Artios in-licenses MD Anderson-Shangpharma’s ART inhibitor programme

Pharmaceutical Technology | November 06, 2019

DNA damage response (DDR)-focused company Artios has in-licensed University of Texas MD Anderson and ShangPharma Innovation’s joint ATR inhibitor programme. As a result, Artios will have exclusive rights to research, development, manufacture and commercialise all products globally – the company expects to submit an investigational new drug application for the lead product in the second half of 2020. Financial terms of the agreement were not disclosed. Artios CEO Dr Niall Martin said: “This programme has the potential to be a highly effective DDR-targeted treatment in cancer. “We look forward to advancing the work done by MD Anderson and ShangPharma for the benefit of cancer patients.” MD Anderson vice-president of the therapeutics discovery team Philip Jones added: “Targeting DNA damage repair has the potential to provide an important therapeutic option for many patients in need of new treatments. “We are pleased Artios will leverage its unique expertise in this field to advance this novel therapy toward the clinic to improve outcomes for cancer patients.” ShangPharma CEO Walter Moos continued: “We are pleased to transition this important programme to the capable development team at Artios, and we hope this ultimately provides an impactful therapy for those afflicted with cancer.”

Spotlight

Formulation, process, and analytical development for antibody-drug conjugates, or ADCs, is complex. While the development of an aqueous solution formulation may be preferred over a lyophilized product, it is useful to initially pursue a dual path and develop drug product formulations for both a sterile solution and a freeze-dried solid presentation, ultimately choosing the most successful candidate for final development. An antibody-drug conjugate, or ADC, consists of a monoclonal antibody (mAb) joined to a highly potent or cytotoxic drug by a stable, chemical linker with labile bonds. The antibody is targeted to attach to an antigen on the surface of a tumor cell. Once the connection is made between surface antigen and antibody, the antibody and linked drug are incorporated into the tumor cell. The drug is then cleaved from the antibody, and goes to work to destroy the tumor cell. Once internalized, the amount of “payload drug” required to cause cell death is relatively small. For that reason, ADC’s are generally better tolerated by patients than more traditional forms of chemotherapy.

Spotlight

Formulation, process, and analytical development for antibody-drug conjugates, or ADCs, is complex. While the development of an aqueous solution formulation may be preferred over a lyophilized product, it is useful to initially pursue a dual path and develop drug product formulations for both a sterile solution and a freeze-dried solid presentation, ultimately choosing the most successful candidate for final development. An antibody-drug conjugate, or ADC, consists of a monoclonal antibody (mAb) joined to a highly potent or cytotoxic drug by a stable, chemical linker with labile bonds. The antibody is targeted to attach to an antigen on the surface of a tumor cell. Once the connection is made between surface antigen and antibody, the antibody and linked drug are incorporated into the tumor cell. The drug is then cleaved from the antibody, and goes to work to destroy the tumor cell. Once internalized, the amount of “payload drug” required to cause cell death is relatively small. For that reason, ADC’s are generally better tolerated by patients than more traditional forms of chemotherapy.

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Ascential Digital Commerce and GSK Consumer Healthcare Announce Launch of Ascential Digital Commerce Connect at Cannes Lions

