Fusion | October 23, 2021
Fusion Pharmaceuticals a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preclinical data that provide further support of its FPI-1966 and FPI-2059 targeted alpha therapies at the 34th Annual European Association of Nuclear Medicine Congress. These data reinforce the clinical dosing regimen of FPI-1966 and highlight the potential of FPI-2059 as an actinium-225 labelled precision medicine targeting NTSR1.
"These data demonstrate the broad potential of our TAT platform across multiple validated targets overexpressed in a variety of solid tumors, We are pleased to share preclinical efficacy and tumor uptake data resulting from the administration of FPI-1966, and we believe strongly that this data will translate into meaningful results for patients with solid tumors overexpressing FGFR3 – a population with high unmet medical need. We look forward to initiating the Phase 1 study around the end of this year."
Chief Executive Officer John Valliant, Ph.D
Data from preclinical studies of FPI-1966, a TAT designed to target and deliver actinium-225 to cancer cells expressing FGFR3, were presented in an oral presentation titled, "FGFR3 Targeted Alpha Therapeutic [225Ac]-FPI-1966 induces regression in preclinical bladder xenograft model". Outcomes demonstrated that FPI-1966 when administered with vofatamab results in high tumor delivery and low off-target uptake. Further, the data showed therapeutic efficacy of FPI-1966 at both single and multiple doses in a preclinical bladder cancer xenograft model.
Data from preclinical studies of FPI-2059, a TAT designed to target and deliver actinium-225 to cancer cells expressing neurotensin receptor 1 (NTSR1), were presented in an oral presentation titled "NTSR1 Targeted Alpha Therapeutic [225Ac]-FPI-2059 induces regression in preclinical colorectal xenograft model". The study results include a head-to-head comparison of therapeutic efficacy obtained from FPI-2059, which delivers an alpha emitting isotope, with [177Lu]-IPN-1087, which delivers a beta emitting isotope on the same targeting molecule. Results demonstrate superior efficacy with [225Ac]-FPI-2059 in a mouse xenograft model of colorectal cancer.
Dr. Valliant continued, "Our science is based on the belief that alpha-emitting isotopes can provide significant therapeutic advantages compared to other commonly used radioisotopes. Preclinical results from our FPI-2059 product candidate provide further validation of this belief and support the diversification of our product portfolio to comprise multiple targeting vehicle types, including small molecules. We are pleased to be advancing further preclinical studies of FPI-2059 as we approach an investigational new drug (IND) filing in the first half of 2022."
[225Ac]-FPI-1966 is a targeted alpha therapy designed to target and deliver an alpha emitting medical isotope, actinium-225, to cancer cells expressing FGFR3; a receptor that is overexpressed on several tumor types, including head and neck and bladder cancers. FPI-1966 utilizes Fusion's Fast-Clear™ linker to connect vofatamab, the human monoclonal antibody that targets FGFR3, with actinium-225. Vofatamab was previously evaluated as a therapeutic agent in a Phase 1b/2 trial and was reportedly well-tolerated. FPI-1966 is advancing to a Phase 1 study following the recent investigational new drug (IND) clearance
FPI-2059 is a targeted alpha therapy combining actinium-225 with IPN-1087, for development as a targeted alpha therapy for various solid tumors. The molecule targets NTSR1, a promising target for cancer treatment, that is overexpressed in multiple solid tumors. IPN-1087 was in Phase 1 clinical development as a lutetium-177-based radiopharmaceutical for pancreatic ductal adenocarcinoma, colorectal cancer and gastric cancers expressing NTSR1. Fusion expects to submit an IND for FPI-2059 in the first half of 2022.
Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), advancing to a Phase 1 study following the recent investigational new drug (IND) clearance; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Fusion and Hamilton, Ontario-based McMaster University are building a current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs.
