NICE recommends Roche’s Tecentriq combo for certain lung cancer patients

pharmaphorum | May 03, 2019

Certain patients with untreated lung cancer in England have a new treatment option after cost-effectiveness body NICE made a draft recommendation that the NHS should fund Roche’s cocktail involving its immunotherapy Tecentriq. The combination of Tecentriq (atezolizumab), Avastin (bevacizumab), plus carboplatin and paclitaxel chemotherapy has been recommended as an option for metastatic non-squamous non-small cell lung cancer in adults with untreated disease whose PD-L1 expression is low or negative. In the final draft guidance NICE has also okayed funding for those with EGFR or ALK-positive mutations, who have failed on a previous targeted therapy, in a decision that could make the treatment available to around 4,800 patients.

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If you want some insights into where the content marketing industry may be headed, it might just help to take a look at where it’s been. As we pointed out when CMI shared its History of Content Marketing infographic in 2012, brands have been telling their stories to audiences for hundreds of years. Not to mention that storytelling itself is one of the oldest forms of communication. Benjamin Franklin first publishes the yearly Poor Richard’s Almanack. The goal is to promote his printing business.


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BUSINESS INSIGHTS

Ellipses Pharma and SunRock Biopharma Enter Into a Licensing Agreement for a First-in-class Bifunctional HER3:TRAIL Fusion Protein

SunRock Biopharma S.L | May 26, 2022

SunRock Biopharma S.L. a biopharmaceutical company that is developing a portfolio of innovative bispecific antibodies to treat incurable cancer, and Ellipses Pharma Limited a global drug development company focused on accelerating the development of new oncology treatments, announce that they have entered into an exclusive licensing agreement for SRB22, a fully human bifunctional HER3:TRAIL fusion protein, which going forward will be known as EP0017. Under the agreement, Ellipses has been granted global rights to develop and commercialise EP0017 and will assume the full cost and responsibility for the remaining pre-clinical and clinical development of the compound. In line with its strategy, Ellipses intends to out licence EP0017 for commercialisation if it proves safe and effective in clinical trials. SunRock will continue to be involved in the development of EP0017 to ensure efficient translational activities through a service agreement with Ellipses. If Ellipses out-licences EP0017, SunRock will also receive milestone payments and royalties. EP0017 is a first-in-class bifunctional fusion protein with a dual mechanism of action. It selectively targets HER3, which is overexpressed in several different tumour types, and additionally, binds to the tumour death receptors DR4 and DR5, inducing tumour cell death. Promising data has been generated in a range of preclinical models that demonstrate the potential of EP0017. Laureano Simón, Ph.D., CEO of SunRock Biopharma, said “The agreement with Ellipses will speed up the development of EP0017, moving this potentially life-changing asset towards the clinic and then hopefully towards cancer patients who desperately need novel approaches to fight invasive tumours.” Rajan Jethwa, MD, CEO of Ellipses Pharma “Our mission is to rapidly develop innovative cancer therapies, to get these therapies into the clinic as quickly as possible and potentially save more lives. We are excited about the opportunity to progress the development of this promising asset and look forward to working with SunRock to expedite the preclinical work.” About SunRock Biopharma S.L. Since its inception in 2014, SunRock has developed a comprehensive pipeline of seven therapeutic antibodies, bispecific antibodies and fusion proteins with proven therapeutic effects against several types of tumours that currently lack a treatment. The innovative spirit of SunRock defines the development of all its molecules, that are the result of a disruptive technological platform that has led to pioneer therapies with an innovative format, including first-in-class bispecific antibodies and fusion proteins that target both novel and well-known therapeutic targets. SunRock’s project portfolio is generating great expectations among patient associations, major hospitals, and biopharmaceutical companies. The Government of Galicia participates in SunRock through the Galicia Innova Tech Fund, FICC. About Ellipses Pharma Limited Ellipses Pharma is a global drug development company based in London, focused on accelerating the development of cancer medicines and treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection with an uninterrupted funding flow to minimize the time it takes to advance lead products through clinical trials and reach patients.

