On May 24, 2021 1 Redx Pharma (AIM: REDX), the drug discovery and development company focused on cancer and
fibrosis, reported that it will be releasing its interim results for the six months ended 31 March 2021 on 7 June 2021 (Press release, Redx Pharma, MAY 24, 2021, View Source [SID1234580479]).

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A live webcast will be held at 12:00pm BST on 7 June 2021 for analysts. To join the webcast, please register in advance by sending an
e-mail to [email protected]
A recording of the webcast will be made available on Redx Pharma’s website following the webcast

On May 24, 2021 Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) ("Aptorum Group" or "Aptorum"), a clinical-stage biopharmaceutical company, reported positive progress in respect of: (i) its ongoing Phase I clinical trial for ALS-4 (a first in-class anti-virulence approach based small molecule targeting Staphylococcus aureus, including, but not limited to Methicillin Resistant Staphylococcus Aureus ("MRSA")), under which two initial cohorts of the single dose ascending dose (SAD) portion of the trial in healthy male and female adult subjects have been completed with no serious adverse events observed (with in total 6 cohorts for SAD and 3 cohorts for multiple ascending dose (MAD) have been planned); and (ii) its ongoing Pre-IND preparation for SACT-1, a repurposed small molecule targeting neuroblastoma, under which the Pre-IND meeting with the US FDA has been completed (Press release, Aptorum, MAY 24, 2021, View Source [SID1234580498]).

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ALS-4’s first-in-human Phase I trial is a randomized, double-blinded, placebo-controlled, single and multiple ascending dose study designed to evaluate safety, tolerability, and pharmacokinetics of orally administered ALS-4 in healthy male and female adult volunteers. Dosing and safety reviews of Cohort A (25mg) and Cohort B (50mg) have been completed and eight subjects (6 received ALS-4 and 2 received placebo) were dosed in each cohort. We are pleased to announce that no human subjects were dropped out of the studies and there were no Serious Adverse Events (SAE) observed. In addition, no relevant clinical changes in respect of vital signs, ECG, clinical laboratory test results and physical examinations were observed compared to the relevant baseline. On this basis, the remaining ALS-4 Phase I study will continue to progress and as of this date, Cohort C (100mg) studies have been initiated.

SACT-1, a repurposed drug candidate for the treatment of neuroblastoma, has completed its Pre-IND meeting with the US FDA. With the guidance provided by the US FDA, SACT-1 is on track to open an IND to commence clinical studies in quarter 3 of 2021.

About ALS-4

As part of Aptorum Group’s Acticule infectious disease platform, ALS-4 is a novel first-in-class orally administered small molecule drug based on an anti-virulence approach targeting staphylococcus aureus including MRSA. ALS-4 targets the antimicrobial resistant properties of the bacteria and is believed to render the bacteria highly susceptible to the host’s immune clearance. ALS-4 is targeted for potential administration on a standalone or on a combination basis with other existing antibiotics such as vancomycin.

About SACT-1

As part of Aptorum Group’s SMART-ACT platform, SACT-1 was discovered from our SMART-ACT platform focused on orphan and unmet diseases. SACT-1 is a repurposed small molecule drug targeted for the treatment of neuroblastoma especially in combination with standard of care based chemotherapies. Our internal in vitro studies demonstrated that SACT-1’s mechanism has enhanced DNA damage and tumor cell death.

On May 24, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS") reported the approval of an investigational new drug application ("IND") by the United States Food and Drug Administration ("FDA") for CpG-STAT3siRNA, the company’s distinctive immuno-oncology RNA therapy for the treatment of multiple cancers (Press release, Scopus BioPharma, MAY 24, 2021, View Source [SID1234580515]).

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A Phase 1 clinical trial for B-cell non-Hodgkin lymphoma will be initiated at City of Hope.

Scopus is a biopharmaceutical company developing transformational therapeutics based on groundbreaking scientific and medical discoveries. City of Hope is a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases near Los Angeles, California.

CpG-STAT3siRNA encompasses both RNA therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment. This highly-distinctive drug candidate was developed in the City of Hope laboratories of Hua Yu, Ph.D. and Marcin Kortylewski, Ph.D. Yu is co-leader of the Cancer Immunotherapeutics Program and Billy and Audrey L. Wilder Professor in Tumor Immunotherapy. Kortylewski is a professor in the Department of Immuno-Oncology.

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).