QIAGEN and NHS England deepen bioinformatics relationship with agreement for HGMD Professional database for NGS interpretation

On March 2, 2022 QIAGEN reported a new two-year licensing agreement with NHS England and NHS Improvement, one of the four public healthcare systems in the United Kingdom. NHS England and NHS Improvement will use QIAGEN’s HGMD Online Professional, the largest, human-certified curated resource for finding disease-causing genetic variants, to support scientists and clinician across its network of 7 NHS Laboratory Hubs (GLHs) in England with clinical reporting and interpretation of genomic data from patients affected by rare genetic disorders (Press release, Qiagen, MAR 2, 2022, View Source [SID1234609437]).

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The agreement marks a significant milestone in QIAGEN’s longstanding collaboration with the NHS and builds on the selection of HGMD Professional by Genomics England to support the 100,000 Genomes Project. This now-completed UK Government initiative sequenced 100,000 complete genomes from individuals with hereditary cancer or rare diseases to improve the diagnosis and future care of genetic disorders. The continued use of HGMD also supports the NHS’s ongoing mission to expand the diversity and reach of genomics in the UK to enable faster, more comprehensive genomic testing on a national scale.

In the UK, more than half a million children and adults are currently affected by genetic diseases, with approximately 30,000 babies born each year with a genetic disorder.1 The new Genome UK strategy aims to analyze five million genomes in the UK by 2023/2024, including the sequencing of 500,000 whole genomes through the NHS Genomic Medicine Service.

"We are honored to provide this service to the NHS and to put the most detailed, up-to-date evidence-based genomic information into the hands of scientists and clinicians performing genetic testing," said Jonathan Sheldon, Senior Vice President and Head of QIAGEN Digital Insights. "HGMD Professional offers users a digital encyclopedia of peer-reviewed genetic information, enabling confident diagnoses in a much more efficient and targeted manner. Our teams at QIAGEN Digital Insights are continuously striving to deliver valuable molecular insights and clinical bioinformatics solutions that will enable predictive, preventative, and personalized care with confidence, and that improve patient outcomes."

Founded and maintained in 1996 by the Institute of Medical Genetics at Cardiff University, Wales, QIAGEN’s HGMD Professional attempts to collate all known (published) gene lesions responsible for human inherited disease, giving users the confidence that the catalogued mutation is properly reported and relevant.

Unlike new machine learning or artificial intelligence platforms that rapidly index millions of journal articles for mutations, HGMD Professional leverages human judgement and expertise – every catalogued genetic variant has been "touched" by a trained scientist to ensure accuracy, relevance, and context. To date, HGMD Professional contains over 352,000 detailed reports on individual gene variants, with over 45,000 new reports added in 2021 alone.

With more than three decades of experience in variant curation, QIAGEN understands the challenges labs face as next-generation sequencing (NGS) advances. The QIAGEN Clinical Insights (QCI) portfolio consists of QIAGEN’s clinical decision support software and molecular databases, including HGMD Professional, the Catalogue Of Somatic Mutations In Cancer (COSMIC), and the most recently added Human Somatic Mutation Database (HSMD)."

ALX Oncology Announces First Patient Dosed in ASPEN-06, a Phase 2/3 Study of Evorpacept for the Treatment of Patients with Advanced Gastric or Gastroesophageal Junction Cancer

On March 2, 2022 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company"), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported the first patient has been dosed in the Phase 2/3 ASPEN-06 study evaluating the combination of evorpacept, a next generation CD47 blocker, and CYRAMZA (ramucirumab), Eli Lilly and Company’s anti-VEGFR2 antibody, added to trastuzumab and paclitaxel for the treatment of patients with HER2-positive gastric cancer or gastroesophageal junction ("GEJ") cancer (Press release, ALX Oncology, MAR 2, 2022, View Source [SID1234609421]).

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ASPEN-06 (NCT05002127) is a randomized phase 2 (open-label) / phase 3 (double-blind), international, multi-center study to evaluate the efficacy of evorpacept in combination with ramucirumab, trastuzumab, and paclitaxel for the treatment of patients whose tumors have progressed following treatment with HER2-targeted therapy and chemotherapy. Approximately 450 adult patients will be enrolled in the study across both phases.

