Bayer, Exscientia to explore AI in drug discovery

PharmaTimes | January 10, 2020

A new collaboration between Bayer and UK-based Exscientia is set to accelerate the discovery of small molecule drugs, focused on cardiovascular disease and oncology. The companies have announced that they will use artificial intelligence (AI) to further the development of drug candidates for three of Bayer’s projects in the areas of cardiovascular disease (CVD) and oncology. Under the terms of the deal, Exscientia will begin by working on three projects with targets agreed between both parties, with eligibility to receive up to £203 million, including “upfront and research payments, near term and clinical milestones.”

Spotlight

Orphan drugs (ODs) for rare diseases (RDs) present pharma companies with the opportunity to address a substantial unmet medical need, with approximately 7,000 RDs, and only about 5% having effective treatments. A large number of patients in the US are affected with these RDs (around 25-30 million people). The majority of RDs affect children. Also, RDs often translate into chronic and deteriorating conditions for patients, the majority being affected and starting in childhood, and often resulting in early death. Significant economic and social burdens exist for patients, caregivers, and the healthcare system to treat RDs.

Spotlight

Orphan drugs (ODs) for rare diseases (RDs) present pharma companies with the opportunity to address a substantial unmet medical need, with approximately 7,000 RDs, and only about 5% having effective treatments. A large number of patients in the US are affected with these RDs (around 25-30 million people). The majority of RDs affect children. Also, RDs often translate into chronic and deteriorating conditions for patients, the majority being affected and starting in childhood, and often resulting in early death. Significant economic and social burdens exist for patients, caregivers, and the healthcare system to treat RDs.

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PHARMACY MARKET

Cardurion Pharmaceuticals Announces Investment of up to $300 Million From Bain Capital

Cardurion Pharmaceuticals | October 28, 2021

Cardurion Pharmaceuticals, Inc a clinical-stage biotechnology company focused on the discovery and development of novel, next-generation therapeutics for the treatment of heart failure and other cardiovascular diseases, today announced it has received a private investment of up to $300 million from Bain Capital Life Sciences and Bain Capital Private Equity. Bain Capital joins existing investors, Takeda Pharmaceuticals and Polaris Partners, in supporting the evolution of Cardurion into a leading cardiovascular biotechnology company. Based in Boston, Massachusetts and with facilities there and in Shonan, Japan, Cardurion’s mission is to transform the treatment of cardiovascular diseases by translating the science of cardiovascular signaling pathways into groundbreaking therapeutics. The Company’s innovative pipeline of cardiovascular drug candidates includes a PDE9 inhibitor and a CaMKII inhibitor program. The investment will support the thoughtful advancement of Cardurion’s pipeline, enable the Company to scale its team, and create an industry-leading platform. “We could not be more excited to welcome Bain Capital as investors in this transformational milestone for Cardurion We have a shared vision to continue to build a world-class cardiovascular company pursuing treatments for a broad range of debilitating diseases. This funding will allow us to advance our first-in-class PDE9 inhibitor into a major Phase 2 trial in heart failure and to support the initiation of first-in-human studies with our CaMKII inhibitor program in several cardiovascular indications. We look forward to leveraging the experience and resources of our investors to build and scale Cardurion as a leading cardiovascular biotechnology company.” Peter Lawrence, Chief Executive Officer of Cardurion “This is an impressive team laser-focused on deep science, innovation, and collaboration in a strategically important therapeutic area where there is high unmet need for patients,” said Adam Koppel, M.D., PhD, a Managing Director at Bain Capital Life Sciences. “We look forward to a lasting partnership with Mike and Peter and their team, supporting the efforts to identify and develop novel therapies while building out a scale platform that can serve as a champion for cardiovascular drug development.” “This investment will accelerate our progress as we work to create transformative new medicines that deliver value for patients and other key stakeholders,” said Michael E. Mendelsohn, M.D., Founder and Chairman of Cardurion. “Cardurion is dedicated to advancing novel mechanisms that yield new treatments for cardiovascular disease, which remains the greatest cause of morbidity and mortality in our society.” In conjunction with Bain Capital’s investment, Koppel and Nicholas Downing, MD, a Principal at Bain Capital Life Sciences, will join the Cardurion Board of Directors. About Cardurion Pharmaceuticals Cardurion Pharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of novel, next-generation therapeutics for the treatment of heart failure and other cardiovascular diseases. Founded by physician-scientist Michael E. Mendelsohn, M.D., and built by a team of physician-scientists and industry leaders with extensive experience in cardiovascular science, drug development and business development, Cardurion Pharmaceuticals is pursuing unique drug discovery and development programs to target major unmet needs in cardiovascular medicine. Cardurion Pharmaceuticals has facilities in Boston, Massachusetts and Shonan, Japan. About Bain Capital Founded in 1984, Bain Capital, LP is one of the world’s leading private multi-asset alternative investment firms with offices on four continents and deep experience in healthcare. Bain Capital manages approximately $150 billion across asset classes and leverages the firm’s shared platform to capture opportunities in strategic areas of focus. Bain Capital Private Equity has partnered closely with management teams to provide the strategic resources that build great companies and help them thrive. A team of more than 275 investment professionals creates value for portfolio companies through its global platform and depth of expertise in key vertical industries including healthcare. Bain Capital Life Sciences pursues investments in biopharmaceutical, specialty pharmaceutical, medical device, diagnostics and enabling life science technology companies globally. The team focuses on companies that both drive medical innovation across the value chain and enable that innovation to improve the lives of patients with unmet medical needs.

