On January 24, 2022 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported new funding for quality projects to improve patient care and outcomes in lung and thyroid cancers (Press release, NCCN, JAN 24, 2022, View Source [SID1234606745]). Funding will be provided through support from Eli Lilly and Company (Lilly).

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"The overall goal of this project is to develop innovative healthcare provider and systems performance and quality improvement initiatives to enhance patient care and outcomes in non-small cell lung cancer and thyroid cancer" said Crystal S. Denlinger, MD, FACP, Senior Vice President, Chief Scientific Officer, NCCN. "Congratulations to all of these inspiring investigators. We are eager to learn their findings and hope they can be expanded to other practices as well."

The selected projects are:

Waddah Arafat, MD, UT Southwestern Simmons Comprehensive Cancer Center
Harnessing an Electronic Health Record (EHR) Genomics Module to Guide Clinical Decisions for Non-Small Cell Lung Cancer (NSCLC) Care
Grace K. Dy, MD, Roswell Park Comprehensive Cancer Center
Multidisciplinary Workflow Optimization to Overcome Challenges in Biomarker Testing and to Expedite Biomarker-Based Treatment Decisions for Patients with NSCLC
Cristina P. Rodriguez, MD and Perrin E. Romine, MD, MSc, University of Washington School of Medicine/Seattle Cancer Care Alliance
Streamlining Molecular Profiling of Thyroid Malignancies in an Academic Tertiary Referral Oncology Center and its Community Satellite Clinics
John Strickler, MD, Duke Cancer Institute
Expansion of the Duke Molecular Tumor Board to Community Oncology Sites Across the Southeast to Support Adoption of Comprehensive Genomic Profiling and Biomarker Driven Therapy Selection for Lung and Thyroid Cancer Patients
"Lilly is committed to supporting initiatives that increase the appropriate use of comprehensive biomarker testing in metastatic non-small cell lung cancer and thyroid cancer," said Anthony N. Sireci, MD, MSc, Vice President, Clinical Biomarkers and Diagnostics Development Loxo Oncology at Lilly. "We are proud to collaborate with NCCN on the selected projects to explore how the proposed innovations can ultimately improve patient care and outcomes."

Proposals were peer reviewed by a Scientific Review Committee, which consisted of leading expert oncologists from NCCN Member Institutions. It is known that predictive biomarker testing on tumor-derived tissue or circulating tumor DNA (ctDNA) plays an important role in the treatment decision-making process for both metastatic non-small cell lung cancer as well as metastatic thyroid cancers. The goal of this project is to provide funding to study projects that, ultimately, are aimed at helping healthcare professionals deliver the optimal guideline-adherent treatment to each patient at the appropriate time. The selected projects are set to be completed within two years. The total amount of grants awarded for this research is approximately $1.2 million.

The NCCN ORP fosters innovation and knowledge discovery that improve the lives of people with cancer and supports preclinical, translational, and clinical research and quality improvement projects in oncology at NCCN Member Institutions. In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website, an informed consent database, and points to consider on the best practices for biorepositories, registries, and databases. For more information, visit NCCN.org/orp.

On January 24, 2022 Samsung Biologics (KRX: 207940.KS), the world’s leading contract development and manufacturing organization, reported strong financial results for the fourth quarter and record-high earnings for the fiscal year of 2021 (Press release, Samsung BioLogics, JAN 24, 2022, View Source;schBoardCtgryCcd=&schString=&schBoardYear=&boardDtm=1642950000000&page=1 [SID1234607434]).

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John Rim, CEO of Samsung Biologics, stated, "With a steep increase in demand for medicines due to the prolonged COVID-19 pandemic, there was a great need for CDMO capabilities around the world to ensure a reliable supply of high-quality biological products. By successfully managing all potential impact from the pandemic with strong business continuity and operational excellence, Samsung Biologics achieved solid growth and increased sales in an extraordinary year and made meaningful progress in building momentum around our long-term business and capacity. Our fourth-quarter financial performance demonstrates our ability to execute a robust and resilient approach to maintaining business continuity while adapting at every level to the needs of our clients and partners. Our concerted efforts have enabled us to achieve our financial targets and lay a foundation to deliver future growth. As we look towards 2022, we remain fully committed to delivering high-quality, life-saving treatments to our partners and patients around the world."

