On March 23, 2020 Nanjing IASO Biotherapeutics reported that it has completed a $60 million Series B financing led by GL Ventures, a Hillhouse Capital VC focusing on early-stage innovative companies (Press release, IASO BioMed, MAR 23, 2020, View Source [SID1234555760]). Founded in 2017, IASO is developing cell therapies for oncology conditions, with more than 10 pipeline products led by autologous and universal CAR-T products for hematological tumors. It is also working on novel TCR-like CAR-T cell therapies for solid tumor indications. Last year, IASO and Innovent announced their anti-BCMA CAR-T produced a 100% overall response rate in patients with relapsed/refractory multiple myeloma.

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On March 16, 2020 NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, reported a corporate update highlighting the continued commercial progress of its RadioGenix System (technetium Tc 99m generator) (Press release, NorthStar Medical Radiostopes, MAR 23, 2020, View Source [SID1234555616]). NorthStar’s RadioGenix System is an innovative, high tech radioisotope separation platform indicated for use in producing the widely used medical radioisotope Tc-99m from non-uranium based molybdenum-99 (Mo-99). Since becoming commercially available in 2018, NorthStar has provided RadioGenix System customers with reliable Mo-99 production and supply, despite ongoing industry supply shortages incurred with legacy, uranium-based production methods. NorthStar also announced progress in its multi-pronged expansion efforts to ensure a reliable, domestically produced Mo-99 supply for the U.S. healthcare system, an expanded product portfolio and deployment of its technological expertise in scaling up commercial production for therapeutic radioisotopes copper-67 (Cu-67) and actinium (Ac-225).

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"Since the RadioGenix System became commercially available in 2018, NorthStar has demonstrated strong, consistent progress in advancing our plans to ensure reliable, non-uranium based radioisotope supply for the United States," said Steve Merrick, President and CEO of NorthStar Medical Radioisotopes. "During the past 16 months and despite disruptive supply shortages from other Mo-99 producers, NorthStar’s RadioGenix System customers have experienced reliable Mo-99 supply, enabling U.S. healthcare providers and their patients to have ready access to medically important Tc-99m diagnostic imaging studies, on time and when they need them. Recent FDA approval of two state-of-the-art filling lines at our Columbia, Mo. facility substantially increases our Mo-99 production efficiencies in filling Mo-99 source vessels that we provide to our customers. In line with our multi-pronged strategy to deploy dual Mo-99 processing hubs in Columbia and Beloit, Wis., we have completed construction of the isotope processing facility in Beloit. Upon completion of equipment installation and qualification, appropriate licensure and FDA approval, the isotope processing facility will augment current processing in Columbia, Mo. and provide dual production hubs for source vessels used by radiopharmacies having RadioGenix Systems. We would like to recognize the support that our partners at the University of Missouri Research Reactor (MURR), with whom we jointly produce Mo-99 in Columbia, Mo., continue to provide to NorthStar. Construction of NorthStar’s electron accelerator facility expansion in Beloit is well underway, with the first pair of accelerators being built in Belgium and planned for installation in Q4 2020. The accelerators will be used to convert Mo-100 to medically useful Mo-99, which will be processed in the adjacent isotope processing facility. This will enhance production efficiencies and complete the creation of dual manufacturing operations to further secure reliable, non-uranium based Mo-99 radioisotope supply for U.S. customers and patients."

"In further planning for future growth, NorthStar has expanded our product portfolio through acquisition of exclusive worldwide rights to an investigational fibrin-targeted cardiac diagnostic imaging agent, known as FibroScint, from Capella Imaging," added Mr. Merrick. "This Tc-99m agent may have potential applications across multiple cardiovascular conditions, and we intend to use RadioGenix System-produced Tc-99m in planned clinical studies. Additionally, NorthStar is broadening its technology platform to address important unmet needs in radioisotope supply. We are applying our development expertise towards commercial-scale production of promising therapeutic radioisotopes such as Cu-67 and Ac-225, which may have potential in treating a range of cancers. As recently announced, NorthStar and Clarity Pharmaceuticals signed a Letter of Intent for U.S. clinical and commercial supply of Cu-67, and the company has similar arrangements in place to supply Ac-225 to several undisclosed customers."

