On April 13, 2021 LintonPharm Co., Ltd., a China-based clinical stage biopharmaceutical company focused on the development of T cell engaging bispecific antibodies for cancer immunotherapy, reported that China’s health authority, National Medical Products Administration (NMPA) authorized the company to proceed with a Phase 1/2 clinical trial (clinicaltrials.gov: NCT04799847) evaluating the safety and efficacy of catumaxomab in patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) whose tumors have recurred due to Bacillus Calmette-Guerin (BCG) vaccine failure (Press release, Lintonpharm, APR 13, 2021, View Source [SID1234577988]). This is LintonPharm’s second clinical program evaluating catumaxomab. In July 2020, the company announced authorization of a Phase 3 trial in advanced gastric cancer which screened its first patient in October 2020.

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Recently, Lindis Biotech, partner of LintonPharm, initiated a dose-finding Phase 1 trial with catumaxomab in NMIBC patients in Germany (clinicaltrials.gov: NCT04819399) and reported an excellent safety profile, which supports the conduct of the Phase 1/2 trial in China.

"Regulatory clearance to move forward with our clinical program evaluating catumaxomab in bladder cancer is another significant milestone for LintonPharm and supports our goal of exploring the potential for this targeted therapy in a broad range of cancers," said Robert Li, Ph.D., DABT, Co-founder and CEO of LintonPharm. "Patients with NMIBC BCG failure have high rates of tumor recurrence and often face a lifetime of surgical intervention which may impact bladder function. New treatment options are needed and we are hopeful that this study puts us one step closer toward helping these patients."

Bladder cancer is the 10th most common cancer worldwide. In 2020, bladder cancer was diagnosed in approximately 573,278 patients globally and approximately 1.8 million people were living with this form of cancer over a five-year period [1]. NMIBC is a cancer found in the tissue that lines the inner surface of the bladder and accounts for approximately 75 percent of all bladder cancer [2]. Transurethral resection of bladder tumor (TURBT) is the current standard of treatment for NMIBC. Relapse is common after TURBT (up to 70 percent at five years) and as a result, patients often undergo multiple surgical procedures over a longer period [2]. Intravesical BCG is commonly used as an adjuvant treatment after TURBT. However, a large number of patients experience tumor recurrence, which is referred to as BCG failure [3]. Radical cystectomy (RC) is usually recommended after BCG failure, but many physicians and patients refrain from RC in favor of preserving bladder function.

About Catumaxomab

Catumaxomab was approved by the European Medicines Agency in 2009 for the treatment of malignant ascites. This bispecific antibody binds to a transmembrane glycoprotein on the tumor cell–the epithelial cell adhesion molecule (EpCAM)–and CD3 on the T cell, and also recruits immune accessory cells through FcγR binding. Catumaxomab destroys tumor cells by engaging T cell and accessory cell mediated cytotoxicity and has the potential to induce long-term vaccinal effects which has been verified in animal models.

Recently, catumaxomab was authorized by regulatory authorities in China, Taiwan (China) and South Korea to conduct a global Phase 3 clinical trial for treating patients with advanced gastric cancer.

On April 13, 2021 Theseus Pharmaceuticals, a biotechnology company shaping the future of targeted oncology by developing best-in-class, pan-variant kinase inhibitors, emerged from stealth reported the close of a $100 million Series B financing led by Foresite Capital (Press release, Theseus Pharmaceuticals, APR 13, 2021, View Source [SID1234577973]). Theseus also announced data from a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting, which demonstrated that the Company’s lead product candidate, THE-630, has potent activity against all major classes of activating and resistance mutations observed in patients with KIT-mutant gastrointestinal stromal tumors (GIST).

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OrbiMed incubated Theseus to develop therapies designed to outsmart treatment-resistant cancer mutations, funding the Company’s Series A in 2018. In addition to Foresite Capital, the Series B raise was supported by a syndicate of other new investors, including Adage Capital Management, Boxer Capital, Farallon Capital Management, Longitude Capital, Nextech Ventures, Omega Funds, Pontifax Venture Capital, Rock Springs Capital, and T. Rowe Price, as well as OrbiMed. In conjunction with the financing, Michael Rome, Ph.D., Managing Director of Foresite Capital, has joined the Theseus Board of Directors, which also includes Carl Gordon, General Partner at OrbiMed.

