Novo Nordisk A/S – Share repurchase programme

On June 14, 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, JUN 14, 2021, View Source [SID1234583961]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 7 May 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 10 May 2021 to 3 August 2021.

Since the announcement as of 7 June 2021, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 13,705,192 B shares of DKK 0.20 as treasury shares, corresponding to 0.6% 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 18 billion during a 12- month period beginning 3 February 2021. As of 11 June 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 14,866,694 B shares at an average share price of DKK 457.93 per B share equal to a transaction value of DKK 6,807,945,570.

Fusion Pharmaceuticals Announces Preliminary Safety and Dosimetry Results from its Single-Dose Portion of the Phase 1 Study of FPI-1434

On June 14, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported the presentation of preliminary Phase 1 data from the single-dose portion of the study at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Virtual Annual Meeting (Press release, Fusion Pharmaceuticals, JUN 14, 2021, View Source [SID1234583977]). The presentations and posters highlight the potential of Fusion’s targeted alpha therapies (TATs) to enable delivery of alpha particle emitting isotopes (225Ac) to targeted tumor cells.

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"The data from our ongoing clinical study of FPI-1434 presented at SNMMI demonstrated that treatment with our actinium-based targeted alpha therapy was well tolerated, and imaging shows uptake of the drug across multiple tumor types," said Chief Executive Officer John Valliant, Ph.D. "Importantly, these data supported our ability to initiate the multi-dosing portion of the study, in which we would expect to begin reaching total cumulative levels of radiation necessary to demonstrate anti-tumor activity."

In both the oral session and the poster titled, "Preliminary Dosimetry Results from a First-in-Human Phase 1 Study Evaluating the Efficacy and Safety of [225Ac]-FPI-1434 in Patients with IGF-1R Expressing Solid Tumors," results from the first three patient cohorts (n=12) demonstrated a favorable safety profile for [225Ac]-FPI-1434. No drug-related serious adverse events and/or dose limiting toxicity were reported in administered activity up to 40 kBq/kg body weight and dosimetric results were within normal organ radiation tolerability limits. The single dose escalation portion of the study has concluded, while enrollment into the multi-dosing cohorts are ongoing.

Preclinical Results Combining FPI-1434 with DNA Damage Response Inhibitor (DDRi) and Immune Checkpoint Inhibitors
In separate oral and poster presentations, Fusion presented preclinical data demonstrating synergistic efficacy against olaparib-resistant colorectal and radioresistant lung cancer xenografts when combining FPI-1434 with olaparib.

The combination of the two therapeutics, using doses that were non-effective as single agents, resulted in anti-tumor efficacy against colorectal and non-small cell lung cancer tumor models. The strongest combination effect appeared to occur at the lowest single agent doses, as FPI-1434’s efficacy dominated at higher dose levels.

Fusion also presented preclinical data showing that treatment with FPI-1434 in combination with immune checkpoint inhibitors resulted in complete tumor eradication. Additionally, an increase in antigen-specific CD8 positive T cells and a strong "vaccine" effect were observed with the combination of IGF-1R TAT and immune checkpoint inhibitors, as noted by the prevention of tumor growth in animals that were reinoculated with the same tumor cells.

Dr. Valliant continued, "We are excited by our preclinical data that show the power of combining a potent TAT with the latest generation of cancer therapies, such as checkpoint inhibitors and DDRis. We view these combinations as an opportunity to bring these next-generation radiopharmaceuticals into earlier lines of therapy for patients, and we look forward to initiating combination studies in human once we have achieved the recommended Phase 2 dose for FPI-1434 monotherapy. Our previously announced collaborations with both Merck and AstraZeneca provide us with multiple opportunities to explore these exciting combination therapies."

Following the conclusion of the SNMMI Annual Meeting, copies of the presentations can be found at View Source

About FPI-1434
FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion’s Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties.