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BUSINESS INSIGHTS

Innovent and GenFleet Announce Exclusive Global License Agreement for GFH925 (KRAS G12C Inhibitor)

Innovent Biologics | September 02, 2021

Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and GenFleet Therapeutics (Shanghai) Inc., a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, today jointly announced that they have entered into an exclusive license agreement for the development and commercialization of GenFleet's lead KRAS G12C candidate, GFH925 in China, including mainland China, Hong Kong, Macau and Taiwan with additional option-in rights for global development and commercialization. GFH925, GenFleet's lead KRAS G12C candidate, has recently received Investigational New Drug (IND) approval from National Medical Products Administration (NMPA) in China. Preclinical data showed that GFH925 has potential best-in-class activity that can effectively inhibit the growth of a variety of tumor cell lines carrying the KRAS G12C mutation, which may be helpful in accelerating the clinical validation of GFH925. In addition, other preclinical data have also demonstrated the potent potential for GFH925 in combination therapies. According to the agreement, Innovent will be responsible for clinical development and commercialization of GFH925 in China, while retaining option-in right for development and commercialization outside of China as well. Following approval of a New Drug Application (NDA), Innovent will leverage its broad commercialization capability that includes an experienced commercialization team with extensive nationwide coverage to roll out GFH925, with the goal to benefit cancer patients in China. GenFleet will continue to be responsible for supplying GFH925 for both development and commercial purposes in China. GenFleet will receive an upfront payment of US$22 million at signing. If Innovent exercises the option-in rights, GenFleet will receive up to US$50 million of global development support from Innovent. Upon achieving certain pre-specified milestones in development, registration, and annual sales performance of GFH925 globally, GenFleet is eligible to receive up to US$240 million in milestone payments in addition to tiered royalties based on annual net sales of GFH925 both in China and global markets. About GFH925 (KRAS G12C Inhibitor) Being developed by GenFleet Therapeutics, GFH925 is a novel, orally active, potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRAS G12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of GFH925 towards G12C. Subsequently, GFH925 effectively inhibits the downstream signal pathway to induce tumor cells' apoptosis and cell cycle arrest. About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 26 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products. About GenFleet Therapeutics Dedicated to serving significant unmet medical needs, GenFleet Therapeutics established its proprietary R&D platform based on the deep understanding of disease biology, translational medicine, as well as researches into latest biological mechanism of cancer pathways, tumor microenvironment and human immunoregulation. GenFleet's rich and diversified pipeline highlights multiple cutting-edge products with novel mechanisms and global IP. Since its inception in 2017, GenFleet has built up industry-leading capabilities and expertise in developing novel drug candidates - both small molecules and biologics. Its pipeline includes over 13 programs in development, four of which have entered clinical stages. GenFleet is expected progress additional programs into clinics, as well as transition from a clinical stage biotech company into a commercial stage biopharmaceutical company in the next 3-5 years.

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RESEARCH

Exscientia and Bristol Myers Squibb Enter Into a Multi-Target, AI-Driven Drug Discovery Partnership

Exscientia, Bristol Myers Squibb | May 20, 2021

Exscientia, an AI-driven pharma tech company in the clinical-stage announced today that it has signed a partnership agreement with Bristol-Myers Squibb Company. Exscientia's portfolio of shared assets will benefit from this extended partnership and will contribute to Bristol Myers Squibb's drug pipeline. The partnership will use artificial intelligence to speed up the development of small molecule therapeutic drug candidates in a variety of therapeutic fields, including oncology and immunology. The agreement is worth up to $1.2 billion including up to $50 million in upfront funding, and up to $125 million in near-to-mid-term future milestones, and other clinical, regulatory, and commercial payments. Exscientia will also receive tiered royalty based on the net sales of any marketed drug products as a result of the partnership. This extended collaboration builds on Exscientia's existing partnership with Bristol Myers Squibb, which began in 2019 with Celgene before Bristol Myers Squibb purchased Celgene. Exscientia will be in charge of the AI design and experimental work needed to identify drug candidates for Bristol Myers Squibb as part of this partnership. Exscientia's AI-driven drug discovery platform will be used to create molecules and will deliver optimized compounds that meet complex design goals quickly and more efficiently than traditional drug discovery. Exscientia's drug discovery platform has a proven track record and has been the one to advance AI-designed small molecule drug candidates into clinical studies. Exscientia has previously partnered with large pharmaceutical firms such as Bayer, Sanofi, and Dainippon Sumitomo, as well as several new biotech companies and the Gates Foundation, highlighting the company's reputation as the go-to partner for high-value AI-driven drug discovery. More than a dozen partnered or wholly-owned drugs are currently in development in the company. Exscientia recently raised $525 million in a Series D investment led by Softbank to expand its technology capability and proprietary drug pipeline. About Exscientia Exscientia's AI-driven, end-to-end drug discovery platform is designed to revolutionize the process of developing new drugs by creating therapeutics for areas of high unmet medical need that could benefit patients in much less time than industry standards. Exscientia is the first clinical-stage organization to bring AI-designed small molecules to the clinic, demonstrating AI's ability to transform the pharmaceutical industry. At the molecular scale, drug design is precision engineering. Exscientia has built dedicated AI systems that effectively learn from a wide range of data and continuously re-apply enhanced information through design iterations to transform the industry. Candidate molecules satisfying complex therapeutic criteria are discovered with groundbreaking efficiency by Exscientia's AI systems, which learn faster and more efficiently than human-led efforts.

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