On July 13, 2022 Royalty Pharma plc (Nasdaq: RPRX) reported that it has agreed to acquire a royalty interest in TRELEGY ELLIPTA (Trelegy) from Theravance Biopharma, Inc. (Nasdaq: TBPH) and Innoviva, Inc. (Nasdaq: INVA) for $1.31 billion in cash up front and up to $300 million in additional payments contingent on the achievement of certain sales milestones (Press release, Royalty Pharma , JUL 13, 2022, View Source [SID1234616648]). The acquisition is expected to close within ten business days.

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Trelegy, marketed by GSK, is a combination of an inhaled corticosteroid (fluticasone furoate) and two bronchodilators (umeclidinium, a long-acting muscarinic antagonist, and vilanterol, a long-acting ß2 adrenoreceptor agonist) in a single delivery device administered once-daily for the maintenance treatment of chronic obstructive pulmonary disease (COPD) and the maintenance treatment of asthma in patients aged 18 years and older(2). Many moderate to severe COPD and asthma patients still experience symptoms and Trelegy has been shown to meaningfully improve lung function and quality of life, as well as reduce exacerbations. In 2021, Trelegy generated sales of $1.68 billion, an increase of 57% at constant exchange rates versus the prior year.

"We are excited to acquire this royalty from Theravance and Innoviva," said Pablo Legorreta, Royalty Pharma’s founder and Chief Executive Officer. "Trelegy is the leading triple combination therapy for COPD and asthma and adds another important, rapidly growing blockbuster therapy to our royalty portfolio. Additionally, providing capital at scale positions Theravance and Innoviva to pursue important strategic initiatives. The transaction involves multiple parties with different motivations and goals and once again highlights how Royalty Pharma can facilitate complex transactions to create win-win solutions for its partners."

Transaction Terms

Royalty Pharma is acquiring from Theravance and Innoviva all of the equity interests in Theravance Respiratory Company, LLC, which is entitled to an upward tiering royalty of 6.5% to 10% on annual worldwide Trelegy sales, payable by GSK. Royalty Pharma will pay to Theravance 85% of the royalties in respect of ex-U.S. net sales after June 30, 2029 and 85% of the royalties in respect of U.S. net sales after December 31, 2030.

Royalty Pharma is also providing Theravance $25 million in upfront funding and a potential $15 million regulatory milestone to support the clinical development of ampreloxetine, an investigational once-daily norepinephrine reuptake inhibitor for the treatment of symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy. Neurogenic orthostatic hypotension is a rare disorder in which the autonomic system fails to regulate blood pressure properly, resulting in low blood pressure upon standing. In exchange, Royalty Pharma will receive a low- to mid-single digit royalty on worldwide sales of ampreloxetine.

Trelegy Financial Contribution

The purchase of royalties on Trelegy will further diversify Royalty Pharma’s portfolio with a premier, blockbuster therapy. Based on the current analyst consensus estimate, Royalty Pharma expects this transaction to add at least $200 million to Adjusted Cash Receipts(1) (non-GAAP) in 2025, resulting in enhanced long-term growth.

Royalty Pharma expects to fund this transaction with existing cash on the balance sheet and to maintain significant financial capacity to deploy capital in additional value-creating opportunities.

Advisors

Goodwin Procter, Jones Day and Maiwald acted as legal advisors to Royalty Pharma.

On July 13, 2022 Novimmune SA (LCB), is an antibody discovery and development company located in Geneva, Switzerland (Press release, Light Chain Bioscience, JUL 13, 2022, View Source [SID1234616646]). LCB reported that the first patient was dosed in the Phase 1, first-in-human trial of NI-1801 in patients with advanced, metastatic, or recurrent solid malignancies expressing mesothelin (MSLN) . NI-1801 is a human IgG1 bispecific antibody based on LCB’s , targeting MSLN and CD47. "NI-1801 is the second κλ body entering clinical evaluation. This represents an important milestone in the development of LCB’s pipeline of bispecific antibodies featuring a truly native human IgG structure," said Nicolas Fischer, Chief Executive Officer.

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The surface protein CD47 is an innate immune checkpoint that allows tumor cells to escape immune surveillance, thus acting as a don’t eat me signal. LCB’s bispecific antibody approach simultaneously targets CD47 and a tumor-specific antigen, here MSLN, to selectively block CD47 on MSLN-expressing malignant cells. "As CD47 is ubiquitous, measures need to be taken to limit the immune response to tumor cells. NI-1801 represents a promising novel treatment approach for several cancers with high medical need. We are excited to further investigate this in our Phase 1 study," said Dr. med. Anja Seckinger, Chief Medical Officer.

The LCB-1801-001 Phase 1 trial is a multi-center, open-label, dose escalation and expansion, first-in-human clinical trial that is expected to enroll approximately 40 patients with MSLN-expressing triple-negative breast, non-squamous non-small cell lung or ovarian cancer. The primary objectives of the dose escalation portion (Part A) are to assess the safety and tolerability of escalating doses of NI-1801, with the goal of establishing a maximum-tolerated dose (MTD) and non-tolerated toxic dose. The expansion part (Part B) will further evaluate the safety and efficacy of NI-1801 administered at or below the MTD in up to 20 additional patients to determine the recommended Phase 2 dose. Additional objectives include evaluation of preliminary efficacy, pharmacokinetics (PK), pharmacodynamics and potential predictive biomarkers.

