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Defence To Present Three Of Its Leading Products At The Upcoming Festival Of Biologics In Basel, Switzerland

On October 6, 2023 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies, reported its participation to the upcoming Festival of Biologics to be held in Basel, Switzerland, October 10-12, 2023 (Press release, Defence Therapeutics, OCT 6, 2023, View Source;utm_medium=rss&utm_campaign=defence-to-present-three-of-its-leading-products-at-the-upcoming-festival-of-biologics-in-basel-switzerland [SID1234635851]).

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The Festival of Biologics is a hub for the life science community to bridge the gap between academia and industry, covering the start to finish of biologics from discovery, through development, to manufacturing, clinical trials and commercialisation. Biologics have completely transformed the way that patients are treated. Biologics are central as they increase the range of options for treatments, giving new opportunities for patients and their clinicians.

With five events in one, the Festival of Biologics encourages conversation across the entire industry to inspire changes, bring forward innovations, and address complex challenges that the biologics industry is facing. In addition, this meeting offers an unparalleled opportunity to hear from stakeholders representing both the science and business communities who report on the latest data impacting cancer therapeutics to fight a wider range of cancers. The Festival of Biologics emphasizes the future needs of the oncology industry and highlights the importance for novel modalities related to cell therapies, vaccines and more effective antibody-drug conjugates (ADCs).

Defence is pleased to present its latest data during the Festival of Biologics on three of its leading products: i) its ARMTM anti-cancer vaccine technology, ii) its anti-cervical protein-based AccuVAC-PT007 vaccine and iii) its advanced AccuTOXTM program as an injectable for solid tumors.

"The three presentations given by our Chief Scientific Officer, Dr. Moutih Rafei, are aimed at two main objectives: i) to share with the scientific community how our innovative Accum platform technology can uplift many weak or moderate biomedical treatments as a means to significantly enhance their therapeutic window of action, and ii) to establish strategic partnerships with major players in the field to accelerate our therapeutics to patients faster", says Mr. Plouffe, CEO and president of Defence.

In addition, Defence has granted incentive stock options to its directors and management to purchase a total of 2,400,000 common shares of Defence pursuant to and in accordance with the terms and conditions of Defence’s stock option plan, subject to any regulatory approval. Each stock option vests immediately and is exercisable at a price of $2.50 per share for a period of ten years from the granted date.

Verastem Oncology Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On October 6, 2023 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported the grant of stock options to purchase 79,084 shares of its common stock to nine new employees (Press release, Verastem, OCT 6, 2023, View Source [SID1234635712]). The awards were granted pursuant to the Nasdaq inducement grant exception as an inducement material to the employees’ acceptance of employment with Verastem Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price equal to $7.84 per share, the closing price of Verastem Oncology’s common stock as reported by Nasdaq on October 2nd, 2023. The stock options to purchase 69,084 shares of common stock that were granted to the nine new employees will vest at a rate of twenty-five percent (25%) on the one-year anniversary of the employees’ date of hire, with the remaining shares vesting quarterly over the next three (3) years in equal quarterly amounts, provided the employees continue to serve as an employee of or other service provider to Verastem Oncology on each such vesting date. A stock option to purchase 10,000 shares of common stock that was granted to one new employee will vest upon the achievement of a certain regulatory milestone, provided the employee continues to serve as an employee of or other service provider to Verastem Oncology on such vesting date.

Merus Announces Abstracts Accepted for Presentation at the ESMO Asia Congress 2023

On October 6, 2023 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the acceptance of abstracts on the bispecific antibody MCLA-129 in non-small cell lung cancer (NSCLC) and in previously treated head and neck squamous cell carcinoma (HNSCC) for presentation at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) Asia Congress 2023 taking place in Singapore December 1-3, 2023 (Press release, Merus, OCT 6, 2023, View Source [SID1234635711]).

MCLA-129 is in clinical development in a phase 1/2, open-label clinical trial evaluating MCLA-129 monotherapy in patients with MET ex14 NSCLC, and in HNSCC, as well as MCLA-129 in combination with osimertinib, a third generation EGFR TKI, in patients with treatment-naïve EGFR mutant (m) NSCLC and in patients with EGFRm NSCLC that have progressed on osimertinib. Merus has discontinued enrollment in the exon20 NSCLC cohort due to competitive reasons.

In addition, an abstract on the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) NSCLC was accepted for presentation. This will be an encore of the upcoming mini-oral presentation that will occur at the ESMO (Free ESMO Whitepaper) Congress 2023 in Madrid, Spain.

Merus is currently enrolling patients into the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer.

Presentations:

Mini-oral presentation:
Title: Efficacy and safety of MCLA-129, an EGFR x c-MET bispecific antibody, combined with osimertinib, as first-line therapy or after progression on osimertinib in non-small cell lung cancer (NSCLC)

Poster presentations:
Title: Efficacy and safety of MCLA-129, an anti-EGFR/c-MET bispecific antibody, in head and neck squamous cell cancer (HNSCC)

Title: Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC)

The abstracts will be available on the ESMO (Free ESMO Whitepaper) Asia Congress website on Sunday, November 26, 2023 at 11:05 a.m. ET. The full presentations will be available on the Merus website at the start of each session.

