Ceptur Therapeutics Launches with $75M Series A Financing to Advance RNA Therapeutics Based on Proprietary U1 Adaptor Technology

On January 18th, 2022 Ceptur Therapeutics reported the completion of a $75M Series A financing (Press release, Ceptur Therapeutics, JAN 18, 2022, View Source [SID1234605578]). The round was co-led by venBio Partners and Qiming Venture Partners USA with participation by new investors Perceptive Xontogeny Venture (PXV) Fund, Bristol Myers Squibb and Janus Henderson Investors along with existing Seed investors Affinity Asset Advisors, Boxer Capital and LifeSci Venture Partners. "We are extremely grateful for the support of our new and existing investors," said Ceptur Therapeutics co-founder, President and CEO P. Peter Ghoroghchian, MD, PhD. "In 2021, we inlicensed and internally expanded our foundational IP portfolio on U1 Adaptor technology; we further recruited a world-class scientific advisory board, comprising academic and industry leaders in oligonucleotide therapeutics. Moving forward, Ceptur will use the proceeds of this financing round to advance our broad discovery pipeline of differentiated genetic medicines." U1 Adaptors are bivalent oligonucleotidesthat engage sequence-specific mRNA and the U1 small nuclear ribonuclear protein (U1 snRNP), which is a ubiquitous intracellular machine that regulates transcription and splicing. U1 Adaptor therapeutics control gene expression at the premRNA level within the nucleus, affording advantageous properties for drugging difficult targets. "Therapeutic approaches that target RNA have become an essential treatment modality for patients with genetic diseases and a priority for many biopharma companies; we believe that the U1 Adaptor technology is a differentiated approach to RNA regulation that has multiple potential advantages over current technologies", said Aaron Royston, M.D., M.B.A., Managing Partner at venBio Partners. "We are excited to further build out Ceptur’s team and capabilities, to demonstrate these unique applications, and, ultimately, to advance novel therapeutics for patients with genetic diseases." Colin Walsh, Ph.D., Partner at Qiming Venture Partners USA, added, "RNA-based drugs have already become an essential tool in our therapeutic arsenal; and, we strongly believe that this modality will continue to deliver meaningful new therapies for patients. Ceptur’s use ofsynthetic oligonucleotides that engage U1 snRNP offers the ability to co-opt this master regulator of the transcriptome to regulate mRNA in a highly targeted fashion. We are thrilled to support Ceptur’s next phase of growth as they apply this disruptive approach for novel therapeutic applications." With this financing, Aaron Royston, M.D., M.B.A., and Colin Walsh, Ph.D., join Ceptur’s Board of Directors. Daniel Heller, M.S., M.B.A., General Partner and Chief Investment Officer at Affinity Asset Advisors, continued, "In leading the Series Seed round, we identified early the potential of U1 Adaptor technology. Over the past year, we have worked closely with Peter and the Ceptur team and are delighted at the progress that has been made towards establishing the platform. In this financing round, we have significantly expanded upon our initial commitment and are inspired to partner with our new investor syndicate to advance U1 Adaptors for unmet patient needs." To realize the revolutionary potential of the U1 Adaptor technology, several new members join Samuel Gunderson, Ph.D., co-founder of Ceptur, Professor of Molecular Biology at Rutgers University, and a leading expert on U1 snRNP biology, on Ceptur’s Scientific Advisory Board: Thomas Andresen, Ph.D. Dr. Thomas L. Andresen is the CEO of T-Cypher Bio and the former CSO of Torque Therapeutics, now Repertoire Immune Medicines. While at Torque, he led the company’s cellular immunotherapy programs from early-stage discovery to CMC scaling and through to clinical development. Dr. Andresen is a serial entrepreneur, having founded several US and EU lifescience companies that further include Nanovi A/S and Monta Biosciences. His company creation track record spans early discovery to commercial and maps across multiple immunotherapy approaches for oncology. Dr. Andresen sits on several boards/advisory boards, including for Tidal Therapeutics (acquired by Sanofi), Monta Biosciences, and Nanovi; in academia, he’s further founded the Institute of Health Technology at the Technical University of Denmark, where he maintains a professorial position. Dr. Andresen has co-authored over >200 research articles, has been listed as an inventor on >45 patent applications, and has received multiple research prizes, including the Elite Research Price from the Danish Ministry of Science. Dennis Benjamin, Ph.D. Dr. Dennis Benjamin is the former SVP of Research at Seagen where he was a key developer of the company’s ADC technology and clinical pipeline. Prior, he worked at Praecis Pharmaceuticals and Genetics Institute, advancing DNA encoded libraries and working in protein and small molecule discovery. Over his career, he has led teams that have discovered 25 biologics and small molecules that entered clinical trials and has contributed to 4 drug approvals. He is currently an advisor and SAB member at several start-up biotechnology companies. Steven Dowdy, Ph.D. Dr. Steven F. Dowdy is a Professor of Cellular & Molecular Medicine at the UCSD School of Medicine and a cancer biologist, specializing in the development and delivery of RNA therapeutics as well as in G1 cell cycle control in cancer. The Dowdy lab is focused on the molecular details of delivery of RNA therapeutics across the endosomal lipid bilayer as well