Pharmacy Market
Globenewswire | June 27, 2023
POINT Biopharma Global Inc. a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, and AdvanCell, a company developing an innovative pipeline of targeted alpha therapies with a platform technology to produce 212Pb radiopharmaceuticals, today announced a collaboration on the development of a global 212Pb radioisotope and radioligand supply chain and drug manufacturing network to specifically support the clinical development and commercialization of 212Pb-labeled radioligands by each company.
212Pb is differentiated as both an alpha and beta-emitting isotope with a simple decay chain that has demonstrated promising clinical results1 in compassionate use and phase 1 settings. 212Pb is produced via a generator using thorium (228Th, 1.9 year half-life) or radium (224Ra, 3.6 day half-life) sources. 228Th is available in significant quantities and has a half-life that supports 212Pb generators with ~1 year shelf-lives stationed at a selected number of regional locations globally. The short half-life of 212Pb (10.6 hours) has the benefit of delivering >99% of the tumor cell–killing radiation in only 72 hours, which reduces the time that the ligand needs to be retained in the tumor, a common limitation for targeted radioligand therapies. The short half-life may also promote the earlier maintenance of functional immune cells infiltrating the tumor relative to longer-lived isotopes. In contrast, only ~20% of the decays from 225Ac occur in 72 hours, so prolonged tumor retention is required to achieve the same payload delivery.
“We constantly strive to use the right isotope for the job, and variations in ligand and tumor characteristics require different isotope properties,” said Joe McCann, Ph.D., Chief Executive Officer of POINT Biopharma. “Adding 212Pb to our toolbox increases the optionality for new programs with the goal of developing new therapeutic options with improved clinical outcomes. Importantly, AdvanCell’s proprietary 212Pb generator technology based on 228Th sources is next-generation technology that we believe can scale to commercial quantities. Having a greater range of isotope choices, combined with supply chain visibility and control over access, will facilitate not only robust clinical development programs but also make eventual supply for commercialization more predictable as we look to expand our pipeline to bring next-generation radioligands to more patients.”
“AdvanCell is delighted to collaborate with POINT Biopharma, whose excellence and track record in manufacturing and clinical development we have admired and respected for some time,” said Andrew Adamovich, Chief Executive Officer of AdvanCell. “AdvanCell was founded on the belief that targeted alpha therapies will change the course of cancer treatment. These treatments have demonstrated incredible efficacy but have been hampered by manufacturing and supply issues. AdvanCell’s technology, in combination with POINT’s demonstrated manufacturing expertise and our joint commitment to developing life-saving therapies, will deliver on the promise of targeted alpha therapy and positively impact the lives of many. As AdvanCell progresses ADVC001, our lead clinical program for the treatment of metastatic prostate cancer, this collaboration will accelerate clinical development and ensure the scaled supply of these important medicines.”
About POINT Biopharma
POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT’s active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment.
About AdvanCell
AdvanCell is a radiopharmaceutical company developing an innovative pipeline of targeted alpha therapies to improve clinical outcomes in cancer patients. AdvanCell’s Targeted Alpha Therapies are powered by a proprietary platform technology – a novel alpha isotope generator that addresses the greatest unmet need in Targeted Alpha Therapy – the reliable and scalable supply of isotope.
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Pharmacy Market
PRNewswire | August 11, 2023
Capital Rx, the health technology company changing the way prescription drugs are priced and patients are cared for in America, has received a strategic investment from Memorial Hermann Health System, a non-profit health system committed to creating healthier Houston communities. Memorial Hermann joins Capital Rx's existing investors in supporting the development of JUDI®, the new standard for backend claims processing platforms in the pharmacy benefit management (PBM) industry, and the overall growth of Capital Rx's full-service PBM and pharmacy benefit administration (PBA) platform as a service (PaaS) solution.
"We're thrilled to have the investment support of Memorial Hermann as we work to modernize this country's claims processing infrastructure and deploy our aligned customer model to more employers, unions, municipalities, and other payers to create enduring change," said AJ Loiacono, Co-Founder & CEO of Capital Rx. "It's especially rewarding because we share the same values and prioritize community, compassion, credibility, and having the courage to be innovative in everything we do."
Capital Rx's JUDI brings exponential operational efficiency and control to Medicare, Medicaid, and commercial plans and prescription claims processing. A modern, open, and scalable platform, JUDI allows for seamless communication and data integration between vendors and across the continuum of care. Importantly, its intuitive design and workflows save time, allowing health systems and other payers to allocate resources more efficiently and toward what matters most: caring for patients and members in the communities and populations they serve.