Mr. Merrick concluded, "Through successful financing efforts, and in conjunction with the U.S. Department of Energy’s National Nuclear Security Administration (DOE/NNSA) Cooperative Agreement awards, NorthStar is strongly positioned to continue its momentum towards being an industry leader in radioisotope technology, production and supply. DOE/NNSA has been instrumental in development of the RadioGenix System, system enhancements and our Mo-99 production activities. We are grateful for the efforts of all our government and business partners, and in particular, the team at MURR, and the many contributions that they have had on our programs. Together with our talented team of more than 200 employees, supply chain partners and our customers, we are working together to provide U.S. patients with reliable access to radioisotopes that can make a difference in healthcare for patients in the United States."

RadioGenix System commercial progress

NorthStar’s successful commercialization of the RadioGenix System continues its steady, planned growth with U.S. radiopharmacy customers.

Since becoming commercially available 16 months ago, RadioGenix Systems have provided customers with reliable Tc-99m supply through U.S. production of Mo-99, despite ongoing shortages from suppliers using legacy, uranium-based production methods.
The number of patient doses available from RadioGenix Systems continues to increase, with tens of thousands of doses provided for patients’ diagnostic imaging studies to date, and product growth continuing to track with the company’s plan.
Ongoing product development programs such as the FDA-approved RadioGenix System version 1.2 continue to help maximize operational utility and efficiency for customers in the production of Tc-99m.
Progress on initiatives to increase U.S. Mo-99 manufacturing and production

In its efforts to support increased Mo-99 production efficiencies and capacity, NorthStar is aggressively expanding for the future to ensure continued reliable domestic Mo-99 supply for the U.S. healthcare system. The company is executing on its multi-pronged expansion strategy for dual production hubs in Beloit, Wis., and Columbia, Mo.

In February, 2020, the FDA approved the addition of two Mo-99 filling lines at NorthStar’s facility in Columbia, Mo., enabling an immediate and significant increase in the speed in which RadioGenix System source vessels are filled, and thus increasing production efficiency and output. NorthStar produces non-uranium based Mo-99 in collaboration with its manufacturing partner, MURR.
NorthStar has two ongoing expansion projects underway in Beloit. The company’s isotope processing facility is nearing completion, and will augment processing at MURR once approved. Upon appropriate licensure by Wisconsin DHS and FDA approval, the facility will enable NorthStar to more than double its production of source vessels, which are used by radiopharmacies with RadioGenix Systems to produce Tc-99m for physicians and their patients.
In March 2019, NorthStar signed a contract with IBA for eight electron beam accelerators. Groundbreaking on its accelerator production facility took place in September 2019, and construction in Beloit is well underway. The initial pair of accelerators is being assembled in Belgium, with installation planned for Q4 2020. Like other NorthStar processes, accelerator production of Mo-99 using the "neutron knock-out" method is non-uranium based, highly efficient and, pending FDA approval, can provide customized scheduling flexibility and minimize supply risks for customers.
In mid-2020, NorthStar anticipates submitting a Prior Approval Supplement (PAS) to the FDA for concentrated Mo-98 (cMo-98). Pending FDA approval, the cMo-98 production process will improve Mo-99 specific activity concentration up to four-fold, and immediately enable larger capacity and multiple sizing options for Mo-99 source vessels for RadioGenix System customers.
NorthStar currently has the capability to meet up to approximately 10% of the U.S. demand for Mo-99. The company’s production capacity is expanding approximately every six months, with the expectation that within three to five years, it will have the capability to regularly supply an estimated 65% of U.S. Mo-99 demand, and up to 100% of U.S. demand in an emergency.
Strategic product portfolio expansion

NorthStar is expanding its company portfolio through strategic acquisitions that complement its current products.

In March 2020, NorthStar announced exclusive, worldwide licensing of an investigational fibrin-targeted cardiac diagnostic imaging agent, from Capella Imaging. The agent, known as FibroScint, may have potential applications across multiple cardiovascular conditions. Clinical investigation of FibroScint will begin with an exploratory Phase 1 study for its potential use in identifying thrombus (blood clots) in patients with serious heart failure who use a left ventricular assist device (LVAD). This Tc-99m imaging agent complements the commercially available RadioGenix System, and NorthStar intends to use RadioGenix System-produced Tc-99m in planned clinical studies.
Development of commercial-scale therapeutic radioisotope production

NorthStar is applying its expertise in the development and commercialization of innovative radioisotope technologies to advance commercial-scale production of therapeutic radiopharmaceuticals such as copper-67 (Cu-67) and actinium-225 (Ac-225).

