On July 13, 2021 Astellas Pharma Inc. (President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that it has been named to the FTSE4Good Index Series for 10 consecutive years, as a company that is performing excellent initiatives in the areas of ESG [environmental (E), social (S), governance (G)] (Press release, Astellas, JUL 13, 2021, View Source [SID1234584802]).

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Astellas has conducted various activities based on the thought that Astellas’ contribution to the sustainability of society means the realization its philosophy. These sustained activities led Astellas to recognize and to be selected in such for a decade.

In the year ended 31 March 2021, Astellas reviewed its past activities and formulated its basic sustainability policy, which aims to improve the sustainability of both the global society and Astellas with the ESG in mind, instead of the conventional CSR-Based management. Astellas is working to further conducte its sustainability activities and expand its information disclosure*1.

Astellas has set "Deepen our Engagement in Sustainability" as one of its new strategic goals in its Corporate Strategic Plan 2021*2. In addition to implementing "Value Protection" which is an initiative to comply with regulations and meet the requirements from the global society, Astellas will further strengthen "Value Creation" activities to provide its patients’ access to innovative therapeutics and take proactive measures to conserve the global environment.

Besides the FTSE4Good Index Series, Astellas also has been named to all ESG investment indices selected by the Government Pension Investment Fund of Japan. These are the FTSE Blossom Japan Index, the MSCI Japan ESG Select Leaders Index, the MSCI Japan Empowering Women Index (WIN), and the S&P/JPX Carbon Efficient Index.

Astellas will continue to work under its basic policy of sustainability, which is to improve the sustainability of both the global society and Astellas while keeping ESG in mind.

On July 13, 2021 Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, reported the closing of a $105 million private financing round (Press release, Nimbus Therapeutics, JUL 13, 2021, View Source [SID1234584800]). The round was led by BVF Partners L.P. (BVF), with participation from existing investors including RA Capital Management and Atlas Venture. Access Biotechnology, Commodore Capital, Logos Capital, Surveyor Capital (a Citadel company), and a large alternative asset manager joined as new investors in this financing.

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"This financing from some of the world’s leading investors is validation of the exciting potential within Nimbus’ product pipeline and the singular expertise Nimbus brings in advancing these products forward. Spurred by compelling data from studies of our novel allosteric TYK2 inhibitor, we will be embarking upon multiple Phase 2 clinical studies in 2021 and 2022 to elucidate the full range of potential patient benefit from this novel therapeutic," said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. "Our clinical expertise with this molecule to date combined with our strong capital position make Nimbus uniquely well-resourced to advance this important medicine through the clinic in the years to come."

In addition to the Phase 2 studies of Nimbus’ allosteric TYK2 inhibitor, the financing will support a first-in-human study of the company’s HPK1 inhibitor candidate in cancer patients with solid tumors, which will begin later this year, and will accelerate preclinical programs against multiple targets in oncology and immunology. The company expects to initiate IND-enabling studies on two novel agents in 2022.

"Nimbus’ pipeline is positioned to deliver multiple clinical readouts over the next 18 months that have the promise to help transform patients’ lives," said Bruce Booth, D.Phil., co-founder and Chairman of the Board of Nimbus. "We are fortunate to have the support of many new investors joining Nimbus, and we welcome Sam Huang from BVF to the Board."

"We’re proud to lead this most recent financing round, and we see the tremendous potential of Nimbus’ vision, pipeline, and team," said Mark Lampert, founder and CEO of BVF.

On July 13, 2021 ISA reported the closing of a EUR 26 million funding round with participation from new investors including Invest-NL and existing investors including Regeneron (Press release, ISA Pharmaceuticals, JUL 13, 2021, View Source [SID1234584799]). The proceeds of this round will be used to advance the lead product ISA101b towards first marketing authorization as well as to broaden the clinical pipeline of immunotherapies based on the Synthetic Long Peptide (SLP) platform technology.

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Gerben Moolhuizen, CEO of ISA Pharmaceuticals, said, "We are very happy with the continued support of our existing partners and shareholders. Invest-NL’s support underlines the innovation at ISA Pharma and potential impact of our SLP immunotherapies for the treatment of serious diseases."

SLP immunotherapies act through the specific activation of the patient’s own immune system. Lead product ISA101b targets cancers caused by human papilloma virus type 16 (HPV16). It is in late stage clinical development in three trials for the treatment of advanced stages of HPV16-positive head and neck cancer and cervical cancer in combination with Libtayo (cemiplimab, anti-PD1 immunotherapy), which is being co-developed by Regeneron and Sanofi.

