On June 23, 2022 Hummingbird Diagnostics GmbH, a leader in reading blood-based microRNAs for early disease detection and characterization, reported a publication in the Journal of Thoracic Oncology Clinical and Research Reports that demonstrates their blood 5-microRNA signature (miRisk) to predict survival following immunotherapy in advanced non-small cell lung cancer (NSCLC) patients with high PD-L1 expression (Press release, Hummingbird Diagnostics, JUN 23, 2022, View Source [SID1234616214]).

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The study builds on results published in March 2022 in npj Precision Oncology [1] and addresses a current clinical dilemma; which advanced-stage NSCLC patients with high PD-L1 expression (≥ 50%) should be treated with immunotherapy (IO) alone versus immunotherapy in combination with chemotherapy (ICT)? Both are currently licensed therapies in international guidelines, yet no biomarkers exist to guide this decision. Optimizing this choice using principles of precision medicine will have significant impacts on patient survival and quality of life, by including toxic chemotherapy only when deemed necessary. Hummingbird’s results demonstrate a significant association between overall survival (OS) and the miRisk score in IO treated patients and furthermore highlight its value as a predictive biomarker for type of treatment (IO or ICT). The score could identify high-risk patients who might benefit from treatment with ICT, as opposed to IO, and support treatment decisions as a blood-based complementary diagnostics.

"Patients with advanced, non-oncogene-driven, non-small-cell lung cancer (NSCLC) with high PD-L1 expression are eligible for treatment with immunotherapy. There is, however, an urgent medical need for biomarkers identifying cases that require additional combination with chemotherapy," says Timothy Rajakumar, MD PhD, Medical Director of Hummingbird Diagnostics and first author on the study. "The miRisk score represents an immune focused biomarker that is specifically predictive of response to immunotherapy and could serve as the foundation for a complementary diagnostic to guide therapeutic decisions and thereby allow physicians to more accurately choose between treating patients with IO alone vs. ICT."

The study was performed in collaboration with Professor Petros Christopoulos from the Thoraxklinik at Heidelberg University Hospital, as well as with Professor Martin Reck, Grosshansdorf. A valuable study cohort was assembled from a total of 155 whole blood samples, prospectively collected from patients with stage IV NSCLC with PD-L1 TPS ≥50%, before they had been initiated on treatment with IO or ICT. These samples were subject to small RNA sequencing and used to train and validate a 5-microRNA model to predict OS (miRisk). This model was significantly associated with OS and, most importantly, with the type of therapy (IO or ICT) therefore offering the promise to support clinical decisions surrounding choice of therapy.

Bruno Steinkraus, PhD, Chief Scientific Officer of Hummingbird Diagnostics remarked: "We believe our analysis will provide a blueprint for host-based integrative biomarker usage in a field of pressing medical need with the emergence of more complex immunotherapy regimens. Taken together with the relatively simple use of a peripheral whole blood test that does not require pipetting at point of care, we envision applicability of this technology to non-invasive therapy guidance for the IO or ICT decision in PD-L1 high patients."

The open-access article can be found online on the journal’s website: View Source(22)00093-5/fulltext

1Rajakumar T et al. A blood-based miRNA signature with prognostic value for overall survival in advanced stage non-small cell lung cancer treated with immunotherapy. NPJ Precis Oncol 2022; 6:19

On June 23, 2022 McKesson Corporation (NYSE: MCK) and HCA Healthcare, Inc. (NYSE: HCA) reported an agreement to form a joint venture combining McKesson’s US Oncology Research (USOR) and HCA Healthcare’s Sarah Cannon Research Institute (SCRI) (Press release, McKesson, JUN 23, 2022, View Source [SID1234616213]). USOR is the research arm of McKesson’s The US Oncology Network and draws from a network of experienced investigators and dedicated clinical staff who specialize in oncology clinical trials. SCRI, which is the research arm of Sarah Cannon, HCA Healthcare’s Cancer Institute, offers end-to-end clinical trial site support services with a deep expertise in early-phase oncology research and drug development as well as a specialized contract research organization (CRO).

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Together, USOR and SCRI will create a fully integrated oncology research organization aimed at expanding clinical research, accelerating drug development and increasing availability and access to clinical trials for community oncology providers and patients, including those in underserved communities. The joint venture plans to offer an expanded clinical research network, a broader portfolio of clinical trials, and enhanced data and analytics capabilities to better match patients with clinical trials.