In February 2020, NorthStar and Clarity Pharmaceuticals signed a Letter of Intent for NorthStar to supply Clarity with Cu-67, a radiopharmaceutical with potential for treating a range of cancers. NorthStar will be a major U.S. supplier of Cu-67 for Clarity in its clinical development and commercialization plans.
Additionally, NorthStar will supply Ac-225 to several undisclosed companies to support their clinical development and commercialization plans for therapeutic radiopharmaceuticals.
Corporate development and industry leadership activities

NorthStar is firmly positioned for sustained growth and increasing industry leadership.

NorthStar completed a $100 million financing with Oberland Capital in July 2019, with proceeds to be used to increase domestic production capacity efforts for Mo-99, implement additional RadioGenix System enhancements and advance its R&D activities.
In July 2019, NorthStar was awarded an additional $30 million Cooperative Agreement by DOE/NNSA to accelerate domestic Mo-99 production, as part of DOE/NNSA’s objective to establish reliable domestic Mo-99 production without the use of highly enriched uranium. NorthStar will use funds from the award to further advance its current neutron capture technology for domestic, non-uranium based Mo-99 production, and to continue development of enhancements for the RadioGenix System.
With an eye to the future, NorthStar is highly engaged in advancing educational initiatives for the nuclear medicine community and widely regarded/recognized as a leader in radioisotope technology development and commercialization.
At the June 2019 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging, the company presented information about the RadioGenix System and Tc-99m production using non-uranium based Mo-99 to an audience of nuclear medicine technologists, and provided an update on the outlook for current and future Mo-99 supply in the general session.
In August 2019, NorthStar and Purdue University College of Pharmacy announced a collaborative agreement expanding the College’s nuclear pharmacy training curriculum. NorthStar provided the College of Pharmacy with a RadioGenix System to enable nuclear pharmacy students the opportunity to become familiar with the advanced yet easy to operate equipment, and the College will provide NorthStar with feedback about the RadioGenix System and early testing of planned enhancements.
In August 2019, NorthStar participated in the Atoms for Humanity Summit, a forum of nuclear experts convened to look at the future of nuclear energy, and participated in a panel discussion around the next generation of nuclear medicine and health.
In February 2020, NorthStar was awarded the World Council on Isotopes’ President’s Award, which recognizes outstanding contributions to the promotion of isotope technologies and the use of isotopes to benefit mankind.
About the RadioGenix System (Technetium Tc 99m Generator)

The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium/non-highly enriched uranium molybdenum-99 (Mo-99) for the production of the important medical radioisotope, technetium-99m (Tc-99m). Prior to availability of RadioGenix technology, the U.S. supply chain for Mo-99 has been subject to frequent and sometimes severe interruptions which negatively impact patient healthcare. Approved by the U.S. Food and Drug Administration in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-uranium/non-highly enriched uranium based Mo-99, designed to help alleviate shortage situations and expand domestic supply.

Indication and Important Risk Information about the RadioGenix System and Sodium Pertechnetate Tc 99m Injection USP

INDICATION

The RadioGenix System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used in the preparation of FDA-approved diagnostic radiopharmaceuticals.

Sodium Pertechnetate Tc 99m Injection is also indicated in

Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
IMPORTANT RISK INFORMATION

Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.
Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
Discard the first eluate from every new Potassium Molybdate Mo 99 Source Vessel to minimize the risk of unintended radiation exposure from Rhenium Re-186.
Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.
Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kit/packs, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 12 hour expiration time from elution is reached, whichever occurs earlier.

On March 23, 2020 CytomX Therapeutics, Inc. (NASDAQ: CTMX, President, Chief Executive Officer and Chairman: Sean McCarthy, D. Phil. "CytomX") and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported they have entered into a strategic collaboration agreement focused on the discovery, research, development and commercialization of novel T-cell engaging bispecific antibodies targeting CD3 and tumor cell surface antigens for the treatment of cancer (Press release, CytomX Therapeutics, MAR 23, 2020, View Source [SID1234555762]). The parties will utilize CytomX’s Probody therapeutic technology platform, as well as its proprietary bispecific formats and CD3 modules.

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"This collaboration with Astellas leverages CytomX’s deep expertise in targeting multiple antibody modalities to the tumor microenvironment," said Sean McCarthy, D. Phil., President, Chief Executive Officer and Chairman of CytomX. "We are excited about the use of our technology to assist Astellas in unlocking the potential of T-cell engaging bispecifics in the treatment of solid tumors, building on the growing proof of concept we have established for our platform."

