Bristol-Myers Squibb’s Opdivo misses its shot at earlier use in liver cancer

fiercepharma | June 24, 2019

Bristol-Myers Squibb’s Opdivo already boasts an FDA approval in liver cancer patients who have been treated with Bayer’s Nexavar. But its quest to jump into the front line just hit a snag. The BMS PD-1 drug failed to beat Nexavar at extending patients’ lives in a phase 3 study, the company acknowledged Monday. The Bayer drug has long been as the standard of care for patients with newly diagnosed hepatocellular carcinoma (HCC), competition-free in that indication until Eisai and Merck & Co.’s Lenvima just recently joined it. While Bristol’s survival data didn’t meet the statistical significance bar in the trial, dubbed CheckMate-459, BMS said there was “a clear trend” toward improvement with Opdivo. With an accelerated second-line nod the FDA granted in 2017, “Bristol seemed to be well positioned from a timing perspective,” in the liver cancer market, which numbers about 11,000 patients in the U.S., Credit Suisse analyst Vamil Divan said in a Monday note to clients. Opdivo has been grabbing share in that indication, and Merck’s rival immunotherapy Ketyruda, which bears its own green light in the setting, just failed to confirm its own approval by showing it couldn't fend off tumor progression or prolong patients’ lives. BMS hasn’t revealed its own overall survival data for second-line use of Opdivo. But the tumor response rate it induced in the CheckMate-040 trial, 14.3%, isn’t that much different from the 17% Keytruda posted in its phase 2 Keynote-224 study.

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Each year lung cancer causes over 1.59 million deaths worldwide, more than any other cancer. Approximately 85% of lung cancer cases are a type of lung cancer called non-small cell lung cancer, and of these 5% are anaplastic lymphoma kinase (ALK)-positive. This type of lung cancer can be effectively targeted by a type of drug called an ALK-inhibitor, but how do they work?


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Basetwo Launches No-Code Artificial Intelligence Platform for Pharmaceutical Manufacturing, Raises $3.8 Million

