On December 1, 2021 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-β therapeutics for oncology and virology, reported that it has submitted clinical study protocol to the US FDA for the initiation of a Phase 2 Trial (designated "M201") for OT-101, the Company’s TGF-β inhibitor, in combination with Anti-PD-1 (Pembrolizumab/Keytruda) as a treatment for patients with Malignant Pleural Mesothelioma (MPM) (Press release, Oncotelic, DEC 1, 2021, View Source [SID1234596348]).

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M201: Phase 2 Trial of TGF-β Inhibition (OT-101) with Anti-PD-1 (Pembrolizumab) in Patients with Malignant Pleural Mesothelioma (MPM) Failing to Achieve or Maintain Response to Checkpoint Inhibition.

OT-101 is a first-in-class anti-TGF-β ribonucleic acid ("RNA") therapeutic that has exhibited single agent activity in relapsed/refractory cancer patients in multiple clinical trials. OT-101 has also demonstrated activity against the SARS-CoV-2 virus, the virus that causes COVID-19, and is currently being evaluated in the Company’s C001 clinical trial against hospitalized severe COVID-19 patients. Both tumor cells and SARS-Cov-2 induce TGF-β as part of their immune evasion mechanism. Consequently, inhibiting TGF-β by OT-101 is expected to impact both cancer and COVID.

The OT-101 oncology program ("OT-101-ONC") is designed to assess the impact of OT-101 across multiple cancer indications where local tumoral secretion of TGF-β suppressed the clinical activity of checkpoint inhibitors, CAR-T, and vaccine. The OT-101-ONC program has been moving forward steadily through strategic alliance with top pharmaceutical companies. Of note is the biomarker program spanning mesothelioma, glioblastoma, lung and colorectal cancers, where AI driven transcriptome analyses will be used to derive the predictive biomarker for TGF-β therapeutics such as OT-101.

"This is the first of a series of planned clinical trials in patients with various solid tumors evaluating clinical benefit while also assessing a host of parameters associated with changes in the tumor microenvironment, including but not limited to T-cell infiltration, expression of various cytokines, and phenotypic and functionality changes pre-therapy versus post-therapy." noted Dr. Anthony Maida, Chief Clinical Office – Translational Medicine.

"The groundwork laid down by OT-101/IL-2 and OT-101/PD-1 will serve as the foundation for future strategic alliances for OT-101/CAR-T and OT-101/Vaccines." said Dr. Vuong Trieu, CEO and Chairman of Oncotelic. "CAR T-cell therapy, in which a patient’s immune T cells are modified so they will bind to cancer cells and kill them, has been shown to benefitted greatly from TGF-β inhibition in early clinical testing."

On December 1, 2021 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported the appointment of Dr. Andrew Colin to the newly created position of Chief Medical Officer, effective December 1, 2021 (Press release, Beyond Air, DEC 1, 2021, View Source [SID1234596347]).

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"I am delighted and honored to welcome Dr. Colin to the Beyond Air family," commented Steve Lisi, Chairman and CEO of Beyond Air. "Dr. Colin’s contributions as a longtime member of our Scientific Advisory Board have already been instrumental to the progress of our ongoing clinical programs, specifically in bronchiolitis and NTM. I am excited to see the growth of our clinical programs under his leadership."

"I am thrilled to join Beyond Air at such an exciting time in the Company’s history," commented Dr. Colin on his appointment as Chief Medical Officer. "Throughout my time on Beyond Air’s Scientific Advisory Board I have developed a productive partnership with the executive team and have become very well versed on the Company’s ongoing clinical programs, as well as strategic plans. I am excited to accelerate these activities and help lead the late-stage development efforts and potential commercialization of both LungFit PRO and LungFit GO systems in acute viral respiratory infections, NTM, and other future indications."

Dr. Colin joins Beyond Air from the Miller School of Medicine of the University of Miami, where he spent the last 16 years, serving as the Professor of Pediatric Pulmonology and Chief of the Division of Pediatric Pulmonology and the Cystic Fibrosis (CF) Program. In this role Dr. Colin directed one of only two Pediatric Pulmonary fellowship training programs in Florida, and throughout his career, has mentored nearly 60 fellows both in the United States and globally. In a career spanning four decades, Dr. Colin has seen many advances in pulmonology and has made significant contributions in multiple facets of the field. While on faculty at Boston Children’s Hospital/Harvard Medical School, he spent a decade studying HIV related lung disease and effects on lung maturation in infants and children, predominantly through application of novel technologies to study infant pulmonary function. Dr. Colin was one of the early participants in the studies for the first CF drug, DNase. As a member of the North American Scientific Advisory Board of the Epidemiology Study of Cystic Fibrosis that was established by Genentech following the DNase studies, he participated in the creation of the first major database for all CF patients in the United States and the basis of multiple subsequent studies. In recent years, his focus has been on nontuberculous mycobacteria (NTM) lung infection, and he was the first to report successful treatment with nebulized amikacin for Mycobacterium abscessus in CF patients.

