On November 22, 2021 ASA (OSE: PHO), The Bladder Cancer Company, reported that President and Chief Executive Officer, Dan Schneider and Chief Financial Officer, Erik Dahl will present a corporate overview and host 1-on-1 meetings with investors at the Piper Sandler 33rd Annual Healthcare conference, being held virtually November 29 through December 2, 2021 (Press release, PhotoCure, NOV 22, 2021, View Source [SID1234595938]).

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 webcast of the presentation will be made available in the Congresses and Events section of Photocure’s website at View Source;events/.

On November 22, 2021 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that the Company has received a No Objection Letter from Health Canada in response to the Clinical Trial Application (CTA) of CT041, an autologous CAR T-cell product candidate against the claudin18.2 protein, "CLDN18.2" (Press release, Carsgen Therapeutics, NOV 22, 2021, View Source;301429649.html [SID1234595937]).

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 of this announcement, CT041 is the only CLDN18.2-targeted CAR T-cell product candidate globally that is being studied in clinical trials with IND clearance from both the FDA and the NMPA, and CTA authorization from Health Canada.

About CT041

CT041 is an autologous CAR T-cell product candidate against the protein CLDN18.2 that has the potential to be the first in its class globally. CT041 targets the treatment of CLDN18.2 positive solid tumors with a primary focus on gastric/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). CT041 has demonstrated promising therapeutic efficacy and favorable safety in ongoing clinical trials. CARsgen believes that CT041 has the potential to become a backbone therapy for GC/GEJ and PC in the future and benefit a large population of patients worldwide.

In addition to the investigator-initiated trials in China, CARsgen has initiated a Phase Ib/II clinical trial for advanced GC/GEJ or PC in China and a Phase 1b clinical trial for advanced GC/GEJ or PC in North America. CT041 was granted PRIME Eligibility by the EMA for the treatment of advanced GC. CT041 received Orphan Drug designation for the treatment of GC/GEJ from the U.S. FDA in 2020 and Orphan Medicinal Product designation for the treatment of gastric cancer from the EMA in 2021. CARsgen has applied to the NMPA for the required regulatory approval for initiating the pivotal Phase II clinical trial in China. The company also intends to conduct a pivotal Phase 2 clinical trial in North America in 2022.

On November 22, 2021 OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of elite cancer responders, reported that Clifford Stocks, Chief Executive Officer, will participate in two upcoming investor conferences (Press release, OncoResponse, NOV 22, 2021, View Source [SID1234595936]).

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!

Presentation details are as follows:

Piper Sandler 33rd Annual Virtual Healthcare Conference

Format: Corporate Presentation;1X1 investor meetings
Time/Date: Presentation will be available beginning Nov. 22, 2021, at 10 a.m. Eastern.

RBC Capital Markets Healthcare Private Company Conference

Format: Fireside chat with analyst-moderated Q&A; 1X1 investor meetings
Time/Date: Thursday, December 16, 2021, at 3:50 p.m. Eastern.

Both presentations will be accessible from the News Center / Events & Presentations page of the OncoResponse website and available for at least 30 days.

On November 22, 2021 EpicentRx, Inc., a clinical-stage biotechnology company at the forefront of oncolytic viruses and small molecules for the treatment of cancer and other inflammatory-driven diseases, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,906,957 entitled "Immunomodulatory Fusion Proteins (Press release, EpicentRx, NOV 22, 2021, View Source [SID1234595935])."

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 composition of matter patent is directed to novel therapeutic proteins, including a TGF-ß Trap Fusion Protein, both alone and in combination with viral expression and delivery vectors. The patent, which contains eight claims and expires no earlier than 2037, strengthens EpicentRx’s intellectual property position and coverage for its lead therapeutic product candidate, AdAPT-001, currently under investigation in a Phase 1 clinical trial for solid tumors. AdAPT-001 is a modified replicating type 5 adenovirus vector ‘armed’ with a TGF-ß trap, which is designed to selectively replicate in and destroy tumor cells.

The purpose of the TGF-ß trap is to sequester the powerful signaling molecule, TGF-ß, short for "transforming growth factor," which is overproduced in many disease states including cancer where TGF-ß is known to suppress the immune system. TGF-ß is also one of the main drivers of fibrotic disorders such as liver cirrhosis, Crohn’s disease, scleroderma, arteriosclerosis, non-alcoholic steatohepatitis (NASH), diabetic nephropathy, idiopathic pulmonary fibrosis, chronic graft vs. host disease, keloid formation and a host of other conditions where excessive scarring replaces healthy tissue.