Basetwo | May 27, 2022

Basetwo, a SaaS AI platform for manufacturers, announced it secured a $3.8M seed round led by Glasswing Ventures and Argon Ventures with additional funding from Caffeinated Capital, Graphite Ventures, MaRs IAF, Pareto Holdings, Plug and Play, and Quiet Capital. The funding supports the launch of the category-making Basetwo AI platform, a first-of-its-kind solution that enables process engineers to rapidly build digital twins of their manufacturing plants leveraging a familiar no-code interface. Basetwo promotes the digitalization of manufacturing systems to foster intelligent manufacturing across the global supply chain. Basetwo intends to be the default platform for continuous improvement in the current Good Manufacturing Process (cGMP), beginning with the pharmaceutical market and expanding to the food and beverage and chemical markets. The pharmaceutical manufacturing market has been challenged in the past two years due to the pandemic and associated supply chain issues. In addition, the rate of drug development and demand for pharmaceuticals has increased at an unprecedented rate, fueled by technological and economic advancement globally. However, manufacturing optimization to meet this demand is still rudimentary and inadequate to meet today’s and future needs. According to ABI Research the pharma industry is predicted to spend over $4.5 billion on digital transformation by 2030, growing at a CAGR of 27%. In addition, the market for digital twins is forecasted to reach $35.5 billion by 2026, a 37% CAGR, according to a recent ResearchandMarkets report, primarily driven by the growing applications of digital twin technology in the pharmaceutical and healthcare industries. Basetwo’s platform powered by “physics-informed machine learning” is well suited for pharmaceutical manufacturing. The Company’s no-code approach brings highly sophisticated capabilities from pre-built models to data pipelines and integrations within a complex manufacturing process to a format familiar to process engineers. Basetwo's ability to predict and understand manufacturing processes improves as more data is gathered, improving return on investment over time. “The introduction of our no-code AI platform lets manufacturers of any size leverage the power of the Internet of Things (IoT) and machine learning (ML) to develop digital twins easily, quickly, and economically. We are excited to have the backing and the expertise from Glasswing Ventures, Argon Ventures, and all our investors as we scale the business.” Thouheed Abdul Gaffoor, Co-Founder and CEO of Basetwo Having previously co-founded and exited Emagin, an AI startup in the heavy industry, Thouheed has seen first-hand the challenges that manufacturers face with maximizing value from machine learning initiatives. To address this challenge, Thouheed left his previous role as Head of AI at Autodesk, and partnered with Thamjeeth Abdul Gaffoor, who co-founded and served as the CFO at Emagin, Tawfeeq Abdul Gaffoor, former Software Engineer at Lyft and Databricks, and Kiefer Eaton, a pharmaceutical industry specialist from Johnson & Johnson. Together, the Basetwo founding team brings deep domain expertise in manufacturing, technology, and pharmaceuticals. “The pharmaceutical manufacturing market is at a critical point, having been heavily challenged by the pandemic and supply chain issues. By creating a digital duplicate of a pharmaceutical manufacturing plant, the Basetwo AI platform allows process engineers to analyze where things might break down — or run more efficiently, and increase resilience,” said Rudina Seseri, Founder and Managing Partner of Glasswing Ventures. “As a category maker, Basetwo has delivered a revolutionary AI-based no-code solution that enables manufacturers to use digital twins for optimization. We anticipate that Thouheed and his team will disrupt the status quo in manufacturing and affect significant change in the industry.” About Basetwo Basetwo is the first no-code AI platform that enables process engineers to rapidly build and operationalize digital twins of their manufacturing plants. From process development to commercial manufacturing, manufacturers use the digital twins they build with Basetwo AI to improve process efficiencies across the value chain. About Glasswing Ventures Glasswing Ventures is an early-stage venture capital firm dedicated to investing in the next generation of AI and frontier technology startups that enable the rise of the intelligent enterprise. The firm was founded by visionary partners with decades of experience in these markets, a disciplined investment approach, and a strong track record of industry-leading returns. Glasswing leverages its deep domain expertise and world-leading advisory councils to invest in exceptional founders who transform markets and revolutionize industries. About Argon Ventures Argon Ventures is a venture fund with a mission to amplify the energy of founders to launch breakthrough products to build impactful, global businesses. The firm’s Intelligent Industry Solutions investment thesis is centered on cutting-edge software platforms that accelerate productivity & drive top-line revenue, transform markets through radical efficiency and create enterprise value through data at scale. Argon’s portfolio spans a number of markets, including digital health, future of work, manufacturing, and others. The founding General Partners collectively bring over four decades of experience as successful operators, investors, advisors, founders and C-level executives of global companies.

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TherapeuticsMD and EW Healthcare Partners Announce Definitive Agreement for EW Healthcare Partners to acquire TherapeuticsMD

TherapeuticsMD, Inc | June 01, 2022

TherapeuticsMD, Inc. an innovative, leading women’s healthcare company, announced that it has entered into a definitive merger agreement to be acquired by an affiliate of EW Healthcare Partners, a private equity firm dedicated to making investments in rapidly growing healthcare companies. Under the terms of the transaction, which has been unanimously approved by TXMD’s board of directors, EW Healthcare Partners will commence a tender offer to acquire all outstanding shares of TXMD common stock for $10.00 per share in an all-cash transaction, followed immediately by a merger. The purchase price represents a premium of 367.3% over TherapeuticsMD’s closing share price on May 27, 2022. “We are very pleased to enter into this agreement with EW Healthcare Partners. Together, we will continue empowering women of all ages through a therapeutic focus in family planning, reproductive health, and menopause management. We have a deep appreciation for EW Healthcare Partners’s depth of expertise and track record and know they will bring an incredible value of knowledge and strategic guidance.” Hugh O’Dowd, Chief Executive Officer of TherapeuticsMD EW Healthcare Partners is one of the largest and oldest private healthcare investment firms with over $4B of capital raised since its inception. EW Healthcare Partners has made investments in over 150 rapidly growing healthcare companies in the pharmaceutical, medical device, diagnostics, and technology-enabled services sectors in the United States and in Europe. “We are pleased to welcome TherapeuticsMD to the EW Healthcare Partners portfolio and are deeply committed to the Company's mission of advancing women’s health. EW Healthcare Partners has already made a significant investment in women’s health through its acquisition of Majorelle. TherapeuticsMD represents a unique opportunity for Majorelle to enter the US market and is a perfect fit with our ambitious plans to create a fast-growing, premier trans-Atlantic women’s health platform. We bring an extensive network and capital to fund the further growth of the combined company,” said Evis Hursever, Managing Director at EW Healthcare Partners. “We look forward to working together with the company’s management team to enhance the patient experience, improve operational efficiency and create one of a very few trans-Atlantic specialty pharma companies dedicated to women’s health,” said Olivier Bohuon, Senior Adviser with EW Healthcare Partners and Chairman of Majorelle. About TherapeuticsMD, Inc. TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. TherapeuticsMD’s products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. TherapeuticsMD is committed to advancing the health of women and championing awareness of their healthcare issues. About EW Healthcare Partners (“EW”) With over $4 billion raised since inception, EW Healthcare Partners is one of the largest and oldest private healthcare investment firms and seeks to make growth equity investments in fast growing commercial-stage healthcare companies in the pharmaceutical, medical device, diagnostics, and technology-enabled services sectors in the United States and in Europe. Since its founding in 1985, EW Healthcare Partners has maintained its singular commitment to the healthcare industry and has been a long-term investor in over 150 healthcare companies, ranging across sectors, stages and geographies. The team is comprised of over 20 senior investment professionals with offices in New York, Houston and London.

