NEW YORK, NY — The FDA Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted that donanemab shows clinical benefit for the treatment of early Alzheimer's disease. If approved, donanemab, developed by Eli Lilly, would become the second disease-modifying drug for Alzheimer's to receive full approval, expanding the arsenal of available drugs needed to treat Alzheimer's with combination therapy.

"Today's vote offers hope that donanemab will be approved in the coming months, but it's important to look at this milestone in the larger treatment landscape for Alzheimer's, which will entail a combination therapy and precision medicine approach," says Dr. Howard Fillit, Co-Founder and Chief Science Officer of the Alzheimer's Drug Discovery Foundation (ADDF). "If approved, donanemab will expand the first class of disease-modifying drugs, serving as the building blocks for future generations of drugs. Anti-amyloids are not a silver bullet, but they offer opportunities for patients to modify the course of the disease while the field works towards developing more novel therapies that target the underlying biology."

The donanemab trials demonstrate the field's ability to conduct innovative and rigorous biomarker-powered trials that provide a definitive answer on a drug's effectiveness. By using a "goldilocks strategy," the TRAILBLAZER-ALZ 2 trial used both amyloid and tau imaging to identify patients who were in the early stages of Alzheimer's and most likely to benefit from treatment.

"It's encouraging to see that some patients essentially enter remission, where they achieve full amyloid clearance with donanemab, with no resurgence in substantial plaque buildup for nearly four years," notes Dr. Fillit. "These findings are a direct result of biomarker tests that can detect, quantify, and monitor plaque buildup in the brain. Biomarkers will continue to revolutionize clinical trial design as we move towards developing drugs that target novel pathways guided by the biology of aging."

This milestone comes at a critical time when drug development is now largely driven by the biology of aging approach. In the current pipeline, nearly 75% of Alzheimer's drugs in development are exploring novel targets related to the various aging pathways like inflammation, metabolic disturbances, and vascular dysfunctions. Some of the promising drugs are from ADDF-funded companies such as Coya Therapeutics, which is developing a combination therapy targeting neuroinflammation, as well as Therini Bio, which is developing a drug to target vascular dysfunction, and PharmatrophiX, which recently completed a phase 2a trial for a neuroprotective drug now ready for phase 2b trials.

Diversity in the drug pipeline coupled with recent advances in biomarkers—notably the advent of accessible and scalable blood-based biomarkers—sets the stage for a new frontier in Alzheimer's care where early detection, diagnosis, and intervention is feasible. Biomarkers will also be integral to the prevention of the disease by identifying patients in the preclinical phase before symptoms present and reducing Alzheimer's risk based on their individual biomarker profiles.

"Today's advisory committee endorsement is a milestone achievement for the researchers, patients, families, and caregivers who have dedicated years to advancing new treatment options, but our work does not end here. We must continue fostering innovation and progress to move closer to the day where Alzheimer's is treated on an individual basis with the help of precision medicine, ultimately halting the progression or preventing the onset of the disease altogether," closes Dr. Fillit.

WASHINGTON, PA – Washington Health System is pleased to announce it has officially joined UPMC, becoming UPMC Washington and UPMC Greene.

In June of 2023, the Boards of Directors of Washington Health System (WHS) and UPMC announced an affiliation agreement between the two entities that would integrate WHS into the UPMC system. One year later, on June 1, 2024, that affiliation became official, ensuring a future of excellent patient care for residents of Washington, Greene and surrounding counties.

“We are elated that the affiliation is complete and look forward to starting a new chapter of collaboration with UPMC,” said Brook Ward, president of UPMC Washington and UPMC Greene. “This affiliation protects the vitality of an essential community asset and solidifies a healthy future for Washington and Greene counties for generations to come.”

UPMC has committed to invest at least $300 million over 10 years to enhance clinical services and upgrade facilities at UPMC Washington and UPMC Greene. These investments by UPMC, combined with contributions the WHS Foundation has made and will continue to make, ensures UPMC Washington and UPMC Greene can provide state-of-the-art health care for local residents for years to come and maintain its position as one of the largest employers in Washington and Greene counties.