"McKesson and HCA Healthcare share a commitment to advancing the next generation of cancer care," said Brian Tyler, chief executive officer, McKesson. "This new joint venture is an important step forward in increasing access to clinical trials, particularly within the community setting, where the majority of all cancer patients are initially treated. Additionally, the joint venture directly aligns with McKesson’s strategic growth priorities by further expanding our differentiated oncology ecosystem and improving the value proposition for provider and biopharma partners."

"Clinical research and partnerships are fundamental to how we address our communities’ most pressing healthcare needs," said Sam Hazen, chief executive officer of HCA Healthcare. "We believe this joint venture with McKesson, which unifies our oncology research experts, will promote the development of individualized therapies and provide more opportunities for cancer patients to receive new treatments."

The transaction is expected to close in 2022. Following the close of the transaction, McKesson will own 51% of the joint venture and have operating control. The joint venture will be governed by a Board of Directors with representation from both McKesson and HCA Healthcare. The new company will be led by SCRI’s Dee Anna Smith, who will serve as chief executive officer, and SCRI’s Howard A. "Skip" Burris, III, MD, who will serve as president. Additionally, USOR’s Robert Coleman, MD will become the new organization’s chief medical officer and SCRI’s David Spigel, MD will be its chief scientific officer.

"When it comes to the fight against cancer, building a network of collaborators is essential. Our impact on patients is evident through our longstanding partnerships with experts from Tennessee Oncology, Florida Cancer Specialists and many other valued oncology programs," said Dee Anna Smith, chief executive officer of Sarah Cannon. "In the last three decades, our collaborations have led to advancing treatment standards for the majority of new cancer therapies that are available to patients today. We believe that coming together with US Oncology Research will complement and strengthen our network so that we can continue to make a greater impact for people living with cancer."

Separately, McKesson will acquire Genospace, SCRI’s personalized medicine platform. Genospace is a leading innovator in precision medicine and clinical trial matching. By becoming a part of McKesson, Genospace will power the oncology data and analytics capabilities for the joint venture as well as enhance the ability of its provider partners to more efficiently identify the most appropriate therapies or clinical trials for their patients.

Research is essential to advancing cancer care from diagnosis through survivorship, and as such, the joint venture will enhance both companies’ cancer care offerings. McKesson’s The US Oncology Network and HCA Healthcare’s cancer network, Sarah Cannon Cancer Institute, are not part of the transaction and will continue to operate independently of the joint venture.

Financial terms of the agreement were not disclosed. The transaction is subject to necessary regulatory approvals and other customary closing conditions.

On June 23, 2022 Pfizer Inc. (NYSE: PFE) reported that its board of directors declared a $0.40 third-quarter 2022 dividend on the company’s common stock, payable September 6, 2022, to holders of the Common Stock of record at the close of business on July 29, 2022 (Press release, Pfizer, JUN 23, 2022, View Source [SID1234616212]). The third-quarter 2022 cash dividend will be the 335th consecutive quarterly dividend paid by Pfizer.

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On June 23, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that its investor relation team will participate in the following upcoming investor conference (Press release, Innate Pharma, JUN 23, 2022, View Source [SID1234616211]):

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Conference Portzamparc – Evenement Corporate Access, Paris (in-person event)
Event Date: June 30, 2022

On June 23, 2022 Galapagos NV (Euronext & NASDAQ: GLPG), CellPoint and AboundBio reported that both companies have entered into definitive agreements with Galapagos, propelling Galapagos into next-generation cell therapy while significantly broadening its portfolio and capabilities (Press release, Galapagos, JUN 23, 2022, View Source [SID1234616210]).

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Through the acquisition of CellPoint and AboundBio, respectively, Galapagos gains access to an innovative, scalable, decentralized and automated point-of-care cell therapy supply model as well as a next-generation fully human antibody-based therapeutics platform. Combined and supported by Galapagos as a fully integrated biopharma, they have the potential to disrupt the CAR-T treatment paradigm. The goal is to expand the current market for CAR-T therapies and have an important impact on patients in need of additional and improved treatment options.