"As we assessed the health care ecosystem for innovative capabilities to help accelerate the evolution of the pharmacy service model and prescription claims processing, Capital Rx's vision for a framework that prioritizes efficiency and allows for exceptional patient care set the company apart for investment consideration," said Feby Abraham, Ph.D., Executive Vice President and Chief Strategy Officer at Memorial Hermann. "Capital Rx's platform is focused on bringing clarity and consistency to drug prices, broadening access to medication, and helping its clients control pharmacy costs, all without sacrificing member service and patient outcomes."
The Health Management Academy's Strategic Partnership Alliance, which explores new venture and investment opportunities on behalf of a group of the country's largest health systems, identified Capital Rx as a mission-aligned disruptor with next-generation technology for its members, including Memorial Hermann.
About Memorial Hermann Health System
Charting a better future. A future that's built upon the HEALTH of our community. This is the driving force for Memorial Hermann, redefining health care for the individuals and many diverse populations we serve. Our 6,700 affiliated physicians and 32,000 employees practice the highest standards of safe, evidence-based, quality care to provide a personalized and outcome-oriented experience across our more than 260 care delivery sites. As one of the largest not-for-profit health systems in Southeast Texas, Memorial Hermann has an award-winning and nationally acclaimed Accountable Care Organization, 17* hospitals, and numerous specialty programs and services conveniently located throughout the Greater Houston area. Memorial Hermann-Texas Medical Center is one of the nation's busiest Level I trauma centers and serves as the primary teaching hospital for McGovern Medical School at UTHealth. For more than 115 years, our focus has been the best interest of our community, contributing nearly $500 million annually through school-based health centers and other community benefit programs. Now and for generations to come, the health of our community will be at the center of what we do – charting a better future for all.
Memorial Hermann Health System owns and operates 14 hospitals and has joint ventures with three other hospital facilities, including Memorial Hermann Surgical Hospital First Colony, Memorial Hermann Surgical Hospital Kingwood, and Memorial Hermann Rehabilitation Hospital-Katy.
About Capital Rx
Capital Rx is a healthcare technology company changing the way prescription drugs are priced and patients are cared for in America. As a Certified B Corp™, Capital Rx is executing its mission through an efficient Single-Ledger Model™ that increases visibility and reduces variability in drug prices. The company's cloud-native enterprise pharmacy platform, JUDI®, connects every aspect of the pharmacy ecosystem, servicing over 2.4 million members for Medicare, Medicaid, and commercial plans.
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Pharmacy Market
PRNewswire | July 18, 2023
Karyopharm Therapeutics Inc. a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to the development program of selinexor for the treatment of patients with myelofibrosis, including primary myelofibrosis, post-essential thrombocythemia myelofibrosis, and post-polycythemia vera myelofibrosis.
"Fast Track Designation for selinexor highlights its potential to address the unmet medical need in myelofibrosis, an important acknowledgement as we continue our pivotal Phase 3 study," said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. "Selinexor's unique mechanism of action, XPO1 inhibition, is a novel and potentially fundamental mechanism in myelofibrosis. We have been highly encouraged by the efficacy and safety data observed to date [in our Phase 1 study] with selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis and believe selinexor has the potential to shift the treatment paradigm. We look forward to continued interaction with the FDA as we advance the development of this promising treatment for patients in need."
In June 2023, Karyopharm initiated a pivotal Phase 3 clinical trial to assess the efficacy and safety of once-weekly selinexor 60 mg in combination with ruxolitinib in JAKi-naïve patients with myelofibrosis. Updated data from the Phase 1 study were presented at the American Association for Cancer Research Annual Meeting 2023, American Society of Clinical Oncology 2023 and European Hematology Association 2023, which showed rapid, deep and sustained spleen responses and robust symptom improvement in patients treated with selinexor 60 mg in combination with ruxolitinib as of the April 10, 2023 cut-off date. Top-line data from the Phase 3 study is expected in 2025. The Company plans to expand its clinical development program in myelofibrosis by investigating selinexor in other JAKi-naïve settings, such as novel combinations, to benefit the greatest number of patients.
Fast Track Designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously. Features of Fast Track Designation include frequent interactions with the FDA review team, and if relevant criteria are met, eligibility for Priority Review and Rolling Review.
About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. is a commercial-stage pharmaceutical company pioneering novel cancer therapies. Since its founding, Karyopharm has been an industry leader in oral Selective Inhibitor of Nuclear Export (SINE) compound technology, which was developed to address a fundamental mechanism of oncogenesis: nuclear export dysregulation. Karyopharm's lead SINE compound and first-in-class, oral exportin 1 (XPO1) inhibitor, XPOVIO® (selinexor), is approved in the U.S. and marketed by the Company in three oncology indications and has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including Europe and the United Kingdom (as NEXPOVIO®) and China. Karyopharm has a focused pipeline targeting multiple high unmet need cancer indications, including in multiple myeloma, endometrial cancer, myelodysplastic neoplasms and myelofibrosis.
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