On July 9, 2024 SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases, reported the successful enrollment of the MERLIN_001 study (Press release, SkylineDx, JUL 9, 2024, View Source [SID1234644758]). This study is the largest independent multicenter prospective investigation to date into the role of Gene Expression Profiling (GEP) testing in melanoma care. This milestone marks the conclusion of enrollment with the final patient now included in this groundbreaking prospective registry study [1].

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MERLIN_001 was designed with the aim of prospectively validating the Merlin Assay – a clinicopathologic GEP model – in an independent multicenter cohort of clinically node negative primary cutaneous melanoma patients, who are undergoing lymphatic mapping and sentinel lymph node biopsy (SLNB) per current clinical guidelines. The primary objective of this study is to evaluate the ability of the Merlin Assay to predict risk of sentinel node metastasis in melanoma patients who are candidates for SLNB. Spanning 9 centers across the US, the study enrolled 1,640 eligible patients over the past 3 years, reflecting a comprehensive real-world cross-section of the melanoma patients referred for SLNB.

Independent prospective validation is crucial for GEP testing to show its clinical value and establish their cost-effectiveness [2]. Previous prospective data from the Netherlands affirmed the performance metrics published from multiple independent international retrospective cohorts. All of these publications conclude that the Merlin Assay can accurately identify patients at low risk for nodal metastasis.

Dharminder Chahal, CEO of SkylineDx, commented: "The successful completion of patient enrollment in the MERLIN_001 study represents a monumental achievement in our melanoma research efforts. We are immensely grateful to all the patients who participated and to our dedicated team of researchers and collaborators. This study underscores our commitment to advancing personalized medicine and improving outcomes for melanoma patients worldwide."

Vernon K. Sondak, MD, Chair of the Department of Cutaneous Oncology at Moffitt Cancer Center in Tampa, FL, and Principal Investigator of the MERLIN_001 study, added: "The importance of this large multicenter investigation cannot be overstated. The collaboration among leading institutions across the country has been instrumental in driving the success of this study. The diverse patient population and the rigorous methodology employed have provided a robust dataset that will significantly advance our understanding of the potential role of gene expression profiling in melanoma, and the results will enhance patient care."

SkylineDx extends heartfelt thanks to all the patients who participated in the MERLIN_001 study. Their confidence and willingness to contribute to this innovative research are invaluable. We also thank our collaborators, healthcare professionals, and research teams for their unwavering support and dedication.

As we move forward, SkylineDx remains committed to analyzing the data collected and sharing comprehensive results with the medical community. The insights gained from the MERLIN_001 study will pave the way for more precise and personalized melanoma care, ultimately benefiting patients globally.

About CP-GEP

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients that combines clinicopathologic (CP) variables with gene expression profiling (GEP). This model is able to assess metastatic potential in cutaneous melanoma patients, thus identifying those at low risk for nodal metastasis who may potentially safely forgo the sentinel lymph node biopsy (SLNB) procedure. The CP-GEP model was developed by Mayo Clinic and SkylineDx BV and it has been clinically validated in multiple studies. More information (including references) may be obtained at www.falconprogram.com. The test has been launched in the United States and Europe as the Merlin Assay. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase access. In the United States, Tempus is commercializing Tempus Merlin test.

Quest Diagnostics launched their own LDT version of the CP-GEP model in the United States under the brand name MelaNodal Predict.

On July 9, 2024 Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, reported that it has acquired Fluent BioSciences, developer of an emerging and highly differentiated single-cell technology (Press release, Illumina, JUL 9, 2024, View Source [SID1234644757]).

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"The addition of Fluent BioSciences to Illumina will provide significant and new capabilities to our customers in a key growth area and advances our multiomics growth strategy," said Steven Barnard, chief technology officer of Illumina. "Single-cell research opens doors to new areas of discovery, and Fluent’s innovative, accessible, and flexible single-cell method will accelerate our ability to deliver full multiomics solutions for our customers."

Fluent’s single-cell analysis technology eliminates the need for complex, expensive instrumentation and microfluidic consumables. This novel approach removes many of the barriers and limitations of current methods, making single-cell analysis accessible for a broader set of customers, and catalyzing new experiments enabled by the ability to perform that assay at the point of sample collection. Fluent’s latest release, PIPseq V, delivers exceptional performance, with the ability to detect cell types often missed with current methods, and the highest scalability, capable of processing a range from 100 cells up to 1 million.

Fluent’s unique technology combined with Illumina’s leading sequencing and informatics solutions including Partek Flow, which enables single-cell multiomic analysis, will provide customers with a complete solution and single point of support so that researchers can advance discovery faster and more economically.

The Fluent team will join Illumina, and PIPseq V will be integrated into Illumina’s product portfolio. The company plans to build on Fluent’s technology to develop full end-to-end solutions for single-cell analysis.

Illumina will remain an open NGS platform and is committed to maintaining and supporting its existing single-cell partnerships. "Our goal is to continue to develop the sequencing eco-system and support the best multiomics solutions like single-cell analysis," Barnard said. "We want customers to have the flexibility to adopt the tools that best fit their needs."

The acquisition closed on July 9, 2024, and has been funded with cash on hand.