as the synthesis of endosomal escape domains to overcome this rate-limiting and billion year-old delivery challenge; its members were the first to synthesize bioreversible, charge neutralizing phosphotriester backbone RNAi prodrug triggers that increase metabolic stability, that augment pharmacokinetics and that enhance endosomal escape. Dr. Dowdy currently serves on five Science Advisory Boards for biotech companies and is an elected member of the Oligonucleotide Therapeutics Society (OTS) Board of Directors. Shridar Ganesan, M.D., Ph.D. Dr. Shridar Ganesan is the Associate Director for Translational Science, Chief of the Section of Molecular Oncology, and the co-Leader of the Clinical Investigations and Precision Therapeutics Program at the Rutgers Cancer Institute of New Jersey; he is also the Omar Boraie Chair in Genomic Science and Professor of Medicine at the Rutgers Robert Wood Johnson Medical School. Dr. Ganesan is a medical oncologist with clinical expertise in triple-negative breast cancer, hereditary breast cancer and rare cancer. His research interests include the characterization of DNA repair abnormalities in cancer with a focus on the BRCA1 tumor suppressor gene, the multimodal molecular characterizations of different cancers, and the identification of biomarkers of response and resistance in early phase clinical trials. He has authored or co-authored over 120 publications, serves on multiple national and international grant review committees and is an Associate Editor of JCO-Precision Oncology. Adrian Krainer, Ph.D. Dr. Adrian Krainer is the St Giles Professor at Cold Spring Harbor Laboratory (CSHL) and Deputy Director of Research of the CSHL Cancer Center. A world-renowned biochemist recognized for his basic work on RNA splicing and the development of its mechanism-based therapeutic applications, his seminal work with antisense oligonucleotides in mouse models of spinal muscular atrophy led to the development of nusinersen (Spinraza), which is the first FDAapproved drug for this disease; he is also a co-founder and a member of the Board of Directors at Stoke Therapeutics (NASDAQ: STOK). Dr. Krainer is the recipient of the Life Sciences Breakthrough Prize, the RNA Society’s Lifetime Achievement Award, the Reemtsma Foundation International Prize in Translational Neuroscience, the Speiser Award in Pharmaceutical Sciences, and the Ross Prize in Molecular Medicine, amongst others. He previously served as the President of the RNA Society and is a member of the National Academy of Sciences, the National Academy of Medicine, the National Academy of Inventors, and the American Academy of Arts & Sciences. Iain Mattaj, Ph.D. Dr. Iain Mattaj is the founding Director of Fondazione Human Technopole in Milan, Italy. Dr. Mattaj has made seminal contributions to the fields of transcription, RNA metabolism, nucleocytoplasmic transport and cell division. His prominent standings in these fields are underlined by his election as the past President of the RNA Society, Fellow of the Royal Society (London), Fellow of the Royal Society of Edinburgh, elected Member of the German Academy of Sciences Leopoldina, Member of Academia Europea, Foreign Honorary Member of the American Academy of Arts and Science, Fellow of the Academy of Medical Sciences (London) and Foreign Associate of the National Academy of Sciences (US). Dr. Mattaj was previously awarded the prestigious Louis-Jeantet Prize for Medicine in 2001. He is further a member of the European Molecular Biology Organization (EMBO) and helped to make The EMBO Journal a highly successful international publication, acting as Executive Editor from 1990 to 2004. Prior to his current appointment, Dr. Mattaj was a member of EMBL Heidelberg, Germany, serving as Group Leader (1985-1990), Coordinator of the Gene Expression Unit (1990-1999), and, subsequently, as the institute’s Scientific Director (1999-2005) and Director General (2005-2018). Henrik Oerum, Ph.D. Dr. Henrik Oerum the co-founder and CSO of Civi BioPharma and has previously founded 3 other oligonucleotide companies. Dr. Oerum has over 25 years of experience in the development and commercialization of oligonucleotide therapeutics, has authored >70 peer reviewed publications, and has been listed as an inventor on numerous patents in the field. In 1993, he founded PNA Diagnostics A/S, where he was also the CSO until 1999. During his tenure at PNA, the company was sold to Boehringer Mannheim (1994) and later to Hoffman-La Roche (1997). In 1996, Dr. Oerum cofounded Exiqon A/S, a nucleic acid diagnostics company that was floated on the Copenhagen Stock Exchange in 2007 (CSE:EXQ). In 2000, he co-founded the LNAoligotherapeutics company Santaris Pharma A/S, where he served as CSO and VP of Business Development until its acquisition by Roche in 2014. Thereafter, he worked for Roche Pharma as Global Head of RNA therapeutics until March 2016, where he left to pursue new opportunities, leading to his founding of CiVi. Thomas Tuschl, Ph.D. Dr. Thomas Tuschl is a Professor of RNA Molecular Biology at Rockefeller University. Dr. Tuschl is world renown for his research on the regulation of RNA and has discovered small interfering RNAs (siRNAs), microRNAs (miRNAs) and piwi-interacting RNAs (piRNAs). He is a member of the German National Academy of Sciences and the recipient of numerous awards, including the NIH Director’s Transformative Research Project Award, the Ernst Jung Prize, the Max Delbrück Medal, the Molecular Bioanalytics Prize, the Meyenburg Prize, the Wiley Prize and the AAAS Newcomb Cleveland Prize. He is also the co-founder and a former Director of Alnylam Pharmaceuticals (NASDAQ: ALNY).

