On June 1, 2021 The Menarini Group reported that additional data have been generated on SEL24/MEN1703, a first-in-class, orally available, dual PIM/FLT3 inhibitor, as part of the DIAMOND-01 trial (Press release, Menarini, JUN 1, 2021, View Source [SID1234583352]). The results will be presented at both the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congresses, held on June 4-8, and June 9-17, respectively.
DIAMOND-01 (CLI24-001; clinicaltrials.gov identifier NCT03008187) is a First-in-Human, Phase I/II, dose escalation and cohort expansion trial of SEL24/MEN1703, a first-in-class, orally available, dual PIM/FLT3 inhibitor licensed by Menarini from Ryvu Therapeutics and currently investigated as a single agent for the treatment of patients with Acute Myeloid Leukemia (AML).

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In the dose escalation part of the DIAMOND-01 trial, SEL24/MEN1703 demonstrated a manageable safety profile up to the recommended dose (RD) of 125 mg/day, along with initial evidence of anti-leukemic activity in a single agent setting.

Data reported in the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) posters refer to patients enrolled in the Phase II, cohort expansion part of the study, which confirmed the manageable safety profile of the drug at the RD and showed preliminary single agent efficacy in relapsed/refractory AML, particularly in patients with IDH mutant disease either naïve or previously exposed to IDH inhibitors. These results warrant further investigation of SEL24/MEN1703 in AML, with a potential to focus in the IDH mutated subset.

"We are thrilled to share encouraging results for SEL24/MEN1703 in treating patients with Acute Myeloid Leukemia," said Dirk Laurent, M.D., Global Therapeutic Area Head – Oncology at Menarini Ricerche, the R&D division of the Menarini Group. "The data, which will be presented in our posters at both ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) annual meetings, provides a strong rationale for further clinical development, including the potential to focus on a molecularly defined subset of patients. This accomplishment reflects our sustained commitment to improving the lives of patients with difficult-to-treat cancer and underscores the value of our precision oncology approach."

ASCO Poster details

Updated results from DIAMOND-01 (CLI24-001) trial: a Phase I/II study of SEL24/MEN1703, a first-in-class dual PIM/FLT3 kinase inhibitor, in acute myeloid leukemia.
Topic: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract Code: 7023, Poster presentation
EHA Poster details

Results from DIAMOND-01 (CLI24-001) trial: First in Human Study of SEL24/MEN1703, a dual PIM/FLT3 Kinase Inhibitor, in patients with Acute Myeloid Leukemia
Topic: Acute myeloid leukemia – Clinical
Abstract Code: EP455, Poster presentation
About SEL24/MEN1703

SEL24/MEN1703 is a first-in-class, orally available, dual PIM/FLT3 inhibitor in-licensed by Menarini from Ryvu Therapeutics. It is an investigational compound, not approved for use by regulatory authorities, currently being evaluated in the DIAMOND-01 trial (CLI24-001; clinicaltrials.gov identifier NCT03008187) for the treatment of Acute Myeloid Leukemia.

About Menarini in Oncology

At Menarini, we understand that patients’ hope for a better life is inextricably linked to the progress of scientific and medical research – that is what drives us forward.

Menarini Ricerche is the Menarini Group’s division dedicated to R&D, with a strong commitment to oncology research and development, focused both on therapeutics and diagnostics. We invest in the development of precision medicine through our pipeline of investigational drugs, which includes both small molecules and biologics investigated for the treatment of hematologic and solid tumors. We are also committed to developing innovative technologies for the detection and analysis of circulating tumor cells through the work of Menarini Silicon Biosystems.

The acquisition of Stemline Therapeutics, a New York-based biopharmaceutical company, marked the entry of the Menarini Group into the U.S. biopharmaceutical oncology market and, together with the license agreement reached with Radius Health, strengthened Menarini’s oncology portfolio with the addition of both commercial and clinical-stage assets.

For further information about Menarini’s pipeline, please visit the dedicated page on our website at View Source

On May 31, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, MAY 31, 2021, View Source [SID1234583305]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 7 May 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 10 May 2021 to 3 August 2021.

Since the announcement as of 25 May 2021, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 12,620,192 B shares of DKK 0.20 as treasury shares, corresponding to 0.5% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 28 May 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 13,781,694 B shares at an average share price of DKK 455.01 per B share equal to a transaction value of DKK 6,270,798,856.