About MCLA-129
MCLA-129 is an antibody-dependent cellular cytotoxicity-enhanced Biclonics that is designed to inhibit the EGFR and c-MET signaling pathways in solid tumors. Preclinical data have shown that MCLA-129 can effectively treat TKI-resistant NSCLC in xenograft models of cancer. MCLA-129 is designed to have two complementary mechanisms of action: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor.

About Zeno
Zeno is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics that utilizes the Merus Dock & Block mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions (NRG1+ cancer). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancer. In preclinical studies, Zeno potently inhibits HER2/HER3 heterodimer formation thereby inhibiting oncogenic signaling pathways, leading to inhibition of tumor cell proliferation and blocking tumor cell survival.

About the eNRGy Clinical Trial
Merus is currently enrolling patients in the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer. The eNRGy trial consists of three cohorts: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer; and other NRG1+ cancer. Further details, including current trial sites, can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com or by calling 1-833-NRG-1234.

Purple Biotech Reports Potential Biomarker Data Support CM24’s Mechanism of Action

On October 6, 2023 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported new biomarker data for its lead oncology drug, CM24, a first-in-class anti-CEACAM1 monoclonal antibody (Press release, Purple Biotech, OCT 6, 2023, View Source [SID1234635710]). Data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference: Pancreatic Cancer in Boston in a scientific poster titled: "Phase 1 Study of CM24 in Combination with Nivolumab in Patients with Advanced Pancreatic Cancer – Survival, Exploratory Biomarkers and Effect on Neutrophil Extracellular Traps (NETs)".

The poster shows that higher pre-treatment levels of tumor infiltrating lymphocytes that express CEACAM1may associated with longer survival in patients treated with CM24 and nivolumab.

In addition, the poster shows high expression of CEACAM1 on neutrophils and NETs , and enhanced levels of serum NETs in PDAC patients, and demonstrates for the first time that CM24 treatment significantly reduced the level of NET marker in patients’ serum.

"These encouraging data, demonstrating increased survival of PDAC patients whose biopsies show higher CEACAM1-positive lymphocytes, are consistent with the CM24 Mechanism of Action (MoA) in suppressing the immune evasion and suggest CEACAM1 expressing lymphocytes as a potential biomarker for CM24 therapy" said Purple Biotech VP R&D, Dr. Hadas Reuveni. "In addition, the significant reduction in the levels of NETs in patients’ serum following treatment with CM24 suggests a novel MoA that may reduce NET-related complications, especially relevant in PDAC patients, and may be used as a potential pharmacodynamic marker for CM24."

The CM24 and nivolumab combination has shown in phase 1 encouraging initial activity and safety profile in PDAC patients who have progressed after second-line therapy. CM24’s novel target is CEACAM1, which is overexpressed on tumor cells and infiltrating immune cells.

CM24 is now being evaluated in a randomized Phase 2 study (NCT04731467) in combination with Bristol Myers Squib’s nivolumab plus standard of care (SoC) chemotherapy, as a second line treatment for pancreatic ductal adenocarcinoma (PDAC). The primary endpoint is overall survival of patients treated with CM24 in combination with nivolumab and SoC chemotherapy vs. SoC chemotherapy alone.

"NETs and CEACAM1 will continue to be monitored and investigated in our ongoing randomized Phase 2 study of CM24 in pancreatic cancer patients," stated Purple Biotech CEO, Gil Efron. "We look forward to reporting data from this study in the near term."

The full poster can be viewed on the Purple Biotech website at View Source

ORIC Pharmaceuticals Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

On October 6, 2023 ORIC Pharmaceuticals, Inc. (Nasdaq:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that on October 2, 2023 (the "Grant Date"), ORIC granted a total of 72,120 non-qualified stock options and 12,040 restricted stock units to four new non-executive employees who began their employment with ORIC in September 2023 (Press release, ORIC Pharmaceuticals, OCT 6, 2023, View Source [SID1234635709]).

These inducement grants were granted pursuant to the ORIC Pharmaceuticals, Inc. 2022 Inducement Equity Incentive Plan, subject to recipient’s continued employment or service through each applicable vesting date. The stock options have an exercise price equal to the closing price of ORIC’s common stock on the Grant Date. Twenty-five percent (25%) of the shares subject to the stock options will vest on the one (1) year anniversary of the Grant Date, with one thirty-sixth (1/36th) of the remaining shares vesting each one-month period thereafter. One-third (1/3rd) of the restricted stock units will vest on each of the first three anniversaries of the Grant Date. The inducement grants are subject to the terms and conditions of the applicable stock option and restricted stock unit agreements and the ORIC Pharmaceuticals, Inc. 2022 Inducement Equity Incentive Plan.

The inducement grants were approved by ORIC’s Compensation Committee of the Board of Directors, as required by Nasdaq Rule 5635(c)(4), and were granted as a material inducement to employment in accordance with Nasdaq Rule 5635(c)(4).