On January 12, 2022  OncoHost, a global leader in next-generation precision oncology for improved personalized cancer therapy, reported results from its ongoing multicenter clinical trial, PROPHETIC (Press release, OncoHost, JAN 12, 2022, View Source [SID1234598648]). These interim results confirm that through proteomic analysis of just one blood test before treatment, OncoHost’s AI platform, PROphet, can predict response to cancer treatment for non-small cell lung cancer (NSCLC) patients with remarkably high accuracy at three months, six months and one year.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"These results are statistically and clinically significant, giving us great hope for the future of precision oncology. The value that this validation will provide, both to cancer patients and their clinicians, is insurmountable," said Dr. Ofer Sharon, CEO of OncoHost. "With just one blood test pre-treatment, we will now be empowered with a level of knowledge that is currently non-existent. Understanding the response probability trajectory for a full twelve months before treatment initiation, combined with insights on resistance associated pathways and proteins, has the potential to allow physicians to make critical clinical decisions earlier, all based on personalized patient data."

PROphet is a first-of-its-kind diagnostic platform that combines proteomic analysis with AI to predict patient response to immunotherapy and identify resistance associated processes with just one blood test pre-treatment. The device employs high-throughput protein analysis technology, scanning approximately 7,000 proteins in a patient’s plasma using the SomaScan platform by SomaLogic (NASDAQ-GM: SLGC), combined with proprietary bioinformatic and machine learning-based algorithms, to identify proteomic patterns that are predictive of patient outcome. PROphet also identifies potential drug targets, advancing the development of novel therapeutic strategies and providing clinicians with potential combination strategies to overcome treatment resistance.

With a focus on patients diagnosed with advanced stages of melanoma or non-small cell lung cancer (NSCLC) receiving immunotherapy, OncoHost’s clinical trials have shown PROphet to have high accuracy. OncoHost continues to open additional clinical trial sites around the world and will be expanding its research to further cancer indications including ovarian cancer, head and neck cancers and urogenital cancers.

The full results of the analysis will be published later this year in a peer-reviewed paper. This announcement comes ahead of OncoHost’s official launch of PROphet in 2022.

On January 12, 2022 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported that the first patient had been dosed in its China phase 2 study (NCT05145907) of efineptakin alfa (also known as TJ107) in combination with pembrolizumab (Keytruda) in patients with advanced solid tumors (Press release, I-Mab Biopharma, JAN 12, 2022, View Source [SID1234598647]). The study will follow a "basket" trial design to include selected tumor types, including triple-negative breast cancer (TNBC) and squamous cell cancer of the head and neck (SCCHN).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Efineptakin alfa, the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7) developed as a T lymphocyte-booster for cancer-related immunotherapy, has distinct advantages over other cytokines such as human IL-2. Efineptakin alfa combined with immune checkpoint inhibitors, such as PD-(L)1 therapies, has a synergistic effect as it increases the number of circulating anti-tumor T cells for tumor suppression. It has been tested as monotherapy and in combination with checkpoint inhibitors to treat advanced solid tumors in the U.S., South Korea and China, with encouraging clinical results.

"As the majority of cancer patients either do not respond or respond poorly to current PD-(L)1 therapies, there are intense attempts to identify an effective agent that can work synergistically with PD-(L)1 antibodies to increase the probability of treatment success," said Professor Ye Guo, Deputy Director of Department of Oncology at Shanghai East Hospital and the principal investigator of the study. "Studies have shown that efineptakin alfa has the potential to address this unmet need. We look forward to further validating the safety and efficacy profile of efineptakin alfa in patients with solid tumors."

"The initiation of efineptakin alfa’s phase 2 study is another example that I-Mab’s pipeline is not only innovative but also mature with a majority of clinical programs being in the advanced clinical development stage," said Dr. Andrew Zhu, President of I-Mab. "Efineptakin alfa is the world’s first rhIL-7 designed to cater to the therapeutic needs of cancer patients, so we are mindful of the importance of this therapy and are committed to expediting the clinical development of a potentially transformative solution for patients in need."

I-Mab is also evaluating efineptakin alfa in another phase 2 clinical trial (NCT04600817) in lymphopenic patients with newly diagnosed glioblastoma multiforme (GBM) who have received standard concurrent chemoradiotherapy. By leveraging the two ongoing clinical studies, the Company aims to rapidly advance the clinical development of efineptakin alfa for approval in Greater China.

