On July 26, 2023 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based in vivo gene editing and ex vivo allogeneic CAR T therapies, reported that it has received final meeting minutes from its recent Type B End of Phase 1 meeting with the U.S. Food and Drug Administration (FDA) for its lead investigational allogeneic CAR T therapy azercabtagene zapreleucel (azer-cel) (Press release, Precision Biosciences, JUL 26, 2023, View Source [SID1234633442]).

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"The objective of our meeting with the FDA was to gain further clarity on the potential registration path for azer‑cel including study design, endpoints and the recommended phase 2 dose for the CAR T relapsed patient setting – a patient population with dire need for better therapeutic options," said Alan List, MD, Chief Medical Officer at Precision BioSciences. "We were able to accomplish the meeting objective and are appreciative of the FDA’s clear and thoughtful advice."

The meeting with the FDA provided clarity and direction on azer-cel development, including a potential pathway toward registration. Based on the advice received from the FDA and clinical data shared during the May 2023 CAR T update, Precision is currently advancing discussions with multiple potential strategic partners for its cell therapy assets, including hematologic and non-hematologic applications.

"The ongoing collaborative discussions are intended to help us meet two key objectives: securing the right partner to build on our clinical-stage CAR T assets and allowing us to focus on core capabilities of in vivo gene editing," said Michael Amoroso, Chief Executive Officer at Precision BioSciences. "We look forward to providing additional updates on our cell therapy strategic partnering initiatives as they develop."

In Vivo R&D Day to be Held on September 12, 2023

Precision will host its in vivo gene editing R&D Day on September 12, 2023. This presentation will be focused on providing an update on ARCUS in vivo gene editing candidates and the broad potential and versatility of the platform. Additionally, this timing will allow strategic partnering discussions around the ex vivo allogeneic cell therapies to mature and enable full investor attention on our in vivo gene editing pipeline.

On July 26, 2023 Nexo Therapeutics reported to have emerged from stealth with a $60 million Series A financing led by founding investor Versant Ventures with participation from New Enterprise Associates and Cormorant Asset Management (Press release, Nexo Therapeutics, JUL 26, 2023, View Source [SID1234633441]). The company also announced a multi-year strategic research collaboration with The University of Texas MD Anderson Cancer Center, the details of which are described in a separate announcement.

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The financing supports Nexo’s platform that combines the power of covalent ligand discovery and chemical biology to unlock a pipeline of novel cancer therapies directed against previously intractable targets.

"For many cancer patients there are no therapies that target the fundamental drivers of their disease," said Andrew Phillips, Ph.D., founder and CEO of Nexo. "At Nexo, we are leveraging innovations in covalent chemistry and chemical biology to enable targeting these fundamental drivers. Our deep expertise in cancer biology and medicinal chemistry will allow us to efficiently advance therapies that provide new treatment options."

Many of the most compelling targets in oncology present significant hurdles for conventional approaches to ligand discovery, selectivity optimization and pharmacology. The reason is ligand discovery often relies on decades-old approaches, many of which struggle to find hits of sufficient quality. Even when there are identified starting points, it is hard to optimize for selectively, potency and pharmacological properties.

The Nexo platform systematically addresses each of the above issues by combining a chemistry engine with chemical biology capabilities.

The company’s chemistry engine, CODON (Covalent Discovery and Optimization), is tailored to solve challenges of ligand discovery. CODON combines a proprietary library that leverages chemical diversity and innovative covalent chemistries with scalable biochemical and in-cell proteomics. This allows the company to identify promising hit compounds and conduct rapid optimization to produce compounds for in vivo studies.

Importantly, the CODON engine uses covalent fragments against all ligandable amnio acids, thus expanding beyond conventional approaches that are constrained to cysteine and enabling discovery against targets that have been refractory to prior approaches. Coupled with the scale and breadth of the internal library and both biochemical and in-cell mass spectrometry capabilities, Nexo will be able to pursue challenging, high-value targets.

Nexo’s chemical biology capability, INFINI-T (Informed Profile Before Initiation of Target), uses the power of chimeric fusion proteins to address target biology and pharmacology questions. The function of these chimeric proteins can be controlled by small molecules in cellular and in vivo models to generate detailed information about the required depth, duration and selectivity of target inhibition. Importantly, the INFINI-T platform provides target product profiles for medicinal chemistry well in advance of lead optimization. This is expected to decrease the time and capital needed to bring drug candidates to the clinic.

