On December 1, 2022 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is pleased to report the publication of positive preclinical data for EVT801, a clinical-stage drug candidate currently in a clinical trial for multiple forms of cancer (Press release, Kazia Therapeutics, DEC 1, 2022, View Source [SID1234624670]).

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The publication, by Michael Paillasse and colleagues, summarizes a large body of preclinical research conducted principally by scientists at Evotec SE and at the University Cancer Institute of Toulouse – Oncopole over a period of several years. It is now published in Cancer Research Communications, a recently-launched journal published by the American Association of Cancer Research (AACR) (Free AACR Whitepaper). The data formed the basis of Kazia’s in-licensing of EVT801 from Evotec in 2021 and has since supported transition of the compound into an ongoing phase I clinical trial in patients with advanced solid tumors.

Key Points

EVT801 is a selective inhibitor of vascular endothelial growth factor receptor 3 (VEGFR3). VEGFs and VEGFRs are well-validated cancer drug targets with multiple FDA-approved products directed to them, but a more selective VEGFR3 inhibitor, such as EVT801, may result in better tolerability and less development of resistance to therapy.

EVT801 was confirmed in preclinical studies to be a potent and selective inhibitor of VEGFR3, with activity in the low nanomolar range. The drug was shown to inhibit the formation of lymphatic vessels in vitro, confirming its intended primary mode of action.

In vivo (animal) experiments showed EVT801 to be more active than both pazopanib (Votrient, Novartis) and sorafenib (Nexavar, Bayer) in the tumor models under investigation.

EVT801 combined with immune checkpoint inhibitors in mouse models of several tumor types showed strongly synergistic activity, with the combination performing better than either drug alone. Immune checkpoint inhibitors are widely used in many cancers, and the class includes drugs such as pembrolizumab (Keytruda, Merck), nivolumab (Opdivo, Bristol Myers Squibb), and ipilimumab (Yervoy, Bristol Myers Squibb).

"These data demonstrate the substantial potential of EVT801 as a cancer therapeutic," stated Dr Michael Paillasse, lead author of the publication. "EVT801 has been shown to act exactly as intended: by impacting the vasculature in and around the tumor. In addition, the evidence of synergy with immunotherapy is persuasive, and we see a considerable opportunity to combine the drug with immune checkpoint inhibitors in clinical trials."

"We are grateful that the results of this public-private translational research initiative have been appreciated by the editors and reviewers of Cancer Research Communications. We will now focus on the clinical development," said Professor Jean-Pierre Delord, co-author and CEO of the IUCT – Oncopole.

"We are delighted to see this exciting and comprehensive body of work now published in a leading peer-reviewed journal," said Dr James Garner, Chief Executive Officer of Kazia. "The data supports our decision last year to in-license EVT801, and clearly points to the future development strategy for the drug. Our collaboration with the Evotec team has already been extremely fruitful, and we look forward to continuing to work together on this very promising drug candidate."

The publication may be accessed via the journal website at View Source

Phase I Clinical Trial Progressing

EVT801 is currently the subject of an ongoing phase I clinical trial as monotherapy in patients with advanced solid tumors (NCT05114668). The study is progressing as planned, with patients currently being dosed within the anticipated therapeutic range. It is expected that initial data from this study will be available in 1H CY2023.

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On December 1, 2022 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company granted stock options to purchase an aggregate of 6,100 shares of Karyopharm’s common stock and an aggregate of 4,200 restricted stock units (RSUs) to two newly-hired employees (Press release, Karyopharm, DEC 1, 2022, View Source [SID1234624669]). These equity awards were granted as of November 30, 2022 pursuant to the Company’s 2022 Inducement Stock Incentive Plan, as amended, as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

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Each of the stock options has an exercise price of $5.29 per share, the closing price of Karyopharm’s common stock on November 30, 2022. Each stock option will vest over four years, with 25% of the total number of shares underlying the stock option vesting on the one-year anniversary of the applicable employee’s employment commencement date and 1/48th of the total number of shares vesting monthly thereafter. Each RSU award will vest over four years, with 25% percent of the shares underlying the RSU award vesting on each of the four consecutive anniversaries of the applicable employee’s employment commencement date. The vesting of each inducement award is subject to the employee’s continued service as an employee of, or other service provider to, Karyopharm through the applicable vesting dates. In addition, each stock option and RSU award will be immediately exercisable in full if, on or prior to the first anniversary of the consummation of a "change in control event," the employee’s employment is terminated for "good reason" by the employee or terminated without "cause" by Karyopharm (as such terms are defined in the applicable stock option or RSU agreement).

