On March 14, 2023 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, and Quantum Leap Healthcare Collaborative ("Quantum Leap") reported that the first patient has been dosed in the I-SPY-P1-TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer (Press release, ALX Oncology, MAR 14, 2023, View Source [SID1234628716]). Sponsored by Quantum Leap, this Phase 1 (open-label), multi-center study arm will investigate evorpacept, a CD47 blocker, in combination with ENHERTU (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody-drug conjugate ("ADC"), to determine the safety, tolerability and efficacy of this drug combination.

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"Evorpacept is a potentially transformative approach to strengthen the anticancer immune response against breast cancer with minimal added toxicity," said Laura Esserman, M.D., co-founder of Quantum Leap, Professor of Surgery and Radiology at the University of California San Francisco, CA. "The combination of a novel CD47 blocker with a HER2-directed ADC represents a promising strategy for patients with advanced breast cancer who develop resistance to other therapies and are in urgent need of new treatment options. The I-SPY Phase 1 program is designed to rapidly assess safety of novel therapy combinations that will help advanced cancer patients, but also rapidly qualify them to be tested in the high-risk early stage setting in the I-SPY 2.2 TRIAL, where complete responses result in curing patients. We are excited to collaborate with ALX Oncology to accelerate the development of this therapeutic combination with the goal of improving patients’ lives, with more effective and less toxic therapies."

About the I-SPY TRIALs

The I-SPY TRIAL ("Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis") was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration ("FDA"), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. The trial now includes the serial testing of agents and combinations with the ability to escalate and de-escalate therapy based on response to treatment, and the ability to start with non-chemotherapy combinations. For more information, visit www.ispytrials.org.

The I-SPY Phase 1 trial is the newest member of the I-SPY master protocols. It is designed to rapidly test the safety and identify the optimal dose of promising combinations of novel therapeutics that might be particularly effective in the early-stage high-risk breast cancer, but where additional safety or dose finding is necessary. The phase 1 trial was designed to accelerate the pace of advancing safe, effective, and less toxic therapies to the early-stage treatments where lives can be saved. The I-SPY 2.2 TRIAL is uniquely poised to test therapies for their ability to result in a complete response where standard chemotherapy can be avoided.

About Quantum Leap Healthcare Collaborative

Quantum Leap Healthcare Collaborative is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate care and research, and to foster high-impact trials with embedded clinical processes and systems technology and improved data management, greater access to clinical trial matching, and greater benefit to patients, providers, and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. For more information, visit View Source

On March 14, 2023 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported publication of abstracts at the 2023 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Ideaya Biosciences, MAR 14, 2023, View Source [SID1234628715]). IDEAYA will present data for its potential first-in-class synthetic lethality programs IDE397, a Phase 1/2 methionine adenosyltransferase 2a (MAT2A) inhibitor, IDE161, a Phase 1/2 poly (ADP-ribose) glycohydrolase (PARG) inhibitor, and Werner Helicase, for which a development candidate is targeted in 2023.

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The abstracts are available online at View Source in advance of the 2023 Annual Meeting of AACR (Free AACR Whitepaper), which will be held April 14-19, 2021. The posters will be available online at View Source following the poster presentations. These data will be presented by IDEAYA in collaboration with Amgen (IDE397) and GSK (IDE397, Werner Helicase).

Abstract 1644: "Dual inhibition of MAT2A and PRMT5 delivers synergistic anti-tumor responses in preclinical models of MTAP-deleted cancer" (Fischer, M. et al.)
Date/Time: Monday April 17, 2023 at 9:00 am – 12:30 pm ET
Session: Experimental and Molecular Therapeutics, Novel Antitumor Agents 4
Location: Poster Section 18, Poster Board 1
Presenters: IDEAYA, Amgen

Abstract 1637: "MAT2A inhibition in MTAP-/- tumors confers mechanistic vulnerabilities to multiple clinically actionable synthetic lethal drug combinations" (Gerrick, K. et al.)
Date/Time: Monday April 17, 2023 at 9:00 am – 12:30 pm ET
Session: Experimental and Molecular Therapeutics, Novel Antitumor Agents 3
Location: Poster Section 17, Poster Board 27
Presenters: IDEAYA, GSK

Abstract 6093: "IDE161, a potential first-in-class clinical candidate PARG inhibitor, selectively targets Homologous-Recombination-Deficient and PARP inhibitor resistant breast and ovarian tumors" (Abed, M. et al.)
Date/Time: Wednesday April 19, 2023 at 9:00 am – 12:30 pm ET
Session: Molecular/Cellular Biology and Genetics, Targeting DNA Damage Response and Novel Pathways
Location: Poster Section 13, Poster Board 1
Presenters: IDEAYA

