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Nascent Biotech Completes Fourth Cohort in Phase 1 Human Trial for Primary and Metastatic Brain Cancer

On September 13, 2022 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company pioneering the development of monoclonal antibodies targeting various cancer types, reported the completion of the Fourth Cohort in dosing patients in the Company’s Phase I trial to evaluate Pritumumab ("PTB") as a treatment for Brain Cancer, including Primary and metastatic Brain Tumors (Press release, Nascent Biotech, SEP 13, 2022, View Source [SID1234619502]).

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After reviewing data gathered from the four completed cohorts, this milestone will allow the trial to advance to a fifth and final cohort. Patient enrollment continues for Phase I and interested parties may review trial requirements at www.clinicaltrials.gov under the search term ‘Pritumumab’.

Following completion of dosing of the Fifth Cohort, the Phase I trial will be complete, and the Company will prepare data for submission to the FDA in preparation for Phase 2 clinical research.

"Having completed four cohorts, we are enthusiastic about moving to our fifth and likely final cohort in the Phase I trial," noted Nascent CEO, Sean Carrick. "The data received so far has been very encouraging. We will continue to perform PK studies on the fourth and fifth cohorts to support an upcoming data submission to the FDA."

PTB is a natural human antibody that binds to Cell surface Vimentin (also referred to as ectodomain vimentin), a protein expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy and seek out only cancer cells without damaging healthy cells.

Marker Therapeutics Awarded $2 Million Grant from U.S. FDA to Support Marker’s Phase 2 ARTEMIS Trial of MT-401 in Post-Transplant AML

On September 13, 2022 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that the Company has been awarded a $2 million grant from the U.S. Food and Drug Administration (FDA) Orphan Products Grants program to support its Phase 2 ARTEMIS trial of its lead multi-tumor-associated antigen (MultiTAA) T cell product candidate, MT-401, in patients with post-transplant acute myeloid leukemia (AML) (Press release, Marker Therapeutics, SEP 13, 2022, View Source [SID1234619501]).

The FDA grant will support the Company’s treatment arm evaluating MT-401 in patients with post-transplant AML with minimal residual disease. MT-401 was granted Orphan Drug Designation for the treatment of patients with AML following allogeneic stem cell transplant in 2020.

"We are pleased to receive this Orphan Products award from the FDA to further clinical development of our multi-antigen targeted T cell therapy in AML, a rare disease with limited treatment options after a stem cell transplant," said Dr. Mythili Koneru, Marker’s Chief Medical Officer. "In our Phase II ARTEMIS study for patients with post-transplant AML, we have observed promising results amongst the MRD+ patients, suggesting that MT-401’s unique and differentiated targeting technology can potentially reach MRD positive patients before relapse. This grant will enable us to further advance our development of MT-401 to potentially treat a patient population where no treatments have been approved. We look forward to further exploration in this patient population."

About Marker’s Phase 2 ARTEMIS Trial

The multicenter Phase 2 AML study is evaluating the clinical efficacy of MT-401 in patients with AML following an allogeneic stem-cell transplant in both the adjuvant and active disease setting. In the adjuvant setting, approximately 120 patients will be randomized 1:1 to either MT-401 at 90 days post-transplant versus standard-of-care observation, while approximately 40 patients with active disease will receive MT-401 as part of the single-arm group.

The primary objectives of the trial are to evaluate relapse-free survival in the adjuvant group and determine the complete remission rate and duration of complete remission in active disease patients. Additional objectives include, for the adjuvant group, overall survival and graft-versus-host disease relapse-free survival while additional objectives for the active disease group include overall response rate, duration of response, progression-free survival and overall survival.

About the U.S. FDA Orphan Products Grants Program

The FDA’s Orphan Products Grants Program awards grants to clinical investigators to support the development of safe and effective medical products for patients with rare diseases. The program has supported clinical research since 1983 and has funded clinical trials that have facilitated the approval of more than 70 products.

