On May 24, 2021 Monopar Therapeutics Inc. (Nasdaq: MNPR) and NorthStar Medical Radioisotopes, LLC, reported the filing of a provisional patent with the U.S. Patent and Trademark Office (USPTO) titled "Bio-Targeted Radiopharmaceutical Compositions Containing Ac-225 and Methods of Preparation (Press release, Monopar Therapeutics, MAY 24, 2021, View Source [SID1234580489])." Radiopharmaceutical therapy is a promising approach to treat cancer and other diseases using radioactive metals bound with proteins/antibodies to target and kill cells. Actinium-225 (Ac-225) is emerging as a radioactive isotope of choice for radiopharmaceuticals due to favorable properties such as its long half-life, high potency, and induction of localized cell death.

This provisional patent relates to the unexpected observation by Monopar and NorthStar that using the metal binding agent 3,6,9,15-tetraazabicyclo[9.3.1]pentadeca-1(15),11,13-triene-3,6,9-triacetic acid (PCTA) to attach Ac-225 to antibodies resulted in nearly 100% binding of Ac-225 to the PCTA-antibody conjugates. If validated through further evaluation, it could potentially improve efficacy and safety and enhance manufacturing efficiency of Actinium-based radiopharmaceuticals.

Based on Monopar and NorthStar’s work to date, PCTA-antibody conjugates appear to bind Ac-225 and its daughter ions such as Bi-213 with high affinity. This could be important in the situation of transportation delays resulting in Ac-225 decaying during transport. Furthermore, when compared to DOTA (the standard binding agent for attaching Ac-225 to an antibody), PCTA-antibody conjugates displayed a significantly higher affinity to Ac-225. This high affinity binding may decrease the amount of Ac-225 and its daughter ions that detach from the antibody, which could potentially increase efficacy and reduce off-target toxicity and enable higher dosing. Monopar and NorthStar plan to explore both internal development and out-licensing opportunities of this promising approach in Actinium-based radiopharmaceuticals.

"Actinium is quickly becoming a premier radioisotope in cancer-targeting therapies, but its potential is limited due to its price and scarcity," said James Harvey, PhD, Chief Scientific Officer of NorthStar. "Enabling radiopharmaceutical manufacturers and drug developers to maximize the binding efficiency of Ac-225, and thereby reduce the quantity of Ac-225 required for purchase and use, would permit this promising class of drugs to reach its full potential."

"Binding Actinium to antibodies using PCTA instead of DOTA has displayed unexpected and unique properties including substantially tighter binding of Ac-225 and a much higher incorporation into the PCTA-antibody conjugate," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar. "This technology could have broad applicability to the manufacturing of numerous radio-immuno-conjugates and may also extend to other proteins."

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On May 24, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported that the first patient has been successfully enrolled and dosed in the clinical trial of pemigatinib (IBI375), a fibroblast growth factor receptor 1/2/3 (FGFR1/2/3) inhibitor, for the treatment of unresectable or metastatic cholangiocarcinoma in China (Press release, Innovent Biologics, MAY 24, 2021, View Source [SID1234580505]). The study is a key component of the global Phase 3 clinical trial, which evaluates the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin in first-line treatment of participants with unresectable or metastatic cholangiocarcinma with a fibroblast growth factor receptor 2 (FGFR2) rearrangement.

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Dr. Hui Zhou, the Senior Vice President of Innovent, stated: ‘Cholangiocarcinoma is the second most common primary liver cancer with a high incidence in Asia due to relatively widespread infection of HBV and parasites.’ He emphasized that a significant portion of patients receive an initial diagnosis of unresectable and/or metastatic status and that first-line systemic therapy is typically gemcitabine plus cisplatin, with a response rate of 26%, median progression-free survival (mPFS) of 8 months and overall survival (mOS) of 11.7 months. ‘The poor prognosis and the side effects associated with systematic chemotherapy increase the urgency of improving upon the treatment efficacy as well as the quality of life of patients with cholangiocarcinoma. Data from previous clinical trials of pemigatinib in participants with advanced cholangiocarcinoma with FGFR2 fusion as second line or later treatment has not only shown satisfactory safety results but also revealed compelling efficacy signals. The results demonstrate that pemigatinib has an objective response rate (ORR) of 35.5%, mPFS of 6.9 months and estimated OS of 21.1 months. With the refractory subjects being seen as the more challenging population and based on the promising data, we believe that participants with FGFR2 rearrangement may benefit from targeted therapy like pemigatinib. We are looking forward to see the therapeutic contribution of pemigatinib in the treatment of cholangiocarcinoma as the pre-NDA process of the drug in China is under preparation’, Dr. Zhou highlighted.

