On March 20, 2024 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), reported that it has been notified by the U.S. Food and Drug Administration (FDA) that its Investigational New Drug Application (IND) submission has been reviewed, and Puma can proceed with the clinical development of alisertib for the treatment of patients with human epidermal growth factor receptor 2-negative (HER2-negative), hormone receptor-positive metastatic breast cancer in Puma’s Phase II ALISCA-Breast1 trial (Study PUMA-ALI-4201) (Press release, Puma Biotechnology, MAR 20, 2024, View Source [SID1234641308]). This trial will investigate alisertib in combination with endocrine treatment (consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen) in chemotherapy-naïve patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer. Patients must have been previously treated with CDK 4/6 inhibitors and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial. Puma plans to initiate this trial in the second half of 2024.

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Patients will be dosed with alisertib given at either 30 mg, 40 mg or 50 mg twice daily on days 1-3, 8-10 and 15-17 on a 28-day cycle in combination with the endocrine therapy of the investigator’s choice. Patients must not have been previously treated with the endocrine treatment that will be given in combination with alisertib in the trial. Each dose level will enroll up to 50 patients. Patients must provide blood samples and tissue-based biopsies so that biomarkers can be evaluated. The primary efficacy end points will include objective response rate, duration of response, disease control rate and progression-free survival. As a secondary endpoint, the Company will be evaluating each of these efficacy endpoints within biomarker subgroups in order to determine whether any biomarker subgroup correlates with response. The goal would be to enhance the efficacy in a biomarker subgroup to improve the efficacy of alisertib as previously seen in preclinical and clinical studies in other cancers, including breast cancer and small cell lung cancer.

Once the optimal alisertib dose is identified, the Company plans to engage with global regulatory agencies regarding the design of a pivotal (Phase III) trial, which it anticipates will be a randomized trial of alisertib plus investigators choice endocrine therapy versus placebo plus investigator’s choice endocrine therapy in patients with chemotherapy naïve HER2-negative, hormone receptor-positive metastatic breast cancer.

"Although there have been new drugs approved for the treatment of ER-positive HER2-negative metastatic breast cancer, there continues to be a need for new drugs and ones that specifically can address patients who have been previously treated with CDK 4/6 inhibitors," said Alvin Wong, Pharm.D., Chief Scientific Officer of Puma Biotechnology. "The TBCRC 041 trial, which was published in JAMA Oncology in March 2023, demonstrated that alisertib is among the first investigational targeted therapies to have demonstrated encouraging clinical activity and have been generally well tolerated in the setting of endocrine and CDK 4/6 inhibitor resistant metastatic breast cancer. We look forward to the initiation of the ALISCA-Breast1 trial in the second half of 2024."

Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, "We are excited to move forward with the development of alisertib in HER2-negative hormone receptor-positive metastatic breast cancer. We believe that the data from TBCRC 041, which tested alisertib alone and with fulvestrant, and the randomized trial of alisertib plus paclitaxel versus paclitaxel alone have demonstrated that alisertib was active in patients with HER2-negative, hormone receptor-positive metastatic breast cancer and in biomarker focused subgroups. We also recognize our fiscal responsibility to the shareholders of the Company and will be carefully managing the development expenses for alisertib so as not to potentially negatively impact the Company’s profitability."

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.