On May 31, 2021 PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, reported that the U.S. Patent and Trademark Office (USPTO) has informed the company that a new US patent will be granted early June 2021 (Press release, PCI Biotech, MAY 31, 2021, View Source [SID1234585159]). The US patent covers the use of fimaVacc in combination with immune checkpoint inhibitors (ICIs).

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The use of ICIs has revolutionised cancer immunotherapy, as this class of drugs may induce long-lasting effects in those patients responding to treatment. Unfortunately, most patients do not respond to ICI therapy and different treatment combination strategies are explored with the aim to increase the number of patients responding. Combining ICIs with therapeutic cancer vaccines that induce relevant immune responses against the tumour cells is regarded as one of the most promising strategies. The patent that soon will be granted in the US covers the use of PCI Biotech’s fimaVacc vaccination technology in combination with important classes of ICIs and an important type of immunological adjuvants (a class of so-called Toll like receptor agonists).

"Increasing the response rates to ICI’s is one of the pharma industry’s main priorities in cancer and therapeutic cancer vaccination is a rational approach to this aim. The fimaVacc technology has delivered encouraging immune responses in early phase clinical trials and this US patent provides relevant intellectual property for the further development of this technology." said Dr. Per Walday, CEO of PCI Biotech.

As part of PCI Biotech’s strategy for applying the PCI technology for therapeutic cancer vaccines, several global patent applications were filed in 2013-2016. Today’s announced US patent secure protection until 2036 and this patent application is still pending in Europe and key Asian markets.

On May 31, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its introduction of the first cryo-electron microscopy (Cryo-EM) system in the Japanese pharmaceutical industry to further accelerate drug discovery research (Press release, Chugai, MAY 31, 2021, View Source [SID1234583291]).

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The cryo-EM, for which the Nobel Prize in Chemistry 2017 was awarded, has been drawing attentions as an innovative technology. The system was introduced for the structural analysis of drug candidate molecules bound to target proteins, which is an essential process in drug discovery research.

Chugai places great emphasis on Structure-Based Drug Design in its drug discovery research, and aims to create quality drug candidate compounds by pursuing precise structure design. X-ray crystallographic analysis, which we have primarily used to obtain molecular structure, requires crystallization of the intracellular protein which a drug candidate targets. The mid-size molecule drug which Chugai focuses on mainly targets such proteins that are difficult to crystallize, which has posed a challenge in the refinement of compound design.

As the cryo-EM does not require the crystallization process, it enables structure analysis of a wider range of molecules including intracellular proteins that are difficult to crystallize, as well as significantly improving research efficiency. We hope that it will enhance our Structure Based Drug Design capability and increase the success rate of compound development. This system we introduced is provided by Thermo Fisher Scientific, and installed at Kamakura research laboratories for the structural analysis of a variety of drug candidate compounds including mid-size molecule drugs.

"The introduction of cryo-EM is expected to greatly transform Chugai’s drug discovery process. It will further enhance the quality and speed of Structure Based Drug Design, and accelerate the discovery of mid-size molecule drugs which we aim to establish as the third modality," said Dr. Osamu Okuda, Chugai’s President and CEO. "Chugai’s drug discovery is supported by its unique scientific and technological capabilities. We will continue to rigorously adopt advanced technologies to realize innovations that contribute to resolve unmet medical needs."

About cryo electron microscopy (Cryo-EM)

Cryo-electron microscopy (Cryo-EM) is a powerful biophysical technique that allows researchers to visualize molecular assemblies at near-atomic resolution. With the rapid technological advancements, structural elucidation of biological molecules such as protein has been rapidly increased, in particular for intractable biological molecules by existing methods such as X-ray crystallography and NMR technique.

Cryo-EM has been recently applied in the pharmaceutical industry around the world due to its ability to accurately and rapidly visualize the intricate interactions between drug and receptor, enabling informed, accelerated drug discovery and structure based drug design.

On May 31, 2021 Kuraray Co., Ltd. (Head Office: Chiyoda-ku, Tokyo; President: Hitoshi Kawahara; hereinafter "Kuraray") reported that it has published the Kuraray Report 2021, an integrated report (A4 size, 52 pages, full color) (Press release, Kuraray, MAY 31, 2021, View Source [SID1234583292]).
The aim of the Kuraray Report is to help shareholders, investors, and all other stakeholders better understand the value that the Kuraray Group creates over the medium to long term by providing a comprehensive overview of financial and non-financial information, including environmental, social and governance data.

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