This study follows the ongoing ASPEN-01 Phase 1b trial in patients with HER2-positive gastric/GEJ cancer who have progressed following treatment with HER2-targeted therapy and chemotherapy (NCT03013218). As presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting in 2021, evorpacept used in combination with ramucirumab, trastuzumab, and paclitaxel demonstrated an initial confirmed objective response rate of 72.2% with a median duration of response of 14.8 months, a 12-month overall survival rate of 79%, and a median overall survival of 17.1 months in patients who historically have low response rates and poor outcomes in this clinical setting [SITC 2021 poster].

"Patients with HER2-positive gastric/GEJ cancer are in need of tolerable and effective treatments, particularly in the 2nd line and later settings where resistance to HER2-directed therapy may have developed," said Keun-Wook Lee, M.D., Ph.D., Professor of Seoul National University College of Medicine and Director of Clinical Trials Center, Seoul National University Bundang Hospital, Seoul, Korea. "Evorpacept’s favorable tolerability coupled with its novel approach of enhancing antibody dependent cellular phagocytosis engages the individual’s own innate anti-cancer immune response distinguishing it from other HER2-targeted approaches."

"We are greatly encouraged by the exciting data that continue to emerge from ASPEN-01 and are pleased to announce the first patient dosed in ASPEN-06," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "This milestone is an important step towards establishing evorpacept as a unique CD47 blocker that may be used in combination with other anti-cancer drugs for difficult-to-treat solid tumors, such as gastric/GEJ cancer, where more treatment options are desperately needed to improve disease outcomes."

About Gastric Cancer and Gastroesophageal Junction Cancer

Gastric cancer begins in the cells lining the inner wall of the stomach and spreads through the outer layers and eventually the body as it grows. It is estimated that there will be over 26,000 newly diagnosed cases of gastric/GEJ cancer at all stages in the U.S. in 2021, and approximately 17 percent of all gastric/GEJ cancer patients have HER2-positive disease. The five-year survival rate is only 5.5 percent for those patients diagnosed with metastatic disease. Gastric/GEJ cancer is even much more common in East Asian countries, with incidence rates 4 to 10 times higher than in the U.S.

Entry into a Material Definitive Agreement

On March 2, 2022, Bristol-Myers Squibb Company (the "Company") reported that it completed the previously announced public offering (the "Offering") of its (i) $1,750,000,000 aggregate principal amount of 2.950% Notes due 2032, (ii) $1,250,000,000 aggregate principal amount of 3.550% Notes due 2042, (iii) $2,000,000,000 aggregate principal amount of 3.700% Notes due 2052 and (iv) $1,000,000,000 aggregate principal amount of 3.900% Notes due 2062 (collectively, the "Notes") (Filing, 8-K, Bristol-Myers Squibb, MAR 2, 2022, View Source [SID1234609420]).

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The Offering was made pursuant to, and in accordance with the terms and subject to the conditions set forth in, a Prospectus Supplement, dated February 15, 2022 and filed with the Securities and Exchange Commission (the "SEC") on February 15, 2022 (the "Prospectus Supplement"), and the Prospectus dated December 13, 2021, filed as part of the shelf registration statement (File No. 333-261623) that became effective under the Securities Act of 1933, as amended, when filed with the SEC on December 13, 2021.

The Notes are governed by and were issued pursuant to that certain Indenture, dated as of June 1, 1993 (the "Base Indenture"), by and between the Company and The Bank of New York Mellon, as trustee, as supplemented by the Thirteenth Supplemental Indenture, dated as of March 2, 2022 (the "Thirteenth Supplemental Indenture" and, the Base Indenture as so supplemented, the "Indenture"). The Indenture contains customary covenants and restrictions, including covenants that require the Company to satisfy certain conditions in order to incur debt secured by liens, engage in sale/leaseback transactions or merge or consolidate with another entity. The Indenture also provides for customary events of default.

The 2032 Notes will bear interest at a rate of 2.950% per annum and will mature on March 15, 2032. The 2042 Notes will bear interest at a rate of 3.550% per annum and will mature on March 15, 2042. The 2052 Notes will bear interest at a rate of 3.700% per annum and will mature on March 15, 2052. The 2062 Notes will bear interest at a rate of 3.900% per annum and will mature on March 15, 2062.

Interest on the Notes will be payable on March 15 and September 15 of each year, beginning on September 15, 2022.

