On September 14, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported a new study as part of the I-SPY 2 trial, sponsored and operated by Quantum Leap Healthcare Collaborative, that will use Signatera, Natera’s personalized and tumor-informed molecular residual disease (MRD) test, to monitor response to neoadjuvant therapy in breast cancer patients across all subtypes (Press release, Natera, SEP 14, 2023, View Source [SID1234635175]).

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This prospective study, in which 600 patients will be monitored in real time, will support efforts to establish circulating tumor DNA (ctDNA) as a composite endpoint and generate additional data on post-surgical ctDNA status in patients treated with neoadjuvant therapy. It expands on the existing collaboration with the ISPY-2 consortium that has led to the publication of multiple studies validating the use of Signatera for neoadjuvant response monitoring and predicting recurrence risk, including studies published in Cancer Cell1 and Annals of Oncology.2

"We are excited to expand our collaboration and help generate a large, prospective dataset to support the incorporation of ctDNA testing into future interventional trials in neoadjuvant breast cancer treatment," said Laura Esserman, MD, MBA, and Laura van ‘t Veer, PhD, professors at the University of California, San Francisco, and principal investigators of the I-SPY study. "We believe this study, in combination with our prior work in I-SPY 2, will help us understand the role that ctDNA can play in decision making for predicting response and improving our ability to determine who needs less therapy and who needs more. This is of utmost importance to patients."

"There is a significant unmet need for more accurate tools to enable precision care for patients diagnosed with breast cancer," said Minetta Liu, MD, chief medical officer of oncology at Natera. "I-SPY 2 serves as an excellent platform to investigate Signatera’s utility in the neoadjuvant and adjuvant settings. This extended collaboration will enhance our understanding of Signatera’s ability to assess therapy response, predict clinical outcomes, and advance a more personalized treatment strategy for patients with breast cancer."

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted four Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions. The test has not been cleared or approved by the US Food and Drug Administration (FDA).

On September 14, 2023 RayzeBio, Inc. (Nasdaq: RYZB), a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, reported the pricing of its upsized $311 million initial public offering of 17,277,600 shares of common stock at a price to the public of $18.00 per share (Press release, RayzeBio, SEP 14, 2023, View Source [SID1234635174]). RayzeBio is offering 16,114,600 shares of common stock and the selling stockholder named in the prospectus is offering 1,163,000 shares of common stock. RayzeBio will not receive any proceeds from the sale of shares by the selling stockholder. The gross proceeds to RayzeBio from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by RayzeBio, are expected to be approximately $290.1 million. In addition, RayzeBio has granted the underwriters a 30-day option to purchase up to an additional 2,591,640 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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The shares are expected to begin trading on The Nasdaq Global Market on September 15, 2023 under the symbol "RYZB." The offering is expected to close on September 19, 2023, subject to the satisfaction of customary closing conditions.

J.P. Morgan, Jefferies, Evercore ISI and Truist Securities are acting as joint book-running managers for the offering.

Registration statements relating to the securities being sold in this offering have been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on September 14, 2023. A copy of the registration statements can be accessed through the SEC’s website at www.sec.gov. This offering is being made only by means of a prospectus forming part of the registration statements relating to these securities. When available, a copy of the final prospectus relating to this offering may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388, or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]; and Truist Securities, Inc., Attention: Prospectus Department, 3333 Peachtree Road NE, 9th floor, Atlanta, GA 30326, or by telephone at (800) 685-4786, 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 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 jurisdiction.

On September 14, 2023 Curasight A/S reported that the previously announced results from the investigator-initiated phase II study using uPAR-PET (uTRACE) in primary brain cancer have been presented in an oral presentation at the World Molecular Imaging Congress (WMIC) 2023 in Prague (Press release, Curasight, SEP 14, 2023, View Source [SID1234635173]).

