10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

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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Global Patient Involvement in Sarcoma Care

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."

Corporate Presentation

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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Marker Therapeutics Announces Clinical Program Updates and Pipeline Expansion

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.

Predicine to Present Six Studies, including the Demonstration of the Clinical Utility of Its PredicineBEACON™, a Tissue-agnostic MRD Liquid Biopsy Solution, in Genitourinary (GU) Cancers at 2022 ASCO-GU Annual Conference

On February 16, 2022 Predicine, a global molecular insights company, reported that it will present six posters highlighting clinical utility of Predicine’s full suite of liquid- and tissue-based comprehensive genomic profiling solutions at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium being held February 17-19, 2022, in San Francisco (Press release, Predicine, FEB 16, 2022, View Source [SID1234608198]).

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The posters are focused on the full spectrum of GU indications, including muscle invasive bladder cancer (MIBC), metastatic castration-resistant prostate cancer (mCRPC), renal cell carcinoma (RCC) and locally advanced and metastatic Upper Tract Urothelial Carcinomas (UTUC). Highlights from the posters include a clinical utility study of PredicineBEACONTM, applied to a urine-based, tissue-agnostic minimal residual diseases (MRD) solution in bladder cancer, as well as blood-based detection of DNA damage repair (DDR) deficiencies in prostate cancer.

The posters to be presented are as follows:

Development and Clinical Application of PredicineBEACONTM Next-Generation Minimal Residual Disease Assay for Genitourinary Cancers.
Novel Use of ctDNA to Identify Locally Advanced and Metastatic Upper Tract Urothelial Carcinoma.
Longitudinal Personalized Urinary Tumor DNA Analysis In Muscle Invasive Bladder Cancer From the Neoadjuvant Immunotherapy Trial RJBLC-I2N003.
Molecular Characterization of Renal Cell Carcinoma with Venous Tumor Thrombus: Genomic Aberrations with Renal Vein Wall Invasion.
Prognostic and Predictive Utility of DNA Damage Response (DDR) Aberrations Detected in cfDNA in Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Age-based Assessment Of Cell-Free DNA Genomic Profiles in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
The full posters can be found at the ASCO (Free ASCO Whitepaper) Genitourinary Cancer Symposium website here.

"Predicine is pleased to present six liquid biopsy and tissue NGS studies at ASCO (Free ASCO Whitepaper)-GU 2022. As part of Predicine’s Phoenix Program, we are committed to building the clinico-genomic knowledgebase in the full spectrum of GU cancers by leveraging Predicine’s proprietary next-generation liquid biopsy technology platform, especially in the MRD space. The data presented demonstrated the great promise of liquid biopsy in personalized cancer care, clinical trials and CDx development," said Dr. Shidong Jia, Founder and Global CEO of Predicine.

Additional peer-reviewed publications on cancer can be found on Predicine’s website here.