On April 24, 2024 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers, reported an upcoming presentation from the Phase 1b trial of botensilimab in combination with balstilimab ("BOT/BAL") in patients with relapsed/refractory microsatellite stable colorectal cancer with no active liver metastases (r/r MSS CRC NLM) will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting, to be held May 31 – June 4, 2024, in Chicago, IL (Press release, Agenus, APR 24, 2024, View Source [SID1234642322]). The poster presentation is for a sub-analysis of the r/r MSS CRC cohort of the Phase 1b study. This sub-analysis was done to determine whether treatment outcomes are correlated with specific sites of metastatic disease in patients with non-active liver mets.

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Presentation Details:

Abstract Title: Botensilimab plus balstilimab in microsatellite stable metastatic colorectal cancer: Assessing efficacy in non-liver metastatic sites.

Abstract Number: 3556

Presenting Author: Marwan Fakih, MD, Division Head, GI Medical Oncology, City of Hope Comprehensive Cancer Center

Session: Poster Session – Gastrointestinal Cancer – Colorectal and Anal

Session Date and Time: June 1, 2024, at 1:30 p.m. – 4:30 p.m. CT

Complete abstracts will be released Thursday, May 23, 2024, at 5:00 p.m. ET. Data presented at the conference will be available to view in the publications section of the Agenus website (View Source) following the ASCO (Free ASCO Whitepaper) Meeting.

About Botensilimab

Botensilimab is an investigational multifunctional anti-CTLA-4 immune activator (antibody) designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

Approximately 900 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational 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 NCT03860272, NCT05608044, NCT05630183, and NCT05529316.

On April 24, 2024 AffyImmune Therapeutics, Inc., a clinical-stage biopharmaceutical company, reported an abstract detailing its affinity-tuned CAR T therapy AIC100 will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting, held May 31-June 4, at McCormick Place Convention Center in Chicago, IL (Press release, AffyImmune Therapeutics, APR 24, 2024, View Source [SID1234642321]).

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"We look forward to presenting our preliminary data at ASCO (Free ASCO Whitepaper), and to provide initial safety and efficacy results from our Phase 1 trial evaluating AIC100 CAR T therapy in patients with advanced thyroid cancers," said Matt Britz, CEO, AffyImmune. "These results mark significant progress, as we continue to advance our affinity-tuned CAR T therapies for patients with unmet medical need."

Presentation Details:

Title: Safety and Efficacy of AIC100 Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients with Advanced Thyroid Cancers: results from the phase 1 study

Presenter: Dr. Samer Ali Srour, University of Texas MD Anderson Cancer Center

Session Type: Poster Session– Head and Neck Cancer

Abstract Number: 6112

Date and Time: June 2, 2024: 9:00 AM – 12:00 PM CDT

Location: McCormick Place Convention Center in Chicago, Illinois

On April 24, 2024 Nuvation Bio Inc. (NYSE: NUVB), a late-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported that updated data from the Phase 2 TRUST-I clinical study (NCT04395677) evaluating taletrectinib in patients in China with ROS1-positive non-small cell lung cancer (NSCLC) will be reported in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31-June 4, 2024 in Chicago, Illinois (Press release, Nuvation Bio, APR 24, 2024, View Source [SID1234642320]).

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Presentation Overview:

Title: Efficacy and safety of taletrectinib in patients with advanced or metastatic ROS1+ non-small cell lung cancer: The phase 2 TRUST-I study
Presenter: Wei Li, M.D., Department of Medical Oncology, Shanghai Pulmonary Hospital, Thoracic Cancer Institute, Tongji University School of Medicine
Date: Saturday, June 1, 2024
Session Time: 4:30-6:00 p.m. CT/5:30-7:00 p.m. ET
Session: Lung Cancer — Non-Small Cell Metastatic
Abstract: 8520

The materials will be made available on the Publications section of nuvationbio.com the morning of the presentation.

About Taletrectinib

Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the potential treatment of patients with ROS1-positive NSCLC.

Taletrectinib is being evaluated for the treatment of patients with ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.

Taletrectinib has been granted Breakthrough Therapy Designations by both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) for the treatment of patients with advanced or metastatic ROS1-positive NSCLC. Based on results of the TRUST-I clinical study, China’s NMPA has accepted and granted Priority Review Designations to New Drug Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who either have or have not previously been treated with ROS1 tyrosine kinase inhibitors (TKIs).

On April 24, 2024 HighField Biopharmaceuticals, a clinical stage immuno-oncology company using lipid-based therapeutics to treat cancer, reported that two HighField abstracts have been accepted with one poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting May 31-June 4, 2024, in Chicago, IL (Press release, HighField Biopharmaceuticals, APR 24, 2024, View Source [SID1234642319]).

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"The ASCO (Free ASCO Whitepaper) meeting is an important opportunity to share our unique lipid-based technology with other clinical investigators," said Yuhong Xu, Ph.D., Founder and CEO of HighField. "Our lipid-based structures represent a new generation of therapeutics targeting the tumor microenvironment for a broad range of cancers."

The abstracts reflect Phase 1 clinical trials of two kinds of lipid-based therapeutics. HFK1 is a drug encapsulated immunoliposome containing doxorubicin for patients with advanced refractory solid tumors having HER2 low and HER2+ expression. HER2 expressing solid tumors include breast, bladder, pancreatic, ovarian, stomach, colon, prostate, lung, uterus and cervix cancers. HF1K16 is a drug encapsulated immune modulating liposome containing all-trans retinoic acid (ATRA) for patients with recurrent and refractory glioma.

HFK1 Poster Presentation
Abstract ID: 3035
Title: The design, preclinical study and Phase 1 dose escalation of a HER2 targeted immunoliposome (HF-K1) for HER2 low solid tumor treatment.
Presenter: Dr. Yuhong Xu, Ph.D.
Presenter Date: Saturday, June 1, 2024 (9am -12pm)

HF1K16 Abstract for Publication
Abstract ID.: e14030
Title: Exploratory phase 1 study of HF1K16 for the treatment of patients with refractory/recurrent advanced glioma: preliminary efficacy and mechanism as a monotherapy.

On April 24, 2024 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported that updated Phase 1/2 data for AU-007 will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting (Press release, Aulos Bioscience, APR 24, 2024, View Source [SID1234642318]). AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors in patients with unresectable locally advanced or metastatic cancers. It is the first AI-designed human monoclonal antibody to be tested in a clinical trial. The ASCO (Free ASCO Whitepaper) meeting is being held online and at McCormick Place in Chicago, Illinois, from May 31–June 4, 2024.

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Details of the poster presentation are as follows:

Poster Title: Updated results of a phase 1/2 study of AU-007, a monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, in patients with advanced solid tumors.
Abstract: 2527
Session Type/Title: Poster Session/Developmental Therapeutics—Immunotherapy
Session Date and Time: Saturday, June 1, 2024, 9:00 a.m.-12:00 p.m. CDT

The poster will be presented in the Exhibit Hall at McCormick Place. An electronic version will also be available on the ASCO (Free ASCO Whitepaper) 2024 online meeting platform.

About AU-007
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the AU-007 Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).