About Advanced Cholangiocarcinoma and FGFR2 Rearrangement

Cholangiocarcinoma is a malignant tumour originated from biliary epithelium cells and it is categorized as intrahepatic or extrahepatic based on anatomical location of origin. The incidence of cholangiocarcinoma has been increasing progressively over the past decade. Surgery is the first priority for patients with resectable disease. However, most cholangiocarcinomas has been in advanced and/or metastatic status at diagnosis and lost the chance for surgical resection. The treatment options for patient who relapse after surgery or have advanced / metastatic disease are limited and the recommended therapy method is systemic chemotherapy with gemicitabine plus cisplatin, which has a medium overall survival of less than a year.

Aberrant signaling through FGFR resulting from gene amplification or mutation, chromosomal translocation, and ligand-dependent activation of the receptors has been demonstrated in multiple types of human cancers. Fibroblast growth factor receptor signaling contributes to the development of malignancies by promoting tumor cell proliferation, survival, migration, and angiogenesis. Results from early clinical studies of selective FGFR inhibitors, including pemigatinib, have shown a tolerable safety profile for the class and preliminary signs of clinical benefit in participants with FGF/FGFR alterations.

About Pemigatinib (Pemazyre)

In April 2020, the U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib), a selective, oral inhibitor of FGFR isoforms 1, 2 and 3, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer with a FGFR2 fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is marketed by Incyte in the United States, Europe and Japan.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the three assets in Mainland China, Hong Kong, Macau and Taiwan. In March 2020, Innovent announced that the first patient was dosed in the pivotal registrational trial evaluating pemigatinib in patients with advanced cholangiocarcinoma in China.

Pemazyre is a trademark of Incyte Corporation.

On May 23, 2021 Genesis MedTech Group ("Genesis"), a leading medical device company, reported it has completed its Series B round, raising significant growth financing (Press release, Genesis Pharma, MAY 23, 2021, View Source [SID1234580469]). General Atlantic, a leading global growth equity firm, led the funding with participation from CITIC Capital and others. The majority of shareholders from Series A followed up with additional investments. Lefei Sun, Managing Director and Head of Healthcare for China at General Atlantic, will join the Genesis Board of Directors.

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The funds will be used to drive the research and development of new products and the commercialization of existing products, as well as enable business expansion in emerging markets around the world. This acceleration in Genesis’ model is expected to enable patients and healthcare practitioners in emerging markets to access innovative medtech products that can address unmet needs faced day-to-day-Genesis’ mission since its inception in 2019.

Meeting Needs Where They Are

Genesis’ purpose was born to solve a growing healthcare issue within emerging markets, where increased health problems and demand for medtech solutions are not proportionally addressed by accessible products currently on the market. Despite rapid developments in medtech innovation globally, many of these products remain out of reach for patients and practitioners in these markets.

Genesis seeks to address this issue and has received significant support from innovators worldwide. Its vertically integrated business model, complete with a wide hospital and clinic network, allows for a deep understanding of patients’ and practitioners’ needs on the ground. Armed with this knowledge, Genesis collaborates with innovators worldwide through an open medtech platform that accelerates meaningful innovations that are cost-effective to meet healthcare needs in these markets.

Warren Wang, Chairman and CEO of Genesis Medtech Group, outlined the importance of collaboration with leading global partners and putting market needs first and foremost: "Our open platform is quintessential in enabling us to bring the world’s leading products and technologies to doctors and patients. We will also invest in adding premier talent, consolidating our R&D capabilities, incubating new technologies, and continuing to pursue solutions that answer the real needs of patients and healthcare practitioners – delivering impact where it is needed most."