CellPoint has developed, in a strategic collaboration with Lonza, a novel point-of-care supply model, which offers the potential for efficient, 7-day delivery of CAR-T therapies and avoids complex logistics, thereby addressing important limitations of current CAR-T treatments. The proprietary platform consists of CellPoint’s end-to-end xCellit workflow management and monitoring software and Lonza’s Cocoon system, a closed, automated manufacturing platform for cell and gene therapies.

Clinical studies with the CellPoint decentralized supply model have been approved by regulatory authorities in Belgium, Spain, and the Netherlands. Two Phase 1/2a studies in rrNHL and rrCLL with a CD19 CAR-T product candidate are currently ongoing with topline results expected in the first half of 2023, providing the opportunity for a rapid clinical validation of the CAR-T point-of-care supply model. In a next step, the aim is to leverage CellPoint’s platform for novel CAR-Ts originating from AboundBio’s unique fully human antibody-based library and biological drug discovery and engineering capabilities, with the goal of bringing three additional differentiated, next-generation CAR-T candidates in the clinic over the next three years.

"With the transactions announced today, we position ourselves as a potential innovator in CAR-T, while building a strong foundation from which we can drive continued innovation for patients with advanced cancers who are in need of new treatment options. Our goal is to bring three differentiated, next-generation CAR-T candidates into the clinic over the next three years," said Paul Stoffels1, MD, CEO of Galapagos. "This is a first key step in our strategic transformation to accelerate and diversify our pipeline with the aim to create short- and long-term value through focused external growth. We continue to explore additional business development opportunities to further leverage our internal capabilities and renew our portfolio, and we expect to communicate a detailed update on our corporate strategy and portfolio later this year. With the support of our collaboration partner Gilead, we warmly welcome the CellPoint and AboundBio teams to Galapagos, and together we look forward to potentially bringing transformational medicines to patients worldwide."

"We are excited to become part of Galapagos to accelerate the development, commercialization and scale-up of our cutting-edge vein-to-vein CAR-T delivery model. Despite the progress with current CAR-T therapies, long lead times, highly manual central manufacturing, and complex logistics remain the limiting factors for large-scale capacity and broad patient access. Our novel decentralized manufacturing and supply model is designed to address these limitations and deliver CAR-T cells at point-of-care, in or near the hospital, thereby offering the potential to significantly shorten time to treatment to one week as compared to the current industry standard of over a month," added Dr. Tol Trimborn, co-founder and CEO of CellPoint.

"We are thrilled to join Galapagos to accelerate our research and realize the full potential of our innovative science. Our next-generation of fully human, multi-paratopic and multi-specific CAR-T constructs offer the potential for deeper, more durable responses to treatment as well as retreatment for relapse following previous CAR-T cell therapy. Combined with CellPoint’s decentralized point-of-care delivery model, we aim to broaden patient access and ultimately change patients’ lives. We are impressed by the leadership and expertise at Galapagos and look forward to our exciting journey ahead", concluded John Mellors, MD, CEO of AboundBio.

Benefits of the transaction
Near-to-mid-term product opportunity

Generating clinical data to validate decentralized manufacturing supply model with CD19 CAR-T for rrNHL/rrCLL
Aim for three next-generation CAR-Ts to the clinic over the next three years
Pipeline and complementary technology platforms to drive future growth

Reinforcing current portfolio with new therapeutic area
Adding fully human antibody-based capabilities and new drug modalities with broad scope
Positions Galapagos as an innovator in cell therapy

Opportunity to deliver life-saving medicines more efficiently, and to more patients
Be at the forefront of scientific and medical innovation
Potential to leverage insights and capabilities of collaboration partner Gilead, who retains option rights to new programs
Transaction terms

Under the terms of the agreements, Galapagos is to acquire all outstanding shares of CellPoint and AboundBio in an all-cash transaction against payment of an upfront amount of €125 million for CellPoint, with an additional €100 million to be paid upon achievement of certain milestones, and against payment of an amount of $14 million for AboundBio. The transactions have been fully executed and the acquisitions were consummated earlier today.

Webcast presentation

Management will host a webcast presentation with Q&A tomorrow, Wednesday 22 June 2022, at 14:00 CET / 8 AM ET. The live webcast can be accessed on the investors section of the Galapagos website, and a replay will be made available shortly after the close of the call.