"We are thrilled by the validation of this discerning group of investors and welcome Michael to Theseus’ board of directors," said William C. Shakespeare, Ph.D., Co-founder and President of Research and Development at Theseus Pharmaceuticals. "For many driver-oncogene targets, current standard-of-care kinase inhibitors have insufficient activity to cover the broad array of variants that could lead to resistance, so they are limited by constantly mutating cancer. At Theseus, we take a pan-variant approach to targeting oncogenes with kinase inhibitors specifically designed to retain their effectiveness even as cancer mutates. Using sophisticated assays, we can predict how cancers will change, enabling new therapies to stay ahead of future mutations and overcome the demonstrated burden of treatment resistance."

Theseus is developing a pipeline of pan-variant tyrosine kinase inhibitors (TKIs) that can anticipate and inhibit new cancer mutations. The Company’s lead candidate, THE-630, is a next-generation pan-variant KIT inhibitor in development for the treatment of refractory GIST. The Company expects to file an IND before the end of the year. Theseus’ pipeline also includes a selective EGFR inhibitor to overcome C797S-mediated resistance to first- or later-line osimertinib treatment for patients with non-small cell lung cancer, and a third kinase target candidate for an undisclosed indication.

Iain Dukes, D. Phil., Co-founder and Interim CEO of Theseus Pharmaceuticals, and Venture Partner of OrbiMed, commented, "The scientific co-founders of Theseus are a team of distinguished drug discovery and development leaders who have pioneered the development of pan-variant kinase inhibitors. Together at ARIAD Pharmaceuticals, they discovered and developed multiple kinase inhibitors in areas of high clinical need, two of which they brought to market, ponatinib and brigatinib, and a third, mobocertinib, that is now in late-stage clinical development. With this foundation of expertise, combined with the backing of a top-tier syndicate of investors, Theseus is well positioned to develop best-in-class, pan-variant TKIs that provide durable benefit for people living with cancer."

At the AACR (Free AACR Whitepaper) meeting, Theseus presented preclinical data demonstrating that THE-630 has potent activity against all classes of activating and resistance mutations observed in KIT-mutated GIST. These data showed that THE-630 was highly efficacious in tumor models containing mutations that confer resistance to approved TKIs. These data highlight the potential for a pan-variant inhibitor such as THE-630 to deliver meaningful clinical benefit for patients with refractory GIST. The presentation can be found on Theseus’ website.

On April 13, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for medical imaging and therapeutic applications, reported a corporate update highlighting progress across its key programs during the past twelve months and upcoming milestones (Press release, NorthStar Medical Radiostopes, APR 13, 2021, View Source [SID1234577989]).

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"NorthStar has made significant advancements across our portfolio over the past year and we are excited about the Company’s future," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "In advancing our plans to ensure reliable, non-uranium based radioisotope supply for the United States, RadioGenix System (technetium Tc 99m generator) sales continue to increase. Our facility expansions, designed to ensure additional production capacity and supply of Mo-99, are nearing completion. Additionally, NorthStar has broadened its technology platform to address critical unmet needs in radioisotope supply by advancing commercial-scale development of promising therapeutic radioisotopes, and our novel cardiovascular SPECT imaging agent, FibroScint, is advancing towards eIND-enabling studies. We are collaborating with IBA to increase global availability of Tc-99 and with Monopar Therapeutics to develop a targeted radiotherapeutic agent for severe COVID-19 and other acute respiratory diseases. NorthStar anticipates sustained progress and growth as we expand our horizons globally and execute strongly in our mission to provide reliable radioisotope supply to support patients’ healthcare needs."

Corporate development and industry leadership
NorthStar is firmly positioned for long term growth and increasing global industry leadership.

