On May 16, 2022 Proteros biostructures GmbH ("Proteros"), an expert in integrated structure-based drug discovery, reported an expansion of its collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) focused on the discovery and development of novel epigenetic drugs (Press release, AstraZeneca, MAY 16, 2022, View Source [SID1234614614]). The new multi-year agreement builds on an ongoing collaboration with AstraZeneca announced in June 2021, to include the development of small molecule inhibitors targeting a second cancer-associated epigenetic protein.

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Under the terms of this new agreement, Proteros will receive research funding and will be eligible for success-based research, development, and commercial milestone payments of up to USD 75 million plus tiered royalties on annual net sales. The collaboration combines Proteros’ expertise in the identification and characterization of inhibitors with novel binding mechanisms for technically challenging drug targets with AstraZeneca’s leadership in the discovery and development of oncology medicines.

"The expansion of our agreement with AstraZeneca with an additional drug discovery program reflects our successful ongoing collaboration to identify selective inhibitors for notoriously challenging disease targets," said Dr. Torsten Neuefeind, CEO of Proteros. "This agreement strengthens our collaboration with a global biopharmaceutical leader and we look forward to joining forces again to discover novel inhibitors with the potential to effectively treat cancer patients in the future."

The Proteros platform will ensure high selectivity to a specific target variant within and across multiple protein families through biochemical, biophysical and cellular assays supported by rapid turnaround in the structural determination of drug-target interactions by X-ray crystallography and cryo-Electron Microscopy technologies.

On May 16, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported financial results for the first quarter ended March 31, 2022 and highlighted recent developments (Press release, Inhibikase Therapeutics, MAY 16, 2022, View Source [SID1234614646]).

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"As we kicked off 2022, we have worked diligently to advance our clinical and preclinical programs as well as extend our thought leadership in Parkinson’s disease. This past month we brought together leading key opinion leaders in the field of movement disorders to host an educational event highlighting the current unmet need, competitive and regulatory landscape in Parkinson’s disease as well as delineated our development strategy for IkT-148009 as a potential therapeutic option for patients," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "As we look ahead, we anticipate dosing the first patients in our Phase 2a study for IkT-148009 in Parkinson’s disease this quarter. This study will allow us to evaluate our selective c-Abl kinase inhibitor in Parkinson’s patients dosed for a 12-week period. In addition, we anticipate submitting our IND application for IkT-001Pro for stable phase Chronic Myelogenous Leukemia as well as report preclinical data from at least one study of IkT-148009 in Multiple Systems Atrophy in the second quarter. As we advance these programs forward, we will continue to be good stewards of capital to maximize shareholder value. We expect our current cash on hand to be sufficient to fund our operations into the third quarter of 2023."

Recent Developments and Upcoming Milestones:
Phase 2a clinical study for IkT-148009: Inhibikase anticipates dosing the first patients in its Phase 2a study of IkT-148009, known as the "201 Trial," in the second quarter. The trial will be a 3:1 randomized, double-blind, twelve-week dosing trial and will evaluate the safety and tolerability of three doses of IkT-148009 in up to 120 patients diagnosed with Parkinson’s disease who have not yet progressed to the need for symptomatic therapy. The trial will also measure a hierarchy of motor and non-motor function inside and outside of the brain as secondary endpoints and will evaluate whether treatment with IkT-148009 leads to a reduction or clearance of pathogenic alpha-synuclein aggregates as exploratory endpoints.

Hosted virtual investor event featuring Key Opinion Leaders in Parkinson’s disease: In April 2022, Inhibikase held a virtual investor event highlighting the Company’s clinical progress of IkT-148009, provided an overview of the current Phase 2 program and described the current unmet need and competitive landscape in Parkinson’s disease. A replay of the event can be accessed here.

Phase 1b study in clinical trial of IkT-148009: In March 2022, Inhibikase presented data from the first cohort of its Phase 1b study for IkT-148009 at the Alzheimer’s & Parkinson’s Diseases Conference (AD/PD). Data suggested that the safety and tolerability profile in patients closely matched that of older healthy volunteers. Pharmacokinetics of IkT-148009 in volunteers and subjects was also similar, further suggesting that the pharmacology of IkT-148009 is consistent across patient groups and penetrates the Central Nervous System. The Company expects to complete dosing of the second cohort of the Phase 1b study in the second quarter of 2022 and present additional data at a medical meeting later this year.

Investigational New Drug application (IND) for IkT-001Pro for stable-phase Chronic Myelogenous Leukemia (CML): In the first quarter of 2022, Inhibikase completed clinical batch manufacturing of its pill formulated IkT-001Pro, a prodrug formulation of imatinib mesylate. The Company is conducting the necessary stability studies for the IND submission package and expects to submit the IND application in the second quarter of 2022. Following clearance by the FDA, the Company expects to initiate bioequivalence studies in accordance with the 505(b)(2) regulatory pathway.

