On November 2, 2022 Aptamer Science that ‘CD25-ApDC immune anticancer agent’, an aptamer-based immune cell targeting anticancer drug delivery technology, was selected for the new drug base expansion research project of the National New Drug Development Project (Press release, Aptamer Sciences, NOV 2, 2022, View Source;idx=231 [SID1234641616]).

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 National New Drug Development Project is a pan-ministerial national R&D project that supports all stages of new drug development to strengthen the global competitiveness of the domestic pharmaceutical and bio industry and secure pharmaceutical sovereignty.

Aptamer Science plans to secure a foundation for expanding aptamer-based drug delivery technology (ApDC) to the area of ​​immunotherapy and anti-cancer drugs by receiving research funding through this project selection and to pursue research in earnest.

‘CD25-ApDC immune anti-cancer drug’ is a treatment that combines a drug with an aptamer that inhibits signal transduction through specific binding to CD25, a biomarker of regulatory T cells that function to suppress immunity in tumor tissue.

The concept is to eliminate tumors by increasing immune activity around the tumor by selectively suppressing the function of Treg cells and relatively inducing the activation of cytotoxic T cells and antigen-labeling cells.

Daegyeon Lee, Director of the New Drug Research Institute, said, "Cancer treatment through controlling the immune environment of tumor tissue is becoming a major strategy that is leading the paradigm shift in overall anticancer drug development.

"As the aptamer-based immunotherapy technology was selected for the national new drug development project, it served as an opportunity to confirm the potential and development competitiveness of the aptamer-drug complex technology that Aptamer Science is focusing on."

"Through this, we have laid the foundation to confirm non-clinical development materials early and promote non-clinical development in earnest," he said.

Aptamer Science attracted 16.5 billion won in investment on October 4 for the purpose of promoting full-scale clinical trials of ‘AST-201 targeted anti-cancer drug’ and developing follow-up pipelines such as new immuno-anticancer drugs and brain disease treatments.

We also plan to promote early technology transfer at the non-clinical stage.

Go to article: Aptamer Science, ‘ApDC immune anti-cancer drug’ selected for national new drug development project

United Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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 November 2, 2022 Pacylex, a clinical-stage NMT inhibitor company developing first-in-class therapies for leukemia, lymphoma, and solid tumor cancers, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PCLX-001 for the treatment of acute myeloid leukemia (AML) (Press release, Greenfire, NOV 2, 2022, View Source [SID1234624501]). The open IND enables a Phase 1/2 clinical study to start in the coming months at The University of Texas MD Anderson Cancer Center, which was recently awarded a US Department of Defense (DOD) grant for this purpose.

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!

Last month the U.S. FDA also granted PCLX-001 Orphan Drug Designation for "treatment of patients with acute myeloid leukemia." PCLX-001 is a first-in-class N-myristoylation inhibitor in clinical development by Pacylex. PCLX-001 is currently being studied in non-Hodgkin lymphoma (NHL) and solid tumor cancer patients at 4 sites in Canada. Pacylex has the first and only NMT inhibitor in clinical studies.

"With this IND clearance, Pacylex opens up a second clinical indication for the investigation of PCLX-001 in patients," said Michael Weickert, PhD, CEO of Pacylex. In the ongoing studies of PCLX-001, seventeen patients have been accrued through 5 dose levels of oral, once-per-day PCLX-001 with no dose limiting toxicities observed.

"Non clinical data suggests that AML may be the cancer type most sensitive to NMT inhibitors, so we are excited to move PCLX-001 into clinical studies in AML patients in the near future," said John Mackey, MD, CMO of Pacylex. Luc Berthiaume, PhD, CSO of Pacylex commented, "It is gratifying to see the pre-clinical work pioneered in my lab, translating to clinical investigations and the potential to help patients in the near future." Data on the scientific rationale for PCLX-001 in AML patients, will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition from 10-13 December 2022.

The ongoing clinical PCLX-001 trial in NHL and solid tumor patients is registered at ClinicalTrials.gov Identifier: NCT04836195.

PCLX-001
PCLX-001 (aka DDD86481) is a first-in-class, small molecule NMT inhibitor originally developed by the University of Dundee Drug Discovery Unit as part of a program to treat African sleeping sickness, funded by Welcome Trust. Pacylex is developing PCLX-001 in the form of a once-a-day pill initially to treat leukemia and lymphoma. PCLX-001 has also been shown to inhibit the growth of lung and breast cancer tumors in animal models. In leukemia, lymphoma and breast cancer patients, the levels of NMT2 are correlated with survival, suggesting an important biological role in these cancers.

On November 2, 2022 Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported that Thomas Willemsen, President and CEO and Dr. Ivan D. Horak, Chief Medical Officer and Chief Scientific Officer, will present at the Stifel Healthcare Conference 2022 (Press release, Tessa Therapeutics, NOV 2, 2022, View Source [SID1234623202]). The conference is taking place November 15-16, 2022, at Lotte New York Palace Hotel, New York City.

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!

During the conference, Mr. Willemsen, Dr. Horak and Wilson W. Cheung, Chief Financial Officer, will conduct one-on-one meetings with registered investors, showcasing Tessa’s business and clinical development strategy, recent corporate achievements, and anticipated milestones.

On November 2, 2022 Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, reported that the request to the U.S. Food and Drug Administration (FDA) for a pre-submission meeting for Herceptin Biosimilar, HD201(Tuznue) has been accepted and the meeting has been scheduled for 14th of December this year (Press release, Prestige BioPharma, NOV 2, 2022, View Source [SID1234623198]).

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 Biosimilar Biological Product Development (BPD) Type 4 Meeting is to discuss the format and content of a Biologics License Application (BLA) in advance of the final submission. The company will discuss the overall development program of HD201 with the FDA to identify potential filing and review issues.

The company has been preparing for FDA BLA for HD201 since 2019 when the company had the Biosimilar Initial Advisory Meeting with the FDA. The FDA bridging study was completed in 2020 and the study result was published in the international journal of Pharmacology Research & Perspectives in July 2021. The study showed HD201’s equivalent pharmacokinetic and safety profile to both US-Herceptin and EU- Herceptin.

Prestige Biopharma’s HD201 is a proposed biosimilar to Roche’s Herceptin (trastuzumab) to be prescribed for the treatment of human epidermal growth factor 2 (HER2) positive breast and metastatic gastric cancer. Trastuzumab targets HER2, which is overexpressed in some types of cancer cells and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.

Currently, a New Drug Submission (NDS) for HD201 is under review by Health Canada and a Marketing Authorisation Application (MAA) by the Korea Ministry of Food and Drug Safety. In addition to filing a new MAA to the European Medicines Agency (EMA), the company also plans to apply for authorisation in other advanced biosimilars markets such as UK, Australia, and Switzerland.