In March 2021, NorthStar implemented organizational changes to drive focused growth for its therapeutic and specialized SPECT radioisotopes business. The new structure enables NorthStar to advance its radioisotope development and commercialization planning efforts in parallel with ongoing expansion programs for increased U.S. Mo-99 capacity and production. In conjunction with other organizational changes, NorthStar appointed Dave Wilson, RPh, BCNP, as Vice President, Advanced Radiopharmaceutical and Therapeutic Technologies to lead these initiatives to commercialization.
In October 2020, NorthStar promoted Chief Financial Officer Paul Estrem to Executive Vice President and he was appointed to the NorthStar Board of Managers. Mr. Estrem has been instrumental in building momentum to create and expand NorthStar’s product portfolio. The expanded role positions him to guide NorthStar’s corporate strategy and drive its planned corporate and business development initiatives.
NorthStar is a widely recognized leader in radioisotope technology development and commercialization and the nuclear medicine industry. In July 2020, NorthStar led an update on its ongoing commercial Mo-99 production, expansion plans and the RadioGenix System at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) event, "Industry Outlook on Current and Future Mo-99 Supply." In September 2020, then-Deputy Secretary of Energy Mark W. Menezes visited NorthStar to learn about its U.S.-based Mo-99 production, underscoring the Department of Energy’s commitment to reviving and expanding the U.S. nuclear sector and to reduce dependence on foreign imports while bringing new opportunities to the heartland.
RadioGenix System commercial progress
NorthStar’s innovative, high tech radioisotope separation platform, the RadioGenix System, uses U.S.-produced, non-uranium based Mo-99 to produce Tc-99m, the most widely used medical radioisotope that informs patient management decisions in 40,000 U.S. imaging studies daily.

RadioGenix System sales continue to steadily increase, with hundreds of thousands of doses provided for patients’ diagnostic imaging studies to date. Since becoming commercially available, RadioGenix Systems have provided reliable Tc-99m supply for customers with U.S.-produced Mo-99, despite intermittent shortages from suppliers using legacy, uranium-based production methods.
Ongoing product development programs continue to maximize operational utility and efficiency in producing Tc-99m. Since initial approval in 2018, NorthStar has received five subsequent Food and Drug Administration (FDA) approvals, the latest in January 2021 for concentrated Mo-98 and RadioGenix System updates.
Commercial U.S. Mo-99 manufacturing and production expansion
NorthStar is the only commercialized U.S. producer of Mo-99. It is aggressively expanding and establishing dual production and processing hubs for additional Mo-99 capacity to better meet customer demand and to ensure sustainable U.S. supply. Two facility expansion projects nearing completion in Beloit, Wisconsin, will augment current Mo-99 production and processing in Columbia, Missouri, conducted in partnership with the University of Missouri Research Reactor (MURR).

NorthStar’s Isotope Processing facility in Beloit will complement current Columbia processing capacity for Mo-99 source vessels. The facility will enable NorthStar to more than double its production of Mo-99, used with RadioGenix Systems to produce Tc-99m. Equipment installation is nearing completion, testing is underway with full qualification to be completed by the end of 2021. NorthStar expects FDA approval for the Beloit Isotope Processing facility in 2022.
NorthStar’s Accelerator Production facility expansion in Beloit will ensure additional Mo-99 capacity, enable flexible production scheduling and minimize customer supply risks. Like other NorthStar processes, accelerator production of Mo-99 using the "neutron knock-out" method is non-uranium based and highly efficient. The first pair of IBA electron beam accelerators will arrive for installation at NorthStar’s facility in April 2021. The Company anticipates accelerator production to begin in 2023, pending appropriate licensure and FDA approval.
In January 2021, the FDA approved NorthStar’s process for producing Mo-99 from concentrated Mo-98 and related software updates for the RadioGenix System. This approval is the first and only commercial-scale production of Mo-99 using concentrated Mo-98 technology. It increases NorthStar’s Mo-99 production capacity up to four times above its current technology, to provide higher activity source vessels to better meet customer demand.
FDA approval of concentrated Mo-98 allows NorthStar to serve as much as 40% of the U.S. demand for Mo-99 by the end of 2021. The Company expects 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.
Commercial-scale therapeutic radioisotope production − Ac-225 and Cu-67
NorthStar is poised to be the first commercial-scale supplier of the important therapeutic radioisotopes Ac-225 and Cu-67, both used to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Current production technology limitations and resultant limited supply have severely constrained development of these promising therapies.