“Our focus is on ensuring residents have access to life-saving services and advanced care that is sustainable into the future and preserving jobs of our talented health care workers,” said Ward. “The community is gaining close-to-home access to the nationally recognized, high-specialty care of UPMC. Our local capabilities will expand, creating a destination for world-class care in southwestern Pennsylvania.”

Clinical collaborations between WHS and UPMC for oncology (UPMC Hillman Cancer Center joint venture), pediatric specialties (UPMC Children’s Hospital of Pittsburgh), women’s health (UPMC Magee-Womens) and heart and vascular care (UPMC Heart and Vascular Institute), have been in place for more than a decade, providing care for more than 10,000 patients annually. UPMC will continue to invest in and advance key services locally, including inpatient and emergency care, women’s health, cardiology, surgical services, diagnostics, primary care and specialty and outpatient services.

“UPMC has a long, successful track record of affiliations with like-minded organizations. We know how essential these hospitals are to this region to preserve needed health care services and livelihoods of thousands touched by them, and we are thrilled to welcome UPMC Washington and UPMC Greene to UPMC,” said Leslie C. Davis, president and CEO of UPMC.

UPMC Washington and UPMC Greene will maintain a local Board of Directors consisting of 11 legacy WHS board members and five newly appointed members from UPMC.

The affiliation does not affect community members’ in-network access to WHS hospitals or doctors. UPMC Washington, UPMC Greene and their affiliated outpatient facilities will continue to honor the contracts that are in place with regional and national insurers.

A formal celebration of the affiliation and a press conference will be announced in the coming days.

CAMBRIDGE, MA and RAHWAY, NJ — Moderna, Inc. and Merck, known as MSD outside of the United States and Canada, announced the first presentation of results from a planned analysis from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV) following complete resection (n=157). With a median follow-up of approximately three years (34.9 months), adjuvant treatment with mRNA-4157 (V940) in combination with KEYTRUDA continued to demonstrate a clinically meaningful and durable improvement in recurrence-free survival (RFS), the primary endpoint of the study, reducing the risk of recurrence or death by 49% (HR [95% CI], 0.510 [0.288-0.906]; two-sided nominal p-value 0.019) compared with KEYTRUDA alone. mRNA-4157 (V940) in combination with KEYTRUDA also continued to demonstrate a meaningful improvement in distant metastasis-free survival (DMFS), a key secondary endpoint of the study, compared with KEYTRUDA alone, reducing the risk of developing distant metastasis or death by 62% (HR [95% CI], 0.384 [0.172-0.858], two-sided nominal p-value 0.015).

These data are being presented during a rapid oral abstract session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract #LBA9512). With an additional year of planned follow-up, these data build on the earlier analysis of the primary and key secondary endpoints of the study, presented in 2023. The 2.5-year recurrence-free survival rate of mRNA-4157 (V940) in combination with KEYTRUDA was 74.8%, as compared to 55.6% for KEYTRUDA alone, with the benefit observed across exploratory subgroups.

"We are encouraged by the latest results from the KEYNOTE-942/mRNA-4157-P201 study. These data highlight the sustained benefit in RFS and DMFS of mRNA-4157 (V940) as adjuvant treatment in combination with KEYTRUDA in people with resected high-risk melanoma. Importantly, this benefit was observed across various patient exploratory subgroups, reflecting the potential of mRNA-4157 (V940) for a broad range of these patients," said Kyle Holen, M.D., Moderna's Senior Vice President and Head of Development, Therapeutics and Oncology. "These findings reinforce our commitment to advancing this innovative treatment in collaboration with Merck, and we are dedicated to harnessing mRNA technology to potentially transform cancer therapy and improve patient outcomes."

"The sustained improvements in recurrence-free survival and distant metastasis-free survival observed at approximately three years in the KEYNOTE-942/mRNA-4157-P201 study provide further support of the potential of mRNA-4157 (V940) in combination with KEYTRUDA to help patients with resected high-risk melanoma," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "We look forward to building on our legacy of turning breakthrough science into medicines that may have a meaningful impact on patients' lives as we continue advancing our broad clinical development program evaluating this novel approach with Moderna."