Forward Looking Statements
This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding Fusion Pharmaceuticals Inc.'s (the "Company") future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the uncertainties inherent in the drug development process, including FPI-1966 and FPI-2059 early stage of development; the ability to move in-licensed targets forward in the clinic; the process of designing and conducting preclinical and clinical trials; the regulatory approval processes; the timing of regulatory filings; and the challenges associated with manufacturing drug products generally and radiopharmaceuticals specifically. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2021 as filed with the SEC and in any subsequent periodic or current report that the Company files with the SEC. All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Fusion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.
Enclara Pharmacia | February 18, 2022
Enclara Pharmacia the market leader in comprehensive pharmacy benefits management (PBM) services to the hospice community, has announced a five-year contract extension to continue providing comprehensive patient medication management services to VITAS Healthcare, the nation’s leading provider of hospice and palliative care. The contract extension affirms the longstanding collaboration between the two companies based on excellence, innovation and quality care for hospice patients and their families.
“The goal of hospice is to provide care and comfort that helps patients maintain the best possible quality of life. Pain and symptom management are central to that work. Our team relies on proper medication management so we value Enclara’s combination of powerful technology and personal service that supports and empowers our team to deliver the best quality care.”
Nick Westfall, president and CEO, VITAS
Mark Morse, CEO, Enclara, said, “VITAS is an industry leader, and with their scale and commitment to continuous improvement in hospice and palliative care, we are able to better identify and respond to the changing needs of the hospice community. This ultimately positions Enclara to better serve hospices of all shapes and sizes.”
Scott Quilty, Chief Commercial Officer, Enclara, noted the VITAS renewal comes as Enclara is completing development of the next generation of its E3 mobile and desktop nurse-facing medication management tools. He said, “I’m grateful to continue this relationship as we prepare to roll out the next generation of our E3 application, E3 ProTM. VITAS’ feedback was essential as we worked to prioritize new features that will empower nurses to efficiently administer clinically appropriate symptom management.”
About Enclara Pharmacia
Enclara Pharmacia is a national full-service PBM and mail order supplier of medications and clinical services developed specifically for the hospice and palliative care industry. Enclara serves over 400 hospice providers and 97,000 patients nationally, helping to reduce pharmacy costs through a clinically driven model that enables home delivery of pharmaceuticals as well as access to a network of over 65,000 local pharmacies, including an actively managed network subset of over 7,000 retail pharmacies, institutional pharmacies, and Enclara’s own automated fulfillment solutions.
About VITAS® Healthcare
Established in 1978, VITAS Healthcare is a pioneer and leader in the American hospice movement. Headquartered in Miami, Florida, VITAS operates 49 hospice programs in 14 states and the District of Columbia. VITAS employs 10,618 professionals who care for patients with advanced illness, primarily in the patients’ homes, and also in the company’s 28 inpatient hospice units as well as in hospitals, nursing homes and assisted living communities/residential care facilities for the elderly. At the conclusion of the third quarter of 2021, VITAS reported an average daily census of 18,026.
Informa Pharma Intelligence | November 26, 2021
Informa Pharma Intelligence, one of the leading business intelligence providers and knowledge partners, is pleased to announce the 2021 hybrid edition of CPhI – P-MEC conducted by CPhI Conference. The Online Conference & Networking is being held between 15th to 30th Nov 2021, while the In-Person event is being held between 24th to 26th Nov 2021 at India Expo Centre– Greater Noida, Delhi.
In a bid to stay afloat towards increasing contemporary demand towards high quality, low cost pharma solutions, CPhI & P_MEC India has curated a platform through this event for a gateway to latest trends and innovative solutions that the market has to offer. The event aims to build better pharma community engagements, network amongst the fraternity and source innovative solutions on-site from exhibitors who have footprints both domestically and globally, and covering the entire pharma supply chain - from APIs, machinery, technology, packaging, outsourcing, finished products and biopharmaceuticals. The industry is anticipated to have a steady growth trajectory and the event organised by CHhI India has focused on the key driving factors for the same. The expansion of medicine manufacturing pertaining to the evolving epidemiological profile of the country will be instrumental for India being the preferred drug manufacturing destination on a global scale. Additionally the event aims to encourage the development of the research-based pharma fraternity.
