On April 6, 2022 Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, reported that John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer, plans to present a company overview at the 21st Annual Needham Virtual Healthcare Conference on Wednesday, April 13, 2022 at 3:45 p.m. ET (Press release, Geron, APR 6, 2022, View Source [SID1234611563]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation will be available through the Investor Relations section of Geron’s website under Events. Following the presentation, the webcast will be archived and available for replay for a period of 30 days.

On April 6, 2022 BiOneCure Therapeutics, Inc. reported that the U.S. Food and Drug Administration (FDA) has cleared the IND for BIO-106, an antibody-drug conjugate (ADC) designed to target TROP-2 to treat a broad range of advanced solid tumors (Press release, BiOneCure Therapeutics, APR 6, 2022, View Source [SID1234611556]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The clinical study cleared by the FDA, known as StarBridge-1, is a Phase I/II, multicenter, open-label study to evaluate the safety, pharmacokinetics and preliminary anti-tumor activity of BIO-106 as monotherapy and in combination with pembrolizumab in patients with advanced cancers

This IND approval is a significant milestone for both our team and the patients we hope to serve.

"This is the first IND approval for BiOneCure. It is a significant milestone for both our team and the patients we hope to serve." said Haifeng Bao, Ph.D., Co-founder and Chief Executive Officer at BiOneCure. "BiOneCure has complete intellectual property rights of the product, covering the payload, antibody and the ADC drug product, The introduction of our innovatively developed ADC candidate BIO-106 validated our approach to the next generation of ADC. We are very excited to bring the new molecule to the clinical stage and look forward to advancing this trial"

About BIO-106
BIO-106 is an anti-Trop-2 ADC to target cancer cells expressing Trop-2, a protein overexpressed in a broad range of tumors including TNBC, HR+/HER2 mBC, NSCLC, and others. BIOneCure has developed BIO-106 using its proprietary TAMTM payload technology to enable homogenous high drug load. In the pre-clinical study, BIO-106 has demonstrated broad anti-tumor activities with excellent safety profile and wide therapeutic window.

On April 6, 2022 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 it has received approval from the National Agency for the Safety of Medicine and Health Products (ANSM) Competent Authority and from the People Protection Ethics Committee (EC) SUD-EST III (CPP Sud-Est III) in France for the Company’s potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer (Press release, CNS Pharmaceuticals, APR 6, 2022, View Source [SID1234611554]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Access to patients is the lifeblood of any clinical study and this approval, in the second most populous country in Europe, provides just that for our Berubicin trial. We have said time and again that our number one priority is the advancement of this potentially pivotal study. This is evidenced by our continuous dedication to driving enrollment and bringing global clinical sites on line. We are grateful to the French Competent Authority and Ethics Committee and their positive feedback on what we believe is an incredibly important clinical program. Across the globe there is an urgent need for GBM treatment options. We will continue to press on in our efforts to advance Berubicin through the clinic and importantly, to patients and their families. I am proud of the progress our team has made to-date and believe there are additional clinical sites to join those that have already been added to this globlal potentially pivotal study," commented John Climaco, CEO of CNS Pharmaceuticals.

Dr. Carole Gourmelon, MD, Institut de Cancérologie de l’Ouest, St Herblain, added, "GBM is a devastating disease with significant unmet need. I have been encouraged by the data Berubicin has demonstrated to date and look forward to further evaluating its potential to provide benefit to patients. Now with the necessary approvals received, I look forward to joining the Company’s efforts to progress Berubicin through the clinic."

Berubicin is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. The potentially pivotal global trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy. Approximately 243 patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive Berubicin or lomustine for the evaluation of Overall Survival, the primary endpoint of the study. Overall Survival is a rigorous endpoint that the U.S. Food and Drug Administration (FDA) has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.