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Global Pharmaceutical Market Drives Innovative Digitalization to Accelerate Drug Discovery

Frost & Sullivan | June 17, 2022

Frost & Sullivan's recent analysis, Global Pharmaceuticals Outlook, finds that the accelerated drug development timelines are driving digitalization and innovation across the pharmaceutical value chain. Data, the decentralization of clinical trials, supply-chain resilience, digital therapeutics, and manufacturing automation are the key areas driving digitalization. The industry also ensures that healthcare will remain precise, preventive, and outcome-based in promoting social and financial inclusion. The global pharmaceuticals market, including small molecules and biologics, is expected to register 3.8% growth, garnering $1.48 trillion by the end of 2022 from $1.43 trillion in 2021 under the aspirational scenario. "The partnerships and horizontal integration of technology companies with life science companies have laid the foundation for rapid and cost-effective drug discovery and development. Further, all major genomics technology companies are channeling their resources to digitalize genomic data for better selection of patients for clinical trials and to reduce the turnaround time for clinical studies." Surbhi Gupta, Healthcare & Life Sciences Senior Industry Analyst Gupta added: "Owing to the growing use of machine learning and artificial intelligence in personalized medicine, the pharmaceuticals industry will move from a symptom-driven treatment approach to a genetics-based approach. Additionally, precision medicine can offer in-depth information about cellular and molecular alterations, accelerating the development of targeted therapies." Digitalization and innovation in the pharmaceuticals industry will unlock new growth opportunities, including: Digital therapeutics companies must excel in areas where many pharmaceutical companies are lacking, including data analytics, interoperability, user-centric design, and flexible business models. Innovative formulation and delivery technologies that improve RNA stability at ambient temperatures will facilitate the rapid global adoption of RNA-based treatments at reduced costs. Contract development and manufacturing companies should partner with global companies to meet the required experience in clinical drug manufacturing and expand market reach in Asia-Pacific. Global Pharmaceuticals Outlook, 2022 is the latest addition to Frost & Sullivan's Healthcare & Life Sciences research and analyses available through the Frost & Sullivan Leadership Council, which helps organizations identify a continuous flow of growth opportunities to succeed in an unpredictable future. About Frost & Sullivan For six decades, Frost & Sullivan has been world-renowned for its role in helping investors, corporate leaders and governments navigate economic changes and identify disruptive technologies, Mega Trends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success. Contact us: Start the discussion

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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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Each year lung cancer causes over 1.59 million deaths worldwide, more than any other cancer. Approximately 85% of lung cancer cases are a type of lung cancer called non-small cell lung cancer, and of these 5% are anaplastic lymphoma kinase (ALK)-positive. This type of lung cancer can be effectively targeted by a type of drug called an ALK-inhibitor, but how do they work?

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