Prior to the applicable Par Call Date (as specified below), the Company may redeem any of the 2032 Notes, the 2042 Notes, the 2052 Notes and the 2062 Notes at its option, in whole or in part, at any time and from time to time at a redemption price (expressed as a percentage of principal amount and rounded to three decimal places) equal to the greater of: (1) (a) the sum of the present values of the remaining scheduled payments of principal and interest thereon discounted to the redemption date (assuming the applicable series of Notes to be redeemed matured on the Par Call Date) on a semi-annual basis (assuming a 360-day year consisting of twelve 30-day months) at the Treasury Rate plus the applicable Make-Whole Spread set forth in the table below less (b) interest accrued to the date of redemption, and 100% of the principal amount of such series of Notes to be redeemed and (2) 100% of the principal amount of the notes to be redeemed, plus, in either case, accrued and unpaid interest thereon to the redemption date.

Fate Therapeutics to Present at Upcoming March Investor Conferences

On March 2, 2022 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that the Company will present at the following upcoming investor conferences (Press release, Fate Therapeutics, MAR 2, 2022, View Source [SID1234609419]):

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Cowen 42nd Annual Health Care Conference available on demand on Wednesday, March 9, 2022 at 11:10 AM ET
Barclays Global Healthcare Conference available on demand on Wednesday, March 16, 2022 at 11:45 AM ET
Oppenheimer 32nd Annual Healthcare Conference available on demand on Thursday, March 17, 2022 at 8:00 AM ET
A live webcast, if recorded, of each presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website shortly after the event.

Akari Therapeutics Appoints Rachelle Jacques as President and Chief Executive Officer

On March 2, 2022 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LBT4) systems are implicated, reported the appointment of Rachelle Jacques as President and Chief Executive Officer of Akari Therapeutics (Press release, Akari Therapeutics, MAR 2, 2022, View Source [SID1234609415]). Ms. Jacques will also join the company’s Board of Directors. Her appointment begins at the end of March 2022.

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Outgoing Chief Executive Officer, Clive Richardson, will continue to serve the Company, supporting Rachelle to accelerate business development and ensuring a smooth transition.

"I am very pleased to be able to welcome Rachelle as CEO of Akari Therapeutics. She has considerable biotechnology experience including a proven track record of bringing advanced therapies for rare diseases to the market," said Ray Prudo, M.D., Akari Therapeutics’ founder and Chairman of the company’s Board of Directors. "With her combined experience in C5 inhibition, immunology and rare diseases, Rachelle has a deep understanding of the potential of Akari’s pipeline. This, together with her strategic experience, affords a springboard to advance our Phase 3 pipeline through potential regulatory approval and towards commercialization, as well as and bring forward our earlier stage pipeline. I very much look forward to working with Rachelle who will be based in the Boston area."

"It’s an exciting time at Akari and I look forward to building on the robust research and development work that has already been completed to advance nomacopan, a unique drug differentiated by its dual mode of action which has the potential to deliver benefits beyond standard complement inhibition," stated Ms. Jacques. "Our pipeline, including two late-stage pivotal programs, has tremendous potential for patients with significant unmet needs and we are working with urgency to realize that promise for them."

Before this appointment, Ms. Jacques served as Chief Executive Officer of Enzyvant Therapeutics Inc., a commercial-stage biotechnology company developing transformative regenerative therapies for rare diseases. Prior to Enzyvant, she served as the Senior Vice President and Global Complement Franchise Head at Alexion Pharmaceuticals, Inc., where she was responsible for global franchise strategy development and execution of the C5 complement inhibitors, eculizumab and ravulizumab, across the therapeutic areas of hematology, nephrology and neurology. She was Vice President of U.S. Hematology Marketing at Baxalta Inc. and then Shire plc, following Shire’s acquisition of Baxalta in 2016. At Baxalta, she served as Vice President of Business Operations after its spinoff from Baxter International Inc. Ms. Jacques held multiple leadership positions at Baxter, including Vice President of Finance, U.S. BioScience Business. Earlier in her career, Ms. Jacques served in various roles at Dow Corning Corporation, including operational management positions in the U.S., Europe, and China.

Ms. Jacques serves on the boards of directors of uniQure N.V. (Nasdaq: QURE) and Corbus Pharmaceuticals (Nasdaq: CRBP). She is co-chair of the Alliance for Regenerative Medicine (ARM) Tissue Engineering & Biomaterials Committee and is a founding member of the ARM Action for Equality Task Force. Ms. Jacques received her B.A. in business administration from Alma College.