Abstract 1628: "A small-molecule inhibitor of WRN selectively kills MSI-H cancer cells and phenocopies WRN genetic defects" (Rao, Y. et al.)
Date/Time: Monday April 17, 2023 at 9:00 am – 12:30 pm ET
Session: Experimental and Molecular Therapeutics, Novel Antitumor Agents 3
Location: Poster Section 17, Poster Board 18
Presenters: IDEAYA, GSK
"We are excited to present foundational preclinical data supporting our clinical-stage IDE397 and IDE161 programs and our preclinical Werner Helicase program. These data include fundamental mechanistic, biological and pharmacological insights which inform our ongoing or future clinical development plans for these programs," said Dr. Michael White, Chief Scientific Officer and Head of Research at IDEAYA Biosciences.

IDEAYA is clinically evaluating IDE397, a potential first-in-class small molecule inhibitor targeting MAT2A, in a Phase 1/2 clinical trial for patients having tumors harboring MTAP deletion. The IDE397 clinical development strategy includes ongoing IDEAYA-sponsored evaluation as monotherapy in select indications and planned Amgen-sponsored evaluation in combination with AMG 193, the Amgen investigational MTA-cooperative PRMT5 inhibitor, pursuant to a Clinical Trial Collaboration and Supply Agreement. IDEAYA owns all commercial rights to IDE397 and its MAT2A program.

IDEAYA is also clinically evaluating IDE161, a potential first-in-class PARG inhibitor, in a Phase 1/2 clinical trial for patients having tumors with HRD, including in BRCA1/2-mutant, ER+ / Her2- breast cancer, which represents approximately 10% to 14% of breast cancer. IDEAYA plans to initiate dosing of a first patient in the Phase 1 dose escalation study in the first quarter of 2023. IDEAYA owns or controls all commercial rights to IDE161 and its PARG program, subject to certain economic obligations under an exclusive, worldwide license with Cancer Research UK / University of Manchester.

IDEAYA is, in collaboration with GSK, preclinically advancing its Werner Helicase inhibitors for tumors with high microsatellite instability (MSI), with development candidate selection targeted in 2023. IDEAYA is eligible to receive future development and regulatory milestones, including up to $10 million aggregate through IND effectiveness – $3 million in connection with IND-enabling studies and an additional $7 million through IND effectiveness. Following selection of a development candidate, GSK will lead clinical development for the Werner Helicase program.

On March 14, 2023 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a precision oncology company, reported that an abstract highlighting pre-clinical data for CRB-601, its avβ8 blocking antibody, has been accepted for presentation at a poster at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, to be held April 14-19, 2023 in Orlando, Fl (Press release, Corbus Pharmaceuticals, MAR 14, 2023, View Source [SID1234628714]).

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Poster Presentation
Title: CRB-601, an avβ8 blocking antibody, prevents activation of TGFb and exhibits anti-tumor activity associated with immune cell remodeling of the tumor microenvironment
Authors: Daqing Wang, Ph.D; Vaishali Shinde, MS; Maneesh Singh, Ph.D.; Rachael Brake, Ph.D.; Andrew Kolodziej, Ph.D.
Date & Time: Apr 16, 2023, 1:30 PM – 5:00 PM

On March 14, 2023 Delfi Diagnostics, Inc., a pioneering developer of a new class of high-performance, accessible liquid biopsy tests for early cancer detection and monitoring, reported that it will present multiple oral and poster presentations showcasing the performance of its next-generation liquid biopsy platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s 2023 annual meeting next month (Press release, Delfi Diagnostics, MAR 14, 2023, View Source [SID1234628713]).

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The presentations from Delfi and other independent researchers using the DELFI platform will provide updates on Delfi’s lung cancer screening clinical trials, describe the DELFI platform’s ability to detect early stage ovarian cancer, and detail how it performs in monitoring the progress of metastatic colorectal cancer patients on chemotherapy.

"We’re excited to present updates on L101, and CASCADE-Lung, our clinical trials evaluating Delfi’s test for lung cancer screening, as well as new data showing how the Delfi platform performs in other applications, including monitoring," said Delfi President and Chief Operating Officer Jenn Buechel "Taken together, these studies begin to demonstrate the wide range of applications Delfi’s high-performing, affordable platform is capable of delivering."