"The Nexo platform is a unique combination of capabilities that can be operated at scale and that offers potential to create effective treatments for cancer and other diseases," said Carlo Rizzuto, Ph.D., managing director at Versant Ventures and a Nexo board member. "We are proud to lead this Series A financing and partner with the highly experienced Nexo team to create a pipeline of differentiated therapeutics."

"We are excited to support Nexo’s bold vision," said Ali Behbahani, M.D., general partner at NEA and a Nexo board member. "Cancer biology continues to provide promising but challenging targets that require innovative approaches, and we look forward to working with the team to translate recent discoveries into novel therapies."

On July 26, 2023 CoImmune, Inc., a clinical stage immuno-oncology company working to redefine cancer treatment using best-in-class cellular immunotherapies, reported the publication of preclinical results with Synthetic Enzyme-Armed Killer (SEAKER) cells in solid tumor melanomas in the peer-reviewed journal Cancer Immunology Research (Press release, CoImmune, JUL 26, 2023, View Source [SID1234633440]).

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The recently published paper titled, "Host Interactions with Engineered T cell Micropharmacies," describes seminal work by researchers at Memorial Sloan Kettering Cancer Center (MSK) including David A. Scheinberg, M.D., Ph.D., Chairman of the Center for Experimental Therapeutics and Deputy Director, Therapeutic Discovery, Sloan Kettering Institute (SKI), and Derek S. Tan, Ph.D., Chairman of the Chemical Biology Program, SKI. The work evaluates SEAKER cells designed to target solid-tumor melanomas in syngeneic mouse models using specific targeting with T cell receptor (TCR) engineered T cells. Results demonstrate that SEAKER cells localize specifically to tumors and activate bioactive prodrugs, providing efficacy against melanoma tumors in immunocompetent hosts.

"As we continue to advance a development program based on our proprietary chimeric antigen receptor (CAR) modified cytokine induced killer (CIK) cell platform, we are investigating technologies that could help deliver additional agents locally to tumor sites to mitigate tumor escape by loss of targeted antigens and tumor induced immunosuppression," said Charles Nicolette, Ph.D., Chief Executive Officer of CoImmune. "Our goal is to overcome the barriers to the treatment of solid tumors, and this new publication evaluating SEAKER cells in solid tumor melanoma models is another encouraging step in that direction."

CoImmune has acquired the rights to several technologies developed at MSK including SEAKER cells that combine the target-seeking power of immune cells with the ability to locally generate a potent anticancer drug at the tumor site without systemic toxicity, also referred to as a "micropharmacy."

"Genetically engineered, cytotoxic, adoptive T cells localize to antigen positive cancer cells inside patients, but tumor heterogeneity and multiple immune escape mechanisms have prevented the eradication of most solid tumors," said Dr. Scheinberg. "SEAKER cells can be designed to express a prodrug converting enzyme to achieve high active anti-tumor drug levels at tumor sites. This preclinical work demonstrates that the SEAKER platform is applicable to many adoptive cell therapies."

On July 26, 2023 GC Genome Corporation, a leading genomic diagnostics company, reported the publication of a new study in Journal of the National Cancer Institute (JNCI), shedding light on the remarkable potential of utilizing circulating tumor DNA (ctDNA) copy number aberration (CNA) for prognosis prediction and molecular profiling in cancer patients in collaboration with the team of Dr. Joohyuk Sohn, MD, professor at Severance Hospital (Press release, GC Genome, JUL 26, 2023, View Source [SID1234633439]).

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”We can gain vital insights into patient prognosis and make informed decisions regarding the most effective treatment strategies through ctDNA CNA analysis for breast cancer patients, ultimately improving patients’ outcomes," said Dr. Chang-Seok Ki, MD, CEO at GC Genome.

The study includes Low-pass whole-genome sequencing (LP-WGS)-based ctDNA data from 207 metastatic breast cancer (MBC) patients to investigate the prognostic value of ctDNA CNA burden, which was subsequently validated in 465 stage II-III triple-negative breast cancer (TNBC) patients who received neoadjuvant chemotherapy in phase III trial (NCT02441933).