Additional efficacy and subgroup data

Data from an exploratory subgroup analysis of the Phase 2b KEYNOTE-942/mRNA-4157-P201 study in patients with resected high-risk melanoma (stage III/IV) following complete resection showed that improvement in RFS was observed with mRNA-4157 (V940) in combination with KEYTRUDA compared to KEYTRUDA alone regardless of tumor mutational burden (TMB) or programmed death-ligand 1 (PD-L1) status.

The RFS benefit of mRNA-4157 (V940) in combination with KEYTRUDA compared to KEYTRUDA alone was maintained across both TMB high (HR [95% CI], 0.564 [0.253-1.258]), TMB non-high (0.571 [0.245-1.331]), PD-L1 positive (0.471 [0.226-0.979]), PD-L1 negative (0.147 [0.034-0.630]), and circulating tumor DNA (ctDNA) negative (0.207 [0.091-0.470]) subpopulations. ctDNA positive HR was not estimable due to the small sample size. There were no significant associations between individual human leukocyte antigen (HLA) alleles and RFS observed for mRNA-4157 (V940) in combination with KEYTRUDA.

The exploratory endpoint of overall survival (OS) favored mRNA-4157 (V940) in combination with KEYTRUDA compared to KEYTRUDA alone, with a 2.5-year OS rate of 96.0% vs. 90.2%, respectively (HR [95% CI], 0.425 [0.114-1.584]).

The safety profile with mRNA-4157 (V940) in combination with KEYTRUDA in KEYNOTE-942/mRNA-4157-P201 remains consistent with the primary analysis. The most common adverse events attributed to mRNA-4157 (V940) in combination with KEYTRUDA were fatigue (60.6%), injection site pain (56.7%), and chills (49.0%). The majority of the adverse events attributed to mRNA-4157 (V940) were Grade 1-2, with fatigue being the most common Grade 3 event and no Grade 4-5 events. Immune-related adverse events occurred in 37.5% of patients receiving the combination and 36% receiving KEYTRUDA alone.

Ongoing clinical development programs

Merck and Moderna have initiated Phase 3 randomized clinical trials evaluating mRNA-4157 (V940) in combination with KEYTRUDA as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma (INTerpath-001, NCT05933577) and non-small cell lung cancer (INTerpath-002, NCT06077760). Both trials are actively enrolling.

In 2024, Merck and Moderna also initiated a two-part Phase 2/3 randomized clinical trial evaluating mRNA-4157 (V940)in combination with KEYTRUDA as neoadjuvant and adjuvant treatment in patients with resectable locally advanced Stage II-IV (M0) cutaneous squamous cell carcinoma (INTerpath-007, NCT06295809), a Phase 2 randomized clinical trial evaluating mRNA-4157 (V940) in combination with KEYTRUDA as adjuvant treatment in patients with intermediate-high-risk, high-risk, or M1 no evidence of disease renal cell carcinoma (INTerpath-004, NCT06307431), and a Phase 2 randomized clinical trial evaluating mRNA-4157 (V940) in combination with KEYTRUDA as adjuvant treatment in patients with high-risk muscle-invasive urothelial carcinoma post-radical resection (INTerpath-005, NCT06305767).

SAN FRANCISCO, CA — Plenful, an AI workflow automation platform streamlining pharmacy and healthcare operations, announced a $17M Series A round, increasing its total raised capital to more than $25 million. This signifies a meaningful step forward in Plenful's mission to modernize pharmacy operations through advanced automation and artificial intelligence.

"Having years of firsthand experience in the trenches of pharmacy and healthcare operations, we intimately understand the challenges faced by professionals in the field," said Joy Liu, CEO and Founder of Plenful. “Our mission is to empower pharmacy and healthcare teams with tools that alleviate the burden of manual administrative tasks, allowing them to focus on what matters most – providing exceptional patient care and empowering their staff. Fueled by new capital, we will continue building out our robust infrastructure, focusing on customer needs in each unique automation set, and expanding the use of machine learning with a focus on LLMs to create the best possible, seamless experience for customers.”

The U.S. healthcare system faces nearly $1 trillion in manual and administrative labor costs, worsened by post-COVID labor shortages and employee burnout. This inflates expenses and hampers service efficiency, ultimately compromising patient care. Moreover, recent significant declines in pharmacist graduation rates have compounded the administrative challenges faced by pharmacy operation teams.

