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.

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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.

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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.

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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.

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"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."

Real-World Data Presented at SUO 2023 Show that Veracyte’s Decipher Genomic Classifier Identifies Patients Whose Prostate Cancer is Likely to Progress

On December 1, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that new data presented today at the 24th Annual Meeting of the Society of Urologic Oncology (SUO 2023) highlight clinical observations and translational research conducted by users of the company’s Decipher Prostate Genomic Classifier (Press release, Veracyte, DEC 1, 2023, View Source [SID1234638096]). These independent, real-world studies provide further evidence supporting the clinical utility of the test in the treatment and management of prostate cancer, particularly for patients considering active surveillance.

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Not all types of prostate cancer require immediate intervention; many can be monitored carefully over time with active surveillance, while more aggressive cancers have better outcomes with treatment. Identifying the appropriate candidates for active surveillance, however, is not always easy, as the clinical indicators used to assess patient risk often do not reliably distinguish between favorable and more aggressive disease.

Researchers at the Washington University School of Medicine in St. Louis presented two posters at the SUO meeting based on separate analyses of their Decipher biopsy cohort of 888 patients with prostate cancer who were seen at their institution between December 2016 and March 2023. In the first study, the researchers analyzed 235 patients who were initially managed with active surveillance, among whom 88 patients ultimately progressed to receive treatment. In evaluating clinical information available prior to treatment, including PSA levels, Gleason score, and results from magnetic resonance imaging (MRI), along with Decipher Prostate Genomic Classifier results, they found that the Decipher Prostate Genomic Classifier score was the only predictor of progression from active surveillance to treatment.

The second study focused on 104 patients who had a multiparametric MRI (mpMRI) result, Gleason Grade Groups 1-3 on biopsy, and Decipher testing prior to treatment with radical prostatectomy (surgery to remove the prostate). The researchers compared all of the available information prior to treatment to determine the best predictor of final pathology after prostatectomy. While multiparametric MRI (mpMRI) is often viewed as prognostic of cancer pathology, this study found that Decipher scores were strongly associated with final pathology, but clinical variables such as PSA levels, Gleason score and mpMRI were not. While mpMRI is often viewed as prognostic of cancer pathology, this study found that only Decipher scores were strongly associated with final pathology, while clinical variables such as PSA levels, Gleason score and mpMRI results were not.

"Accurately predicting disease progression in patients with prostate cancer is essential so they can receive the treatment that is best suited for them," said Eric Kim, M.D., associate professor of surgery at Washington University School of Medicine in St. Louis and senior author of both posters. "Our studies consistently demonstrated that data from the Decipher Prostate Genomic Classifier was more reliably predictive of prostate cancer progression and underlying pathology than any other clinical data available, including MRI."

Two other studies came from researchers at the University of Miami who used the ongoing Miami MAST prospective trial (MRI selection for active surveillance versus treatment; NCT02242773) to better understand cancer progression at the molecular level. In one study, researchers characterized 224 samples from 124 patients based on cancer progression. Assessment with the Decipher Prostate Genomic Classifier and biological insights from the Decipher Genomic Resource for Intelligent Discovery (GRID) research tool indicated that Decipher scoring was associated with grade progression, but not volume progression, of prostate cancer.

Finally, a large-scale, population-based study of over 52,000 patients tested with the Decipher Prostate biopsy test, led by investigators from the University of Michigan, found wide variation in Decipher risk distribution within and across clinical stage groups, suggesting that genomic assessment identified something that the clinical information does not. From this population-based initiative they concluded that integration of the test into clinical care can provide more precise prognosis estimates for patients and lead to better individualized risk assessment.

"We developed the Decipher Prostate Genomic Classifier to provide actionable information that helps guide patient care," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "The data presented at SUO 2023 show how users of our test, conducting prospective research on their own patients, affirm the utility of Decipher in real-world settings. This real-world evidence and scientific research conducted by Decipher users shows how physicians can refine their surveillance or treatment plans based on a more comprehensive view of each patient’s cancer. We are very grateful for the work conducted by these clinician-scientists on behalf of the entire prostate cancer research community."