Medivir’s MIV-818 obtains the International Nonproprietary Name fostroxacitabine bralpamide

On January 18, 2022 Medivir AB (Nasdaq Stockholm: MVIR-B) reported that the World Health Organization (WHO) has selected the International Nonproprietary Name (INN) fostroxacitabine bralpamide as the official generic name for the company’s patented candidate drug MIV-818, which is in clinical development in primary liver cancer (Press release, Medivir, 18 18, 2022, View Source [SID1234605592]).

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Medivir’s main project, fostroxacitabine bralpamide (MIV-818), is the company’s proprietary candidate drug with a unique mechanism of action, which makes fostroxacitabine bralpamide attractive to be combined with a multitude of other drugs for the treatment of hepatocellular carcinoma (HCC). In the ongoing study, fostroxacitabine bralpamide is administered in two different combinations, either with Lenvima, a tyrosine kinase inhibitor, or with Keytruda, an anti-PD-1 checkpoint inhibitor.

– "We are now able to use a generic name for our candidate drug, and for us that is an important step towards a product for the treatment of HCC," said Magnus Christensen, interim CEO and CFO of Medivir.

For further information, please contact:
Magnus Christensen, Interim CEO and CFO, Medivir AB
Phone: +46 (0)8 5468 3100
E-mail: [email protected]

About fostroxacitabine bralpamide
Fostroxacitabine bralpamide (also named MIV-818) is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. Fostroxacitabine bralpamide has completed a phase 1b monotherapy study, and a combination study in HCC was recently initiated.

About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 11 percent. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

Compugen Expands COM701 Intellectual Property Portfolio with New U.S. Patent Covering Triple Combination Use with anti-PD-1 and anti-TIGIT Antibodies

On January 18, 2022 Compugen Ltd. (NASDAQ-GM: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the United States Patent and Trademark Office (USPTO) has granted Compugen a new patent covering method of use for COM701, Compugen’s potential first-in-class therapeutic antibody targeting PVRIG, or back-up anti-PVRIG antibody, in triple combination with any anti-PD-1 and any anti-TIGIT antibody for the treatment of cancer (Press release, Compugen, 18 18, 2022, https://www.prnewswire.com/news-releases/compugen-expands-com701-intellectual-property-portfolio-with-new-us-patent-covering-triple-combination-use-with-anti-pd-1-and-anti-tigit-antibodies-301462635.html [SID1234605590]).

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U.S. Patent No. 11,225,523 titled "Triple Combination Antibody Therapies" augments previously issued patents by expanding and protecting the use of COM701 for treating cancer patients, to include the triplet combination of COM701 with any anti-PD-1 antibody and any anti-TIGIT antibody.

"We are focused on maintaining our first mover advantage in the clinic, as the only company with monotherapy, doublet and triplet combination clinical studies evaluating PVRIG, TIGIT, and PD-1. We believe that this patent protection of triple combination regimens further strengthens our leadership position as we continue to execute on our clinical programs based on our DNAM axis hypothesis to treat patients with inflamed and less inflamed tumors who are not responding to current standard of care." said Anat Cohen-Dayag, Ph.D., President and Chief Executive Officer of Compugen.

U.S. Patent No. 11,225,523 is expected to expire no earlier than August 2037 in the United States.

About COM701

COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, blocking the interaction with its ligand, PVRL2. In pre-clinical studies, blockade of PVRIG by COM701 has demonstrated potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. Compugen has identified PVRIG and TIGIT as key parallel and complementary inhibitory pathways in the DNAM axis, which also intersect with the well-established PD-1 pathway. Research from Compugen suggests that these three pathways have different dominance in different tumor types and patients, implying that to induce effective antitumor responses, certain patient populations may require the blockade of different combinations of these three pathways. To test this hypothesis, Compugen has established a science-driven, biomarker informed clinical program, which evaluates different combinations of these axis members across tumor types. Compugen is the only company with clinical assets targeting both PVRIG and TIGIT in its portfolio allowing it to explore the potential of blocking these parallel and complementary members of the DNAM axis comprehensively to drive robust immune responses.

Treadwell Therapeutics engages Genezen to advance its T cell receptor-based cell therapy pipeline

On January 18, 2022 Treadwell Therapeutics, a clinical stage, multi-modality biotechnology company developing novel therapeutics for highly aggressive cancers, and Genezen, a cell and gene therapy Contract Development and Manufacturing Organization (CDMO) reported to have confirmed a partnership agreement to accelerate the production of T cell receptor (TCR)-based candidates to address unmet needs in cancer patients (Press release, Treadwell Therapeutics, 18 18, 2022, View Source [SID1234605587]).

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The agreement will see Genezen, which focuses on early-phase process development, vector production and analytical testing services, take two Treadwell TCRypt platform assets from early-phase development through scale up, past first clinical stages to GMP readiness and manufacturing.

Treadwell’s Head of Cell Therapy, Dr. Shawn Kubli said: "We are very confident that Genezen’s extensive viral vector experience and industry-leading manufacturing expertise will bring great benefits for this partnership and further our success in the timely advancement of our cell therapy clinical program, with expected initiation of clinical studies in 2023."

The Treadwell projects will be initiated in Genezen’s new process development and analytical lab, which offers a full suite of process development capabilities to support cGMP and commercial readiness, upstream and downstream process improvements, research grade and preclinical vector production, and analytical assay development and validation.

"Genezen’s new state-of-the-art facility, a dedicated viral vector process and analytical development lab, was a major factor in our decision alongside great customer service and support. The team’s flexibility and responsiveness are vital for our early-stage projects and key to delivering potentially life-saving therapies for patients" added Ryan Dietz, VP Corporate Development at Treadwell.

Raymond Kaczmarek, Chief Executive Officer at Genezen said: "Our partnership provides Treadwell with a range of services for its pre-clinical and clinical pipeline of next generation TCR-based cell therapy programs.

"As a client, Treadwell can leverage our team’s expertise and proven track record to successfully accelerate its development programs. We are fully committed to supporting Treadwell in its drive to take drug products to market and patients faster."

Genezen’s new lab is the first phase of a multiphase master plan for a 75,000+ square foot cGMP-compliant lentiviral and retroviral vector production facility. The next phase, with cGMP production suites, is currently underway and due to complete in early 2022.

The end-to-end capabilities will facilitate Genezen’s delivery of optimized closed and semi-automated processes for viral vector production.

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.