Hypertrust Patient Data Care Team joins BSMA Europe Annual Event 2022

On September 13, 2022 Hypertrust Patient Data Care reported that it is joining the Bio Supply Chain Management Alliance (BSMA) annual European conference in Belgium (Press release, Hypertrust Patient Data Care, SEP 13, 2022, http://www.hypertrust-patient.com/hypertrust-patient-data-care-team-joins-bsma-europe-annual-event-2022 [SID1234619500]). It will take place in La Hulpe on 29th September 2022 .

Hypertrust Patient Data Care’s Managing Director Andreas Göbel is happy to be part of the event. BSMA is bringing life sciences supply chain professionals together to improve excellence across the supply chain by fostering innovation and exchanges between peers. Come and meet Andreas Göbel in Brussels on 29th September 2022 in La Hulpe. He is looking forward to exciting discussions in person with visitors about life sciences supply chains.

Half-Year Financial Report 2022

On September 13, 2022 Onxeoreported its half-year financial report 2022 (Presentation, Onxeo, SEP 13, 2022, View Source;hy-financial-report-2022.pdf [SID1234619499]).

GeneCentric to Present Data on the Purity Independent Subtyping of Tumor (PurIST) Test at AACR Pancreatic Conference

On September 13, 2022 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported the poster presentation of further clinical validation data for PurISTSM, a novel RNA-expression test, in collaboration with Tempus (Press release, GeneCentric Therapeutics, SEP 13, 2022, View Source [SID1234619498]). PurIST identifies patients with the classical subtype of pancreatic ductal adenocarcinoma (PDAC) that are likely to experience longer overall survival (OS) with standard of care (SOC) FOLFIRINOX than patients with the basal subtype of PDAC. The presentation will be made at the 8th AACR (Free AACR Whitepaper) Special Conference on Pancreatic Cancer in Boston, Massachusetts, which runs from September 13-16, 2022.

Title: Purity Independent Subtyping of Tumor (PurIST): Real-world data validation of a pancreatic ductal adenocarcinoma (PDAC) gene expression classifier and its prognostic implications

First Author: Stephane Wenric, PhD, Principal Scientist, Computational Systems Biology, Tempus, Chicago, Illinois

Presenting Author: James M. Davison, PhD, Senior Translational Genomics Scientist, GeneCentric Therapeutics, Durham, NC

PurIST is a laboratory developed test (LDT) validated by Tempus using a real-world dataset of advanced PDAC patients. Over 250 patients with advanced PDAC who were previously treated with SOC FOLFIRINOX or gemcitabine/nab-paclitaxel were identified in Tempus’ multimodal data library. RNA sequencing (RNAseq) was performed on either primary or metastatic tumor tissue using the CAP/CLIA-validated Tempus xT assay platform. Patients were identified as either basal or classical molecular subtype. For FOLFIRINOX-treated patients, those with a classical molecular subtype had extended survival compared to those with basal molecular subtype. Survival was similar for FOLFIRINOX and gemcitabine/nab-paclitaxel treatment regimens in basal patients, but classical patients had extended survival when treated with FOLFIRINOX.

Further details surrounding test development and validation will be presented as part of an upcoming publication.

About Pancreatic Cancer

Pancreatic cancer is one of the most common cancers worldwide, and the National Cancer Institute estimates there will be 62,210 new cases and 49,830 deaths in the U.S. in 2022. It is the third-leading cause of cancer-related deaths in the U.S. and has the highest mortality rate of all major cancers. More than 90% of pancreatic cancers are pancreatic ductal adenocarcinoma (PDAC), and the 5-year overall survival for resectable/borderline-resectable and non-resectable PDAC is approximately 20-30% and 1-3%, respectively. The average patient diagnosed with Stage IV PDAC will live for about one year after diagnosis. The three main treatments for PDAC are surgical resection (if diagnosed early), radiation therapy and chemotherapy. For resectable tumors, surgical resection is provided with curative intent, however, for non-resectable tumors, chemotherapy such as FOLFIRINOX or gemcitabine with nab-paclitaxel is often used.