Plenful, founded by experienced pharmacy and healthcare operators, provides a practical solution: a highly-configurable AI software designed to streamline and automate a variety of pharmacy administrative tasks in one platform. Available for health system pharmacies, specialty pharmacies, long term care pharmacies, compounding pharmacies, specialty providers, and more, Plenful reduces manual work by up to 97 percent and can identify millions of dollars in savings opportunities.

Leveraging AI and machine learning, Plenful addresses key pain points in the industry, driving revenue growth and decreasing time and costs for its customers, which include Tampa General Hospital, Renown Health, Salinas Valley Health, Blue Cross Blue Shield, and dozens of other innovative healthcare teams. 

"Our organization has greatly benefited from Plenful's automated software, which has streamlined the oversight of our 340B program. Their team members who supported our go-live efforts were knowledgeable, responsive, and attentive to our organization's needs. I recommend Plenful to any organization seeking to leverage machine learning to sustain and advance their 340B program," said Clement Miller, Chief Operating Officer at Salinas Valley Health.

The Series A funding round was led by TQ Ventures, with participation from Bessemer Venture Partners, Mitchell Rales (Co-founder and Chairman of Danaher), Susa Ventures, and existing investors.

“The ongoing pharmacy labor shortages and increasing workflow complexities highlight the urgent need to enhance operations and reduce administrative burdens through AI and automation technology,” said Andrew Marks, partner and co-founder at TQ Ventures. “We invested in Plenful because of their team, their deep understanding of customer pain points, their strong progress and execution, and their vision for a better healthcare system. As a venture capital firm that backs founders building the future, we believe Plenful represents the future of pharmacy and healthcare operations."

TEL AVIV, ISRAEL — BioLineRx Ltd., a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced a multi-center Phase 1 clinical trial sponsored by St. Jude Children's Research Hospital, Inc. to evaluate motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with sickle cell disease (SCD). Investigators in the trial from St. Jude Children's Research Hospital, Inc. and two other clinical sites have extensive SCD gene therapy clinical development experience and are recognized leaders in the field.

Hematopoietic stem cell transplantation after genetic modification is potentially curative for patients with SCD. Significant quantities of HSCs (minimum 16.5-20 million cells/kg) are required for genetic manipulation and transplant success, however, the most commonly used drug for collection of stem cells, granulocyte colony-stimulating factor (G-CSF), is contraindicated in patients with SCD. Peripheral blood mobilization of stem cells using the mobilization agent plerixafor is the current strategy to collect HSCs for SCD gene therapies, however limitations exist including the need for multiple collection cycles to achieve the necessary HSC yields. For some, gene therapy may be prohibitive by the failure to obtain adequate numbers of HSCs. 

"The recent FDA approvals of two gene therapies for sickle cell disease in the U.S. is an exciting development for the sickle cell community," said Ella Sorani, PhD, Chief Development Officer at BioLineRx. "Through this new trial with St. Jude, and our ongoing collaboration with investigators at Washington University School of Medicine in St. Louis, we are excited to be working with leaders in gene therapy and stem cell mobilization to evaluate potential new mobilization options for patients with SCD." 

Enrollment in the St. Jude Children's Research Hospital, Inc. study is expected to begin in the next few months. Initial data from the Washington University School of Medicine in St. Louis sponsored clinical trial (ClinicalTrials.gov Identifier: NCT05618301) is anticipated in the second half of 2024. 

Motixafortide, BioLineRx's lead therapeutic candidate, was approved by the U.S. Food & Drug Administration (FDA) in September 2023, in combination with filgrastim (G-CSF), to mobilize HSCs for collection and subsequent autologous transplantation in patients with multiple myeloma, under the brand name APHEXDA®.

PITTSBURGH, PA — Imagine Pharma, a biotech company focused on advancing the commercialization of its novel IMG-1 polypeptide in Oral Delivery, Therapeutics, and Regenerative Medicine, announced today that the West Virginia University (WVU) Health System, which operates under the brand WVU Medicine, has awarded a contract to the Company to provide human clinical islet isolation services for patients undergoing a total pancreatectomy and autologous islet cell transplant (TPAIT). TPAIT is a surgical procedure to remove the diseased pancreas, harvest the insulin-secreting islet cells of the pancreas, then reinfuse or transplant those cells into the patient to manage blood sugar. Pancreatectomy without the islet transplant would result in diabetes or the inability to regulate blood sugar.