Ascential Digital Commerce and GSK Consumer Healthcare | June 15, 2022

Ascential Digital Commerce, whose technology driven products power brands to win in digital commerce, and GSK Consumer Healthcare, a science-led healthcare company, will join forces on June 20th during the Cannes Lions International Festival of Creativity to launch Ascential Digital Commerce Connect, a first-of-its-kind, data-rich, digital commerce platform that provides C-suite executives with visibility of brand sales and performance from multiple data sources. Ascential Digital Commerce Connect improves reaction time to market dynamics, increasing a brand's performance in the rapidly growing eCommerce retail market. Ascential Digital Commerce and GSK Consumer Healthcare partnered together to develop Ascential Digital Commerce Connect to provide visibility and clarity of GSK Consumer Healthcare's eCommerce brands performance, improve reaction time to market dynamics and position the brand for further growth. GSK Consumer Healthcare anticipates eCommerce growth to reach the mid-teens percentage of the business by 2025, thereby making eCommerce a priority channel to drive overall sales. According to Nasdaq research, 95% of all purchases by 2040 will be conducted via eCommerce and a 2021 IDC study revealed that the digital commerce applications market will see double-digit growth through 2025. “Visibility of data is becoming increasingly vital to businesses every day. Especially as eCommerce has become a core business capability for businesses around the globe, managing data streams for those businesses has become increasingly challenging.” Filippo Battaini, Research Manager at IDC Retail Insights The Ascential Digital Commerce Connect web-based platform captures, analyzes, visualizes, and displays critical marketing data about each brand and competitor to monitor key activities and answer marketers' key questions when it comes to Understanding the current brand/sales performance in the eCommerce marketplace – standalone vs. key competitors and owned channels vs. major online retailers like Amazon and Alibaba Dissecting what brand health looks like regionally throughout EMEA, US/North America, Asia-Pacific, and Latin America Navigating potential challenges and outages around supply chain, research and development, disruptive markets, and other key metrics. More accurately calculating marketing spending as a percentage of gross revenue During Cannes Lions 2022, Ascential Digital Commerce and GSK Consumer Healthcare will host a panel discussion to discuss the catalyst for developing Ascential Digital Commerce Connect and how GSK Consumer Healthcare currently leverages the platform for brand success. Product demos will also be available to showcase the platform. "The next five years represent a tipping point in the retailing industry," says Duncan Painter, CEO at Ascential. "Retailers and brands with the deepest, most recent insights into the digital performance of their products and services will gain an informed, competitive edge. The Connect platform turns data into actionable insights, and GSK Consumer Healthcare is on a strong path to further realize eCommerce growth." "Healthcare today is driven by the digital economy, whether consumers and patients are searching for healthcare information and services online, logging into exercise classes, ordering health and beauty products from their favorite online retailers, or managing prescription medications online," says Taryn Marella, Global Head of Digital Commerce, GSK Consumer Healthcare. "Ascential Digital Commerce Connect delivers actionable insights that help us monitor the health of our business and identify growth opportunities, update messaging and enhance creativity in the digital environment." About Ascential Digital Commerce Ascential Digital Commerce powers the global eCommerce ecosystem. Our platform allows brands, businesses and their agency partners to connect to consumers in every touchpoint of their journey to purchase goods and products. We transform data into actionable insights, allowing brands to build their competitive edge and drive growth with better, faster decisions. We solve the most complex challenges that global brands and businesses face in the digital commerce landscape with technology and human expertise to drive sales growth on the leading digital eCommerce marketplaces globally. About Ascential Ascential delivers specialist information, analytics, and eCommerce optimization platforms to the world's leading consumer brands and their ecosystems. Our world-class businesses improve performance and solve problems for our customers by delivering immediately actionable information combined with visionary longer-term thinking across Digital Commerce, Product Design, and Marketing. We also serve customers across Retail & Financial Services. With over 2,800 employees across five continents, we combine local expertise with a global footprint for clients in over 120 countries. Ascential is listed on the London Stock Exchange. About GSK Consumer Healthcare GSK’s Consumer Healthcare business is on track to become an independent company through a proposed demerger from GSK, expected in July 2022. The new business, to be named Haleon, is expected to be a world-leader in consumer healthcare. Led by its purpose to deliver better everyday health with humanity, it will be strongly positioned to play a vital role in a growing sector that is more relevant than ever. Haleon will have a world-class portfolio of category-leading global brands, including Sensodyne, Voltaren, Panadol and Centrum, brands that are trusted by healthcare professionals, customers and people worldwide to improve the health and wellbeing of individuals and their communities.

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Astellas and Sutro Biopharma Announce Worldwide Strategic Collaboration to Advance Novel Immunostimulatory Antibody-Drug Conjugates (iADCs)

