On September 14, 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 gaseous NO (gNO) for the treatment of solid tumors, reported that Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, is scheduled to present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit being held virtually from September 20th to 23rd (Press release, Beyond Air, SEP 14, 2021, View Source [SID1234587703]).

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Presentation Details:

Date and Time: Wednesday, September 22, 2021 at 9:05 AM – 9:45 AM ET
Webcast: View Source
Participation: Management will participate in additional 1-on-1 meetings virtually
Please contact your representative at Oppenheimer to schedule a virtual one-on-one meeting with Beyond Air during the conference.

On September 14, 2021 Pyxis Oncology ("Pyxis" or the "Company") reported the appointment of Jay M. Feingold, M.D., Ph.D., as Chief Medical Officer (Press release, Pyxis Oncology, SEP 14, 2021, View Source [SID1234590283]).

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"Jay’s track record of success taking oncology ADC programs from discovery to commercial launch coupled with his deep understanding of clinical development perfectly align with our mission to improve the lives of patients with difficult-to-treat cancer," said Lara Sullivan, M.D., Chief Executive Officer of Pyxis. "We look forward to working closely with Jay to build and execute our development strategies to advance our portfolio of next generation ADC and immunotherapy programs to the clinic."

Dr. Feingold added, "I am excited to lead the clinical development activities for Pyxis’ robust portfolio which presents a significant opportunity to meaningfully impact the lives of patients with cancer. I am eager to work alongside the team to build on the Company’s impressive preclinical data, further strengthen the clinical strategy and shepherd its candidates towards the next stage of development to significantly improve the treatment landscape for patients with cancer."

Dr. Feingold holds 20 years of experience in clinical development and medical affairs with a history of successfully bringing new hematology and oncology drugs to market. Most recently, Dr. Feingold served as Chief Medical Officer and Senior Vice President of ADC Therapeutics, where he led the clinical development of six ADCs for hematologic malignancies and solid tumors. Previously, Dr. Feingold worked as Vice President of U.S. Medical Affairs and Chairman of the Global Medical Affairs Oversight Committee at Daiichi Sankyo. Earlier in his career, Dr. Feingold held various executive roles of increasing responsibility at Wyeth Pharmaceuticals and was a member of the Departments of Medicine and Pediatrics and an Associate Director of the Bone Marrow Transplant Program at the University of Connecticut. Dr. Feingold earned his M.D. and Ph.D. from the Albert Einstein College of Medicine and trained in Pediatrics and Pediatric Hematology and Oncology at the UCLA Center for the Health Sciences.

On September 14, 2021 Emergent BioSolutions Inc. (NYSE:EBS) and Providence Therapeutics reported they have entered into a five-year contract development and manufacturing (CDMO) services agreement spanning Emergent’s integrated capabilities, including development services, bulk drug substance formulation and drug product manufacturing, to support Providence’s COVID-19 messenger RNA (mRNA) vaccine development (Press release, Emergent BioSolutions, SEP 14, 2021, View Source [SID1234587669]). In 2022, Emergent will manufacture tens of millions of doses of PTX-COVID19-B drug product, as well as batches of PTX-COVID19-B formulated bulk drug substance with the potential to yield hundreds of millions more doses, for global populations in need of pandemic relief.

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Under the terms of the five-year agreement, Emergent will provide current Good Manufacturing Practice (cGMP) manufacturing services for two presentations of the PTX-COVID19-B vaccine product, both the formulated bulk drug substance and finished drug product (fill/finish), at Emergent’s facility in Winnipeg, MB, Canada. Additional process and analytical development services will occur from Emergent’s Center of Excellence for Development Services in Gaithersburg, Maryland. The baseline agreement signed between Emergent and Providence Therapeutics is valued at approximately $90 million, covering manufacturing services, studies to support global supply chain activities, as well as facility and equipment investments.

"Emergent’s commitment to fight the COVID-19 pandemic is anchored in our partnerships with innovators who share the same mission to address public health threats around the world," said Adam R. Havey, executive vice president and chief operating officer at Emergent BioSolutions. "This collaboration is a testament to Emergent’s long heritage and experience in Canada. We are proud that Providence has chosen our Winnipeg team and site to manufacture its Canadian mRNA technology in Western Canada, one of the few facilities in the country manufacturing large quantities of mRNA COVID-19 vaccine doses today."

As commented by Brad Sorenson, Providence CEO, "Providence is very pleased to have the resources necessary to ramp up commercial manufacturing of its COVID vaccine here in Canada. We look forward to working side-by-side with Emergent to deliver tens of millions, and potentially hundreds of millions of doses of our world-class vaccine to developing countries across the globe. It has always been Providence’s mission to produce the highest quality medicines at affordable prices, and with Emergent’s help we are closer to achieving this goal."

