On August 22, 2022 Pillar Biosciences, the leader in Decision Medicine, developers and distributors of next-generation sequencing (NGS) tests which localize testing and reduce time to treatment initiation and overall testing costs, reported that its oncoRevealTM Dx Colon Cancer Assay has received approval from the China National Medical Products Administration (NMPA) (Press release, Pillar Biosciences, AUG 22, 2022, View Source [SID1234618553]). The IVD assay is now commercially available in China, the U.S., and Europe as a companion diagnostic (CDx) to identify patients with colorectal cancer whose tumors express wild-type KRAS status and may benefit from treatment with specific targeted therapies.

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"The oncoReveal Dx Colon Cancer Assay localizes NGS testing and efficiently provides a highly accurate genetic profile of KRAS mutations in metastatic colorectal cancer patients," said Randy Pritchard, Chief Executive Officer of Pillar Biosciences. "This approval is important for oncologists across China who need a more streamlined, efficient and accurate means of identifying the right therapy for their individual patients. By making testing more widely available, and enabling faster results, we can significantly reduce the amount of time it takes to initiate treatment and enable patients to more confidently continue along their life journey."

The oncoReveal Dx Colon Cancer Assay is a companion diagnostic test that identifies patients with metastatic colorectal cancer who have KRAS wild-type tumor status and may benefit from treatment with approved therapies, Erbitux (cetuximab) or Vectibix (panitumumab). The assay utilizes Pillar’s highly accurate and sensitive SLIMamp NGS testing technology to generate data that optimizes selection of precision therapies for cancer patients. This is the Company’s first NMPA approved diagnostic product. Pillar’s oncoReveal Dx Lung & Colon Cancer Assay previously received CE-IVD certification in Europe in April 2020 and U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) in July 2021.

On August 22, 2022 Bruker reported a new 8 mm 15N TROSY Cryoprobe for enabling novel NMR functional structural biology investigations into larger globular proteins and protein complexes (Press release, Bruker, AUG 22, 2022, View Source [SID1234618552]). The new technology also facilitates cell biology research into highly dynamic intrinsically disordered proteins (IDPs) or protein regions that often play key roles in signaling pathways via phosphorylation, e.g. in cancer. The new 8 mm 15N TROSY Cryoprobe provides twice the sensitivity of previous 5 mm detection, and 50% greater 13C sensitivity at 800 MHz. It allows researchers to obtain essential information in crowded IDP spectral regions for the unambiguous assignment of IDP backbone resonances.

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Dr. Haribabu (‘Hari’) Arthanari, Associate Professor in the Department of Biological Chemistry and Molecular Pharmacology at Harvard Medical School, and in the Department of Cancer Biology at the Dana-Farber Cancer Institute, stated: "We can now greatly expand the scientific scope of functional structural biology by high-field NMR with 15N-detected experiments to study non-deuterated protein systems, like disordered proteins or globular proteins, which can now be made in flexible eukaryotic expression systems. The new 8mm 15N TXO Cryoprobe holds promise to unleash the power of 15N-detection at high fields. I am very excited to see which previously inaccessible but important scientific and pathobiology questions this innovative NMR technology can address."

Bruker also announces the technology introduction of a novel 160 kHz Ultra-fast spinning Magic Angle Spinning (MAS) NMR probe for advancements in solid-state membrane protein, prion, and aggregates research. This new probe, which mechanically spins 160,000 times per second, provides a further significant resolution increase, and can record solids HCN NMR spectra in just tens of minutes. The significantly increased new capabilities of this 160 kHz 0.4mm MAS probe at high NMR fields may enable novel insights and discoveries in neurodegenerative diseases, like Parkinson’s and Alzheimer’s, and in other cell and disease biology fields.

Dr. Guido Pintacuda, CNRS Research Director and Director of the Lyon High-field NMR Center explained: "The new Bruker 160 kHz MAS HCN probe will push structural, cellular and disease biology research into the next phase of the solid-state NMR scientific evolution. Not only will this expand the diversity and molecular size range of biological systems such as membrane proteins, amyloid fibrils, prions, and aggregates amenable for analysis by solid-state NMR, but it will accelerate their investigation and increase the amount of information that can be extracted from these important biological systems."

Bruker is also very pleased to announce the installation and acceptance of the 1.2 GHz Avance NMR at University of Lille in France, which will be a part of the national infrastructure INFRANALYTICS. This first 1.2 GHz NMR in France will allow researchers in Lille, and from all over France, to advance their understanding of functional structural biology and advanced materials.

Professor Jean-Pierre Simorre, Research Director, and Deputy Director INC at CNRS, commented: "We are thrilled to have received our 1.2 GHz NMR system. The power and resolution of 1.2 GHz will provide the unique ability to study proteins in their natural state and examine their structural details, including binding and dynamics of molecular structures and complexes, for our fundamental cell biology and pathobiology research."

