AnHeart Therapeutics Announces Oral Presentation at the European Lung Cancer Congress (ELCC) 2023

On March 13, 2023 AnHeart Therapeutics ("AnHeart"), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, reported acceptance of an oral presentation at the European Lung Cancer Congress (ELCC) 2023, held in Copenhagen, Denmark and virtually, March 29 – April 1 (Press release, AnHeart Therapeutics, MAR 13, 2023, View Source [SID1234628608]).

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This oral presentation at ELCC 2023 will provide updated efficacy and safety data of taletrectinib regional Phase 2 study (TRUST-I, NCT04395677) with about 1.5-year follow-up in patients. Taletrectinib is a potent, next-generation, CNS-active, ROS1 tyrosine kinase inhibitor (TKI). In previous reports from the TRUST-I study, taletrectinib showed meaningful clinical efficacy and favorable safety profiles in patients with ROS1+ NSCLC (n=109) regardless of crizotinib pretreatment status.

Separately, a global taletrectinib Phase 2 clinical trial (TRUST-II, NCT04919811) is ongoing and actively enrolling patients in North America, Europe and Asia.

The details of the oral presentation are as follows:

Title: Updated Efficacy and Safety of Taletrectinib in Patients with ROS1+ Non-Small Cell Lung Cancer (NSCLC)

Presentation Session Number: 14MO

Presenter: Dr. Wei Li, Shanghai Pulmonary Hospital and Thoracic Cancer Institute, Tongji University School of Medicine, Shanghai, China

Date: Friday March 31, 2023

Location: Auditorium 1, Bella Center Copenhagen, Copenhagen, Denmark

The ELCC 2023 Program can be accessed online at: View Source

Kezar Life Sciences to Change Virtual R&D Day Date to March 15, 2023

On March 13, 2023 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported that the Company will pull forward its virtual Research and Development (R&D) Day to Wednesday, March 15, 2023 at 4:30 pm ET/1:30 pm PT (Press release, Kezar Life Sciences, MAR 13, 2023, View Source [SID1234628607]).

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"The goal of Kezar’s R&D Day is to set expectations for 2023, provide updates on our two clinical assets, and highlight the productivity from our Discovery team. We are progressing more quickly than planned with initiating PALIZADE, our next study of zetomipzomib for the treatment of lupus nephritis, and look forward to sharing the details," said John Fowler, Kezar’s Co-founder and Chief Executive Officer.

In addition, Craig S. Lammert, M.D., Assistant Professor of Medicine at Indiana University School of Medicine and Executive Director of the Autoimmune Hepatitis Association, will present on autoimmune hepatitis (AIH), the unmet need, and the treatment landscape. PORTOLA, a signal seeking study of zetomipzomib in AIH, initiated in the first quarter 2023.

The presentation will be followed by a Q&A session.

Presenters:

John Fowler, Chief Executive Officer, Co-Founder
Noreen Roth Henig, M.D., Chief Medical Officer
Craig S. Lammert, M.D., Assistant Professor of Medicine at Indiana University School of Medicine, and Executive Director of the Autoimmune Hepatitis Association
Neel Anand, D. Phil. (Ph.D.), Senior Vice President, Research and Drug Discovery
To register for this event, please visit the Events & Presentations page of Kezar’s website. On the day of the event, a live webcast and conference call will be accessible from the Events & Presentations page of Kezar’s website. Additionally, a replay of the event will be available for 90 days following the presentation.

About Zetomipzomib

Zetomipzomib (KZR-616) is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1 and Phase 2 clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases.

About Lupus Nephritis

Lupus nephritis (LN) is one of the most serious complications of systemic lupus erythematosus (SLE). LN is a disease comprising a spectrum of vascular, glomerular and tubulointerstitial lesions and develops in approximately 50% of SLE patients within 10 years of their initial diagnosis. LN is associated with considerable morbidity, including an increased risk of end-stage renal disease requiring dialysis or renal transplantation and an increased risk of death. There are limited approved therapies for the treatment of LN. Management typically consists of induction therapy to achieve remission and long-term maintenance therapy to prevent relapse.

About Autoimmune Hepatitis

Autoimmune hepatitis (AIH) is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients’ physical health and quality of life. Lifelong maintenance therapy is required to avoid relapse and burdensome adverse effects. If left untreated, AIH can lead to cirrhosis, liver failure and hepatocellular carcinoma. In the United States, AIH affects approximately 140,000 individuals, with incidence rates increasing. The cause of this condition remains unclear, with females affected four times as often as males. Currently, standard of care treatment for AIH is chronic, immunosuppressive treatment with corticosteroids that frequently cause life-altering side effects, including diabetes, osteoporotic fractures and cataracts. There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression from using corticosteroids.