To date, Emergent has partnered with numerous pharmaceutical and biotech innovators, as well as the U.S. government and non-government organizations in providing critical contract manufacturing services (drug substance manufacturing, drug product manufacturing and development services) in response to the COVID-19 pandemic.

On September 14, 2021 TumorGen Inc., a biotechnology company, and PhenoVista Biosciences LLC, a specialized contract research organization, reported that they are partnering to characterize metastatic cancer cell clusters (MCCCs) (Press release, TumorGen, SEP 14, 2021, View Source [SID1234587686]). By revealing the traits that govern MCCCs, they hope to identify potential therapeutic targets and catalyze efforts to develop much-needed anti-metastatic drugs.

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"The analytical imaging power PhenoVista can bring to our MCCC capture technology is essential," said TumorGen Founder, President and CEO, Jeffrey K. Allen, Ph.D. "Working directly with PhenoVista will help leverage our MCCC capture capabilities to identify unseen drug targets. With this data, TumorGen will be well-positioned to begin commercialization efforts and establish partnerships with biopharmaceutical companies focused on emerging anti-metastatic therapeutics."

TumorGen will use its microfluidic platform to capture MCCCs from patient blood. PhenoVista will apply its specialized cell analysis technologies to illuminate how these clusters hold together and avoid the body’s immune response. Revealing these inter-cellular signals will change how we understand metastasis, leading to new therapies.

"Characterizing MCCCs with our high-content imaging technology could reveal the critical inter-cellular communication within the cluster that makes it so deadly," said James Evans, Ph.D., PhenoVista Biosciences CEO. "Illuminating the complex interactions between cancer cells and immune cells, such as macrophages, and neutrophils, will reveal how MCCCs evade immune surveillance and form new tumors."

Metastasis (the spread of malignant cells throughout the body) causes over 90% of cancer deaths. Scientists have known MCCCs drive this spread but have lacked easy methods to investigate these critically important cell clusters. Also significant is that MCCCs contain both cancer and immune cells, thus providing the opportunity to develop cutting-edge therapies based on immuno-oncology which can inhibit metastasis.

"Understanding MCCC cell status, including whether immune cells are tumor suppressive or tumor supportive, is critically important," said Darren Finlay, Ph.D., Director of Tumor Analysis at Sanford Burnham Prebys Medical Discovery Institute, an NCI-Designated Cancer Center. Finlay is co-investigator on TumorGen’s recent SBIR grant from the National Cancer Institute. "These findings could provide huge insights to leverage the immune system to develop first-in-class, anti-metastatic drugs."

On September 14, 2021 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy-based therapies, reported that the company’s Focal One and ExactVu technologies were featured in several poster presentations at the American Urological Association (AUA) 2021 Annual Meeting, which was held virtually from September 10-13 (Press release, EDAP TMS, SEP 14, 2021, View Source [SID1234587704]). EDAP was a Gold sponsor of the event.

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Details of two noteworthy presentations are as follows:

Title: Focal Ablation Versus Radical Prostatectomy for Intermediate-Risk Prostate Cancer: Interim Analysis of a Randomized Controlled Trial

Lead author: Eduard Baco, MD, Oslo University Hospital, Norway

Summary: This is the first randomized controlled clinical trial comparing focal therapy with robotic surgery. The data suggest that at one-year post treatment, Focal One achieved good oncological efficacy while preserving erectile function and urinary continence better than radical prostatectomy.

Title: High-Intensity Focused Ultrasound (HIFU) vs Radical Prostatectomy (RP) in the Curative Treatment of ISUP 1-2 Localized Prostate Cancer: Oncological Intermediate Results of the HIFI Study

Lead author: Pascal Rischmann, MD, Toulouse University Hospital, France

Summary: In this prospective comparative study sponsored by the French Association of Urology and financed by the French Ministry of Health, 3364 patients (HIFU: 1988, radical prostatectomy: 1376) were prospectively included across 42 French treatment centers. The intermediate results presented show a salvage-treatment-free survival rate significantly higher in the HIFU arm (97.5%) compared to the radical prostatectomy arm (90.3%).

"The data from these studies presented at this year’s AUA Annual Meeting once again strongly support high intensity focused ultrasound as an alternative to far more invasive radical prostatectomy," stated Marc Oczachowski, Chairman & Chief Executive Officer of EDAP. "In terms of both efficacy and long-term survival, Focal One offers patients a superior treatment option without the debilitating side effects associated with surgery. Data such as these, together with the growing roster of healthcare institutions in the US and elsewhere who champion our technology and the progress we are making securing reimbursement, are key to our long-term growth and we are pleased to add to the expanding body of evidence at this prestigious urology conference showing the many benefits of HIFU."