"At Astellas, immuno-oncology is a Primary Focus of our research and development strategy, and we are working on the development of next-generation cancer immuno-therapy using new modalities/technologies," stated Naoki Okamura, Representative Director Corporate Executive Vice President, Chief Strategy Officer and Chief Financial Officer, Astellas."We look forward to the collaboration with CytomX, which will enable us to leverage both companies capabilities and expand our next-generation immuno-oncology therapeutic pipeline as we continue to dedicate our efforts to deliver innovative treatments for diseases with high unmet medical needs."

Probody therapeutics are designed to remain inactive until they are activated by proteases in the tumor microenvironment. As a result, Probody therapeutics are designed to bind selectively to tumors and minimize binding to healthy tissue, thereby reducing toxicities and potentially creating safer, more effective therapies. Probody T-cell engaging bispecifics are antibody constructs capable of directing cytotoxic T-cells to tumor microenvironments, leading to cell-mediated anti-cancer activity.

Under the agreement, CytomX and Astellas will collaborate on several initial programs. CytomX will lead research and discovery activities, up to clinical candidate selection, that will be funded by Astellas. Astellas will lead and fund preclinical and clinical development and commercialization activities. Astellas will make an upfront cash payment of $80 million to CytomX with CytomX eligible to receive future preclinical, clinical and commercial milestones of over $1.6 billion. CytomX is also eligible to receive tiered royalties on global net sales that range from high-single digits to mid-teens.

For a specified number of targets, prior to the initiation of the first pivotal clinical trial for a product directed toward such target, CytomX may exercise an option to co-fund a pre-determined portion of clinical development costs. For these products, CytomX is eligible to receive a pre-specified portion of profits in the United States and tiered low-double digit to mid-teen percentage royalties on net sales outside of the United States. CytomX may later elect to co-commercialize the products directed toward such targets in the United States.

On March 23, 2020 A study jointly conducted by Dean and Professor Takuya Fukushima, M.D., Ph.D., Graduate School of Health Sciences, University of the Ryukyus, and NEC Corporation reported that it has discovered a novel diagnostic biomarker for acute adult T-cell leukemia/lymphoma and been published in Blood Advances, a medical journal from the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, NEC, MAR 23, 2020, View Source [SID1234555742]).

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Key points of the announcement:

A comprehensive proteomic analysis of samples from the Okinawa HTLV-1/ATL Biobank revealed that the expression level of soluble tumor necrosis factor receptor 2 (sTNFR2) was elevated in ATL patients compared to asymptomatic HTLV-1 carriers
As a biomarker, sTNFR2 in the blood plasma of ATL patients is expected to be more sensitive and more specific than other biomarkers previously reported. Although it is known that several proteins are found at higher levels in ATL patients, this study has discovered a proteomic biomarker with enhanced sensitivity and specificity
Observation of sTNFR2 expression levels may help in the early diagnosis of ATL onset in HTLV-1 carriers. This may also help ATL patients through improvement of therapeutic outcomes, evaluation of treatment response, and prediction of prognosis

Adult T-cell leukemia/lymphoma (ATL) is a mature T-cell neoplasm associated with human T-cell leukemia virus type-1 (HTLV-1). Studies have shown that Japan has the largest population of HTLV-1 carriers, especially the Okinawa and Kyushu regions, and correspondingly a high incidence of ATL (reference 1, 2). The main routes of transmission of HTLV-1 are vertical transmission from an infected mother to child through breastfeeding, and horizontal (sexual) transmission.

A 2008 to 2010 nationwide survey conducted by the scientific research arm of Japan’s Ministry of Health, Labor and Welfare estimated that there is a total of 1,080,000 carriers in Japan, and that the proportion of carriers in the metropolitan Kanto and Kinki regions has been on the rise (reference 3). The majority of HTLV-1 carriers remain asymptomatic throughout their lives, with only 5% exhibiting clinical features of ATL.

Nevertheless, treatment of ATL remains exceptionally challenging, and the acute and lymphoma subtypes are known to be aggressive. Aggressive ATL patients typically have a poor prognosis, with a median survival time of 8 to 10 months. To diagnose early ATL onset and improve the treatment of ATL, research is being conducted to identify ATL risk factors among HTLV-1 carriers, and although a high proviral load is known to be a risk factor for ATL progression, a definitive factor that can be used to predict the onset of ATL has yet to be identified. Moreover, ATL is known to increase the levels of plasma proteins such as lactase dehydrogenase and soluble interleukin-2 receptor, but this increase is not specific to ATL and is not as useful as a predictor of ATL onset.