About KZR-261 and the Inhibition of Protein Secretion

KZR-261 is a first-in-class small molecule compound, derived from Kezar’s research and discovery platform of protein secretion pathway inhibitors. This broad-spectrum anti-tumor agent directly targets the Sec61 translocon and inhibits multiple cancer drivers both within tumor cells and the tumor microenvironment. A Phase 1 clinical trial is underway for the treatment of solid tumor malignancies.

Kezar’s drug discovery platform of protein secretion pathway inhibitors is a novel approach with broad application. The protein secretion pathway is a highly conserved and ubiquitously functioning pathway in all cells in the body and involves a conserved protein complex called the Sec61 translocon, the target of Kezar’s compounds. In preclinical models, Kezar’s library of protein secretion inhibitors have demonstrated broad activity with far-reaching potential in oncology, immune-oncology, and autoimmunity.

Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT8007, an Antibody-Drug Conjugate Targeting Nectin-4 for the Treatment of Advanced Solid Tumors

On March 13, 2023 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in a Phase 1 clinical study evaluating BAT8007, an antibody-drug conjugate (ADC) that targets Nectin-4 (Press release, BioThera Solutions, MAR 13, 2023, View Source [SID1234628605]). The multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors aims to evaluate the safety and tolerability of BAT8007. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumors.

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BAT8007 is an antibody-drug conjugate (ADC) targeting Nectin-4 designed for the treatment of solid tumors. Nectin-4 (Nectin cell adhesion molecule 4) belongs to the nectin subfamily of immunoglobulin-like adhesion molecules that participate in Ca(2+)-independent cell-cell adhesion. Nectin-4 has high expression levels in a normal embryo and fetal tissues, while those expression levels decline in adulthood and has limited distribution in healthy tissues.

Nectin-4 is overexpressed in a variety of solid tumors, such as urothelial carcinoma, breast cancer, non-small cell lung cancer, pancreatic cancer, esophageal cancer and head and neck cancer, etc. High expression levels of Nectin-4 in tumors is associated with poor prognosis for patients. Nectin-4 is a validated drug target with one approved drug for the treatment of solid tumors and is a target of high interest for new drug discovery.

BAT8007 was developed by using Bio-Thera’s proprietary ADC linker-payload that includes a cleavable but systemically stable linker, a small molecule topoisomerase I inhibitor and high DAR. The small molecule topoisomerase I inhibitor payload carried by BAT8007 has a strong cell membrane penetration ability. Consequently, when targeted cancer cells are killed, the payload has shown to be released and kill nearby cancer cells, producing a bystander effect, which has the potential to overcome the heterogeneity of the tumor. BAT8007 has demonstrated high anti-tumor activity, good stability, and safety in both in vitro and in vivo pharmacological studies.

Bio-Thera Solutions is developing four other ADCs based on its proprietary linker-payload, including ADCs targeting FRα, B7H3, Her2, Trop2. All of the ADCs in Bio-Thera’s pipeline are currently in early-stage clinical studies.

Telix’s ZIRCON Phase III Kidney Cancer Imaging Study Presented in "Game Changing" Session at EAU

On March 13, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported additional positive results from its completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118).1 (Press release, Telix Pharmaceuticals, MAR 13, 2023, View Source [SID1234628604]).

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The results were featured in a "Game Changing" oral session delivered by Professor Dr. Peter Mulders from Radboud University Medical Centre (Netherlands), a ZIRCON Principal Investigator, at the 38th Annual European Association of Urology (EAU) Congress, on Saturday, 11 March 2023.

Game Changing sessions are reserved for Phase III trials or other developments that the EAU’s Scientific Congress Office believes will have a large impact on daily practice.

New data presented:

TLX250-CDx demonstrated a high degree of consistency between readers with a very high sensitivity (85.5%) and specificity (87.0%) overall, and 85.5% / 89.5% for small masses (<4cm), confirming optimal SUVmax thresholds for image interpretation;
The correlation of CAIX expression on histology with imaging results.
Professor Dr. Peter Mulders commented, "I’m delighted to be at EAU, the leading urological event in Europe, sharing further detailed results from Telix’s Phase III ZIRCON study with the medical community. New data reinforces the clinical potential of this investigational agent, even in small renal masses which are most prevalent and present the highest diagnostic challenge, with remarkable consistency across readers. On behalf of Telix, I’d like to thank all the European sites and patients for their participation in this ground-breaking study."

Telix is in the process of establishing expanded access studies and supporting named patient programs for TLX250-CDx in the United States and Europe.

CNS Pharmaceuticals Announces it Has No Exposure to Silicon Valley Bank Issues

On March 13, 2023 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported that it is aware that the Federal Deposit Insurance Corp. has taken control of Silicon Valley Bank ("SVB") due to liquidity concerns (Press release, CNS Pharmaceuticals, MAR 13, 2023, View Source [SID1234628603]). The Company does not hold any deposits or investments at SVB.

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