On March 30, 2021 Ikena Oncology, Inc. (Nasdaq: IKNA) ("Ikena"), a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer, reported the closing of its initial public offering of 8,984,375 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,171,875 additional shares of common stock, at a public offering price of $16.00 per share (Press release, Ikena Oncology, MAR 30, 2021, View Source [SID1234577381]). The aggregate gross proceeds to Ikena from the offering were approximately $143.8 million, before deducting underwriting discounts and commissions and other offering expenses.

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Jefferies, Cowen, Credit Suisse and William Blair acted as joint book-running managers for the offering.

The registration statement relating to these securities has been filed with the Securities and Exchange Commission ("SEC") and became effective on March 25, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at [email protected].

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 state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 30, 2021 Illumina, Inc. (NASDAQ: ILMN), reported that it disagrees with, and will oppose, the U.S. Federal Trade Commission (FTC)’s challenge to its previously announced acquisition of GRAIL, a pre-commercial company founded to accelerate early screening of cancer (Press release, Illumina, MAR 30, 2021, View Source [SID1234577380]). Illumina will pursue its right to proceed with the transaction, the impact of which would accelerate the adoption of a breakthrough multi-cancer early detection blood test.

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Cancer kills around 10 million people annually worldwide and 600,000 people in the United States alone. Survival rates are higher when cancer is detected early. Seventy-one percent of all deadly cancers do not currently have a screening test. GRAIL’s Galleri test is able to detect more than 50 cancers across all stages, more than 45 of which do not have recommended screening in the United States. And, in 93 percent of the positive results, the test correctly identified the tissue of origin – all with a specificity greater than 99 percent.

"Illumina’s commitment to advancing human health by innovating next generation sequencing is unwavering. Improving early cancer detection is the most promising approach to bending the cancer mortality curve," said Francis deSouza, Chief Executive Officer of Illumina. "We have a deeply vested interest in ensuring that all organizations have equal and fair access to high quality, reliable and cost-effective sequencing to enable them to develop breakthrough products, such as liquid biopsy, and make them accessible to the greatest number of patients possible, quickly and safely."

Illumina originally founded GRAIL five years ago and the two companies do not compete in any way. In reuniting the two organizations, Illumina will leverage its global scale of manufacturing and clinical capabilities, as well as its global regulatory and reimbursement expertise, to bring early-stage, multi-cancer testing to patients more quickly and more affordably, resulting in more lives being saved.

"Combining GRAIL’s innovative multi-cancer early detection test with Illumina’s experience and scale will enable more patients in both the United States and worldwide to garner access to GRAIL’s test faster," said Hans Bishop, Chief Executive Officer of GRAIL. "We continue to believe that together we could transform cancer care by catching more cancers earlier."

Illumina strongly believes that acquiring GRAIL is in the best interest of patients, is procompetitive, and benefits the multi-cancer early detection field as a whole. The FTC’s challenge to the proposed transaction is a marked departure from longstanding antitrust precedent. Illumina intends to pursue all legal options in order to complete the acquisition and deliver the strategic benefits to its stakeholders. For clinical oncology customers, Illumina has offered contractual guarantees of equal and fair access to Illumina sequencing, and a commitment to drive down prices by more than 40 percent by 2025.

On March 30, 2021 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported that eight abstracts were selected for poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which will be conducted virtually from April 10 – 15, 2021 and May 17 – 21, 2021 (Press release, BostonGene, MAR 30, 2021, View Source [SID1234577379]).

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The presentations underscore the importance of the application of novel and cutting-edge analytical tools to improve the diagnosis and treatment for cancer patients. These tools were applied across a wide range of cancers to further understand tumor biology and identify biomarkers for diverse therapies in an effort to propel precision medicine to the forefront of clinical decision making.

