BMS' head and neck cancer hopes take a hit with Opdivo-Yervoy trial flop

fiercepharma | April 25, 2019

Bristol-Myers Squibb already has one Opdivo approval in previously treated head and neck cancer, but it won’t make that two. The company, which was testing its immuno-oncology star alongside Yervoy in previously treated patients whose disease had recurred or spread, said Thursday that the pair had failed to outdo Opdivo on its own. For now at least, Bristol isn’t sharing details on the phase 2 miss. But one thing is clear: The regimen won’t be backing up Opdivo in second-line head and neck cancer, where it’s currently battling Merck’s Keytruda.

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Pfizer and IBM leaders discuss their collaboration to develop remote monitoring solutions that aim to transform Parkinson’s disease care. BlueSky configures wearable devices to recognize the activities of daily living, creating a unique technology scalable across all fields of medicine.

Spotlight

Pfizer and IBM leaders discuss their collaboration to develop remote monitoring solutions that aim to transform Parkinson’s disease care. BlueSky configures wearable devices to recognize the activities of daily living, creating a unique technology scalable across all fields of medicine.

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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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Charles River and Valo Health Announce Strategic Partnership to Provide Clients with Access to AI-Enabled Drug Discovery Solutions

Charles River Laboratories International, Inc. and Valo Health, LLC, | January 20, 2022

Charles River Laboratories International, Inc. and Valo Health, LLC, the technology company using human-centric data and computation powered by artificial intelligence (AI) to transform the drug discovery and development process, today announced the formation of a multiyear strategic partnership. This agreement will combine Valo’s Opal Computational Platform with Charles River’s drug discovery and development capabilities to offer a new transformative, AI-enabled drug discovery and development platform. Recognizing the challenges of preclinical drug discovery, from high costs, time, and attrition rates, Valo and Charles River have joined forces to create enhanced drug discovery solutions that aim to transform the entire preclinical drug discovery process. Valo and Charles River intend to create and deliver offerings that produce preclinical assets with key performance characteristics optimized for client preferences. The partnership’s combined offerings will utilize Valo’s Opal Platform for small molecule development, which leverages a “closed-loop” in silico-experimental platform that rapidly iterates using program data to identify novel compounds, and leverages Charles River’s capabilities in all aspects of discovery optimization, including medicinal chemistry, ADME, biology, pharmacology, and ultimately safety testing and IND submission. The combination of Valo’s scientific innovation and deep technological expertise with Charles River’s end-to-end portfolio and industry-leading scientific bench has the potential to significantly accelerate a client’s discovery and development efforts by integrating data and compute to streamline and de-risk experimental science, enabling a faster and more effective process from de novo molecule design through lead optimization. The combined offering will be launched in the first half of 2022 and will be available exclusively from Charles River. About Valo Health Valo Health, LLC is a technology company built to transform the drug discovery and development process using human-centric data and artificial intelligence (“AI”) computation. As a digitally native company, Valo aims to full integrate human-centric data across the entire drug development lifecycle into a single unified architecture, thereby accelerating the discovery and development of life-changing drugs while simultaneously reducing the cost, time, and failure rate. The company’s Opal Computational Platform™ consists of an integrated set of capabilities designed to transform data into valuable insights that may accelerate discoveries and enable Valo to advance a robust pipeline of programs across cardiovascular metabolic renal, oncology, and neurodegenerative disease. Founded by Flagship Pioneering and headquartered in Boston, MA, Valo also has offices in Lexington, MA, San Francisco, CA, Princeton, NJ, and in Branford, CT. About Charles River Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them.

