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

On December 1, 2021 2seventy bio, Inc. (Nasdaq: TSVT), an emerging immuno-oncology company, reported financial results and recent highlights for the third quarter ended September 30, 2021 (Press release, 2seventy bio, DEC 1, 2021, View Source [SID1234596339]).

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"We launched 2seventy bio a few short weeks ago and I’m highly encouraged by the way our team has taken this challenge head on," said Nick Leschly, chief kairos officer. "Our urgency to bring transformative cell therapies forward is driven by the ultimate goal, which is to provide more time to patients and their families devastated by cancer. We have hit the ground running, with the first IND acceptance for our program in AML, and another anticipated in the bNHL program by the end of the year. Exciting times are ahead, and we are fired up for 2022 as ABECMA continues to deliver for MM patients and our product engine drives more disruptive next-gen cell therapies forward in both liquid and solid tumors."

RECENT HIGHLIGHTS

COMPANY LAUNCH – On November 4, 2021, 2seventy bio launched as an independent, publicly traded company with a robust cell therapy pipeline across a range of hematologic and solid tumors including the SC-DARIC33 and bbT369 candidates that are planned, subject to IND acceptance, to enter the clinic by the first half of 2022. 2seventy bio’s portfolio also includes a development and 50/50 U.S. commercialization partnership with Bristol Myers Squibb (BMS) for ABECMA, a first-in-class B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy, in relapsed or refractory multiple myeloma.
SC-DARIC33 IND – Today, 2seventy bio is announcing that the FDA has accepted the IND for SC-DARIC33, an investigational, pharmacologically controlled CD33-targeted autologous T cell product, developed in collaboration with Seattle Children’s Therapeutics for the potential treatment of acute myeloid leukemia (AML). PLAT-08, the Phase 1 study of SC-DARIC33 in relapsed/refractory pediatric AML, led by Seattle Children’s Therapeutics, is now open and enrolling patients (NCT: 05105152). This study is a first-in-human investigation of the DARIC T cell platform.
ASH PRESENTATIONS – On November 4, 2021, 2seventy bio announced that it will present data from its portfolio of oncology cell therapies at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. These presentations include new pre-clinical data on SC-DARIC33, and in partnership with BMS, updated results from the ongoing Phase 1 CRB-402 study of the BCMA-targeted CAR T cell therapy bb21217 in patients with relapsed and refractory multiple myeloma (RRMM). In addition, a range of analyses will be presented from the pivotal KarMMa trial of ide-cel, in partnership with BMS.
UPCOMING ANTICIPATED MILESTONES

Acceptance of investigational new drug (IND) application for bbT369 in bNHL by the end of 2021.
Presentation of new preclinical data from the SC-DARIC33 program at the 63rd ASH (Free ASH Whitepaper) Annual Meeting in December 2021.
Presentation of clinical data from the ongoing CRB-402 study of bb21217 at the 63rd ASH (Free ASH Whitepaper) Annual Meeting in December 2021.
SELECT THIRD QUARTER AND YEAR-TO-DATE 2021 FINANCIAL RESULTS

The results for the period ended September 30, 2021, have been prepared on a carve-out basis and are derived from bluebird bio, Inc.’s consolidated financial statements and accounting records. Upon separation on November 4, 2021, bluebird bio made a contribution to 2seventy bio of approximately $441.5 million in cash and cash equivalents, which is expected to be sufficient to fund current planned operations for at least the next twelve months.
Revenues: Total revenues were $19.3 million for the three months ended September 30, 2021 compared to $18.4 million for the three months ended September 30, 2020. Total revenues were $38.5 million for the nine months ended September 30, 2021 compared to $238.2 million for the nine months ended September 30, 2020. The increase for the three-month period was primarily driven by revenue recognized under our collaboration arrangement with BMS. The decrease in the nine-month period was primarily driven by revenue recorded in connection with the May 2020 BMS contract modification in the second quarter of 2020.
ABECMA Revenue: BMS reported total U.S. revenues of $67 million for ABECMA (idecabtagene vicleucel; ide-cel) in the third quarter of 2021. 2seventy bio reported net collaboration revenue of $12.3 million for the third quarter of 2021, which includes our share of revenue and costs associated with the commercialization of ABECMA in the U.S.
R&D Expenses: Research and development expenses were $61.1 million for the three months ended September 30, 2021 compared to $72.3 million for the three months ended September 30, 2020. Research and development expenses were $202.4 million for the nine months ended September 30, 2021 compared to $227.6 million for the nine months ended September 30, 2020. The decrease for the three-month period was primarily driven by decreased R&D costs under our collaboration with BMS and decreased manufacturing expenses. The decrease for the nine-month period was primarily driven by decreased manufacturing expenses.
SG&A Expenses: Selling, general and administrative expenses were $23.0 million for the three months ended September 30, 2021 compared to $22.1 million for the three months ended September 30, 2020. Selling, general and administrative expenses were $69.0 million for the nine months ended September 30, 2021 and September 30, 2020. The increase for the three-month period was primarily driven by an increase in employee compensation, benefit, and other headcount related expenses.
Net Loss: Net loss was $60.0 million for the three months ended September 30, 2021 compared to $72.1 million for the three months ended September 30, 2020. Net loss was $231.2 million for the nine months ended September 30, 2021 compared to $43.3 million for the nine months ended September 30, 2020.