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PHARMACY MARKET

Vivera Partners with NINDS of NIH to Identify Potential Stuttering Treatments

Vivera Pharmaceuticals, Inc. | May 18, 2022

Vivera Biosciences, a division of Vivera Pharmaceuticals dedicated to the research and development of innovative medical technologies and pharmaceutical therapies, is pleased to announce its collaborative progress on a Cooperative Research and Development Agreement with the National Institute of Neurological Disorders and Stroke an Institute within the National Institutes of Health that aims to foster and advance cutting-edge neuroscience research to reduce the burden of neurological disease. The collaboration aims to identify therapeutic agents for the potential treatment of stuttering disorders, estimated to affect approximately 70 million people worldwide. Stuttering, also referred to as childhood-onset fluency disorder, is a neurological condition characterized by speech disfluencies, which can be disabling to patients affected. While there are currently no FDA-approved therapies for stuttering, in recent years, much has been discovered to understand the underlying neurological basis for the disorder. Scientists at Vivera and NINDS have discovered differences in the structure and function of the areas of the brain that regulate the timing and initiation of speech related to stuttering. These neurological revelations and the potential to develop related therapeutics inspired the partnership between Vivera and NINDS. The initiative is unique because of the individuals it will be led by: Vivera Biosciences' Investigator, Gerald A. Maguire, M.D., D.F.A.P.A., and NINDS' Principal Investigator, Shahriar SheikhBahaei, Ph.D. Both are persons who stutter and doctors who have dedicated their careers to understanding the disorder they share with millions of others and one they are working to develop novel treatments for. "I am grateful to the NIH, NINDS, and Vivera Biosciences for supporting this translational collaborative research with my friend and colleague, Dr. SheikhBahaei, as we potentially develop therapeutics to assist our stuttering community," said Dr. Maguire. Dr. Maguire is a world-renowned clinical researcher. He has over three decades of experience as an academic psychiatrist and has served as principal investigator for numerous studies involving investigational medications for various neuropsychiatric disorders, specializing in stuttering. "This collaboration may be an initial step toward developing novel and personalized therapeutic approaches for changing the course of the disorder for people who stutter," Dr. SheikhBahaei. Dr. SheikhBahaei's graduate studies focused on how astrocytic networks control activities of respiratory motor circuits within the brainstem. He currently leads the Neuron-Glia Signaling and Circuits Unit at NINDS, whose goal is to understand how different glial and neural cell types in the brain contribute to the neural circuits controlling voluntary speech production to enhance the ability to intervene in motor control disorders like stuttering. "Vivera is confident in our choice in partnership with NIH," said Vivera's Chief Medical Officer, Stephen J. McColgan, M.D., M.B.A. "Since day one, Vivera has been dedicated to the research and development of patient-centric treatments," said Paul Edalat, CEO of Vivera. "This partnership with NIH and NINDS is about bettering the lives of people who stutter, further solidifying the Company's commitment to our mission." About Vivera Pharmaceuticals Vivera Pharmaceuticals is an innovative, science-driven pharmaceutical company located in Southern California. The Company has global exclusivity to license the patented and patent-pending TABMELT® sublingual drug delivery system for pharmaceutical use and holds its own issued patents on ZICOH®, a smart dose-controlled electronic medical device. The Company has also received a Notice of Allowance for its portable telemedicine station, MDZone. With multiple divisions, including its pharmaceutical, neurosciences, medical technology, biosciences, and advanced diagnostics divisions, Vivera Pharmaceuticals is vertically integrated with patented technology, manufacturing capabilities, and distribution for its products.

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BUSINESS INSIGHTS

invoX Pharma to Acquire F-star Therapeutics, Inc. a Pioneering Next Generation Bispecific Discovery Platform and Clinical Programs

F-star Therapeutics, Inc. | June 24, 2022

invoX Pharma a wholly owned subsidiary of Sino Biopharmaceutical Limited focused on research and development and business development activities outside of China, and F-star Therapeutics, Inc. a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives, today announced that the companies have entered into a definitive agreement whereby invoX will acquire all of the issued and outstanding shares of F-star common stock for $7.12 per share. The proposed acquisition values F-star at approximately $161 million. The transaction has been unanimously approved by the invoX and F-star Boards of Directors and is expected to close in the second half of 2022. F-star’s proprietary platform technology pioneers the use of tetravalent (2+2) bispecific antibodies that enable the simultaneous targeting of two different antigens and a unique set of pharmacology to deliver focused, potent and safe immune activation in the tumor microenvironment. Four programs are progressing in clinic, three based on F-star’s tetravalent platform and one next generation STING agonist, with multiple further undisclosed programs in development. These programs represent potentially first- and best-in-class drug candidates for many areas of unmet medical need, including patients with cancer and other serious diseases who have few other options available. Leveraging its modular antibody technology, F-star has forged collaborations with major international biopharma companies across a wide range of therapeutic areas including oncology, immunology and neurology. invoX, established in 2021 in the United Kingdom, is Sino Biopharm’s international expansion platform, focusing on R&D and business development activities outside of China, with a core focus on oncology and respiratory therapeutics. F-star will form a key element of invoX’s strategy to accelerate Sino Biopharm’s development of innovative medicines to transform the lives of patients worldwide, complementing its existing R&D platforms and pipeline. “Today’s proposed acquisition is aligned with invoX’s strategy to become a fully integrated biopharmaceutical company with an advancing pipeline of innovative products addressing unmet healthcare needs, worldwide. We are excited to welcome F-star employees and look forward to working with them as we invest in the company to progress and grow its clinical pipeline to realize the full potential of the platform.” Ben Toogood, Chief Executive Officer of invoX Eliot Forster, Chief Executive Officer of F-star said: “We believe our tetravalent bispecifics offer the best approach to tackle hard-to-treat cancers and other serious diseases, with the ambition to deliver longer and improved lives for patients. Today’s announcement is good news for F-star, for our shareholders and, of course, for patients. This transaction enables greater and longer-term opportunities to develop the F-star platform and accelerate delivery of our novel medicines as we work together towards a future free from cancer and other serious diseases. I’d like to thank the fantastic team at F-star as well as our partners for all their hard work, support and dedication and I’m delighted to share this exciting development.” About invoX Pharma invoX Pharma was incorporated in March 2021 and is a wholly owned subsidiary of Sino Biopharm, a global top 40 pharmaceutical company with more than 24,000 employees. United Kingdom-based invoX is Sino Biopharm’s international expansion platform, focusing on R&D and business development activities outside of China, with a core focus on oncology and respiratory therapeutics. At its core, the Company aspires to improve patients’ lives by creating access to innovative medicine. About Sino Biopharm Sino Biopharm, together with its subsidiaries, is a leading, innovative research and development driven pharmaceutical conglomerate in China, with a business scope that is vertically integrated including research and development, manufacturing and sales and marketing infrastructure. The Company’s product offerings include a variety of biologics and small molecule drugs, and in therapy areas that include hepatology, oncology, cardiovascular and cerebrovascular diseases, orthopaedics, digestive and immune and respiratory diseases. About F-star Therapeutics, Inc. F-star Therapeutics, Inc. is a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives. F-star is committed to working towards a future free from cancer and other serious diseases, through the use of tetravalent (2+2) bispecific antibodies to create a paradigm shift in treatments. The Company has four second-generation immuno-oncology therapeutics in the clinic, each directed against some of the most promising IO targets in drug development, including LAG-3 and CD137. F-star’s proprietary antibody discovery platform is protected by an extensive intellectual property estate. F-star has over 500 granted patents and pending patent applications relating to its platform technology and product pipeline. The Company has attracted multiple partnerships with biopharma targeting significant unmet needs across several disease areas, including oncology, immunology, and CNS.

