On August 29, 2022 RedCloud Bio (the "Company"), an innovative biotech company integrating structural pharmacology and computational approaches to advance small molecule drug discovery and development, reported that completion of the first patient dosing for its next-generation EGFR TKI H002 in its H002-101CN study (Press release, RedCloud Bio, AUG 29, 2022, View Source [SID1234618746]). The study is a multicenter phase I/IIa clinical trial in China for advanced NSCLC. H002 is a next-generation EGFR TKI discovered and developed by RedCloud Bio for treatment of prior EGFR TKI-resistant NSCLC, including those with C797S mutation.

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"Dosing of this first patient is an important clinical and scientific milestone in RedCloud Bio’s new drug development journey," said Dr. Mai-Jing Liao, CEO of RedCloud Bio. "Increasing use of third-generation EGFR TKI in both first-line and second-line EGFR mutation-positive NSCLC patients has been associated with a rise in resistance to third-generation EGFR TKI drugs – and is now a major unmet medical need for patients around the globe. Dr. Liao noted: "H002 has demonstrated in preclinical studies both strong and broad-spectrum activities against multiple EGFR mutation combinations, and high selectivity and safety profile. The drug candidate has great potential to treat prior EGFR-TKI resistant lung cancer patients, including those with brain metastases. RedCloud Bio is looking forward to bringing a much-needed precision medicine to advanced NSCLC patients worldwide."

Study Design

The H002-101CN Phase I/IIa clinical study consists of two parts: a dose-escalation component to assess the safety, tolerability, maximum tolerated dose, optimal biological effect dose or recommended phase II dose, pharmacokinetic parameters and preliminary antitumor activity of H002 monotherapy. A second segment includes dose expansion to assess antitumor activity, safety and pharmacokinetic parameters of H002 monotherapy at selected doses for NSCLC patients with defined mutations. This study will also monitor and evaluate multiple biomarkers to provide guidance for subsequent clinical trial design.

About H002

H002 is a fourth generation EGRF inhibitor discovered and developed by RedCloud Bio. In preclinical studies, the candidate has exhibited broad-spectrum potency and high selectivity against multiple EGFR mutations, including single point mutations (Del19 and L858R), double mutations (Del19/C797S, L858R/C797S, Del19/T790M and L858R/T790M); and triple mutations (Del19/T790M/C797S and L858R/T790M/ C797S). These studies also demonstrated that H0002 has durable antitumor activity and a desirable safety profile. H002 has shown potent anti-tumor activities in an EGFR-positive brain metastases model.

Phase I/IIa clinical studies for H002 in advanced NSCLC have been initiated in both US and China. RedCloud Bio plans to globally develop H002 as a next-generation EGFR kinase inhibitor to address the high unmet clinical needs for EGFR TKI resistant NSCLC.

On August 29, 2022 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the management team will participate in and attend one-on-one meetings at four investor conferences in September 2022 as follows (Press release, Gracell Biotechnologies, AUG 29, 2022, View Source [SID1234618745]):

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Wells Fargo Healthcare Conference 2022 (September 7 – 9, 2022)
Fireside Chat: September 7 at 9:45 a.m. ET
One-on-one meetings: Wednesday, September 7, 2022
Location: Boston, MA

Citi’s 17th Annual BioPharma Conference (September 6 – 8, 2022)
Panel Presentation: September 8 at 11:20 a.m. ET
One-on-one meetings: Thursday, September 8, 2022
Location: Boston, MA

H.C. Wainwright 24th Annual Global Investment Conference (September 12 – 16, 2022)
Presentation: September 12 at 3:30 p.m. ET
One-on-one meetings: Monday, September 12 & Friday, September 16, 2022
Location: New York, NY and Virtual

Cantor Call and Genetic Medicines Conference (September 15, 2022)
Panel Presentation: September 15 at 10:40 a.m. ET
One-on-one meetings: September 15, 2022
Location: New York, NY

Webcast of the presentations will be available on the News and Events section of Gracell’s investor website. A replay of the webcast will be available for 30 days following the event.

