On March 20, 2024 Antennova, a clinical-stage biotech company focused on oncology reported completion of the first dosing cohort in the Phase I study for the anti-CD24 antibody, ATN-031 (also known as ATG-031) (Press release, Antengene, MAR 20, 2024, View Source [SID1234641307]). The dose escalation trial is evaluating ATN-031 in patients with advanced solid tumors or B-cell non-Hodgkin’s lymphoma (B-NHL), (NCT06028373). The PERFORM trial is being conducted at four cancer centers in the U.S., led by The University of Texas MD Anderson Cancer Center.

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A total of five late stage cancer patients have been enrolled based on the Bayesian Optimal Interval (BOIN) design of the trial in the first dosing cohort. To date, no dose-limiting toxicities (DLTs) have been reported among the 5 patients. Tumor shrinkage based on CT scan was observed in one heavily pre-treated patient (7 prior lines of therapy).

"Introducing the first anti-CD24 program for late stage cancer patients in the U.S. is a very important milestone for Antennova. We are especially grateful to the participation in the study by our patients and study centers, and encouraged to observe early clinical activity in this heavily pre-treated patient population based on clinical evaluation and translational data. We are working closely with study sites and investigators at MD Anderson, the University of California, San Francisco, the University of Colorado, and Yale University Cancer Center and look forward to providing periodic updates and presentations at major international medical conferences throughout the study." commented by Jay Mei, M.D., Ph. D., Founder and Chairman of the Board.

The PERFORM trial is a first-in-human, multi-center, open-label, Phase I dose-finding/escalation study of ATN-031 in patients with advanced solid tumors or B-NHL. The study’s primary objective is to evaluate the safety and tolerability of ATN-031 as a monotherapy, and determine the appropriate dose for Phase II studies. The secondary objective is to characterize the pharmacology, evaluate the immunogenicity, and assess the preliminary efficacy of ATN-031.

About ATN-031

ATN-031 is a first-in-class humanized anti-CD24 monoclonal antibody which inhibits the "don’t eat me" signal while stimulating the "eat me" signal, and enhances macrophage-mediated phagocytosis of cancer cells. Tumor cells evade the surveillance of the human immune system by over-expressing "don’t eat me" surface proteins that signal macrophages to prevent the detection and phagocytosis of cancer cells. CD24 is a prominent "don’t eat me" signal that plays a significant role in tumor immune evasion by suppressing macrophage-mediated phagocytosis. Compared to CD47, another "don’t eat me" target, CD24, has a more markedly restricted distribution in normal tissues and higher expression in cancerous tissues, especially solid tumors. Importantly, CD24 is differentiated from CD47 because it is not expressed on human red blood cells, allowing for a wider therapeutic window and minimal on-target-off-tumor toxicity.

CD24 acts as a novel innate immune checkpoint, orchestrating immune evasion through its interaction with the inhibitory receptor Siglec-10 (sialic-acid-binding Ig-like lectin 10), expressed on tumor-associated macrophages (TAMs). Preclinical data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in 2023 (AACR 2023) and the Society for Immunotherapy in Cancer Annual Meeting in 2022 (SITC 2022) demonstrated that ATN-031 can specifically bind to CD24 with nM affinity and block the interaction of CD24 and Siglec-10. Furthermore, ATN-31 induces efficient phagocytosis with a picomolar EC50 and stimulates the pro-inflammatory cytokines production by macrophages.

On March 20, 2024 ImmunoScape, a biotechnology company focused on next-generation T Cell receptor (TCR)-based immunotherapies, reported that three abstracts have been accepted for poster presentations at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 5-10, 2024 in San Diego, California (Press release, immunoSCAPE, MAR 20, 2024, View Source [SID1234641306]).

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Presentation details are as follows:

Title: Discovery and development of T cell receptors targeting MAGE family antigens for adoptive T cell therapy against solid tumors
Presenter: Juliana Velez Lujan, Ph.D., ImmunoScape, Senior Scientist
Session Title: Adoptive Cell Therapies 1: Tumor Antigen-Specific T-cells and TCR-T
Date & Time: Sunday, April 7, 2024, 1:30 p.m. – 5:00 p.m. PT
Location: Poster Section 1
Poster Number: 13

Title: Deep Immunomics pipeline for discovery and validation of novel cancer-specific T cell receptors
Presenter: Hannah Fields, ImmunoScape, Scientist
Session Title: Adoptive Cell Therapies 1: Tumor Antigen Specific T-cells and TCR-T
Date & Time: Sunday, April 7, 2024, 1:30 p.m. – 5:00 p.m. PT
Location: Poster Section 1
Poster Number: 8

Title: A validated bioinformatics tool-set for predicting TCR specificity
Presenter: Andreas Wilm, ImmunoScape, Director of Computational Biology
Session Title: Database Resources, Statistical Methods, and Other Tools
Date & Time: Monday, April 8, 2024, 1:30 p.m. – 5:00 p.m. PT
Location: Poster Section 36
Poster Number: 19

Full abstracts will be available on the AACR (Free AACR Whitepaper) Online Program Planner. Following the conference, the posters will be made available under the "Publications" page on ImmunoScape’s website.

