On January 25, 2022 AmerisourceBergen, a global healthcare solutions leader, and TrakCel, the leading innovator of cellular orchestration solutions, reported an integrated technology platform designed to accelerate patient access to prescribed cell and gene therapies and deliver complete visibility throughout the treatment journey (Press release, TrakCel, JAN 25, 2022, View Source [SID1234607618]). The enhanced offering combines two platforms—OCELLOS, TrakCel’s advanced therapy orchestration platform, and Fusion, a customer relationship management and patient support ecosystem powered by AmerisourceBergen’s Lash Group, a market leader in patient support services.

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The platform increases connectivity between hub patient services and providers, resulting in a seamless and timely exchange of benefits and eligibility information which expedites patient enrollment and support, ultimately helping patients start on therapies sooner. The new offering adds to AmerisourceBergen’s robust portfolio of services and solutions that support the needs of cell and gene therapy innovators, providers and patients throughout the product and treatment journey—from pre-clinical and commercial logistics to market access and reimbursement consulting and patient support services.

"The fast-growing pipeline of cell and gene therapies represents immense hope for patients around the world, but their unique nature can pose challenges throughout the patient journey, such as eligibility and coverage barriers that can delay access to the treatment," said Willis Chandler, president of Manufacturer Services and Commercial Solutions at AmerisourceBergen. "By combining the capabilities of Fusion and OCELLOS, we’re streamlining the path to care, improving speed-to-therapy and creating a heightened level of connectivity across the supply chain. This represents an important step in AmerisourceBergen’s ongoing commitment to build an end-to-end service offering that supports innovators in enhancing patient access to these critical therapies."

TrakCel’s OCELLOS streamlines the orchestration of clinical and commercial stage therapies, from subject enrollment to treatment and administration, ensuring chain of custody and chain of identity are managed at each step of the patient journey. Fusion leverages emerging technologies, such as artificial intelligence and machine learning, for benefit verification, prior authorization, and multi-channel communication between payers, providers, and patients.

Through this integrated platform, the bi-directional flow of data starts when a provider creates a patient account and captures enrollment information within OCELLOS. The data is then securely delivered to the patient hub, where Fusion’s advanced technology begins to determine patients’ eligibility through benefits verification. If needed, a Lash Group coordinator will initiate benefits investigation and prior authorization. Providers receive a near real-time response of the patient’s coverage determination in OCELLOS and can take the next steps to move the prescribed treatment process forward.

"Ensuring that medicines are delivered efficiently and safely to patients is of utmost priority and progressing treatment pathways smoothly and quickly is critical both to successful treatment and to a good patient experience," said Ravi Nalliah, Chief Product and Strategy Officer for TrakCel. "These goals can only be achieved if data is shared securely, accurately and in real-time."

The integrated platform serves as the latest collaboration between AmerisourceBergen and TrakCel to support advanced therapy developers. AmerisourceBergen’s global specialty logistics provider, World Courier, collaborates with multiple orchestration platform providers, including TrakCel, to deliver systems that enable stakeholders to maintain chain of custody, chain of identity and traceability throughout shipments.

For more information on the integrated platform and AmerisourceBergen’s solutions to support cell and gene therapy manufacturers, visit View Source

On January 24, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer, reported that positive interim engraftment data from the first four cohorts of the CIMON trial with MaaT033, the Company’s high-richness, high-diversity, Microbiome Ecosystem Therapy for oral administration (Press release, MaaT Pharma, JAN 24, 2022, View Source [SID1234606708]). These results represent the first confirmation of MaaT033’s mechanism of action in humans. MaaT033 is the company’s second product in clinical development and is intended to improve survival in patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT), which represents approximately 22,000 patients every year in the 7 major markets. Its oral formulation, designed for targeted delivery in the intestine, may support long-term, ambulatory use.

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In this dose-ranging study, data from four out of five intended cohorts showed satisfactory safety and good microbiome engraftment, which is characterized by the presence of microbial OTUs[1] in the gut as a result of product administration and that were not present at treatment start.

Based on this positive data, the Company will close the CIMON trial to enable faster than planned completion and evaluation of the full data from the trial, in order to advance MaaT033 towards a planned Phase 2/3 trial, which could start in the second half of 2022. Complete results from the Phase 1b CIMON trial are expected in the first half of 2022.

"These interim results are an important milestone for MaaT Pharma as MaaT033 is our second product, and our first oral formulation, to demonstrate proof of engraftment in humans. This expands the potential of our proprietary Microbiome Ecosystem Therapy (MET) platform to the ambulatory setting, after positive data achieved in aGvHD with MaaT013, an enema product for acute, hospital use. This is the first step towards treating larger patient populations that may benefit from orally-administered microbiome therapies, including patients receiving allo-HSCT, but also patients with solid tumors."

said Hervé Affagard, CEO and co-founder of MaaT Pharma.

MaaT033 is intended to improve survival outcomes in hemato-oncology patients receiving allo-HSCT by protecting and restoring their gut microbiome. In these patients, intensive chemotherapy and antibiotic treatments that are administered to prepare for the allo-HSCT procedure result in a severely damaged gut microbiome. Importantly, higher gut microbiome diversity at the time of allo-HSCT has been correlated to higher survival and lower risks of complications, including incidence of graft-vs-host-disease and multi-resistant infections[2].

"With a very satisfactory safety profile and very promising engraftment data in the first four cohorts of this trial, we believe we have the appropriate amount of data in hand to confidently move forward with MaaT033’s clinical development, without testing the highest planned dose of nine capsules a day. We look forward to further exploring the data from CIMON and preparing for a Phase 2/3 trial start."

added John Weinberg, MD, Chief Medical Officer at MaaT Pharma.

The CIMON Phase 1b trial (NCT04150393) is an open-label, dose-ranging study and has enrolled to date a total of 21 patients in four cohorts (up to three capsules a day for 14 days) across six sites in France. CIMON is designed to investigate the maximum tolerated dose of MaaT033, over 7 or 14 days of therapy, that supports optimal gut microbiome colonization in patients with acute myeloid leukemia or high-risk myelodysplastic syndrome who have undergone intensive chemotherapy. Overall, four Data and Safety Monitoring Board meetings have been conducted evaluating the safety of the trial. All concluded in support of the continuation of the study with the latest taking place in December 2021. Complete results from the trial will be submitted for a presentation at an upcoming key major conference in hemato-oncology as well as for peer-reviewed publication.

[1] OTU or Operational Taxonomic Unit is used to classify bacteria at the genus level, based on sequence similarity of the 16S marker gene. An OTU consists of a group of bacteria whose 16S marker gene shows a sequence identity of 97 percent and above.
[2] Peled, J.U. & al N Engl J Med 2020;382:822-34
About MaaT033

MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness Microbiome Ecosystem Therapy. It is manufactured at MaaT Pharma’s centralized European cGMP production facility. MaaT033 is designed to restore the gut ecosystem to full functionality to improve clinical outcomes as well as to control adverse events related to conventional treatments for liquid tumors. The capsule formulation facilitates administration while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory ButycoreTM species, which characterize MaaT Pharma’s Microbiome Ecosystem Therapies.

On January 24, 2022 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in a fireside chat during the B. Riley Securities’ 2022 Virtual Oncology Investor Conference, taking place on Thursday, January 27, 2022, at 10:00 AM ET (Press release, TG Therapeutics, JAN 24, 2022, View Source [SID1234606727]).

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A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source A replay of the webcast will be available on TG’s website following the event.

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.