On March 19, 2024 Cantex Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, reported that the Company’s CEO, Stephen Marcus, M.D., will be an expert speaker at 5th Annual Glioblastoma Drug Development Summit, which will be held March 26-28 at the Hilton Boston Logan Airport (Press release, Cantex, MAR 19, 2024, View Source [SID1234641279]).

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In a podium presentation titled, "Delving into a Clinical Update on Azeliragon for GBM – Implementable Lessons for Small Molecule Success," Dr. Marcus will update the Company’s progress with its two ongoing azeliragon Phase 2 clinical trials. In those clinical trials, azeliragon is being studied in combination with radiation therapy with or without temozolomide in patients with newly diagnosed glioblastoma (GBM). In addition, Dr. Marcus will also highlight azeliragon’s potential effect on cerebral edema and its potential ability to reduce dexamethasone dosing in GBM treatment.

GBM is a highly malignant primary brain tumor for which current therapeutic options provide a limited life extension benefit. In 2023, Cantex received Food and Drug Administration Orphan Drug Designation for azeliragon for the treatment of glioblastoma. FDA Orphan Drug Designation provides Cantex with seven years of azeliragon marketing exclusivity from the time of product launch for the orphan indication, and several other important benefits, including assistance in the drug development process, tax credits for clinical costs, and exemptions from certain FDA fees.

"We look forward to meeting with esteemed colleagues and researchers to discuss the many important advances being made to combat this challenging and devastating form of cancer and azeliragon’s progress in our two Phase 2 GBM clinical trials," said Dr. Marcus. "We are excited to discuss this novel clinical candidate and its unique mechanism of action, which we believe has the potential to impact several devastating cancers that continue to challenge researchers, oncologists, and patients."

Details of the event are as follows:

Event:

5th Annual Glioblastoma Drug Development Summit

Presentation Title:

Delving into a Clinical Update on Azeliragon for GBM- Implementable Lessons for Small Molecule Success

Date & Time:

11:30 a.m. ET, March 27, 2024

Location:

Hilton Boston Logan Airport, Boston, MA

Registration:

https://glioblastoma-drugdevelopment.com/register/

During the conference, Dr. Marcus will conduct one-on-one meetings to review the Company’s business and clinical development strategy, recent corporate achievements, and upcoming milestones.

About Azeliragon

Azeliragon is an orally administered capsule, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the tumor microenvironment. Azeliragon was discovered by and originally under development for Alzheimer’s disease by vTv Therapeutics Inc. (NASDAQ: VTVT) from which Cantex licensed worldwide rights to azeliragon. Clinical safety data from these trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated.

Cantex has ongoing Phase 2 clinical trials in glioblastoma, brain metastasis, pancreatic cancer, breast cancer, and a Phase 3 trial in hospitalized patients with pneumonia to prevent acute kidney injury. These trials are based on azeliragon’s robust preclinical data as well as its extensive clinical safety information from randomized placebo-controlled clinical trials.

On March 19, 2024 Adela, Inc., an innovator in blood testing for minimal residual disease monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, reported data will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 5-10, 2024 from its tissue-agnostic minimal residual disease (MRD) assay (Press release, Adela, MAR 19, 2024, View Source [SID1234641278]). These data demonstrate the feasibility of the assay for cfDNA cancer signal quantification and prognostic prediction in HPV-positive and HPV-negative head & neck cancers following treatment. Data will also be presented on the analytical performance of Adela’s platform.

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In addition, Daniel De Carvalho, Ph.D., Adela’s Chief Scientific Officer, has been selected to serve as Chair of the Plenary Session "Discovery Science in Early Cancer Biology and Interception". Dr. De Carvalho will also present in the session "New Liquid Biopsy Technologies for Detection and Characterization of Cancer".

Adela plans to commercialize its first product, a tissue agnostic test for minimal residual disease (MRD) monitoring, in 2025. The product will be based on Adela’s genome-wide methylome enrichment platform, which utilizes the company’s patented technology, cfMeDIP-seq, originally developed by Dr. De Carvalho at University Health Network’s Princess Margaret Cancer Centre, in collaboration with investigators at Sinai Health System. Adela’s technology efficiently captures extensive, biologically-relevant genomic information to maximize test performance and improve treatment decisions. It can be applied across the entire cancer care continuum and is initially being developed for MRD and multi-cancer early detection.