Professor Olivier Lafon at the University of Lille, and Director of Lille High-Field NMR Facility, expanded: "The 1.2 GHz NMR spectrometer will strongly improve the sensitivity and resolution for quadrupolar isotopes, such as 14N, 17O, 25Mg, 33S, 63Cu, and 67Zn, in materials and solid-state biomolecules. This will notably open new avenues for the study of dynamics, hydrogen bonds, disulfide bonds and metal centers of many metalloproteins, nucleic acids and carbohydrates."

Moreover, as announced at Euromar 2022, Bruker has received three orders for compact 1.0 GHz NMR systems from the RIKEN Center for Biosystems Dynamics Research in Yokohama, Japan, the Precision Medicine and Metabolism Lab at CIC bioGUNE, and the BioNMR Group at Universitat de Barcelona, both in Spain. The Ascend Evo 1.0 GHz NMR magnet utilizes hybrid high temperature superconductor (HTS) technology for operation at 4.2 Kelvin in single-story labs. The significantly reduced footprint, weight, and ceiling height, along with a 65% reduction in helium consumption, provides more structural biology principal investigators, universities, and research centers, as well as biopharma companies access to the sensitivity and resolution of GHz NMR. The 1.0 GHz system complements Bruker’s well-established Avance Neo 1.1 GHz and 1.2 GHz two-story 2 Kelvin NMR systems.

Bruker now offers combined bioTop and DynamicsCenter software to simplify and automate experimental setup, measurements, and processing for protein dynamics analysis. DynamicsCenter combines NMR assignments with 3D protein structures imported from crystallography or cryo-EM.

On August 22, 2022 PanTher Therapeutics ("PanTher" or the "Company"), a clinical-stage oncology company developing next-generation targeted therapies for solid tumors, reported that received a $14.2 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) (Press release, PanTher Therapeutics, AUG 22, 2022, View Source [SID1234618551]). The funding will be used to expand clinical development through Phase 2 of PanTher’s lead investigational therapy, PTM-101, a minimally invasive, implantable treatment for non-metastatic pancreatic cancer that provides direct, sustained release of a known therapeutic agent at the tumor site.

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"Being selected for this highly competitive grant after thorough scientific, medical, regulatory and commercial due diligence, validates the clinical progress achieved so far as well as our mission. This award emphasizes the potential of PTM-101 to significantly benefit individuals with pancreatic cancer, while underscoring the urgent need for safe and effective options for hard-to-treat solid tumors," said Laura Indolfi, PhD, Chief Executive Officer and co-founder of PanTher Therapeutics.

PTM-101 is the first product to emerge from the company’s proprietary Sagittari platform, and it is currently being tested as a first-line treatment in a Phase 1 trial for locally advanced pancreatic cancer.

The Sagittari️ platform leverages interventional oncology procedures to design superior localized cancer treatments with adaptability to multiple solid tumor indications. The enabled customizable products are engineered for precisely transporting proven and novel therapeutic agents on target to attack cancer at the source.

"We are extremely grateful for the support from CPRIT and excited to build deeper collaborations with the local oncology and entrepreneurial communities with the establishment of our operations in Texas," continued Indolfi. "The funding will not only bring PTM-101 through the next phase of clinical development but will also allow us to accelerate the advancement of our novel Sagittari platform technology by expending internal resources to broaden our pipeline."

PanTher was one of nine companies working in the oncology space that received product development funding from CPRIT, with the grants totaling $64 million. The CPRIT also awarded nine prevention grants focused on increasing cancer-prevention and three recruitment grants aimed at enhancing cancer research efforts across Texas.

On August 22, 2022 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported financial results for the second quarter ended June 30, 2022, and provided a corporate update (Press release, MAIA Biotechnology, AUG 22, 2022, View Source [SID1234618550]).

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"We continue to make significant progress with advancing the clinical development of THIO. We recently dosed the first patient in our Phase 2 clinical trial for NSCLC, THIO-101, for Non-Small Cell Lung Cancer. We have received orphan drug designation from the FDA for two other oncology indications – SCLC and HCC," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer.

"We are thrilled to have recently strengthened our balance sheet with the completion of our July IPO and continue to maintain no long-term debt," stated Joe McGuire, MAIA’s Chief Financial Officer.

Corporate Highlights

FDA Orphan Drug Designation for THIO for SCLC: The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to THIO, a telomere-targeting agent currently in development to evaluate its activity in NSCLC cancer indications, for the treatment of small-cell lung cancer (SCLC).

First patient dosed in Phase 2 trial in NSCLC: The first patient has been dosed in MAIA’s Phase 2 clinical trial, THIO-101, evaluating the administration of THIO in sequence with cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC). The trial designed to evaluate THIO’s anticancer activity and potential immune system activation effects in NSCLC patients by administering THIO in advance of the checkpoint inhibitor cemiplimab (developed by Regeneron), allowing for patient immune system activation and PD-1 sensitivity to take effect.