NorthStar is applying its commercial-scale radioisotope production expertise to provide reliable Ac-225 and Cu-67 supply to advance clinical research and for commercial radiopharmaceutical products. The Company is leveraging the same technology expertise demonstrated by the successful launch of the RadioGenix System and non-uranium based Mo-99 supply.
NorthStar has relationships in place with several large pharmaceutical companies to provide clinical trial supply and commercial-scale quantities of Ac-225 and Cu-67. The Company expects to secure long-term supply agreements during 2021.
Specialized SPECT portfolio
NorthStar is actively developing and growing its strategic portfolio of specialized single photon emission computed tomography (SPECT) radiopharmaceuticals to meet increasing clinical needs for SPECT imaging, driven by scientific advancements in cardiology and oncology.

NorthStar has an exclusive, global licensing agreement with Capella Imaging, Inc. for FibroScint, a novel fibrin-specific diagnostic imaging agent labeled with Tc-99m for SPECT imaging. Pending successful development, FibroScint will have an initial application in the imaging of thrombus (blood clots) associated with left ventricular assist devices (LVADs), and other potential imaging applications in deep vein thrombosis and pulmonary embolism. NorthStar intends to use RadioGenix System-produced Tc-99m in planned clinical studies of FibroScint. Advanced preclinical development is underway, with an exploratory Investigational New Drug (IND) filing for a Phase 1 study planned for early 2022.
NorthStar is evaluating additional potential opportunities in specialized SPECT radiopharmaceuticals to address unmet healthcare needs and synergies with its product portfolio.
Partnerships and collaborations
NorthStar selectively partners with leading organizations in strategic collaborations designed to augment its portfolio, maximize synergies and drive growth in areas of unmet medical need.

In June 2020, NorthStar and Monopar Therapeutics Inc. (Nasdaq: MNPR) announced a collaboration to help combat severe COVID-19 and other severe respiratory diseases. The collaboration will couple Monopar’s targeted monoclonal antibody MNPR-101 to a therapeutic radioisotope supplied by NorthStar to create a highly selective agent with potential to spare healthy cells while quickly reducing cytokine storms and their harmful systemic effects. In December 2020, Monopar and NorthStar announced that a clinical candidate was selected, enabling preclinical studies to begin and advancing one step closer to reaching human clinical trials.
In March 2021, NorthStar and IBA (Ion Beam Applications S.A., EURONEXT) announced a collaboration to increase global availability of Tc-99m, with potential to result in non-uranium Mo-99 being the leading worldwide source of Tc-99m. Worldwide, diagnostic imaging studies using Tc-99m inform healthcare decisions for approximately 30 million patients annually. The collaboration enables companies outside the United States to access Tc-99m Generation Systems (TCM Generation Systems) that utilize NorthStar’s proprietary non-uranium based Mo-99 produced using IBA’s accelerators and beamlines. Early discussions with interested companies are underway.
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 based 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 (FDA) in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-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

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.
Unintended Re-186 Exposure: 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 24 hour expiration time from elution is reached, whichever occurs earlier.

On April 13, 2021 Bridge Biotherapeutics reported that the company’s former vice president, Lee Kwang-hee, the company established a new bio company named, Boostimmune, (Press release, Boostimmune, APR 13, 2021, View Source [SID1234634467]). It is a determination to develop an immuno-anticancer agent that will be effective against various cancers with MDSC inhibitor technology introduced by the University of Tokyo.

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Former Vice President Lee left Bridge Bio early this year and established BoostImmune in February. The company is located in Pangyo, Seongnam-si, Gyeonggi-do, and a total of three people, including CEO Lee Kwang-hee, are working. CEO Lee said, "We established the company for the purpose of developing a protein-based immuno-oncology drug, not a synthetic drug."

Tadatsugu Taniguchi, professor emeritus at the University of Tokyo, is the co-founder. Professor Tada is a scholar who first discovered ‘interleukin 2’ and ‘interferon beta’, regular customers of immunology research, and has published 300 papers related to immunology alone. There are multiple pipeline tasks, including MDSC inhibitors introduced by the University of Tokyo.

CEO Lee explained, "There are various mechanisms that prevent immune cells from working properly, and one of them is MDSC (Myeloid derived suppressor cell)." Representative Lee pursued a master’s degree in molecular biology at Seoul National University and a doctoral course at Washington University School of Medicine in the United States, and accumulated research and development experience at the US National Institutes of Health (NIH), Genentech, and Sanofi.

While working at Bridge Bio, he has experience in clinical application (IND) to the U.S. Food and Drug Administration (FDA) for three drugs: ulcerative colitis treatment (BBT401), idiopathic pulmonary fibrosis treatment (BBT877), and non-small cell lung cancer treatment (BBT176). .

