On October 3, 2022 Median Technologies (Paris:ALMDT) reported the formation of their Clinical Advisory Board (CAB) for iBiopsy Lung Cancer Screening (Press release, MEDIAN Technologies, OCT 3, 2022, View Source [SID1234621645]). This group of world class physicians brings comprehensive expertise in the space of Lung Cancer Screening to guide Median in the development of iBiopsy LCS AI/ML tech-based CADe/CADx SaMD (software as medical device), which detects and characterizes lung cancer nodules in high risk populations, ultimately aimed at improving patient outcomes as well as clinical workflows.

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"We are privileged to have the opportunity to bring together this group of truly world-class physicians and academic leaders, who’s expertise and invaluable insights will help guide our late stage development as we approach pivotal clinical studies towards regulatory approval, and beyond" said Thomas Bonnefont, iBiopsy COO and CCO at Median.

"I am pleased and honored to be working with this team of distinguished and highly accomplished clinicians, who’s wealth of knowledge and experience will help Median deliver on optimizing the Lung Cancer Screening routine and saving patient lives." said Yan Liu M.D., Chief Medical Officer of Median

Introducing the members of Clinical Advisory Board for Lung Cancer Screening (in alphabetical order):

Philippe Grenier
Professor, Thoracic Radiologist and Head of the Artificial Intelligence project, Hopital Foch, Suresnes (France)

Francesco Grossi
Director of the Division of Medical Oncology and Associate Professor at the University of Insubria, Varese (Italy)

Luis Seijo Maceiras
Director of Pneumology Department – Clinica Universidad de Navarra, Madrid (Spain)

Carey Thomso
Chair, Department of Medicine and Director, Multidisciplinary Thoracic Oncology and Lung Cancer Screening Program, Mount Auburn Hospital/Beth Israel Lahey Health, Cambridge, Massachusetts (United States) – Associate Professor of Medicine at Harvard Medical School, Boston, Massachussets (United States)

Anil Vachani
Director of Clinical Research, Section of Interventional Pulmonary and Thoracic Oncology, Penn Medicine, Associate Professor of Medicine at the Hospital of the University of Pennsylvania, Philadelphia (United States)

David Yankelevitz
Professor of Radiology and Director of the Lung Biopsy Service at the Icahn School of Medicine, Mount Sinai, New York City (USA)

Javier Zulueta
Senior Faculty and Chief of the Division of Medicine (Pulmonary, Critical Care and Sleep Medicine) at Mount Sinai Morningside, Professor of Medicine, Icahn School of Medicine, Mount Sinai, New York City (USA)

About iBiopsy: iBiopsy is based on the most advanced technologies in Artificial Intelligence (AI) and Data Science (DS), benefiting from Median’s expertise in medical image processing. iBiopsy targets the development of innovative AI/ML-based Software as Medical Device, to be used in several indications for which there are unmet needs regarding early diagnosis, prognosis and treatment selection in the context of precision medicine. iBiopsy currently focuses on lung cancer, liver cancer (HCC) and liver fibrosis (NASH).

On October 3, 2022 SQZ Biotechnologies Company (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported the publication of preclinical research on the SQZ Activating Antigen Carrier (AAC) platform (Press release, SQZ Biotech, OCT 3, 2022, View Source [SID1234621644]). The data, published in Frontiers in Immunology, demonstrated that the company’s Cell Squeeze platform can be used to generate AACs by engineering red blood cells (RBCs) with antigen and adjuvant that can drive antigen-specific activation of T cells both in mouse in vivo and human in vitro systems. The study also used a mouse tumor model to show that the efficacy of the AAC therapy could be further enhanced by combining with the chemotherapeutic agent, Cisplatin.

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"This paper demonstrates the potential of our technology to generate an effective red blood cell-derived cancer immunotherapy," said Howard Bernstein, M.D., Ph.D., Chief Scientific Officer at SQZ Biotechnologies. "The ability of the Cell Squeeze platform to engineer RBCs to leverage the natural process of RBC clearance for T cell activation represents a promising new therapeutic approach to cancer treatment. We look forward to building on these preclinical results in our ongoing Phase 1/2 clinical trial."

The company’s engineered RBCs are designed to transport their cargo of antigen and adjuvant to professional antigen presenting cells (APCs) in the body. The published data demonstrate that when these professional APCs process the engineered RBC, they present the desired antigen to endogenous T cells and drive their activation. This approach to generate RBC therapeutics could be tailored to deliver a variety of antigen and adjuvant materials, and other possible agents, to potentially enhance different aspects of anti-tumor immunity.

"We are excited about the preclinical findings of our AAC program, which has shown potential in both monotherapy settings and in combination with chemotherapy," said Scott Loughhead, Ph.D., VP of Translational Research at SQZ Biotechnologies. "AACs represent a truly differentiated approach that offers the opportunity for broad applicability across solid tumor types."

