On February 16, 2022 EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, and THREAD, a leading technology and service provider enabling electronic clinical outcome assessments (eCOAs) and decentralized clinical trials (DCTs), reported a new combined offering to give pharmaceutical companies a comprehensive and simultaneous view of clinical research participants, followed by data and detailed analysis across the care continuum (Press release, EVERSANA, FEB 16, 2022, View Source;real-world-data-rwd-driven-evidence-and-commercialization-solution-301483355.html [SID1234608853]).

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The new solution combines EVERSANA’s integrated commercial services, rich electronic medical record (EMR) data, and RWD-driven recruitment capabilities with THREAD’s leading decentralized clinical trial platform to aggregate and link patient-generated and secondary regulatory-grade RWD. Together in a single platform, the offering enables continuous active, passive, retrospective and prospective data collection with patient consent and identity security as central tenets. Data linkages will be performed using Datavant’s technology to ensure patient privacy and data security.

"While certainly complex to deliver, this new solution gives pharmaceutical clients the gift of simplicity. For example, we’ve reduced the data collection and security burden on sites and participants and enabled rapid go-live, consent and enrollment while reducing registry and startup costs," said Jim Lang, CEO, EVERSANA. "Our commercial services are designed to reduce burdens like these to help our clients refocus their time and energy on future innovations for patients worldwide."

"Putting all available real-world data to work is imperative to optimize the development of new treatments and our understanding of marketed therapies," said John Reites, CEO, THREAD. "By combining the power of THREAD’s technology platform with EVERSANA’s rich, diverse data sets, clinical studies can be more efficient, comprehensive and inclusive, providing researchers with a totality of evidence to inform their research."

The combined offering showcases immediate value, by supporting the capture and curation of clinical and real-world data across the full spectrum of clinical research and care. From digital recruitment to RWD collection and analysis, study participants are engaged throughout the research period. Registry data can be further enriched with other RWD assets and are deidentified and linked for analytic access across multiple sources.

"We are proud to support the digitization of evidence generation and amplify the benefit of remote evidence generation by securely connecting data across the health data ecosystem," said Travis May, Co-Founder and President, Datavant. "Connecting real-world data augments the depth of data on each patient while increasing the cost-efficiency of the entire study."

The partnership expands both companies’ position on the front line of real-world evidence innovation. Included in a growing list of industry partnerships:

EVERSANA recently announced an agreement with Janssen Research & Development, LLC (Janssen) to transform clinical data into the much-needed evolution of chronic disease care through real-word data, data science analysis and regulatory-grade studies.
THREAD recently acquired inVibe, the leading voice-powered research and insights technology solution for the life sciences and health care industries. THREAD’s addition of inVibe’s voice research technology and consulting services to its comprehensive, decentralized research platform follows the company’s acquisition of Modus Outcomes in November 2021.
Earlier in 2021, EVERSANA launched its Chronic Disease Real-World Data solution, which enables life sciences stakeholders to conduct regulatory-grade research studies, generate evidence and provide data-driven insight and proactive support to improve the chronic, comorbid patient experience.

Amgen has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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On February 16, 2022 The Life Raft Group reported A recent paper published in Cancers, was the result of a global roundtable sponsored by CTOS and SPAEN (Press release, The Life Raft Group, FEB 16, 2022, View Source [SID1234608205]).

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Held on November 9, 2021, patients and advocates from Sarcoma Patients EuroNet (SPAEN) and medical experts from the Connective Tissue Oncology Society (CTOS) met as an ancillary part of the CTOS 2021 Annual meeting. Representatives from both organizations discussed the challenges and roadblocks to effective global sarcoma care and management. This paper highlights the major findings and proposes potential future steps.

Both the LRG’s Sara Rothschild, Vice President of Program Services, and Piga Fernández, LRG Global Consultant, who was also representing Fundación GIST Chile, were invited to this roundtable, as patient advocates, with the goal in mind of publishing a paper on sarcoma care and the challenges globally. Their role was to give their opinion, as patients and patient advocates on the topics that were discussed.
According to Piga, "As patient advocates, participating in this Round Table was very important. It was a great opportunity to make visible the difficult journey sarcoma patients must travel before reaching the final correct diagnosis and correct treatment. The main difficulties identified were the lack of specialists, difficult access to treatments and the long time that patients have to wait until they reach a center of excellence where they can be treated effectively. We were able to highlight the need to educate primary care professionals, to shorten the time of diagnosis, and the importance of global collaborative efforts to address the multiple problems sarcoma patients have."

According to SPAEN, "It’s a remarkable first step of a truly global initiative of Sarcoma Experts and Patient Advocates with the aim to address and overcome challenges in sarcoma care together. We brought experience and expertise from all stakeholders, from many parts of the world, from different areas of expertise together and hope to continue to do so! With hard work, enthusiasm, dedication, collaboration, and time, we aim to ultimately improve sarcoma management for patients around the globe."

