On December 21, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, reported that the first patient has received their first dose in its home instillation study of UGN-102 in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) (Press release, UroGen Pharma, DEC 21, 2021, View Source [SID1234597537]).

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 objective of this Phase 3b study, which aims to enroll up to ten patients across four centers, is to demonstrate whether UGN-102 can be administered at home by a qualified home health professional, avoiding the need for repeated visits to a healthcare setting for instillation.

"The ease of UGN-102 instillation is of great benefit to these patients who are generally older, suffer from multiple comorbidities, and often rely on caregivers to drive them to medical appointments," said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. "Home instillation is especially convenient for the patient and less burdensome for caregivers as they navigate persistent challenges caused by repeated medical appointments. We look forward to demonstrating the versatility of UGN-102 in this study as we prepare to initiate the single-arm, pivotal Phase 3 ENVISION Study of UGN-102 in early 2022."

Patients in the ongoing Phase 3b study will receive six once-weekly intravesical instillations of UGN-102. The initial treatment visit will occur at the investigative site and instillation will be performed by a qualified physician. Treatment visits two to six will take place at the patient’s home and instillation will be performed by a properly trained and qualified home health professional. The primary endpoint of the study is the incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, discontinuations from at home study treatment, and clinically significant abnormalities in laboratory tests (hematology, serum chemistry, and urinalysis).

About UGN-102 (mitomycin for intravesical solution)
UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.

About LG-IR-NMIBC
With 80,000 estimated cases of bladder cancer per year, approximately 35,000 are low-grade NMIBC patients comprised of both low-risk (approximately 15,000) and intermediate risk (approximately 20,000). These patients face a future of recurrence and additional surgeries. Recurrence in LG-IR-NMIBC is a pervasive and often underestimated problem. In patients who recur, it is estimated that 68 percent will experience two or more recurrence episodes throughout the course of their disease, a considerably high and frequent rate in contrast to other non-metastatic cancers.

Currently, the only effective primary treatment available is a surgical procedure known as transurethral resection of the bladder (TURBT). The more the procedure is performed, the more it imposes burden and serious risks on patients. Research shows that 25 percent of patients are not appropriate for TURBT due to physical factors such as age and comorbid conditions or an unwillingness to undergo surgery. Major challenges exist with the current standard of care and these patients deserve a new primary, non-surgical treatment option.

On December 21, 2021 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that Ms. Belen Toledo MSc., from the laboratory of Professor Macarena Perán Ph.D., at the University of Jaén, Spain, recently completed an important experimental thesis on the effects of proenzyme therapy and the impact on the tumor microenvironment, which is key to the development, invasion, metastatic spread, and recurrence of solid tumors (Press release, Propanc, DEC 21, 2021, View Source [SID1234597536]). Ms. Toledo also reconfirmed proenzymes kill cancer stem cells (CSCs). This research is part of the "Proenzymes Optimization Project 1" (POP1) Joint Research and Drug Discovery Program at the Universities of Jaén and Granada, Spain, designed to produce synthetic recombinant, commercial scale quantities of the two proenzymes, trypsinogen and chymotrypsinogen.

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 encouraging results demonstrates that proenzymes have a specific effect on tumor cells and CSCs, but also effects other tumor elements in the tumor microenvironment. However, the most significant conclusion from Ms. Toledo is that the proenzymes also caused a reversal of the malignant tumor phenotype, which was, "most unexpected, very exciting and powerfully conclusive." The process that causes a reversal of the tumor phenotype is called differentiation, which is fundamentally how proenzymes exert anti-tumor, anti-cancer and anti-metastatic effects. Therefore, proenzyme treatment, also known as differentiation therapy, exerts these effects on malignant cells, but leaves healthy cells alone.

"The tumor microenvironment displays certain characteristics common to all solid tumors. Proenzymes normalize this tumor microenvironment," said Dr. Julian Kenyon Mb., ChB., M.D., Propanc’s Chief Scientific Officer. "Therefore, the process of cell differentiation induced by the proenzymes will be applicable to all cancers from solid tumors, as well as sarcomas. This is truly a remarkable finding and may be the key to unlocking the uncontrolled spread of malignant tumors, the main cause of patient death for cancer sufferers. As a result of these findings, I believe there is an urgency in advancing our lead product candidate, PRP, into clinical trials."

The POP1 program is designed to produce a backup clinical compound to the Company’s lead product candidate, PRP. The objective is to produce large quantities of trypsinogen and chymotrypsinogen for commercial use that exhibits minimal variation between lots and without sourcing the proenzymes from animals. Propanc is undertaking the challenging research project in collaboration with the Universities of Jaén and Granada, led by research scientists Mr. Aitor González MSc. and Ms. Toledo, supported by Profs. Perán and Juan Antonio Marchal, M.D., representing the Universities respectively, and Dr. Kenyon.

On December 21, 2021 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported that the Company will present virtually at the annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2022 at 11:15 a.m. ET (Press release, PerkinElmer, DEC 21, 2021, View Source [SID1234597535]).

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!

Prahlad Singh, president and chief executive officer of PerkinElmer, will provide an update on the Company and its strategic priorities.