Study Findings:

Generation of AACs: Investigators used the Cell Squeeze technology to engineer RBCs with E6 and E7 antigens and the adjuvant, poly I:C. This process generates AACs that resemble aged RBCs which triggers rapid clearance by professional APCs.
Effective Delivery to APCs: The method leverages the natural process of RBC clearance to deliver tumor antigens to endogenous professional APCs without the use of chemical or viral vectors.
Antigen-Specific Activation of T cells: AAC uptake, antigen processing, and presentation by APCs drove antigen-specific activation of T cells in mouse in vivo and human in vitro systems. In a mouse model of HPV16+ tumors, AAC therapy demonstrated significant anti-tumor effects including 12-fold improvement in CD8+ T cell infiltration and 900-fold improvement in E7 antigen-specific CD8+ T cell infiltration compared to untreated animals.
Enhanced Efficacy with Addition of Cisplatin: The combination of AAC therapy and the chemotherapeutic agent Cisplatin, a common treatment for HPV-driven tumors, increased the efficacy of the treatment in a preclinical tumor model.
About SQZ-AAC-HPV
SQZ AACs are generated by squeezing red blood cells (RBCs) with antigens and activating adjuvant. The process is tuned to make the engineered RBCs appear aged. Once administered to patients, SQZ AACs aim to be rapidly taken up by professional antigen presenting cells through a natural process to destroy aged RBCs in the body known as eryptosis. After being taken up, the encapsulated antigen and adjuvant within SQZ AACs is released, allowing for antigen processing and maturation of professional, endogenous antigen presenting cells in the lymphoid organs, and drives subsequent activation of HPV-specific T cells. SQZ-AAC-HPV is the first product candidate from the SQZ AAC platform.

About Human Papillomavirus Positive Cancers
Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years, often leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer, HPV+ tumors account for 4.5% of all cancers worldwide resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.

On October 3, 2022 Novocure (NASDAQ: NVCR) reported that it will report financial results for the third quarter 2022 on Thursday, October 27, 2022, before the U.S. financial markets open (Press release, NovoCure, OCT 3, 2022, View Source [SID1234621643]). Novocure management will host a conference call and webcast to discuss the company’s financial results for the three and nine months ended September 30, 2022, at 8 a.m. EDT on Thursday, October 27, 2022. To access the conference call by phone, use the following registration link, and dial-in details will be provided.

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The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On October 3, 2022 Seneca Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to the development of novel immunotherapies for difficult to treat solid cancers reported it had received FDA clearance to begin a Phase I/II clinical study utilizing Seneca Valley Virus ("SVV-001") in combination with a checkpoint inhibitor (Press release, Seneca Therapeutics, OCT 3, 2022, View Source [SID1234621642]). This Phase I/II study with SVV-001 is in patients that are TEM8 positive and SVV-001 permissive with neuroendocrine tumors or neuroendocrine carcinomas. The study should begin enrollment early in 2023.

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On October 3, 2022 Kite, a Gilead Company (Nasdaq: GILD), reported the U.S. Food and Drug Administration (FDA) has approved the company’s retroviral vector (RVV) manufacturing facility in Oceanside, California, for commercial production (Press release, Kite Pharma, OCT 3, 2022, View Source [SID1234621639]). Viral vectors are key components needed to manufacture Kite’s cell therapies to treat certain blood cancers. Kite is the only cell therapy company with in-house commercial and clinical trial viral vector manufacturing capabilities, augmenting its strong external supply partners.

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CAR T-cell therapies are one-time treatments individually made starting from a patient’s own white blood cells, called T-cells. The cells are removed through a process similar to donating blood and sent to Kite’s specialized manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR). During this process, a viral vector is used to encode the CAR in the patient’s T-cells so the engineered T-cells can recognize and attack the patient’s cancer cells in certain types of blood cancers. Once an individual therapy is created for a patient, the cells are carefully preserved, packed and sent back to the hospital to be infused back into the patient. Over 10,000 patients have been treated with Kite’s CAR T-cell therapies globally through more than 300 authorized treatment centers around the world, including 117 of the leading cancer hospitals in the U.S.

"The FDA approval of our commercial viral vector manufacturing facility further strengthens our global cell therapy manufacturing network with the addition of an in-house capability to produce a crucial element in the CAR T process, which is especially important as patient demand continues to grow," said Christi Shaw, Chief Executive Officer of Kite. "This milestone is several years in the making and reflects our continued commitment to, and investment in, bringing the curative intent of cell therapy to patients."

The Oceanside site is part of Kite’s global commercial manufacturing network that includes facilities in El Segundo, California, Amsterdam, Netherlands, and a recently FDA-approved Maryland site. This forms the largest dedicated in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing. Kite has continued to increase its manufacturing network capacity to meet increasing demand, ensuring scheduling availability to meet the needs of physicians and their patients.

"The cell therapy manufacturing process is complex and requires specific materials, including viral vectors that play a critical role in ‘engineering’ a patient’s own T-cells to recognize and attack their cancer. The certainty of timely and dependable viral vector production supplied by our own facility provides an additional level of control essential for reliably delivering CAR T-cell therapy on a large commercial scale as well as providing supply for clinical trials to develop future treatments," said Chris McDonald, Global Head of Technical Operations, Kite.

The company continues to invest in its cell therapy workforce, employing approximately 100 employees at the 100,000-square-foot space. The capabilities and operations are fully scalable and will allow Kite to accommodate additional vector manufacturing as cell therapy science advances.