On December 16, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the launch of NeXT Personal, a next-generation, tumor-informed liquid biopsy assay designed to detect and quantify molecular residual disease (MRD) and recurrence in patients previously diagnosed with cancer (Press release, Personalis, DEC 16, 2021, View Source [SID1234597332]). NeXT Personal delivers industry-leading MRD sensitivity down to the 1 part-per-million range, an approximately 10- to 100-fold improvement over other available technologies. This enables earlier detection across a broader variety of cancers and stages, including typically challenging early stage, low mutational burden, and low-shedding cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

NeXT Personal leverages whole genome sequencing of a patient’s tumor to identify up to 1,800 specially-selected somatic variants that are subsequently used to create a personalized liquid biopsy panel for each patient. The targeted panel is then used to sequence millions of unique DNA molecules from a patient’s blood sample. Aggregation of signal across these sequences using proprietary algorithms enables part-per-million sensitivity. Personalis’ innovative methods are covered by its broad range of early and subsequent intellectual property filings.

Going beyond other tumor-informed MRD assays, NeXT Personal also simultaneously detects and quantifies clinically relevant mutations in circulating tumor DNA (ctDNA) that may be used in the future to help guide therapy, when cancer is detected. These include known targetable cancer mutations, drug resistance mutations, and new variants which can emerge and change over time, especially under therapeutic pressure.

"With this launch, Personalis is extending what an MRD product can deliver," said John West, Personalis’ Chief Executive Officer. "With its dramatic increase in sensitivity, we expect to address a range of tumors which were out of reach with earlier technologies. With its broader information content, we also go beyond detection of a tumor, to provide the additional characterization needed to understand and eventually help manage disease."

"NeXT Personal addresses the need for higher sensitivity assays, opening the door for earlier detection and more sensitive monitoring of patient response to therapy across a broader range of cancers and stages. Today’s release is targeted towards biopharma partners and clinical collaborators. In 2022, we plan to release NeXT Personal as a clinical test, which we expect will yield opportunities for earlier intervention and treatment for cancer patients," said Dr. Richard Chen, Personalis’ Chief Medical Officer and SVP of R&D.

On December 16, 2021 Perimeter Medical Imaging AI, Inc. (TSX-V:PINK)(OTC:PYNKF) (FSE:4PC) ("Perimeter" or the "Company"), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, reported the initiation of a multi-center, randomized, two-arm pivotal clinical trial to evaluate its Perimeter B-Series OCT with ImgAssist AI for use during breast conservation surgery (Press release, Perimeter Medical Imaging AI, DEC 16, 2021, View Source [SID1234597331]). The first patient procedures were performed by Richard E. Fine, MD and Michael Berry, MD, leading breast surgeons based out of the Margaret West Comprehensive Breast Center in Germantown, Tennessee.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Richard E. Fine, Director of Education & Research, Margaret West Comprehensive Breast Center, West Cancer Center & Research Institute, stated, "We are excited to be the first site to enroll a patient in the Perimeter pivotal trial that is evaluating the use of Perimeter B-Series OCT imaging technology combined with artificial intelligence. There is a strong unmet medical need to provide breast cancer surgeons with specimen imaging tools to aid their decisions ‘real time’ in the operating room. Through this pivotal study, we can assess if the Perimeter B-Series with artificial intelligence demonstrates an improvement over the current standard of care – potentially setting a new standard for specimen imaging technology during breast conservation surgery."

Dr. Michael Berry, Director of Margaret West Comprehensive Breast Center, commented, "Approximately 15% to 20% of women who undergo breast conservation surgery require reoperation if their surgeon fails to get clear margins. By combining optical coherence tomography with deep learning algorithms, this innovative technology could assist us, as surgeons, to better identify regions of interest on scanned samples, enabling ‘real-time’ decisions on margin status in the OR."

Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, "The initiation of this pivotal trial marks another milestone in our ATLAS AI project and an important step in the clinical development of our breakthrough-device-designated Perimeter B-Series OCT with AI assisted software, which represents the next generation of our commercially available flagship Perimeter S-Series OCT. Our hope is that clinical data generated from this study will provide supporting evidence that our technology can help breast cancer physicians improve outcomes for patients and potentially reduce the burden of additional costs within the healthcare system. We expect that this study will be completed by the end of 2022."

On December 16, 2021 Neogene Therapeutics, Inc., a preclinical stage biotechnology company pioneering a new class of fully individualized T cell receptor (TCR) therapies to treat cancer, reported the appointment of Raphaël Rousseau, M.D., Ph.D. as Chief Medical Officer (Press release, Neogene Therapeutics, DEC 16, 2021, View Source [SID1234597330]). Dr. Rousseau brings more than 20 years of extensive experience in oncology drug development, including engineered T cell therapies, in both academia and the biotechnology industry. He joins Neogene’s executive team and will be based in its U.S. headquarters in Santa Monica.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We’re thrilled to welcome Raphaël at this crucial and exciting time in our company’s growth. He is a strong leader, who has led teams across all phases of development and has successfully built and executed multiple global clinical programs," said Carsten Linnemann, Ph.D., President, Chief Executive Officer and co-founder of Neogene. "Raphael’s broad experience with cell therapy and neo-antigen targeting drug modalities will be critical in helping us to diversify our pipeline and advance our programs into the clinic with the goal of bringing T cell therapies to patients across a broad spectrum of solid tumors."