NI-1801 induces antibody-dependent cellular phagocytosis (ADCP) and antibody-dependent cell-mediated cytotoxicity of a variety of MSLN-positive cancer cell lines in vitro. ADCP is negligible or unaffected by a CD47-sink effect mimicked by CD47-expressing red blood cells. NI-1801 does not induce in vitro hemagglutination or platelet aggregation. In multiple preclinical (xenograft) models, NI-1801 inhibits tumor growth in mice. NI-1801 was well tolerated and demonstrated favorable pharmacokinetics in multiple non-human primate studies.

On July 13, 2022 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported it has agreed to sell approximately 16.6 million shares of its common stock to a select group of institutional and accredited investors in a private placement, at a price per share of $7.21 (Press release, Gossamer Bio, JUL 13, 2022, View Source [SID1234616645]). Gross proceeds are expected to be approximately $120 million, before deducting offering expenses. The financing is expected to close on July 15, 2022, subject to customary closing conditions.

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The financing includes participation from new and existing institutional investors, including EcoR1 Capital, New Enterprise Associates (NEA), Weiss Asset Management, Madison Avenue Partners, Rock Springs Capital, Boxer Capital, Invus, and Monashee Investment Management, and certain directors and executive officers of Gossamer. Participating investors entered into lock-up agreements with Gossamer to restrict their ability to sell Gossamer shares.

"We are very pleased this high-quality group of investors came together to support the seralutinib program at this important juncture," said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer. "These additional funds will allow us to accelerate and expand our investment in seralutinib ahead of the Phase 2 TORREY Study topline results in the fourth quarter of this year."

In addition to supporting the seralutinib program, Gossamer intends to use the net proceeds from the proposed financing to fund research and development of its other product candidates and development programs and for working capital and general corporate purposes. The proceeds from this financing, combined with current cash, cash equivalents and marketable securities, and access to its debt facility is expected to be sufficient to fund operating and capital expenditures into mid-2024.

The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Gossamer has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in this private placement.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On July 13, 2022 DNAnexus, Inc., a leading provider of cloud-based biomedical data analysis software serving the life sciences community, and Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported a collaboration aimed at accelerating research and reducing the time to design, validate, and commercialize new, high-quality, next-generation sequencing (NGS)-based diagnostic tests (Press release, Twist Bioscience, JUL 13, 2022, View Source [SID1234616644]). As part of the collaboration, Twist customers are able to use the integrated DNAnexus platform with Twist’s NGS Methylation Detection System and Unique Molecular Identifier (UMI) Adapter System to simplify data analysis after sequencing.

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The Twist NGS Methylation Detection System provides robust sample preparation and target enrichment solutions for identifying methylated regions in the human genome. Rare diseases, cancer, and other disorders can be identified by unique methylation patterns within samples. The NGS Methylation Detection System uses highly sensitive hybridization capture-based technology that can be integrated into diagnostic tests. This workflow can also be used to better characterize and understand the genetic mechanisms linked to specific conditions including cancer, neurodegeneration, and rare diseases. The Twist UMI Adapter System detects low-frequency variants in low-input sample sources such as cell-free DNA (cfDNA) and can be used to enable cancer research. The DNAnexus platform allows users to easily explore and analyze complex datasets in a single, scalable, cloud-based environment.

"This collaboration with DNAnexus is another example of our ongoing commitment to providing our customers with the tools they need for complete, customized, end-to-end workflows," said Emily M. Leproust, PhD, CEO and co-founder of Twist Bioscience. "Our customers can now access industry-leading computational infrastructure platforms to support their bioinformatics needs and reduce their data analysis timeline after performing a sequencing run with our NGS Methylation Detection and UMI Adapter Systems."

Today, DNAnexus has more than 12,000 users across 48 countries and works with the largest and most innovative pharmaceutical companies, diagnostic laboratories, and academic medical centers around the world, along with the UK Biobank and the FDA. The platform provides a comprehensive cloud environment that supports the entire diagnostic development and production cycle from R&D through to deployment of the validated test. The environment was designed to meet the most rigorous standards for quality, security, privacy, and safety.

"Twist’s proprietary synthetic DNA tools continue to be used to advance research and precision medicine and to change the way diagnostics are developed," said John Ellithorpe, PhD, President of DNAnexus. "With the integrated DNAnexus platform, Twist customers can now reduce the complex data analysis bottleneck, which we believe will offer significant time savings and cost advantages."

On July 13, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult to treat cancers, reported that the Company will report second quarter 2022 financial results on Thursday, July, 21, 2022, after market close (Press release, Cytori Therapeutics, JUL 13, 2022, View Source [SID1234616643]). Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.

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A live webcast will be available at ir.plustherapeutics.com/events.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s website under the ‘For Investor’ section. The webcast will be available on the Company’s website for 90 days following the live call.