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CStone announces the GEMSTONE-302 study of sugemalimab met the endpoint of overall survival in the first-line treatment of metastatic non-small cell lung cancer patients

On January 18, 2022 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, reported that the GEMSTONE-302 registrational clinical study of sugemalimab for the first-line treatment of metastatic (stage IV) non-small cell lung cancer (NSCLC) met the overall survival (OS) endpoint (Press release, CStone Pharmaceauticals, 18 18, 2022, View Source [SID1234605574]). The results demonstrated that sugemalimab in combination with chemotherapy showed statistically significant and clinically meaningful OS improvement in patients. Based on the previously reported impressive progression-free survival (PFS) data, the National Medical Products Administration (NMPA) of China approved sugemalimab in combination with chemotherapy for the first-line treatment of patients with metastatic squamous and non-squamous NSCLC in December 2021. A detailed presentation of the OS analysis will be reported at an upcoming international academic conference.

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Professor Caicun Zhou, Principal Investigator of the GEMSTONE-302 registrational clinical study of sugemalimab and Director of the Department of Oncology, Shanghai Pulmonary Hospital, Tongji University, said, "Globally, the mortality of lung cancer ranks first among all malignant tumors. The goal of first-line treatment for advanced lung cancer is to maximally prolong survival benefits for patients and to delay disease progression. The prespecified OS analysis data further confirmed that sugemalimab in combination with chemotherapy provided durable survival benefits to patients. Sugemalimab has the potential to reshape the first-line treatment landscape of advanced NSCLC and could become the preferred immune-oncology therapy for the treatment of advanced NSCLC."

