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.

On May 4, 2021 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that it will report its first quarter 2021 financial and operating results on Thursday, May 13, 2021, following the close of the U.S. financial markets (Press release, Lineage Cell Therapeutics, MAY 4, 2021, View Source [SID1234579105]). Lineage management will also host a conference call and webcast on Thursday, May 13, 2021, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2021 financial and operating results and to provide a business update.

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Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through May 21, 2021, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 4996965.

On May 4, 2021 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported its interim management statement for the period ending March 31, 2021 (Press release, Molecular Partners, MAY 4, 2021, View Source [SID1234579121]).

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"Molecular Partners continues to grow and expand the reach of our DARPin therapeutics platform, with the COVID-19 pandemic forming a meaningful change agent for us," said Patrick Amstutz, Ph.D., chief executive officer of Molecular Partners. "Twelve months ago, we were only at the initiating stages of our COVID-19 program, while this year we are approaching Phase 3 clinical trials with our partners at Novartis. I am extremely proud of our team and partners for not only bringing us to this stage of development in our new antiviral program, but also for continuing to advance our targeted oncology pipeline."

Research & Development Highlights
COVID-19 antiviral programs:
Completed Phase 1 dosing of ensovibep (MP0420) across three dose cohorts, and announced initial positive results
Published data showing that ensovibep is effective in vitro against all variants of concern analyzed
Initiated single-arm Phase 2 study of ensovibep in COVID-19 positive patients, in the ambulatory setting
A global Phase 2 – 3 study in ambulatory patients in collaboration with Novartis initiating enrollment in May 2021
AMG 506 (MP0310) in solid tumors:
Proof of mechanism of action achieved, showing dose-dependent tumor accumulation and local activation of immune cells, as demonstrated after the first dose
Clinical studies ongoing to establish optimal dose regimen and activity with weekly dosing
MP0317 (FAP X CD40):
Investigational New Drug Application (IND)-enabling work near completion
Expected to enter the clinic in the second half of 2021
Four scientific posters published recently at the 2021 American Academy for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, virtually from April 10-15:
Initial results highlighting the Company’s new AML focused multi-specific T-cell engager program
Additional data presented for MP0317, CD3 T cell engagers, and peptide-MHC DARPin programs

Operational and financial highlights:
Election of two new members to the Company’s Board of Directors: Agnete Fredriksen, Ph.D., and Dominik Höchli, M.D.
Strong financial position with CHF 145.6 million in cash (incl. short term deposits) as of
March 31, 2021
Net cash used in operating activities of CHF 29.9 million in Q1 2021
Operating loss of CHF 18.5 million and net loss of CHF 16.6 million in Q1 2021
Company funded into 2023, excluding any potential payments from R&D partnerships

Clinical Updates:
COVID-19 program advancing in the clinic
Molecular Partners’ lead anti-COVID-19 therapeutic candidate, ensovibep (MP0420), has been administered to healthy subjects in the Company’s Phase 1 trial, with initial results showing it to be safe and well-tolerated, with a half-life in the range of 2-3 weeks. Additionally, a single-arm Phase 2 trial with ensovibep in COVID-19 ambulatory patients was initiated in March 2021 at a single center in the Netherlands. The initial Phase 1 results have informed the decision to move forward with the EMPATHY clinical trial program in April 2021, which is being conducted by our partner Novartis, with Molecular Partners as sponsor. The EMPATHY trial is a global, multi-center Phase 2 and 3 study that will seek to enroll 2,100 patients with COVID-19 in the ambulatory setting, to evaluate the safety and efficacy of ensovibep in preventing worsening symptoms and hospitalizations. In parallel, ensovibep will also be tested in hospitalized COVID-19 patients, in a new sub-trial of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-3) Program Phase 3 clinical trial.

In addition to the clinical development, ensovibep continues to be tested in vitro for its inhibition of infectivity in newly discovered variants of the virus. To date, ensovibep has been shown to be effective in inhibiting viral infectivity in all variants and point mutations of concern.

Phase 1 trial of AMG 506 (MP0310) (FAP X 4-1BB)
As presented in December 2020 at our R&D day, preliminary clinical data from the ongoing Phase 1 clinical trial of AMG 506 (MP0310) show that the molecule performs as intended. AMG 506 (MP0310) showed colocalization with FAP at low concentrations, and the FAP binding was observed to be dose dependent, with a saturation of the tumor-expressed FAP in high AMG 506 (MP0310) concentrations. Furthermore, by analyzing paired biopsies of patients, significant tumor-localized increases in immune activation were seen across multiple immune cell types after a single injection, while systemic inflammatory markers were unchanged, and no AMG 506 (MP0310) activity was seen in peripheral tissues.

Additional dosing work is ongoing in the current Phase 1 clinical trial to test dosing regimens, including the exploration of weekly dosing, aiming to identify the right dose to provide durable activity after several injections of our tumor localized 4-1BB agonist.

MP0317 (FAP x CD40) IND-enabling work complete, scheduled to enter the clinic in H2 2021
In April 2021, Molecular Partners presented data from the MP0317 program at the AACR (Free AACR Whitepaper) conference, showing new mechanism of action (MOA) data on the tumor-localized immune agonist MP0317, the second DARPin protein in the Company’s immuno-oncology pipeline. As previously indicated, the company anticipates entering the clinic with MP0317 on the second half of 2021.

First CD3 T cell engager program to focus on AML therapies
As recently presented at the AACR (Free AACR Whitepaper) conference, Molecular Partners’ first CD3 T cell engager will be focused on targeting AML tumor cells as well as T cells, to activate the immune cells against the tumor. Initial proof of concept data shows the Company was able to achieve a wide therapeutic window using a triple- tumor-antigen targeting CD3 DARPin engager molecule.

Balance sheet: Strong cash and equity positions as of March 2021
Molecular Partners’ financial performance for the first three months of 2021 reflects an operating cash outflow of CHF 29.9 million. Cash and short-term deposits decreased by CHF 28.1 million in Q1 2021 to CHF 145.6 million as of March 31, 2021 (year-end 2020: CHF 173.7 million). The decrease in cash and short-term deposits was driven by a large prepayment of CHF 9.3 million for the manufacturing of commercial supply for ensovibep.

As of March 31, 2021, the company employed 151.6 FTEs, a 9% increase year-over-year, with approximately 82% of employees serving in R&D functions.

Financial outlook 2021
For the FY 2021, at constant exchange rates, the company continues to expect total expenses of CHF 65-75 million, of which around CHF 6 million will be non-cash effective costs.

In terms of cash outflow the company expects a gross cash utilization of CHF 85-95 million for FY2021, which includes a total of CHF 20 million payable to Novartis for the manufacturing of commercial supply (of which CHF 9.3 million occurred during Q1 2021). This cash flow guidance does not include any potential receipts from R&D partnerships.

With CHF 145.6 million cash at hand and no debt as per March 31, 2021 the company expects to be funded into 2023, excluding any potential receipts from R&D partners.

Financial Calendar
26 August 2021 Publication of Half-year Results 2021 (unaudited)

28 October 2021 Interim Management Statement Q3 2021

About DARPin therapeutics
DARPin therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins that open a new dimension of multi-functionality and multi-target specificity in drug design. A single DARPin candidate can engage more than five targets, and its flexible architecture and small size offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. DARPin therapeutics have been clinically validated through to registration via the development of abicipar, Molecular Partners’ most advanced DARPin drug candidate. The DARPin platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields. DARPin is a registered trademark owned by Molecular Partners AG.