"The Indian pharmaceutical industry has been growing at double digits year-on-year, and remains committed to not only providing solutions to the healthcare needs of the country, but also to the world. As the world is battling the pandemic at different levels, here in India, we remain committed to ramping up production capabilities of some key medicines across infectious and non-infectious diseases to ensure their availability and accessibility to the country and the world. The CPhI – P-MEC India show is the single location for all pharmaceutical and allied companies to get together and share insights, techniques and technology that will help meet these demands."
Speaking at the sidelines of the CPhI – P-MEC India show, Mr Yogesh Mudras, Managing Director, Informa Markets in India
As a part of the management team of the CPhI – P-MEC 2021 event, Mr Poornachandra Tejasvi, Senior Director, Emerging Markets, India, at Informa Pharma Intelligence said, "As a representative of the world's leading pharmaceutical business intelligence provider, its heart-warming to be a part of the CPhI – P-MEC event where we get to share meaningful insights drawn from real-time news, trends, market analysis, special reports, to key pharmaceutical companies in the country and the world. Globally we provide intelligence to over 10,000 customers and 3,000 of the top pharma, biotech and biosimilar companies with the collective support of more than 300 respected Business Intelligence subject matter analysts, editors, and thought leaders located across countries. The 2021 CPhI – P-MEC event will be a great opportunity to reconnect with the stakeholders of the pharmaceutical world and provide them with any form of data intelligence and analysis as needed."
The Indian pharmaceutical market is growing at 15% annually, twice the world market growth rate. While its generics market is growing strong, it is also evolving into a cradle for new drugs. Therefore, with India being one of the strongest emerging markets in the global pharma industry, it presents great opportunities for all international pharmaceutical companies to explore, the platform by CPhI & P-MEC provides full access to the exhibitors to source new pharma solutions and find the right partners for your business with the ongoing hybrid expo showcasing the full drug development supply-chain from exporting, outsourcing, manufacturing, machinery, regulations, pricing, and market access to, packaging, labelling, and digitalization.
The P-MEC event is the single destination in the country today for all things associated with the latest innovative pharma solutions that the world has to offer. The venue will also host the latest types of equipment associated with research and development and analytical solutions followed by cleanroom engineering design, certifications and the latest types of air purification solutions. The packaging technology on display will include a comprehensive range of glass, pouches, bottles, caps, tubes and plastic packages as well as printing and trademark solutions.
CPhI India is a sister brand of CPhI Worldwide – A key event that all professionals from the international pharmaceutical and allied industries look forward to year on year. CPhI India and its co-located event, P-mec India, are the largest and most comprehensive pharmaceutical industry events in South Asia. This event is specifically important to the country as India is already labelled as the pharmacy of the world in addition to the vaccine manufacturing prowess showcased in 2019-2020.
About Informa Pharma Intelligence
Trusted by over 3,000 of the world's leading pharmaceutical, biotech, medical device companies, and CROs, the Pharma Intelligence suite of intelligence solutions, which include Datamonitor Healthcare™, Sitetrove™, Trialtrove™, Pharmaprojects™, Biomedtracker™, Scrip™, Pink Sheet™ and In Vivo™, deliver vital, accurate, and timely intelligence and analysis about the drug development pipeline to pharmaceutical and biomedical decision makers around the world. A global team of subject area experts track and analyse key diseases, clinical trials, drug approvals and R&D activities, to deliver data needed to make decisions and create real-world opportunities for growth.
About CPhI Conferences
The world's largest pharmaceutical exhibition, CPhI Worldwide represents every stage of the pharmaceutical supply chain - from ingredients and FDF, to machinery, packaging, outsourcing and biopharmaceuticals.
Each year the CPhI brand unites more than 100,000 pharmaceutical professionals from all over the world through exhibitions, conferences and online communities. CPhI offers healthcare experts a chance to network, identify business opportunities and expand the global market through online and in-person interactions, with events in Europe, China, Korea, India, Japan, Southeast Asia and North America.