Dr. Jason Yang, Chief Medical Officer of CStone, said, "We’ve had exciting news about sugemalimab successively in recent days. After being approved in China last month and with the first batch of prescriptions issued recently, now the OS analysis of the GEMSTONE-302 study demonstrated that sugemalimab in combination with chemotherapy brought significant improvement to the overall survival of patients even with high percentage of patients in the chemotherapy control group received subsequent PD-1/PD-L1 inhibitors, including crossover treatment based on the protocol design, after disease progression. As OS represents the gold standard efficacy endpoint in cancer clinical trials, the achievement of the OS endpoint further demonstrates the important value of sugemalimab in the first-line treatment of NSCLC. Sugemalimab is a PD-(L)1 monoclonal antibody addressing both stage III and stage IV NSCLC in all comer settings, and the new drug application of sugemalimab in stage III NSCLC is under regulatory review and a pivotal phase II trial just met its primary endpoint of overall response rate in patients with relapsed and refranctory natural killer/T-cell lymphoma. In addition, we are advancing the registrational studies of sugemalimab in gastric cancer, esophageal squamous cell carcinoma, and lymphoma, so as to enable sugemalimab to benefit a broader population of cancer patients."

About Sugemalimab

The anti-PD-L1 monoclonal antibody sugemalimab was discovered by CStone using OmniRat transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may allow a reduced the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

Currently, the NMPA of China has approved sugemalimab (Cejemly) in combination with pemetrexed and carboplatin as first-line treatment of patients with metastatic non-squamous NSCLC, lacking EGFR and ALK genomic tumor aberrations; and in combination with paclitaxel and carboplatin as first-line treatment of patients with metastatic squamous NSCLC. In addition, sugemalimab is being investigated in a number of ongoing clinical trials, including one Phase 2 registrational study for lymphoma and four Phase 3 registrational studies in stage IV NSCLC, stage III NSCLC, gastric cancer, and esophageal cancer, respectively.

CStone formed a strategic collaboration agreement with Pfizer Inc. (NYSE: PFE) that includes the development and commercialization of sugemalimab in mainland China, and a framework to bring additional Oncology medicines to the Greater China market.

About the GEMSTONE-302 study

The GEMSTONE-302 study (ClinicalTrials.gov registration number: NCT03789604; drug clinical trial registration number: CTR20181452) is a randomized, double-blind Phase 3 study, designed to evaluate the efficacy and safety of sugemalimab in combination with chemotherapy as a first-line treatment patients with stage IV NSCLC as compared to placebo in combination with chemotherapy. The primary endpoint of the study was investigator-assessed PFS. Secondary endpoints included OS, BICR-assessed PFS and safety

In August 2020, the GEMSTONE-302 study met its primary endpoint of significantly prolonged PFS, with the risk of disease progression or death reduced by 50% with sugemalimab combined with chemotherapy, as compared to placebo combined with chemotherapy, as assessed by the independent data monitoring committee (iDMC) at the planned interim analysis. PFS data were presented in a Proffered Paper Oral Presentation (Late-Breaking Abstract) at the ESMO (Free ESMO Whitepaper) Asia 2020.

In July 2021, the final analysis of PFS from the GEMSTONE-302 study showed that sugemalimab in combination with chemotherapy demonstrated further improvement in PFS, with the risk of disease progression or death reduced by 52%, together with a trend toward improved OS. Data were presented in a Mini Oral Presentation (Late-Breaking Abstract) at the IASLC 2021 World Conference on Lung Cancer. The results of the GEMSTONE-302 study were published in The Lancet Oncology in January 2022.

Seagen Reports Data From SEA-CD40 in Combination With Other Therapies in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI)

On January 18, 2022 Seagen Inc. (Nasdaq:SGEN) reported data from a phase 1 clinical trial combining SEA-CD40 with chemotherapy and an anti-PD-1 in patients with metastatic PDAC at the ASCO (Free ASCO Whitepaper) GI annual meeting taking place in San Francisco, January 20 – 22, 2022 (Press release, Seagen, JAN 18, 2022, View Source [SID1234605552]). SEA-CD40 is a novel, investigational, nonfucosylated monoclonal receptor-agonistic antibody directed to CD40, which is expressed on antigen-presenting cells. In preclinical models, the combination of SEA-CD40 and chemotherapy resulted in antitumor activity which is further enhanced with anti-PD-1 treatment.

