On January 4, 2022 Genprex reported that FDA has granted a fast track designation to a combination comprised of the immunogene therapy quaratusugene ozeplasmia (REQORSA) and pembrolizumab (Keytruda) for use in patients with histologically confirmed, unresectable, stage III or IV non–small cell lung cancer (NSCLC) who experienced disease progression following treatment with pembrolizumab (Press release, Genprex, JAN 4, 2022, View Source [SID1234607477]).1

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 product utilizes Genprex, Inc.’s proprietary ONCOPREX Nanoparticle Delivery System, which is believed to be the first systemic gene delivery platform leveraged for cancer in humans, according to the clinical-stage gene therapy company.2

Quaratusugene ozeplasmia is comprised of the tumor suppressor gene, TUSC2, which is encapsulated in a nanoparticle composed from lipid molecules with a positive electrical charge. The product is intravenously administered, and was designed to target cancer cells, which are known to generally have a negative charge. Once the product is taken into the cancer cell, the gene is expressed into a protein that can restore select defective functions that arise in the cancer cell.

The gene therapy has a multimodal mechanism of action in that it can disrupt cell-signaling pathways that are responsible for the replication and proliferation of cancer cells; it can also re-establish pathways for apoptosis and modulate the immune system so that it responds against cancer cells.

Additionally, the pan-kinase inhibitor simultaneously inhibits the EGFR and AKT pathways both in vitro and in vivo. When a cancer cell takes up the TUSC2-containing nanoparticle, it is reprogrammed to die. It is known that resistance to existing targeted agents and checkpoint inhibitors can develop when alternate bypass pathways are activated. The multimodality activity of the gene therapy allows it to block emerging bypass pathways and reduce the probability of drug resistance.

"We are thrilled to receive a second fast track designation from the FDA for REQORSA in patients with late-stage NSCLC, this time in combination with the checkpoint inhibitor pembrolizumab," Rodney Varner, president and chief executive officer at Genprex, stated in a press release. "This fast track designation is an important step in our efforts to accelerate clinical development of REQORSA and another validation of the potential of REQORSA to treat the unmet medical need of patients with late-stage NSCLC."

In the first quarter of 2022, the company expects to launch the open-label, multicenter, phase 1/2 Acclaim-2 trial (NCT05062980), which will evaluate the safety and efficacy of the gene therapy in combination with pembrolizumab in patients with previously treated NSCLC.3

On January 4, 2022 Genprex reported that The US Food and Drug Administration (FDA) has granted fast track designation (FTD) to it’s lead drug candidate, Reqorsa Immunogene Therapy, plus Keytruda to treat histologically confirmed unresectable stage III or IV non-small cell lung cancer (NSCLC) (Press release, Genprex, JAN 4, 2022, View Source [SID1234607494]).

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 combination treatment is intended for use in NSCLC patients whose disease advanced on receiving Keytruda treatment.

Keytruda is a checkpoint inhibitor of Merck & Co’s (MSD).

Genprex anticipates commencing a multicentre, open-label Phase I/II Acclaim-2 clinical trial of Reqorsa plus Keytruda to treat NSCLC in the first quarter of this year.

This is the second FTD granted by the FDA for Reqorsa.

The first status was granted for Reqorsa plus AstraZeneca’s Tagrisso to treat histologically confirmed unresectable stage III or IV NSCLC patients with EGFR mutations that advanced on receiving Tagrisso.

According to the preclinical data, Reqorsa plus Keytruda demonstrated to be efficient over treatment with Keytruda alone to boost survival in mice with a humanised immune system having metastatic lung tumours.

The drug’s multiple impacts on the immune system such as a rise in natural killer cells and a reduction in PD-L1 expression on cancer cells were observed in these mice studies.

This is believed to add to the synergy of Reqorsa seen with Keytruda.

On January 4, 2022 Alamar Biosciences (Alamar), a platform company focused on transforming the field of proteomics to enable the early detection of cancer and other diseases, and Abcam (AIM:ABC; NASDAQ:ABCM), a global innovator in life sciences research tools, reported a strategic partnership to further understanding of the human proteome (Press release, Abcam, JAN 4, 2022, View Source [SID1234598011]).