Dr. Rousseau most recently served as Executive Vice President, Head of Product Development, and Chief Medical Officer at Gritstone bio, where he was responsible for the company’s global clinical development strategies and expansion of its neoantigen-based immunotherapies. He led the buildout of the clinical development organization and execution of Gritstone’s clinical strategy including conducting several phase 1 and phase 2 clinical trials. Prior to Gritstone bio, Dr. Rousseau served as the Global Franchise Head of Pediatrics at Genentech and Roche, where he successfully led a global development and study management team and served as the Chair of the Development Review Committee for early and late-stage pediatric asset reviews. While at Genentech, he oversaw the clinical development of the company’s oncology portfolio from first-in-human to registrational trials for several pediatric hematology and oncology indications. Prior to joining industry, Dr. Rousseau was a Professor of Medical and Pediatric Oncology at the Université Claude Bernard in Lyon, France, and the head of the pediatric translational research program at Léon Bérard Cancer Center. There, he created and led the first European academic consortium for the conduct of a phase 1 study using CD19-targeting CAR T cells for the treatment of pediatric high-risk leukemias. Earlier in his career, Dr. Rousseau was a fellow at Baylor College of Medicine in Houston, where he worked with Dr. Malcolm Brenner at the Center for Cell and Gene Therapy. Dr. Rousseau received a Ph.D. in Therapeutic Biotechnologies from the Université Denis Diderot and an M.D. from the Université René Descartes in Paris. He is board certified in pediatrics and has a sub-specialty certification in pediatric hematology-oncology.

"I’m proud to be joining the Neogene team, which has been making great strides in the field of neoantigen-directed T cell therapy, and excited about helping advance our pioneering research into the clinic to potentially help patients who currently have limited treatment options," said Dr. Rousseau. "This is a field that I am extremely passionate about, and I am excited to apply my expertise in successfully advancing these promising therapies into clinical trials as we work to change the solid cancer treatment paradigm."

On December 16, 2021 Vifor Pharma Group reported the divestment of its finished drug product manufacturing business to CordenPharma, a full-service Contract Development & Manufacturing Organization (CDMO) of APIs, Excipients, Drug Products, and associated Packaging services (Press release, Vifor Pharma, DEC 16, 2021, View Source [SID1234597323]). This decision reinforces Vifor Pharma’s strategy to transform the company into a multi-brand commercial organization, focusing on its core capabilities in-licensing, partnering and commercializing products in nephrology, and to further grow and maximize opportunities of its iron portfolio.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In support of our ambitious growth strategy, optimizing our manufacturing footprint will enable us to build an even stronger, more efficient organization focusing on core capabilities in nephrology, and to maximize and leverage our market-leading expertise and intellectual property in iron deficiency," commented Abbas Hussain, CEO of Vifor Pharma. "With CordenPharma, we have found the best suitable solution for our manufacturing employees and the drug production activities in Fribourg, Ettingen and Lisbon. With this agreement, Vifor Pharma is well positioned to continuously drive the company sustainably and profitably over the long term, for all our stakeholders."

Dr. Michael Quirmbach, Chief Executive Officer & President of CordenPharma said: "The acquired Vifor Pharma sites have competent teams with great cultural fit, state-of-the art infrastructure, and a strong compliance track record. This excellent opportunity aligns well with our strategy to broaden our CDMO capabilities. By incorporating these three Vifor Pharma manufacturing facilities into our global network, we look forward to not only supplying Vifor Pharma as a manufacturing partner, but also closing gaps in our service offering for oral solid dosage drug product manufacturing and increasing our overall capacity. In addition, this acquisition further strengthens our fully-integrated solutions to our customers."

Under the terms of the signed share purchase agreement, CordenPharma acquires all shares in Vifor SA, Fribourg (including its Ettingen branch), and OM Pharma SA, Lisbon, thus taking over Vifor Pharma’s finished drug product manufacturing operations at the three sites. The divestment will trigger an asset impairment, to be reported with Vifor Pharma’s 2021 financial results. The companies have agreed not to disclose financial terms of the agreement.

CordenPharma will integrate the new facilities into its existing CDMO network of Current Good Manufacturing Practice (cGMP) and R&D plants across Europe & the US, and organize the operations of the Fribourg, Ettingen and Lisbon sites under its Small Molecule Platform. It plans to utilize the existing manufacturing workforce, while continuing to produce and supply Vifor Pharma products. Vifor Pharma’s Swiss and Portuguese country commercial organizations, located in Fribourg and Lisbon, will remain with Vifor Pharma Group. Vifor Pharma and CordenPharma will jointly ensure long-term continuity of supply for customers and patients who depend on them.

This divestment, including all financial implications, has been disclosed to CSL Limited in the course of the due diligence process preceding the publication of the pre-announcement of the public tender offer by CSL Limited on 14 December and in so far has no impact on such tender offer.

Vifor Pharma and CordenPharma anticipate closing the transaction in Q1 2022, contingent on customary closing conditions.

On December 16, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that the company has been added to the NASDAQ Biotechnology Index (NASDAQ: NBI) (Press release, Mustang Bio, DEC 16, 2021, View Source [SID1234597317]). The annual re-ranking of the NASDAQ Biotechnology Index will become effective prior to market open on Monday, December 20, 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The NASDAQ Biotechnology Index (NBI) is a modified market-cap weighted index designed to track the performance of a set of securities listed on the NASDAQ Stock Market (NASDAQ) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The NBI is re-ranked each year and is calculated under a modified capitalization-weighted methodology. Companies in the NBI must meet eligibility requirements, including minimum market capitalization, average daily trading volume and seasoning as a public company, among other criteria. Additionally, the NBI forms the basis for a number of Exchange Traded Funds (ETFs), including the iShares NASDAQ Biotechnology ETF (Nasdaq: IBB). More information about the NBI can be found at View Source