The WVU Health System is the state's largest health system and largest private employer, operating 21 hospitals. Its flagship hospital, WVU Medicine J.W. Ruby Memorial Hospital, has been nationally recognized as an approved NPF Center by the National Pancreas Foundation for its focus on multidisciplinary treatment of pancreatitis.

"Autologous islet transplantation offers a reliable, scalable, cost-effective approach to chronic or total pancreatitis, providing patients with reduced pain and better quality of life," said Brian Boone, M.D., Surgical Oncologist at the WVU Cancer Institute and Assistant Professor in the Department of Microbiology, Immunology, and Cell Biology at the WVU School of Medicine. "We are excited to work with Imagine Pharma as we grow our islet cell transplantation program."

Imagine Pharma has successfully completed the first islet isolation procedure for WVU Medicine, which was performed by Imagine Pharma at the Cook MyoSite facility in Pittsburgh, Pennsylvania.

"We look forward to working with the team at WVU Medicine to support their work in this critical area and contribute to better outcomes for their patients," said Dr. Rita Bottino, Director of Islet Services at Imagine Pharma, and an expert in the field of islet isolation.

ST. LOUIS, MO — Express Scripts, the pharmacy benefits services business of The Cigna Group's Evernorth, is making it easier for people to access a broader range of care services at independent pharmacies. This new collaboration with CPESN® USA, a network of pharmacy providers that deliver health services, is a direct result of guidance from the organization's Independent Pharmacy Advisory Committee, which includes 38 pharmacists from all regions of the United States and is led by former independent pharmacy owner, Stephanie Smith Cooney, Pharm.D, senior director of independent pharmacy affairs at Express Scripts.

"Local pharmacies are the doorway to essential health care for many people, and independent pharmacies are critical to closing gaps in care for many communities," said Adam Kautzner, Pharm.D, president of Evernorth Care Management and Express Scripts. "This collaboration with CPESN USA represents a meaningful step forward as we advance on our commitment to deepen relationships with independent pharmacists and remove barriers to quality care at the community level."

Initially, efforts with CPESN USA will focus on enhanced care services for Medicare beneficiaries living with hypertension and diabetes, with plans to expand to additional capabilities and offerings. It's estimated that diabetes affects roughly one in five Medicare beneficiaries aged 65 years and up, and 64% of people with Medicare fee-for-service report to have a diagnosis of hypertension. CPESN pharmacies will provide enhanced care, including coordination with other health providers to address care gaps, identification of at-risk people paired with pharmacist-led interventions, and informed medication management and optimization. CPESN USA's network of over 3,500 pharmacies in 44 states also adds new options for care delivery within the Express Scripts retail pharmacy network.

"CPESN pharmacies have proven their ability to improve the health of the patients we serve while reducing overall healthcare costs," said Alison Haas, Pharm.D., owner of a CPESN pharmacy in Jackson Center, Ohio, and director of value based contracting for CPESN USA. "We are looking forward to the upcoming collaboration with Express Scripts and are hopeful to quickly bring additional opportunities to our pharmacy providers and, in turn, improve the health of our mutual patients."

"It is critical that independent pharmacy perspectives are heard and considered across the pharmacy services industry," emphasized Cooney. "Our Independent Pharmacy Advisory Committee provides a forum for this dialogue, and has already produced impactful changes, including this collaboration with CPESN USA, which will elevate independent pharmacists' work and allow them to focus on providing people with the best care possible."

THOUSAND OAKS, CA — Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved IMDELLTRA™ (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA has received accelerated approval based on the encouraging response rate and duration of response (DoR) observed in clinical studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

"The FDA's approval of IMDELLTRA marks a pivotal moment for patients battling ES-SCLC. This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients," said Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen. "This approval further demonstrates our commitment to addressing aggressive cancers through our second FDA-approved Bispecific T-cell Engager (BiTE^®) molecule. IMDELLTRA offers these patients who are in urgent need of new innovative therapies hope, and we're proud to deliver this long-awaited effective treatment to them."

