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Strata Oncology Announces Presentations on Proprietary Multivariate Biomarkers at North America Conference on Lung Cancer and San Antonio Breast Cancer Symposium

On December 1, 2023 Strata Oncology, Inc. ("Strata"), a next-generation precision oncology company enabling smarter cancer treatment, reported that it will present new data in scientific posters at the 2023 North America Conference on Lung Cancer (NACLC) taking place December 1-3, 2023 in Chicago, Illinois and the San Antonio Breast Cancer Symposium (SABCS) taking place December 5-9, 2023 in San Antonio, Texas (Press release, Strata Oncology, DEC 1, 2023, View Source [SID1234638101]).

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The data to be presented includes results for innovative, proprietary predictive biomarkers for response to anti-PD-1/PD-L1 immunotherapy and antibody-drug conjugates (ADCs) — the Immunotherapy Response Score (IRS) and ADC Treatment Response Score (ADC TRS), respectively. Strata has developed these biomarkers and others using data collected through an observational clinical trial protocol called the Strata Trial (NCT03061305). All of these biomarkers take advantage of the company’s unique molecular profiling platform that combines DNA and quantitative RNA sequencing on a single small tumor tissue sample.

"Many of the most exciting recent advances in cancer treatment – such as immunotherapy and antibody-drug conjugates – do not currently have biomarkers that can accurately predict response. Strata has taken on this challenge by advancing multivariate predictive treatment selection algorithms that capture the complex biology required for a tumor response," said Scott Tomlins, M.D., Ph.D., Strata Oncology co-founder and chief medical officer. "We believe that this type of strategy is required to fully realize the potential of precision oncology to improve patient outcomes. We look forward to sharing our latest advances at NACLC and SABCS."

Poster presentation details are below. Both posters will be available on the Strata Oncology website following the presentation.

North America Conference on Lung Cancer (NACLC)

Poster Title: Validation of Immunotherapy Response Score (IRS) for Predicting Pembrolizumab Monotherapy Benefit in First Line (1L) Non-small cell lung cancer (NSCLC)

Session Date and Time: Saturday, December 2, 5:40-6:55 PM CST

San Antonio Breast Cancer Symposium (SABCS)

Poster Title: A Multivariate Biomarker to Guide Antibody-Drug Conjugate Selection and Provide Insight on Response Differences Across Breast Cancer Subtypes

Session Date and Time: Wednesday, December 6, 12:00-2:00 PM CST

Intensity Therapeutics Selected for Spotlight Oral Presentation at the 2023 San Antonio Breast Cancer Symposium

On December 1, 2023 Intensity Therapeutics, Inc. (Nasdaq: INTS), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that it has been selected for a spotlight oral presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS) on December 8, 2023 (Press release, Intensity Therapeutics, DEC 1, 2023, View Source [SID1234638100]). Dr. Angel Arnaout will be conducting the oral presentation which will highlight the efficacy and immunomodulatory effects of INT230-6 in early-stage breast cancer.

Spotlight Oral Presentation Details

Concurrent Poster Spotlight Session Block #6
PS16 Enhancing Immunotherapy for Triple Negative Breast Cancer: Novel Therapies and Biomarkers
Moderator: Hope S. Rugo, MD, FASCO, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California
Title: Intra-tumoral dosing of INT230-6 in early-stage breast cancer patients induces tumor cell necrosis and immunomodulatory effects: A phase II randomized window-of-opportunity study – the INVINCIBLE trial
Presentation #: PS16-03
Date and Time: Friday, December 8, 7:00 – 8:00 a.m. CT
Location: Stars at Night Ballroom 3 & 4
Presenter: Angel Arnaout, M.D., MSc, Ottawa Hospital Research Institute, Ontario Institute of Cancer Research
Discussant: Sangeetha Reddy, M.D., M.S.C.I., UT Southwestern Medical Center, Dallas, Texas

Mammogen to Showcase New Data at SABCS 2023 Demonstrating Clinical Efficacy of Its genTRU-breast™ qPCR Blood Test in Early-Stage Breast Cancer

On December 1, 2023 Mammogen, a pioneering leader in women’s health and a subsidiary of early detection parent company, IVBH, reported groundbreaking clinical data at the 2023 San Antonio Breast Cancer Symposium (SABCS) (Press release, Mammogen, DEC 1, 2023, View Source [SID1234638099]). The poster, titled "Development of a plasma-based real-time qPCR gene expression assay for targeted screening and diagnosis of early-stage breast cancer," showcases the strength and innovation of Mammogen’s proprietary genTRU-breast clinical assay.