"We are proud to present at the AACR (Free AACR Whitepaper) Annual Meeting. These results demonstrate BostonGene’s unique ability to identify novel and personalized treatment options through next generation multi-platform analytics, further advancing and optimizing outcomes for each cancer patient," said Nathan Fowler, MD, Chief Medical Officer at BostonGene.

Details of the poster presentations are below:

Title: AI-driven multifaceted predictive biomarkers of response to tyrosine kinase inhibition and immune checkpoint blockade in clear cell renal cell carcinoma
Session: PO.CL06.06 – Immune Response to Therapies
Poster: 516
Presenter: Natalia Miheecheva, MSc, BostonGene

Research conducted with Washington University School of Medicine in St Louis.

Title: Association of circulating myeloid derived suppressor cells with systemic lymphopenia following chemoradiotherapy in glioblastoma
Session: PO.CL06.04 – Immune Mechanisms Invoked by Therapies
Poster: 507
Presenter: Dinesh Thotala, PhD, Washington University School of Medicine in St Louis

Research conducted with Washington University School of Medicine in St Louis.

Title: Astraea: A first-in-class biomarker database integrating genomic, transcriptomic, and tumor microenvironment properties for precision oncology
Session: PO.BSB01.03 – Database Resources
Poster: 205
Presenter: Azamat Gafurov, MSc, BostonGene

Title: Evaluating the clinical utility of RNA-seq-based PD-L1 expression and cellular deconvolution as alternatives to conventional immunohistochemistry in clear cell renal cell carcinoma
Session: PO.BSB01.02 – Application of Bioinformatics to Cancer Biology
Poster: 161
Presenter: Natalia Miheecheva, MSc, BostonGene

Research conducted with Washington University School of Medicine in St Louis.

Title: Integrated multiregional transcriptomic and multi-parameter single-cell imaging analysis of clear cell renal cell carcinoma elucidates diverse cellular communities present within the tumor microenvironment
Session: PO.TB06.04 – Immune Cells in the Tumor Microenvironment
Poster: 2742
Presenter: Natalia Miheecheva, MSc, BostonGene

Research conducted with Washington University School of Medicine in St Louis.

Title: MutAnt: Mutation annotation machine learning algorithm for pathogenicity evaluation of single nonsynonymous nucleotide substitutions in cancer cells
Session: PO.BSB02.01 – Artificial Intelligence and Machine Learning
Poster: 192
Presenter: Aleksandr Sarachakov, MSc, BostonGene

Title: Predictors of treatment responses in a preoperative window of opportunity trial of nivolumab in resectable squamous cell carcinoma of the head and neck
Session: PO.ET02.03 – Role of the Microenvironment in Therapeutic Response
Poster: 1441
Presenter: Nikita Kotlov, MSc, BostonGene

Research conducted with Thomas Jefferson University.

Title: Tumor immune microenvironment based molecular functional clustering reveals a prognostic signature that predicts overall survival in patients with gastric cancer
Session: PO.TB06.08 – Tumor Immune System Interactions
Poster: 3182
Presenter: Prashant V. Thakkar, Weill Cornell Medicine

Research conducted with Weill Cornell Medicine.

The e-poster website will be launched Saturday, April 10, 2021, the first day of the AACR (Free AACR Whitepaper) Virtual Annual Meeting. All e-posters will be made available for browsing on the AACR (Free AACR Whitepaper) Annual Meeting website on this date.

Additionally, the abstracts will be published in an online-only Proceedings supplement to the AACR (Free AACR Whitepaper) journal Cancer Research after the completion of the AACR (Free AACR Whitepaper) Virtual Annual Meeting.

On March 30, 2021 Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, reported it has acquired the exclusive, worldwide rights to develop, manufacture and commercialize NTI-1309, an innovative PET oncology imaging agent from Noria Therapeutics, Inc (Press release, Lantheus Medical Imaging, MAR 30, 2021, View Source [SID1234577378]).