"Lung cancer is a complex and devastating disease, and less than 3% of patients with ES-SCLC live longer than five years," said David P. Carbone, M.D., Ph.D., professor of internal medicine and director of the James Thoracic Oncology Center at the Ohio State University Medical Center. "In the DeLLphi-301 trial, the median overall survival was 14.3 months, with 40% of patients responding to treatment with tarlatamab. These responses were remarkably durable, representing a major advancement in the SCLC treatment paradigm."

IMDELLTRA is the first and only DLL3-targeting Bispecific T-cell Engager therapy that activates the patient's own T cells to attack DLL3-expressing tumor cells.

"After decades of minimal advancements in the SCLC treatment landscape, there is now an effective and innovative treatment option available," said Laurie Fenton Ambrose, co-founder, president, and CEO of GO2 for Lung Cancer. "Today's FDA approval marks a significant milestone for the SCLC community as the availability of a targeted bispecific therapy brings forward new possibilities to those living with this aggressive disease."

The FDA accelerated approval of IMDELLTRA is based on results from the Phase 2 DeLLphi-301 clinical trial that evaluated IMDELLTRA in patients with SCLC who had failed two or more prior lines of treatment, and who had received the 10 mg every two weeks dosing (Q2W) regimen. Results from the study found that IMDELLTRA at the 10 mg Q2W dose (N=99) demonstrated a robust objective response rate (ORR) of 40% (95% Confidence Interval [CI]: 31, 51) and median DoR of 9.7 months (CI: 2.7, 20.7+). The median overall survival (mOS) was 14.3 months, with final and complete survival data yet to mature.

The IMDELLTRA label includes a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), in addition to warnings and precautions for cytopenias, infections, hepatotoxicity, hypersensitivity, and embryo-fetal toxicity. The most common (> 20%) adverse reactions reported among patients were CRS (55%), fatigue (51%), pyrexia (36%), dysgeusia (36%), decreased appetite (34%), musculoskeletal pain (30%), constipation (30%), anemia (27%), and nausea (22%). Permanent discontinuations due to treatment-emergent adverse events (TEAEs) were infrequent (7%). CRS was largely confined to the first and second dose, predominantly grade 1 or 2, and was generally managed with supportive care.

PHILADELPHIA and LEHIGH VALLEY, PA — Jefferson and Lehigh Valley Health Network ("LVHN") have signed a definitive agreement to combine, creating a leading integrated academic health care delivery system, alongside a national research university and an expanded not-for-profit health plan. The unified system, which would be in the Top 15 not-for-profit health systems in the U.S., will increase access to high-quality and affordable care, clinical research and health plan offerings and address health inequities for urban and rural communities in Eastern Pennsylvania and Southern New Jersey. The deal is expected to be completed later this summer, pending final reviews and execution of closing conditions. Jefferson and LVHN announced in December that they had signed a letter of intent to combine.

"We are delighted to take this next step toward combining with Lehigh Valley Health Network—it is the future, not only for our organizations but also for care in our region," said Joseph G. Cacchione, MD, Chief Executive Officer, Jefferson. "Through our integrated operating model, the combined organization will provide the communities we serve with access to the highest quality care, the benefits of continuous research and innovation, a network of specialists, clinical trials, and so much more, while also building an organization that prioritizes health through value-based care. This combination promotes access, choice, innovation, opportunity, increased equity and stability—for patients, physicians, faculty, staff, students and health plan members and our communities at-large."

Under the terms of the agreement, the systems will integrate clinical care, operations and identity to create a regional system that delivers the highest quality care to those it serves.

"We could not be more excited about what lies ahead for communities across Eastern Pennsylvania and Southern New Jersey," said Brian A. Nester, DO, MBA, President and Chief Executive Officer, Lehigh Valley Health Network. "As our collective teams worked these past months, we confirmed what we had believed to be true when we signed our initial letter of intent—Jefferson is the ideal partner for Lehigh Valley Health Network, our teams and our patients. We look forward to continuing the important work of improving the health and well-being of our communities together."