BoostImmune’s role model is Genentech. Genentech is a first-generation protein drug company. Herceptin (breast cancer treatment), Rituxan (autoimmune disease treatment), and Avastin (metastatic colorectal cancer treatment), which are blockbuster biopharmaceuticals developed by Genentech, achieved sales of $6 billion (6.75 trillion won), $6.5 billion, and $7.1 billion, respectively, in 2019. . In 2009, Roche acquired Genentech for $47 billion (approximately 52 trillion won) and took the copyright.

On April 13, 2021 Cofactor Genomics, the company bridging the precision medicine gap, reported commencement of the first multicenter clinical trial of its OncoPrismTM diagnostic assay, using the company’s patented approach to generating multidimensional immune biomarkers (Press release, Cofactor Genomics, APR 13, 2021, View Source [SID1234577954]). Fifteen hospitals and healthcare networks, including Mayo Clinic, MultiCare Institute for Research and Innovation, and Revive Research Institute, are currently enrolling in the PREDAPT (Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies) Trial to evaluate use of the OncoPrism test in patients with recurrent and metastatic squamous cell carcinoma of the head and neck (RM-HNSCC) to effectively predict a patient’s response to immunotherapy. The company expects additional sites to join the trial before the end of 2021.

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While the trial will initially recruit RM-HNSCC patients, the protocol is approved for recruitment of patients with 10 additional indications where independent market research has identified an unmet clinical need in predicting tumor response to immunotherapy. Specimens collected in the study will be analyzed at Cofactor’s CAP/CLIA accredited laboratory.

"Opening recruitment for the PREDAPT study is a significant milestone for Cofactor. It represents not only the world’s first Predictive Immune Modeling clinical validation study, but the first of many studies we intend to sponsor. These studies will lead to predictive diagnostics that are undeniably needed in the field, for therapies that are in development or those already on the market," stated David Messina, PhD, Cofactor’s Chief Operating Officer. "Physicians do not currently have adequate information to predict tumor response to immune checkpoint inhibitors, resulting in ineffective and inconsistent treatment. This is ultimately a heavy burden on both patients and the healthcare system that supports them; we intend to change that."

The study includes both retrospective and prospective specimen collection, but does not require any additional visits or surgery outside of standard care for enrolled patients. The PREDAPT trial builds on preliminary results recently presented that showed the performance of a multidimensional RNA biomarker built using the company’s Predictive Immune Modeling approach was more effective than the on-label PD-L1 immunohistochemistry (IHC) assay in predicting tumor response to anti-PD-1 therapy in RM-HNSCC.

PREDAPT is uniquely designed to be a decentralized study. To enable that, Cofactor has contracted Curebase as the CRO partner, who enables highly virtual clinical trials by offering a full-service CRO and eClinical Platform, complete with eConsent, electronic data capture, and remote monitoring capabilities. This enables individual investigators, who may be passionate about science and improving patient outcomes, the ability to participate in the clinical trial even if their hospital is unable to participate as a traditional clinical site. It has also enabled Cofactor to establish two major recruitment streams to ensure maximum diversity and streamlined recruitment, traditional clinical sites and direct-to-patient recruitment.

"The PREDAPT study is exactly what we had in mind when we built the Curebase platform. Using software-powered, decentralized research methods, we are proving with Cofactor that any patient can be part of a clinical trial no matter where they live," noted Tom Lemberg, CEO at Curebase.

Despite the thousands of new clinical trials that are started every year and the significant advances made in launching innovative therapies such as immunotherapies, physicians are still prescribing the wrong therapy to more than 80 percent of patients.1 The gap in matching these innovative therapies to the patients that will benefit (and avoiding those who will not respond or may have adverse reactions) is a major problem in healthcare.

"Technologies that are capable of playing matchmaker and bridging this gap are key," said Jarret Glasscock, PhD, Cofactor’s Chief Executive Officer. "The field of Predictive Immune Modeling is building this next generation of predictive diagnostics that are showing an enhanced ability to accurately predict patient response prior to treatment. We expect these technologies to not only improve patient treatment paths, but to also provide cost savings to the entire healthcare system."

Sites interested in joining this high impact study may contact [email protected] or express their interest here.