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 BerGenBio ASA (OSE:BGBIO), BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported that BerGenBio CEO Mr. Richard Godfrey is presenting at the following virtual conference (Press release, BerGenBio, MAY 21, 2021, View Source [SID1234583869]):

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ABGSC Life Science Summit, virtual

Date: 25 May

Live presentation at 10.30hrs CET

The presentation will be made available on the Company website:
www.bergenbio.com/investors/presentations/

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases.

In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor to ACE2, to which the spike protein of the SARS-CoV-2 virus attaches and enters the host cell, and AXL expression is upregulated that leads to suppression of the Type 1 Interferon immune response by host cells and in their environment.

Research data confirms bemcentinib inhibits SARS-CoV-2 host cell entry and promotes the anti-viral Type I interferon response. Data from a Phase II in human clinical trial has shown that treatment with AXL inhibitor bemcentinib increased the rate ventilator free survival in hospitalised COVID-19 patients.

In cancer, increase in AXL expression has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers. AXL suppresses the body’s immune response to tumours and drives treatment failure across many cancers. High AXL expression defines a very poor prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib, therefore, have potential high value as monotherapy and as the cornerstone of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases including fibrosis.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potential first-in-class, potent and highly selective AXL inhibitor, currently in a broad phase II clinical development programme. It is administered as an oral capsule and taken once per day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity.

On May 21, 2021 Janux Therapeutics reported that it has filed to raise up to $100 million in an IPO (Press release, Janux Therapeutics, MAY 21, 2021, View Source [SID1234580465]). The Merck-partnered biotech wants the money to take a clutch of T-cell engager drug candidates into phase 1 clinical trials.

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San Diego-based Janux has raised $201 million from investors including Avalon Ventures and RA Capital since setting up shop in 2017. Using the money, Janux has established a preclinical pipeline based on its TRACTr platform. The platform is designed to overcome the limitations of existing T-cell engagers and, in doing so, realize the potential of the modality in solid tumors.

Now, with candidates against PSMA, EGFR and TROP2 going through IND-enabling studies on route to clinical development, Janux is turning to public investors to finance the next stage of its evolution.

Using the IPO haul, Janux plans to submit four INDs, starting in the first half of next year. The PSMA candidate is leading the way, trailed by the EGFR and TROP2 assets and an early-stage PD-L1xCD28 costimulatory bispecific.

The areas of focus put Janux up against bigger companies with more advanced assets. Regeneron, for example, took a PSMA bispecific into the clinic in 2019. Bayer, in collaboration with Amgen, moved a candidate into human testing back in 2012, although Janux sees the difficulties that program ran into as evidence of the differentiation of its asset. Amgen now has a different PSMA drug in the clinic.

Janux is asking public investors to back it on the strength of early-stage evidence. The IPO paperwork features the findings of an initial proof-of-technology study that showed its EGFR prospect did not lead to cytokine release syndrome in nonhuman primates and drove tumor shrinkage in a mouse model. Janux has preclinical data on its other candidates, too.

In addition to the early evidence, Janux has the validation of its investor syndicate and Merck, which teamed up with the biotech late last year to work on TRACTr candidates against two cancer targets.

The Merck collaboration, which is currently Janux’s sole source of revenue, generated $380,000 for the biotech over the first three months of the year. Merck paid $8 million upfront to kick off work on the first collaboration and will pay the same amount when the second target is selected.

Janux could ultimately receive almost $500 million in success-based fees per target, but the payments are heavily backloaded, with $350 million tied to sales milestones. The development and regulatory milestones are worth up to $142.5 million per target.

On May 21, 2021 Guardant Health, Inc. (Nasdaq: GH) reported that the U.S. Food and Drug Administration (FDA) has approved the Guardant360 CDx liquid biopsy test as the first and only companion diagnostic for Janssen Biotech, Inc.’s (Janssen’s) RYBREVANT (amivantamab-vmjw) (Press release, Guardant Health, MAY 21, 2021, View Source [SID1234580459]).

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The Guardant360 CDx test will be used for tumor mutation profiling, or comprehensive genomic profiling, to identify patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor the EGFR exon 20 insertion mutation and may benefit from targeted treatment with RYBREVANT after progressing on or after platinum-based chemotherapy.

Lung cancer is the leading cause of cancer death in the U.S.1, and NSCLC represents approximately 84 percent of all lung cancers.2 EGFR mutations are present in about one-third of patients with NSCLC,3 and EGFR exon 20 insertion mutations are the third most prevalent mutation type.4 These mutations are highly resistant to chemotherapy and tyrosine kinase inhibitors (TKI)4, and until now, a targeted therapeutic has not existed.

"Today’s FDA approval of Guardant360 CDx as a companion diagnostic for RYBREVANT, the first targeted therapy to treat EGFR exon 20 mutations, is a key milestone for patients who, until now, have had limited treatment options," said Helmy Eltoukhy, Guardant Health CEO. "We are proud to offer our Guardant360 CDx liquid biopsy blood test as a companion diagnostic so that patients may have access to comprehensive genomic profiling in order to see if they are eligible to receive this new treatment."

For oncologists, the FDA-approved Guardant360 CDx provides comprehensive genomic results from a simple blood draw in seven days, helping them move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including those most relevant to clinical care and NSCLC treatment guidelines.

Since being introduced, the Guardant360 test has become widely accepted for blood-based comprehensive genomic profiling with more than 200 peer-reviewed publications. It has been trusted by more than 9,000 oncologists, with more than 150,000 tests performed to date, and is broadly covered by Medicare and many private payers, representing over 200 million lives.

On May 21, 2021 Imago BioSciences, Inc. ("Imago"), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), reported that updated Phase 2 data from its two clinical programs for bomedemstat (IMG-7289) will be highlighted in e-poster presentations at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress, held online June 9 – 17, 2021 (Press release, Imago BioSciences, MAY 21, 2021, View Source [SID1234580458]).

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2021 EHA (Free EHA Whitepaper) Virtual Congress Presentation Information

Title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) for the Treatment of Essential Thrombocythemia
Session Title: Myeloproliferative neoplasms – Clinical
Abstract: EHA (Free EHA Whitepaper)-2504

Title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) for the Treatment of Advanced Myelofibrosis
Session Title: Myeloproliferative neoplasms – Clinical
Abstract: EHA (Free EHA Whitepaper)-2787

The abstracts are available on the EHA (Free EHA Whitepaper) Annual Congress website at www.ehaweb.org/congress. All e-poster presentations will be made available on the EHA (Free EHA Whitepaper) website for on-demand viewing on June 11, 2021.