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 field of proteomic analysis is in the spotlight. Its advance not only enhances the understanding of fundamental biology, but also sheds light on the status of human health and disease. A deeper understanding of the proteome is set to play a crucial role in enabling the next wave of innovations in research, diagnostics and therapeutics. Powering this effort requires new technology platforms that are able to address the two essential goals in proteomic analysis, namely the ability to go as deeply as possible to detect very low abundance proteins and the ability to profile thousands of proteins in a single sample.

"Alamar is working to enable the early detection of cancer and other diseases by simultaneous measurement of hundreds to thousands of targets, even those present in minute amounts. We are very happy to partner with Abcam to access their extensive portfolio of recombinant monoclonal antibody pairs, which will accelerate our ability to bring our proteomic discovery tools to researchers"
Dr. Yuling Luo
Founder & CEO of Alamar

"We are excited to be partnering with Alamar as they develop an automated proteomics platform that has the potential to offer unprecedented combination of sensitivity, plex-level and dynamic range. The NULISA technology platform will provide an important tool for life science research, pharmaceutical development and diagnostics, enhancing understanding of the circulating proteome and supporting low abundance biomarker discovery. Such capability will be critical for the discovery and measurement of many proteins in human plasma and other samples that are currently undetectable."
Dr Emma Sceats
SVP Sales, Service and Business Development at Abcam

Abcam’s portfolio of over 1,300 fit-for-purpose recombinant antibody pairs is actively curated to ensure that it is representative of the key disease areas of interest. Designed to enhance biomarker discovery and support deeper understanding of the circulating proteome, the portfolio has been pre-validated specifically for multiplex applications.

On January 4, 2022 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported that members of its management team will present at the following investor conferences in January 2022 (Press release, Alpine Immune Sciences, JAN 4, 2022, View Source [SID1234598047]):

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!

H.C. Wainwright BIOCONNECT Virtual Conference
Date: Monday, January 10, 2022
Time: Available on demand beginning 7:00 a.m. ET/4:00 a.m. PT
Event: Company Presentation

J.P. Morgan Healthcare Conference
Date: Thursday, January 13, 2022
Time: 12:00 p.m. ET/9:00 a.m. PT
Event: Company Presentation

Webcasts of the H.C. Wainwright, and J.P. Morgan presentations will be available online in the investor relations section of the company’s website at View Source A replay of the presentations will be available on the company website for 90 days following the webcast.

On January 4, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported it has met two significant milestones as it progresses toward cGMP manufacture of Rhenium-186 NanoLiposome (186RNL) (Press release, Cytori Therapeutics, JAN 4, 2022, View Source [SID1234598064]).

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 Company has entered into a master services agreement (MSA) with IsoTherapeutics Group LLC for the development, manufacture and supply of current Good Manufacturing Practices (cGMP) grade Rhenium-186 isotope for the Company’s 186RNL investigational radiotherapeutic. This agreement will help ensure Rhenium-186 meets U.S. Food and Drug Administration requirements for use in late-stage clinical trials. Under the MSA, IsoTherapeutics will develop a synthesis process and in-process manufacturing controls, test method development and validation, stability studies, as well as manufacture cGMP Rhenium-186. The Company anticipates that the MSA will lead to clinical and commercial supply agreements for the drug product with IsoTherapeutics at the appropriate stage of development. This agreement will strengthen the Company’s long term cGMP supply sustainability strategy, as it will own the intellectual property rights for the manufacturing and testing of the Rhenium-186 target.

Additionally and importantly, Plus Therapeutics completed the technology transfer of analytical test methods with Piramal Pharma Solutions (PPS) for 186RNL drug product intermediate. This is an important milestone as it precedes the completion of the process transfer and the manufacturing of cGMP drug product intermediate. As previously disclosed, Plus Therapeutics entered into a MSA with PPS in early 2021 for the development, manufacture and supply of Plus Therapeutics’ 186RNL intermediate drug product.

"These are important steps towards our goal to confirm fully compliant 186RNL available by mid-2022 for our ongoing clinical trials in adults with recurrent glioblastoma, leptomeningeal metastases and other life cycle management trials," said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "We are delighted to develop a strong, effective collaboration with IsoTherapeutics, a company with extensive capabilities in radiopharmaceuticals technology and development. Their demonstrated expertise is precisely what we are looking for in a manufacturing partner."