Lilly to Participate in Guggenheim Biopharma Strategy Series

On June 14, 2021 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Guggenheim Biopharma Strategy Series – Biopharma’s Next Decade: Views from the Top on Global Strategy and Innovation – on Friday, June 18, 2021 (Press release, Eli Lilly, JUN 14, 2021, View Source [SID1234583945]). Daniel Skovronsky, M.D., Ph.D., Lilly’s Chief Scientific and Medical Officer and President of Lilly Research Laboratories, will participate in a virtual fireside chat at 11:00 a.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

Phio Pharmaceuticals Scheduled to Participate in Two Upcoming Investor Events in June

On June 14, 2021 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that its Chief Executive Officer, Dr. Gerrit Dispersyn, will participate in the AGP Summer Healthcare Symposium and a fireside chat hosted by H.C. Wainwright which are being held virtually on June 17, 2021 and June 22, 2021, respectively (Press release, Phio Pharmaceuticals, JUN 14, 2021, View Source [SID1234583962]).

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Logo – View Source

AGP Summer Healthcare Symposium:
Date: June 17, 2021
Event: One-on-one Meetings – organized through AGP representatives

H.C. Wainwright Fireside Chat:
Date: June 22, 2021
Time: 10:00 am EST
Webcast: Register Here

Interested parties may also access the H.C. Wainwright Fireside Chat webcast through the "Investors – Events and Presentations" section of the Company’s website. The webcast will be archived and available on the Company’s website for 90 days.

Hummingbird Bioscience to Speak at 2021 Virtual Symposium: "VISTA: A New Immune Checkpoint in Cancer, Autoimmunity and Beyond"

On June 14, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets, reported that its Chief Scientific Officer and co-founder, Dr Jerome Boyd-Kirkup, will be speaking at the 2021 virtual symposium "VISTA: A New Immune Checkpoint in Cancer, Autoimmunity and Beyond", taking place on June 18, 2021 (Press release, Hummingbird Bioscience, JUN 14, 2021, View Source [SID1234583978]).

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Hosted by Randolph Noelle, PhD, Professor of Microbiology and Immunology, Department of Microbiology and Immunology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth; and Padmanee Sharma, MD, PhD, Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, University of Texas, MD Anderson Cancer Center, the event gathers leading immunology experts across industry and academia to discuss the emerging checkpoint molecule, VISTA, including its function, the role it plays in several disease areas and current development programs.

Hummingbird will be speaking in the following sessions:

Session Title: VISTA regulation of the tumor microenvironment in human cancer
Date/Time: June 18, 2021 from 9:50 AM to 10:35 AM ET

Session Title: VISTA advances into clinical development
Date/Time: June 18, 2021 from 12:20 PM to 1:05 PM ET

"The presence of VISTA is increasingly implicated as a resistance mechanism to other immune checkpoint therapies, including anti-PD-1 and anti-CTLA-4 antibodies. This conference is an excellent opportunity to share insights and knowledge, including Hummingbird’s experience with our highly differentiated clinical stage anti-VISTA antibody, HMBD-002," said Dr Boyd-Kirkup.

Hummingbird’s rationally targeted anti-VISTA neutralizing antibody, HMBD-002, is the only IgG4 isotype anti-VISTA neutralizing antibody that is currently in development for the treatment of cancers with VISTA-mediated immune suppression, including triple negative breast cancer and non-small cell lung cancer. Pre-clinical studies have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs survival, with no observed toxicity. It has also shown synergy when used in combination with anti-PD-1 therapy. The Phase 1 clinical trial for HMBD-002 is anticipated to commence later this year.

To learn more about the symposium and register to attend, please visit: https://bit.ly/3hBzIUj.

About HMBD-002

HMBD-002 is a unique anti-VISTA neutralizing antibody, and the only IgG4 isotype anti-VISTA antibody currently in development. It was engineered to bind to VISTA at a specific site that is predicted to be essential for ligand-binding and function, thus inhibiting VISTA and neutralizing its immunosuppressive activity without depleting VISTA expressing cells that play many important roles in the immune system.

Pre-clinical studies have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs survival, with no observed toxicity. It has also shown synergy when used in combination with anti-PD-1 therapy.

HMBD-002 is being developed for multiple cancers that have strong evidence of VISTA mediated suppression both as a monotherapy and in combination with PD-1 inhibitor.

Hummingbird’s first-in-class anti-VISTA therapeutic antibody is advancing to clinical trials with support from a US$13.1 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT).