On December 2, 2021 Leucid Bio ("Leucid" or the "Company"), a biotech company pioneering next-generation cell therapies for hard-to-treat cancers, reported that it has entered a strategic collaboration with Lonza to utilize Lonza’s Cocoon Platform for the Company’s forthcoming Phase I clinical trial, through to commercial manufacturing (Press release, Lonza, DEC 2, 2021, View Source [SID1234596422]).

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Under the terms of the collaboration, Leucid will utilise Lonza as its preferred manufacturer, aiming to deliver high quality cell therapies quickly and cost-effectively to patients in a decentralized manufacturing model. Leucid is, in turn, one of Lonza’s preferred collaborators on the Cocoon Platform, and both companies will work together to optimise and streamline the manufacturing process for Leucid’s CAR-T therapies. As a preferred collaborator, Leucid will have early access to new Cocoon Platform technologies.

Founded to translate 20 years of pioneering CAR-T research led by Dr John Maher at King’s College London, Leucid has developed a proprietary engine that builds upon Dr Maher’s novel parallel CAR-T model which positions these molecules in a more natural biological configuration. The Company’s technology confers properties on the CART-cells that enable them to consistently outperform previous generations of CAR-T therapies in pre-clinical studies. As a result, this leads to enhanced T-cell potency and persistent long-term response with reduced toxicity.

Artin Moussavi, Chief Executive Officer of Leucid Bio, said: "Following on from our successful Series A financing, we are delighted to be working with Lonza and its Cocoon Platform. This agreement will allow us to accelerate our path to the clinic, treating more patients sooner, potentially at point-of-care, and help to solve the key issues facing CAR-T therapeutics."

John Maher, Chief Scientific Officer of Leucid Bio, added: "This is a fantastic opportunity to collaborate with Lonza, enabling us to develop a state-of-the-art scalable manufacturing process. This will significantly help Leucid to efficiently transition our CAR-T pipeline for maximum patient benefit."

Nicholas Ostrout, Head of Commercial Development within Personalized Medicine at Lonza, commented: "We look forward to working with Leucid to bring its revolutionary, novel cancer immunotherapies to the clinic and patients. Use of the Cocoon Platform, coupled with the array of process development, manufacturing expertise and tools that Lonza brings, will provide a smooth route to commercial approval. By leveraging the Cocoon Platform’s unique capabilities, this collaboration aims to illustrate the promise and feasibility of manufacturing autologous immunotherapies in a decentralized model, into approved routine use."

CAR T-cell therapy is a revolutionary technology in which the patient’s own immune cells are reprogrammed so they can recognise and destroy cancer cells. This has proven to be a powerful therapy for refractory blood cancers, but has not yet been very effective for the treatment of solid tumours.

Leucid’s LEU-011 programme is a NKG2D-targeted CAR T-cell therapy in pre-clinical development for the treatment of solid tumours and haematological malignancies. The NKG2D receptor is an activating immune receptor that triggers cell death upon recognition of human NKG2D ligands expressed on transformed, infected or damaged cells. LEU-011 has potential for the treatment of multiple cancer types as NKG2D ligands are expressed on more than 80% of human tumour cells.

On December 1, 2021 Accro Bioscience (Suzhou) Limited ("Accropeutics Bioscience"), a China-based leadingbiotechnology company, reported that the company has recently raised over $50 million in an oversubscribed Series B round (Press release, Accro Bioscience, DEC 1, 2021, View Source [SID1234632773]). The financing was led by HongtaiAplus with participation from South China Venture Capital, Shenzhen Capital Group, Suzhou Oriza Holdings, and others.

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"Accropeutics Bioscience will leverage the funds to advance clinical development, pre-clinical research and international partnerships," said Dr. Xiaohu Zhang, co-founder and CEO of Accropeutics Bioscience, "We are very pleased with the support and confidence of our current and new investors."

"We appreciate the R&D and execution capabilities of the team, and look forward to the continuous breakthroughs of Accropeutics Bioscience in the future," said Morningside.

"We are optimistic about the development of Accropeutics Bioscience," said HongtaiAplus, "We are delighted to lead this round of financing and look forward to the in-depth cooperation with Accropeutics Bioscience in the future."

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 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.