On November 30, 2022, Intellia Therapeutics, Inc. (the "Company" or "Intellia") entered into an Underwriting Agreement (the "Underwriting Agreement") with Goldman Sachs & Co. LLC (the "Underwriter"), related to a public offering (the "Offering") of 6,550,219 shares of common stock of the Company, par value $0.0001 per share (the "Common Stock") at a price to the public of $45.80 per share (Filing, 8-K, Intellia, DEC 1, 2022, View Source [SID1234624668]). In addition, the Company granted the Underwriter an option exercisable for 30 days from the date of the Underwriting Agreement to purchase, at the public offering price less any underwriting discounts and commissions, up to an additional 982,532 shares. The Company estimates that the net proceeds from the offering will be approximately $293.5 million after deducting the underwriting discount and its estimated offering expenses. The offering is expected to close on December 2, 2022, subject to customary closing conditions.

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The Company made certain customary representations, warranties and covenants concerning the Company and the registration statement in the Underwriting Agreement and also agreed to indemnify the Underwriter against certain liabilities, including liabilities under the Securities Act of 1933, as amended (the "Securities Act"). The Offering was made pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-251022), including the prospectus dated November 30, 2020, as supplemented by a prospectus supplement dated November 30, 2022. This Current Report on Form 8-K does not constitute an offer to sell or the solicitation of an offer to buy any of the shares of Common Stock.

The foregoing description of certain terms of the Underwriting Agreement and the transactions contemplated thereby does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Underwriting Agreement, which is attached as Exhibit 1.1 hereto and is incorporated by reference herein. A copy of the opinion of Goodwin Procter LLP, relating to the legality of the ordinary shares, is filed as Exhibit 5.1 hereto and is incorporated by reference herein.

On December 1, 2022 Integra LifeSciences reported acquisition of Surgical Innovation Associates (SIA) Inc (Filing, 8-K, Integra LifeSciences, DEC 1, 2022, View Source [SID1234624667]).

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On December 1, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that new data from its portfolio of blood tests will be presented at the 2022 San Antonio Breast Cancer Symposium, December 6-10 in San Antonio, Texas (Press release, Guardant Health, DEC 1, 2022, View Source [SID1234624665]). The six poster presentations highlight the use of the Guardant360 blood test and the GuardantINFORM real-world evidence dataset to identify critical biomarkers and acquired co-mutations, track associated treatment patterns and clinical outcomes, and monitor molecular response to therapy based on specific breast cancer driver mutations.

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"We look forward to sharing new data at the San Antonio Breast Cancer Symposium demonstrating the utility of our blood tests to increase the understanding of potential biomarker targets and the mechanisms of molecular response in patients with advanced breast cancer," said Helmy Eltoukhy, Guardant Health co-CEO. "The presentations will show how data from comprehensive genomic profiling tests provide critical insights that can contribute to the development of more effective therapies and improved patient outcomes."

Full List of Guardant Health Presentations

Guardant360

ctDNA molecular response based on breast cancer driver mutations predicts progression in aromatase inhibitor-sensitive first line treatment of oestrogen receptor-positive (ER+) HER2-negative (HER2-) advanced breast cancer (Poster PD17-02)
TRK inhibitor in a patient with metastatic triple negative breast cancer and NTRK fusions identified via cell-free DNA analysis (Poster P5-02-13)
Cell-free DNA detection of GATA3 mutations in metastatic hormone receptor positive breast cancer: a multi-institutional analysis of incidence, co-mutations, and clinical outcomes (Poster P5-02-07)
Co-occurring alterations in PALB2 germline carriers identified by liquid biopsy in patients with advanced breast cancer (Poster P5-03-18)
Characterization of the genomic landscape of breast carcinoma patients with NF1 alterations using comprehensive cell-free tumor DNA next-generation sequencing (Poster P5-05-03)
Guardant360 and GuardantINFORM

Real-world second-line treatment patterns and associated clinical outcomes for 2795 patients with advanced HR+ HER2- breast cancer treated with first-line CDK4/6 inhibitors (Poster P4-01-18)
The full abstracts are available on the officialSABCS 2022website.