High baseline ctDNA CNA burden was correlated with poor overall survival (OS) and progression-free survival (PFS) of MBC patients and poor disease-free survival was also observed independently of pathologic complete response (pCR), thereby emphasizing the robust prognostic significance of ctDNA CNA burden. PFS and OS are critical indicators of therapeutic efficacy in cancer patients.

”These results will indeed set a solid foundation in paving the way for the integrating of ctDNA CNA analysis into routine clinical practice, offering personalized and targeted treatment options,” said Dr. Eun-Hae Cho, MD, Chief Technical Officer at GC Genome. "Our dedication to further research aims to ensure that our technology can make valuable contributions to more individuals who are battling against cancer over the world.

On July 26, 2023 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the second quarter ended July 1, 2023 (Press release, Thermo Fisher Scientific, JUL 26, 2023, View Source [SID1234633436]).

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Second Quarter 2023 Highlights

•Second quarter revenue was $10.69 billion, 3% lower versus the same quarter last year. Core organic revenue growth was 2%.
•Second quarter GAAP diluted earnings per share (EPS) was $3.51.
•Second quarter adjusted EPS was $5.15.

•The macroeconomic environment was more challenging in the second quarter and our PPI Business System helped the company to effectively navigate the environment.

•Strong execution of our proven growth strategy, launching a range of high-impact, innovative new products, including the groundbreaking Thermo Scientific Orbitrap Astral mass spectrometer, a significant advancement in mass spectrometry offering high resolution and speed to enable the discovery of new proteins and advance precision medicine; the Thermo Scientific Metrios 6, a fully automated scanning transmission electron microscope incorporating advanced machine learning to accelerate semiconductor development; the Gibco OncoPro Tumoroid Culture Medium Kit, to accelerate development of novel cancer therapies; and the first FDA-cleared assays for risk assessment and clinical management of preeclampsia, a serious pregnancy complication.

•Further strengthened our industry-leading commercial engine and trusted partner status with the opening of a state-of-the-art customer center of excellence in Milan, allowing us to consolidate capabilities from across the company to better serve our customers and enhance productivity.

•Shortly after the quarter ended, announced a definitive agreement to acquire CorEvitas for approximately $0.9 billion. Highly complementary to our leading clinical research business, CorEvitas provides regulatory-grade, real-world evidence solutions to pharmaceutical and biotechnology companies with objective data and clinical insights to improve patient care and clinical outcomes.

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•Building on our environmental, social and governance priorities, we published our 2022 Corporate Social Responsibility Report, highlighting our actions in these areas and reflecting our commitment to society and our stakeholders.

"The macroeconomic environment became more challenging in the second quarter. Economic activity in China slowed, and across the economy more broadly, businesses became more cautious in their spend," said Marc Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "The team is leveraging our PPI Business System to effectively manage through this dynamic environment."

Casper added, "Our experienced management team has a long track record of successfully navigating and capitalizing on dynamic macro environments. We are incredibly well positioned to create value for all of our stakeholders and ensure a bright future for our company."

Second Quarter 2023

Revenue for the quarter declined 3% to $10.69 billion in 2023, versus $10.97 billion in 2022. Organic revenue was 3% lower, Core organic revenue growth was 2%, and COVID-19 testing revenue was $0.08 billion.

GAAP Earnings Results

GAAP diluted EPS in the second quarter of 2023 was $3.51, versus $4.22 in the same quarter last year. GAAP operating income for the second quarter of 2023 was $1.58 billion, compared with $2.00 billion in the year-ago quarter. GAAP operating margin was 14.8%, compared with 18.2% in the second quarter of 2022.

Non-GAAP Earnings Results

Adjusted EPS in the second quarter of 2023 was $5.15, versus $5.51 in the second quarter of 2022. Adjusted operating income for the second quarter of 2023 was $2.37 billion, compared with $2.61 billion in the year-ago quarter. Adjusted operating margin was 22.2%, compared with 23.7% in the second quarter of 2022.

Annual Guidance for 2023

Given the macroeconomic environment, Thermo Fisher is revising revenue and adjusted EPS guidance for the full year. The company now expects 2023 revenue to be a range of $43.4 to $44.0 billion, with Core organic revenue growth of 2 to 4%, and adjusted EPS of $22.28 to $22.72.

Use of Non-GAAP Financial Measures

Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.