Sutro Biopharma, Inc.; Astellas Pharma Inc. | June 28, 2022

Astellas Pharma Inc. and Sutro Biopharma, Inc. announced a worldwide, strategic collaboration and licensing agreement focused on the discovery and development of novel immunostimulatory antibody-drug conjugates. The collaboration leverages the unique cancer-fighting potential of iADCs as a novel modality, enabled by Sutro’s ability to engineer complex conjugated antibodies, and Astellas’ global oncology R&D expertise. “We are delighted to work with Astellas, a premier biopharmaceutical company with substantial expertise in immuno-oncology, on this novel modality. iADCs hold promise well beyond the existing success of ADCs. Sutro’s unique conjugation technology enables dual conjugations that site-specifically incorporate a potent cytotoxin that can directly kill tumor cells together with an immunostimulatory component that has the potential to locally prime an immune response to the patient’s particular tumor cells. We look forward to collaboratively exploring the potential of this approach to treat cold tumors and bring new drug therapies to patients who do not respond to existing immunotherapies.” William J. Newell, Sutro’s Chief Executive Officer Naoki Okamura, Chief Strategy Officer, at Astellas commented, "Astellas considers Immuno-Oncology as one of the Primary Focuses of its R&D strategy; our goal is to bring effective drugs to patients who do not respond to existing immune checkpoint inhibitors. Sutro is a leading company in the area of iADCs, a new modality, and has its own original iADC technologies. The strategic partnership with Sutro will help us expand our pipeline and widen the choice of cancer immunotherapies.” A key challenge with cancer immunotherapies, including immune checkpoint inhibitors, is the tumor microenvironment*1 within cold tumors creating barriers to immune cell infiltration and thus preventing the cure. The immune checkpoint inhibitors approved to date are efficacious as a monotherapy in only about 20% of cancer types, which vary widely*1. This strategic partnership will engage in the development of iADCs, a next generation modality with the potential for effective and efficient approaches for treatment of cold tumors so as to bring new drug therapies to patients who do not respond to existing therapies. An iADC, which combines an antibody with a small molecule compound that induces immunogenic cell death*2 in addition to an immune activating molecule, has the potential to boost the anti-cancer action. This partnership will enable Astellas and Sutro to mutually leverage strengths in their respective fields to accelerate iADC development for three distinct biological targets; Sutro will engage in research and preclinical studies to identify candidate compounds and then Astellas will pursue clinical development. Sutro has advanced technologies for linking drugs to antibodies and proprietary component parts, including candidate antibodies and linkable cytotoxins and immunostimulatory molecules. For development of iADCs, Astellas will utilize the strength of its global R&D and commercialization capabilities in the area of antibodies and the small molecular components. These iADCs may have the potential to provide new therapeutic options for treatment of cancers for which no broadly effective therapy is currently available. Under the terms of the agreement, Sutro will receive an upfront cash payment of US$90 million to develop iADCs for three biological targets and may be eligible to receive up to US$422.5 million in development, regulatory and commercial milestones for each product candidate, and tiered royalties ranging from low double-digit to mid-teens on worldwide sales of any commercial products that may result from the collaboration, subject to Sutro’s cost and profit sharing option for the United States. Sutro has the option to share in the costs and profits for developing and commercializing product candidates in the United States. If Sutro exercises this option for a particular product candidate, Astellas and Sutro will equally share the costs of such co-development and co-commercialization, with the resulting profits/losses from co-commercialization also shared equally in the United States.

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Novavax Submits Application to the U.S. FDA for Emergency Use Authorization for Novavax COVID-19 Vaccine,

Novavax, Inc. | August 16, 2022

Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that it submitted an application to the U.S. Food and Drug Administration for Emergency Use Authorization of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 as a homologous and heterologous booster in adults aged 18 and older. "It's important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations. Based on the data presented to the FDA's VRBPAC and the CDC ACIP, we believe our vaccine offers a broad, long-lasting immune response against a range of variants." Stanley C. Erck, President and Chief Executive Officer, Novavax Authorized Use The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. About the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) The Novavax COVID-19 Vaccine, Adjuvanted is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. The Novavax COVID-19 Vaccine, Adjuvanted contains purified protein antigen and can neither replicate, nor can it cause COVID-19. The Novavax COVID-19 Vaccine, Adjuvanted is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations. About Matrix-M™ Adjuvant Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response. About Novavax Novavax, Inc. is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 Vaccine, Adjuvanted, the company's COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including in the U.S., European Union and with the World Health Organization. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine candidate in a Phase 1/2 clinical trial, which combines the Novavax COVID-19 Vaccine, Adjuvanted and NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is also evaluating an Omicron strain-based vaccine as well as a bivalent format Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

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