Preclinical studies evaluating IkT-148009 in animal models of Multiple System Atrophy (MSA): Inhibikase expects to report preclinical data evaluating IkT-148009 in at least one of two animal models of MSA in the second quarter of 2022. Depending on the preclinical results in animal models of MSA and subject to agreement with the FDA and equivalent regulatory bodies in the European Union, Inhibikase may advance IkT-148009 into a Phase 2a clinical study in the fourth quarter of 2022.
First Quarter 2022 Financial Results
Net Loss: Net loss for the quarter ended March 31, 2022, was $4.7 million, or $0.18 per share, compared to a net loss of $2.6 million, or $0.26 per share for the first quarter in 2021.

R&D Expenses: Research and development expenses were $3.0 million for the quarter ended March 31, 2022, compared to $2.4 million in the quarter ended March 31, 2021. The increase was driven by a $2.1 million increase in non-grant related research offset by a decrease of $1.2 million in grant related research expenditures and a decrease of $0.4 million in non-cash stock compensation expense. The non-grant related research was expended primarily in connection with the Company’s Phase I PD clinical trial.

SG&A Expenses Selling, general and administrative expenses for the quarter ended March 31, 2022 were $1.7 million compared to $1.6 million for the first quarter in 2021. The increase was primarily due to increased headcount resulting in increased compensation expense of $.2 million, increased legal fees, board fees, investor relation and consulting fees of $0.1 million and a net increase of $0.2 million for other normal operating expenses offset by decreased non-cash stock-based compensation expense of $0.4 million.

Cash Position: Cash and cash equivalents were $36.6 million as of March 31, 2022. The Company expects that existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the third quarter of 2023.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00am ET Tuesday, May 17, 2022. Participants should dial 877-407-4018 (United States) or 201-689-8471 (International) with the conference code 13729218. A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

On May 16, 2022 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company developing the next generation of therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported new preclinical data showing that silencing BRD4 with PH-894, a self-delivering RNAi INTASYL compound, can be used to improve the characteristics of CAR-T cell products during the activation and expansion phases of the cell manufacturing process (Press release, Phio Pharmaceuticals, MAY 16, 2022, View Source [SID1234614662]). These new data will be presented at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting, which is being held in Washington D.C., from May 16-19, 2022.

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"Hurdles that are faced with current CAR T-cell therapy treatment for solid tumors include cell persistence and cell exhaustion. Due to the immunosuppressive environment of the tumor, CAR T-cells may become exhausted, thereby limiting the efficacy of treatment for cancer patients," said Dr. Simon Fricker, Phio’s VP of Research and Development. "These data demonstrate that PH-894 could enhance the activity of CAR-T cells by improving the quality of the final CAR-T cell product by overcoming immunosuppression, reversing exhaustion, and preserving a phenotype associated with cell persistence. There is potential for PH-894 to play a role in boosting the potency of the next generation of CAR-T cell products to enhance adoptive cell therapy for solid tumors without using genetic manipulation."

Data from the studies conducted assessed the potential of PH-894 to improve the quality and potency of HER2-targeted CAR-T cells in a CAR-T expansion model. CAR-T cells were activated with an OKT3 antibody and treated with PH-894. Results showed that PH-894 reduced the expansion-associated production of BRD4 and BRD4-regulated genes and mitigated the production of inhibitory receptors and markers of T cell exhaustion, PD-1, TIGIT and TIM3. Additionally, PH-894 preserved putative T cell stem-cell memory and central memory, phenotypes associated with cell persistence, on HER2-CAR-T cells that were otherwise depleted by cell expansion without the use of PH-894.

Phio’s presentation detailing the data presented at ASGCT (Free ASGCT Whitepaper) titled, "Self-delivering RNAi Targeting BRD4 (PH-894) Improves the Phenotype of HER2-CAR-T Cells During Expansion" will be made available on the "Investors – Events and Presentations" section of the Company’s website (click here).

On May 16, 2022 Catamaran Bio, Inc., a biotechnology company developing off-the-shelf chimeric antigen receptor (CAR)-NK cell therapies to treat cancer, reported that it is presenting new preclinical data at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, being held in Washington, DC (Press release, Catamaran Bio, MAY 16, 2022, View Source [SID1234614678]). The data demonstrate successful engineering of CAR-NK cells to preserve and enhance NK cell activity in the immunosuppressive tumor microenvironment.

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"The ability to enable robust functioning of CAR-NK cells in the immunosuppressive solid tumor microenvironment will be critical to the success of cell therapies," said Vipin Suri, PhD, MBA, Chief Scientific Officer of Catamaran Bio. "We are presenting data on a TGFβ receptor that lacks an intracellular signaling domain and acts as a TGFβ trap, as well as proprietary next generation switch receptors that reconfigure inhibitory TGFβ signaling to be stimulatory. Both approaches lead to protection from TGFβ immunosuppression of CAR-NK cells as well as neighboring immune cells. The approaches we are presenting at ASGCT (Free ASGCT Whitepaper) are part of our innovative switch receptor platform which includes multiple strategies to convert other immunosuppressive signals into beneficial signals that stimulate and enhance the therapeutic activity of NK cells."

