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]).

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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])."

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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.

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"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.

On November 22, 2021 Medicure Inc. ("Medicure" or the "Company") (TSXV: MPH) (OTC: MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, reported its results from operations for the quarter ended September 30, 2021 (Press release, Medicure, NOV 22, 2021, View Source [SID1234595933]).

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Quarter Ended September 30, 2021 Highlights:

Recorded total net revenue from the sale of products of $4.9 million during the quarter ended September 30, 2021 compared to $3.5 million for the quarter ended September 30, 2020;
Recorded total net revenue from the sale of AGGRASTAT of $2.9 million during the quarter ended September 30, 2021 compared to $3.4 million for the quarter ended September 30, 2020;
Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA1) for the quarter ended September 30, 2021 was $282,000 compared to adjusted EBITDA of $4,000 for the quarter ended September 30, 2020;
Net loss for the quarter ended September 30, 2021 was $946,000 compared to a net loss of $1.05 Million for the quarter ended September 30, 2020
Financial Results

Net revenues for the three months ended September 30, 2021 were $4.9 million compared to $3.5 million for the three months ended September 30, 2020. Net revenues from AGGRASTAT for the three months ended September 30, 2021 were $2.9 million compared to $3.4 million for the three months ended September 30, 2020. ZYPITAMAG contributed $388,000 for the three months ended September 30, 2021, compared to $105,000 for the three months ended September 30, 2020. Marley Drug, which was acquired in December 2020, contributed $1.64 million for the three months ended September 30, 2021.

Net revenues for the nine months ended September 30, 2021 were $14.9 million compared to $9.2 million for the nine months ended September 30, 2020. Net revenues from AGGRASTAT for the nine months ended September 30, 2021 were $8.3 million compared to $8.7 million for the nine months ended September 30, 2020. ZYPITAMAG contributed $941,000 for the nine months ended September 30, 2021 compared to $371,000 for the nine months ended September 30, 2020. Marley Drug contributed $5.62 million for the nine months ended September 30, 2021. Additionally, SNP contributed $66,000, during the nine months ended September 30, 2021, compared to $53,000 for the nine months ended September 30, 2020.

The volume of AGGRASTAT sold in Q3, 2021 was consistent with demand in Q3, 2020. The Company continues to show strong patient market share with AGGRASTAT, and demand from hospitals, driven by the Company’s sales and marketing team. There was an increase in demand for ZYPITAMAG, which was facilitated by sale through Marley Drug and the Company expects growth in ZYPITAMAG revenues going forward. Marley Drug sales remain consistent, and the Company expects growth in sales as marketing is expanded.

Adjusted EBITDA for Q3, 2021 was $282,000 compared to $4,000 for Q3, 2020. The increase in adjusted EBITDA for Q3, 2021 is the result of changes in research and development spending and the recovery of a liability associated with PREXXARTAN.

Adjusted EBITDA for the nine months ended September 30, 2021 was $471,000 compared to negative $1.02 million for the nine months ended September 30, 2020. The improvement in adjusted EBITDA for the nine months ended September 30, 2020 is the result of lower selling and research and development expenses and increasing revenues with Marley Drug and ZYPITAMAG sales and the recovery of a liability associated with PREXXARTAN.

Net loss for the three months ended September 30, 2021 was $946,000 or $0.09 per share compared to net loss of $1.05 Million or $0.10 per share for the three months ended September 30, 2020.

Net loss for the nine months ended September 30, 2021 was $2.6 million or $0.26 per share compared to $2.5 million or $0.23 per share for the nine months ended September 30, 2020. The loss per share increased due to a reduced share count due to the NCIB that took place during 2020.

At September 30, 2021, the Company had unrestricted cash totaling $3.3 million up from the $2.7 million of unrestricted cash held as of December 31, 2020. Cash flows from operating activities for the nine months ended September 30, 2021 totaled $1.82 million compared to cash flows used in operating activities of $1.05 million for the nine months ended September 30, 2020.

All amounts referenced herein are in Canadian dollars unless otherwise noted.

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.

On November 22, 2021 Qurient Co. Ltd. (KRX: 115180), a clinical-stage biotech company based in Korea, reported that the company has entered into a clinical collaboration agreement with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ., USA,, for clinical study of Q702, a triple inhibitor of Axl/Mer/CSF1R) in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) (Press release, Qurient Therapeutics, NOV 22, 2021, View Source [SID1234595931]).

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Under this agreement, Qurient will conduct a phase 1b/2 study in the U.S. and Korea to evaluate safety and efficacy of Q702 and KEYTRUDA in combination for the treatment of selected advanced solid tumors, including esophageal, gastric, hepatocellular, and cervical cancers.

Kiyean Nam, Ph.D., CEO of Qurient, said, "We are pleased to collaborate with MSD to evaluate Q702 in combination with KEYTRUDA for the treatment of esophageal, gastric, hepatocellular, and cervical cancers, where limited immuno-oncology treatment options are currently available. We have previously shown the potential additive benefit of Q702 in combination with anti-PD-1 therapy in preclinical models, so this combination study is designed to evaluate clinical benefit of Q702 and KEYTRUDA for patients."

Terms of the collaboration were not disclosed.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About Q702

Q702 is an orally available novel Axl/Mer/CSF1R inhibitor and is designed to modulate innate immune components leading to T cell activation. Q702 was also shown to increase antigen presentation in the tumor cells demonstrating dual mode of action. A phase 1/2 clinical trial is currently underway in the U.S. (Clinical Trials.gov Identifier: NCT04648254) to evaluate safety and efficacy of Q702 as a monotherapy treatment for solid cancers.