Jefferson and LVHN have long shared a commitment to community and improving lives. Both organizations have embraced models of care that prioritize the health and well-being of patients, investing in the growing field of population health management and quality-focused care services, which when combined will only accelerate. Upon closing, the integrated system will operate 30 hospitals and more than 700 sites of care, supported by more than 65,000 employed faculty, clinicians and staff. The combined organization will offer new educational opportunities for current clinicians and enable exceptional recruiting opportunities. It will expand health plan access that will help vulnerable, at-risk populations receive care to live well and stay out of the hospital. Lastly, the combination will strengthen financial stability, allowing for investments in innovative technologies and better patient outcomes.

Upon the closing of the transaction, Jefferson's Cacchione will continue to serve as Chief Executive Officer of the Jefferson enterprise. LVHN's Nester will serve as Executive Vice President/Chief Operating Officer of the Jefferson enterprise and President of the legacy Lehigh Valley Health Network, reporting directly to Dr. Cacchione. Dr. Baligh R. Yehia will serve as Executive Vice President/Chief Transformation Officer of the Jefferson enterprise and President of the legacy Jefferson Health, while continuing to report directly to Dr. Cacchione. The newly integrated Board of Trustees and leadership team will be comprised of members from both systems.

Both Jefferson and LVHN will continue to operate as independent entities until the combination closes. The parties are committed to ensuring the patients and communities they serve continue to have access to exceptional care from their clinicians during completion of this process.

CAMBRIDGE, MA – Takeda and AC Immune SA announced an exclusive, worldwide option and license agreement for AC Immune’s active immunotherapies targeting toxic forms of amyloid beta (Abeta), including ACI-24.060 for the treatment of Alzheimer’s disease.

ACI-24.060 is an anti-Abeta active immunotherapy candidate designed to induce a robust antibody response against the toxic forms of Abeta believed to drive plaque formation and Alzheimer’s disease progression. By inducing plaque clearance and efficiently inhibiting plaque formation in the brain, ACI-24.060 has the potential to delay or slow Alzheimer’s disease progression. ACI-24.060 is being investigated in the ongoing ABATE randomized, double-blind, placebo-controlled Phase 1b/2 trial to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of the investigational immunotherapy in subjects with prodromal Alzheimer’s disease and in adults with Down syndrome.

“As pioneers in the field of active immunotherapy, we are developing an innovative approach that could change the treatment paradigm for Alzheimer’s disease and address the multifaceted burden that patients and the broader community face. We believe the maximum impact of ACI-24.060 can best be realized by partnering with Takeda at this critical juncture in its development, which will help us move rapidly into Phase 3,” said Dr. Andrea Pfeifer, CEO of AC Immune. “This agreement allows us to leverage the developmental expertise, strategic vision and financial capacity of an accomplished organization that has demonstrated its ability to execute the type of comprehensive global program required for Phase 3 trials in Alzheimer’s disease while allowing us to focus on completing Phase 1b/2 development and accelerating our efforts to replicate this success with enhanced funding for our early-stage pipeline.”

AC Immune will be responsible for completing the ABATE trial. Following option exercise, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory activities as well as worldwide commercialization.

“At Takeda, we are committed to tackling some of society’s most debilitating illnesses, including Alzheimer’s disease. We are excited to partner with AC Immune on this ground-breaking treatment approach, which leverages novel technology with the potential to offer patients a treatment with differentiated efficacy, safety and ease of administration,” said Sarah Sheikh, M.Sc., B.M., B.Ch, MRCP, Head, Neuroscience Therapeutic Area Unit and Head, Global Development at Takeda. “Combining AC Immune’s deep experience with active immunotherapy approaches with Takeda’s expertise in neuroscience drug development and commercialization, we have an incredible opportunity to deliver real impact to the Alzheimer’s community.”

Under the terms of the agreement, AC Immune will receive an upfront payment of $100 million and be eligible to receive an option exercise fee and additional potential development, commercial and sales-based milestones of up to approximately $2.1 billion if all related milestones are achieved over the course of the agreement. Upon commercialization, AC Immune will be entitled to receive tiered double-digit royalties on worldwide net sales.

Further details related to the agreement are available in the Form 6-K filed today by AC Immune with the U.S. Securities and Exchange Commission (SEC). The effectiveness of Takeda’s license following option exercise is subject to the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act.