Details of the presentations appear below:

Oral Presentations:

Title: Prospective evaluation of cell-free DNA fragmentomes for lung cancer detection
Session Title: Behavioral and Biological Opportunities to Improve Cancer Prevention, Early Detection, and Disparities
Session Date/Time: 4/18/23 2:30 PM – 4:30 PM
Abstract Number: 5766

Title: Cell-free DNA fragmentation profiling for monitoring therapeutic response in metastatic colorectal cancer
Session Title: Increasing the Clinical Utility of Cell-Free DNA Testing
Session Date/Time: 4/18/23 2023 2:30 PM – 4:30 PM
Abstract Number: 5714

Poster Presentations:

Title: Early detection of ovarian cancer using cell-free DNA fragmentomes
Session Title: Omics and Imaging Approaches in Cancer Risk, Early Detection, and Response Assessment
Session Date and Time: 4/16/23 1:30 PM – 5:00 PM
Location: Section 28
Poster Board Number: 15
Abstract Number: 773

Title: CASCADE-LUNG: Validation of a blood-based assay that evaluates cell-free DNA fragmentation patterns to detect lung cancer
Session Title: Phase II and Phase III Clinical Trials in Progress
Session Date and Time: 4/17/23 9:00 AM – 12:30 PM
Location: Section 46
Poster Board Number: 26
Abstract Number: CT068

On March 14, 2023 Cantargia (Cantargia AB) (Nasdaq Stockholm: CANTA) reported that two abstracts on its lead asset, the antibody nadunolimab (CAN04), have been selected for poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting 2023 (AACR 2023) (Press release, Cantargia, MAR 14, 2023, View Source [SID1234628712]). A key finding is that pancreatic cancer (PDAC) patients with high tumor levels of IL1RAP, the target of nadunolimab, benefit most from nadunolimab combined with chemotherapy. This further strengthens previously reported signs of clinical efficacy of nadunolimab in PDAC. The abstract disclosing these and additional biomarker data has now been published, as well as a second abstract on anti-metastatic effects in models of cancer. AACR (Free AACR Whitepaper) 2023 is held in Orlando on 14-19 Apr 2023.

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"We are thrilled to be presenting new results at the AACR (Free AACR Whitepaper) Annual Meeting, one of the biggest conferences for cancer research. The new findings strengthen the positive results when nadunolimab is added to first-line chemotherapy in pancreatic cancer and strongly support our controlled clinical trials," said Göran Forsberg, CEO of Cantargia.

Clinical results and biomarkers in PDAC
Results from the phase I/IIa clinical trial CANFOUR, which evaluates nadunolimab combined with chemotherapy in first-line PDAC, have shown stronger efficacy of the combination than expected from chemotherapy alone. New findings based on analyses of tumor biopsies from these patients indicate that high tumor levels of IL1RAP correlate with better response to treatment, including longer progression-free survival and overall survival. This suggests that the interaction between nadunolimab and IL1RAP is integral to the positive effects reported in PDAC. Patients with the strongest treatment-related reductions of serum IL-6, IL-8 and CRP, markers related to the mode-of-action of nadunolimab, also display favorable efficacy. Updated and more detailed results will be presented in the poster at AACR (Free AACR Whitepaper) 2023, details of which can be found below:

Published abstract number: 2172
Abstract title: Tumor IL1RAP levels and reduction in serum biomarkers correlate with response in PDAC patients treated with nadunolimab, an anti-IL1RAP monoclonal antibody, in combination with gemcitabine and nab-paclitaxel
Session category: Clinical Research Excluding Trials
Session title: Biomarkers of Therapeutic Benefit 3
Session date and time: Monday Apr 17, 2023 9:00 AM – 12:30 PM ET

Preclinical results in models of cancer
New preclinical results for nadunolimab will also be presented at the meeting in a second poster. These data demonstrate that a surrogate antibody for nadunolimab reduces the number of lung metastases in two different tumor models. Detailed analyses of the lung tissue also show that the surrogate antibody regulates genes associated with cell migration and activation, indicating an effect on the environment in metastatic tissue. Details of this poster can be found below:

Published abstract number: 6429
Abstract title: A surrogate to the anti-IL1RAP antibody nadunolimab induces tumor microenvironment changes to the metastatic lung and reduces metastatic lesions in mouse models of metastatic cancer
Session category: Immunology
Session title: Immunotherapy Strategies and Mechanisms
Session date and time: Wednesday Apr 19, 2023 9:00 AM – 12:30 PM ET

Abstracts for both posters can be accessed at View Source

An R&D Day presenting Cantargia’s ongoing development including the new results in PDAC is planned for late April 2023, following AACR (Free AACR Whitepaper) 2023.

For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: [email protected]

This is information that Cantargia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 21.30 CET on 14 March 2023.