On August 29, 2022 Genomadix reported it has entered into a know-how license agreement and stock purchase agreement with Mayo Clinic to advance its point of care molecular analyzer technology (Press release, Mayo Clinic, AUG 29, 2022, View Source [SID1234618744]). The Genomadix CubeTM uses polymerase chain reaction (PCR) technology in a small and portable footprint to generate timely (one hour), accurate test results, expanding the reach beyond centralized labs.

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The Genomadix CubeTM testing system already delivers environmental testing for potentially deadly Legionella bacteria in water sources such as building cooling towers and CYP2C19 genotype guided antiplatelet therapy in Europe with efforts underway for US authorization. Additionally, a COVID-19 product has been developed with introduction slated (pending authorization) for later in 2022.

"We are extremely proud to be collaborating with Mayo Clinic to progress our technology and mission to make highly accurate molecular testing available for the benefit of patients. This collaboration seeks to seed new product developments with focused expertise provided by Mayo Clinic experts" commented Steve Edgett, Genomadix’s CEO

Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research.

On August 29, 2022 ZAP Surgical Systems, Inc. reported that Denver-based Neurosurgery One became the first provider in the Rocky Mountain region to treat patients using the ZAP-X Gyroscopic Radiosurgery platform (Press release, ZAP Surgical Systems, AUG 29, 2022, View Source [SID1234618743]). ZAP-X is the latest advancement in completely non-invasive brain tumor treatment and aims to set new standards in patient safety, comfort, convenience, and treatment accuracy. Neurosurgery One doctors are now performing stereotactic radiosurgery (SRS) using ZAP-X in an outpatient facility in the south Denver metro area of Littleton, Colorado.

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The first patient, a male in his 50s who has lived in Colorado for forty-five years, was treated for an acoustic neuroma (also known as vestibular schwannoma), a benign tumor of the nervous system. Acoustic neuromas are known to cause hearing loss, in addition to pain, dizziness and balance problems.

"As an electrical contractor with a passion for kiteboarding, windsurfing, skiing and foiling, I live a very active lifestyle, so maintaining my quality of life is extremely important," said Bill Lawson, the first ZAP-X patient treated at Neurosurgery One. "I am excited to be the first ZAP-X patient in Colorado. Knowing that I was treated by the most modern, cutting-edge technology with an excellent team behind the treatment is very rewarding."

"Our neurosurgeons have treated patients for decades with stereotactic radiosurgery as a precise non-surgical option for cranial conditions, including brain tumors, meningiomas, trigeminal neuralgia, and vestibular schwannomas," said Dr. J. Adair Prall, MD, FAANS, senior partner and CEO of Neurosurgery One in Denver. "Having the ZAP-X system now allows us to treat our patients with the latest SRS technology and provide world-class care in a convenient and easy-to-access location."

Stereotactic Radiosurgery is a well-established procedure to non-invasively treat many primary and metastatic brain tumors with high-intensity radiation, and often provides equivalent or superior clinical outcomes to surgery. When compared to historical whole brain radiotherapy (WBRT), which often requires many weeks of radiation treatment, SRS minimizes healthy brain tissue exposure and has demonstrated improved preservation of patient cognitive function.

"Unlike multi-purpose, full-body radiotherapy systems, ZAP-X was purpose-built without compromise for treating the brain with SRS," said Dr. Darlene Bugoci, radiation oncologist in Littleton. "This focused approach supports the clinical objective of reducing radiation exposure to healthy brain tissue and mitigating the risks of potential neuro-cognitive deficit and related complications."

Being the first and only "vault-free" radiation delivery technology, ZAP-X also eliminates the long-standing practice of prolonged patient isolation in a two-to-three-million-pound concrete bunker during treatment. This pioneering approach also now allows the clinical team, and in some instances, family members to be adjacent to the patient during treatment, with the goal of creating a more comfortable and confident patient experience.

On August 29, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conferences (Press release, Gilead Sciences, AUG 29, 2022, View Source [SID1234618742]):

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Wells Fargo Healthcare Conference on Thursday, September 8 at 10:25am Eastern Time

Morgan Stanley Annual Global Healthcare Conference on Tuesday, September 13 at 10:35am Eastern Time

Baird Global Healthcare Conference on Wednesday, September 14 at 9:40am Eastern Time

The live webcasts can be accessed at the company’s investors page at investors.gilead.com. The replays will be available for at least 30 days following the presentation.