Dr. Colin has received numerous awards for his contributions to the field of pulmonology. At Harvard he received a Pulmonary Teaching Award named after him, and in 2004 he received the Klaus Peter International Teaching Award. For his contributions to the field and support for its global recognition, Dr. Colin was named Honorary Fellow of the Pediatric Pulmonary Societies of the Philippines, Hong Kong, Taiwan, Thailand, and the Pediatric Society of Guatemala. Additionally, he has been on the editorial board of "Pediatric Pulmonology" for over 25 years, is an active reviewer for multiple journals, and is an active member of the American Thoracic Society (ATS) and the European Respiratory Society. At the ATS 2017 International Conference, Dr. Colin was recognized with the Society’s first Lifetime Contributions to Pediatric Respiratory Medicine Award. He received his M.D. at Technion-Israel Institute of Technology, Haifa, Israel in 1976 and completed his pediatric training in hospitals related to that medical school. He was trained in Pediatric Pulmonology and Pediatric Intensive Care at Hadassah Hospital in Jerusalem and subsequently completed a formal fellowship in Pediatric Pulmonology at Children`s Hospital Boston, Harvard Medical School, where he remained on the faculty for 15 years.

On December 1, 2021 Notable Labs, Inc. (Notable), a clinical-stage predictive precision therapeutics company and CicloMed LLC (CicloMed), a developmental-stage pharmaceutical company reported that they have initiated a Phase 1B/2A clinical trial of fosciclopirox in patients with refractory acute myelogenous leukemia (AML) under the terms of a co-development agreement (Press release, Notable Labs, DEC 1, 2021, View Source [SID1234596343]). In the ongoing open-label, Phase 1B/2A trial currently underway at The University of Kansas Cancer Center, Notable is applying its high-fidelity predictive precision medicines platform with the goal of assessing patient responsiveness to fosciclopirox.

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"Notable’s unique predictive precision medicines platform has the potential to develop cancer treatments precisely for the patients predicted to respond, reducing the risks for patients of receiving treatments that don’t work for them. Moreover, developing a treatment in selected clinical responders enables smaller clinical trials and the potential to expedite development timelines," said Thomas Bock, M.D., Chief Executive Officer of Notable. "Fosciclopirox is a strategically and deliberately selected program, as it has already performed well on our predictive precision medicines platform."

"The initial phase of our collaboration with Notable focused on optimizing the Notable predictive precision medicine platform for sensitivity to fosciclopirox on AML patient samples," said Tammy Ham, CEO of CicloMed. "The encouraging results from this work led to our co-development agreement and the initiation of our on-going clinical trial."

Under the terms of the co-development agreement, CicloMed holds the primary responsibility for executing clinical trial operations while Notable is primarily focused on optimizing Notable’s predictive precision medicine platform. Both parties will be responsible for the costs associated with the on-going clinical trial.

About Fosciclopirox
Fosciclopirox was discovered by scientists at The University of Kansas Cancer Center, a National Cancer Institute designated cancer center and the Institute for Advancing Medical Innovation (IAMI), University of Kansas Medical Center’s product development enterprise. Fosciclopirox is part of an open-label, Phase 1B/2A study to characterize the efficacy, safety, PK, and pharmacodynamics of fosciclopirox administered alone and in combination with cytarabine in patients with relapsed or refractory AML. CicloMed was formed in 2016 as a public-private partnership between BioNovus Innovations LLC and IAMI, with fosciclopirox as the partnership’s lead drug development candidate.

On December 1, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for GSK4381562 (formerly SRF813) to proceed into a first-in-human clinical trial (Press release, Surface Oncology, DEC 1, 2021, View Source [SID1234596341]). GSK4381562 is a fully human IgG1 antibody targeting PVRIG (also known as CD112R), an inhibitory protein expressed on natural killer cells (NK cells) and T cells.

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In December 2020, Surface announced it had entered into an agreement in which GSK exclusively licensed worldwide development and commercial rights to GSK4381562. Surface will receive a $30 million milestone payment in conjunction with the initiation of the first Phase 1 study for GSK4381562 and is eligible to receive an additional $700 million in future milestone payments, as well as be eligible to receive tiered royalties on global net sales.