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The oral presentation expanded on the topline results released earlier this year on June 29th and were presented in the session "Prospective Phase II Trial of [68Ga-NOTA-AE105] uPAR-PET/MRI in Patients with Primary Gliomas: Prognostic Value and Implications for uPAR-Targeted Radionuclide Therapy" by Dr. Aleena Azam from Rigshospitalet and University of Copenhagen. The abstract of the presentation will, together with the other abstracts presented at the WMIC, be published in an upcoming issue of the medical journal Molecular Imaging and Biology (Springer Publisher).

The Phase II study was carried out in 24 glioma patients, 22 with high-grade gliomas and 2 with low-grade gliomas. Of the high-grade gliomas, 16 were grade IV (Glioblastomas). All 24 patients underwent a uPAR-PET scan with 68Ga-NOTA-AE105 (uTRACE), and tumor uptake was evaluated as SUV values. The patients were followed over time to assess progression-free survival (PFS) and overall survival (OS). Patients were divided into high and low uPAR groups. Of the Glioblastomas 94% (15 of 16) were uPAR-PET positive. uPAR-PET was highly prognostic, and the high uptake group compared to the low uptake group had a more than 10-fold poorer prognosis (hazard ratio).

"We are proud that the investigator-initiated phase II trial in brain cancer was selected for an oral presentation at the World Molecular Imaging Congress in Prague. We believe this Phase II clinical data supports our focus on brain cancer and we will make every effort to move our theranostic strategy with uTRACE and uTREAT in these patients forward. The current poor prognosis in these patients and the need for better therapies make us committed to bring our technology fast forward to we hopefully will be able to help the patients to a better outlook and life.", said Ulrich Krasilnikoff, CEO of Curasight.

About high grade glioma and glioblastoma

Treatment of glioblastoma presents a significant unmet medical need, necessitating innovative and effective treatments. Curasight’s research and development efforts aim to address this challenge and improve the lives of patients facing aggressive brain cancer. Glioblastoma is the first indication for uTREAT, but uTREAT has also potential in several other cancer types expressing the biomarker uPAR. A total of approx. 65,000 patients are diagnosed with primary brain tumors and more than 30,000 patients are diagnosed with the aggressive form, glioblastoma, annually in the US and EU. Approximately 10 % of the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50 % of the patients die within 14 months and after five years from diagnosis only 5 % are still alive.

On September 14, 2023 Medivir AB (Nasdaq: MVIR) (Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that the company will present at the Pareto Securities Healthcare Conference, Today, September 14, at 12.55 CET (Press release, Medivir, SEP 14, 2023, View Source [SID1234635172]).

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CEO Jens Lindberg will give an updated presentation of the company following the recently presented promising interim results from the ongoing phase 1b/2a combination study with fostrox + Lenvima in primary liver cancer (HCC).

The presentation will be available after the meeting on Medivirs website; www.medivir.com.

On September 14, 2023 Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Limited, committed to cutting edge antibody technology innovation and provider of integrated antibody discovery and development solutions from "Idea to IND" (I to I), reported an agreement with BeiGene, Ltd. to expand the companies’ discovery strategic collaboration leveraging Nona’s proprietary Harbour Mice platform (Press release, Nona Biosciences, SEP 14, 2023, View Source [SID1234635171]).

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Through the collaboration, BeiGene will be granted access to Nona Biosciences’ proprietary fully human transgenic mice platform Harbour Mice. Previously, in 2018, BeiGene obtained rights to use the proprietary Harbour Mice H2L2 platform for multiple antibody programs. This expanded collaboration between Nona and BeiGene will extend to the Harbour Mice HCAb (heavy chain only antibody format) platform to further improve therapeutic antibody discovery efficiency and flexibility.

"We are delighted to broaden our collaboration with BeiGene on antibody discovery. Our platform has enabled biotechnology and pharmaceutical companies as well as academia to accelerate innovative drug discovery for more than a decade. BeiGene has been a long-term partner for us, and partnership expansion is emblematic of Nona’s accumulated knowledge and expertise in drug discovery," said Jingsong Wang, MD, PhD, Chairman of Nona Biosciences.