Highlights of the data presented on TGFβ switch receptors for CAR-NK cell therapies are as follows:

Abstract #313: Dominant Negative Receptor for TGFβ

A TGFβ dominant negative receptor (DNR) was shown to protect the function of both the engineered CAR‑NK cells and neighboring NK cells from the immunosuppressive effects of TGFβ.

CAR-NK cells engineered with this TGFβ DNR demonstrated reduction of downstream TGFβ activity as shown by >90% reduction of SMAD2 phosphorylation (a downstream signal of TGFβ activity) even at supraphysiological doses of TGFβ.
By acting as a sink, the TGFβ DNR also protected neighboring NK cells from immunosuppressive TGFβ signaling, resulting in approximately a 3-fold reduction in potency of TGFβ in inducing SMAD2 phosphorylation.
Co-expression of the TGFβ DNR with a HER2-CAR construct restored CAR-dependent cytotoxicity in the presence of TGFβ.
Abstract #331: Next Generation TGFβ Switch Receptors

Building on its success using TGFβ-DNRs to prevent immunosuppression, Catamaran also engineered synthetic receptors that effectively converted TGFβ signals into cell stimulatory signals.

A diverse set of switch receptors were engineered with a TGFβ receptor extracellular domain, coupled with various intracellular domains.
These proprietary next generation TGFβ switch receptors successfully reversed TGFβ-mediated inhibition, promoted NK cell expansion in vitro, and enhanced NK cell functional responses.
Chronic TGFβ stimulation strengthened NK cell tumor killing and target-induced cytokine secretion, and incorporation of the switch receptors also protected the cells from suppressive TGFβ signaling.

On May 16, 2022 RadNet, Inc., (NASDAQ: RDNT) reported that it has received FDA clearances for its DeepHeatlh Saige-DX mammography and Quantib Prostate 2.0 MRI artificial intelligence ("AI") algorithms (Press release, RadNet, MAY 16, 2022, View Source [SID1234614705]).

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Saige-DX: AI Mammography Diagnostic Software

Saige-Dx, a more advanced successor to our FDA approved Saige-Q worklist triage software, is a cancer detection tool that enables radiologists to more effectively detect the presence or absence of breast cancer with the use of artificial intelligence. DeepHealth’s powerful new AI technology automatically identifies suspicious lesions in mammograms and assigns a suspicion level to each finding and to the entire case. It helps detect and diagnose breast cancer earlier while reducing unnecessary recalls.

"In our study to support FDA clearance, all 18 radiologists who participated exhibited improved performance when using Saige-Dx, resulting in the largest increase in performance across all mammography AI products on the market to date. The improved performance was reflected in both an increase in the percentage of the cancers detected and a lower false positive rate when using Saige-Dx," said Bill Lotter, Ph.D., CTO, and co-founder of DeepHealth.

"Saige-Dx is built on our advanced deep-learning algorithms. Our highly accurate AI, as is described in a Nature Medicine article last year, showed the ability to find cancer one to two years earlier than fellowship-trained breast imaging radiologists. The approval of Saige-Dx represents another step forward in advancing cancer care. The feedback from physicians who have worked with our software tools is overwhelmingly positive, making them more accurate and efficient at interpreting mammography images," said Gregory Sorensen, M.D., CEO, and co-founder of DeepHealth.

Quantib Prostate 2.0: An AI Powered Solution for Prostate MRI Reading and Reporting

Quantib Prostate is an AI-based software solution that advances the MRI prostate reporting workflow and is accessible directly from the radiologist’s reading station. The solution comes with a suite of tools to improve reporting quality and speed, including AI-based segmentations and volumetry, PSA density calculation, precise registration and movement correction, one-click segmentation of lesion candidates, PI-RADS scoring support, and standardized reporting to facilitate easy and comprehensive communication of results. FDA 510k special clearance has been given for a major upgrade to the solution (from release 1.3) that now includes fully automatic prostate zone segmentation (in addition to prostate gland segmentation) and automated initiation of localization of lesions on the PI-RADS sector map.

"We are delighted to present this update of Quantib Prostate, including a selection of new features that our customers requested over the past few months. We seek to continuously improve our software to support radiologists and urologists in the best way possible, and we deliver updated solutions to our customers as quickly as possible," said Arthur Post Uiterweer, CEO of Quantib.

Dr. Howard Berger, President and Chief Executive Officer of RadNet, said, "We are very proud that two of our subsidiaries, DeepHealth and Quantib, have received FDA clearance for their flagship products. Artificial intelligence will have a transforming impact on radiology and cancer care, and we are committed to delivering those advances to patients and healthcare providers. These recent approvals will help us drive improved patient outcomes while lowering costs. The Biden administration, through its Cancer Moonshot program, is committed to significantly reducing the mortality rates from cancer in the coming decades. We believe that these AI tools will play an important role in the early detection and diagnosis of cancer, resulting in improved survival rates and better patient outcomes."