To access the presentation, a live audio webcast will be available via this page. A replay of the presentation will be posted on the PerkinElmer Investor Relations website after the event and will be available for 30 days following.

On December 21, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that Thomas (Tom) C. Heineman, M.D., Ph.D., has been promoted to the role of Chief Medical Officer (CMO) (Press release, Oncolytics Biotech, DEC 21, 2021, View Source [SID1234597534]). Dr. Heineman has over two decades of experience leading clinical development programs and previously served as Oncolytics’ Global Head of Clinical Development and Operations.

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!

"Tom’s clinical expertise, deep understanding of oncology drug development, and impressive track record make him an ideal fit as our CMO," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Since joining Oncolytics in August 2020, Tom has provided crucial insights that have enabled the efficient advancement of our lead breast cancer program and facilitated our pipeline’s expansion into additional indications. Looking forward, Tom’s strategic guidance will continue to be an invaluable asset as we move towards a registration study in metastatic breast cancer and advance our broader pipeline."

Dr. Heineman added, "The opportunity to serve as Oncolytics’ CMO is exciting. Pelareorep’s ability to recruit anti-cancer immune cells into tumors and promote an inflamed microenvironment positions it as a potential immunotherapeutic backbone that can enable the success of a wide range of immuno-oncology agents. We have demonstrated clinical proof-of-concept in several high unmet need indications and are now building on these results in ongoing trials. As CMO, I look forward to leading the clinical development of pelareorep through these and future trials, and to my continued work alongside my highly talented colleagues at Oncolytics."

Prior to joining Oncolytics, Dr. Heineman was Senior Vice President and Head of Clinical Development at Denovo Biopharma. Prior to his time at Denovo, he served as Vice President and Head of Clinical Development at both Genocea Biosciences and Halozyme Therapeutics. At Halozyme, Dr. Heineman was also Head of Translational Medicine and oversaw clinical trials in indications such as breast and pancreatic cancer. Dr. Heineman’s experience further extends to big pharma and academia, as he previously worked as Senior Director, Global Clinical Research and Development at GlaxoSmithKline and as an Associate Professor at the Saint Louis University School of Medicine.

Dr. Heineman has co-authored over 60 peer-reviewed publications and is board certified in Internal Medicine and Infectious Diseases. He completed his fellowship in Infectious Diseases at the National Institutes of Health and his internship and residency at the University of Maryland. Dr. Heineman earned his M.D. and Ph.D. in Virology at the University of Chicago.

On December 21, 2021 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported the expansion of an existing collaboration and license agreement between its subsidiary, Icagen, and GlaxoSmithKline (GSK) (Press release, Ligand, DEC 21, 2021, View Source [SID1234597533]). The expansion will leverage Icagen’s ion-channel-based discovery technology and unique expertise in small molecule therapeutics targeting transmembrane proteins. This new agreement builds upon the initial December 2020 agreement to identify and develop inhibitors of a specific genetically-validated molecular target relevant to neurological diseases.

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!

"We are very pleased to expand our collaboration with GSK to include a second neurological target," said Matt Foehr, President and COO of Ligand. "Over the past year this has been a productive relationship combining our technologies and expertise with GSK’s history of successfully working with others to access innovation and deliver next-generation transformational medicines."

"We look forward to strengthening our collaboration to identify genetically-validated targets for neurological diseases utilizing Icagen’s technology," said John Lepore, Senior Vice President, Head of Research, GSK. "Our expanded collaboration provides a framework to advance drug discovery by maximizing the strengths of our two scientific organizations to develop novel drug candidates efficiently and effectively."

In addition to all payments available under the original 2020 collaboration and license agreement, under the terms of the expanded collaboration and license agreement, Ligand will receive an upfront payment of $10 million and is eligible for development and regulatory milestones up to $67.5 million. Furthermore, should the potential new medicine receive regulatory approval in major markets, the deal provides for commercial milestone payments to Ligand of up to $60 million at first commercial sale, and up to $120 million in sales-related milestone payments. Ligand will receive tiered royalties on net sales of any drug that is commercialized by GSK.

Ligand will be responsible for most preclinical activities up to lead optimization, with Ligand and GSK collaborating to identify candidates for entry into IND-enabling studies. GSK has the exclusive option to license any identified molecules and will be responsible for the further development and commercialization of any drug candidates identified through the collaboration.

About Icagen Ion Channel Technology

The Icagen technology is focused primarily on ion channel and transporter novel drug discovery. Ion channels and transporters are key components in a wide variety of biological processes that involve rapid changes in cells and have broad therapeutic applicability including oncology, metabolic disease, pain, neurological diseases, infectious diseases and others. The Icagen technology leverages proprietary expertise in the combination of biological assays, medicinal chemistry, and in silico and computational chemistry applications to enable the discovery of ion channel targeting therapeutics. Partners in the pharmaceutical industry leverage Icagen’s platform to develop first-in-class therapies for patients in need, typically under collaborative arrangements through the time of clinical candidate selection, with partners responsible for subsequent clinical development and commercialization.