On October 14, 2021 Purple Biotech Ltd. (the "Registrant" or the "Company") reported that the Company entered into a settlement agreement with Lupin Ltd. and its subsidiary Lupin Pharmaceuticals, Inc. (collectively, "Lupin"), resolving the Company’s patent litigation against Lupin (Press release, Purple Biotech, OCT 14, 2021, View Source [SID1234591220]). The litigation concerned Lupin’s filing of an Abbreviated New Drug Application (ANDA) seeking approval from the U.S. Food and Drug Administration (FDA) to market a generic version of the Company’s commercial drug CONSENSI. This agreement with Lupin allows Lupin to enter the market on March 1, 2030 and earlier, under certain circumstances.

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 October 14, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its third quarter 2021 financial results will be released on Thursday, October 28, after the market closes (Press release, Gilead Sciences, OCT 14, 2021, View Source [SID1234591255]). At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s third quarter 2021 financial results and will provide a business update .

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 live webcast will be available on the investor relations page of View Source and will be archived on www.gilead.com for one year.

On October 14, 2021 OncoNano Medicine, Inc. reported that results from a Phase 2 study of its lead clinical development candidate, pegsitacianine, presented as a late- breaking oral presentation at the 2021 World Molecular Imaging Congress (WMIC) (Press release, OncoNano Medicine, OCT 14, 2021, View Source [SID1234591223]). This late- breaking oral presentation by Dr. Jason Newman of the University of Pennsylvania Health System revealed the fluorescent nanoprobe, pegsitacianine, provided real-time surgical imaging in a tumor-agnostic manner for the accurate identification of malignant tissue in the operating room.

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!

Pegsitacianine is an intraoperative fluorescence imaging agent under development by OncoNano Medicine for the detection of cancerous tissue in patients undergoing removal of their solid tumor. Relying on an ultra pH-sensitive activation mechanism of OncoNano’s ON-BOARDTM platform, pegsitacianine exists in a fluorescently dark ( "Off") state at physiological pH but transitions rapidly to a fluorescently "On" state in the presence of the elevated acidic tumor microenvironment. Pegsitacianine’s unique mechanism of action provides it with the potential to function as a tumor agnostic imaging agent compatible with most clinical cameras designed for ICG imaging across a variety of solid tumor types. Pegsitacianine has previously been studied in a Phase 1 clinical trial where breast, head and neck, colorectal, and esophageal cancers were successfully imaged following an intravenous dose of pegsitacianine.

"The Phase 2 study results for pegsitacianine presented at the recent World Molecular Imaging Congress indicate this fluorescent nanoprobe has the potential to change the current surgical paradigm," said Dr. Newman. "With the real-time feedback that pegsitacianine provides, we could now have a tool that offers real-time surgical imaging on margin status and provides a greater degree of confidence in achieving complete tumor resection. Given the unique activation mechanism of targeting a universally dysregulated tumor metabolic signature, pegsitacianine could be beneficial in aiding surgical oncologists across multiple tumor disciplines."

The recently completed Phase 2 study (NCT03735680) was a non-randomized, open-label, multi-center study being conducted at three U.S. sites. This exploratory study further confirmed the selected dose-schedule, expanded upon the drug’s safety profile and increased the number of tumor types in which pegsitacianine imaging was shown to be feasible. Together, the results demonstrated that pegsitacianine is well-tolerated in patients and provides the surgeon with accurate, real-time feedback in the operating room. Intraoperative imaging observations demonstrated a high correlation with the pathological assessments of collected tissues, and imaging can be reliably performed using multiple FDA-cleared NIR imaging devices. Results from evaluable patients demonstrated favorable sensitivity (100%) and specificity (92%) values, as well as a strong negative predictive value (100%) for detecting histologically normal tissue that was collected as part of standard of care surgery.

"The high sensitivity and specificity valuesfrom the Phase 2 trial not only corroborated our Phase 1 observations to further support the use of OncoNano’s ON-BOARDTM platform in surgical imaging, but also highlight the potential benefit of this pH-activatable platform for tumor-targeted delivery of therapeutic payloads with an increased therapeutic window," commented Jinming Gao, PhD, OncoNano’s Chief Scientific Officer.

On October 14, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that new data further validating the clinical utility of the company’s Decipher Prostate genomic test will be presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2021 taking place October 24-27, 2021, in Chicago (Press release, Veracyte, OCT 14, 2021, View Source [SID1234591240]).

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!

In two, separate oral presentations, investigators will share findings from studies that assessed the Decipher Prostate test in multiple, large Phase 3 randomized trials. The studies evaluated the test’s utility in patients with newly diagnosed, clinically high-risk prostate cancer receiving definitive radiotherapy as well as among patients experiencing biochemical disease progression following radical prostatectomy.

"The Decipher Prostate data that will be shared at this year’s ASTRO meeting provide exciting new evidence that the test could positively and profoundly impact shared decision-making, resulting in individualized treatment decisions in both the post-biopsy and post-prostatectomy prostate cancer settings," said Tina Nova, Ph.D., Veracyte’s general manager, Thyroid and Urologic Cancers.

Following are details of the abstract presentations:

Dates/Times:

Media Briefing: Monday, October 25, 9:30 – 10:30 a.m. CT

Oral Presentation: Tuesday, October 26, 8:35 a.m. CT

Title:

Validation of a 22-gene Genomic Classifier in the NRG Oncology/RTOG 9202, 9413 and 9902 Phase III Randomized Trials: A Biopsy-Based Individual Patient Meta-Analysis in High-Risk Prostate Cancer

Abstract #:

95 (oral presentation)

Presenter:

Paul L. Nguyen, M.D., Dana-Farber / Brigham and Women’s Cancer Center

Location:

McCormick Place West, Room W181 a/b/c

Date/Time:

Tuesday, October 26, 8:25 a.m. CT

Title:

Performance of a Genomic Classifier (GC) within a Phase 3 Randomized Trial of Dose Escalated Salvage Radiotherapy (SRT) after Radical Prostatectomy (RP)

Abstract #:

94 (oral presentation)

Presenter:

Alan Dal Pra, M.D., University of Miami – Sylvester Cancer Center

Location:

McCormick Place West, Room W181 a/b/c

On October 14, 2021 Quantum Corporation (NASDAQ: QMCO) reported it will release financial results for its second fiscal quarter ended September 30, 2021, on Wednesday, November 3, 2021, after the close of the market. Jamie Lerner, Quantum’s Chairman and CEO, and Mike Dodson, Chief Financial Officer, will host a conference call at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss the financial results.

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!

Analysts and investors are invited to dial into the conference call using the following information:

Date: Wednesday, November 3, 2021
Time: 5:00 p.m. ET (2:00 p.m. PT)
Conference Call Number: 1-866-424-3436
International Call Number: +1-201-689-8058
Passcode: 13724393
Webcast link (listen only) and presentation slides: View Source

A telephone replay of the conference call will be available approximately two hours after the conference call and will be available through November 10, 2021. To access the replay dial 1-877-660-6853 and enter the pass code 13724393 at the prompt. International callers should dial +1-201-612-7415 and enter the same passcode. Following the conclusion of the live call, a replay of the webcast will be available on the Company’s website for at least 90 days.