On February 5, 2024 Astellas reported the financial results for the first nine months (April 1, 2023 – December 31, 2023) of the fiscal year 2023 ending March 31, 2024 (FY2023) (Press release, Astellas, FEB 5, 2024, View Source [SID1234639834]).

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!

On February 5, 2024 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on February 2, 2024, for FoundationOne CDx Cancer Genomic Profile to be used as a companion diagnostic for Pfizer Japan Inc’s polyadenosine 5’ diphosphate ribose polymerase (PARP) inhibitor, TALZENNA capsules (generic name: talazoparib tosilate), which is approved for BRCA gene mutation-positive castration-resistant prostate cancer with distant metastases (Press release, Chugai, FEB 5, 2024, View Source;category= [SID1234639832]).

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!

"We are pleased that FoundationOne CDx Cancer Genomic Profile was approved as a companion diagnostic for talazoparib for BRCA gene mutation-positive castration-resistant prostate cancer with distant metastases," said Chugai’s President and CEO, Dr. Osamu Okuda. "Castration-resistant prostate cancer is considered an advanced cancer that is difficult to treat, and there is a high unmet medical need. By expanding companion diagnostics, we aim to increase the value of this test for smooth consideration of treatment plans, improve access for prostate cancer patients, and contribute to the advancement of cancer treatment."

This approval enables the detection of BRCA1/2 gene mutations using the FoundationOne CDx Cancer Genome Profile to assist of the decision to use talazoparib for BRCA gene mutation-positive castration-resistant prostate cancer with distant metastases. The efficacy and safety of combination therapy of talazoparib and enzalutamide* for BRCA gene mutation-positive castration-resistant prostate cancer with distant metastases was evaluated in the global phase III study TALAPRO-2. Pfizer Japan Inc. obtained approval from the MHLW on January 18th, 2024.

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized healthcare in oncology and contributing to patients through the expansion of Comprehensive Genome Profile.

* Enzalutamide is the generic name of Xtandi tablets, a prostate cancer treatment drug for which Astellas Pharma Inc. has manufacturing and marketing approval.

Approval information The underlined and bolded part has been newly added.

Intended uses or indications

The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate, dacomitinib hydrate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib, brigatinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib, encorafenib, binimetinib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
Microsatellite instability high nivolumab (genetical recombination)
Microsatellite instability high Solid tumors pembrolizumab (genetical recombination)
Tumor mutational burden high pembrolizumab (genetical recombination)
NTRK1/2/3 fusion gene entrectinib, larotrectinib sulfate
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib, talazoparib tosilate
FGFR2 fusion genes Biliary tract cancer pemigatinib
About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

Trademarks used or mentioned in this release are protected by laws.

On February 4, 2024 Acepodia (6976:TT), a clinical stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 (γδ2) T cell platforms to address gaps in cancer care, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for ACE2016, an allogeneic gamma delta 2 (γδ2) T cell therapy for the treatment of epidermal growth factor receptor (EGFR)-expressing malignancies in patients with solid tumors (Press release, Acepodia, FEB 4, 2024, View Source [SID1234639831]).

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!

This clearance enables Acepodia to initiate a Phase 1, first-in-human trial evaluating the safety, tolerability and pharmacodynamics of ACE2016 in adults with locally advanced or metastatic EGFR-expressing solid tumors. Acepodia expects to begin the trial in the coming months and treat the first patient in the second half of 2024.

"This milestone is a key step as we advance our pipeline of next generation cell therapies and explore the potential of our novel Antibody-Cell Conjugation (ACC) technology in solid tumors, which remain to be unmet medical needs in the cell therapy field," said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. "The rapid progression of obtaining the third IND approval within 18 months highlights the team’s remarkable efficiency and dedication to advancing innovative programs swiftly. With our third program in the clinic, we are proud to continue progressing the field of cell therapy with the goal of delivering powerful, accessible treatments for patients through a first-of-its-kind approach."

About ACE2016

ACE2016 is an off-the-shelf γδ2 T cell therapy candidate developed from Acepodia’s proprietary ACC platform. ACE2016 targets EGFR-expressing solid tumors through antibody conjugated γδ2 T cells that target tumors driven by the cancer-causing EGFR gene. Leveraging the advantages of ACC technology and Acepodia’s proprietary γδ2 T cell platform, ACE2016 has shown promising cytotoxicity against several EGFR-expressing cancers in various pre-clinical study models. The Phase 1 trial will evaluate the safety, tolerability and pharmacodynamics of ACE2016 in patients with locally advanced or metastatic EGFR-expressing solid tumors. The trial is expected to dose its first patient in the second half of 2024.

On February 2, 2024 Hanmi reported its fourth quarter and full year 2023 financial results (Presentation, Hanmi, FEB 2, 2024, View Source [SID1234644665]).

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!

On February 2, 2024 TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that the final median overall survival (mOS)1 for newly diagnosed glioblastoma patients receiving NOX-A12, TME Pharma’s CXCL12 inhibitor, with the VEGF inhibitor bevacizumab and radiotherapy in the GLORIA expansion arm has reached 19.9 months (Press release, TME Pharma, FEB 2, 2024, View Source [SID1234639827]).

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 mOS achieved by NOX-A12 in combination with radiotherapy and bevacizumab compares very favorably to the matched standard of care reference cohort, which achieved an mOS of 10.5 months, and exceeds what TME Pharma believes to be all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy.2 The NOX-A12-based therapy achieved this result despite having a more difficult population to treat since only patients with residual detectable tumor after surgery were included in the GLORIA trial, while competing trials also included patients with complete removal of the detectable tumor who have a better expected survival outcome.

Based on these data, TME Pharma has submitted an Investigational New Drug (IND)3 application and a Fast-Track Designation4 request to the US Food and Drug Administration (FDA) for the use of NOX-A12 in the treatment of aggressive adult brain cancer, glioblastoma. TME Pharma targets approval of the IND and a decision on the Fast-Track Designation by the FDA before the end of March 2024. The goal is to have an FDA-approved clinical trial protocol in glioblastoma with an expedited regulatory path in place in order to maximize chances of securing the necessary funding for the upcoming clinical trial via partnership, investment or other strategic transaction types.

"With the survival data from the GLORIA cohort receiving NOX-A12, bevacizumab and radiotherapy reaching an unprecedented median overall survival of 19.9 months for the population of patients recruited, we see here compelling evidence of the potential of this combination to provide significant survival benefit to patients suffering from aggressive brain cancer over both standard of care and other competing therapies being developed clinically," said Aram Mangasarian, CEO of TME Pharma. "The survival data formed a key part of our regulatory interactions, and following our recent constructive advice meeting with the FDA we are confident of being able to achieve our target of an approved IND and a decision on a Fast-Track Designation for NOX-A12 by the end of Q1 2024. We believe the strong clinical data produced by the GLORIA trial along with a clear regulatory roadmap will allow us to attract the right partner and financing for NOX-A12 to achieve its potential to become the best available therapy for glioblastoma patients."