On July 9, 2024 IDEAYA Biosciences, Inc. (Nasdaq: IDYA) reported the pricing of an underwritten public offering of common stock and pre-funded warrants. IDEAYA is selling 7,228,572 shares of common stock and pre-funded warrants to purchase 285,715 shares of common stock in the offering (Press release, Ideaya Biosciences, JUL 9, 2024, View Source [SID1234644756]). The shares of common stock are being sold at a public offering price of $35.00 per share, before underwriting discounts and commissions, and the pre-funded warrants are being sold at a public offering price of $34.9999 per pre-funded warrant. The exercise price of the pre-funded warrants is $0.0001 per share. In addition, IDEAYA has granted the underwriters a 30-day option to purchase up to an additional 1,127,142 shares of its common stock at the public offering price per share, before underwriting discounts and commissions. The aggregate gross proceeds to IDEAYA from this offering are expected to be approximately $263,000,000, before deducting underwriting discounts and commissions and other offering expenses, and excluding the exercise of any pre-funded warrants. The offering is expected to close on or about July 11, 2024, subject to the satisfaction of customary closing conditions.

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J.P. Morgan, Goldman Sachs & Co. LLC, Jefferies and RBC Capital Markets are acting as joint book-running managers for the offering.

The securities described above are being offered by IDEAYA pursuant to an automatically effective shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission, or the SEC. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, copies of which may be obtained, when available, by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Goldman Sachs & Co. LLC by mail at Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at 866-471-2526, or by email at [email protected]; Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; or RBC Capital Markets, by mail at RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, 8th Floor, New York, NY 10281, or by telephone at 877-822-4089, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On July 9, 2024 Zai Lab Limited (the "Company" or "we") reported an additional opportunity to access capital denominated in RMB through a debt facility with China Merchants Bank on favorable commercial terms to support our working capital needs in mainland China (Filing, 8-K, Zai Laboratory, JUL 9, 2024, View Source [SID1234644753]). As a result, on July 5, 2024, the Company issued a maximum-amount irrevocable letter of guarantee (the "Guarantee") to China Merchants Bank Co., Ltd., Shanghai Branch ("CMB") pursuant to which the Company will guarantee working capital loans of up to RMB250 million (approximately $34.4 million) from CMB to our wholly-owned subsidiary, Zai Lab (Shanghai) Co., Ltd. ("Zai Lab Shanghai"), and Zai Lab Shanghai entered into a Credit Agreement with CMB with respect to the RMB250 million facility. The credit facility will be available for one year, and key terms of the specific working capital loans, including the amount, term, and interest rate, will be included in the specific transaction documents. The Credit Agreement contains customary representations and warranties and affirmative and restrictive covenants, including a requirement to obtain prior written consent from CMB before engaging in certain transactions that could have an adverse impact on its debt repayment ability, such as mergers, acquisitions, spin-offs, equity transfers, and other material matters such as external investments and substantial increases in debt financings.

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The description of the Guarantee and Credit Agreement contained herein is qualified in its entirety by reference to the Guarantee, a copy of which is attached hereto as Exhibit 10.1, and the Credit Agreement, a copy of which is attached hereto as Exhibit 10.2, each of which is incorporated herein by reference.

To date, Zai Lab Shanghai has not entered into any working capital loans under this debt facility.

On July 9, 2024 Taiho Pharmaceutical Co., Ltd. ("Taiho") and Arcus Biosciences, Inc. (NYSE:RCUS) reported that Taiho exercised its option for quemliclustat (International Nonproprietary Name; development code: AB680), an investigational small molecule CD73 inhibitor, in Japan and certain other territories in Asia (excluding mainland China). This option exercise is based on an option and license agreement between Taiho and Arcus contracted in September 2017 (Press release, Taiho, JUL 9, 2024, View Source [SID1234644752]). This is the fourth option exercise by Taiho to an Arcus program.

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In exchange for the exclusive license of quemliclustat, Taiho will make an option exercise payment, as well as additional payments upon achievement of clinical, regulatory and commercialization milestones, and, if any products from the program are approved, will pay royalties on net sales of such products.

Quemliclustat is an investigational small molecule CD73 inhibitor. In 2024, Arcus plans to initiate the global, registrational Phase 3 study PRISM-1, comparing quemliclustat plus chemotherapy to chemotherapy alone as a treatment for patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). Advancement to a Phase 3 study is based on overall survival results observed in the Phase 1b ARC-8 study that were presented earlier this year at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (ASCO GI) Cancers Symposium. Through this collaboration, Taiho will further support the development and potential commercialization of quemliclustat and will operationalize the PRISM-1 study in Japan as part of its mission to deliver innovative drugs to patients and medical professionals.

About Quemliclustat

Quemliclustat is an investigational small molecule CD73 inhibitor. CD73 is the primary enzymatic producer of immunosuppressive adenosine in the tumor microenvironment, and high CD73 expression is associated with significantly poorer prognosis in several tumor types. Quemliclustat has been shown to block the production of adenosine. Once the immunosuppressive effects of adenosine are removed, activation of antitumor immune cells may be restored, resulting in cancer cell death. In addition to the planned registrational Phase 3 study PRISM-1 by Arcus, quemliclustat is being codeveloped by Arcus and Gilead Sciences in combination with other molecules within the companies’ portfolios with chemotherapy, including Phase 2 studies in lung and upper gastrointestinal cancers. Quemliclustat is an investigational medicine and is not approved for use globally.

About Taiho and Arcus Agreement

Based on the option and license agreement that Taiho and Arcus entered into in 2017, Taiho has obtained exclusive development and commercialization rights to a total of four programs in Japan and certain other territories in Asia (excluding mainland China): (1) quemliclustat, CD73 inhibitor program, announced today; (2) etrumadenant, a dual A2a/b adenosine receptor antagonist program in 2018; (3) zimberelimab, the anti-PD-1 program in 2019, and; (4) domvanalimab and AB308, both the anti-TIGIT program in 2021. For other territories in the world, Gilead obtained the rights to commercialize in the U.S. and to copromote with Arcus, and Gilead has exclusive rights to develop and commercialize outside the U.S