According to the Okinawa HTLV-1/ATL Research Network, a research group which is connected to various hospitals in Okinawa, there are approximately 70 aggressive ATL cases annually in Okinawa. Professor Takuya Fukushima and his colleagues partnered with NEC Corporation to form a joint research team with the objective of discovering a new biomarker that will enable the early detection of ATL. This was achieved by performing a comprehensive blood-based proteomic analysis of blood plasma specimens from the Okinawa HTLV-1/ATL biobank to compare asymptomatic HTLV-1 carriers (AC) and ATL patients.

Through SOMAscan, a proteomic analysis platform provided by US-based SomaLogic Inc., expression levels of 1,305 plasma proteins were analyzed in 40 AC and 40 ATL patients. From this study, 333 types of proteins were found to have significantly different levels in the two study groups. Subsequently, those proteins with especially large differences were further analyzed using ELISA. Results showed that soluble tumor necrosis factor receptor 2 (sTNFR2) was found in remarkably elevated levels in ATL patients, especially acute ATL, compared to AC subjects.

Tumor necrosis factor (TNF) is a cytokine, and the subtype, TNF-α, induces apoptosis of solid tumor cells. TNF-α is also known to be involved in the induction of inflammation and apoptosis, and the inhibition of tumorigenesis. TNFR2 is one of the receptors of TNF-α, and is involved in the proliferation of tumors. sTNFR2 refers to TNFR2 that have shed from the surface of cells and are freely floating in the blood. This study has also revealed that TNFR2 are highly expressed on acute ATL cell surfaces. To date, there have been no research findings indicating elevated TNFR2 levels in ATL patients, and the results of this study represent the potential clinical utility of sTNFR2 as a biomarker to diagnose acute ATL.

Looking ahead, the clinical significance of elevated sTNFR2 levels in onset prediction, early diagnosis, and prognosis prediction should be examined. Moreover, analyzing the mechanism by which TNFR2 is released from the surface of cells may prove to be important in paving the way for new treatment options.

References

Gessain A, Cassar O (2012) Epidemiological aspects and world distribution of HTLV-1 infection. Front Microbiol 3: 388.
Nosaka K, Iwanaga M, Imaizumi Y, Ishitsuka K, Ishizawa K, Ishida Y, Amano M, Ishida T, Uike N, Utsunomiya A, Ohshima K, Kawai K, Tanaka J, Tokura Y, Tobinai K, Watanabe T, Uchimaru K, Tsukasaki K (2017) Epidemiology and clinical features of adult T-cell leukemia-lymphoma in Japan, 2010-2011: A nationwide survey. Cancer Sci 108(12): 2478-2486
Satake M, Yamaguchi K, Tadokoro K (2012) Current prevalence of HTLV-1 in Japan as determined by screening of blood donors. J Med Virol 84: 327-335.

On March 23, 2020 UroGen Pharma Ltd. (Nasdaq:URGN) a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, reported promotions for key members of the Executive Leadership Team (Press release, UroGen Pharma, MAR 23, 2020, View Source [SID1234555763]). These appointments will better position the Company for its next growth phase with the anticipated approval and launch of its first product candidate, UGN-101 (mitomycin gel) for instillation, for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). In December 2019, the U.S. Food and Drug Administration accepted for filing and granted priority review for the Company’s UGN-101 application and assigned a Prescription Drug User Fee Act (PDUFA) action date of April 18, 2020.

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Effective April 1, 2020, the following individuals will be promoted to the following roles:

Jeff Bova, Chief Commercial Officer
Marina Konorty, PhD, Executive Vice President, Research & Development and Technical Operations
James Ottinger, RPh, Executive Vice President, Regulatory Affairs and Quality
Elyse Seltzer, MD, Chief Development Officer
"I am delighted to announce the promotions of these outstanding colleagues and to see firsthand how they will continue to help transform the Company with their expanded responsibilities. UroGen’s accomplishments to date have been a direct result of their tireless efforts, and I look forward to continuing to work with this talented and experienced team as we together embark on the most transformational time for our company," said Liz Barrett, President and Chief Executive Officer of UroGen. "We are rapidly approaching potential approval and commercialization of our lead product candidate, UGN-101, for the treatment of patients with low-grade upper tract urothelial cancer. With this team, I’m confident in our ability to deliver on the promise of our RTGel platform and advance our pipeline of product candidates for patients in areas of unmet need."

