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.

On February 16, 2022 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases, reported that it will provide a corporate update and report financial results for the fourth quarter and full year 2021 after the market closes on Wednesday, February 23, 2022 (Press release, Xencor, FEB 16, 2022, View Source [SID1234608184]).

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Xencor management will host a conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers and referencing conference ID number 5290676. A live webcast of the conference call will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. The webcast will be archived on the company website for 30 days.

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 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.

On February 16, 2022 Electra Therapeutics, Inc., a clinical stage biotechnology company developing antibody therapies that target signal regulatory proteins (SIRP), reported a $84 million Series B financing co-led by Westlake Village BioPartners and OrbiMed (Press release, Electra Therapeutics, FEB 16, 2022, View Source [SID1234610665]). Other participating investors include Redmile Group, Cormorant Asset Management, Cowen Healthcare Investments, RA Capital, and New Leaf Venture Partners. Electra was previously funded by its parent company, Star Therapeutics.

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Electra is building a pipeline of novel therapies targeting SIRP, a family of cell surface receptors on various immune cell types. The company is taking a first-in-class approach to engage SIRP beyond the current drug development efforts in cancer, by targeting specific SIRP proteins to deplete targeted pathological immune cells. ELA026, the company’s lead product candidate, exhibits this novel mechanism of action and is currently in Phase 1 clinical studies, including a trial in secondary hemophagocytic lymphohistiocytosis (sHLH), a life-threatening inflammatory disease. ELA026 is also advancing in other immunological diseases. In addition, the company’s pipeline includes preclinical programs in immunology and immuno-oncology.

"We are thrilled to introduce Electra and share our novel approach to targeting SIRP," said Adam Rosenthal, PhD, CEO and Co-founder of Electra. "Our team has made rapid progress advancing our lead product candidate, ELA026, from an idea to the clinic in less than 3 years, and we are excited by each of our three pipeline programs targeting numerous diseases with significant unmet need."

Proceeds from the financing will be used to continue advancing ELA026 in clinical trials for sHLH and other immunological diseases. The funding will also support advancement of an additional preclinical pipeline program targeting SIRP in immunology, as well as Electra’s immuno-oncology platform that leverages SIRP to promote targeted depletion of tumor cells.

"It is inspiring to see the rapid progress and success of Electra’s pioneering work in targeting SIRP to develop therapies for immunological diseases. ELA026 represents a novel mechanism for targeting diseases driven by aberrant myeloid and T cell activity, and has enormous potential to address life-threatening diseases like sHLH, as well as other severe inflammatory diseases," said Beth Seidenberg, MD, Founding Managing Director at Westlake Village BioPartners.

Electra’s Board of Directors consists of Beth Seidenberg, MD, Founding Managing Director at Westlake Village BioPartners; Carl Gordon, PhD, CFA, Managing Partner at OrbiMed; Nancy Stagliano, PhD, Executive Board Chair, and Adam Rosenthal, PhD, CEO and Co-founder of Electra. Electra’s Board observers are Amrit Nagpal, Managing Director at Redmile Group and Vijay Lathi, Managing Director at New Leaf Venture Partners.

"We are impressed by the bold vision of the Electra team which has deep insights into drug discovery and development, and we are pleased to support Electra as they translate their approach with SIRP to patients in need of innovative treatment options," said Carl Gordon, PhD, CFA, Managing Partner at OrbiMed.

About Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Secondary hemophagocytic lymphohistiocytosis (sHLH) is a life-threatening hyperinflammatory condition for which there is no approved treatment. sHLH can be triggered by cancer, immunotherapy, infection, or an autoimmune disease. Once triggered, sHLH requires immediate intervention. Without treatment, it can rapidly progress from symptoms such as persistent fever, hepatomegaly and/or splenomegaly, and cytopenias, to multi-organ failure and death. Even with the current use of off-label treatments that have toxicity challenges and limited efficacy, sHLH remains fatal in approximately 60% of adults within 3.5 years.