag Holdings Pty Ltd. A new institutional shareholder, Acorn Capital, also participated in the Placement.

The proceeds from the Placement will be used to fund enabling activities for the Company’s planned Phase 2 clinical trials in pancreatic cancer and pulmonary fibrosis and provide working capital for the Company. The Phase 2 enabling activities include manufacture of drug substance and drug product, conduct of additional toxicology studies to support extended dosing in pulmonary fibrosis patients and clinical planning and lodgement of regulatory filings to support clinical trials in patients with pancreatic cancer.

Commenting on the results of the Placement, Amplia’s Chief Executive Officer DrJohn Lambert said "We are delighted to receive the continuing support of existing investors as well as to welcome new investors to our register. Over the last year, Amplia has put in place the necessary foundations for our planned Phase 2 clinical program for AMP945. Specifically, the recent completion of dosing in our Phase 1 trial of AMP945 together with the exciting results we have seen in our parallel non-clinical studies have provided the clinical safety data and preclinical rationale needed for us to push forward into Phase 2 clinical studies."

Taylor Collison acted as Lead Manager for the Placement.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On May 4, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that it is a national sponsor of the Colorado Melanoma Foundation, a non-profit organization (Press release, Castle Biosciences, MAY 4, 2021, View Source [SID1234579138]). Castle will collaborate with the Colorado Melanoma Foundation and Epiphany Dermatology to provide free skin cancer screenings and public education through the Sun Bus initiative. The Sun Bus is a mobile skin cancer screening station and sun safety education classroom.

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The Colorado Melanoma Foundation and The Sun Bus, beginning in May, will travel to locations in Texas, Colorado, Arizona and New Mexico, providing free skin cancer checks, as well as educating visitors on ways to prevent skin cancer deaths through free sun safety education sessions.

"The purpose of the 2021 Sun Bus Free Skin Cancer Screening Tour is to help re-engage public attention on skin cancer screening as we come out of the pandemic," stated Dr. Neil Box, director of the Sun Bus and president of the Colorado Melanoma Foundation. "Most of us have been focused on maintaining social distancing and helping limit the spread of COVID-19, but it is important not to neglect our regular health screenings."

"May is Skin Cancer Awareness Month, and it is an important time for us to reiterate our commitment to improving the lives of patients with skin cancer," said Derek Maetzold, president and chief executive officer of Castle. "Our collaboration with the Colorado Melanoma Foundation and the Sun Bus initiative is intended to help educate the public and encourage early detection and screening. With our suite of dermatologic diagnostic tests, we’re passionate about providing patients with the most accurate and personalized care. And that begins with screenings, awareness and an understanding of the risks of skin cancer."

To see when The Sun Bus is in your area, visit View Source

On May 4, 2021 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that it has received a response from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application that the study for selection and treatment of Prostate-Specific Membrane Antigen (PSMA) positive prostate cancers using 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA may proceed (Press release, Clarity Pharmaceuticals, MAY 4, 2021, View Source [SID1234579036]).

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The SECuRE trial (Systemic Cu theranostics in prostate cancer) is a Phase I/IIa study for identification and treatment of PSMA-expressing metastatic castrate resistant prostate cancer (mCRPC), which will be conducted in the U.S. (NCT04868604)1. It is a theranostic multi-centre, single arm, dose escalation study with a cohort expansion planned for up to 44 patients. The trial employs diagnostic Positron Emission Tomography imaging with 64Cu-SAR-bisPSMA for selection of patients suitable for therapy cycles with 67Cu-SAR-bis-PSMA.

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of death worldwide2. The American Cancer Society estimates in 2021 there will be 248,530 new cases of prostate cancer in the U.S. and around 34,130 deaths from the disease3. For metastatic prostate cancer, the 5-year relative survival rate is 30%, indicating a high unmet need for early detection and better treatment options for mCRPC. Annually, there are around ~34,000 men in the U.S. who are diagnosed with mCRCP3, ~90% of whom have tumours which express PSMA4.

Although there are some new therapeutic radiopharmaceutical agents for prostate cancer in late phase clinical trials, given the large patient population, product supply for therapeutic radiopharmaceuticals presents a constraint as they rely on the production of therapeutic isotopes from a small number of nuclear reactors, with reactor shutdowns often causing isotope shortages around the globe.

Clarity’s SAR-bisPSMA product utilises two isotopes of copper, which do not have the same constraints:

The therapeutic product utilises copper-67, which is being produced domestically in the USA on electron accelerators, avoiding the issues commonly associated with the production of isotopes on nuclear reactors.
The diagnostic product utilises copper-64, which is regularly produced in significant volumes on cyclotrons in the U.S., and has a half-life of 12.7 hours, avoiding the short half-life issues of other diagnostic isotopes.
The diagnostic and therapeutic products can be centrally manufactured and shipped as finished product direct to the treatment centres, which removes the need for dedicated radiopharmacy facilities at treatment centres.
Dr Alan Taylor, Clarity’s Executive Chairman, commented on the IND approval, "The FDA response suggests not only the importance of developing novel treatments for men with late-stage prostate cancer, whose prognosis is currently very poor, but also validates Clarity’s copper pairing paradigm and the centralised manufacturing concept, which differentiates it from the competitor products and enables product supply to the levels suitable for use in large patient indications."

"We are very excited to commence the SECuRE trial in mCRCP patients and have engaged a world class group of key opinion leaders in the prostate cancer space to support the development of 64/67Cu SAR-bisPSMA. Clarity’s Global Clinical Development Group has unrivalled experience in the commercialisation of the only currently approved radiotherapeutic for prostate cancer. The FDA response is a crucial milestone in the development of SAR-bisPSMA theranostics and we are looking forward to progressing this trial at some of the leading cancer centres in the U.S. as part of our ultimate goal of developing better treatments for children and adults with cancer," said Dr Taylor.

Reference List
National Institute of Health, U.S. National Library of Medicine, View Source
World Cancer Research Fund, Prostate Cancer Statistics, View Source
American Cancer Society, Cancer Statistics Center, View Source!/cancer-site/Prostate
A. Silver, I. Pellicer, W. R. Fair, W. D. Heston and C. Cordon-Cardo 1997. "Prostate-specific membrane antigen expression in normal and malignant human tissues." Clinical Cancer Research. vol. 3, 81-85, January 1997

On May 4, 2021 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, reported that the company will participate at the BofA Securities 2021 Virtual Health Care Conference (Press release, Ascendis Pharma, MAY 4, 2021, View Source [SID1234579063]). Company executives will provide a business overview and an update on the Company’s pipeline programs.

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Details

Event BofA Securities 2021 Virtual Health Care Conference
Location Virtual
Date Tuesday, May 11, 2021
Time 4:15 p.m. Eastern Time
A live audio webcast of the presentation will be available on the Investors and News section of the Company’s website at www.ascendispharma.com. A webcast replay will also be available on the Company’s website shortly after conclusion of the event for 30 days.

On May 4, 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, MAY 4, 2021, View Source [SID1234579086]). 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 has repurchased B shares for an amount up to DKK 3.0 billion in the period from 3 February 2021 to 3 May 2021. The programme is now concluded.

Since the announcement as of 26 April 2021, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 5,657,389 B shares of DKK 0.20 as treasury shares, corresponding to 0.2% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 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 3 May 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 6,754,777 B shares at an average share price of DKK 444.12 per B share equal to a transaction value of DKK 2,999,924,849.