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In the ongoing phase 1 trial, SEA-CD40 was combined with chemotherapy [gemcitabine and nab-paclitaxel (GnP)], and an anti-PD-1 (pembrolizumab), in 61 patients with untreated metastatic PDAC. Of these, 40 patients received 10 mcg/kg and 21 patients received 30 mcg/kg of SEA-CD40. Key endpoints include confirmed objective response rate (cORR) per RECIST v1.1 by investigator, progression-free survival (PFS) and overall survival (OS).

Activity of SEA-CD40 in combination with GnP and pembrolizumab was observed in both doses of SEA-CD40 tested. The overall (N = 61) cORR was 44 percent, median PFS was 7.4 months (95 percent CI: 5.6-9.0), and median OS was 15.0 months (95 percent CI: 7.8-19.9).

Follow-up for efficacy is ongoing.

The regimen demonstrated a manageable and tolerable safety profile. Overall, ≥ grade 3 treatment-emergent adverse events (TEAEs) were fatigue, nausea, neutropenia, infusion-related reaction, chills, diarrhea, and pyrexia.

This combination also showed evidence of immune activation consistent with the SEA-CD40 mechanism of action.

"Preliminary activity is encouraging based on historical chemotherapy outcomes. Further survival follow up is required to inform our next steps in pancreatic cancer," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "We are continuing to advance the ongoing phase 2 trial of SEA-CD40 in melanoma and in non-small cell lung cancer."

The abstract published at the ASCO (Free ASCO Whitepaper) GI meeting can be found here.

Details of Seagen Presentation at ASCO (Free ASCO Whitepaper) GI:

Abstract Title

Abstract #

Presentation

Presenter

Preliminary Results of a Phase 1 Study of SEA-CD40, Gemcitabine, Nab-Paclitaxel, and Pembrolizumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma (PDAC).

#TPS451

January 21, 2022

12:05 PST

Poster Session B: Pancreas, Small Bowel, and Hepatobiliary Tract

David Bajor, M.D.

Case Western Reserve University

More information about the SEA-CD40 phase 1 clinical trial, including enrolling centers, is available by visiting www.clinicaltrials.gov.

About Sugar-Engineered Antibody (SEA) Technology

Seagen’s proprietary SEAs are monoclonal antibodies engineered to lack fucose, a sugar molecule that can limit the potential of therapeutic antibodies to engage an anticancer immune response. Enhanced binding to effector cells results in better crosslinking and activation of CD40 signaling in immune cells. Preclinical data indicate SEAs have the potential to work alone and in combination with a broad range of anticancer therapies. The clinical activity and safety of SEAs are currently under investigation.

Servier presents its 2020/21 annual results, its R&D strategy and pipeline

On January 18, 2022 Servier, an independent global pharmaceutical group, published its results for the 2020/21 financial year, ending on September 30, 2021, and presented its research and development pipeline (Press release, Servier, JAN 18, 2022, View Source;utm_medium=rss&utm_campaign=servier-presents-its-2020-21-annual-results-its-rd-strategy-and-pipeline [SID1234605550]).

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Olivier Laureau, President of Servier: "In 2020/21, the Servier Group continued to grow despite a difficult environment. We have significantly strengthened our position in oncology with the acquisition of the Agios Pharmaceuticals’ oncology business. The oncology strategy that we initiated in 2017 is now bringing results with new medicines and future indications for patients with hard-to-treat cancers. Our position in cardiometabolism remains very significant and our growth in venous diseases has been important. The Group has also initiated a deep digital transformation to accelerate its development and performance. We also strengthened our presence in key markets, particularly in Japan and the United States, while consolidating our production, bioproduction and R&D activities in France. Servier thus confirms its choice to maintain strong research and production capabilities in France, even though 96% of the Group brand-name medicines are distributed outside France. This choice contributes to the French and European health independence."

Growth driven by an increase in sales volume

The Servier Group revenue for the 2020/21 financial year increased by 4.3% compared to 2019/20 at constant exchange rates (+0.8% at current rates) to reach €4.725 billion.
Revenue evolution is the result of a volume growth of 5.3%; i.e., €246 million. Oncology contributed €153 million to this growth, €69 million of which was generated by the acquisition of the Agios Pharmaceuticals’ oncology business. The growth in volume of the other segments was negatively impacted, due to new government measures in China.