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NTI-1309 targets fibroblast activation protein (FAP), a target with potential broad imaging applicability and targeting implications in oncology. FAP is overexpressed in the tumor microenvironment, specifically in tumor-associated fibroblasts, which are believed to modulate tumor progression and immune response. Given its expression in tumors coupled with low expression in normal tissue, FAP has the potential to become an important biomarker for precision medicine in cancer. Already a focus of significant research by academics and the pharmaceutical industry, a FAP biomarker has potential to address unmet medical needs and to impact the clinical management of stroma-dense tumors, such as breast, colon, lung and pancreatic cancer.

Under terms of the agreement, Noria will drive the early clinical development of NTI-1309, leveraging its experience with early-stage imaging development. Upon completion of the Phase 1 study, NTI-1309 will be integrated into Lantheus’ portfolio of imaging biomarkers and included in the offering to academic centers and pharmaceutical companies for use in oncology drug development programs. Simultaneously, Lantheus will assess options for bringing this important biomarker to market through Lantheus-sponsored trials.

"Lantheus is committed to advancing innovative imaging biomarker solutions to find, fight and follow cancer," said Etienne Montagut, Senior Vice President of Corporate Development at Lantheus. "We believe FAP is a promising target for cancer imaging and has broad potential to inform diagnosis and staging, to guide patient selection for therapy, and to monitor response to treatment across multiple tumor types. This partnership with Noria enables us to progress this development program in a timely fashion, leverage our established leadership in imaging and state of the art artificial intelligence, and position us to monetize this biomarker offering, which has the potential to unlock deep, data-driven insights to inform R&D and clinical decision-making."

"The Noria team is excited to partner with a proven leader in imaging diagnostics with the experience and resources to advance this development program. Noria is pleased to have been entrusted by Lantheus to continue the development of NTI-1309, leveraging our platform and very experienced team," said Allan M. Green, MD, PhD, JD, Co- Founder and CEO of Noria Therapeutics, Inc.

Terms of the transaction include an upfront license and development fee to Noria, certain development and regulatory milestones, and royalties if NTI-1309 is commercialized.

On March 30, 2021 Guardant Health, Inc. (Nasdaq: GH) reported that the Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT) status for the Guardant360 CDx test (Press release, Guardant Health, MAR 30, 2021, View Source [SID1234577377]). The Guardant360 CDx test is the first FDA-approved liquid biopsy for comprehensive tumor mutation profiling across all solid cancers.

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Under the Protecting Access to Medicare Act of 2014 (PAMA), CMS determination confirms that the Guardant360 CDx test meets the criteria for ADLT status, which is reserved for innovative products that provide novel clinical information that cannot be obtained by any other method, and for FDA-approved tests. Obtaining ADLT status initiates a specific, market-based approach to pricing the test for Medicare patients. During the nine-month period beginning April 1, 2021 and ending December 31, 2021, Guardant Health will collect, assess and submit private-payer payment rate data for the test, the median of which will be used by CMS to determine the Medicare pricing, beginning January 1, 2022. During this nine-month period, the Guardant360 CDx test will be reimbursed at a rate of $5,000 for all Medicare patients.

"Obtaining ADLT status for our Guardant360 CDx test is an important milestone that not only demonstrates the value that our FDA-approved liquid biopsy test brings to patients with advanced cancer, but also paves the way for broader payer coverage," said Helmy Eltoukhy, Guardant Health CEO. "We believe this milestone is a critical step to ensuring that all patients have access to our Guardant360 CDx test, so that their treatment is informed by comprehensive genomic profiling in-line with today’s medical guidelines."

Each year, more than 600,000 people die from cancer in the United States,1 many of whom may have benefitted from comprehensive genomic profiling (CGP) to guide a more personalized treatment plan based on a growing list of effective CGP-informed targeted therapies. Clinical studies show that patients receiving targeted therapies have improved progression-free survival and higher overall response rates relative to chemotherapy or immunotherapy.2-8 Guardant360 CDx offers patients and clinicians a simple, faster blood test to help inform personalized treatment options.