On December 21, 2021 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported the presentation of preclinical data from its theranostic in development, VMT-alpha -NET, at the 2021 International Chemical Congress of Pacific Basin Societies (Pacifichem 2021 Congress), taking place virtually, December 16-21, 2021 (Press release, Viewpoint Molecular Targeting, DEC 21, 2021, https://viewpointmt.com/viewpoint-molecular-targeting-presents-preclinical-data-from-vmt-net-theranostic-in-development-for-the-treatment-and-diagnosis-of-neuroendocrine-tumors-at-the-pacifichem-2021-congress/ [SID1234597538]).

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The abstract titled, "Chemical structure modifications to chelator and linker compositions for improved pharmacokinetics of 203/212Pb peptide-based radiopharmaceuticals," was presented

In the Advancements in the Chemistry of Targeted Alpha Therapy (#180) symposium session by Michael K. Schultz, PhD, Chief Science Officer of Viewpoint.

"Emerging evidence suggests that alpha-particle therapy has the potential to significantly improve tumor response. The preclinical data from VMT-alpha -NET demonstrated to-date provides strong evidence that our VMT- -NET image-guided approach can meet the need for an effective therapy with a promising toxicity profile. We are pleased with the progress of VMT-alpha -NET and are committed to advancing the development of this important theranostic forward," commented Dr. Schultz.

The preclinical study was designed to explore chemical modifications to the chelator and chelator-peptide linker of SSTN analogs to optimize for 203Pb/212Pb image-guided alpha-particle radionuclide therapy for SST2R expressing tumors. PEG linkers of varying length were explored to improve tumor cell binding/internalization, in vivo tumor targeting, and renal clearance. In vitro and in vivo performance properties (e.g., radiolabeling, renal clearance) were compared to DOTATOC (203Pb/212Pb).

VMT-a-NET was identified with significantly improved performance. [203Pb]VMT-alpha-NET significantly improved: (1) SST2R IC50 binding affinity (>2-fold); (2) cellular uptake and internalization (a factor of 20); (3) tumor accumulation/retention; and (4) renal clearance compared to [203Pb]DOTATOC. With these improvements, the tumor:kidney ratio (%ID/ gram) improved more than 8-fold (24 h post injection) in AR42J tumor bearing mice compared to [203Pb]DOTATOC. [212Pb]VMT-alpha-NET therapy was effective and well-tolerated in mice (renal injury biomarkers NGAL’ CREA), achieving a 70% complete response rate in tumor bearing mice.

Based on the preclinical data seen to-date, Viewpoint believes that VMT- -NET is well-positioned to apply the new transformative power of alpha-particle treatment to NET tumors and other cancers that express the SST2R biomarker.

The Company recently commenced an investigator-initiated Phase 1 imaging study of VMT-alpha -NET for imaging somatostatin receptor subtype 2 (SSTR2)-positive neuroendocrine tumors, being conducted at the University of Iowa Hospitals and Clinics. The images obtained from the Phase 1 imaging study will inform future therapeutic trials of [212Pb]VMT-alpha-NET alpha-particle therapy for this tumor type. In parallel to this investigator-initiated imaging trial, the Company plans to move forward with a Phase 1/2a therapy study of VMT- -NET for the treatment of neuroendocrine tumors.

About the Pacifichem 2021 Congress

The 2021 International Chemical Congress of Pacific Basin Societies will take place virtually, December 16-21, 2021. Pacifichem 2021 will be the eighth in the series of successful cosponsored scientific conferences of Pacific Basin Chemical Societies. Founded in 1984, these conferences have been held in Honolulu, Hawaii about every five years.

About Neuroendocrine Tumors

Neuroendocrine tumors are rare forms of cancers that occur most commonly in the pancreas or other areas of the gut such as the stomach, small intestine, rectum, colon, or appendix. A neuroendocrine tumor may grow slowly or aggressively and spread to other parts of the body. Diagnosis and treatment of neuroendocrine tumors depend on the type of tumor, its location, whether it produces excess hormones, how aggressive it is and whether it has spread to other parts of the body. Some approaches may include surgery, radiation, and chemotherapy.

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]).

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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.

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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]).

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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.

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"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.