Leo Holwerda, Director Capital at Invest-NL, notes: "Our investment in ISA Pharmaceuticals is a good example of how our TOPSS program can help promising Dutch start-ups and innovative companies which were affected by COVID-19. Invest-NL is happy to support ISA Pharmaceuticals to accelerate its clinical studies and we are confident that the company will succeed in bringing its lead therapy for patients with HPV16-positive head & neck cancer and cervical cancer to the market. This innovative and impactful therapy will strengthen the prospects of many patients."

Persistent HPV16 infection can cause head & neck, cervical and anogenital cancers. These cancers can be severe and life-threatening with low overall survival rates once these cancers progress to advanced stages. HPV16 is a major cause of head & neck cancer with over 25,000 new cases and 11,000 deaths in Europe (source) and 46,000 new cases and 9,000 deaths in the US (source).
HPV16 is also responsible for about 50% of cervical cancer cases. Cervical cancer is the 2nd most common cancer in women aged 15 to 44 years in Europe, with over 60,000 new diagnoses and 25,000 deaths each year in Europe. Globally there are more than 500,000 new patients and 300,000 deaths (source).

The SLP technology platform is at the basis of several ISA pipeline products that are scheduled to proceed into clinical trials over the next few years. Three promising products are in the final stages of pre-clinical development. ISA104 targets the hepatitis B virus (HBV) in chronically infected patients. Chronic HBV is a major cause of liver cirrhosis and liver cancer and affects over 250 million people worldwide (source). ISA103 is aimed at tumours that express PRAME, a protein closely associated with the malignant behaviour of cells in numerous types of cancers. ISA106 is a potential treatment for high risk COVID-19 infected patients.

On July 12, 2021 Albany Molecular Research, Inc. (AMRI), a leading global contract research, development and manufacturing organization serving the pharmaceutical and biopharmaceutical industries, reported that it is changing its name to Curia, effective July 12, 2021 (Press release, Curia, JUL 12, 2021, View Source [SID1234644965]). The new name reinforces the company’s strategic positioning as an end-to-end global CDMO, applying its scientific expertise and extensive capabilities from research and development (R&D) through to commercial manufacturing to enable its pharmaceutical and biotechnology customers to advance important new products that improve lives. Along with the name change, the company is introducing a new brand identity including a new website: CuriaGlobal.com.

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The name Curia is derived from a Latin word for purposeful assembly and references Curia’s patient-inspired mission. The company recently celebrated three decades of growth since its founding in Albany, New York. Today, Curia offers a global suite of R&D and commercial manufacturing capabilities, with industry-leading expertise to help its customers accelerate the journey from idea to impact. Curia employs more than 3,000 people in 21 locations around the world, including more than 600 chemists, 70 biologists, 225 senior scientists and approximately 400 quality and regulatory specialists. The company’s ongoing commitment to science that scales is demonstrated by its 564 active patents and its production of more than 20 treatments included on the list of essential medicines from the World Health Organization.

"Our new name reflects the assembled deep expertise of our people, the breadth of our products, services and solutions, and our relentless determination to help customers advance from curiosity to cure," said Curia Chairman and CEO John Ratliff. "Our new brand honors our foundation in research and innovation while creating a platform for our ambitions of life-changing science so we can make ever-growing contributions to improving patients’ lives. Over the past three decades we have broadened and deepened our capabilities to become a leading provider of CDMO solutions. Today marks the beginning of the next chapter in our history."

On July 12, 2021 48Hour Discovery Inc and RayzeBio reported the companies have entered a strategic research collaboration to discover and develop novel peptide-based radiopharmaceuticals for the treatment of cancer (Press release, 48Hour Discovery, JUL 12, 2021, View Source [SID1234586901]).

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"We are excited to work with a cutting edge biotechnology company like RayzeBio" said Ratmir Derda, CEO of 48Hour Discovery "For this collaboration project, 48Hour Discovery will identify potent ligands for a series of targets selected by RayzeBio. This project will help us further validate the potential of our billion-scale molecular libraries and cloud-based discovery pipeline. We are looking forward to accelerating the preclinical programs of RayzeBio and providing peptide drug candidates that will advance the radiopharmaceutical field."

"48Hour Discovery has a promising proprietary platform for novel peptide discovery," said Ken Song, M.D., CEO of RayzeBio. "We are intrigued by the potential to quickly discover novel binders."

Under the terms of the agreement, 48HD will receive undisclosed payments. RayzeBio has exclusive rights to develop and commercialize peptides discovered under the collaboration, and an option to further expand the collaboration to include additional targets.