About Efineptakin alfa

Efineptakin alfa, also known as TJ107/GX-I7/NT-I7, is the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7), known to boost T lymphocytes by increasing their number and functions. It emerged from Genexine’s proprietary hyFc platform for the discovering of long-acting biologics. I-Mab has acquired exclusive rights from Genexine to develop and commercialize efineptakin alfa in Greater China. Efineptakin alfa may have utility in cancer treatment-related lymphopenia (low blood lymphocyte levels), a common condition that occurs in cancer patients who have received chemotherapy or radiation therapy, for which there is no approved treatment. Efineptakin alfa has also been shown to synergize with a PD-1 antibody in various tumor animal models potentially through increased T-lymphocyte activation and proliferation.

On January 12, 2022 MYND Life Sciences Inc. ("MYND" or the "Company") (CSE: MYND) (OTC: MYNDF) a biopharmaceutical research and development company creating innovative precision medicines for patients with relentless neurological diseases, reported that it has entered into Collaborative Research Agreement (the "Agreement") with the University of British Columbia ("UBC") focussing on Novel Therapies for Neurological Diseases (Press release, University Of British Columbia, JAN 12, 2022, View Source [SID1234598646]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MYND is creating safe and effective precision medicines based on proprietary technologies, targeting intractable diseases affecting the Central Nervous System, aiming to improve the standard of care for patients. This research seeks to test new compounds, including Psilocybins which may modify neurological diseases. Through 38 Health Canada licenses issued under their Section J exemptions of the Food and Drug Act issued to the UBC Laboratory, MYND possesses the enviable ability to examine the unique actions of analogues of Psilocybin. The focus is to develop, validate and patent the ability of Psilocybin-based drugs to modify outcomes in disease.

"We are very excited to announce our second Collaborative Research Agreement focussing on diseases of the brain," stated Dr. Lyle Oberg, MYND’s Chief Executive Officer. "We have a unique opportunity to improve the wellness and quality of life of millions of people and families torn apart by the tragedy of dementia and other debilitating diseases of the Central Nervous System. The MYND management team has a wealth of scientific, clinical and operational experience, and is well networked within the pharmaceutical industry. The Psilocybin sector is rapidly transitioning to become a pharmaceutical industry and MYND holds a unique position within the sector in terms of building upon our unique intellectual property and a valuable portfolio of related patents","

The Company has a broad development pipeline, including advancing clinical programs, such as novel biomarkers for depression and MYND is expecting results from its pivotal trial to validate these biomarkers. Through its subsidiary MYND Diagnostics INC., this includes conducting an adaptive dose finding single phase 2b clinical trial funded by the Australian Government of the efficacy and safety of psilocybin assisted psychotherapy ("PAP") in the treatment of people diagnosed with treatment resistant depression ("TRD") in collaboration with clinical researchers at Monash University. Furthermore, MYND anticipates entering clinic trials with three additional programs in the course of 2022/2023. After progressing to clinical proof of concept, MYND will continue to have the option to enter into partnerships for late-stage development and commercialization.

"We are continuing to translate our innovative approaches, while maintaining our scientific excellence," stated Dr. Wilfred Jefferies, Chief Science Officer at MYND. "We have unique technologies with differentiating potential and access to state-of-the-art facilities. This funding will allow us to accelerate our research dramatically leading to more rapid translation of our studies. This is a really exciting time for MYND and our team."

DEPARTURE OF AN OFFICER OF THE COMPANY

MYND’s Chief Operating Officer, Jordan Cleland, is moving on from the company to pursue other professional opportunities effective the end of day, January 11, 2022. Cleland was MYND’s first hire in August of 2020 and provided operations set up and support in the formative months of the company. Cleland’s duties will be assumed by Dr. Chahaat Singh who will assume the role of Operations and Research Manager with MYND. Dr. Singh has a Ph.D. in Medical Genetics, a M. Sc. In Microbiology, and brings a wealth of research experience to the position. Singh has biotech industry experience with the firms IMTech and Panacea and recently co-authored an article in the Lancet dealing with Alzheimer’s Disease. Mynd would like to thank Mr. Cleland for his dedication to the company and wishes him well in his future endeavours.