FOURTH QUARTER & FISCAL YEAR 2021 RESULTS

Fourth quarter 2021 revenue was KRW 444.3 billion, an increase of 18% from KRW 375.3 billion reported for the fourth quarter in the previous year, attributable to increased utilization of Plants 1 and 3, and sales activities bringing in new contracts.

Fourth quarter 2021 operating profit was KRW 128.8 billion, 39% higher than the prior-year period leveraging steady sales growth.

Fourth quarter 2021 net profit reached KRW 79.3 billion, a decrease of KRW 16.9 billion from KRW 96.2 billion in the fourth quarter a year ago, and fourth quarter 2021 operating margin was 29% due to increased utilization across all plants and improved product mix.

Samsung Biologics demonstrated strong operational excellence and business agility in 2021 with Plants 1, 2, and 3 in stable operations, and laid a strong mRNA business foundation through signing strategic partnership agreements with Moderna for fill and finish and Greenlight Biosciences for the manufacturing of mRNA vaccines. Samsung Biologics also launched its newest CDO process platform, S-CellerateTM, which offers an expedited process for the development and commercialization of monoclonal antibodies.

FISCAL YEAR 2022 OUTLOOK

At the JP Morgan Healthcare Conference, the company addressed the three core pillars of its multidimensional growth plan, which includes increasing manufacturing capacity, enhancing portfolio diversification, and expanding facilities overseas.

In addition to steadily securing client pre-sales, Plant 4 construction is expected to complete six months ahead of schedule, commencing operations to support 10KL production capacity in Q4 2022 and 15KL by mid-2023. Upon its full completion, the company is expected to hold a total of 620KL of capacity, reaffirming its position as the world’s largest CDMO.

As part of its growth plan, Samsung Biologics is planning to start the construction of a new facility, Plant 5 in 2022 where it will offer multi-modal product services including cell and gene therapies and next-gen vaccines utilizing mRNA, pDNA and viral vectors, all at a single site. This is in addition to the mRNA vaccine drug substance (DS) manufacturing suite, which is expected to be ready for cGMP operations at its existing facility in Songdo within the earlier part of this year.

The company is further venturing into securing additional land within Songdo for the construction of future plants and an Open Innovation Center, as well as overseas in multiple locations to maximize both its manufacturing capacity to produce large-scale biologics and be in closer proximity to its global clients, further expanding its global footprint beyond its San Francisco R&D center.

With the increasing importance of sustainability, Samsung Biologics will continue to prioritize its ESG commitments through steady improvement in lowering operational GHG emissions and participating various climate change initiatives including the Sustainable Markets Initiative in the lead up to COP27.

On January 24, 2022 SQZ Biotechnologies Company (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for SQZ-eAPC-HPV, authorizing the company to proceed with initiating a Phase 1/2 clinical trial of the novel cell therapy candidate (Press release, SQZ Biotech, JAN 24, 2022, View Source [SID1234606709]). The company plans to initiate its COMMANDER-001 Phase 1/2 clinical trial of SQZ-eAPC-HPV in patients who have HPV16+ solid tumors, including head and neck, cervical, and anal cancers, and have progressed following standard therapies.

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SQZ-eAPC-HPV is created by delivering five different mRNAs into a patient’s monocytes, B cells, T cells, and NK cells – engineering four cell types with five functions in a single step. In preclinical models, SQZ eAPCs have been shown to generate robust CD8 T cell responses against multiple antigens, including HPV16 proteins, through simultaneous expression of antigens, CD86, membrane bound IL-2, and membrane bound IL-12.

"We believe SQZ eAPCs represent a major advance in cell therapy with the largest number of multiplexed components ever advanced into clinical testing. We are incredibly excited to explore its potential for patient impact," said Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies. "SQZ eAPCs build upon the promising preliminary monotherapy clinical activity shown by our first SQZ APC platform. Through multiplexed engineering of a patient’s monocytes, B cells, T cells, and NK cells, we are able to integrate antigen presentation and enhanced immunological functions into a single clinical candidate that could become a powerful weapon against solid tumors."