On February 16, 2022 Prelude Therapeutics Incorporated (the "Company") Presented the Corporate presentation (Presentation, Prelude Therapeutics, FEB 16, 2022, View Source [SID1234608202]).

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On February 16, 2022 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported an update on the Company’s clinical programs, manufacturing processes and pipeline (Press release, Marker Therapeutics, FEB 16, 2022, View Source [SID1234608201]).

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"We are excited to announce an improved T cell manufacturing process, expansion of our pipeline into solid tumor and off-the-shelf cell therapies, and encouraging results from the six-patient safety lead-in stage of our Phase 2 AML trial, where one MRD positive patient converted to MRD negative following treatment with MT-401, Marker’s lead MultiTAA-specific T cell product candidate," said Peter L. Hoang, Marker’s President and Chief Executive Officer. "Our new T cell manufacturing process, which will be implemented in AML and additional planned trials, is designed to produce a much more potent product with increased antigen specificity and diversity and further reduces manufacturing time to just nine days."

Mr. Hoang continued: "Further, we are pleased to announce a planned expansion of our pipeline into pancreatic cancer, our first Company-sponsored trial evaluating MultiTAA cell therapy for the treatment of solid tumors, and a Company-sponsored Phase 1 trial in lymphoma. We are also excited to expand our AML trial with MT-401-OTS, a scalable, off-the-shelf product candidate with the potential to match patients to treatment in under three days. Looking ahead, we plan to develop additional off-the-shelf product candidates in other hematological malignancies and solid tumors, with the goal of significantly improving access to promising cell therapies."

Safety Lead-in Results from Phase 2 AML Trial

The results of the safety lead-in stage of the Marker Phase 2 AML trial support the potential for MT-401 as a treatment option for patients with AML in the post-transplant setting. The purpose of the safety lead-in was to test the safety for patients using a new reagent in the manufacturing process. Three patients were treated with MT-401 using the legacy reagent and three additional patients were treated with MT 401 using the new reagent. The safety lead-in enrolled five patients with active disease: one MRD positive patient and five frank relapse patients.

The initial results from the safety lead-in are as follows:

·No dose limiting toxicities, cytokine release syndrome or neurotoxicity were observed. The results were consistent with the safety data observed in more than 150 patients treated in the Phase 1/2 studies at the Baylor College of Medicine.

·1 MRD+ patient became MRD- after infusion with MT-401

·No objective responses from the frank relapse patients

·Immuno-monitoring data indicates the evidence of epitope spreading after infusion of MT-401 in the patient who converted from MRD+ to MRD-

The safety lead-in satisfied safety requirements with the FDA and the main Phase 2 stage of the AML trial began enrolling in July 2021.

MultiTAA-Specific T Cell Therapy Manufacturing

The Company developed and is implementing a new nine-day MultiTAA-specific T cell manufacturing process for its current Company-sponsored Phase 2 AML trial as well as future clinical trials using a patient-specific manufacturing approach. The new manufacturing process marks additional manufacturing improvements compared to the processes used in the Baylor College of Medicine Phase 1/2 trials (36-day manufacturing time) and the current AML trial (20-day manufacturing time). The new nine-day manufacturing process enables increased antigen specificity and diversity, which has exhibited a strong linear correlation to anti-tumor activity in vitro. The new process produces a patient product that is four times more potent, with the potential to greatly improve tumor killing.

Pipeline Expansion

The Company plans to initiate additional Marker-sponsored clinical trials across other indications. The Company has initiated activities to support the advancement of the pipeline but beginning any additional clinical trial is subject to the receipt of additional funding:

·Patient-specific product candidates

oMT-601, a six-antigen product, for the treatment of pancreatic cancer and lymphoma

oThe Company intends to file Investigational New Drug applications (INDs) for MT-601 in pancreatic cancer and lymphoma in 2022 and expects to initiate these trials in 2023

·Off-the-shelf (OTS) product candidates

oPatients will be dosed using "banked" products based on human leukocyte antigen (HLA) matching

oThe OTS platform is designed to eliminate manufacturing wait time and patient product can be shipped to patients immediately

oHigh scalability where one donor has the potential to provide more than 100 patient products

oAn OTS program in AML is already approved under the Company’s current Phase 2 AML IND. The Company is currently in the process of developing its patient cell bank inventory and expects to dose the first patient in 2023.

oThe Company expects to expand OTS clinical trials in other hematological malignancies and solid tumors

·Preclinical / development activities

oAnalyzing potential of a 12-antigen product

oAssessing potential of combination therapies for MT-401 and MT-601

Webcast and Conference Call

Marker will host a conference call and webcast at 5:00 p.m. EST today to discuss the clinical program updates. The webcast will be accessible in the Investors section of the Company’s website at www.markertherapeutics.com. Individuals can participate in the conference call by dialing 877-869-3847 (domestic) or 201-689-8261 (international) and referring to the "Marker Therapeutics Clinical Program Update Call." The archived webcast will be available for replay on the Marker website following the event.