"We are extremely pleased with the issuance of this foundational patent, which not only expands the breadth of our oncolytic adenovirus intellectual property portfolio but also, and perhaps, more importantly, covers the TGF-ß trap protein as a standalone therapeutic, independent of the oncolytic virus, to treat a range of disease relevant processes for which TGF-β is a key driver from immune system evasion by cancer cells to fibrosis," said Tony R. Reid, M.D., Ph.D., Chief Executive Officer of EpicentRx.

About AdAPT-001

AdAPT-001 is an oncolytic virus which is part of the company’s proprietary AdAPT Immunotherapy Platform, a platform developed on a genetically modified version of the human adenovirus that has been uniquely designed to preferentially infect and kill cancer cells. Currently in an ongoing Phase 1 trial for solid tumors, AdAPT-001 encodes a ligand trap comprised of the ligand-binding domain of the TGF-β receptor, which is fused to the portion of the human antibody known as the Fc domain.

On November 22, 2021 DNAtrix, a biotech company advancing virus-driven immunotherapies for cancer, reported that data from the Phase 1 study of DNX-2401 in diffuse intrinsic pontine glioma (DIPG) was presented in an oral presentation at the 26th Annual Meeting and Education Day of the Society for Neuro-oncology (SNO), which was held from November 18-21, 2021 in Boston, MA (Press release, DNAtrix, NOV 22, 2021, View Source [SID1234595934]). DNX-2401 is an adenovirus-based immunotherapy that is engineered to selectively kill tumor cells and trigger a robust anti-tumor immune response. It has received FDA Fast Track and Rare Pediatric Disease designations for DIPG.

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!

"DIPG is a rapidly progressing tumor with the worst prognosis of any pediatric cancer," said Jeffrey Knapp, chief executive officer of DNAtrix. "Patients receiving conventional radiation therapy typically have a median overall survival of between eight and eleven months, with less than ten percent of the patients reaching the two-year survival mark. The preliminary overall survival data from the DNX-2401 Phase 1 study show a median survival of close to 18 months, with three patients still in follow-up. This is a significant and remarkable impact on overall survival in this difficult-to-treat tumor type, and we look forward to completing the study."

The Phase 1 study evaluated DNX-2401 followed by conventional radiation therapy in 12 newly diagnosed DIPG patients. Tumor reductions were reported for 9 patients (75%), including 3 confirmed (25%) responses per RAPNO criteria. As of the data cutoff, median overall survival was 17.8 months with follow-up ongoing for three patients. No dose-limiting toxicities were observed, and the treatment regimen was well-tolerated.

Oral Presentation Details:

Title:

Safety, efficacy, and survival results from a Phase 1 study of the oncolytic adenovirus DNX-2401 followed by standard of care radiotherapy for newly diagnosed diffuse intrinsic pontine glioma (DIPG)

Abstract Number:

CTIM-08

Presenter:

Jaime Gallego Perez-Larraya, M.D.

Date/Time:

November 21, 2021 at 12:00PM EST

About DNX-2401
DNX-2401 is an oncolytic adenovirus engineered specifically to infect, replicate in, and directly kill cancer cells, as well as elicit a broader anti-tumor immune response. DNX-2401 is currently being evaluated as a potential treatment for highly aggressive brain tumors, including recurrent glioblastoma in adults and newly-diagnosed diffuse intrinsic pontine glioma (DIPG) in children. Clinical studies have demonstrated that DNX-2401 was well tolerated and extended survival for patients with recurrent glioblastoma. DNX-2401 has been granted Fast Track for recurrent glioblastoma and Orphan designation by the FDA and PRIME and Orphan designation by the EMA for high grade glioma, as well as Fast Track and Rare Pediatric Disease designations by the FDA for DIPG.

About DIPG
Diffuse intrinsic pontine glioma (DIPG), also known as diffuse midline glioma, is a rare and highly aggressive infiltrative tumor of the brainstem with the worst prognosis of any pediatric cancer. No effective treatments are available and novel treatment approaches are needed.