On December 1, 2021 Freenome, a privately held biotech company, reported a partnership with Siemens Healthineers to collaborate in multiomics and radiomic breast cancer diagnostics to identify suitable markers for early breast cancer detection through blood to augment existing imaging technologies (Press release, Freenome, DEC 1, 2021, View Source [SID1234596326]).

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The partnership leverages Freenome’s expertise in machine learning and multiomics to detect early cancer, utilizing epigenetic, proteomic, genomic, immunologic and other data types to maximize clinical accuracy for future screening tests. This collaboration will allow Freenome and Siemens Healthineers to share their technologies by connecting imaging and clinical data with molecular data to identify new suitable markers of breast cancer that are complementary to those identified using current imaging.

"With their multiomics approach in molecular diagnostics, Freenome is our partner of choice for this study," said Rangarajan Sampath, Head of the Center for Innovation in Diagnostics (CID), Siemens Healthineers. "Our collaboration in the identification and development of new biomarkers will allow us to work together toward a new patient-centric pathway to diagnose early-stage breast cancer."

By modeling Freenome’s multiomics data enabled by artificial intelligence and machine learning based methodologies, researchers seek to identify the most effective biomarkers and molecular features to improve the identification of breast cancer.

"Siemens Healthineers is an established leader in the development of imaging and diagnostic technologies, especially in breast cancer screening with more recent improvements leveraging 3D mammograms or digital breast tomosynthesis," said Mike Nolan, chief executive officer, Freenome. "This collaboration will give us even more insights on how we can incorporate unique data types to address the unmet medical needs for one of the most common cancers."

On December 1, 2021 TOT BIOPHARM International Company Limited (TOT BIOPHARM, 1875.HK) reported its self-developed Pusintin (TAB008, bevacizumab injection) has been officially granted approval by the National Medical Products Administration ("NMPA") for marketing in mainland China (i.e., excluding Hong Kong, Macau and Taiwan regions) for the treatment of patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer and patients with metastatic colorectal cancer (Press release, Tot Biopharm, DEC 1, 2021, View Source [SID1234596363]). Pusintin is the first antibody drug of TOT BIOPHARM approved for marketing.

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Bevacizumab is a humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF) which can specifically bind to VEGF and block the binding of VEGF to its receptor, thereby reducing angiogenesis and inducing degeneration of existing blood vessels, and inhibit tumor growth. As a broad-spectrum anti-tumor drug, bevacizumab injection has become a globally recommended standard therapy in the treatment guidelines for a variety of malignant tumors, which had abundant real-world evidence of its efficacy and safety since its entry into the market in 2004. Bevacizumab injection has currently been included in the National Medical Insurance Directory. According to the Frost & Sullivan Report, bevacizumab’s market share in China will increase to RMB 6.4 billion in 2023 and RMB 9.9 billion in 2030.

Pusintin is a biosimilar to bevacizumab injection sold under the trade name of Avastin in China. TOT BIOPHARM strictly followed the NMPA’s "Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars" and has taken rigorous and comprehensive head-to-head comparisons between Pusintin and the reference bevacizumab. The results from pharmaceutical studies, non-clinical studies, and clinical studies proved that Pusintin has similar PK characteristics with the originator drug and presents clinically equivalent with highly similarity in safety and immunogenicity.

Bevacizumab has been approved for 8 indications globally, and 6 indications in China, including mCRC, NSCLC, glioblastoma multiforme (GBM), and for the treatment of hepatocellular carcinoma (HCC), ovarian cancer, and cervical cancer. According to the "Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars", Pusintin will be eligible for application by way of extrapolation for use in all indications of Avastin approved in China.

TOT BIOPHARM has established large-scale commercial production base in Suzhou Industrial Park that meets international standards, covering an area of 50,000 square meters with a capacity of monoclonal antibodies reaches 20,000L until the first half of 2022. Pusintin adopts the self-developed Perfusion-batch mixed culture technology (PB-Hybrid Technology) for commercial production. This technology has been verified in the production of Phase III clinical drugs, which can simplify the process and shorten the production cycle, reduce production costs, and greatly improve the cost advantage of Pusintin.

Dr. Liu Jun, CEO of TOT BIOPHARM, said, "We are very pleased for the Pusintin ‘s marketing approval of NMPA, which can provide high-quality and affordable treatment options for more cancer patients. This is really a key milestone for TOT BIOPHARM. Meanwhile, it has once again verified the superiority of our one-stop innovative drug R&D and production platform. By virtue of our highly competitive commercial production platform and technology platform, we will constantly accelerate the implementation of innovative achievements and improve the availability of medicines, and let the achievements of national medicine benefit more patients."

On December 1, 2021 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported it has received Breakthrough Device designation from the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for its ZetaMet (Zeta-BC-003) technology (Press release, Zetagen Therapeutics, DEC 1, 2021, View Source [SID1234643705]). Previously known as ZetaFuse, ZetaMet (Zeta-BC-003) is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone.

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"We are pleased to receive this important designation from the Agency and look forward to partnering with them," said Joe C. Loy, CEO of Zetagen Therapeutics. "Our researchers have discovered an entirely new pathway for an established molecule which, if proven successful in human clinical trials, could create a new treatment paradigm for the hundreds of thousands of patients living with cancers that involve metastatic bone lesions."

ZetaMet (Zeta-BC-003) works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as "osteoblasts", and inhibits cells associated with bone degradation called "osteoclasts". The combination technology has, thus far, in preclinical studies, demonstrated its ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration.

Bone metastases are common among cancer patients and occur when cells from the primary cancerous tumor relocate to the bone. When these cancers relocate, they can cause changes to the bone, damaging it in a process called osteolysis. Osteolysis can cause small holes within the bone, weakening it and increasing the risk of breakage. These holes are called "lytic lesions." Among cancers which metastasize to bone, Breast and Prostate are most prevalent, amounting to approximately 70-percent of cases.[1]

ZetaMet (Zeta-BC-003) has successfully passed its preclinical trials and is being prepared for its first human clinical trial in early 2022.

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 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that the company will present at the RBC Capital Markets Healthcare Private Company Conference, taking place virtually on December 15-16, 2021 (Press release, Sapience Therapeutics, DEC 1, 2021, View Source [SID1234596364]).

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Dr. Barry Kappel, CEO and President, will participate in a fireside chat on December 16, 2021 at 2:30 PM ET. In addition, company management will participate in one-on-one meetings with life science investors during the event.