On January 24, 2022 Samsung Biologics (KRX: 207940.KS), the world’s leading contract development and manufacturing organization, reported that 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;fiscal-year-2021-financial-results-301466346.html [SID1234606749]).

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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.

For more details on performance and financials, please refer to the Earnings Release.

On January 24, 2022 OBI Pharma, a Taiwan biopharma company (TPEx: 4174), reported that the first patients have been enrolled in both of the Phase 2 studies of OBI-999, an antibody drug conjugate (ADC) cancer therapy targeting Globo H, and OBI-3424, a prodrug targeting the enzyme aldo-keto reductase 1C3 (AKR1C3) (Press release, OBI Pharma, JAN 24, 2022, View Source [SID1234606748]).

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The Phase 2 cohort expansion part of the OBI-999-001 (ClinicalTrials.gov Identifier: NCT04084366) entitled "A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients with Advanced Solid Tumors" has now begun enrollment. The Phase 2 part of the study will enroll Globo H expressing patients with pancreatic, colorectal and other high Globo H expression solid tumors in more than ten medical centers in the United States and Taiwan.

The Phase 2 cohort expansion part of the OBI-3424-001 (ClinicalTrials.gov Identifier: NCT03592264) entitled "A Phase 1/2 Study of OBI-3424 in Subjects with Advanced Solid Tumors" has also begun enrollment. This study will enroll AKR1C3 expressing patients with pancreatic and other high AKR1C3 expressing solid tumors in select oncology medical centers in the United States.

OBI’s Chairman and Chief Executive Officer, Michael Chang, PhD, noted "OBI Pharma strives to develop novel therapeutics for cancer patients worldwide. Based upon the impressive Phase 1 safety study and preclinical data of OBI-999 and OBI-3424, we are excited to commence our Phase 2 efficacy and safety study in patients with high Globo H or AKR1C3 antigen expression in solid tumors. We would like to thank the commitment of our international investigators to bring these 1st-in-class cancer therapeutic products to potential patients in our ongoing study."

OBI anticipates completing the enrollment of both Phase 2 studies in the second half of 2023.

About OBI-999

OBI-999 is a novel first-in-class Antibody Drug Conjugate (ADC) with a proprietary linker technology that provides a consistent Drug-to-Antibody ratio (DAR) for cancer treatment that is based on Globo H, an antigen expressed in up to 15 epithelial cancers. OBI-999 uses a Globo H antibody to target cancer cells of high Globo H expression. By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells. In pre-clinical xenograft animal models in multiple tumor types (gastric, pancreatic, lung and breast), OBI-999 has demonstrated profound tumor shrinkage at various doses. In human Phase 1 study, OBI-999 was well-tolerated, and achieved a favorable safety margin which warrants further clinical development. OBI-999 is currently in a Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04084366) in medical centers in the US and Taiwan. OBI Pharma owns global rights to OBI-999.

About OBI-3424

OBI-3424 is a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3), and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme. This selective mode of activation distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are non-selective.

AKR1C3 overexpression has been documented in a number of treatment-resistant and difficult-to-treat cancers including hepatocellular carcinomas (HCC), castrate-resistant prostate cancer (CRPC), and T-cell acute lymphoblastic leukemia (T-ALL). AKR1C3 is highly expressed in up to 15 solid and liquid tumors.

Furthermore, individualized patient selection by staining for AKR1C3 overexpression by immunohistochemistry can be performed based on tumor biopsies or circulating tumor cells to identify patients with other tumor types most likely to respond to treatment with OBI-3424, and thus offering the possibility for a streamlined clinical development strategy.

OBI-3424 is currently in a Phase 2 trial (ClinicalTrials.gov Identifier: NCT03592264) in medical centers in the US. OBI owns global rights to OBI-3424 except the Asia Pacific region.

On January 24, 2022 RhoVac AB ("RhoVac") reported that the Canadian Intellectual Property Office ("CIPO") has issued a "Notice of Allowance", which means that it intends to grant RhoVac’s patent application for RV001 (onilcamotide) cancer vaccine (Press release, RhoVac, JAN 24, 2022, View Source [SID1234606747]). The company has previously been granted patents relating to onilcamotide in USA, Europe and Japan. The Canadian patent will provide RhoVac’s onilcamotide vaccine with broad protection in a key market and significantly strengthens the company’s patent portfolio.

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The Canadian Intellectual Property Office ("CIPO") has communicated its intention to grant RhoVac’s Patent Application No. 2,710,061. The patent covers RhoVac’s onilcamotide cancer vaccine, possible variants of the vaccine and the use of such vaccines in the treatment or prevention of metastatic cancer where RhoC is expressed. Once the issue fee is paid by RhoVac and necessary formalities have been completed by CIPO, the patent will be granted. The patent term will then extend to December 2028, potentially longer if an application for a Certificate of Supplementary Protection is filed and granted in Canada.

Patents from this first patent family have previously been granted in USA, Europe and Japan for treatment with onilcamotide of metastatic cancer expressing the RhoC protein. The Canadian patent, when granted, will complement these granted patents and another pending US application in this family

CEO Anders Månsson comments:"This patent provides very important protection for our cancer vaccine in Canada, which is an important territory for innovative therapies such as onilcamotide. This patent, when granted, will give product protection for our vaccine, along with additional protection for its use in the treatment and prevention of metastatic cancer [where RhoC is expressed], and in combination therapies".

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.

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.