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ITM Receives Equity Investment of EUR 25 Million from Strategic Partner Grand Pharma

ITM Isotope Technologies Munich SE | February 17, 2022

ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company and Grand Pharmaceutical Group Limited (GP), a diversified global pharmaceutical company listed in Hong Kong, today announced that ITM and a subsidiary of GP have entered into a definitive agreement under which GP will make a EUR 25 million (USD 28 million) equity investment in ITM. The agreement will further deepen the strategic collaboration between the two companies and support ITM to further expanding its broad pipeline of precision oncology treatments and diagnostics in Greater China. The equity investment follows the recent licensing agreement between the two companies which provides GP with exclusive rights to develop, manufacture and commercialize ITM’s precision oncology radiopharmaceutical candidates, ITM-11 (n.c.a. 177Lu-edotreotide) and ITM-41 (n.c.a. 177Lu-zoledronate) as well as ITM-11’s companion diagnostic, TOCscan® (68Ga-edotreotide) in mainland China, Hong Kong, Macau and Taiwan. “We believe GP’s investment reinforces our global leadership position as a radiopharmaceutical developer and manufacturer while providing us with additional strategic support in expanding our presence in Asia with a recognized leader by our side. While we focus on advancing the late-stage development of our lead candidate, ITM-11 in GEP-NET patients, we look forward to further enhancing our global footprint to meet the needs of a growing patient population requiring precision oncology treatments.” Steffen Schuster, Chief Executive Officer of ITM “Targeted Radionuclide Therapies and Diagnostics are a core focus area for us. We believe that ITM, as one of the largest medical radioisotope manufacturers with a broad clinical pipeline and a deep understanding of the clinical landscape, has the ability to usher in a new era of precision medicine,” said Frank Zhou, Chief Executive Officer of GP. “This second agreement is a testament to the strong relationship we have formed, sharing the common goal of providing innovative and high-quality radiopharmaceuticals to the patients we serve.” ITM is built on longstanding experience in the production and supply of high-quality medical radioisotopes for cancer treatment and diagnosis with an established global supply network. The company has forward-integrated to develop a broad pipeline of Targeted Radionuclide Diagnostics and Therapeutics designed to provide medical benefit for hard-to-treat cancer indications. The company’s lead candidate, ITM-11 (n.c.a. 177Lu-edotreotide) is being developed for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and is currently undergoing two phase III clinical trials, COMPETE for patients with grade 1 and grade 2 GEP-NETs and COMPOSE for grade 2 and grade 3 GEP-NETs. TOCscan® (68Ga-edotreotide) is the companion diagnostic to ITM-11 for the diagnosis and staging of neuroendocrine tumors (NETs). ITM-41 is in preclinical development for the treatment of osteosarcoma and bone metastases. About Targeted Radionuclide Therapy Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific entities such as receptors which are expressed on the cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying tumor tissue. The highly precise localization of the radioisotope potentially enables targeted treatment with minimal impact to healthy surrounding tissue. ITM Isotope Technologies Munich SE ITM, a radiopharmaceutical biotech company, is dedicated to providing the most precise cancer radiotherapeutics and diagnostics to meet the needs of patients, clinicians and our partners through excellence in development, production and global supply. With patient benefit as the driving principle for all we do, ITM is advancing a broad pipeline, including two phase III studies, combining its high-quality radioisotopes with targeting molecules to develop precision oncology treatments. ITM is leveraging its leadership and nearly two decades of radiopharma expertise combined with its worldwide network to enable nuclear medicine to reach its full potential for helping patients live longer and better. About Grand Pharmaceutical Group Limited Grand Pharmaceutical Group Limited (0512.HK) is a diversified global pharmaceutical enterprise. The company sticks to core values and principles of patients-centered, market-oriented and innovation-driven. GP has extensive capabilities in R&D, manufacture and commercialization of pharmaceutical products, advanced medical devices, active pharmaceutical ingredients, bio-technology products, and nutritional products. Its core product portfolio covers several major therapeutic areas including cerebro-cardiovascular emergency, respiratory and Ear, Nose & Throat (the “ENT”) as well as ophthalmic treatments and selective internal radiation therapy for tumor treatment. The global innovative product pipeline of GP is well-established and diversified, covering the field of precision intervention, oncology, severe anti-infection and respiratory and ENT. With the strategy of “global expansion and dual-cycle operation”, GP has formed a new pattern of domestic and international cycles that synergize with each other. GP devoted to health and dedicated to science through R&D and M&A activities. GP is accomplishing its promises to physicians and patients and trying our best to make meaningful contributions to our society.

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