Top 5
brand-name medicines
in 2020/21 sales
– Daflon (€473 million)
– Diamicron (€441 million)
– Coversyl (€269 million)
– Preterax (€266 million)
– Oncaspar (€262 million)

Exchange rate variations had a negative impact of -€156 million on the 2020/21 revenue. The pressure on prices negatively impacted the revenue by -€54 million.

The revenue of brand-name medicines amounts to €3.306 billion for the 2020/21 financial year, i.e., a growth of 4.8% at constant rates (+0.6% at current rates) compared to 2019/20.

The revenue of generic medicines is up by 2.9% at constant rates (+1.1% at current rates), compared to the previous year, reaching €1.419 billion. Today, the Group has over 1,500 generic drugs covering most pathologies which are distributed worldwide by four subsidiaries: Biogaran, the leader in the generics market in France1 for the third consecutive year, EGIS in Eastern Europe, Pharlab in Brazil and Swipha in Nigeria.

The 2020/21 EBITDA remains stable compared to the previous financial year at €625 million, representing 13.2% of Group revenue, as well as the operating income which amounts to €278 million, i.e. 5.9% of Group revenue.

Pascal Lemaire, Executive Vice President Finance at Servier: "The 2020/21 financial year was marked by an important milestone in our oncology strategy with the successful acquisition and integration of the Agios Pharmaceuticals oncology business. The revenue increase was driven by sales of our brand-name medicines in oncology (+34.9%) with a particularly strong performance for Tibsovo in the United States and Onivyde in Japan. Despite the negative impact of exchange rates and pressure on sales in China related to government reforms, the Group’s revenue increased by +4,3% at constant rates (+0.8% at current rates) compared to the previous year. The 2020/21 results demonstrate the strength of the Group and confirm its ability to successfully integrate new acquisitions. We are confident that we will achieve our 2025 goals and continue to serve patient needs across the world."

Key figures (as of September 30, 2021)

Table of key figures for the Servier fiscal year to September 2021

Accelerated growth in oncology

The acquisition of Agios Pharmaceuticals’ oncology business demonstrates how the Group’s strategy in oncology is accelerating. Since the beginning of the 2020/21 financial year, Servier has allocated more than half of its R&D budget to the discovery and development of cancer treatments. The Group’s major investment in oncology is now reflected in the seven medicines now available to patients.

The Group’s brand-name medicine revenue in oncology amounted to €604 million compared to €448 million in 2019/20, representing a 34.9% increase. This strong increase is explained by the inclusion of Tibsovo into the portfolio resulting from the acquisition of Agios oncology (+€69 million), and sales of Onivyde which doubled compared to the previous financial year. This performance is supported by Japan, where Nihon Servier initiated the marketing of Onivyde in June 2020. Accordingly, the Japanese subsidiary recorded an 87.5% increase in revenue at current rates, reaching €90 million in 2020/21 compared to €48 million in 2019/20.

Sustained activity in cardiometabolism and significant growth in venous diseases

Sales of brand-name medicines in cardiometabolism amounted to €2.067 billion (i.e., 44% of Group revenue), down 3.2% at constant rates (-6.9% at current rates) compared to 2019/20 (€2.221 billion) due in particular to a slowdown in sales in China.

Daflon is an important part of the Group’s growth. In 2020/21, sales increased by 13,6% at constant rates (+7.5% at current rates), up €473 million compared to €440 million in 2019/20, propelling Daflon to the forefront of the Group’s brand-name medicines in terms of revenue. The Group has announced an investment of €100 million for its Oril Industrie site (Normandy, France) to double the production capacity of the active ingredient of Daflon by 2023 in order to meet the global growing demand. With the new production unit, innovative manufacturing processes will be implemented as well as the introduction of a new synthesis route to improve the efficiency and environmental performance of the production of the active ingredient.

Group driven by international sales of brand-name medicines

The share of Group revenue generated outside the European Union remains stable compared to the previous financial year and represents more than half of the consolidated revenue; i.e., 51%. The Group has distributed over a billion boxes of medicines worldwide.
China remains the Group’s leading brand-name subsidiary, despite a 22.8% drop, which was due to government reforms, with a revenue of €353 million compared to €457 million in 2019/20.

