On July 28, 2023 Immuno-oncology leader, Agenus Inc. ("Agenus") (Nasdaq: AGEN), reported that a data update from the phase 1 expansion cohort of botensilimab (multifunctional CTLA-4 antibody) in combination with balstilimab (PD-1 antibody) for patients with advanced, refractory sarcomas has been selected for an oral presentation at the upcoming ESMO (Free ESMO Whitepaper) Congress, to be held October 20 – 24, 2023 in Madrid, Spain (Press release, Agenus, JUL 28, 2023, View Source [SID1234633489]).

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Presentation Details:

Abstract Title: Efficacy and safety of botensilimab (BOT) plus balstilimab (BAL) in patients (pts) with refractory metastatic sarcoma (NCT03860272)
Abstract Number: 1919MO
Presenting Author: Breelyn A. Wilky, MD, Director of Sarcoma Medical Oncology, Deputy Associate Director for Clinical Research, University of Colorado Cancer Center
Presentation Date and Time: 10/21/2023, 10:15pm – 11:45pm CEST

Data presented at the conference will be available to view in the publications section of the Agenus website (View Source) following the ESMO (Free ESMO Whitepaper) Conference.

About Botensilimab
Botensilimab, an investigational multifunctional CTLA-4 antibody, is designed to extend immunotherapy benefits to "cold" tumors, which have not historically responded to standard of care or other investigational therapies. Besides binding to the CTLA-4 receptor, its Fc-enhanced structure induces a memory immune response, downregulates regulatory T cells, and activates T cells, thereby enhancing immune responses. Approximately 600 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT05608044, NCT05630183, and NCT05529316.

On July 28, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported the completion of enrollment to the randomized, double-blind phase III ALTAIR clinical trial (JapicCTI-205363/NCT04457297) (Press release, Natera, JUL 28, 2023, View Source [SID1234633488]). ALTAIR is the circulating tumor DNA (ctDNA)-guided treatment escalation arm of the CIRCULATE-Japan adaptive trial platform evaluating the utility of the Signatera molecular residual disease (MRD) test in patients with stage II-IV resectable colorectal cancer (CRC). CIRCULATE-Japan also includes the observational GALAXY study and the randomized phase III VEGA trial for ctDNA-guided treatment de-escalation. The company expects to share primary results from ALTAIR in mid-2024.

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The ALTAIR investigators have met their goal to enroll >240 patients who tested ctDNA-positive at any time within 2 years after surgery, but with no clinical or radiographic evidence of disease. ctDNA-positive patients are randomized to placebo or TAS-102 (trifluridine/tipiracil), a therapy commonly used for patients with metastatic CRC. The primary endpoint of the study is disease-free survival. ctDNA clearance is a secondary endpoint.

"In this study, we aim to establish the utility of Signatera in the adjuvant and surveillance settings by showing we can improve outcomes for patients with detectable ctDNA before it becomes evident on imaging," said Dr. Takayuki Yoshino of the National Cancer Center Hospital East, Kashiwa, Chiba, Japan and primary investigator of the CIRCULATE-Japan trial. "Randomized studies such as ALTAIR can help provide compelling evidence to support the use of ctDNA testing as a tool to guide treatment decisions in CRC."

Completion of enrollment to ALTAIR follows the release of multiple new datasets in 2023 highlighting the clinical utility of Signatera in CRC. In January, the results of >1,000 patients (>7,200 plasma time points) from GALAXY were published in Nature Medicine, demonstrating the ability of Signatera to identify patients with stage II-IV resectable CRC who are at an increased risk of recurrence and to predict who is most likely to benefit from adjuvant chemotherapy. Similar results were reported at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June 2023 with additional data from an expanded cohort of >2,000 patients (>3,800 plasma time points) from the same study.

"The completion of enrollment to ALTAIR marks a significant milestone that will build on recent data from the GALAXY study and bring us one step closer to a future of ctDNA-guided cancer care," said Dr. Minetta Liu, chief medical officer of oncology at Natera. "We are proud to partner with our collaborators from CIRCULATE-Japan to accelerate precision medicine and transform care for patients with resectable CRC."

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions.

On July 28, 2023 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that the Compensation Committee of IDEAYA’s Board of Directors granted non-qualified stock options to purchase an aggregate of 51,200 shares of the Company’s common stock to two newly hired employees (Press release, Ideaya Biosciences, JUL 28, 2023, View Source [SID1234633487]). The stock options were granted under the IDEAYA Biosciences, Inc. 2023 Employment Inducement Incentive Award Plan (2023 Inducement Plan) as an inducement material to such individuals’ entering into employment with IDEAYA in accordance with Nasdaq Listing Rule 5635(c)(4).

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The 2023 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of IDEAYA, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with IDEAYA, pursuant to Nasdaq Listing Rule 5635(c)(4).

The stock options have an exercise price of $21.07 per share, which is equal to the closing price of IDEAYA’s common stock on The Nasdaq Global Select Market on the date of grant. The stock options have a 10-year term and will vest over four years, with 25% of the options vesting on the first anniversary of the vesting commencement date and the remaining 75% of the options vesting in equal monthly installments over the three years thereafter. Vesting of the stock options is subject to such employee’s continued service to IDEAYA on each vesting date.

On July 28, 2023 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported that Company Management will participate in a Fireside chat and one-on-one investor meetings during the BTIG Virtual Biotechnology Conference 2023, taking place on August 7-8, 2023 (Press release, AC Immune, JUL 28, 2023, View Source [SID1234633486]).

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During the Fireside chat, Dr. Andrea Pfeifer, CEO of AC Immune SA, will discuss the Company’s clinical stage active immunotherapy pipeline to treat and, ultimately, prevent Alzheimer’s and other neurodegenerative diseases.

The live Fireside chat will take place on August 8, 2023, at 9:30 am (EDT) / 3:30 pm (CEST). AC Immune’s Management will take investor meetings on the same day. A replay will also be available through the BTIG Virtual Biotechnology Conference platform.

On July 28, 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 that two abstracts were selected for presentation at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) 2023 (Press release, Merus, JUL 28, 2023, View Source [SID1234633485]).

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The presentations will highlight updated interim clinical data for the targeted bispecific antibody, zenocutuzumab (Zeno), with an abstract and oral presentation concerning NRG1 fusion positive (NRG1+) non-small cell lung cancer (NSCLC) and an abstract presentation concerning NRG1+ pancreatic ductal adenocarcinoma (PDAC). The abstracts will be presented at the ESMO (Free ESMO Whitepaper) Congress 2023 taking place in Madrid, Spain October 20-24, 2023.

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.

Title: Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC)
Speaker: Alison Schram
Mini Oral 1315MO
Lecture Time 9:35-9:40 CEST
Saturday, October 21

Title: Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) pancreatic ductal adenocarcinoma (PDAC)
Poster Session 1618P
Sunday, October 22

The full abstracts will be published online via the ESMO (Free ESMO Whitepaper) website at 00:05 CEST on Monday, October 16. They will be available concurrently on the Merus website.

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.

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.