Poster Session Details:

Presentation ID: PO1-28-06
Abstract Title: Development of a plasma-based real-time qPCR gene expression assay for targeted screening and diagnosis of early-stage breast cancer.
Session: Poster Session 1
Date: Wednesday, December 6, 2023
Time: 12:00 PM – 2:00 PM
Location: Henry B. Gonzalez Convention Center, San Antonio, Texas

This presentation follows Mammogen’s successful CLIA validation of the genTRU-breast assay, announced last month, a landmark achievement for the company and a transformative milestone in early-stage breast cancer detection.

Elizabeth Cormier-May, CEO of Mammogen, commented, "This data is a testament to our commitment to unlocking the quality-of-life preservation that exists in the earliest stages of breast cancer. The statistically significant >99% sensitivity and 89% specificity in stage I breast cancer, achieved during CLIA validation of our novel real-time qPCR assay, reinforces Mammogen’s position as a leader in accurate, affordable, scalable, and socially responsible diagnostics in women’s health."

Kazia Therapeutics Announces $2 Million Registered Direct Offering

On December 1, 2023 Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused drug development company, reported that it has entered into a definitive agreement for the purchase and sale of up to an aggregate of 4,444,445 of the Company’s American Depositary Shares ("ADSs") (or ADS equivalents in lieu thereof), each ADS representing ten (10) ordinary shares of the Company, at a purchase price of $0.45 per ADS (or ADS equivalent in lieu thereof), in a registered direct offering (Press release, Kazia Therapeutics, DEC 1, 2023, View Source [SID1234638098]). The Company has also agreed to issue in a concurrent private placement unregistered warrants to purchase up to an aggregate of 4,444,445 ADSs. The warrants will have an exercise price of $0.583 per ADS, will be immediately exercisable upon issuance, and will expire five and one-half years from the date of issuance. The closing of the offering is expected to occur on or about December 5, 2023, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be approximately $2 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering as working capital for general corporate purposes.

The securities described above (excluding the warrants and ADSs underlying the warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form F-3 (File No. 333-259224) that was originally filed with the Securities and Exchange Commission (the "SEC") on September 1, 2021, and declared effective on September 8, 2021. The offering of such securities in the registered direct offering is being made only by means of a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained, when available, from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs representing ordinary shares underlying such warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying ADSs may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, 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.

280Bio doses first patient in Phase I clinical trial of TEB-17231, an oral pan-RAS inhibitor in patients with advanced cancers harboring mutations in KRAS, HRAS, or NRAS

On December 1, 2023 280Bio, Inc., a clinical stage biotechnology company focused on the development of precision oncology medicines, reported that the first patient was treated with TEB-17231 (YL-17231), a small molecule inhibitor of RAS signaling (Press release, 280Bio, DEC 1, 2023, View Source [SID1234638097]). 280Bio is a wholly owned subsidiary of Shanghai Yingli Pharmaceuticals, Inc. (Yingli Pharma) of Shanghai, China. KRAS, NRAS and HRAS genes are frequently mutated in many tumor indications causally associated with promoting tumor cell growth. TEB-17231 demonstrated potent inhibition of tumor cell proliferation in vitro and in vivo in preclinical research, exhibiting activity with different KRAS, NRAS and HRAS alterations, including tumors that have become resistant to KRAS G12C inhibitors.

"We are gratified that the first patient has been dosed with our novel pan-RAS inhibitor, marking a major step in TEB-17231’s clinical development, and introducing new medicines for the patients we hope to serve." said Michael Hui, Chief Executive Officer of 280Bio Inc., "This milestone highlights our commitment to addressing unmet needs in cancers through precision oncology approaches. We look forward to continued enrollment and dosing of patients in this trial."

This first US patient was enrolled at The University of Texas MD Anderson Cancer Center, Houston, Texas, by David Hong, MD, Deputy Chair of Investigational Cancer Therapeutics and lead investigator on the trial.

Reflecting on the high unmet need for new cancer agents, Dr. Zusheng Xu, Head of Research and Development of Yingli Pharma, said "TEB-17231 was developed to have a broader activity against the oncogenic RAS signaling pathways, than is currently demonstrated for many of the KRAS inhibitors. With its excellent pharmacologic and in vivo anti-tumor properties, we are hopeful that TEB-17231 will also be determined to be safe and efficacious by continuous oral dosing in patients."