————————————————–

9

Nine out of ten boxes of brand-name medicines are distributed outside France

————————————————–

The U.S. subsidiary is now the Group’s second-largest subsidiary, ahead of Russia (€247 million), with a revenue of €255 million, up 31.4% (€194 million in 2019/20). This performance is due, in particular, to the inclusion in the portfolio of Tibsovo that is marketed in the United States and resulting from the acquisition of the oncology business of Agios Pharmaceuticals.

An agile and cross-functional R&D model

Claude Bertrand, Executive Vice President Research & Development at Servier: "Servier is pursuing the transformation of its R&D activity to deliver a new molecular entity every 3 years, with an increased effort in oncology, as well as focused investments in neuroscience and autoimmune diseases, in line with the Group’s strategy. Our goal is to develop new medicines for patients with high unmet medical needs and for smaller populations. The recent acquisitions have significantly strengthened our pipeline as well as our innovation capabilities in oncology. We now have a biotechnology center of expertise in Denmark, enhanced by our investment in bioproduction in France, as well as a new R&D center in Boston in the United States which will open in the spring of 2022. The Servier Research and Development Institute in Paris-Saclay, which is expected to open in 2023, will be the heart of the Group’s global R&D organization."

An agile and cross-functional R&D model

More patient-centric, with translational medicine
More focused, with a research focused on three therapeutic areas (oncology, neuroscience and immuno-inflammation) for restricted populations.
More efficient, with a more open and dynamic approach, which will be accelerated by the future Servier R&D Institute in Paris-Saclay

A strengthened and balanced pipeline
Pipeline at the end of December 2021

Summary of the Servier pipeline to December 2021

* New Molecular Entity
** Single Pill Combination – Fixed Combinations

With 40 projects in clinical development, including 19 new molecular entities, and 36 research projects2, resulting from significant and ongoing investment in R&D (more than 20% of brand-name revenue), Servier focuses its research and development efforts in therapeutic areas with high unmet medical need: oncology, neuroscience and immuno-inflammation. In cardiometabolism, Servier’s strategy is to pursue incremental innovation in order to continue to address patient needs. We focus on optimizing our existing medicines through, in particular, Single Pill Combinations (SPCs), medicines combined in a single tablet.

————————————————–

+ 50 %

Oncology represents more than 50% of the R&D pipeline

————————————————–

Servier has placed oncology among its priorities and allocates more than 50% of its R&D budget to fighting cancer and addressing critical unmet patient needs. The Group focuses on cancers in specific populations that are difficult to treat, such as gastrointestinal, hematologic, pancreatic and pediatric cancers, and conducts its R&D programs using several approaches: apoptosis (or programmed cell death), immuno-oncology, with many research programs developed following the acquisition of Symphogen in 2020, and the metabolism of the cancer cell, an approach developed by teams from the oncology business of Agios Pharmaceuticals.

The acquisition of Agios Pharmaceuticals’ oncology business has significantly strengthened the oncology pipeline, with projects at all stages of research and development.

During this financial year, Servier has doubled the number of R&D programs in neuroscience and immuno-inflammation.

In neuroscience, Servier targets proteinopathies, characterized by the abnormal accumulation of specific proteins, as in Parkinson’s disease or amyotrophic lateral sclerosis.

The neuroscience pipeline includes two clinical development projects. The first is in partnership with Ose Immunotherapeutics on a potential treatment for Sjögren’s syndrome, an autoimmune disease characterized by lymphoid infiltration of the salivary and tear glands causing dry mouth and eyes. The second should start in 2022 and is in partnership with Oncodesign in Parkinson’s disease, a neurodegenerative disease characterized by the destruction of a specific group of neurons, dopamine neurons in the black substance of the brain. More than 6.3 million people worldwide are affected by Parkinson’s disease3.

An open and collaborative innovation dynamic

Servier is committed to open and collaborative innovation. The Group collaborates with a network of partners including pharmaceutical and biotech companies as well as academic laboratories.
During the 2020/21 financial year, Servier entered new partnerships and reached significant milestones in collaborative studies with partners.

