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Nimbus Therapeutics Announces $105 Million Private Financing to Advance Pipeline Including Multiple Clinical Programs

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.

ISA announces successful closing of EUR 26 million funding round

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.

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.

AMRI becomes Curia

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.

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."

48Hour Discovery and RayzeBio Announce Strategic Research Collaboration

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]).

"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.

Biogen and Innocare Announce License and Collaboration Agreement For Orelabrutinib, an Innovative CNS Penetrant BTK Inhibitor For the Potential Treatment of Multiple Sclerosis

On July 12, 2021 Biogen Inc. (Nasdaq: BIIB) and InnoCare Pharma Limited (HKEX: 09969) reported that they have entered into a license and collaboration agreement for orelabrutinib, an oral small molecule Bruton’s tyrosine kinase inhibitor (BTKi) for the potential treatment of multiple sclerosis (MS) (Press release, Biogen, JUL 12, 2021, View Source [SID1234584816]). Orelabrutinib is a covalent BTKi with high selectivity and the ability to cross the blood-brain barrier, and is currently being studied in a multi-country, placebo-controlled Phase 2 trial in relapsing-remitting MS.

Orelabrutinib inhibits BTK, which is a key enzyme that is part of the signaling cascade of immune cells including B cells and myeloid cells. With the ability to cross the blood brain barrier, orelabrutinib has the potential to inhibit B cell and myeloid cell effector functions in the central nervous system (CNS), and may provide a clinically meaningful benefit on progression in all forms of MS. By addressing the progressive biology of the disease, orelabrutinib may offer people living with MS an additional treatment option and the possibility to slow disease progression.

"Given the complex and chronic nature of MS, we believe the unique characteristics of orelabrutinib, combining high selectivity and CNS penetrance, may translate to potential clinical advantages relative to other BTKi programs," said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. "For over 30 years, Biogen has led in MS research and today has a leading portfolio of MS products. We are focused on developing next-generation approaches that we hope will improve outcomes for those living with progressive and relapsing forms of MS."

"Biogen is a recognized leader in neuroscience and we believe this transaction will help advance the development of orelabrutinib in MS," said Jasmine Cui, Ph.D., Co-Founder, Chairwoman and Chief Executive Officer at InnoCare. "We are excited about the potential of orelabrutinib for the treatment of patients with all forms of MS given the potential efficacy and safety profile, plus a promising level of blood-brain barrier penetration. BTK inhibitors may have the potential to transform the treatment paradigm of autoimmune diseases, in particular MS."

Under the terms of the agreement, Biogen will have exclusive rights to orelabrutinib in the field of MS worldwide and certain autoimmune diseases outside of China (including Hong Kong, Macau and Taiwan), while InnoCare will retain exclusive worldwide rights to orelabrutinib in the field of oncology and certain autoimmune diseases in China (including Hong Kong, Macau and Taiwan). InnoCare will receive a $125 million upfront payment and is eligible to receive up to $812.5 million in potential development milestones and potential commercial payments should the collaboration achieve certain development, commercial milestones and sales thresholds. InnoCare is also eligible to receive tiered royalties in the low to high teens on potential future net sales of any product resulting from the collaboration. Closing of the collaboration is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions.

About Orelabrutinib
Orelabrutinib is a small molecule Bruton’s tyrosine kinase inhibitor (BTKi) developed for the treatment of cancer and in development for the potential treatment of autoimmune diseases.

In the field of multiple sclerosis, orelabrutinib is a BTKi with high selectivity and ability to cross the blood-brain barrier and could achieve high-target occupancy in the central nervous system. It is currently being investigated in a global Phase 2 study in RRMS patients.

In the field of oncology, InnoCare received approval for orelabrutinib from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (R/R SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (R/R MCL).

About Bruton’s Tyrosine Kinase Inhibitors
Bruton’s tyrosine kinase (BTK) is a tyrosine kinase that is encoded by the BTK gene in humans. BTK plays a crucial role in B-cell receptor signaling cascade in B cells leading to B cell proliferation, survival, differentiation and cytokine production. BTK also plays a key function in myeloid cell signaling. Central nervous system (CNS) penetrant BTK small molecule inhibitors work by inhibiting B cells and myeloid cells in the periphery and in the CNS. Among myeloid cells expressing BTK, microglia, which reside in the CNS, have been shown to express high level of BTK in multiple sclerosis.