Jeff Bova, Chief Commercial Officer

Mr. Bova joined UroGen in 2017 and most recently served as UroGen’s Senior Vice President of Commercial. He is an experienced pharmaceutical industry executive with extensive leadership experience across key commercial functional areas, including national sales, marketing, and managed care. Prior to UroGen, he spent 20 years at Bayer Healthcare, holding multiple senior-level leadership positions of increasing responsibility. Most recently at Bayer, Mr. Bova served as Vice President of Oncology Sales, where he led a field sales force of more than 200 in marketing well-known brands such as Xofigo, Stivarga, and Nexavar. He also previously served as Vice President of Marketing for Bayer’s prostate cancer franchise where he designed, developed, and led the highly successful launch of Xofigo. Mr. Bova holds a Master’s Degree in business administration from Xavier University and a Bachelor of Science in finance and marketing from the University of Cincinnati.

Marina Konorty, PhD, Executive Vice President, Research & Development and Technical Operations

Dr. Konorty joined UroGen as Chief Chemist in 2011 and most recently served as UroGen’s Senior Vice President of Research and Development and Head of Israeli Operations. In her role as Chief Chemist, Dr. Konorty was responsible for development of the RTGel reverse-thermal hydrogel technology platform, including optimization of its delivery properties and verifying its suitability as a drug carrier in humans. She has subsequently led development of the manufacturing processes and specifications associated with RTGel-formulated drug products for the UroGen clinical development pipeline. Prior to UroGen, Dr. Konorty served as Project Manager at TransPharma Medical, a medical device and drug delivery company. A published author with multiple patents, she holds a PhD in organic chemistry from the Weizmann Institute of Science and a Master of Science and Bachelor of Science in chemical engineering from the Technion Institute of Technology.

James Ottinger, RPh, Executive Vice President, Regulatory Affairs and Quality

Mr. Ottinger joined UroGen in 2017 and most recently served as Senior Vice President of Regulatory Affairs, and has been directly responsible for guiding the regulatory pathway for UGN-101’s potential U.S. FDA approval. He is an experienced pharmaceutical industry executive with more than 30 years of strategic regulatory experience, having supported the successful development, approval, and marketing of a number of new drugs throughout his career. Prior to joining UroGen, Mr. Ottinger served as Senior Vice President of Global Regulatory Affairs at Teva Pharmaceutical Industries, Ltd., where he was responsible for global regulatory oversight of Teva’s portfolio of branded, generic, and over-the-counter products. Earlier in his career, Mr. Ottinger led both regulatory affairs and quality assurance with Premier Research Group Limited, and regulatory positions of increasing responsibility at Wyeth Research (acquired by Pfizer, Inc.). He holds a Bachelor of Science in pharmacy from the Temple University School of Pharmacy and is a registered pharmacist in the State of Pennsylvania.

Elyse Seltzer, MD, Chief Development Officer

Dr. Seltzer joined UroGen in 2017 and most recently served as UroGen’s Senior Vice President of Clinical Development. She brings a strong track record in clinical development within the pharmaceutical industry. Prior to joining UroGen, Dr. Seltzer served as Chief Medical Officer of Nabriva Therapeutics, where she was a key member of the management team that took the company public, and was responsible for the clinical and regulatory strategy and implementation of the company’s clinical development of Xenleta (lefamulin) for community acquired pneumonia. Dr. Seltzer joined Nabriva from GlaxoSmithKline (GSK), where she was Vice President of Global Clinical Sciences and Operations. Prior to joining GSK, Dr. Seltzer served as Chief Medical Officer at Tengion, a regenerative medicine company, where she established and built the company’s clinical organization. Dr. Seltzer previously held senior clinical development roles at Centocor and Vicuron and began her industry career at SmithKline Beecham (now GSK). Before joining the pharmaceutical industry, she practiced consultative Infectious Diseases and HIV care. Dr. Seltzer holds an MD from the New York University School of Medicine, completed her Internal Medicine training at the University of Pennsylvania Medical Center and her Infectious Diseases Training at Yale New Haven Hospital.

As UroGen positions itself for the next stage of growth, Stephen Mullennix, who has served as Chief Operating Officer, will be departing the company to pursue other opportunities. Mr. Mullennix has played an important role building the foundation for operational and financial efficiencies as the Company prepared for commercialization. Mr. Mullennix’s responsibilities will be transitioned to Mr. Bova, Dr. Konorty, and Mr. Ottinger, in their expanded roles.