By focusing on engineering physiological mechanisms, SQZ cell therapies do not require patient pre-conditioning and have thus far been well tolerated in clinical study. Similar to our other clinical programs, SQZ eAPCs can be manufactured in under 24 hours and have the potential for future implementation on our point-of-care platform.

The SQZ eAPC trial is the third FDA IND clearance for a clinical candidate based on the company’s Cell Squeeze technology.

About SQZ-eAPC-HPV

SQZ Enhanced Antigen Presenting Cells (eAPC) are derived from peripheral blood mononuclear cells (PBMCs), which are primarily composed of monocytes, T cells, B cells, and

img61662729_0.jpgEmpowering Cells to Change Lives

NK cells, and engineered with various mRNA encoding for multiple target antigens and immuno-stimulatory signals, including CD86 and membrane bound IL-2 and IL-12. The company presented preclinical findings in November 2021 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) showing that SQZ eAPCs generated robust T cell responses in human in-vitro models. Additionally, it was demonstrated that HPV16-encoding mRNA delivery to PBMCs stimulated CD8+ T cells across a range of HLA haplotypes, supporting eAPC clinical development in broad HPV16+ patient populations.

COMMANDER-001 Trial Design

SQZ-eAPC-HPV is being evaluated in a Phase 1/2 clinical trial (COMMANDER-001) for the treatment of HPV16+ advanced or metastatic solid tumors. The investigational candidate, which targets E6 and E7 oncoproteins, is being studied as a monotherapy and in combination with pembrolizumab, an immune checkpoint inhibitor. The study consists of two parts. The first part is designed to assess safety and tolerability of multiple doses of SQZ-eAPC-HPV in treatment-experienced patients, following a dose escalation scheme for monotherapy, and a dose de-escalation for the combination with pembrolizumab. The second part of the study will assess clinical response in less treatment-experienced patient populations.

About Human Papillomavirus Positive Cancers

Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer HPV+ tumors account for 4.5% of all cancers worldwide, resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.

On January 24, 2022 TScan Therapeutics, Inc. (Nasdaq: TCRX), a biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate TSC-100 for the treatment of patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation (HCT) (Press release, TScan Therapeutics, JAN 24, 2022, View Source [SID1234606728]). The target of TSC-100 is the minor histocompatibility antigen HA-1, which is a lineage-specific antigen found on blood cells. The Company will now submit the clinical protocol to Institutional Review Boards (IRB) for the initial study sites and expects to begin dosing patients in the first half of 2022.

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TSC-101 is targeted to the lineage-specific blood cell antigen HA-2, which is a novel target for cell therapy. The Company received a brief communication from the FDA indicating that the TSC-101 IND has been placed on hold pending additional assessment of the risk of off-tumor reactivity for TSC-101. The Company expects to receive further written communication from the FDA in the near future and plans to work with the agency to resolve its questions as quickly as possible.

"FDA clearance of our IND application for TSC-100 is an important milestone for our lead liquid tumor program as it marks the first clinical-stage product candidate to advance from our pipeline of therapies geared to treat unmet needs in major cancer indications," said David Southwell, President and Chief Executive Officer. "We are excited about the potential of both TSC-100 and TSC-101 to prevent relapse in leukemia patients following HCT. We are looking forward to initiating our Phase 1 multi-arm clinical trial in the first half of this year, with preliminary data expected in the second half of 2022. We will be opening the TSC-101 arm upon FDA clearance of the TSC-101 IND."

"FDA clearance of our TSC-100 IND is significant as it allows us to move forward with the umbrella clinical protocol for our hematologic cancer study," said Gavin MacBeath, Chief Scientific Officer. "This is a great accomplishment for our organization and validation of our TCR discovery platform. Importantly, the INDs for TSC-100 and TSC-101 were based on our proprietary T-Integrate cell engineering platform, which includes our advanced non-viral vector and our in-house GMP manufacturing capabilities. We intend to use this same platform to develop enhanced TCR-T cell therapies for our solid tumor program."