Lefei Sun, Managing Director and Head of Healthcare for China at General Atlantic, added, "We are excited to help propel the work that Genesis is doing to advance access to healthcare and innovative medical solutions in emerging markets. We believe Genesis’ capability set is highly differentiated through the combination of its technology, product and team, with a comprehensive portfolio underpinned by a scalable and integrated platform. This latest round of funding will enable Genesis to continue to tackle disparities in medtech accessibility across global markets. We look forward to partnering with Genesis in this next chapter of its growth."

To date, Genesis’ product portfolio includes surgical, neurovascular, peripheral vascular and cardiovascular products. Genesis collaborated with medtech leaders in bringing multiple innovations into China as part of its commitment to making quality healthcare more affordable and accessible for emerging markets.

On May 22, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported two Memoranda of Understanding (MoU) with the government of South Korea: one MoU with the Korea National Institute of Health (KNIH), an agency of the Korea Centers for Disease Control and Prevention Agency (KDCA) for a new collaboration on mRNA vaccine research in South Korea; and an additional MoU with the Ministry of Trade, Industry and Energy of the Republic of Korea (MOTIE), the Ministry of Health and Welfare of the Republic of Korea (MOHW) to explore local manufacturing opportunities for mRNA vaccines in South Korea (Press release, Moderna Therapeutics, MAY 22, 2021, View Source [SID1234580468]).

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The MoUs were signed today by Kwon Junwook, Director, KNIH and Stéphane Bancel, Moderna’s Chief Executive Officer at a signing ceremony in Washington, D.C. With these MoUs, Moderna and the KNIH will explore areas of collaboration for scientific research on mRNA vaccines. The teams will engage in discussions regarding collaboration opportunities such as pre-clinical or clinical development of mRNA vaccine candidates against viruses that create a high burden of disease in South Korea. These MoUs may also facilitate discussions between Moderna and South Korea for a potential manufacturing facility for mRNA vaccines in South Korea.

"We thank the South Korean government and we look forward to exploring this collaboration to bring mRNA vaccines that may help address areas of unmet need," said Stéphane Bancel, Chief Executive Officer of Moderna. "We will continue to explore options for establishing potential local manufacturing opportunities in South Korea."

Also announced at the signing ceremony, Moderna and Samsung Biologics have entered into a Manufacturing Services and Supply Agreement in which Samsung Biologics in South Korea will provide large scale, commercial fill-finish manufacturing for COVID-19 Vaccine Moderna intended for the supply of markets outside of the U.S. starting in the third quarter of 2021.

Earlier this year, Moderna announced that as it continues to scale its commercial network, the Company plans to open a commercial subsidiary in South Korea in 2021.

The Ministry of Food and Drug Safety of South Korea (MFDS) approved Moderna’s application for Conditional Marketing Authorization for Moderna’s COVID-19 vaccine on May 21. GC Pharma in South Korea is the Company’s marketing authorization holder and distributor of Moderna’s COVID-19 vaccine for South Korea. South Korea has secured access to 40 million doses of COVID-19 Vaccine Moderna.

Authorized Use

Moderna’s COVID-19 vaccine is authorized pursuant to a Conditional Marketing Authorization in South Korea for use in adults aged 18 years and older.

About the COVID-19 Vaccine Moderna

The COVID-19 Vaccine Moderna (referred to in the U.S. as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the National Institutes of Health (NIH) on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of the vaccine. On July 8, the Phase 2 study completed enrolment.

Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On November 30, 2020, the Company also announced that it filed for Emergency Use Authorization with the U.S.FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has also received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar, Taiwan, the Philippines, Thailand, Brunei, Paraguay, Japan, South Korea an Emergency Use Listing (EUL) from the World Health Organization (WHO).

On May 21, 2021 AQILION AB (publ) reported by that the Swedish version of the 2020 Annual Report has been published and is available on the company’s website (Press release, Aqilion, MAY 21, 2021, View Source [SID1234580436]).

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The 2020 Annual Report in Swedish can be downloaded from the company’s website, www.aqilion.com (Corporate/Financial Reports). An English translation of the Annual Report is estimated to become available on Aqilion’s website during the week commencing on June 14, 2021.