"GSK4381562 is a differentiated anti-PVRIG antibody and represents a new therapeutic approach designed to enhance NK and T cell activation in the tumor microenvironment," said Rob Ross, M.D., chief executive officer. "We are pleased to have reached this milestone with our partners at GSK and look forward to continued advancement of this promising program in the clinic."

About GSK4381562:

GSK4381562 is a fully human, IgG1 antibody targeting PVRIG (also known as CD112R), an inhibitory protein expressed on natural killer cells (NK cells) and T cells. GSK4381562 binds to a distinct epitope on PVRIG and blocks the interaction of PVRIG with CD112, its binding partner that is overexpressed on tumor cells. Preclinically, GSK4381562 promotes the activation of both NK cells and T cells, with the potential to elicit a strong anti-tumor response and promote immunological memory.

On December 1, 2021 Genomic Testing Cooperative, LCA (GTC) reported that it will be presenting at the annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting new data on the use of their proprietary machine learning approaches in the diagnosis of acute graft-versus-host disease (aGVHD) and for the stratifying of patients with diffuse large B-cell lymphoma (DLBCL) based on outcome after treatment with the standard R-CHOP (Press release, Genomic Testing Cooperative, DEC 1, 2021, View Source [SID1234596340]). GTC will also present studies on their liquid biopsy and its reliability in detecting cytogenetic abnormalities in myeloid neoplasms and in monitoring minimal residual disease after stem cell transplant. These studies were performed in collaboration with multiple academic institutions that contributed clinical data. GTC is the only diagnostic company that offers molecular testing based on cooperative (Co-Op) business model. By working with other members of the Co-Op, the company is able to develop and validate tests in efficient ways reducing the cost of testing and innovation. GTC shares the intellectual property rights of three of the four innovative tests with John Theurer Cancer Center and Hackensack Meridian Health, both members of the Co-Op. Dr. Andre Goy, Chairman and Chief Physician Officer at John Theurer Cancer Center, Chairman of Oncology at Hackensack Meridian School of Medicine and Professor of Medicine at Georgetown University said "being a part of the cooperative group at GTC has been extremely productive and enabled John Theurer Cancer Center to offer state-of-the-art precision medicine, not only for selecting therapy but for developing cutting edge approaches for monitoring patients".

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The presented work reflects the current GTC innovation strategy in improving cancer care. GTC uses RNA data and targeted transcriptome generated by next generation sequencing (NGS) along with new machine learning approaches to predict the presence of aGVHD and for stratifying patients with DLBCL. These are examples of how genomics can improve patient care. aGVHD remains a major cause of morbidity and mortality in patients after hematopoietic stem cell transplant. Proper and early diagnosis of this serious complication of transplant will trigger prophylaxis therapy and treatment that may improve outcome. Similarly predicting patients with DLBCL who will not respond well to the current standard R-CHOP therapy will help in selecting different therapeutic approaches and new clinical trials.

GTC is developing new indications in liquid biopsy testing and extensively exploring new technology to improve patient care. ASH (Free ASH Whitepaper) presentations show that their liquid biopsy can reliably predict cytogenetic abnormalities in patient with hematologic neoplasms and can be used for diagnosis and management of patients with myeloid neoplasm. Another presentation shows that liquid biopsy is reliable in monitoring patients after hematopoietic stem cell transplant. Dr. Maher Albitar, founder, chief medical officer, and chief executive officer of GTC stated "GTC was established as a co-op business to improve patient and democratizing genomics through efficient innovation and collaboration". He added "Advances in genomics and machine learning are opening new opportunities in medicine to improve outcome in cancer care. Our new studies that are presented at ASH (Free ASH Whitepaper) are examples of how a cooperative business model can deliver".

Following are the list and dates and times of the presentations:

1)Reliability of Liquid Biopsy and Next Generation Sequencing in Monitoring Residual Disease Post-Hematopoietic Stem Cell Transplant, Saturday, December 11, 2021: 5:30 PM-7:30 PM

2)Bone Marrow-Based Biomarkers for Predicting aGVHD Using Targeted RNA Next Generation Sequencing and Machine Learning , Sunday, December 12, 2021: 6:00 PM-8:00 PM

3)Determining Clinical Course of Diffuse Large B-Cell Lymphoma Using Targeted Transcriptome and Machine Learning Algorithms; Sunday, December 12, 2021: 6:00 PM-8:00 PM
4) Reliability of Cell-Free DNA (cfDNA) Next Generation Sequencing in Predicting Chromosomal Structural Abnormalities and Cytogenetic-Risk Stratification of Patients with Myeloid Neoplasms; Monday, December 13, 2021: 6:00 PM-8:00 PM