————————————————–

+ 70

Servier is involved in more than 70 scientific partnerships and collaborations around the world

————————————————–

In oncology, Servier has signed two new partnerships, one with the American biotech company Celsius Therapeutics in to pursue new therapeutic targets for the treatment of colorectal cancer (CRC), and the other with the Japanese biotechnology company PRISM BioLab in the field of immuno-oncology.

Two important milestones have been achieved for the discovery of new therapeutic targets in oncology in research and in the preclinical phase as part of the partnership with the British laboratory Vernalis. Overall, Servier has 18 oncology partnerships4.

In neuroscience, Servier has established three new partnerships. The first is a research collaboration with Mina Therapeutics, a pioneering company in RNA activation therapies, in order to identify and develop therapies using small activating RNAs (saRNA). The second is a strategic collaboration with Nymirum, in order to identify and develop RNA-modulating drugs for the treatment of neurological diseases. Servier has also entered into a partnership with the company X-Chem to identify and develop new small molecules for the treatment of neurological disorders.

Additionally, Servier and Oncodesign, a French biotech specializing in precision medicine, announced in June 2021 the selection of a preclinical candidate from their collaboration in Parkinson’s disease. Working together since March 2019, the Group and the French biotech are leading the discovery of LRRK2 kinase inhibitors and their action as potential therapeutic agents against Parkinson’s disease.

In immuno-inflammation, a first patient was enrolled in August 2021 in the phase 2 clinical trial, conducted with the French biotechnology company Ose Immunotherapeutics, which evaluates the efficacy and safety of an antibody blocking the interleukin 7 receptor in Sjögren’s syndrome.

Finally, Servier has also partnered with Biolabs, an internationally recognized American incubator company, to manage the start-up incubator dedicated to new innovative companies in the health sector and located at the future Servier R&D Institute in Paris-Saclay.
The opening of the Research and Development Institute in Paris-Saclay is a major step in the transformation of Servier R&D demonstrating its ambition to facilitate a more open, more dynamic and more productive research for the benefit of patients.

Photo of the start-up incubator at the Servier R&D Institute in Paris Saclay

The Servier R&D Institute will work directly with the Group’s R&D centers, based in Denmark (Ballerup), the United States (Boston) and Hungary (Budapest), as well as the 15 international therapeutic research centers responsible for conducting clinical studies, and with its international network in charge of external innovation.

As of 2023, 1,500 R&D employees of the Group will be together at this new center, which will enable Servier to address the main challenges of the pharmaceutical industry today: discovering new therapeutic solutions for patients.

Data from CORIST-trial to be presented at ASCO Gastrointestinal Cancers Symposium

On January 18, 2022 Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported that it will have clinical data for its lead compound SCO-101 presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium taking place on January 20-22, 2022 (Press release, Scandion Oncology, JAN 18, 2022, View Source,c3486737 [SID1234605549]).

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Pharmacokinetic data from part 1 of the CORIST Phase II-trial in patients with metastatic colorectal cancer will be announced at a poster presentation. These data will provide details to the topline results communicated earlier documenting the unique mode of action for SCO-101 which provides a significant potentiation of the chemotherapy Irinotecan when combined with the chemotherapy regimen FOLFIRI (which includes Irinotecan).

"We are very pleased to have these data accepted for presentation at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, making it available to a large number of physicians and other stakeholders. We are excited by the data that confirms the potential of SCO-101 to significantly improve treatment options for patients", says Bo Rode Hansen, President & CEO of Scandion.

The combination of SCO-101 and FOLFIRI resulted in a dramatically increased exposure and half-life of SN-38, the active metabolite of Irinotecan. In other words, SCO-101 has the potential to make the chemotherapy much more effective without increasing side effects for patients.

Further to these findings, part 1 of the CORIST trial has also, as previously announced, helped establish a well-tolerated dose of SCO-101 in combination with FOLFIRI. Further, the trial identified the oncogene RAS as a predictive biomarker, helping to optimize patient inclusion in the ongoing second part of the trial, which is expected to conclude in the second half of 2022.

The abstract titled "Evaluation of SN-38 PK profile in patients with RAS wild-type metastatic colorectal cancer treated with a combination of SCO-101 and FOLFIRI" will be published at the conference website later today: View Source