With the acceptance of the IND for TSC-100 in hematologic malignancies, TScan plans to initiate a multi-arm Phase 1 umbrella trial designed to evaluate TSC-100 compared to standard-of-care in patients who are undergoing allogeneic HCT. Pending acceptance from the FDA regarding the IND for TSC-101, the Company will then initiate the TSC-101 arm of this trial in the same patient population. Primary endpoints include safety and dose-finding, and secondary and exploratory endpoints include relapse rate versus standard-of-care as well as qualitative biological readouts including minimal residual disease and kinetics of donor chimerism. Once the recommended Phase 2 dose has been identified, the study will transition to Phase 2 to assess relapse rates of treated patients versus the standard-of-care arm

On January 24, 2022 Illumina, Inc. (NASDAQ: ILMN) and the National Cancer Center Japan reported an international joint research project that will use Illumina’s high-throughput DNA sequencing to analyse the blood-based genomic profile and clinical information of patients living with Nasopharyngeal Carcinoma (Press release, Illumina, JAN 24, 2022, View Source [SID1234606746]). The study will be known as a part of the Asian Multicenter Prospective Study of Circulating Tumor DNA Sequencing (A-TRAIN).

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We are immensely proud to contribute to this international collaboration and prospective study. Through our joint efforts, we will fuel initiatives that improve health outcomes for people living with nasopharynx cancer and progress the development of personalized treatment, especially those in the Asian community where this carcinoma is most prevalent.

We are immensely proud to contribute to this international collaboration and prospective study. Through our joint efforts, we will fuel initiatives that improve health outcomes for people living with nasopharynx cancer and progress the development of personalized treatment, especially those in the Asian community where this carcinoma is most prevalent.
One of the main research areas of the project is nasopharyngeal carcinoma, a rare tumor of the head and neck which originates in the nasopharynx and has a higher incidence rate in Asian countries. More than 80 percent of new cases occur in Asia, with Southeast Asian countries accounting for 67 percent of the global burden of all cancer. Nasopharyngeal cancer ranked ninth among incident cancers and eighth among cancer deaths in Southeast Asia.

"We are immensely proud to contribute to this international collaboration and prospective study," said Gretchen Weightman, Head of Global Commercial Strategy and General Manager of Asia Pacific and Japan at Illumina. "Through our joint efforts, we will fuel initiatives that improve health outcomes for people living with nasopharynx cancer and progress the development of personalized treatment, especially those in the Asian community where this carcinoma is most prevalent."

"As nasopharyngeal carcinoma occurs more frequently in Asia and is more difficult to treat, there is a strong need to develop new treatments," said Dr. Kan Yonemori, Principal Investigator at A-TRAIN. "A comprehensive genome profiling panel is a powerful tool to help solve this problem by using blood for genetic analysis. We are grateful for Illumina’s support in enabling this important research in numerous Asian countries."

The A-TRAIN study led by the National Cancer Center Hospital Japan is an international joint research project in a number of Asian countries to develop novel treatments based on genomic abnormalities for cancers that are common in Asia. The overall project includes research involving patients with cervical cancer, ovarian cancer, ovarian clear cell carcinoma, nasopharyngeal carcinoma, endometrial cancer and breast cancer, the database will be constructed and analysed by examining genomic abnormalities comprehensively by liquid biopsy, together with clinical information such as treatment details and prognosis.

The study will be conducted as part of an international collaborative study under the Asian clinical TriaLs network for cAncerS (ATLAS) project, which aims to accelerate the implementation of clinical research and to develop personalized treatments. In this study, genomic analysis of blood samples of up to 96 patients with nasopharynx cancer will be analyzed using Illumina’s TruSight Oncology 500 ctDNA.

Over the next year, the resulting data will be used by the Japan-led initiative to establish a platform for international collaborative trials with Malaysia, Thailand, the Philippines, Indonesia and Vietnam, which are actively promoting cancer treatment development in the Asian region.

About TruSight Oncology 500
TSO 500 is a Research Use Only comprehensive pan-cancer assay designed to identify 523 known and emerging tumor biomarkers. TSO 500 utilizes both DNA and RNA from tumor samples to identify key variants critical for cancer development and progression, such as small DNA variants, fusions, and splice variants. Based on the content of TSO 500, Illumina will be adding an in vitro diagnostic test to the TruSight Oncology product family. This comprehensive tumor profiling assay will have similar chemistry and analytics to TSO 500. To learn more about TSO 500, click here.