On March 20, 2024 Bayer AG and Thermo Fisher Scientific Inc. reported a collaboration to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx) together (Press release, Bayer, MAR 20, 2024, View Source [SID1234641305]). These will help identify patients who may benefit from Bayer’s growing portfolio of precision cancer therapies by offering decentralized genomic testing and rapid turnaround time.

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The CDx will be developed using Thermo Fisher’s Oncomine Dx Express Test* on the Ion Torrent Genexus Dx System*, a fully integrated NGS platform that can deliver results on a patient’s tumor or liquid biopsy sample in as little as 24 hours.

"We are committed to developing new treatment options for patients with unmet medical needs, reducing exposure to treatments that are not as likely to provide benefit or can spare them unnecessary side effects," said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. "The collaboration with Thermo Fisher Scientific perfectly complements Bayer’s precision medicine strategy and fits our ambition to further advance the field of genomic testing and personalized treatment in Oncology, providing the right treatment to the right patient at the right time."

"We are committed to providing simple and fast next-generation sequencing-based solutions using tumor and liquid biopsy samples that support future access to targeted therapies, thereby helping to improve patient outcomes," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "The combination of our experience in developing distributable CDx tests with the game-changing turnaround time offered by our Genexus Dx System, allows clinical teams to quickly gather results to better understand the impact of these therapies. Pairing this with Bayer’s growing precision oncology portfolio, we are well-positioned for the potential to help ensure that eligible patients can be quickly matched with the right treatment."

Financial terms of the cooperation were not disclosed.

*The Genexus Dx instrument and the Oncomine Dx Express Test are currently CE-IVD and are only available in countries that accept the CE mark.

On March 20, 2024 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported that management will participate in a fireside chat at the H.C. Wainwright 2nd Annual Cell Therapy Virtual Conference on Tuesday, March 26, at 1:00 p.m. ET (Press release, Arcellx, MAR 20, 2024, View Source [SID1234641304]).

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A live webcast of this discussion will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcast will be archived and available for 30 days following the event.

On March 20, 2024 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported that it has initiated the Phase 2a portion of the BGBC016 clinical study of its selective AXL inhibitor bemcentinib in combination with standard of care therapy in first-line Non Small Cell Lung Cancer (NSCLC) patients harboring a STK11 mutation (STK11m) (Press release, BerGenBio, MAR 20, 2024, View Source [SID1234641303]).

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The initiation of Phase 2a follows a positive recommendation by the independent Drug Safety Monitoring Board (DSMB) which evaluated the safety of the combination of bemcentinib with pembrolizumab (Keytruda) and doublet chemotherapy in first-line (1L) NSCLC patients enrolled in the Phase 1b portion of the study.

Patients with STK11m NSCLC have a significantly poorer response to current therapies, including immune checkpoint inhibitors, when compared with patients with wild-type (non-mutated) STK11. AXL plays a significant role in the survival and spread of cancer and STK11m NSCLC patients have a high expression of AXL suggesting that AXL is an important target to prevent disease progression and resistance to existing therapies. Bemcentinib’s selective inhibition of AXL has been shown to improve the response to immune checkpoint inhibition in STK11m patient-derived preclinical models and in early clinical studies. There are currently no targeted therapies available for the STK11m NSCLC patient population, which represents up to 20% of 1L NSCLC patients.

Cristina Oliva, Chief Medical Officer of BerGenBio commented, "We are very pleased that no new safety signals have been identified and are encouraged by the recommendation of the DSMB to continue the study as planned. We have therefore, opened the Ph2a portion of the study with the goal of reporting initial efficacy data as the next step in validating the benefit of bemcentinib in combination with standard therapies in 1L NSCLC."

Martin Olin, Chief Executive Officer of BerGenBio added, "The high unmet medical need in 1L STK11m NSCLC patients is widely recognized. Bemcentinib represents a novel treatment modality which may significantly improve the outcome for patients, and we are pleased to have achieved this important milestone."