Presentation Details

Abstract # 2427: The development of a tissue-agnostic genome-wide methylome enrichment MRD assay for applications across the cancer care continuum for head and neck malignancies
Geoffrey Liu1
Mon Apr 8, 2024 9 am-12:30 pm PT
Section 40 Poster Board Number 23

Abstract # 5024: Analytical performance of a genome-wide methylome enrichment platform to detect minimal residual disease from plasma-derived cell-free DNA
Hestia Mellert2
Tues Apr 9, 2024 9am – 12:30pm PT
Section 40 Poster Board Number 11

Discovery Science in Early Cancer Biology and Interception
Dr. Daniel De Carvalho (Chair)
Sat April 6, 2024 4:15 PM PT
Hall GH

New Liquid Biopsy Technologies for Detection and Characterization of Cancer Dr. Daniel De Carvalho
Tues April 9, 2024 12:30 – 2:00 PM PT
Ballroom 20 CD

On March 19, 2024 Mabwell (688062.SH), an innovative-driven biopharmaceutical company with entire industry chain, reported the clinical study data of the 9MW2821 for patients with cervical cancer as focused plenary oral presentation at the Society of Gynecologic Oncology (SGO) annual meeting on March 16, 2024 (Press release, Mabwell Biotech, MAR 19, 2024, View Source;the-first-published-clinical-data-of-nectin-4-targeting-adc-developed-by-mabwell-in-cervical-cancer-demonstrates-its-outstanding-therapeutic-potential-302092792.html [SID1234641277]).

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The data showed good efficacy and safety of 9MW2821 in patients with cervical cancer, which is expected to bring new breakthroughs for the treatment of recurrent or metastatic cervical cancer, meeting a large number of unmet clinical needs.

9MW2821 is the first drug to report clinical data for the indication of cervical cancer among the drugs with the same target in the world.

Report on Study Data of Nectin-4-Targeting Antibody-drug Conjugate (ADC) for the Treatment of Recurrent or Metastatic Cervical Cancer

This phase I/II, multicenter, open-label, clinical study was led by Professor Zhang Jian of Fudan University Shanghai Cancer Center, and Professor Yang Huijuan of Fudan University Shanghai Cancer Center represented the study team to give an in-depth report at the meeting. The study results were highly recognized by experts on site. Further clinical study data are expected to provide more treatment options for patients with recurrent or metastatic cervical cancer.

Clinical Findings

The systemic treatment drug options and efficacy for recurrent or metastatic cervical cancer are relatively limited. The cervical cancer cohort in the phase I/II study of 9MW2821 enrolled patients with Nectin-4-positive recurrent or metastatic cervical cancer who had progressed on or after doublet platinum-containing chemotherapy with or without bevacizumab and received no more than two previous systemic regimens for recurrent or metastatic disease. Eligible patients received intravenous 9MW2821 1.25mg/kg on days 1, 8 and 15 of each 28-day cycle until confirmed disease progression, death, intolerable adverse effects or withdrawal from the study.

As of September 25, 2023, in the cervical cancer expansion cohort of the study, the detection rate of Nectin-4 expression was 89.67%, and the rate of Nectin-4 IHC 3+ was 67.82%. A total of 40 patients were enrolled in the study, 57.5% of the patients had previously received platinum-based doublet chemotherapy combined with bevacizumab, and 60% of the patients had previously received platinum-based doublet chemotherapy and immune checkpoint inhibitor therapy.

In terms of efficacy, the overall response rate (ORR) and disease control rate (DCR) of 37 patients evaluable for efficacy were 40.54% and 89.19%, respectively, with one complete response (2.70%) and 14 partial responses (37.84%). Median progression-free survival (PFS), overall survival (OS), and duration of response (DOR) were not reached yet. Among patients with Nectin-4 IHC 3+, the ORR and DCR of 26 patients evaluable for efficacy were 50.00% and 92.31%, respectively. Among patients on or after doublet platinum-containing chemotherapy, the ORR and DCR of 21 patients evaluable for efficacy were 38.10% and 85.71%, respectively.

In terms of safety, treatment-related adverse events (TRAEs) occurred in 92.50% of participants. Grade3-4 TRAEs occurred in 70.00% of participants, with neutropenia (40.00%), rash (17.50%) and gamma-glutamyl transferase increased (12.50%) being the most frequently reported. Nodeaths related to treatment were reported.

The above study results indicate that 9MW2821 has controllable safety and positive efficacy in patients with cervical cancer.

About 9MW2821

9MW2821 is the first site-specific conjugated novel ADC targeting Nectin-4 developed by Mabwell using ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first product to enter clinical study among the products with the same target developed by Chinese companies. Multiple clinical studies of 9MW2821 have been conducted in China to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of 9MW2821 in patients with various advanced solid tumors.