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PHARMACY MARKET

Harbour BioMed Announces IND Approval for Next-Gen Anti-TSLP Fully Human Monoclonal Antibody

Harbour BioMed | February 22, 2022

Harbour BioMed announced that China National Medical Products Administration had approved its investigational new drug (IND) application for HBM9378 a next-gen fully human antibody targeting thymic stromal lymphopoietin for the treatment of moderate-to-severe asthma. HBM9378/SKB378 is a co-development project conducted by HBM and Kelun-Biotech, who together equally share the global rights in respect of HBM9378. The IND approval of HBM9378 is an achievement of the strategic collaboration between the parties. According to the strategic collaboration and license agreement between HBM and Kelun-Biotech, the parties will jointly explore innovative therapies of monoclonal antibodies and antibody-drug conjugate. Building on HBM's innovative business model leveraging its productive R&D platform to lead the next generation of valuable and innovative therapies and its mission to address the unmet medical needs, HBM will continue to expand its collaboration with industry leading partners and further leverage on the combined capabilities of HBM and its collaborators. "HBM9378/SKB378, a next-gen fully human monoclonal antibody, is developed from HBM's H2L2 platform. Its long half-life optimization and outstanding biophysical properties support the favorable dosing advantage. The approval of this IND application once again proves HBM's powerful innovation capability. Unleashing the power of our unique R&D engine, we are highly confident and determined to defeat intractable diseases across the world." Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed About HBM9378/SKB378 HBM9378/SKB378 is a fully human monoclonal antibody against TSLP generated from two heavy chains and two light chains (H2L2) platform. It inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP receptor. TSLP plays important roles in DC cell maturation, T helper 2 (Th2) cell polarization and inflammation, particularly in both eosinophilic and non-eosinophilic inflammation asthma. About Asthma Asthma is a heterogeneous disease defined by the history of respiratory symptoms that vary over time and in intensity, together with variable expiratory airflow limitation. The disease is estimated to affect more than 300 million people worldwide and affect more than 45.7 million adult people (≥20 years) in China. Approximately 5-10% of those afflicted with asthma have severe disease that is poorly controlled. Despite the use of medium to high dose inhaled corticosteroids (ICS) in combination with a long-acting β2-agonist (LABA), currently available biologic therapies and oral corticosteroids (OCS), many severe asthma remain uncontrolled. Current biologics are mainly targeting Type 2 severe asthma which manifests clinically with a combination of peripheral eosinophilia, sputum eosinophilia and/or elevated fractional exhaled nitric oxide (FENO). Severe asthma patients experience frequent exacerbations, significant limitations on lung function and a reduced quality of life. The healthcare burden associated with care for these patients is also high. Therefore, there are still significant unmet needs to develop safer and broader therapies for severe asthma. About Harbour BioMed Harbour BioMed is a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners and select acquisitions.

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Spotlight

If you want some insights into where the content marketing industry may be headed, it might just help to take a look at where it’s been. As we pointed out when CMI shared its History of Content Marketing infographic in 2012, brands have been telling their stories to audiences for hundreds of years. Not to mention that storytelling itself is one of the oldest forms of communication. Benjamin Franklin first publishes the yearly Poor Richard’s Almanack. The goal is to promote his printing business.

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