A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

The FDA recently granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

About Berubicin

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

On April 6, 2022 AffyImmune Therapeutics, Inc., a clinical stage biotechnology company using its Tune & Track platform to develop CAR T cells for the treatment of solid cancers, reported that it will present an abstract in a poster session at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans, Louisiana, which is being held April 8 – 13 (Press release, AffyImmune Therapeutics, APR 6, 2022, View Source [SID1234611550]). Presented findings will highlight research using AffyImmune’s Tune & Track platform for the affinity tuning of the interaction between CAR T cells and cancer antigen, tracking of CAR T cells in real-time, and armoring of CAR T cells with cytokines.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the abstract and poster are as follows:

Title: Focused IL-12 cytokine delivery enhances function of affinity-tuned and real-time tracked ICAM-1-specific CAR T cells in solid tumors
Presenting Author: Michael Gallagher, PhD, Scientist
Session Category: Adoptive Cell Therapy 1
Poster Number: 558/12
Abstract Number: 4978
Presentation Type: Poster
Date, Time, and Location: Sunday, April 10, 1:30 – 5:00 pm, Poster Section 36

On April 6, 2022 Lunit reported the presentation of two abstracts featuring its AI research on cancer treatment at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 (Press release, Lunit, APR 6, 2022, View Source [SID1234611545]). The meeting will be held from April 8 to 13 at the Ernest N. Morial Convention Center in New Orleans, Louisiana. This year marks Lunit’s fourth time presenting its findings at AACR (Free AACR Whitepaper).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As a leading provider of state-of-the-art cancer diagnostic technology, Lunit has focused on developing novel AI biomarkers for application in immunotherapy. Since 2019, the company has released groundbreaking findings based on its AI-powered tissue analysis platform, ‘Lunit SCOPE,’ demonstrating the software’s predictive value in identifying patients eligible for immunotherapy. The upcoming AACR (Free AACR Whitepaper) presentations will showcase Lunit’s AI biomarker platform, Lunit SCOPE IO—part of the Lunit SCOPE product line.

Lunit SCOPE IO analyzes a patient’s cancer tissue slide image by observing the distribution of tumor-infiltrating lymphocytes (TIL)—one of the representative immunocytes that fight cancer cells. Based on the spatial distribution pattern of TILs and cancer cells in the tumor microenvironment, Lunit SCOPE IO identifies the tissue sample as one of three immune phenotypes: inflamed, immune-excluded, and immune-desert.

In one of its abstracts, Lunit presents the correlation between its AI-based immune phenotype method and aberrant transforming growth factor-beta (TGF-B) pathways in pan-carcinoma.

For TILs to fight cancer cells, they must be located in proximity to each other. The aberrant TGF-B pathway in the tumor environment has been highlighted as one of the core resistance pathways that inhibit immunotherapy by excluding TILs from the tumor area. This type of distribution is classified as the immune-excluded phenotype, in which TILs are separated from the cancer cells.

Upon conducting a large-scale, pan-carcinoma analysis, Lunit’s research team found that an aberrant TGF-B pathway is indeed associated with the immune-excluded phenotype, as well as increased proportions of cancer stroma.

"This was a multi-omics study incorporating genome-based analysis that shows a direct correlation between immune phenotypes with the TGF-B pathway," said Chan-Young Ock, Chief Medical Officer at Lunit. "By developing our AI to analyze TIL and their spatial relationship with cancer stroma, Lunit was able to initiate the first study that directly compares immune phenotypes and TGF-B expression on a large-scale database."

The company will also deliver an oral presentation on the distinct clinical outcomes and molecular profiles among immune phenotypes in endometrial cancer.

Lunit’s studies thus far first focused on the validity of immune phenotyping as a biomarker for advanced non-small cell lung cancer (NSCLC). However, this study demonstrates that similar AI-based spatial analysis can bring clinically significant results as a biomarker in endometrial cancer.

The study aimed to analyze the differences between the three immune phenotypes in endometrial cancer using clinical data, pathological slides, and genetic expression registered in the National Cancer Institute’s "The Cancer Genome Atlas" (TCGA). Results indicated that the inflamed phenotype (TILs located close to cancer cells) showed the best overall survival outcome. Furthermore, this particular phenotype was associated with the highest expressions of PD-L1 and CTLA4—immune checkpoint proteins that act as important biomarkers in predicting immunotherapy response.

"Given the significant differences in survival outcome depending on each phenotype, AI-based tumor microenvironment classification using Lunit SCOPE IO may serve as a clinically significant, prognostic biomarker in endometrial cancer," said Brandon Suh, CEO of Lunit. "We plan to expand the range of our research to validate the efficacy of Lunit SCOPE IO in all cancer types originating from the epithelium."

The Lunit team will be exhibiting at AACR (Free AACR Whitepaper), at booth 1364.