The phase III clinical study of 9MW2821 monotherapy has officially been initiated in patients with locally advanced or metastatic urothelial carcinoma who have previously received platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The phase I/II clinical study of 9MW2821 in combination with PD-1 inhibitors is also ongoing, with the first patient already enrolled. The phase II clinical study for the indication of esophageal carcinoma will continue enrollment and evaluation, and communication for the initiation of phase III clinical study will be expedited. 9MW2821 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in February 2024 for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Currently, 9MW2821 is the first therapeutic drug targeting Nectin-4 in the world to disclose clinical efficacy and safety data for indications of cervical cancer and esophageal carcinoma.

About Cervical Cancer

Cervical cancer is the 4th most common neoplasm and the 4th leading cause of cancer death in females worldwide (excerpted from "Worldwide trends in cervical cancer incidence and mortality, with predictions for the next 15 years, Cancer 2021"). According to the "World Cancer Report 2020" released by the International Agency for Research on Cancer (IARC), there were 600 thousand new cases of cervical cancer worldwide in 2020 and up to 340 thousand deaths caused by cervical cancer. In February 2024, the National Cancer Center published the Cancer Burden Data in China in 2022 on Journal of the National Cancer Center (JNCC), showing that there were 150.7 thousand new cases of cervical cancer and 55.7 thousand deaths in China, ranking 8th and 9th respectively in terms of new cases and number of deaths. Compared with the 119 thousand new cases and 37 thousand deaths released in February 2022 for the same period in 2016, significant increases are observed.

On March 19, 2024 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that results of its preclinical studies on ATG-101 (PD-L1/4-1BB bispecific antibody) were published in Cancer Research in a paper titled ATG-101 is a tetravalent PD-L1×4-1BB bispecific antibody that stimulates anti-tumor immunity through PD-L1 blockade and PD-L1-directed 4-1BB activation[1] (Press release, Antengene, MAR 19, 2024, View Source [SID1234641276]). Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), publishes impactful original studies, reviews, and opinion pieces of high significance to the broad cancer research community. It has a 5-year impact factor of 13.

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"Although immune checkpoint inhibitors (ICIs) have transformed cancer treatment, many patients do not achieve desired treatment outcomes due to innate or acquired resistance," said Dr. Bing Hou, Antengene’s Head of Discovery Science & Translational Medicine, and the corresponding author of the paper. "While 4-1BB has been recognized as a powerful immune stimulating target, the development of therapeutic 4-1BB agonists has been hampered by hepatotoxicity and suboptimal efficacy. In the Cancer Research paper, we present studies used to characterize the differentiated preclinical features and mechanism of action of ATG-101, a tetravalent PD-L1/4-1BB bispecific antibody. ATG-101 activates 4-1BB+ T cells in a PD-L1-crosslinking dependent manner, which minimizes the hepatotoxicity associated with existing 4-1BB agonists and suppresses the growth of ICI-resistant tumors. We wish to continue contributing to the academic community through publications in the future."

"The dedication and relentless efforts of our research team have led to the publication of the preclinical work in the prestigious journal Cancer Research and the development of a new clinical program," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO." The Phase I study of ATG-101 is currently in the sixth dose escalation cohort and the drug is approaching its biologically active dose with good tolerability. Early observations indicate that a partial response has been observed in a patient with microsatellite stable (MSS) metastatic colon adenocarcinoma with liver metastasis. Moreover, there have also been multiple patients with durable stable disease. These early observations are indeed very encouraging. Moving forward, we will continue working closely with the study sites and investigators to bring a new treatment option to patients who have previously relapsed/progressed on ICIs."

Reference

[1] ATG-101 is a tetravalent PD-L1×4-1BB bispecific antibody that stimulates anti-tumor immunity through PD-L1 blockade and PD-L1-directed 4-1BB activation. Cancer Res (2024). DOI:10.1158/0008-5472.CAN-23-2701.

About ATG-101

ATG-101 is a novel PD-L1/4-1BB bispecific antibody that was designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile. ATG-101 is currently being developed in Australia, China, and the U.S. in the Phase I study for the treatment of advanced/metastatic solid tumors and B-cell non-Hodgkin lymphoma (B-NHL).

On March 19, 2024 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, reported that the Company’s President and Chief Executive Officer, Kristin Yarema, Ph.D., will participate in a virtual fireside chat at the H.C. Wainwright 2nd Annual Cell Therapy Virtual Conference on Tuesday, March 26, 2024 at 1:00pm PT | 4:00pm ET (Press release, Poseida Therapeutics, MAR 19, 2024, View Source [SID1234641275]).

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A live webcast of the fireside chat will be available on the Investors & Media Section of Poseida’s website, www.poseida.com. A replay of the webcast will be available for approximately 90 days following the presentation.