On January 12, 2022 GenomOncology reported that GenomOncology (GO) Pathology Workbench has been selected by Labcorp’s OmniSeq to support the analysis and reporting of OmniSeq INSIGHT℠, a comprehensive genomic and immune profiling test for solid tumors (Press release, GenomOncology, JAN 12, 2022, View Source [SID1234598644]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

OmniSeq INSIGHT combines genomic and immune profiling to comprehensively characterize a patient’s tumor to identify potential treatment and clinical trial options. OmniSeq INSIGHT examines the full coding region of 523 genes by next generation sequencing for mutations, copy number alterations, fusions microsatellite instability (MSI), tumor mutation burden (TMB), and expression of 64 immune genes in the tumor microenvironment. The test also includes PD-L1 by immunohistochemistry.

"Our partnership with GenomOncology has advanced our ability to efficiently classify variants, match therapies and identify trials located within 200 miles of the patient’s home," says Shengle Zhang, MD, Laboratory Director of OmniSeq. "This highly customized laboratory information system supports OmniSeq’s competitive turnaround time of matched precision medicine options to ordering clinicians for their cancer patients."

To streamline variant review, interpretation, and case reporting, OmniSeq implemented the highly customized GO Pathology Workbench. Central to the GO Pathology Workbench’s function is a proprietary, algorithmically-driven database of evidence and guideline-based therapeutic options and clinical trials. The results are displayed in the comprehensive OmniSeq INSIGHT test report.

"The adaptability and versatility of the GO Pathology Workbench enabled us to efficiently customize the workbench to accommodate the unique features of the OmniSeq INSIGHT test. By providing the knowledge and evidence needed for effective variant interpretation, GO Pathology Workbench provides a tool to support OmniSeq INSIGHT’s swift turnaround time," said Matt Stachowiak, PhD, Director of Product Management at GenomOncology.

In June 2021, Labcorp (NYSE: LH), a leading global life sciences company, acquired OmniSeq. OmniSeq INSIGHT is available to U.S.-based clinicians exclusively through Labcorp, and across Canada through Dynacare, a Labcorp company. The test is also available to global biopharmaceutical companies exclusively through Labcorp Drug Development. For more information about OmniSeq INSIGHT, visit oncology.labcorp.com/omniseq.

On January 12, 2022 Samsung Biologics (KRX: 207940.KS) reported its sustainable growth plan for this year at the 2022 Annual JP Morgan Healthcare Conference, which is held virtually from January 10th to 13th with leaders from major pharmaceutical and biopharmaceutical companies and key investors (Press release, Samsung BioLogics, JAN 12, 2022, View Source [SID1234598643]). During the main track presentation today, John Rim, President and CEO of Samsung Biologics, addressed the company’s vision for 2022 and business goals including three core pillars of multidimensional growth plan, encompassing expanded manufacturing capacity, continued advancements in business portfolio, and greater global footprint.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"For Samsung Biologics, 2022 will be a year where we will be able to take a great leap forward for sustainable growth and endeavor to maximize our capabilities as a leading CDMO," said John Rim, CEO of Samsung Biologics during his presentation at the conference. "Through proactive investment in increasing our manufacturing capacity, enhancing portfolio diversification, and expanding facilities in overseas, Samsung Biologics will be able to accelerate the build-up of its core success drivers as the next growth engine of the industry."

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

The company is further venturing into securing additional sites within Songdo for the construction of Plant 6 and Open Innovation Center, and also overseas in multiple locations to maximize both its manufacturing capacity to produce large-scale biologics and be in close proximity to its global clients.

Samsung Biologics’ Plant 4 is currently under stable construction to be partially operational by the end of this year and the company is steadily securing pre-sales of clients. Upon the full completion of Plant 4 in 2023, the company is expected to hold a total of 620,000L of capacity, reaffirming its position as the world’s largest CDMO.

Samsung Biologics demonstrated strong operational excellence and business agility in 2021 with all Plants 1, 2, and 3 in stable operations, marking record-high financial results in two consecutive quarters. The company successfully laid a robust foundation in the mRNA business area through signing strategic partnership agreements 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.

In light of the increasing importance of actions towards sustainability, Samsung Biologics issued its first annual sustainability report, consolidating the company’s policies for an enhanced ESG management system. The company was recently added to the DOW Jones Sustainability World Index (DJSI) in recognition of its commitment to ESG matters.

"The strategic roadmap and milestones outlined today illustrate the key success drivers for our growth this year as well as lay a strong groundwork for sustainable growth opportunities ahead of us," Rim added. "With our continued investment in capacity, portfolio, and global footprint, we will evolve as the top biopharmaceutical company and offer diversified services as the next growth engine of the industry."