Research collaboration with Nationwide Children’s Hospital: MAIA has entered into a research and collaboration agreement with the Nationwide Children’s Hospital to evaluate the potential of THIO in combination with current standard-of-care therapies for brain cancer. The organizations will conduct preclinical studies to assess the efficacy and safety of THIO in combination with radiotherapy and immune checkpoint inhibitors in vitro and in vivo models.

FDA Orphan Drug Designation for THIO for HCC: The FDA has granted ODD to THIO for the treatment of hepatocellular carcinoma (HCC).

Wholly owned subsidiaries established to support global development of THIO: MAIA established two wholly owned subsidiaries in Romania and Australia to broaden and accelerate its global development plan for THIO.

Initial public offering (IPO): MAIA completed its IPO on August 1st and has commenced trading on the NYSE American under the ticker symbol "MAIA." The gross proceeds from the initial public offering and the exercise of the overallotment option were $11.5 million prior to deducting underwriting discounts, commissions, and other offering expenses.

Second Quarter 2022 Financial Results

Cash Position: The Company had cash totaling $8.2 million as of June 30, 2022, compared to $10.6 million in cash as of December 31, 2021. Current cash with proceeds from the initial public offering is anticipated to be sufficient to fund operations for the next 24 months.

Research and Development (R&D) Expenses: R&D expenses were approximately $2.1 million for the quarter ended June 30, 2022, compared to approximately $0.6 million for the same quarter of 2021. The increase for the quarter was primarily due to the increase in clinical expenses related to clinical preparation and the startup of the THIO trials of approximately $1.0 million, an increase in payroll and bonus expenses of approximately $0.6 million, offset by a decrease in stock-based compensation of approximately $0.1 million. R&D expenses included approximately $0.2 million and $0.3 million of non-cash stock compensation expense in the second quarter 2022 and 2021, respectively.

General and Administrative (G&A) Expenses: G&A expenses were approximately $1.3 million for the quarter ended June 30, 2022, compared to approximately $0.9 million for the same quarter of 2021. The increase for the quarter was primarily due to approximate increases in payroll and bonus expenses of $0.2 million, professional fees of $0.2 million, and other general fees of $0.1 million, offset by a decrease in stock-based compensation of approximately $0.1 million. G&A expenses included approximately $0.4 million and $0.4 million of non-cash stock compensation expense in the quarters ended June 30, 2022, and 2021, respectively.

Other Income (Expense): Other income was approximately $0.1 million for the quarter ended June 30, 2022, and other expense for the quarter ended June 30, 2021, was approximately $2.0 million. Other income in the quarter ended June 30, 2022, consisted primarily of approximately $0.1 million in Australian research and development incentives. Other expense for the quarter ended June 30, 2021, primarily consisted of interest expense of approximately $0.3 million, the change in the fair values of the warrant liability of approximately $1.6 million, and the change in the fair value of the bifurcated embedded features of approximately $0.1 million.

Net Income (Loss): Net loss was approximately $3.3 million for the quarter ended June 30, 2022, as compared to net loss of approximately $3.5 million for the same quarter of 2021.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On August 22, 2022 Prana Thoracic, Inc., reported that Nucore Medical, Inc., the company’s wholly owned subsidiary has been awarded a $3M grant from the Cancer Prevention and Research Institute of Texas ("CPRIT"). Prana Thoracic is a medical device company developing the first minimally invasive lung tissue excision tool for early interception of lung cancer (Press release, Prana Thoracic, AUG 22, 2022, View Source [SID1234618549]). The CPRIT award will help fund the commercialization of Prana Thoracic’s technology through first-in-human studies.

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"We’re excited to be recognized by CPRIT and believe this award speaks to the potential of Prana Thoracic’s surgical oncology devices. This funding will accelerate our technology to the bedside, enabling us to provide Texans and patients all over the world with a definitive diagnosis of their pulmonary nodules earlier in their patient journey," said Joanna Nathan, CEO and founder of Prana Thoracic.

Lung cancer is the leading cause of cancer death in the U.S., making up almost 25% of all cancer deaths. Most lung cancers are diagnosed late, after the disease has spread, making survival limited. While over 14 million patients in the U.S. each year are eligible for lung cancer screening, less than 5% of these patients are currently undergoing the procedure. With Prana Thoracic’s technology – which is minimally invasive and tissue-sparing – physicians can target nodules that are challenging to sample, leading to definitive diagnosis, and dramatically improving outcomes.

"There has long been a gap between a simple needle biopsy of a nodule deep in the lung and opening the chest to remove a large segment of the lung to help diagnose early lung cancer, particularly when the nodules are very small," Dr. Edward Boyle, MD, founder and one of the inventors of the technology. "As inventors, we partnered with the Johnson & Johnson MedTech Center for Device Innovation to help take this through design and early testing. At this point we are eager to advance the technology through first-in-human studies."