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.

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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]).

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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.

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)".

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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

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]).

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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).

On October 6, 2023 Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious diseases and autoimmune conditions, reported that it will present three-year Phase 3 survival data for KIMMTRAK in metastatic uveal melanoma at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 commencing on 20 October (Press release, Immunocore, OCT 6, 2023, View Source [SID1234635708]).

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In addition to the oral presentation, the company will present three posters sharing data on the effect of subsequent therapies, including checkpoint inhibitors, on overall survival from KIMMTRAK treatment for metastatic uveal melanoma; the reprogramming effect of KIMMTRAK on immunosuppressive M2 macrophages; and the lack of impact of BRAF mutation on KIMMTRAK treatment in advanced cutaneous melanoma.

Presentation and poster details

Title: Three-year survival with tebentafusp in previously untreated metastatic uveal melanoma in a phase 3 trial (LBA50)
Presenting author: Sophie Piperno-Neumann
Session: Mini oral session – Melanoma and other skin tumours, Saturday 21 October, 2023

Title: Tebentafusp reprograms immunosuppressive tumor-associated M2 macrophages towards anti-tumoral M1 macrophages (2238P)
Presenting author: Josep M. Piulats
Session: Poster display, Saturday 21 October, 2023

Title: BRAF mutation status does not impact outcomes with tebentafusp in advanced cutaneous melanoma
Presenting author: Alexander N. Shoushtari
Session: Poster display, Sunday 22 October, 2023

Title: Effect of subsequent therapies including checkpoint inhibitors on overall survival in a phase 3 randomized trial of tebentafusp in first line metastatic uveal melanoma: long-term follow up
Presenting author: Marlana Orloff
Session: Poster display, Sunday 22 October, 2023

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About ImmTAC molecules for cancer
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumors.

About KIMMTRAK
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.

About Phase 3 IMCgp100-202 Trial
IMCgp100-202 (NCT03070392) is a randomized pivotal trial that evaluated overall survival (OS) of KIMMTRAK compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01-positive adult patients with previously untreated mUM. KIMMTRAK demonstrated an unprecedented OS benefit with a Hazard Ratio (HR) in the intent-to-treat population favoring KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine).